Minneapolis-St. Paul, Minn. and New York, NY, August 22, 2018 – Calyxt, Inc. (NASDAQ: CLXT) and Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) announced today its Board of Directors has appointed Yves Ribeill, Ph.D., as Interim Chief Executive Officer, effective immediately. Dr. Ribeill replaces Federico Tripodi, who is leaving the Company to pursue other opportunities. Currently a member of Calyxt’s Board of Directors, Dr. Ribeill will work closely with the executive management team to promote the development of the Company’s products to benefit consumers, including the commercial launch of Calyxt’s high-oleic soybean oil.

In addition, the Board of Directors of Calyxt appointed Jonathan Fassberg, founder of the Trout Group and currently Co-Chief Executive Officer of Solebury Trout, as a member of the Board of Directors and a member of the Audit Committee.

“Given Yves’ extensive prior experience in healthcare, coupled with his strategic abilities, business development experience and broad network, the Board is confident he will bring the right combination of skills necessary to succeed during this pivotal period for Calyxt,” said Dr. André Choulika, Chairman of Calyxt’s Board of Directors. “The Company is making significant strides to develop healthy food products for consumers, and we expect Dr. Ribeill to solidify Calyxt’s position as a leader in the field.” Dr. Choulika added, “the Company would like to thank Mr. Tripodi for his service as CEO and wishes him the very best in his future endeavors”.

“Healthy eating and healthy living go hand-in-hand,” added Dr. Ribeill. “I strongly believe that Calyxt will play a vital role in keeping people healthy across the world, and the Company has enormous potential to create foods that exhibit healthy characteristics. At Calyxt, we have the unique opportunity to lead an important trend in agriculture towards creating healthier crops and food ingredients. We view it as our duty to address the health and nutrition concerns of today’s society by developing better, more nutritious foods for consumers.”

Yves Joseph Ribeill, Ph.D., founded SCYNEXIS, Inc (NASDAQ: SCYX) and served as President and CEO from 1999 to 2015. Dr. Ribeill has more than 35 years of experience in the healthcare industry, with an expertise in anti-infective diseases including bacterial, fungal, viral and parasiticidal and in microbiome-centric diseases. Prior to moving to the U.S. 21 years ago, Dr. Ribeill held several management positions during his international career with Rhône-Poulenc and Aventis in France and in the UK. Dr. Ribeill was a member of the Scientific Advisory Committee of the World Health Organization, the Medicines for Malaria Venture and is currently Vice Chairman of the Triangle Global Health Consortium in North Carolina.

Conference Call Details

Calyxt to hold a conference call for investors Wednesday, August 22, 2018 at 8:30a.m. ET – 7:30a.m. CT.

The live dial-in information for the conference call is:

US & Canada only: 877-407-9747

International: 412-902-0044

Replay Information

Conference ID #: 13673206

Replay Dial-In (Toll Free US & Canada): 877-660-6853

Replay Dial-In (International): 201-612-7415

Expiration Date: 9/5/18

Webcast URL (archived for 6 months):

https://78449.themediaframe.com/dataconf/productusers/clxt/mediaframe/26097/indexl.html

“Stefan’s deep medical expertise, strong track record of alliance- and relationship-building and previous C-level experience, all position him to make an immediate impact on the development and long-term strategic planning for Cellectis’ innovative product portfolio,” said Dr. André Choulika, Cellectis Chief Executive Officer. “As we continue to evolve our efforts to accelerate the access to patients of our off-the-shelf, gene-edited CAR T-cell product candidates, Stefan will be a key driver in the advancement of our product pipeline and programs overall.”

Dr. Scherer is a board-certified physician, bringing more than two decades of medical and scientific research and business experience from his time at various pharma and biotech companies to Cellectis. In his prior role as Head of Early Development, Strategy and Innovation for U.S. Oncology at Novartis, Stefan was responsible for the strategic direction and management of the Company’s immuno-oncology and targeted therapy portfolios. In addition, Stefan built a comprehensive clinical research alliance network and developed an immuno-oncology translational research team to harness scientific discovery for targeted patient outcomes.

Before Novartis, he served as Chief Medical Officer at Biocartis SA in Switzerland, where he was responsible for the medical development, marketing strategy and both business and academic partnerships. Prior to Biocartis, Dr. Scherer held key roles at F. Hoffman-La Roche / Genentech over the course of six years, as well as a number of other clinical and research roles of increasing responsibility.

"Given Cellectis’ powerful clinical momentum at this point in time, I am joining the Company at an exciting point in its evolution,” added Dr. Scherer. “I look forward to contributing my experience and expertise to further the development of Cellectis’ innovative CAR T product candidates that address what are truly some of the biggest health challenges of our time. I am also eager to work with my colleagues to advance the full potential of the Company’s unique technology for the benefit of patients and their families globally."

• FDA approves IND for UCART22 in B-ALL patients, which is the 3^rd allogeneic gene-edited CAR T-cell product candidate approved for clinical trials in the United States

• Allogene and Servier alliances to accelerate commercialization of allogeneic CAR T-Cell therapies

• $191M follow-on offering by Cellectis and $61M follow-on offering by Calyxt[1]

• Cash[2] position of $491M is expected to fund operations until 2022

New York, N.Y. – August 1st, 2018 – Cellectis S.A. (Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), today announced its results for the three-month period ended June 30, 2018 and for the six-month period ended June 30, 2018.

During the first half of 2018 Cellectis worked to speed up the clinical development of its allogeneic CAR T-cell product candidates. An amendment to the UCART123 Phase 1 protocol for AML enables the acceleration of the development of this product candidate. We received approval for our IND application for UCART22 in B-ALL and this UCART22 clinical trial is expected to start recruiting patients in the second half of this year. UCART22 is the third allogeneic CAR T-cell product candidate developed by Cellectis to enter the clinic. With the closing of our recent follow-on offering, we strengthened Cellectis’ shareholder base and secured financing for Cellectis to develop and manufacture more fully owned product candidates, to establish commercial capabilities, seek marketing approvals through the filing of one or more Biologics License Applications and pursue other critical milestones for one or more of our current product candidates. 

Second Quarter 2018 and Recent Highlights

UCART123

In May, the FDA approved an amendment to the protocol for the Phase 1 clinical trial of Cellectis’ UCART123 product candidate in patients with acute myeloid leukemia (AML). The amendment allows an immediate 4x increase of current dose level 1 from 6.25x10⁴ to 2.5x10⁵ UCART123 cells per kilogram and increases dose levels 2 and 3 to 6.25x10⁵ and 5.05x10⁶ UCART123 cells per kilogram, respectively. The treatment interval was shortened from 42 days to 28 days between the first 2 patients at each new dose tested (42 days only in case of aplastic bone marrow), and then to 14 days for the subsequent patients. The new protocol also allows for a potential second infusion of UCART123. The MD Anderson Cancer Center has been added as new clinical site for the AML study in addition to Weill Cornell Medical Center.

UCART22

In June, the FDA approved Cellectis’ Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for UCART22, Cellectis’ second wholly controlled TALEN® gene-edited product candidate, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL) in adult patients. UCART22 is the 3rd allogeneic, off-the-shelf, gene-edited CAR T-cell product candidate developed by Cellectis to be approved by the FDA for clinical trials in the United States. UCART22 is designed to target and kill CD22 expressing cells. Like CD19, CD22 is a cell surface antigen expressed from the pre-B-cell stage of development through mature B-cells and is expressed in more than 90% of patients with B-ALL. Approximately 85% of ALL cases involve precursor B-cells (B-ALL). Cellectis intends to begin the UCART22 Phase 1 study in the second half of 2018. The clinical research for UCART22 will be led by Dr. Nitin Jain, Assistant Professor, and Prof. Hagop Kantarjian, Chairman in the Department of Leukemia and University Chair in Cancer Medicine, at The University of Texas MD Anderson Cancer Center in Houston.

UCART19 and Corporate Collaboration

In April, Allogene Therapeutics, Inc. (“Allogene”), a new biotechnology company co-founded by Dr. Arie Belldegrun and Dr. David Chang, the former CEO and CMO of Kite Pharma, Inc., respectively, announced that it has entered into an asset contribution agreement with Pfizer, Inc. (“Pfizer”), pursuant to which Allogene purchased Pfizer’s portfolio of assets related to allogeneic CAR T-cell therapy, including the Research Collaboration and License Agreement dated June 17, 2014 (as amended from time to time, the “Collaboration Agreement”) signed between Pfizer and Cellectis. Cellectis remains eligible to receive clinical and commercial milestone payments of up to $2.8 billion, or $185 million per target for 15 targets, and tiered royalties in the high single digits on net sales of any products that are commercialized by Allogene under the Collaboration Agreement. As part of the transaction, Allogene has also received Pfizer’s rights to UCART19, which were sub-licensed to Pfizer by Les Laboratoires Servier (“Servier”), which has an exclusive license to UCART19 from Cellectis under the Product Development, Option, License and Commercialization Agreement between Servier and Cellectis dated as of February 17, 2014 (the “Servier Agreement”).

Capital raise

In April, Cellectis closed a follow-on offering of 6,146,000 American Depositary Shares (“ADS”) at a public offering price of $31.00 per ADS resulting in gross proceeds of $190.5 million. In May, Calyxt closed a follow-on offering of 4,057,500 ADS at a public offering price of $15.00 per ADS resulting in gross proceeds of $60.9 million. Cellectis purchased 550,000 shares of common stock at the public offering price of $15.00.

R&D

In June, Cellectis reported the publication of a study in Scientific Reports, a Nature Publishing Group journal, describing the development of the CubiCAR, an all-in-one Chimeric Antigen Receptor (CAR) architecture with an embedded multi-functional tag for purification, detection and elimination of CAR T-cells. This added versatility has the potential to streamline the manufacturing of CAR T-cells to allow their tracking and efficiently eliminate CAR T-cells in clinical settings.  This novel architecture was developed through a collaboration of Cellectis and Allogene researchers.

Academic Collaboration

In May, Cellectis and the Wyss Institute for Biologically Inspired Engineering at Harvard University announced that they will collaborate, utilizing Cellectis’ TALEN® gene editing technology, to advance the Wyss Institute’s efforts to recode the entire genome of cell lines derived from humans and other species under the global Genome Project-Write, led by Prof. George Church, Core Faculty member at the Wyss Institute, Professor of Genetics at Harvard Medical School (HMS) and of Health Sciences and Technology at Harvard and the Massachusetts Institute of Technology (MIT). The Recode Project, a part of Genome Project-Write, lays the technical foundation to extensively and functionally modify existing genomes in cells and whole organisms, and aims to convert them into research tools as well as clinical and biotechnological products. Under the collaboration with Cellectis, Prof. Church and his team will be given access to Cellectis’ TALEN® gene editing technology.

Financial Results

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).

Second quarter 2018 Financial Results

Cash: As of June 30, 2018 Cellectis had $491.1 million in total cash, cash equivalents and current financial assets compared to $282.1 million as of March 31, 2018. This increase of $209.0 million primarily reflects the net cash provided by financing activities of $230.9 million, including (i) the net proceeds, after deducting underwriting discounts and commissions and offering expenses, of $178.6 million from the Cellectis follow-on offering, (ii) the net proceeds, after deducting underwriting discounts, commissions and offering expenses and the purchase price with respect to 550,000 shares of Calyxt common stock purchased by Cellectis in the offering, of $48.8 million from Calyxt’s follow-on offering and (iii) the exercise of Cellectis and Calyxt stock options during the period for $5.1 million, partly offset by (i) the net cash flows used by operating activities of $12.5 million, (ii) the unrealized negative translation effect of exchange rate fluctuations on U.S. dollar cash, cash equivalents and current financial assets of $9.2 million.

We believe that our cash, cash equivalents and current financial assets of $491.1 million as of June 30, 2018 will be sufficient to fund our operations until 2022.

Revenues and Other Income: During the quarters ended June 30, 2017 and 2018, we recorded $9.0 million and $8.3 million, respectively, in revenues and other income. This decrease of $0.7 million is due to a $1.5 million decrease in collaboration revenues, of which $0.4 million represented decreased recognition of upfront fees already paid to Cellectis and $1.1 million represented a decrease in research and development cost reimbursements, partly offset by a $0.8 million increase in research tax credit.

Total Operating Expenses: Total operating expenses for the second quarter of 2017 were $28.8 million, compared to $30.0 million for the second quarter of 2018. The non-cash stock-based compensation expenses included in these amounts were $12.4 million and $9.1 million, respectively.

R&D Expenses: For the quarters ended June 30, 2017 and 2018, research and development expenses decreased by $0.6 million from $18.6 million in 2017 to $18.0 million in 2018. Personnel expenses decreased by $0.8 million from $9.2 million in 2017 to $8.4 million in 2018, primarily due to a $1.5 million decrease in non-cash stock based compensation expense partly offset by an increase of $0.7 million in wages and salaries. Purchases and external expenses increased by $1.1 million from $8.9 million in 2017 to $10.0 million in 2018, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials, expenses for process development and expenses associated with the use of laboratories and other facilities. Other expenses, which relate to continuing leases and other commitments, decreased by $0.9 million for the second quarter of 2018 compared to the second quarter of 2017.

SG&A Expenses: During the quarters ended June 30, 2017 and 2018, we recorded $10.0 million and $11.2 million, respectively, of selling, general and administrative expenses. The increase of $1.2 million primarily reflects an increase of $1.9 million in purchases and external expenses and an increase of $0.3 million in other expenses related to taxes, various depreciation and amortization, partly offset by a decrease of $1.0 million in personnel expenses from $7.9 million to $6.9 million. This decrease in personnel expenses was attributable to a decrease of $1.9 million in non-cash stock-based compensation expenses, partly offset by an increase of $0.9 million in wages and salaries.

Financial Gain (Loss): The financial gain is $12.0 million for the second quarter of 2018 compared with a financial loss of $6.7 million for the second quarter of 2017. The change in financial result was mainly attributable to a $19.7 million increase in net foreign exchange gain and a $1.7 million increase in interest income partly offset by a $2.7 million decrease of foreign exchange derivatives fair value adjustment.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the three-month period ended June 30 2017 and 2018, we recorded a net loss attributable to shareholders of Cellectis of $26.5 million (or $0.75 per share) and net loss attributable to shareholders of Cellectis of $7.3 million (or $0.17 per share), respectively. Adjusted net loss attributable to shareholders of Cellectis for the second quarter of 2017 was $14.1 million ($0.40 per share) compared to adjusted net income attributable to shareholders of Cellectis of $1.3 million ($0.03 per share), for the second quarter of 2018. Adjusted net income (loss) attributable to shareholders of Cellectis for the second quarter of 2017 and 2018 excludes non-cash stock-based compensation expenses of $12.4 million and $8.5 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.

Six-month period 2018 Financial Results

Cash: As of June 30, 2018 Cellectis had $491.1 million in total cash, cash equivalents and current financial assets compared to $297.0 million as of December 31, 2017. This increase of $194.1 primarily reflects the net cash provided by financing activities of $234.4 million, including (i) the net proceeds, after deducting underwriting discounts and commissions and offering expenses, of $178.6 million from the Cellectis follow-on offering, (ii) the net proceeds, after deducting underwriting discounts, commissions and offering expenses and the purchase price with respect to 550,000 shares of Calyxt common stock purchased by Cellectis in the offering, of $48.8 million from Calyxt’s follow-on offering, and (iii) the exercise of Cellectis and Calyxt stock options during the period for $8.4 million, partly offset by (i) the net cash flows used by operating activities of $32.5 million, (ii) the unrealized negative translation effect of exchange rate fluctuations on U.S. dollar cash, cash equivalents and current financial assets of $7.1 million and (iii) the net cash provided by investing activities of $0.7 million.

Revenues and Other Income: During the six-month period ended June 30, 2017 and 2018, we recorded $19.3 million and $16.4 million, respectively, in revenues and other income. This decrease of $2.9 million is mainly due to a $2.3 million decrease in collaboration revenues, which corresponds to a decrease in research and development cost reimbursements and a $0.7 million decrease in research tax credits, partly offset by a $0.1 million increase in other licenses revenue.  

Total Operating Expenses: Total operating expenses for the six-month period ended June 30, 2017 were $58.9 million, compared to $63.0 million for the six-month period ended June 30, 2018. The non-cash stock-based compensation expenses included in these amounts were $26.1 million and $21.0 million, respectively.

R&D Expenses: For the six-month periods ended June 30, 2017 and 2018, research and development expenses amounted to $38.2 million and $36.4 million, respectively. Personnel expenses decreased by $2.6 million from $19.7 million in 2017 to $17.1 million in 2018, primarily due to a $4.3 million decrease in non-cash stock-based compensation expense, partly offset by a $1.7 million increase in wages and salaries. Purchases and external expenses increased by $1.4 million from $17.5 million in 2017 to $18.9 million in 2018, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials, expenses related to process development and expenses associated with the use of laboratories and other facilities. Other expenses, which relate to continuing leasing and other commitments, decreased by $0.6 million for the six-month period ended June 30, 2018 compared to the corresponding period of 2017.

SG&A Expenses: During the six-month periods ended June 30, 2017 and 2018, we recorded $19.8 million and $25.2 million, respectively, of selling, general and administrative expenses. The increase of $5.5 million primarily reflects (i) an increase of $3.5 million in purchases and external expenses, (ii) an increase of $0.5 million in other expenses related to taxes, various depreciation and amortization and (iii) an increase of $1.5 million in personnel expenses from $15.5 million to $17.0 million, attributable to a $2.2 million increase in wages and salaries, partly offset by a $0.8 million decrease in non-cash stock based compensation expense.

Financial Gain (Loss): The financial result was a loss of $6.6 million for the six-month period ended June 30, 2017 compared with a financial gain of $10.0 million for the six-month period ended June 30, 2018. The change in financial result was mainly attributable to a $18.8 million increase in net foreign exchange gain and a $2.0 million increase in interest income, partly offset by a $3.8 million decrease of foreign exchange derivatives fair value adjustment and a $0.2 million decrease on net gain realized on the repositioning of instruments.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the six-month periods ended June 30, 2017 and 2018, we recorded a net loss attributable to shareholders of Cellectis of $46.2 million (or $1.30 per share) and a net loss attributable to shareholders of Cellectis of $32.4 million (or $0.83 per share), respectively. Adjusted net loss attributable to shareholders of Cellectis for the six-month period ended June 30, 2017 was $20.1 million ($0.57 per share) compared to adjusted net loss attributable to shareholders of Cellectis of $12.7 million ($0.32 per share) for the six-month period ended June 30, 2018. Adjusted net loss attributable to shareholders of Cellectis for the six-month periods ended June 30, 2017 and 2018 excludes a non-cash stock-based compensation expense of $26.1 million and $19.7 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.

At the meeting, during which more than 64% of voting rights were exercised, all the resolutions for which the management recommended a vote in favor, were adopted.

The resolutions adopted by Cellectis' shareholders included notably:

• Approval of the annual financial statements for the financial year ended December 31, 2017;
• Approval of the consolidated financial statements for the financial year ended December 31, 2017.
• Renewal of the term of office of Director of Mr. André Choulika, Mr. David Sourdive and Mr. Alain Godard;
• Renewal of the term office of Ernst & Young et Autres, and J.M.H. Conseil as Company’s Statutory Auditors.

The full results of the vote can be examined on the company’s website www.cellectis.com/en/investors/general-meetings/

June 12, 2018 – New York (N.Y.) – Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced the publication of a study in Scientific Reports, a Nature Publishing Group journal, describing the development of the CubiCAR, an all-in-one Chimeric Antigen Receptor (CAR) architecture with an embedded multi-functional tag for purification, detection and elimination of CAR T-cells. This added versatility has the potential to streamline the manufacturing of CAR T-cells to allow their tracking and efficiently eliminate CAR T-cells in clinical settings.

“The power and novelty of this technology lies in the integration of these multiple functions in one unique CAR molecule. To identify an optimal CAR architecture, we selected 15 different CAR constructs and evaluated their ability to enable T-cell depletion and promote tumor eradication,” said Julien Valton, Ph.D., Innovation Team Leader of Cellectis. “The development of this novel architecture was in collaboration with our colleagues at Allogene.”

“The CubiCAR architecture represents a major step forward in the development of CAR-T therapies in the treatment of various cancers,” added Philippe Duchateau, Ph.D., Chief Scientific Officer of Cellectis. “Not only is the CubiCAR architecture an integrated, compact safeguard allowing for the fast and efficient depletion of CAR T-cells, it is also compatible with multiple scFvs that are designed against different targets, which gives it the unique potential to make CAR T-cell immunotherapies safer.”

“The transformational impact of autologous CAR T therapy for the treatment of hematologic cancers has been firmly established. We plan to evaluate this CubiCAR approach and other novel CAR T engineering developed in partnership with our colleagues at Cellectis across our extensive CAR T pipeline,” said Barbra Sasu, Ph.D., Chief Scientific Officer of Allogene. “As we look to the future of allogeneic cell therapy, we can apply the scientific understanding gained from earlier therapies to the next wave of innovation to develop best-in-class allogeneic cell therapy.”

Julien Valton, Ph.D., Innovation Team Leader, Cellular Engineering & Adoptive CAR T-Cell Immunotherapy

Dr. Julien Valton obtained his Ph.D. at the University Joseph Fourier in Grenoble, France, where he was trained as an enzymologist. He then joined the Yale School of Medicine to apply his knowledge to therapeutic research by investigating the mechanism of inhibition of receptor tyrosine kinases that are involved in the development of gastrointestinal cancer. In 2009, he moved a step further into the field of applied science by joining the Innovation Department of Cellectis, where he actively participated in using and improving TALEN® gene editing technology for targeted gene therapy and genome engineering. He is now using TALEN® along with protein engineering techniques to develop the next-generation CAR T-cells to treat different malignancies.

A Versatile Safeguard for Chimeric Antigen Receptor T-Cell Immunotherapies

Julien Valton¹, Valerie Guyot², Bijan Boldajipour⁴, Cesar Sommer³, Thomas Pertel³ Alexandre Juillerat¹, Aymeric Duclert², Barbra Johnson Sasu³, Philippe Duchateau² and Laurent Poirot²

1 Cellectis, Inc., 430E, 29th Street, NYC, NY 10016, USA;

2 Cellectis S.A., 8 rue de la Croix Jarry, 75013 Paris, France;

3 Allogene Therapeutics, 270 Littlefield Ave., South San Francisco, CA 94080, USA;

4 Pfizer Inc., 230 E Grand Ave, South San Francisco, CA 94080, USA.

The notice convening the General Meeting states the detailed agenda and is available on the website of the Company:

http://www.cellectis.com/en/investors/general-meetings/

Shareholders, regardless of the number of shares they own, shall have the right to attend the meeting, be represented by a proxy or vote by mail.

The right to attend meetings shall be governed by all applicable laws and regulations and be conditional upon the registration, for accounting purposes, of the shares in the name of the shareholder or a designated intermediary on the second working day preceding the shareholders' meeting at midnight, Paris time, either in the registered share accounts kept by the Company or the bearer share accounts kept by the authorized intermediary.

Holders of registered ordinary shares shall not be required to meet any formality and shall be granted access upon proof of identity.

Holders of bearer ordinary shares must submit a certificate of participation, issued by their financial intermediary at least two working days before the date of the meeting.

It is recalled that, pursuant to the applicable law:

• the duly completed proxy form must be received by the Company's registered office or SGSS at least two days prior to the date of the meeting, i.e. no later than June 22, 2018.
• holders of bearer shares must add to their form a certificate of participation issued by the financial intermediary with whom their shares are deposited.

June 4, 2018 – New York (N.Y.) – Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced today that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for UCART22, Cellectis’ second wholly controlled TALEN® gene-edited product candidate, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL) in adult patients.

UCART22 is the 3^rd allogeneic, off-the-shelf, gene-edited CAR T-cell product candidate approved by the FDA for clinical trials in the U.S., following UCART19 (exclusively licensed to Servier and under joint development agreement between Servier and Allogene), and Cellectis’ UCART123. Cellectis intends to begin the UCART22 Phase 1 study in the second half of 2018. The research for UCART22 will be led by Dr. Nitin Jain, Assistant Professor, and Prof. Hagop Kantarjian, Chairman in the Department of Leukemia and University Chair in Cancer Medicine, at The University of Texas MD Anderson Cancer Center in Houston.

“The FDA’s approval of Cellectis’ UCART22 IND application for the treatment of B-ALL puts us one step closer to providing patients in need with a better access to an effective drug candidate for such a rare, devastating disease,” said Prof. Stéphane Depil, Senior Vice President, Research & Development, and Chief Medical Officer, Cellectis. “With this opportunity, Cellectis is well-positioned to further its work in the off-the-shelf gene-editing space, in the hope of helping patients to beat B-ALL in the near future.”

“Given that Cellectis is leading the allogeneic CAR-T approach across today’s medical landscape – first, with the FDA’s IND approval for UCART123 last year and now, with approval of UCART22 IND – we are eager to bring an innovative therapy to the market for patients who are suffering from B-ALL everywhere,” added Stephan Reynier, Chief Regulatory and Compliance Officer, Cellectis. “The bottom line is that patients are in dire need of effective, affordable and easily accessible treatments across the board, and our off-the-shelf product candidates aim to do just that.”

About UCART22

UCART22 is an allogeneic, off-the-shelf gene-edited T-cell product candidate designed for the treatment of B-ALL. Like CD19, CD22 is a cell surface antigen expressed from the pre-B-cell stage of development through mature B-cells. CD22 expression occurs in more than 90% of patients with B-ALL.[1]

UCART22 clinical trial is a Phase 1, open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART22 (allogeneic engineered T-cells expressing anti-CD22 chimeric antigen receptor) in patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia (B-ALL). Dose level 1 to be administered is 1x10⁵ UCART22 cells per kilogram. Dose levels 2 and 3 are respectively at 1x10⁶ and 5x10⁶.

ALL is a heterogeneous hematologic disease characterized by the proliferation of immature lymphoid cells in the bone marrow, peripheral blood, and other organs. It can start either with early B-cells or T-cells at different stages of maturity. The American Cancer Society’s estimates for acute lymphocytic leukemia (ALL) in the United States for 2018 (including both children and adults) are about 5,960 new cases of ALL and about 1,470 deaths from ALL. Approximately 85% of ALL cases involve precursor B-cells (B-ALL).

The manufacturing process of Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, non-alloreactive engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. Their production is industrialized with defined pharmaceutical release criteria.

Information about ongoing clinical trials is publicly available on dedicated websites, such as:

www.clinicaltrials.gov in the U.S.

www.clinicaltrialsregister.eu in Europe

Treatment interval shortens between patients from 42 days to 28 days, then to 14 days for subsequent patients

MD Anderson Cancer Center added as new clinical site for the AML study

May 22, 2018 – New York (N.Y.) – Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced today the approval of an amendment to the protocol for the Phase 1 clinical trial of Cellectis’ UCART123 product candidate in patients with acute myeloid leukemia (AML).

The main changes to the protocol include:

• Dose level 1 to be administered increases from 6.25x10⁴ to 2.5x10⁵ UCART123 cells per kilogram. Dose levels 2 and 3 are now respectively at 6.25x10⁵ and 5.05x10⁶. Dose level -1 is now at 1.25x10⁵. The product’s safety and tolerability profile allowed Cellectis to increase dose levels with a capping at 80kg equivalent.

• The dose limiting toxicities (DLT) observation period decreases from 42 to 28 days post-UCART123 infusion, except for patients with aplastic bone marrow at Day 28 for whom the DLT observation period remains 42 days.

• The time interval between the first and the second patient for UCART123 infusion at each new dose level tested shortens from 42 days to 28 days (42 days in case of aplastic anemia) then to 14 days for subsequent patients.

• A potential second UCART123 infusion is implemented.

In addition, a new AML clinical center has been opened at MD Anderson Cancer Center in Houston, Texas, aiming at increasing the patient enrollment pace. The study is led by Prof. Hagop Kantarjian, MD, Department Chair, Department of Leukemia, Division of Cancer Medicine, and Dr. Naveen Pemmaraju, MD, Assistant Professor, being Principal Investigator.

“This amendment approval for Cellectis’ UCART123 protocol is an important step in the progression of our study, and opening another clinical site at MD Anderson – one of the world’s most premier cancer centers – puts the Company on solid ground to help as many AML patients as possible with this innovative new therapy,” said Prof. Stéphane Depil, Senior Vice President, R&D, and Chief Medical Officer at Cellectis. “Off-the-shelf gene editing immunotherapy is continuing to revolutionize the landscape of modern medicine, and we hope that this approach leads to a lifesaving treatment for AML patients in the near future.”

“As Cellectis has been working very closely with the concerned parties to review the details of UCART123 study to date, we are eager to hit the ground running with the new protocol in an effort to find a truly effective treatment for AML patients with high unmet medical needs,” added Stéphan Reynier, Chief Regulatory and Compliance Officer at Cellectis. “We look forward to obtaining additional data so that we can address such a rare and devastating disease.”

The FDA review period for this protocol amendment has passed and Cellectis obtained IRB’s approval.

More information about this trial is available at ClinicalTrials.gov.

About UCART123 clinical trial

Our first wholly controlled product candidate, UCART123, is a gene edited T-cell investigational drug that targets CD123, an antigen expressed at the surface of leukemic cells in AML. Cellectis received in February 2017 an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to conduct Phase 1 clinical trial with UCART123 in patients with AML. This marks the first allogeneic, “off-the-shelf” gene-edited CAR T-cell product candidate that the FDA has approved for clinical trial.

UCART123 clinical trial in AML is a Phase 1, open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART123 (allogeneic engineered T-cells expressing anti-CD123 chimeric antigen receptor), administered in patients with relapsed/refractory AML, and patients with newly diagnosed high-risk AML.

The clinical research is coordinated by principal investigator Prof. Gail J. Roboz, MD, at Weill Cornell, Professor of Medicine at Weill Cornell Medicine and Director of the Clinical and Translational Leukemia Programs at Weill Cornell Medicine and NewYork-Presbyterian.

AML is a devastating clonal hematopoietic stem cell neoplasm that is characterized by uncontrolled proliferation and accumulation of leukemic blasts in bone marrow, peripheral blood and, occasionally, in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure and death. In the U.S. alone, there are in 2017 an estimated 21,000 new AML cases per year, with 10,000 estimated deaths per year.[1]

Calyxt is a consumer-centric food- and agriculture-focused company. As of closing, Cellectis owns approximately 70.6% of Calyxt’s outstanding shares of common stock.

Citigroup, Goldman Sachs & Co. LLC and Jefferies acted as book-running managers for the offering. Wells Fargo Securities acted as lead manager and BMO Capital Markets Corp. acted as co-manager.

A registration statement on Form S-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission and was declared effective on May 17, 2018. This offering was made only by means of a prospectus.  A copy of the prospectus may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by facsimile at (212) 902-9316, or by email at prospectus-ny@ny.email.gs.com; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340, or by e-mail at Prospectus_Department@Jefferies.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Calyxt is a consumer-centric food- and agriculture-focused company. Following the offering, Cellectis will own approximately 70.6% of Calyxt’s outstanding shares of common stock.

Citigroup, Goldman Sachs & Co. LLC and Jefferies are acting as book-running managers for the offering. Wells Fargo Securities is acting as lead manager and BMO Capital Markets Corp. is acting as co-manager.

A registration statement on Form S-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission and was declared effective on May 17, 2018. This offering will be made only by means of a prospectus. A copy of the prospectus may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by facsimile at (212) 902-9316, or by email at prospectus-ny@ny.email.gs.com; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340, or by e-mail at Prospectus_Department@Jefferies.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

In connection with the offering, Calyxt granted the underwriters a 30-day option to purchase up to an additional 457,500 shares of Calyxt’s common stock. The closing of the offering is expected to occur on May 22, 2018, subject to customary closing conditions.

Calyxt is a consumer-centric food- and agriculture-focused company. Following the offering, Cellectis will own approximately 71.6% of Calyxt’s outstanding shares of common stock.

Citigroup, Goldman Sachs & Co. LLC and Jefferies are acting as book-running managers for the offering. Wells Fargo Securities is acting as lead manager and BMO Capital Markets Corp. is acting as co-manager.

A registration statement on Form S-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission and was declared effective on May 17, 2018. This offering will be made only by means of a prospectus. A copy of the prospectus may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by facsimile at (212) 902-9316, or by email at prospectus-ny@ny.email.gs.com; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340, or by e-mail at Prospectus_Department@Jefferies.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Calyxt is a consumer-centric food- and agriculture-focused company. Cellectis owns approximately 79.1% of Calyxt’s outstanding shares of common stock.

Citigroup, Goldman Sachs & Co. LLC and Jefferies are acting as book-running managers for the proposed offering, Wells Fargo Securities is acting as lead manager and BMO Capital Markets is acting as co-manager.

This offering will be made only by means of a prospectus (included in the registration statement on Form S-1). A copy of the preliminary prospectus may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by facsimile at (212) 902-9316, or by email at prospectus-ny@ny.email.gs.com; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340, or by e-mail at Prospectus_Department@Jefferies.com.

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. The registration statement is available at www.sec.gov. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

• Universal CAR T-Cells Targeting CS1 (UCARTCS1) for the Treatment of Multiple Myeloma

Agnès Gouble¹, Roman Galetto¹, Rohit Mathur³, Stephanie Filipe¹, Isabelle Chion-Sotinel¹, Jing Yang³, Jin He³, Robert Z. Orlowski³, Sattva S. Neelapu³ and Julianne Smith²

¹Cellectis SA, 8 rue de la croix Jarry, 75013 Paris, France

²Cellectis, Inc., 430 East 29th Street, 10016 New York, NY

³Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030

Poster number: 130

Cancer - Targeted Gene & Cell Therapy I

Wednesday, May 16, 2018 at 5:30 PM - Stevens Salon C, D

• Repurposing endogenous immune pathways to improve chimeric antigen receptor T-cells potency

M. Sachdeva¹, B. Busser¹, S. Temburni¹, A. Juillerat¹, L. Poirot², P. Duchateau², J. Valton¹;

¹Cellectis, Inc., New York, NY

²Cellectis, Paris, France

Poster number: 774

Cell Therapies III

Friday, May 18, 2018 at 5:45 PM - Stevens Salon C, D

• Engineering CAR T-Cells with an Integrated off Switch to Enhance Safety Performance

Alexandre Juillerat¹, Diane Tkach¹, Brian W. Busser¹, Sonal Temburni¹, Julien Valton¹, Aymeric Duclert², Laurent Poirot² and Philippe Duchateau²

¹Cellectis, Inc., 430E, 29th Street, NYC, NY 10016

²Cellectis SA, 8 rue de la Croix Jarry, 75013 Paris, France

Poster number: 739

Cancer - Immunotherapy, Cancer Vaccines III

Friday, May 18, 2018 at 5:45 PM - Stevens Salon C, D

Presented by Allogene Therapeutics, Inc.:

• Cynomolgus macaque gene-edited CAR T-cell platform: towards a reliable in vivo allogeneic model to assess safety and Efficacy

Diego A. Vargas-Inchaustegui¹, Rory Dai¹, Alexandre Juillerat², Christopher Do¹, Kris Poulsen¹, Thomas Pertel¹, Barbra Sasu¹

¹Allogene Therapeutics, Inc., South San Francisco, CA,

²Cellectis, Inc., New York, NY

Poster number: 131

Cancer - Targeted Gene & Cell Therapy I

Wednesday, May 16, 2018 at 5:30 PM - Stevens Salon C, D

Abstracts are available on the ASGCT website. The 4 posters to be presented at the 2018 ASGCT Annual Meeting will be available on the Cellectis website after May 19, 2018.

• Allogene takes over Pfizer’s rights under the Research and License Agreement with Cellectis, to accelerate development and commercialization of allogeneic off-the-shelf UCART therapies

• Harvard’s Wyss Institute partners with Cellectis to recode the human genome using TALEN® gene editing technology

• Cash[1] position of $282 million as of March 31, 2018

• Cash position above $450 million after taking into consideration the $190.5 million total gross proceeds from its follow-on offering of ADSs

May 7, 2018 – New York (N.Y.) – Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced today its results for the three-month period ended March 31, 2018.

“2018 is off to a strong start for Cellectis and the message is clear – off-the-shelf, gene edited CAR T-cells are the next wave of innovation in oncology. As leaders and pioneers of this space, we continue to show our excellence, notably in manufacturing, which is a critical segment of the value chain, with the completion of the production of a 3^rd UCART product, UCART22, enabling the recent IND filing in ALL. We are also excited about the ongoing clinical development of UCART123 in high-risk AML and BPDCN patients, and we will aim to accelerate our clinical trial timelines. Finally, after close to 4 years of a rewarding and productive partnership with Pfizer, Cellectis is thrilled by the assumption of this partnership by Allogene Therapeutics, Inc., which is a new company that was formed by Dr. Arie Belldegrun and Dr. David Chang, former top executives of Kite Pharmaceuticals. We believe that our collaboration with Allogene opens a huge opportunity to accelerate the development of certain of our allogeneic CAR T-cells that were developed together with Pfizer and Servier,” said André Choulika, Chairman and Chief Executive Officer, Cellectis.

“Furthermore, we are humbled by our recent partnership with Prof. George Church and Harvard’s Wyss Institute, utilizing the TALEN^® gene editing technology in the Genome Recode Project—a project to recode the human genome and create the first ever virus-resistant human cells. This milestone project of modern biology will influence the future of gene editing in human science in this 21^st Century.”

RECENT CORPORATE HIGHLIGHTS

Cellectis - Therapeutics

IND filing for UCART22 in Acute Lymphoblastic Leukemia (ALL)

On May 2, 2018, Cellectis filed an IND with the FDA for its UCART22 product candidate to be investigated in a Phase I clinical trial in ALL patients. This submission marks the third UCART product candidate IND application.

Harvard’s Wyss Institute partnership on Human Recode Project, part of GP-Write

On May 1, 2018, Cellectis announced that the Recode Project, a part of Genome Project-Write, will use Cellectis’ TALEN® gene editing technology to seek to create the first virus-resistant human cells for manufacturing therapeutics and develop new cell-based therapies. The cell lines would be engineered to be able to carry out their normal functions while being resistant to debilitating viral infections, and could offer synthetic biologists opportunities for engineering entirely new functions.  The Recode Project is led by Prof. George Church, Core Faculty member at the Wyss Institute, Professor of Genetics at Harvard Medical School (HMS) and of Health Sciences and Technology at Harvard and the Massachusetts Institute of Technology (MIT).

Strategic collaboration with Allogene Therapeutics, Inc. 

On April 3, 2018, Pfizer, Inc. (“Pfizer”) and Allogene Therapeutics, Inc. (“Allogene”) entered into an asset contribution agreement, the closing of which was announced on April 9, 2018, pursuant to which Allogene purchased Pfizer’s portfolio of assets related to allogeneic CAR T-cell therapy (the “Asset Contribution Transaction”), including the Research Collaboration and License Agreement dated June 17, 2014 (as amended from time to time, the “Collaboration Agreement”) signed between Pfizer and Cellectis. Cellectis remains eligible to receive clinical and commercial milestone payments of up to $2.8 billion, or $185 million per target for 15 targets, and tiered royalties in the high single digits on net sales of any products that are commercialized by Allogene under the Collaboration Agreement. As part of the Asset Contribution Transaction, Allogene has received Pfizer’s rights to UCART19, which were sub-licensed to Pfizer by Les Laboratoires Servier (“Servier”), which has an exclusive license to UCART19 from Cellectis under the Product Development, Option, License and Commercialization Agreement between Servier and Cellectis dated as of February 17, 2014.

We believe that this alliance with Allogene’s dedicated team will lead to a strong acceleration of CAR T therapies.

$190.5 million raised in a follow-on offering

On April 10, 2018, Cellectis closed a follow-on offering of 5,646,000 American Depositary Shares, each representing one ordinary share of Cellectis (“ADS”), at a public offering price of $31.00 per ADS.

Cellectis today announced that on May 4, 2018, the underwriters partially exercised their option to purchase additional ADSs with respect to 500,000 additional ADSs (the “Option”), under the same terms and conditions as the initial offering completed on April 10, 2018 of 5,646,000

ADSs at a public offering price of $31.00 per ADS. The settlement-delivery of the Option is contemplated on May 11, 2018, subject to customary conditions.

The gross proceeds for the Option are $15.5 million, bringing the total gross proceeds for the follow-on offering, as increased by the Option, to $190.5 million, before deducting the expenses related to the offering and the underwriting discounts and commissions payable by Cellectis.

The ADSs are listed on the Nasdaq Global Market under the symbol “CLLS” and Cellectis’ ordinary shares are listed on the Euronext Growth market of Euronext in Paris under the symbol “ALCLS”.

The Company intends to use the net proceeds from this offering (i) to establish commercial capabilities, including a proprietary state-of-the-art gene-edited cell manufacturing plant for commercial supplies for its current proprietary immuno-oncology UCART product candidates, (ii) to fund the advancement of one additional UCART product candidate, (iii) to pursue new human therapeutics approaches based on its proprietary gene editing technology outside of oncology and (iv) for working capital and other general corporate purposes.

Elsy Boglioli Named Chief Operating Officer

Following the retirement of Dr. Mathieu Simon as Executive Vice President and Chief Operating Officer, Elsy Boglioli was named Chief Operating Officer in March 2018. Prior to assuming the COO role, Ms. Boglioli served as Executive Vice President, Strategy and Corporate Development. Ms. Boglioli joined Cellectis in December 2017 from The Boston Consulting Group (BCG), where she served as Partner and Managing Director, and leader of BCG’s biotech-focused business in Europe.

Conferences

American Association for Cancer Research (AACR) 2018 Annual Meeting

Cellectis and its academic partners presented at the AACR Annual Meeting held in Chicago in April 2018 three posters showcasing the Company’s allogeneic, off-the-shelf, CAR-T product candidates:

• • Repurposing endogenous immune pathways to improve chimeric antigen receptor T-cells potency;
  • Preclinical efficacy of allogeneic anti-CD123 CAR T-cells for the therapy of blastic plasmacytoid dendritic cell neoplasm (BPDCN); and
  • Prediction of immunotherapy outcome by multimodal assessment of minimal residual disease and persistence of allogeneic anti-CD123 CAR T-cells (UCART123) in pre-clinical models of acute myeloid leukemia.

European society for Blood and Marrow Transplantation (EBMT) 2018 Annual Meeting

Preliminary data from the UCART19 clinical trials were presented at the 44th EBMT Annual Meeting in March 2018 in Lisbon, Portugal. UCART19, which is exclusively licensed to Servier, is an investigational allogeneic anti-CD19 CAR T-cell product, being studied in adult and pediatric patients with relapsed or refractory (R/R) CD19-positive B-cell acute lymphoblastic leukemia (B-ALL). Servier is the sponsor of both clinical trials.

Calyxt, Inc. – Cellectis’ plant science subsidiary

As of March 31, 2018, Cellectis owned approximately 79.1% of Calyxt, Inc.’s outstanding common stock. Calyxt’s common stock is listed on the Nasdaq market under the ticker symbol “CLXT”. Please refer to Calyxt’s Q1 2018 Earnings Press Release and its quarterly report on Form 10-Q for the period ended March 31, 2018 for further information.

Financial Results

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).

First quarter 2018 Financial Results

Cash: As of March 31, 2018 Cellectis had $282.1 million in total cash, cash equivalents and current financial assets compared to $ 297.0 million as of December 31, 2017. This decrease of $14.9 million primarily reflects (i) the net cash flows used by operating activities of $20.0 million, (ii) the net cash flows provided by investing activities of $0.6 million, partially offset by (iii) the net cash flows provided by financing activities of $3.5 million due to the exercise of Cellectis and Calyxt stock options during the period and (iv) the unrealized positive translation effect of exchange rate fluctuations on U.S. dollar cash and cash equivalents and current financial assets of $2.2 million.

We believe that our cash, cash equivalents and current financial assets, together with the net proceeds from our follow-on offering will be sufficient to fund our operations through 2021.

Revenues and Other Income: During the three-month periods ended March 31, 2017 and 2018, we recorded $10.3 million and $8.1 million, respectively, in revenues and other income. This decrease of $2.2 million is mainly due to (i) a $0.8 million decrease in revenues under our collaboration agreements, of which a $1.1 million decrease relates to lower research and development cost reimbursements, partially offset by a $0.3 million increase in recognition of upfront fees already paid to Cellectis, (ii) a $0.1 million increase in other licenses revenue, and (iii) a $1.5 million decrease in research tax credits due to lower research and development purchases and external expenses during the period that are eligible for the tax credit.

Total Operating Expenses: Total operating expenses for the three-month period ended March 31, 2018 were $33.0 million, compared to $30.0 million for the three-month period ended March 31, 2017. The non-cash stock-based compensation expenses included in these amounts were $12.0 million and $13.6 million, respectively.

R&D Expenses: For the three-month periods ended March 31, 2017 and 2018, research and development expenses decreased by $1.2 million from $19.6 million in 2017 to $18.4 million in 2018. Personnel expenses decreased by $1.8 million from $10.4 million in 2017 to $8.7 million in 2018, primarily due to a $2.7 million decrease in non-cash stock based compensation expense, partly offset by a $0.9 million increase in wages and salaries. Purchases and external expenses increased by $0.2 million from $8.7 million in 2017 to $8.9 million in 2018, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials, process development and expenses associated with the use of laboratories and other facilities. Other expenses relate to continuing leasing and other commitments by $0.4 million.

SG&A Expenses: During the three-month periods ended March 31, 2017 and 2018, we recorded $9.7 million and $14.0 million, respectively, of selling, general and administrative expenses. The increase of $4.3 million primarily reflects (i) an increase of $2.5 million in personnel expenses from $7.7 million to $10.2 million, attributable to a $1.4 million increase in wages and salaries, a $1.1 million increase in non-cash stock based compensation expense, (ii) a $1.6 million increase in purchases and external expenses and (iii) a $0.2 million increase of other expenses relate to taxes, various depreciation and amortization and other commitments.

Financial Gain (Loss): The financial loss was de minimis for the three-month period ended March 31, 2017 compared with financial loss of $2.1 million for the three-month period ended March 31, 2018. The change in financial result was mainly attributable to (i) the decrease in net foreign exchange gain ($1.0 million), and (ii) the decrease of foreign exchange derivatives fair value ($1.1 million).

Net Income (Loss) Attributable to Shareholders of Cellectis: During the three-month periods ended March 31, 2017 and 2018, we recorded a net loss attributable to shareholders of Cellectis of $19.8 million (or $0.56 per share) and a net loss attributable to shareholders of Cellectis of $25.4 million (or $0.71 per share), respectively. Adjusted net loss attributable to shareholders of Cellectis for the three-month period ended March 31, 2018 was $14.2 million ($0.39 per share) compared to adjusted net loss attributable to shareholders of Cellectis of $6.2 million ($0.17 per share), for the three-month period ended March 31, 2017. Adjusted loss attributable to shareholders of Cellectis for the three-month periods ended March 31, 2018 and 2017 excludes a non-cash stock-based compensation expense of $11.3 million and $13.6 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.

May 2, 2018 – New York (N.Y.) – Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced today that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to initiate a Phase 1 clinical trial for UCART22, Cellectis’ second wholly controlled TALEN® gene-edited product candidate, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL) in adult patients.

Pending regulatory clearance, Cellectis plans to initiate a Phase I clinical trial in the third quarter of 2018. The clinical research will be led by Dr. Nitin Jain, Assistant Professor, and Prof. Hagop Kantarjian, Chairman in the Department of Leukemia and University Chair in Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston.

“This IND application for UCART22 is an important regulatory milestone for the Company,” said Stephan Reynier, Chief Regulatory and Compliance Officer, Cellectis. “The first ever FDA approval for a CAR T-cell therapy, directed against CD19, for pediatric and young patients with R/R B-ALL occurred in 2017. However, further CART approaches are needed, as some limitations of the CD19-CART treatment appear to be due to the expansion of CD19-negative leukemia clones.[1] The UCART22 product candidate will be evaluated in relapsed or refractory CD22 B-ALL, including relapses after CD19 CAR-T administration.”

Acute lymphoblastic leukemia (ALL) is a rapidly progressing form of leukemia that is characterized by the presence of a large number of immature white blood cells in the blood and bone marrow. In 2016, an estimated 6,590 new cases were diagnosed in the U.S., with over 1,400 deaths due to ALL.[2]  Approximately 85 percent of ALL cases involve precursor B-cells (B-ALL).

UCART22 is an allogeneic, off-the-shelf gene-edited T-cell product candidate designed for the treatment of B-ALL. Like CD19, CD22 is a cell surface antigen expressed from the pre B-cell stage of development through mature B-cells and CD22 expression occurs in more than 90 percent of patients with B-ALL.[3]

“Given the high unmet medical need for patients who suffer from B-ALL, filing the IND is the first vital step to potentially creating a treatment to be manufactured on an industrial scale, allowing these patients to get the help that they need much faster,” added Prof. Stéphane Depil, Senior Vice President Research & Development and Chief Medical Officer. “We are dedicated to making this a reality as soon as possible and look forward to hitting the ground running with the clinical trial once we obtain regulatory clearance.”

The manufacturing process of Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, non-alloreactive engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. Their production is industrialized with defined pharmaceutical release criteria. 

Information about ongoing clinical trials is publicly available on dedicated websites such as:

www.clinicaltrials.gov in the U.S.

www.clinicaltrialsregister.eu in Europe

and developing new cell-based therapies

May 1, 2018 – Boston (MA) & New York (N.Y.) – Today the Wyss Institute for Biologically Inspired Engineering at Harvard University and Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS) a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced that they will collaborate to further advance the Wyss Institute’s efforts to recode the entire genome of cell lines derived from humans and other species, and to develop new tools and methods facilitating this goal. The cell lines would be engineered to resist debilitating viral infections while carrying out their normal functions, or even perform entirely new functions.

The Recode project lays the technical foundation to extensively and functionally modify existing genomes in cells and whole organisms, and aims to convert them into research tools as well as clinical and biotechnological products.

The collaboration project was announced at the May 1 Genome Project-write 2018 Scientific Working Meeting, conducted by the Center of Excellence for Engineering Biology, as part of the first grand-scale, community-wide GP-write project to develop such ultra-safe cells.

Previously, the group of George Church, Core Faculty member at the Wyss Institute, Professor of Genetics at Harvard Medical School (HMS) and of Health Sciences and Technology at Harvard and the Massachusetts Institute of Technology (MIT), published on efforts to radically recode the bacterium E. coli’s genome. The researchers reduced the number of codons – the sequence units in the DNA that encode the amino acids the bacterium’s proteins are composed of – from 64 to 63. This caused the recoded bacteria to become resistant to most viruses and to be ‘biocontained’ in their intended laboratory environments since their survival can be linked to chemicals not found in the wild.

Building on these accomplishments, Church said, “the Recode project will create ultra-safe human cells that are resistant to infection with all viruses and prions. These cells and the technologies we are developing along the way will enable more effective ways to manufacture protein therapeutics, vaccines, cell therapies and transplantable organs.”

Under the collaboration with Cellectis, Church and his team will be given access to the company’s TALEN® gene editing technology. TALEN, short for transcription activator-like effector nucleases, are genome engineering enzymes that can introduce changes into the DNA code with high specificity and across an entire genome, and they can be multiplexed to make multiple changes at a time. “In the Recode project, our capabilities to edit genomes and invent new tools for high-level multiplexing of these efforts perfectly align with Cellectis’ expertise and strengths. Cellectis' TALEN gene editing technology will contribute much to the success of this project,” said Church.

All protein-coding DNA sequences in a cell’s genome consist of triplet codons containing three of the four basic nucleotide bases known in shorthand as A, T, G and C. In addition, the beginning of a protein-coding DNA sequence is signaled by a START codon and its end with a STOP codon to enable the appropriate translation of DNA into the proteins’ amino acid sequences. As most amino acids are redundantly encoded by two to six triplet codons, Church and his team seek to compress the codon usage for specific amino acids from six down to four codons.

To achieve this, the team will deploy sequence-tailored TALEN® enzymes to help modify codons at 400,000 locations across the protein-coding regions of the human genome. The lab can then delete the genes encoding the RNA molecules known as transfer RNAs that the cells previously required during their protein synthesis to add amino acids corresponding to the eliminated codons.

"We are looking forward to collaborating with the Wyss Institute and George Church’s group on this very exciting Recode project using Cellectis’ technology to recode the entire genome of human and other species cell lines, " said Dr. André Choulika, Chief Executive Officer of Cellectis. "The precision, the performance and the flexibility of TALEN® technology makes it the optimal gene editing platform for such a cutting-edge project."

This simplification of the protein-encoding portion of the genome can prevent viruses, which need the full repertoire of codons to produce their own proteins, from hijacking the host cells’ protein-synthesizing machinery. It will also allow researchers to re-purpose eliminated amino acid codons for the incorporation of nonstandard synthetic amino acids that can enable new protein functions and provide a reliable means for containing recoded cell lines in laboratory or industrial environments.

“The Recode project and partnership between synthetic biologists at the Wyss Institute and Cellectis represents a major new application area for genome engineering that could open up entirely new paths for prevention of infectious disease, as well as for biomanufacturing, organ transplantation, and regenerative medicine,” said Wyss Institute Founding Director Donald Ingber, M.D., Ph.D., who is also the Judah Folkman Professor of Vascular Biology at HMS and the Vascular Biology Program at Boston Children’s Hospital, as well as Professor of Bioengineering at the Harvard John A. Paulson School of Engineering and Applied Sciences.

April 16, 2018, 8:00 AM - 12:00 PM Central Time
Section 45

• Repurposing endogenous immune pathways to improve chimeric antigen receptor T-cells potency

M. Sachdeva¹, B. Busser¹, S. Temburni¹, A. Juillerat¹, L. Poirot², P. Duchateau², J. Valton¹;
¹Cellectis, New York, NY, ²Cellectis, Paris, France
 

April 16, 2018, 1:00 PM - 5:00 PM Central Time
Section 24

• Preclinical efficacy of allogeneic anti-CD123 CAR T-cells for the therapy of blastic plasmacytoid dendritic cell neoplasm (BPDCN)

T. Cai¹, K. L. Black², A. Naqvi², R. Galetto³, A. Gouble³, J. Smith⁴, A. Cavazos¹, L. Han¹, Q. Zhang¹, V. Kuruvilla¹, S. N. Sergej Konoplev¹, S. S. Neelapu¹, A. A. Lane⁵, M. L. Guzman⁶, H. Kantarjian¹, A. Thomas-Tikhonenko², N. Pemmaraju¹, M. Konopleva¹;
¹UT MD Anderson Cancer Ctr., Houston, TX, ²The Children's Hosp. of Philadelphia, Philadelphia, PA, ³Cellectis SA, Paris, France, ⁴Cellectis Inc, New York, NY, ⁵Dana-Farber Cancer Inst., Boston, MA, ⁶Weill Cornell Med. Coll., New York, NY

April 18, 2018, 8:00 AM - 12:00 PM Central Time
Section 31

• Prediction of immunotherapy outcome by multimodal assessment of minimal residual disease and persistence of allogeneic anti-CD123 CAR T-cells (UCART123) in pre-clinical models of acute myeloid leukemia

M. Sugita¹, N. Mencia-Trinchant¹, N. Ewing-Crystal¹, G. Suppa¹, R. Galetto², A. Gouble², J. Smith³, G. J. Roboz¹, D. C. Hassane¹, M. L. Guzman¹;
¹Weill Cornell Med., New York, NY, ²Cellectis SA, Paris, France, ³Cellectis Inc, New York, NY

Abstracts are available on the AACR website. The three posters to be presented at the 2018 AACR Annual Meeting will be available on the Cellectis website after April 18, 2018.

Goldman Sachs & Co. LLC, Citigroup and Barclays acted as book-running managers for the offering. Nomura acted as lead manager and Oppenheimer & Co. and Ladenburg Thalmann acted as co-managers.

A shelf registration statement on Form F-3 (including a prospectus) relating to Cellectis’ American Depositary Shares was filed with the Securities and Exchange Commission (the “SEC”) and has become effective. A copy of the prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526 or by email at prospectus-ny@ny.email.gs.com, Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146 or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at (888) 603-5847 or by email at barclaysprospectus@broadridge.com.   

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. In particular, no public offering of the ADSs will be made in Europe.

Special Note Regarding Forward-Looking Statements

This press release contains “forward-looking” statements that are based on our management’s current expectations and assumptions and on information currently available to management. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Further information on the risk factors that may affect company business and financial performance is included in Cellectis’ Annual Report on Form 20-F for the year ended December 31, 2017, and subsequent filings Cellectis makes with the SEC from time to time. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

South San Francisco, Calif., April 9, 2018 – Allogene Therapeutics, Inc. (Allogene) today announced the completion of the previously announced transaction between Pfizer Inc. (NYSE: PFE) and Allogene for Pfizer’s portfolio of assets related to allogeneic chimeric antigen receptor T cell (CAR T) therapy, an investigational immune cell therapy approach to treating cancer.

On April 3, 2018, Allogene and Pfizer announced that the companies had entered into a definitive asset contribution agreement for Pfizer’s allogeneic CAR T portfolio. As a result of the completed agreement, Allogene has received from Pfizer the rights to 16 preclinical CAR T assets licensed from Cellectis and Servier and one clinical asset licensed from Servier, UCART19, an allogeneic CAR T therapy that is being developed for treatment of CD19-­‐ expressing hematological malignancies. In partnership with Servier, UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I. UCART19 utilizes TALEN® gene editing technology pioneered and owned by Cellectis.

With the agreement completed, Allogene is well-­‐positioned to rapidly advance the portfolio of CAR T assets contributed by Pfizer into potential innovative new therapies, and ultimately to reach patients in need more quickly. “The completion of our agreement with Pfizer represents a bold undertaking by leaders in the field to expedite the development of the next wave of cancer immunotherapies,” said David Chang, M.D., Ph.D., President and Chief Executive Officer of Allogene.

Pfizer will continue to participate financially in the CAR T portfolio’s development through a 25 percent ownership stake in Allogene. Prior to the agreement completion, Gilead Sciences joined Allogene’s premier Series A investment consortium that already included TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer, and Pfizer, among others.

Centerview Partners acted as financial advisor to Pfizer, with Ropes & Gray LLP acting as its legal advisor. Cooley LLP served as legal counsel to Allogene, Vida Venture and TPG. Gibson Dunn & Crutcher LLP also served as legal counsel to TPG.

Goldman Sachs & Co. LLC, Citigroup and Barclays are acting as book-running managers for the offering. Nomura is acting as lead manager and Oppenheimer & Co. and Ladenburg Thalmann are acting as co-managers.

A shelf registration statement on Form F-3 (including a prospectus) relating to Cellectis’ American Depositary Shares was filed with the Securities and Exchange Commission (the “SEC”) and has become effective. Before purchasing American Depositary Shares in the offering, you should read the prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein.  You may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov.  Alternatively, a copy of the prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526 or by email at prospectus-ny@ny.email.gs.com, Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146 or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at (888) 603-5847 or by email at barclaysprospectus@broadridge.com.   

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. In particular, no public offering of the ADSs will be made in Europe.

Special Note Regarding Forward-Looking Statements

This press release contains “forward-looking” statements that are based on our management’s current expectations and assumptions and on information currently available to management. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Further information on the risk factors that may affect company business and financial performance is included in Cellectis’ Annual Report on Form 20-F for the year ended December 31, 2017, and subsequent filings Cellectis makes with the SEC from time to time. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Goldman Sachs & Co. LLC and Citigroup are acting as book-running managers for the offering. Barclays is also acting as a book-running manager.  Nomura is acting as lead manager and Oppenheimer & Co. and Ladenburg Thalmann are acting as co-managers.

A shelf registration statement on Form F-3 (including a prospectus) relating to Cellectis’ American Depositary Shares was filed with the Securities and Exchange Commission (the “SEC”) and has become effective. Before purchasing American Depositary Shares in the offering, you should read the preliminary prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. You may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the preliminary prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526 or by email at prospectus-ny@ny.email.gs.com, Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146 or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at (888) 603-5847 or by email at barclaysprospectus@broadridge.com.  

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. In particular, no public offering of the ADSs will be made in Europe.

Special Note Regarding Forward-Looking Statements

This press release contains “forward-looking” statements that are based on our management’s current expectations and assumptions and on information currently available to management. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Further information on the risk factors that may affect company business and financial performance is included in Cellectis’ Annual Report on Form 20-F for the year ended December 31, 2017, and subsequent filings Cellectis makes with the SEC from time to time. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

April 3, 2018 – New York (N.Y.) – Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), and Allogene Therapeutics, Inc. (Allogene), a biotechnology company focused on the rapid advancement of allogeneic CAR T therapies targeting blood cancers and solid tumors, announced today that Allogene intends to assume from Pfizer the global strategic collaboration to develop “off-the-shelf” CAR T immunotherapies for oncology. This agreement was initially formed with Cellectis in June 2014.

Earlier today, Allogene and Pfizer announced that the two companies have entered into an asset contribution agreement for Pfizer’s allogeneic CAR T-cell therapy portfolio, which includes 16 preclinical assets and UCART19. Subject to certain closing conditions, Allogene will assume the strategic collaboration and license agreement with Cellectis, with exclusive rights to develop and commercialize previously defined allogeneic UCART programs directed at select targets. Cellectis will remain eligible to receive clinical and commercial milestone payments of up to $2.8 billion, or $185 million per target for 15 targets and tiered royalties in the high single digits on net sales of any products that are commercialized by Allogene under the agreement. This new alliance, with Allogene’s dedicated team, is expected to lead to a strong acceleration of CAR T therapies.

Allogene, co-founded and led by former executives of Kite Pharma, is well-positioned to catalyze the next revolution in cell therapy with its leaders’ unrivaled experience in the clinical development of autologous CAR T therapy. Arie Belldegrun M.D., FACS, Founder and former Chairman, President and Chief Executive Officer of Kite, will serve as Executive Chairman of Allogene, and David Chang, M.D., Ph.D., former Executive Vice President, Research and Development and Chief Medical Officer of Kite, will serve as President and Chief Executive Officer of Allogene. 

Cellectis’ CAR T platform provides a proprietary, allogeneic approach that uses engineered T-cells from a healthy donor for use in multiple patients. This is distinct from autologous approaches that use a patient’s own T-cells to target tumor cells.

“Allogeneic represents the next transformative step in medicine, as it will potentially allow patients all over the world to quickly receive these potentially life-saving therapies in the most efficient and cost-effective way possible. The last four years of partnership with Pfizer have been very rewarding and productive. Pfizer was among the early adopters of the allogeneic approach, seeing that gene-edited CART programs are the future of immunotherapy to treat cancer. We sincerely thank everyone involved in this collaboration, from the top management to the scientists, for their foresight and their belief in our common portfolio,” said Dr. André Choulika, Ph.D., Cellectis’ Chairman & Chief Executive Officer. “We strongly believe Allogene, together with Cellectis, will from the best possible team to continue this collaboration. Our expertise in allogeneic CART and gene-editing combined with the leadership of Drs. Arie Belldegrun and David Chang and their exemplary track record and execution in cell therapy paves the way for the future in off-the-shelf products enhanced by gene editing.”

“We have built mutual trust and respect over the years in the CAR T industry and this collaboration will be the starting point for a long-term partnership,” said David Chang, M.D., Ph.D., President and Chief Executive Officer of Allogene. “Our mission at Allogene is to catalyze the next revolution in cancer treatment through the development of allogeneic CAR T therapies directed at blood cancers as well as solid tumors. We believe this collaboration fuels our mission and we look forward to partnering with Cellectis to accelerate the development of allogeneic cell therapies.”

“Dr. Simon has been incredibly instrumental in the strategic and operational direction of the therapeutic activities at Cellectis. Among his many achievements during his tenure, Dr. Simon helped to fundamentally transform Cellectis from a research-oriented biotech company to a clinical-stage biopharma player. I warmly thank him for his service,” said Dr. Choulika, Cellectis Chief Executive Officer. “I look forward to Elsy Boglioli’s leadership as our new Chief Operating Officer as we enter the next phase of the Company’s development.”

Dr. Mathieu Simon has served as Cellectis’ Executive Vice President since 2012 and as Chief Operating Officer since 2013. He was a member of Cellectis’ board of directors as well.

“I am truly proud of our achievements at Cellectis over the last six years, including building a solid product candidate portfolio, advancing two allogeneic product candidates developed by Cellectis into the clinic and working strategically alongside our collaboration partners. It has been a great privilege to serve Cellectis and I am now ready to retire with enthusiasm for the Company’s future, confidence in the work that the Cellectis management team will continue, and gratitude for the many colleagues I have had the great pleasure to work with,” said Dr. Mathieu Simon. “I am delighted with Elsy Boglioli’s appointment as COO. Elsy brings a wealth of biopharmaceutical industry experience, having worked with leading pharmaceutical companies. Her unique blend of capabilities, relationships, and expertise will be invaluable assets to Cellectis.”

• GMP manufacturing of UCART22, representing already the third allogeneic, off-the-shelf, TALEN® gene-edited CAR T-Cell campaign after UCART19 and UCART123

• UCART123 patient enrolment resumed in December for both Ph1 trials in acute myeloid leukemia (AML) and in blastic plasmacytoid dendritic cell neoplasm (BPDCN), following the lift of the clinical hold by the FDA in November 2017

• High multiplexed gene editing efficiency presented using TALEN® in T-Cells with simultaneous double knock-out and double knock-in achieved at 68.1%

• Nasdaq IPO of Calyxt in July, with gross proceeds of $64.4 million to Calyxt; Cellectis retains 79.3% ownership as of February 28, 2018.

• Cash[1] position of $297 million as of December 31, 2017, compared to $291 million as of December 31, 2016

March 12, 2018 – New York (N.Y.) –(Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced today its results for the three-month period ended December 31, 2017 and for the year ended December 31, 2017.

“I would like to highlight what remarkable progress we made in 2017, by transforming the off-the-shelf CAR T-cell concept into reality. I believe I can say without a doubt that we have only just scratched the surface of what a powerful treatment CAR T-cell therapy represents. 2018 will be a turning point for Cellectis, extending our lead in the allogeneic CAR T-cell field,” said André Choulika, Chairman and Chief Executive Officer, Cellectis.

Earnings Call Details

Cellectis to hold a conference call for investors on Tuesday, March 13, 2018 at 8 a.m. EDT – 1 p.m. Paris Time. The call will include the company's fourth quarter 2017 and year-end financial results.

The live dial-in information for the conference call is:

US & Canada only: 877-407-3104

International: 201-493-6792

In addition, a replay of the call will be available for 6 months following the conference by calling 877-660-6853 (Toll Free US & Canada); 201-612-7415 (Toll Free International).

The archived webcast of this event will be available archived for 6 months:

https://78449.themediaframe.com/dataconf/productusers/clls/mediaframe/23530/indexl.html

Cellectis - Therapeutics

UCART19: TALEN® gene-edited, allogeneic CAR T-Cell product candidate in ALL patients, exclusively licensed to Servier

Intermediary results from the two Phase I clinical trials of UCART19 were presented by Servier at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta. UCART19 is an investigational allogeneic anti-CD19 CAR T-cell product candidate, used in adult and pediatric patients with relapsed or refractory (R/R) CD19-positive B-cell acute lymphoblastic leukemia (B-ALL). These first-in-human data demonstrated the safety and tolerability of UCART19, resulting in an 83% complete remission rate across the adult and pediatric patient populations at day 28 post CAR T-cell infusion. Our commercial partner Servier is currently expanding the UCART19 clinical studies in multiple centers in the U.S. and Europe and we are expecting further clinical updates by year-end 2018.

Additional results from the two Phase I clinical trials with UCART19 will be presented on March 21, 2018 during the European society for Blood and Marrow Transplantation (EBMT) Annual Meeting to be held in Lisbon, Portugal.

Successful GMP manufacturing of UCART22, representing already the third allogeneic, off-the-shelf, TALEN® gene-edited CAR T-cell campaign after UCART19 and UCART123

UCART22 is currently in GMP manufacturing, expected to yield clinical supplies for the planned Ph1 study in ALL patients. Pending the completion of the manufacturing campaign, Cellectis plans to file an Investigational New Drug (IND) application in the first half of 2018. The UCART22 manufacturing campaign represents already the third consecutive manufacturing campaign of a TALEN® gene-edited CAR T-cell campaign after UCART19 and UCART123, positioning Cellectis as a leader in the allogeneic, off-the-shelf CAR T-cell space.

UCART123: Cellectis’ TALEN® gene-edited, allogeneic CAR T product candidate in AML and BPDCN Patients

In December 2017, patient enrollment has resumed in both Phase I clinical trials of UCART123 in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). On November 6, 2017, Cellectis announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on both Phase I trials of UCART123. In connection with the lifting of the clinical hold, Cellectis agreed with the FDA to certain revisions to be implemented in Phase I UCART123 protocols.

Corporate

Cellectis announced on December 4, 2017 the appointments of Ms. Elsy Boglioli to the role of Executive Vice President, Strategy and Corporate Development, and Prof. Stéphane Depil, MD, PhD, to the role of Senior Vice President Research & Development and Chief Medical Officer. Ms. Boglioli’s responsibilities include directing the long-term strategy and current business priorities of Cellectis to ensure that the overall mission of the Company is fulfilled. Ms. Boglioli joins Cellectis from Boston Consulting Group (BCG), where she served as Partner and Managing Director, and leader of BCG’s biotech-focused business in Europe. Prof. Depil’s responsibilities include bringing Cellectis' product candidates to clinical-stage development, strategic and operational management of all therapeutic activities, and supervising research and development projects for the Company. Prof. Depil continues his academic and research activities as adjunct Professor at Léon Bérard Cancer Center & University Claude Bernard in Lyon, France.

Scientific Publications

A poster has been presented at the Keystone Conference in February 2018, showcasing the high gene-editing efficiency of TALEN®. A T-cell was edited using TALEN®, to knock out the TCR alpha and beta chain, knock out the B2M molecule, knock in the CAR construct and knock in an NK cell inhibitor. This simultaneous double knock out and double knock in resulted at a 68.1% efficiency.

A study has been published in November 2017 in Molecular Therapy — Nucleic Acids describing the educated engineering of highly specific and efficient TAL nucleases (TALEN®) targeting PD1, a key T-cell immune checkpoint.

Upcoming Investor Conferences

Cellectis will participate in Oppenheimer’s 28th Annual Healthcare Conference & Sachs BioCapital USA Forum both on March 21 in New York, and Guggenheim Conference on Disruptive Technologies in Immuno-Oncology on March 27, 2018 in New York.

Calyxt

On December 12, 2017 Calyxt signed a partnership with Farmer’s Business Network, Inc (FBN^SM), the independent farmer-to-farmer network, to expand the distribution and grower base of Calyxt’s identity-preserved high oleic soybeans in the upper Midwest region, including South Dakota and Minnesota. This new partnership enables FBN Direct^TM to distribute Calyxt’s identity-preserved high oleic soybean seeds to growers in its network.

Calyxt announced on March 1, 2018 having contracted over 10,000 acres with 50 farmers in the Midwest. Overall, these growers collectively farm over 100,000 acres, half of which are expected to produce soybeans. Twenty percent of the soybeans that are anticipated to be planted consist of Calyxt’s high-oleic variety.

Corporate

Initial Public Offering: On July 25, 2017, Calyxt completed an initial public offering of its common stock, selling an aggregate of 8,050,000 shares of common stock at a price of $8.00 per share (including 1,050,000 shares of common stock pursuant to the exercise by the underwriters of their option to purchase additional shares). Calyxt received net proceeds of approximately $58.0 million, after deducting underwriting discounts and commissions and offering expenses. As part of the IPO, Cellectis purchased 2,500,000 shares of common stock for a value of $20.0 million, which is included in the net proceeds that Calyxt received. Calyxt used $5.7 million of the proceeds to cover a portion of the outstanding obligations owed to Cellectis. As of February 28, 2018, Cellectis owns 79.3% of the outstanding Calyxt’s common shares.

Financial Results

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).

Effective in the third quarter of 2017, Cellectis changed the presentation currency of its consolidated financial statements from the euro to the U.S. dollar, in order to enhance comparability with peers, which present their financial statements primarily in U.S. dollar.

Fourth quarter 2017 Financial Results

Cash: As of December 31, 2017, Cellectis had $297.0 million in total cash, cash equivalents and current financial assets compared to $304.1 million as of September 30, 2017. This decrease of $7.1 million reflects (i), the net cash flows used by operating activities of $9.5 million and (ii) net cash provided by investing activities of $0.5 million, partially offset by (iii) the unrealized positive translation effect of exchange rate fluctuations on U.S. dollar cash, cash equivalents and current financial assets of $2.0 million and (iv) net cash flows provided by financing activities of $0.9 due to the exercise of Cellectis warrants and stock options during the period.

Cellectis expects that its cash, cash equivalents and current financial assets of $297.0 million as of December 31, 2017 will be sufficient to fund its current operations into 2020.

Revenues and Other Income: During the quarters ended December 31, 2016 and 2017, we recorded $13.0 million and $6.9 million, respectively, in revenues and other income. This decrease of $6.1 million is mainly due to (i) a $2.4 million decrease in collaboration revenues of which $1.4 million represented decreased recognition of upfront already paid to Cellectis and a $1.0 million decrease in research and development cost reimbursements, (ii) a $0.1 million decrease in license revenue, (iii) a $2.2 million decrease in research credit tax and (iv) a $1.4 million decrease in subsidies and other revenues.

Total Operating Expenses: Total operating expenses for the fourth quarter of 2017 were $34.7 million, compared to $33.3 million for the fourth quarter of 2016. The non-cash stock-based compensation expenses included in these amounts were $10.8 million and $14.1 million, respectively.

R&D Expenses: For the quarters ended December 31, 2016 and 2017, research and development expenses increased by $0.6 million from $20.2 million in 2016 to $20.7 million in 2017. Personnel expenses decreased by $2.5 million from $12.5 million in 2016 to $10.0 million in 2017, primarily due to a $2.8 million decrease in non-cash stock based compensation expense and a $0.8 million decrease in social charges on stock options grants, partly offset by a $1.1 million increase in wages and salaries. Purchases and external expenses increased by $2.4 million from $7.0 million in 2016 to $9.3 million in 2017, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials, expenses related to process development and expenses associated with the use of laboratories and other facilities. Other expenses increased by $0.7 million for the fourth quarter of 2017 compared to the fourth quarter of 2016, mainly driven by impairment of assets in 2017 related to the Montvale site ($0.8 million).

SG&A Expenses: During the quarters ended December 31, 2016 and 2017, we recorded $12.3 million and $13.0 million, respectively, of selling, general and administrative expenses. The increase of $0.7 million primarily reflects an increase of $0.9 million in purchases and external expenses, and is partially offset by (i) a $0.1 million decrease in personnel expenses from $9.6 million to $9.5 million, attributable, among other things, to a $0.5 million decrease in social charges on stock options grants partially offset by a $0.3 increase in wages and salaries and an increase of $0.1 million in non-cash stock-based compensation expense, and (ii) a $0.1 million decrease in other expenses.

Financial Gain (Loss): The financial gain was $6.9 million for the fourth quarter of 2016 compared with a financial loss of $1.0 million for the fourth quarter of 2017. The change in financial result was primarily attributable to an increase in net foreign exchange loss of $9.7 million due to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts, partially offset by an increase of $1.5 million in fair value adjustment income on our foreign exchange derivatives and current financial assets and an increase of $0.3 million in interest income.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the three months ended December 31, 2016 and 2017, we recorded a net loss attributable to shareholders of Cellectis of $13.5 million (or $0.38 per share) and net loss attributable to shareholders of Cellectis of $27.2 million (or $0.76 per share), respectively. Adjusted net loss attributable to shareholders of Cellectis for the fourth quarter of 2017 was $16.4 million ($0.46 per share) compared to adjusted net income attributable to shareholders of Cellectis of $0.6 million ($0.02 per share), for the fourth quarter of 2016. Adjusted net income (loss) attributable to shareholders of Cellectis for the fourth quarter of 2017 and 2016 excludes non-cash stock-based compensation expense of $10.8 million and $14.1 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted income (loss) attributable to shareholders of Cellectis.

Full year 2017 Financial Results

Cash: As of December 31, 2017 Cellectis had $297.0 million in total cash, cash equivalents and current financial assets compared to $ 291.2 million as of December 31, 2016. This increase of $5.8 million primarily reflects (i) the proceeds of $38.0 million in the Calyxt IPO, (ii) the net cash provided by investing activities of $1.8 million, including $7.0 million of proceeds from Calyxt’s sale leaseback transaction, and (iii) the unrealized positive translation effect of exchange rate fluctuations on U.S. dollar cash, cash equivalents and current financial assets of $15.1 million, partially offset by net cash flows used by operating activities of $52.3 million.

Revenues and Other Income: During the years ended December 31, 2016 and 2017, we recorded $56.4 million and $33.7 million, respectively, in revenues and other income. This decrease of $22.7 million is mainly due to (i) a $19.1 million decrease in collaboration revenues, of which $8.5 million represents one-time milestone revenue received during the second quarter of 2016 with the first patient dosed in the Phase I clinical trial for UCART19, $6.0 million represents decreased recognition of upfront fees already paid to Cellectis, $1.9 million represents decreased research and development cost reimbursements and $2.8 million represents decreased revenue from payments by Servier for the supply of raw materials and batches of UCART19 products, partially offset by the increase of $0.1 million in other services and products provided to Pfizer, and (ii) a $0.5 million decrease in other licenses revenue, (iii) a $1.7 million decrease in research tax credits, and (iv) a $1.4 million decrease in subsidies and other revenues.

Total Operating Expenses: Total operating expenses for the year ended December 31, 2017 were $126.4 million, compared to $123.7 million for the year ended December 31, 2016. The non-cash stock-based compensation expenses included in these amounts were $48.9 million and $58.6 million, respectively.

R&D Expenses: For the years ended December 31, 2016 and 2017, research and development expenses increased by $0.8 million from $78.5 million in 2016 to $79.2 million in 2017. Personnel expenses decreased by $11.1 million from $49.0 million in 2016 to $37.9 million in 2017, primarily due to a $9.4 million decrease in non-cash stock based compensation expense, and a $2.8 million decrease in social charges on stock options grants, partly offset by a $1.1 million increase in wages and salaries. Purchases and external expenses increased by $10.7 million from $27.7 million in 2016 to $38.5 million in 2017, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials, expenses related to process development and expenses associated with the use of laboratories and other facilities. 2017 expenses include manufacturing costs related to UCART123, UCART CS1 and UCART22 and expenses related to UCART123 clinical trials. Other expenses increased by $1.1 million mainly due to impairment of assets in 2017 related to Montvale site ($0.8 million).

SG&A Expenses: During the years ended December 31, 2016 and 2017, we recorded $43.4 million and $44.7 million, respectively, of selling, general and administrative expenses. The increase of $1.3 million primarily reflects (i) an increase of $1.0 million in personnel expenses from $33.5 million to $34.5 million, attributable to a $2.0 million increase in wages and salaries and a $1.2 million increase in non-cash stock-based compensation expense, partly offset by a decrease of $2.2 million of social charges on stock options grants, and  (ii) a $0.1 increase in other expenses due to higher business taxes and higher provisions, partially offset by a $0.3 million decrease in purchases and external expenses.

Financial Gain (Loss): The financial loss was almost null for the year ended December 31, 2016 compared with financial loss of $11.0 million for the year ended December 31, 2017. The change in financial result was mainly attributable to an decrease in net foreign exchange gain ($17.2 million), partly offset by an increase of foreign exchange derivatives fair value adjustment ($5.8 million), and an increase in interest income ($0.5 million).

Net Income (Loss) Attributable to Shareholders of Cellectis: During the years ended December 31, 2016 and 2017, we recorded a net loss attributable to shareholders of Cellectis of $67.3 million (or $1.91 per share) and a net loss attributable to shareholders of Cellectis of $99.4 million (or $2.78 per share), respectively. Adjusted net loss attributable to shareholders of Cellectis for the year ended December 31, 2017 was $50.4 million ($1.41 per share) compared to adjusted net loss attributable to shareholders of Cellectis of $8.6 million ($0.24 per share), for the year ended December 31, 2016. Adjusted loss attributable to shareholders of Cellectis for the year ended December 31, 2017 and 2016 excludes a non-cash stock-based compensation expense of $48.9 million and $58.6 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.

Results from the CALM (UCART19 in Advanced Lymphoid Malignancies) study will be presented during an oral session by Reuben Benjamin, MD, PhD, Principal Investigator and consultant hematologist at King’s College Hospital, London, United Kingdom, on March 21, 2018 at 9:30 am (Room 5A). The CALM study is an open label, dose-escalation study designed to evaluate safety, tolerability and antileukemic activity of UCART19 in adult patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

Presentation title: First-in-human study with UCART19, an allogeneic anti-CD19 car T-cell product, in high-risk adult patients with CD19+ R/R B-cell ALL: preliminary results of CALM study[1]

The PALL (Pediatric Acute Lymphoblastic Leukemia) study is a phase 1, open label, study to evaluate the safety and the ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory B-ALL. PALL was initiated in the UK in June 2016. Paul Veys, MD, PhD, Director of the Bone Marrow Transplant Unit at Great Ormond Street Hospital (GOSH), London, United Kingdom, will share data during an oral session on March 21, 2018 at 11:40 am (Auditorium IV).

Presentation title: Gene-edited allogeneic CAR19 T-cells (UCART19) induce molecular remission ahead of allo-sct in high risk pediatric patients with CD19+ relapsed/refractory B-cell Acute Lymphoblastic Leukemia²

Servier is the sponsor of both studies. In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being codeveloped by Servier and Pfizer.

About UCART19

UCART19 is an allogeneic CAR T-cell product candidate being developed for treatment of CD19-expressing hematological malignancies, gene edited with TALEN®. UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I. The current approach with UCART19 is based on the preliminary positive results from clinical trials using autologous products based on the CAR technology.  UCART19 has the potential to overcome the limitation of the current autologous approach by providing an allogeneic, frozen, “off-the-shelf” T cell based medicinal product.

In November 2015, Servier acquired the exclusive rights to UCART19 from Cellectis. Following further agreements, Servier and Pfizer began collaborating on a joint clinical development program for this cancer immunotherapy. Pfizer has been granted exclusive rights by Servier to develop and commercialize UCART19 in the United States, while Servier retains exclusive rights for all other countries.

Both patents claim methods by which T-cells are gene edited using transient expression of CRISPR/Cas9 components. These inventions are based on the early work initiated by inventors at Cellectis when the CRISPR technology first came to light.

These therapeutic-focused patents follow the grant by the European Patent Office of patent No. EP3004337 for similar inventions and previous intellectual property that Cellectis has obtained over the last two decades for major gene editing technologies including meganucleases, TALEN^®, MegaTAL and CRISPR.

“Cellectis is a pioneering gene editing company that has always been keen to be at the forefront of all gene editing technologies,” said Dr. André Choulika, Cellectis Chairman & CEO. “We have been the first to explore the potential of CRISPR in its early days in various applications, including therapeutics and plants. These early findings ultimately led to the grant of this set of new patents. As such, these patents only reinforce Cellectis’ leadership position in the gene editing industry.”

Convinced of their strong value for the future development of engineered CAR T-cells, Cellectis will make these patents available for licensing to companies that are willing to use CRISPR technologies in T-cells. The technical knowledge in these patents could, for example, help users engineer allogeneic CAR T-cells while suppressing genes involved in checkpoint inhibitions, such as PD-1, engineer drug resistance, or remove MHC (Major Histocompatibility Complex) related genes. The technology could also be used to insert a DNA CAR construct by gene targeting a specific locus in the genome of T-cells.

The inventors of these patents are Dr. André Choulika, Chairman & CEO of Cellectis and one of the pioneers in the development of nuclease-based genome editing technologies; Dr. Philippe Duchateau, Cellectis Chief Scientific Officer and seasoned gene editing expert; and Dr. Laurent Poirot, Cellectis Head of Early Discovery and expert of gene functions in immune cells.

Claims 1 and 2 of US 9,855,297:

1. A method of preparing genetically modified primary T-cells for immunotherapy comprising the steps of: (a) transfecting mRNA encoding an RNA-guided endonuclease into the primary T-cells, wherein the RNA-guided endonuclease is expressed from the transfected m RNA; (b) introducing a DNA vector that encodes a specific guide RNA, wherein the specific guide RNA directs the RNA-guided endonuclease to at least one targeted locus in the T-cell genome into the primary T-cells; (c) cleaving at least one targeted locus in the T-cell genome with the RNA-guided endonuclease; (d) generating a genetic modification at the site of the cleavage; and (e) expanding the resulting genetically modified T-cells.

2. The method of claim 1, wherein the RNA-guided endonuclease is Cas9.

Claim 1 of US 9,890,393:

1.         A method of preparing T-cells for immunotherapy comprising the step of:

(a)       genetically modifying primary T-cells by introduction and/or expression into the cells of at least:

- a RNA-guided endonuclease; and

- a specific guide RNA that directs said endonuclease to at least one targeted locus in the T-cell genome,

wherein said RNA-guided endonuclease is expressed from transfected mRNA;

wherein said RNA-guided endonuclease comprises the amino acid sequence set forth in SEQ ID NO:1 or SEQ ID NO:2; and

(b)       expanding the resulting cells.

To access the live webcast of Cellectis presentation and subsequent breakout session, please visit http://www.cellectis.com/en/agenda/. A replay of the webcast will be available on Cellectis website for 90 days.

Results from the CALM (UCART19 in Advanced Lymphoid Malignancies) Trial

The CALM study (UCART19 in Advanced Lymphoid Malignancies) is an open label, dose-escalation study designed to evaluate the safety, tolerability and anti-leukemic activity of UCART19 in adult patients with R/R B-ALL. Five out seven patients treated achieved molecular remission at Day 28 post UCAR19. Molecular remission is defined by negative minimal residual disease (MRD). MRD is a measurement of the number of residual leukemic cells that remain after treatment.

“These early results for UCART19 are very encouraging both in terms of manageable safety and the impressive complete molecular remission rate in these hard-to-treat adult patients with R/R B-ALL,” said Reuben Benjamin, Principal Investigator of the CALM Study and Consultant Hematologist at King’s College Hospital, United Kingdom. “This first cohort explored a lower dose of UCART19 that is approximately one tenth of that used in most autologous CAR-T trials. These results support additional evaluation of UCART19 at varying doses.”

Only one Grade 1 cutaneous acute graft versus host disease (GvHD) occurred. No severe neurotoxicity was observed. Cytokine release syndromes (CRS) were mild and manageable except in one patient treated with UCART19 at the first dose level, who developed CRS Grade 4 and neutropenic sepsis leading to death at Day 15.

Results from the PALL (Pediatric Acute Lymphoblastic Leukemia) Trial

The PALL (Pediatric Acute Lymphoblastic Leukemia) study is a phase 1, open label study designed to evaluate the safety and ability of UCART19 to induce molecular remission defined by MRD negativity at Day 28 to enable allogeneic stem cell transplantation in pediatric patients with high-risk R/R B-ALL. Results showed all five children achieved MRD negativity, enabling them to proceed to allogeneic stem cell transplant. Only one Grade 1 cutaneous acute GvHD occurred. No severe neurotoxicity was observed. Cytokine release syndromes were mild in the majority of cases and were all manageable.

Servier is the sponsor of both studies that are active in Europe and the United States.

“We are proud to present the first clinical trial data with UCART19 in patients with heavily pretreated R/R ALL,” said Patrick Therasse, MD, PhD, Head of Research and Development-Oncology for Servier. “We believe this innovative, allogeneic CAR T-cell approach could be disruptive to the patient community.”

About UCART19

UCART19 is an allogeneic CAR T-cell product candidate being developed for treatment of CD19-expressing hematological malignancies, gene edited with TALEN®. UCART19 is initially being developed in adult and pediatric ALL and is currently in Phase I. UCART19 has the potential to overcome the limitation of the current autologous approach by providing an allogeneic, frozen, “off-the-shelf” T cell based medicinal product.

In November 2015, Servier acquired the exclusive rights to UCART19 from Cellectis. Following further agreements, Servier and Pfizer began collaborating on a joint clinical development program for this cancer immunotherapy. Pfizer has been granted exclusive rights by Servier to develop and commercialize UCART19 in the United States, while Servier retains exclusive rights for all other countries.

“Stéphane Depil’s deep medical, academic, and clinical regulatory oncology experience – specifically in R&D for all phases within the pharmaceutical, biotechnology, and clinical research spaces – will be invaluable as he leads Cellectis’ strategy and promotes awareness of the breakthrough work that we are doing as a leader and innovator in the gene-editing field,” said Dr. André Choulika, Cellectis CEO. “His strategic alliance-building, collaboration skills, understanding of the global environment with oncological clinical research, and firsthand experience running a pharma company all add a great degree of ability and depth to our leadership team. This will be tremendously advantageous as Cellectis continues its efforts to cure cancer with our off-the-shelf gene-edited CAR T-cell product candidates.”

Prof. Depil is a board-certified physician in hematology, with over 15 years of experience in oncology clinical development, both in hospital / university and pharmaceutical companies. Prior to joining the Léon Bérard Cancer Center & Cancer Research Center of Lyon, France as Medical Director of the Cancer Immunotherapy Program, he served as Chief Executive Officer at Netris Pharma, where he was responsible for the management of an oncology startup and preclinical development of a first-in-class monoclonal antibody in Phase I. Prior to Netris, Stéphane Depil worked at Servier for 8 years in a variety of roles, including Director of Oncology Research and Development, where he managed 20 programs: 5 in the clinic, 7 at late preclinical stages, and 8 at early preclinical stages. He also directly supervised over 100 licensing opportunities.

“As we are at a transformative moment in history with CAR T-cell therapy, Cellectis is harnessing the power of gene editing to improve patients’ lives through the allogeneic approach,” added Prof. Depil. “As such, Cellectis is well-positioned to make its mark with the Company’s unique pioneering approach, and I look forward to joining the team at this pivotal time. This is an unprecedented era of biopharmaceutical innovation to develop next-generation therapeutics that will transform patient care as we know it today.”

December 4, 2017 – New York (N.Y.) – Cellectis (Alternext: ALCLS - Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced today that the Company has appointed Elsy Boglioli to the role of Executive Vice President, Strategy and Corporate Development. Ms. Boglioli’s responsibilities include directing the long-term strategy and current business priorities of Cellectis to ensure that the overall mission of the Company is fulfilled. Ms. Boglioli joins Cellectis from Boston Consulting Group (BCG), where she served as Partner and Managing Director, and leader of BCG’s biotech-focused business in Europe.

“Ms. Boglioli’s extensive experience working with leading pharmaceutical companies, along with her in-depth expertise on portfolio and innovation strategies across the board, will be particularly vital for Cellectis as we continue along the path to market for our game-changing allogeneic CAR T-cell product candidates,” said Dr. André Choulika, Cellectis CEO. “We look forward to having her on board during this pivotal time in the Company’s history so that we can bring a transformative new type of cancer care to patients in need across the globe as quickly and efficiently as possible.”

Ms. Boglioli has far-reaching expertise within the pharma and medtech industries, focusing on everything from corporate strategy and M&A to research. At BCG, she was also a member of the global biopharma leadership team and global strategy practice management team and served as regional head of the strategy practice for Europe.

“As off-the-shelf immunotherapies have such enormous potential to advance cancer treatment today, I jumped at the chance to join Cellectis, as the Company is not only developing a next-generation cure for cancer, but it’s also truly defining the future of care as we know it today,” added Ms. Boglioli. “This is all about creating products that are both cost-effective and available to patients all over the world, which will ultimately create a fundamental shift in how we approach medicine moving forward.”

Ms. Boglioli graduated from Ecole Polytechnique in Paris, France and holds a master’s degree in economy and management from Pompeu Fabra University in Barcelona, Spain.

November 20, 2017 – New York (N.Y.) – Cellectis (Alternext: ALCLS - Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced today the publication of a study in Molecular Therapy — Nucleic Acids describing the educated engineering of highly specific and efficient TAL nucleases (TALEN®) targeting PD1, a key T-cell immune checkpoint.

In this report, Anne-Sophie Gautron, Ph.D., Alexandre Juillerat, Ph.D., and their collaborators used a strategy developed by Cellectis to control TALEN® targeting based on a proprietary technology leveraging the exclusion capacities of non-conventional RVDs. This approach allows combined disruptions of the desired TRAC and PDCD1 loci by TALEN® while eliminating low frequency off-site processing. By adjusting a few RVDs, they provided a rapid and straightforward redesign of optimal TALEN® combinations for multiplex gene editing. This approach can greatly benefit gene editing for therapeutic applications where high editing efficiencies need to be associated with maximal specificity and safety.

Anne-Sophie Gautron, Ph.D. Project leader Immunotherapy

Dr. Anne-Sophie Gautron, Ph.D., graduated in immunology from the University Pierre et Marie Curie/Pasteur Institute, Paris 6, France. After receiving her Ph.D. in immunology in 2009 from the University René Descartes, Paris 5, France, she joined the Neurology and Immunobiology departments at Yale University, Connecticut, where she studied the role of regulatory T-cells in inhibiting pathogenic Th1 and Th17-cell responses. In 2014, she joined the Early Discovery team of Cellectis in Paris, France, working on the development of the next generation of CAR T-cells for adoptive immunotherapy. In 2017, she joined the CAR development group to lead projects associated with the development of new CAR-expressing engineered T-cells for administration as “off-the-shelf” immunopharmaceuticals for cancer treatment.

Alexandre Juillerat, Ph.D. Innovation Team leader

Dr. Alexandre Juillerat, Ph.D., graduated in Chemistry from the University of Lausanne, Switzerland. After receiving in 2006 his Ph.D. in protein engineering from the École Polytechnique Fédérale de Lausanne (EPFL, Switzerland), he moved to the laboratory of Structural Immunology at the Institut Pasteur in Paris, France, performing structure-function studies on a major adhesin of plasmodium falciparum. In 2010, he joined the R&D department of Cellectis in Paris, France, working on the development and implementation of sequence specific designer nucleases including the transcription activator-like effector nucleases TALEN®. He then joined the Cellectis facility based in New York, NY, USA, leading projects associated with the development of the T-cell chimeric antigen receptor (CAR) technology.

Fine and predictable tuning of TALEN gene editing targeting for improved T-cell adoptive immunotherapy

Anne-Sophie Gautron^1,3, Alexandre Juillerat^2,3, Valérie Guyot¹, Jean-Marie Filhol¹, Emilie Dessez¹, Aymeric Duclert¹, Philippe Duchateau¹ and Laurent Poirot¹.

¹Cellectis SA, 8 rue de la croix Jarry, 75013 Paris, FRANCE

²Cellectis Inc, 430E, 29th street, NYC, NY 10016, USA

³These authors contributed equally to this work.

http://www.sciencedirect.com/science/article/pii/S2162253117302664?via=ihub

• Preliminary results of the first-in-human clinical trials of UCART19 will be presented at the 59th American Society of Hematology (ASH) annual meeting

• Completion on July 25, 2017 of the Nasdaq-listed IPO of Calyxt, a 79,8% owned subsidiary of Cellectis - with $64.4 million in gross proceeds to Calyxt

• Cash[1] position of $304 million as of September 30, 2017

Cellectis agreed with the FDA to the following main revisions to be implemented in Phase 1 UCART123 protocols to lift the hold:

• Decrease of the cohort dose level to 6.25x10⁴ UCART123 cells/kg;
• Decrease of the cyclophosphamide dose of the lympho-depleting regimen to 750 mg/m²/day over three days with a maximum daily dose of 1.33 grams of cyclophosphamide;
• Inclusion of specific criteria at Day 0, the day of UCART123 infusion, such as no new uncontrolled infection after receipt of lymphodepletion, afebrile, off all but replacement dose of corticosteroids, no organ dysfunction since eligibility screening;
• Provision to ensure that the next three patients to be treated in each protocol will be under the age of 65;
• Provision to ensure that the enrollment will be staggered across the UCART123 protocols AML123 and ABC123: at least 28 days should elapse between the enrollments of two patients across the two studies.

Cellectis is currently working with the investigators and clinical sites to obtain IRB’s approval on the revised protocols and resume patient enrollment.

About UCART123

Our first wholly-controlled product candidate, UCART123, is a gene edited T-cell investigational drug that targets CD123, an antigen expressed at the surface of leukemic cells in AML, as well as on leukemic and other tumoral cells in BPDCN. Cellectis received in February 2017 an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to conduct Phase 1 clinical trials with UCART123 in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). This marks the first allogeneic, “off-the-shelf” gene-edited CAR T-cell product candidate that the FDA has approved for clinical trials.

AML is a devastating clonal hematopoietic stem cell neoplasm that is characterized by uncontrolled proliferation and accumulation of leukemic blasts in bone marrow, peripheral blood and, occasionally, in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure and death. In the U.S. alone, there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year.

The clinical research at Weill Cornell is led by principal investigator Dr. Gail J. Roboz, Professor of Medicine at Weill Cornell Medicine and Director of the Clinical and Translational Leukemia Programs at Weill Cornell Medicine and NewYork-Presbyterian.

BPDCN is a very rare and aggressive hematological malignancy that is derived from plasmacytoid dendritic cell precursors. BPDCN is a disease of bone marrow and blood cells but also often affects skin and lymph nodes.

The UCART123 clinical program at MD Anderson is led by Dr Naveen Pemmaraju, MD, Associate Professor, Dr Marina Konopleva, Professor, and Professor Hagop Kantarjian, MD, Department Chair, Department of Leukemia, Division of Cancer Medicine.

Learn more about the ongoing clinical trials at www.clinicaltrials.gov

Oral presentations:

• UCARTCS1 product candidate targeting Multiple Myeloma

502. Universal SLAMF7-Specific CAR T-Cells As Treatment for Multiple Myeloma

Abstract: https://ash.confex.com/ash/2017/webprogram/Paper106073.html

Session Name: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Novel Immunotherapeutic Strategies in Multiple Myeloma Session

Sunday, December 10, 2017 at 5:15 PM

Location: Bldg B, Lvl 3, B308-B309 (Georgia World Congress Center)

Rohit Mathur¹, Zheng Zhang¹, Jin He¹, Roman Galetto², Agnès Gouble², Isabelle Chion-Sotinel², Stéphanie Filipe², Annabelle Gariboldi², Tanooha Veeramachaneni¹, Elisabet E. Manasanch¹, Sheeba K. Thomas¹, Hans C. Lee¹, Krina K. Patel¹, Donna M. Weber¹, R. Eric Davis¹, Robert Z. Orlowski¹, Julianne Smith³, Jing Yang¹, and Sattva S. Neelapu¹

¹Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA

²Cellectis SA, 8 rue de la croix Jarry, 75013 Paris, France

³Cellectis Inc, 430 East 29th Street, 10016 New York, NY, USA

• UCART22 product candidate targeting B-Acute Lymphoblastic Leukemia

808. Pre-clinical Activity of Allogeneic Anti-CD22 CAR T-Cells for the Treatment of B-cell Acute Lymphoblastic Leukemia

Abstract: https://ash.confex.com/ash/2017/webprogram/Paper105595.html

Session Name: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: CAR-T Cell Immunotherapy

Monday, December 11, 2017: 5:15 PM

Location: Bldg C, Lvl 1, Hall C4 (Georgia World Congress Center)

Julia Wells PhD¹, Tianyu Cai, PhD¹, Cécile Schiffer-Manniou PhD², Stéphanie Filipe, PhD², Agnès Gouble, PhD², Roman Galetto, PhD², Nitin Jain MD¹, Elias Jabbour MD¹, Julianne SmithPhD³ and Marina Konopleva, MD, PhD¹

¹Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

²Cellectis SA, Paris, France

³Cellectis Inc, New York, NY

Poster Presentation:

• UCART123 product candidate targeting Blastic Plasmacytoid Dendritic Cell Neoplasm

2625. Pre-Clinical Studies of Allogeneic Anti-CD123 CAR T-Cells for the Therapy of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Abstract: https://ash.confex.com/ash/2017/webprogram/Paper105789.html

Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II

Sunday, December 10, 2017 from 6:00 PM to 8:00 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Tianyu Cai¹, Roman Galetto², Agnès Gouble², Julianne Smith³, Antonio Cavazos¹, Lina Han¹, Qi Zhang¹, Vinitha Kuruvilla¹, Sergej Konoplev⁴, Sattva S. Neelapu⁵, Andrew A. Lane⁶, Monica Guzman⁷, Hagop Kantarjian¹, Naveen Pemmaraju¹, Marina Konopleva¹

¹Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

²Cellectis SA, Paris, France

³Cellectis Inc, New York, NY

⁴Department of Hematopathology, The University of MD Anderson Cancer Center, Houston, TX

⁵Department of Lymphoma and Myeloma, The University of MD Anderson Cancer Center, Houston, TX

⁶Dana-Farber Cancer Institute, Boston

⁷Department of Medicine, Weill Cornell Medical College, New York, NY

Results from the CALM (UCART19 in Advanced Lymphoid Malignancies) study will be shared as an oral presentation by Reuben Benjamin, principal investigator and consultant hematologist at King’s College Hospital, United Kingdom, on December 11 at 7.15 pm (EST). The CALM study is an open label, dose-escalation study designed to evaluate safety, tolerability and antileukemic activity of UCART19 in patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL). The study was initiated in the UK in August 2016.

The abstract for this presentation is available on the ASH website: https://ash.confex.com/ash/2017/webprogram/Paper100804.html

The PALL (Pediatric Acute Lymphoblastic Leukemia) study is a phase 1, open label, study to evaluate the safety and the ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory B-ALL. PALL was initiated in the UK in June 2016. Waseem Qasim, principal investigator of the PALL study and consultant in pediatric immunology and reader in cell and gene therapy at Great Ormond Street Hospital for Children, United Kingdom, will present results from the trial during a poster session on December 9 from 5.30 pm to 7.30 pm.

The abstract for this presentation is available on the ASH website: https://ash.confex.com/ash/2017/webprogram/Paper100183.html

Servier is a sponsor of both studies. In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being codeveloped by Servier and Pfizer.

Dr. Mathieu Simon has served as Cellectis’ Executive Vice-President since 2012 and as Chief Operating Officer since 2013. Dr. Simon was Chief Executive Officer of former subsidiary Cellectis therapeutics and has been instrumental in the strategic and operational management of all therapeutic activities.

• September 6, 2017, André Choulika, CEO of Cellectis, to present at the Wells Fargo Conference in Boston from 4:10 to 4:40pm ET

• September 11, 2017, André Choulika to present at the Morgan Stanley Global Healthcare Conference in New York from 9:20 to 9:50am ET

• September 26, 2017, André Choulika to present at the Ladenburg Thalmann 2017 Conference in New York from 2:00 to 2:25pm ET

• September 28, 2017, André Choulika to present at the Leerink Rare Disease & Immuno-Oncology Conference in New York at 2:30 pm ET

Cellectis is working closely with the investigators and the FDA in order to resume the trials with an amended protocol including a lowered dosing of UCART123.

The clinical hold was initiated after Cellectis reported one fatality in the BPDCN clinical trial (ABC study). This was the first patient treated in the BPDCN study, a 78-year-old male treated with one prior therapy, who presented with relapsed/refractory BPDCN with 30% blasts in his bone marrow and cutaneous lesions (biopsy-proven BPDCN) at baseline prior to conditioning regimen. He received 30mg/m²/day fludarabine for 4 days and 1g/m²/day cyclophosphamide for 3 days, as a preconditioning regimen. On August 16, 2017 (Day 0), he received 6.25x10⁵ UCART123 cells per kilogram, the first dose level explored in the protocol, without complication. At Day 5, the patient experienced a grade 2 Cytokine Release Syndrome (CRS)[1], and a grade 3 lung infection, which quickly improved after a first dose of tocilizumab and institution of anti-infective therapy (broad spectrum intravenous antibiotics). He then experienced at Day 8 a grade 5 CRS, together with a grade 4 Capillary Leak Syndrome^[2]. Despite a treatment in keeping with CRS management including administration of corticosteroids and tociluzumab x 2 as well as intensive care unit support, the patient died on Day 9.

The first patient treated in the AML study was a 58-year-old woman, with 84% blasts in her bone marrow at baseline prior to conditioning regimen. On June 27, 2017 (Day 0), the patient received the same preconditioning regimen and the same dose of UCART123 as the BPDCN patient, without complication. She experienced an initial grade 2 CRS at Day 8, worsening to a grade 3 at Day 9 and resolving at Day 11 with treatment management in intensive care unit. She also experienced a grade 4 Capillary Leak Syndrome at Day 9, resolved at Day 12.

No GvHD[3] was reported for any of these patients.

The DSMB (Data Safety Monitoring Board) met on August 28 and recommended lowering the dose to 6.25x10⁴ UCART123 cells per kilogram in both studies and capping cyclophosphamide to a total dose of 4g over 3 days.

August 17, 2017 – New York (N.Y.) – Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART), announced today that the first patient with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) has been dosed in Cellectis’ Phase I clinical study using the Company’s wholly controlled TALEN® gene edited product candidate UCART123 at the MD Anderson Cancer Center. UCART123 is the first allogeneic, “off-the-shelf” gene edited CAR T-cell product candidate targeting CD123 to be investigated in U.S. clinical trials.

The UCART123 clinical program for BPDCN is led by Dr. Naveen Pemmaraju, MD, Assistant Professor, Professor Marina Konopleva MD, PhD, and Professor Hagop Kantarjian, MD, Department Chair, Department of Leukemia, Division of Cancer Medicine, at the MD Anderson Cancer Center.

The clinical trial will investigate the safety and efficacy of UCART123 in patients with BPDCN in the relapsed, refractory and front-line setting. BPDCN is a rare and aggressive hematological malignancy classified in the myeloid diseases among the acute leukemias that are derived from plasmacytoid dendritic cell precursors. It is a bone marrow disease that also often affects skin and lymph nodes.

Given its rarity and recent recognition as a distinct clinicopathological entity, no standardized therapeutic approach has been established for BPDCN, and the optimal therapy remains to be defined. Although transient responses are achieved by combination chemotherapy regimens that are used to treat acute leukemia or lymphoma, most patients relapse with the drug-resistant disease.

“We are eager to progress through clinical trials with UCART123, Cellectis’ wholly controlled gene-edited product candidate, next with the treatment of BPDCN, rare but aggressive entity,” said Dr. Loan Hoang-Sayag, Cellectis’ Chief Medical Officer. “With this innovative treatment, the hope is that our “off-the-shelf” approach will transform the way we think about cancer care and serve as the next step in curing this disease through the power of gene editing.”

• IND clearance granted by the FDA to Servier and Pfizer related to the Phase I clinical trials of UCART19 in ALL patients

• Closing of the Calyxt’s Nasdaq IPO with $64.4 million in gross proceeds to Calyxt on July 25, 2017

• Strong cash position of $272 million^[1] (€238 million) as of June 30, 2017

New York, N.Y. – August 2, 2017 – Cellectis S.A. (Alternext: ALCLS - Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART), today announced its results for the three-month period ended June 30, 2017 and for the six-month period ended June 30, 2017.

Second Quarter 2017 and Recent Highlights

Cellectis - Therapeutics

UCART123: Cellectis’ most advanced, wholly controlled TALEN® gene-edited, allogeneic CAR T product candidate

• First patient administration of UCART123 product candidate - in Acute Myeloid Leukemia (AML), marking the start of the Phase I dose escalation study.

• • For AML patients, the Phase I clinical trial is being conducted at Weill Cornell Medicine New York - Presbyterian Hospital, and led by Gail J. Roboz, MD, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine.

• • For Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) patients, the Phase I clinical trial is being conducted at MD Anderson Cancer Center, and is led by Naveen Pemmaraju, MD, Assistant Professor, and Hagop Kantarjian, MD, Professor and Department Chair, Department of Leukemia, Division of Cancer Medicine.

UCART19: exclusively licensed to Servier 

• IND clearance obtained for Servier, in collaboration with Pfizer, to proceed with UCART19 Phase I clinical trials in the U.S. in patients with relapsed /refractory acute lymphoblastic leukemia (ALL).
• UCART19 Phase I clinical trials in pediatric and adult ALL patients are ongoing at University College London (UCL) and Kings College London (KCL), in the UK, sponsored by Servier.

Manufacturing

• On-going manufacturing of UCART CS1, an allogeneic CAR T-cell product candidate for Multiple Myeloma
• Signed a Development and Manufacturing Agreement on July 27, 2017 with MolMed S.p.A for the development and manufacturing of UCAR T-cell product candidates

IP/ Patent portfolio

U.S. patent 8,921,332, which claims the use of chimeric restriction endonucleases for directing chromosomal gene editing in cells by homologous recombination (HR), initially issued on Dec. 30, 2014, was upheld by the United States Patent and Trademark Office (USPTO) after a reexamination initiated in October 2015.

Grant by the European Patent Office of patent No. EP3004337, covering a method of using RNA-guided endonucleases, such as Cas9 or Cpf1 for the genetic engineering of T-cells.

Conferences

• Presentation of data on Cellectis’ UCART product candidates at the ASGCT 20th Annual Meeting in Washington, D.C., USA.

• Presentations on Cellectis-controlled programs and Pfizer/Cellectis collaboration programs at the 2017 American Association for Cancer Research (AACR) Annual Meeting:

• Wholly-controlled Program UCART22: An Allogeneic Adoptive Immunotherapy for Leukemia Targeting CD22 with CAR T-cells;
• Collaboration Programs:
  • Allogeneic EGFRvIII Chimeric Antigen Receptor T-cells for Treatment of Glioblastoma and
  • Differential Modulation of the PD-1 Pathway Impacts the Anti-Tumor Activity of CAR T- cells.

• Company’s founder, Chairman and CEO, Dr. André Choulika participated at the 2017 Milken Institute Global Conference as a panelist for a session titled, “Humankind vs. Cancer: The Scorecard” on Wednesday, May 3, 2017.

Corporate Governance

• Cellectis Shareholders’ General Meeting was held at the Company’s head office in Paris on June 26, 2017. At the meeting, more than 73% of voting rights were exercised, and all resolutions recommended by the board of directors, were adopted, including:
  • the appointment of two new directors to the board of directors, Mr. Rainer Boehm and Mr. Hervé Hoppenot; and
  • the renewal of the term of office of director of Mr. Laurent Arthaud, Mr. Pierre Bastid and Mrs. Annick Schwebig.

Calyxt Inc. – Cellectis’ plant science subsidiary

• Calyxt closed its IPO with $64.4 million in gross proceeds to Calyxt from the sale of approximately 8 million shares at $8 per share, including the full exercise of the underwritter’s overallotment option and Cellectis’ purchase of $20.0 million of shares in the IPO. Calyxt’s shares of common stock are traded on NASDAQ under the symbol “CLXT”. Cellectis owns approximately 79.9% of Calyxt’s outstanding shares of common stock.  

• Calyxt launched, under a services agreement with University of Minnesota U.S. field trials for powdery mildew-resistant spring wheat variety, representing its fourth gene-edited crop to undergo trials

• Joseph B. Saluri was named as General Counsel and Executive Vice President, Corporate Development. Mr. Saluri brings to Calyxt over 24 years of legal, business development, strategic planning and project management experience in the global agri-business space.

• Calyxt signed an agreement with a third-party for the sale and leaseback of its Roseville, MN, greenhouse and warehouse facility and construction of the remaining facility. The completion of the sale is conditioned on Calyxt and the buyer entering into a new facility construction agreement and a lease in respect of the property in the forms contemplated by the sale agreement.

Financial Results

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).

Second Quarter 2017 Financial Results

Cash: As of June 30, 2017, Cellectis had €237.6 million in total cash, cash equivalents and current financial assets compared to €258.5 million as of March 31, 2017. This decrease of €20.9 million reflects (i) net cash flows used by operating activities of €10.0 million, (ii) capital expenditures of €0.7 million and (iii) the unrealized negative translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €11.0 million; partially offset by (iv) the increase in equity mainly attributable to the exercise of share warrants for €0.8 million.

Revenues and Other Income: During the quarters ended June 30 2016 and 2017, we recorded €18.1 million and €8.2 million, respectively, in revenues and other income. This decrease is mainly due to a €10.0 million decrease in collaboration revenues of which €7.7 million represented milestone, revenues received during the second quarter of 2016 with the first patient dosed in Phase I clinical trial for UCART19, and a decrease of €2.0 million in recognition of upfront already paid to Cellectis. 

Total Operating Expenses: Total operating expenses for the second quarter of 2017 were €26.2 million, compared to €28.2 million for the second quarter of 2016. The non-cash stock-based compensation expenses included in these amounts were €11.3 million and €14.4 million, respectively.

R&D Expenses: For the quarters ended June 30, 2016 and 2017, research and development expenses decreased by €2.6 million from €19.5 million in 2016 to €16.9 million in 2017. Personnel expenses decreased by €3.2 million from €11.6 million in 2016 to €8.4 million in 2017, primarily due to a €3.1 million decrease in non-cash stock based compensation expense, partly offset by a €0.1 million increase in wages and salaries. Purchases and external expenses and other expenses increased by €0.5 million from €7.5 million in 2016 to €8.0 million in 2017, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials and expenses associated with the use of laboratories and other facilities.

SG&A Expenses: During the quarters ended June 30, 2016 and 2017, we recorded €8.6 million and €9.1 million, respectively, of selling, general and administrative expenses. The increase of €0.5 million primarily reflects an increase of €0.6 million in personnel expenses from €6.5 million to €7.1 million, attributable, among other things, to an increase of €0.6 in wages and salaries and an increase of €0.1 million in non-cash stock-based compensation expense, partially offset by a decrease of €0.2 million in purchases and external expenses.

Financial Gain (Loss): The financial gain was €3.8 million for the second quarter of 2016 compared with a financial loss of €6.0 million for the second quarter of 2017. The change in financial result was primarily attributable to a decrease in net foreign exchange loss of €11.5 million due to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts and an increase of €1.9 million in fair value adjustment income on our foreign exchange derivatives and current financial assets.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the three months ended June 30, 2016 and 2017, we recorded a net loss attributable to shareholders of Cellectis of €6.3 million (€0.18 per share on both a basic and a diluted basis) and net loss attributable to shareholders of Cellectis of €24.1 million (€0.68 per share on both a basic and a diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the second quarter of 2017 was €12.8 million (€0.36 per share on both a basic and a diluted basis) compared to adjusted income attributable to shareholders of Cellectis of €8.1 million (€0.23 per share on both a basic and a diluted basis), for the second quarter of 2016. Adjusted income (loss) attributable to shareholders of Cellectis for the second quarter of 2017 and 2016 excludes non-cash stock-based compensation expense of €11.3 million and €14.4 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted income (loss) attributable to shareholders of Cellectis.

First Six Months 2017 Financial Results

Cash: As of June 30, 2017, Cellectis had €237.6 million in total cash, cash equivalents and current financial assets compared to € 276.2 million as of December 31, 2016. This decrease of €38.6 million primarily reflects (i) net cash flows used by operating activities of €25.2 million, (ii) capital expenditures of €1.4 million and (iii) the unrealized negative translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €13.0 million; partially offset by an increase in equity mainly attributable to the exercise of share warrants for €1.0 million.

Cellectis expects that its cash, cash equivalents and current financial assets of €237.6 million as of June 30, 2017 will be sufficient to fund its current operations to 2019.

Revenues and Other Income: During the six-month periods ended June 30, 2016 and 2017, we recorded €27.6 million and €17.8 million, respectively, in revenues and other income. This decrease is mainly due to (i) a €10.4 million decrease in collaboration revenues of which €7.7 million represented milestones revenues received during the second quarter of 2016 with the first patient dosed in the Phase I clinical trial for UCART 19, a decrease of €3.5 million in recognition of upfront fees already paid to Cellectis and a decrease of €0.8 million in research and development cost reimbursements; partially offset by an increase of €1.5 million in revenue related to supply to Servier, partly offset by (ii) an increase of €0.7 million in research tax credits.

Total Operating Expenses: Total operating expenses for the six-month period ended June 30, 2017 were €54.4 million, compared to €58.1 million for the six months ended June 30, 2016. The non-cash stock-based compensation expenses included in these amounts were €24.1 million and €27.8 million, respectively.

R&D Expenses: For the six-month periods ended June 30, 2016 and 2017, research and development expenses decreased by €3.1 million from €38.4 million in 2016 to €35.3 million in 2017. Personnel expenses decreased by €5.3 million from €23.5 million in 2016 to €18.2 million in 2017, primarily due to a €3.7 million decrease in non-cash stock based compensation expense, and a €1.7 million decrease in social charges on stock options; grants partly offset by a €0.1 million increase in wages and salaries. Purchases and external expenses increased by €2.0 million from €14.2 million in 2016 to €16.2 million in 2017, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials and expenses associated with the use of laboratories and other facilities.

SG&A Expenses: During the six-month periods ended June 30, 2016 and 2017, we recorded €19.1 million and €18.2 million, respectively, of selling, general and administrative expenses. The decrease of €0.9 million primarily reflects (i) a decrease of €0.4 million in personnel expenses from €14.8 million to €14.3 million, attributable, among other things, to a decrease of €1.5 million of social charges on stock options grants, partly offset by a €1.1 million increase in wages and salaries, and (ii) a decrease of €0.6 million in purchases and external expenses.

Financial Gain (Loss): The financial loss was €5.3 million for the six-month period ended June 30, 2016 compared with financial loss of €6.1 million for the six-month period ended June 30, 2017. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts for €3.9 million partially offset by the fair value adjustment on our derivative instrument and financial current asset for €3.0 million.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the six-months periods ended June 30, 2016 and 2017, we recorded a net loss attributable to shareholders of Cellectis of €35.7 million (€ 1.01 per share on both a basic and a diluted basis) and a net loss attributable to shareholders of Cellectis of €42.7 million (€1.20 per share on both a basic and diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the six-month period ended June 30, 2017 was €18.6 million (€0.52 per share on both a basic and a diluted basis) compared to adjusted loss attributable to shareholders of Cellectis of €7.9 million (€0.22 per share on both a basic and a diluted basis), for the six-month period ended June 30, 2016. Adjusted loss attributable to shareholders of Cellectis for the six-month periods ended June 30, 2017 and 2016 excludes a non-cash stock-based compensation expense of €24.1 million and €27.8 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.

Calyxt is Cellectis’ gene editing agriculture company. Cellectis owns approximately 79.9% of Calyxt’s outstanding shares of common stock.

Citigroup, Jefferies and Wells Fargo Securities acted as joint book-running managers for the proposed offering. BMO Capital Markets and Ladenburg Thalmann acted as co-managers.

A registration statement on Form S-1 relating to these securities was declared effective by the U.S. Securities and Exchange Commission.  A copy of the final prospectus relating to this Offering may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340, or by e-mail at Prospectus_Department@Jefferies.com, or Wells Fargo Securities, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, at (800) 326-5897 or by email at cmclientsupport@wellsfargo.com. 

The final prospectus is also available at www.sec.gov.  This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.

This therapeutic-focused patent follows previous intellectual property that Cellectis has obtained over the two last decades for major gene editing technologies including meganucleases, TALEN^®, MegaTAL and CRISPR.

“Cellectis is a pioneering gene editing company that has always been at the forefront of all gene editing technologies,” said Dr. André Choulika, Cellectis Chairman & CEO. “We have been the first to explore the potential of CRISPR in its early days in various applications, including therapeutics and food, and these early findings ultimately led to the grant of this new patent. While Cellectis has selected TALEN® as the most robust and adaptable technology for human therapeutic use and for the Company’s product pipeline, our team does sometimes use CRISPR-based nucleases for T-cell research, as it is a less-expensive option and convenient for gene discovery purposes. As such, this patent only further reinforces Cellectis’ leadership position in the gene editing industry, with more patents coming down the pike for the Company in the near future.”

Convinced of its strong value for future development of engineered CAR T-cells, Cellectis will make this patent available for licensing to companies that are willing to use this technology in T-cells.

The inventors of this patent are Dr. André Choulika, Chairman & CEO of Cellectis and one of the pioneers in the development of nuclease-based genome editing technologies; Dr. Philippe Duchateau, Cellectis Chief Scientific Officer and seasoned gene editing expert and Dr. Laurent Poirot, Cellectis Head of Early Discovery and expert of gene functions in immune cells.

Claim 1 of the EP3004337 patent

1) A method of preparing T-cells for immunotherapy comprising the steps of:

(a) Genetically modifying T-cells by introduction into the cells and/or expression in the cells of at least:

- a RNA-guided endonuclease; and

- a specific guide RNA that directs said endonuclease to at least one targeted locus in the T-cell genome,

wherein said RNA-guided endonuclease is expressed from transfected mRNA,

and said guide RNA is expressed in the cells as a transcript from a DNA vector;

(b) expanding the resulting cells in vitro.

Calyxt is Cellectis’ gene editing agriculture company. Prior to the Offering, Cellectis owned 100% of Calyxt’s outstanding shares of common stock.  Immediately following completion of the Offering after giving effect to the 2,500,000 shares of common stock Cellectis purchased in the Offering, Cellectis will own approximately 83.1% of Calyxt’s outstanding shares of common stock (or 79.9% if the underwriters exercise their option to purchase additional shares in full). 

Citigroup, Jefferies and Wells Fargo Securities are acting as joint book-running managers for the proposed offering. BMO Capital Markets and Ladenburg Thalmann are acting as co-managers.

A registration statement on Form S-1 relating to these securities was declared effective by the U.S. Securities and Exchange Commission.  The Offering is being made only by means of a prospectus.  A copy of the final prospectus relating to this Offering, when available, may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340, or by e-mail at Prospectus_Department@Jefferies.com, or Wells Fargo Securities, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, at (800) 326-5897 or by email at cmclientsupport@wellsfargo.com. 

The final prospectus will also be available at www.sec.gov.  This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.

Calyxt is Cellectis’ 100% owned gene editing agriculture company. Cellectis intends to retain majority ownership of Calyxt.

Citigroup, Jefferies and Wells Fargo Securities are acting as joint book-running managers for the proposed offering. BMO Capital Markets and Ladenburg Thalmann are acting as co-managers.

This offering will be made only by means of a prospectus (included in the registration statement on Form S-1). A copy of the preliminary prospectus may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340, or by e-mail at Prospectus_Department@Jefferies.com, or Wells Fargo Securities, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, at (800) 326-5897 or by email at cmclientsupport@wellsfargo.com.

A registration statement relating to these securities has been filed with the SEC but has not yet become effective.  The registration statement is available at www.sec.gov or https://www.cellectis.com/FINAL.calyxt.s1.july.10.2017.pdf.  These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.

For further information, please contact:

Media contacts

Jennifer Moore, VP Communications
Phone: 917-580-1088
email: media@calyxt.com / media@cellectis.com

Caitlin Kasunich / Nick Opich
KCSA Strategic Communications
Phone: 212-896-1241 / 212-896-1206
email: ckasunich@kcsa.com / nopich@kcsa.com

Investor Relations contact

Simon Harnest, VP Corporate Strategy and Finance
Phone: 646-385-9008
email: simon.harnest@cellectis.com

###

“We are delighted to welcome Rainer Boehm and Hervé Hoppenot to our Board. Rainer’s experience in drug commercialization will be invaluable as we work to develop the next generation CAR T-cell immunotherapies. Hervé brings deep expertise in oncology which will be a major benefit to our team we continue to innovate to bring UCART product candidates to the clinic,” said André Choulika, CEO Cellectis. “With these two esteemed leaders, we are adding to the expertise of our Board of Directors to help guide Cellectis into our next phase.”

Rainer Boehm spent 29 years at Novartis, working locally, regionally and globally in various Senior Management roles, after building his career in Marketing & Sales and Medical Affairs. He led all emerging markets regions as well as the United States and Canada, either for Oncology or the Pharmaceuticals division. His most recent assignments were Chief Commercial and Medical Affairs Officer globally for Novartis Pharma, as well as ad interim CEO and Division Head Pharma. Rainer launched and oversaw the commercialization of many brands during his career, amongst them Femara, Zometa and Glivec, as well as Cosentyx and Entresto. His broad interests include leadership development, coaching and mentoring, access to medicines and new business models including solutions to leverage digital medicines and real world evidence. Rainer has a medical degree from the University of Ulm in Germany, and a Master of Business Administration from Schiller University in France.

“I am honored to join the Board and look forward to providing strategic advice on drug commercialization to strengthen Cellectis’ market leading position. Cellectis is a company with tremendous potential,” said Rainer Boehm, Cellectis’ newest Board member. “I see exciting opportunities for Cellectis to address unmet medical needs and make a meaningful difference in people’s lives. What Cellectis is accomplishing is transformative and we have the potential to move the needle forward for healthcare in a positive way. ”

Hervé Hoppenot joined Incyte Corporation in 2014 as President and Chief Executive Officer, and was appointed Chairman of the Board of Directors in 2015. Incyte is one of the fastest growing biopharmaceutical companies in the U.S. Incyte’s team of more than 1,000 scientists, clinicians, and other team members operating in 15 countries, strives to discover and develop first-in-class and best-in-class medicines for cancer and other diseases. The Company is advancing a diverse portfolio of large and small molecules comprised of 18 development candidates against 14 different molecular targets and in 2016 Incyte reported revenue of more than $1 billion.

Prior to joining Incyte, Mr. Hoppenot was the President of Novartis Oncology, which included $11 billion in global sales, the largest oncology pipeline in the industry and 8000 employees in 50 countries. Prior to joining Novartis in 2003, Mr. Hoppenot started his career in 1983 with Rhone Poulenc, later known as Aventis, where he served in several senior roles of increasing responsibility, including Vice President of Oncology and Head of the US Oncology business unit. He and his family are dual citizens of France and the United States, having moved to the U.S. in 1991.

"Despite many advances in oncology, there remains a need to continue to advance the science to meet the needs of patients. Through its work in developing CAR T immunotherapies, Cellectis has an opportunity to make a significant contribution to the treatment of cancer,” Mr. Hoppenot said. "I am excited to be joining the Cellectis Board during this important time of growth."

June 27, 2017 – New York (N.Y.) – Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART), announced today the first administration in the Phase I clinical study in Acute Myeloid Leukemia (AML) for its investigational product UCART123, one of the Company’s wholly-controlled TALEN® gene-edited product candidates. This marks the first allogeneic, “off-the-shelf” gene-edited CAR T-cell product candidate targeting CD123 to be investigated in clinical trials.

This clinical research in AML is led by Principal Investigator Dr. Gail J. Roboz, Professor of Medicine at Weill Cornell Medicine and Director of the Clinical and Translational Leukemia Programs at Weill Cornell Medicine and NewYork-Presbyterian Hospital.

The clinical trial will investigate the safety and efficacy of UCART123 in patients with AML. AML is a devastating clonal hematopoietic stem cell neoplasm which is characterized by uncontrolled proliferation and accumulation of leukemic blasts in bone marrow, peripheral blood and, occasionally, in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure. In the U.S., there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year. While complete response rates can be as high as 80 percent in younger patients who undergo initial induction cytotoxic chemotherapy, the majority of AML patients relapse and die from the disease. AML patients with high-risk genetic features have an especially urgent unmet medical need, as their outcomes are dismal with all existing treatment modalities, including allogeneic stem cell transplantation.

“After being granted rapid approval from Regulatory Authorities and Institutional Review Boards to initiate UCART123 studies, the enrollment and treatment of the first patient represents a major milestone for Cellectis, and we are eager to hit the ground running with the recruitment of our first patient for our second UCART123 Phase I study in BPDCN soon,” said Dr. Loan Hoang-Sayag, Cellectis Chief Medical Officer. “This first program targeting CD123 will be a paradigm shift for our Company, as it will provide a wealth of valuable additional knowledge and data to drive our gene-edited allogeneic CAR T-cell platform.”

“We are excited to be enrolling our first patient with UCART123 and are hopeful that this novel immunotherapy modality will prove to be a significant and effective weapon against AML,” said Dr. Roboz.

The clinical trial is part of a strategic translational research alliance that was formed between Cellectis and Weill Cornell Medicine in 2015. Dr. Monica Guzman, an associate professor of pharmacology in medicine at Weill Cornell Medicine, is co-principal investigator whose work focuses on preclinical and early-stage testing to optimize the development of stem cell-targeted cancer drugs.

At the meeting, during which more than 73% of voting rights were exercised, all the resolutions for which the management recommended a vote in favor, were adopted.  

The resolutions adopted by Cellectis' shareholders included:

• Appointment of two new directors to the board of directors, Mr Rainer Boehm and Mr Hervé Hoppenot;
• Renewal of the term of office of Director of Mr Laurent Arthaud, Mr Pierre Bastid and Mrs Annick Schwebig;
• Approval of the annual financial statements for the financial year ended December 31, 2016;
• Approval of the consolidated financial statements for the financial year ended December 31, 2016.

The full results of the vote can be examined on the company’s website https://www.cellectis.com/en/investors/general-meetings/

Citigroup, Credit Suisse and Jefferies are acting as joint book-running managers for the proposed offering. Wells Fargo Securities is acting as lead manager and Ladenburg Thalmann is acting as co-manager.

This offering will be made only by means of a prospectus (included in the registration statement on Form S-1). When available, a copy of the preliminary prospectus may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, NY 10010, or by telephone at (800) 221-1037, or by email at newyork.prospectus@credit-suisse.com; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340, or by e-mail at Prospectus_Department@Jefferies.com.

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. The registration statement is available at https://www.cellectis.com/FINAL.calyxt.s1.june.23.2017.pdf. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.

The convening meeting stating the detailed agenda is posted on the website of the Company:
http://www.cellectis.com/en/investors/general-meetings/

Shareholders, regardless of the number of shares they own, shall have the right to attend the meeting, be represented by a proxy or vote by mail. If the shareholders are individuals, they may only appoint as proxy their spouse or partner in civil union or another shareholder of the Company.

The right to attend meetings shall be governed by all applicable laws and regulations and be conditional upon the registration, for accounting purposes, of the shares in the name of the shareholder or a designated intermediary on the second working day preceding the shareholders' meeting at midnight, Paris time, either in the registered share accounts kept by the Company or the bearer share accounts kept by the authorized intermediary.

Holders of registered shares shall not be required to meet any formality and shall be granted access upon proof of identity.

Holders of bearer shares must submit a certificate of participation, issued by their financial intermediary at least two (2) working days before the date of the meeting.

The shareholder wishing to vote by mail, may request the appropriate form by sending a registered letter with acknowledgement of receipt, to Ms. Marie-Bleuenn Terrier, Cellectis, 8, rue de la Croix Jarry, 75013 Paris, no later than six (6) days prior to the date of the meeting.

It is recalled that, pursuant to the law:

• the duly completed ballot form must be sent to the Company's registered office or to Société Générale at least three (3) days prior to the date of the meeting, i.e. no later than June 22, 2017;
   
• holders of bearer shares must add to their form a certificate of participation issued by the financial intermediary with whom their shares are deposited;
   
• shareholders who have voted by mail shall no longer be able to attend the meeting or be represented by a proxy.

Written questions may be sent no later than the fourth (4^th) working day prior to the date of the shareholders' meeting, i.e. no later than June 20, 2017:

• to the registered office by registered letter with acknowledgement of receipt, addressed to the chairman of the Board of Directors; or
   
• by e-mail to: investors@cellectis.com.

These written questions must be accompanied by a certificate of registration, either in the registered share accounts or in the bearer share accounts.

About Cellectis
Cellectis is a clinical-stage biopharmaceutical company focused on developing a new generation of cancer immunotherapies based on gene-edited T-cells (UCART). By capitalizing on its 17 years of expertise in gene editing – built on its flagship TALEN® technology and pioneering electroporation system PulseAgile – Cellectis uses the power of the immune system to target and eradicate cancer cells.
Using its life-science-focused, pioneering genome engineering technologies, Cellectis’ goal is to create innovative products in multiple fields and with various target markets.
Cellectis is listed on the Nasdaq market (ticker: CLLS) and on the NYSE Alternext market (ticker: ALCLS). To find out more about us, visit our website: www.cellectis.com

Talking about gene editing? We do it. TALEN® is a registered trademark owned by the Cellectis Group.
 

For further information, please contact:

Media contacts:
Jennifer Moore, VP of Communications, 917-580-1088, media@cellectis.com
Caitlin Kasunich, KCSA Strategic Communications, 212-896-1241, ckasunich@kcsa.com

IR contact:
Simon Harnest, VP of Corporate Strategy and Finance, 646-385-9008, simon.harnest@cellectis.com

May 10, 2017 – New York (N.Y.) – Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced that U.S. patent 8,921,332, which claims the use of chimeric restriction endonucleases for directing chromosomal gene editing in cells by homologous recombination (HR), initially issued on Dec. 30, 2014, has been upheld by the United States Patent and Trademark Office (USPTO) after a reexamination initiated in October 2015.

U.S. patent 8,921,332 claims a general method for modifying chromosomal DNA sequences at a genomic site of interest within a cell by using a chimeric restriction endonuclease such as zing finger nucleases, TAL-effector nucleases, Mega-TALs and CRISPR/Cas9. This technique, commonly referred to as gene targeting or targeted insertion, is now frequently used to modify the genome within plants, animals and cell lines.

The inventors of this patent are Dr. André Choulika, Cellectis’ Chairman and CEO, and Dr. Richard C. Mulligan, a Harvard Medical School Professor. Institut Pasteur and Boston Children’s Hospital, the owners of the patent, have granted exclusive rights to Cellectis under this patent. It belongs to a patent family that claims the basic uses of chimeric restriction nucleases for gene editing in cells.

Following the patent’s reexamination, the USPTO issued a Notice to Issue Reexamination Certificate in which it is stated that all 55 claims of the patent are maintained, asserting that: "The '632 patent, Smith et al., the '150 patent, Kim et al. and the '261 patent individually or in combination neither teach or suggest the method of modifying a specific sequence in a chromosomal DNA of a cell in vitro by contacting the cell with a chimeric restriction endonuclease and a targeted DNA as recited in the present claims."

• IND clearance granted by the FDA to Servier and Pfizer related to the Phase I clinical trials of UCART19 in ALL patients

• Considering the IPO of Calyxt, Cellectis’ plant sciences subsidiary

• Cash position of $277 million^[1] (€259 million) as of March 31, 2017

New York, N.Y. – May 9, 2017 – Cellectis S.A. (Alternext: ALCLS - Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced its results for the three-month period ended March 31, 2017.

RECENT CORPORATE HIGHLIGHTS

Cellectis - Therapeutics

UCART123 - Cellectis’ most advanced, wholly controlled TALEN® gene-edited product candidate

• Investigational New Drug (IND) approval received from the U.S. Food and Drug Administration (FDA) to conduct Phase I clinical trials in patients with AML and BPDCN.

• First clinical trial approval by the FDA for an allogeneic, “off-the-shelf” gene-edited CAR T-cell product candidate.

• AML clinical program to be led, at Weill Cornell, by Gail J. Roboz, MD, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine.

• BPDCN clinical program to be led, at MD Anderson Cancer Center, by Naveen Pemmaraju, MD, Assistant Professor, and Hagop Kantarjian, MD, Professor and Department Chair, Department of Leukemia, Division of Cancer Medicine.

• Completion of cGMP manufacturing runs of UCART123 at large scale, to provide doses for initiating planned Phase I clinical trials in AML and BPDCN patients.

UCART19, exclusively licensed to Servier

• The FDA has granted Pfizer and Servier with Investigational New Drug (IND) clearance to proceed in the U.S. with Phase I clinical development of UCART19 to treat patients with relapsed/refractory acute lymphoblastic leukemia.

• Phase I clinical trials in pediatric and adult ALL patients are ongoing at University College London (UCL) and Kings College London (KCL), UK, sponsored by Servier.

Scientific Conferences

• Data on both wholly-controlled Cellectis programs and Pfizer/Cellectis collaboration programs have been presented at the American Association for Cancer Research (AACR) Annual Meeting:

• UCART22: An allogeneic adoptive immunotherapy for leukemia targeting CD22 with CAR T-cells
• Allogeneic EGFRvIII Chimeric Antigen Receptor T-cells for treatment of glioblastoma
• Differential modulation of the PD-1 pathway impacts the anti-tumor activity of CAR T-cells

Clinical Advisory Board

• Formation of a Clinical Advisory Board (CAB) comprising leading experts in the hematologic malignancies / stem cell transplant, immunotherapy and hematology-oncology clinical research fields to serve as a strategic resource to Cellectis in connection with the clinical development of UCART123.

Calyxt Inc. – Cellectis’ plant science subsidiary

• In April 2017, Cellectis announced that it is exploring the possibility of an initial public offering (IPO) of a minority interest in its plant sciences business, Calyxt.

• New Technology Framework Agreement with Plant Bioscience Limited pursuant to which Calyxt received an option to obtain exclusive license to new crops traits.

• Former Cargill executive Manoj Sahoo joined Calyxt as the Company’s Chief Commercial Officer. As part of Calyxt’s executive team Mr. Sahoo is building a commercial partnership network and executing a go-to-market plan for Calyxt. Mr. Sahoo is joining Calyxt from Cargill, where he worked in the Food Ingredients and Bio-industrial Enterprise

Financial Results

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“IASB”).

First quarter 2017 Financial Results

Cash: As of March 31, 2017 Cellectis had €258.5 million in total cash, cash equivalents and current financial assets compared to €276.2 million as of December 31, 2016. This decrease of €17.7 million reflects (i) net cash flows used by operating activities of €15.3 million, (ii) capital expenditures of €0.5 million and (iii) the unrealized negative translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €1.9 million.

Cellectis expects that its cash, cash equivalents and current financial assets of €258.5 million as of March 31, 2017 will be sufficient to fund its current operations to 2019.

Revenues and Other Income: During the quarters ended March 31, 2016 and 2017, we recorded €9.5 million and €9.7 million, respectively, in revenues and other income. This increase primarily reflects (i) an increase of €0.8 million in research tax credit, (ii) a decrease of €0.4 million in collaboration revenues, due primarily to a decrease of €1.4 million in upfront recognition and a decrease of €0.3 million in R&D costs reimbursement, been partially offset by an increase of €1.3 million in supply agreements with Servier, and (iii) a decrease in revenue from licenses of €0.2 million.

Total Operating Expenses: Total operating expenses for the first quarter of 2017 were €28.2 million, compared to €29.9 million for the first quarter of 2016. The non-cash stock-based compensation expenses included in these amounts were €12.8 million and €13.4 million, respectively.

R&D Expenses: For the quarters ended March 31, 2016 and 2017, research and development expenses decreased by €0.5 million from €18.9 million in 2016 to €18.4 million in 2017. Personnel expenses decreased by € 2.1 million from €11.9 million in 2016 to €9.8 million in 2017, primarily due to a €1.7 million decrease in social charges on stock option grants and a €0.5 million decrease in non-cash stock based compensation expense, partly offset by a €0.1 million increase in wages and salaries. Purchases and external expenses increased by €1.5 million from €6.6 million in 2016 to €8.2 million in 2017, mainly due to increased expenses related to UCART123 and the development of other product candidates, including payments to third parties, purchases of biological materials and expenses associated with the use of laboratories and other facilities.

SG&A Expenses: During the quarters ended March 31, 2016 and 2017, we recorded €10.5 million and €9.1 million, respectively, of selling, general and administrative expenses. The increase of €1.4 million primarily reflects (i) a decrease of €1.1 million in personnel expenses from €8.3 million to €7.2 million, attributable, to a decrease of €1.5 million of social charges on stock options grants and a decrease of €0.1 million of non-cash stock-based compensation expense, partly offset by a €0.5 million increase in wages and salaries, and (ii) a decrease of €0.4 million in purchases and external expenses.

Financial Gain (Loss): The financial loss was €9.1 million for the first quarter of 2016 compared with an almost nil financial result for the first quarter of 2017. The change in financial result was primarily attributable to a decrease in net foreign exchange loss of €7.6 million due to the effect of exchange rate fluctuations on our USD cash and cash equivalent accounts, an increase of €1.0 million in fair value adjustment income on our foreign exchange derivatives and current financial assets and a €0.2 million net gain realized on the repositioning of foreign exchange derivative instruments.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the quarters ended March 31, 2016 and 2017, we recorded a net loss of €29.5 million (or €0.84 per share on both a basic and a diluted basis) and a net loss of €18.6 million (or €0.53 per share on both a basic and a diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the first quarter of 2017 was €5.8 million (€0.16 per share on both a basic and a diluted basis) compared to adjusted income attributable to shareholders of Cellectis of €16.1 million (€0.46 per share on both a basic and a diluted basis), for the first quarter of 2016. Adjusted income (loss) attributable to shareholders of Cellectis excludes non-cash stock-based compensation expense of €12.8 million and €13.4 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.

CELLECTIS S.A.

STATEMENT OF CONSOLIDATED FINANCIAL POSITION

 (€ in thousands)

CELLECTIS S.A.

STATEMENT OF CONSOLIDATED OPERATIONS – First quarter

 (unaudited)

(€ in thousands, except per share data)

Note Regarding Use of Non-GAAP Financial Measures

Cellectis S.A. presents Adjusted Income (Loss) attributable to shareholders of Cellectis in this press release. Adjusted Income (Loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS. We have included in this press release a reconciliation of this figure to Net Income (Loss) attributable to shareholders of Cellectis, the most directly comparable financial measure calculated in accordance with IFRS. Because Adjusted Income (Loss) attributable to shareholders of Cellectis excludes Non-cash stock-based compensation expense—a non-cash expense, we believe that this financial measure, when considered together with our IFRS financial statements, can enhance an overall understanding of Cellectis’ financial performance. Moreover, our management views the Company’s operations, and manages its business, based, in part, on this financial measure. In particular, we believe that the elimination of Non-cash stock-based expenses from Net Income (Loss) attributable to shareholders of Cellectis can provide a useful measure for period-to-period comparisons of our core businesses. Our use of Adjusted Income (Loss) attributable to shareholders of Cellectis has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under IFRS. Some of these limitations are: (a) other companies, including companies in our industry which use similar stock-based compensation, may address the impact of Non-cash stock-based compensation expense differently; and (b) other companies may report Adjusted Income (Loss) attributable to shareholders or similarly titled measures but calculate them differently, which reduces their usefulness as a comparative measure. Because of these and other limitations, you should consider Adjusted Income (Loss) attributable to shareholders of Cellectis alongside our IFRS financial results, including Net Income (Loss) attributable to shareholders of Cellectis.

RECONCILIATION OF GAAP TO NON-GAAP NET INCOME – First quarter

 (unaudited)

(€ in thousands, except per share data)

New York, N.Y. – April 27, 2017 – Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced that the Company’s founder, Chairman and CEO, Dr. André Choulika, has been selected as a speaker for the 2017 Milken Institute Global Conference. Dr. Choulika will participate as a panelist for a session titled, “Humankind vs. Cancer: The Scorecard” on Wednesday, May 3, 2017, at 10 a.m. local time.

This panel will focus on both the opportunities and challenges that come with fighting cancer using new targeted therapies and breakthrough immuno-oncology drugs, addressing questions such as: Why do many breakthrough treatments work for some patients but not others? What are some of the risks that are associated with emerging treatments? Can patients, governments and insurers continue to meet the rising costs of cancer treatment? Will the changes in administration impact commitments that are made through the Cancer MoonShot and 21^st Century Cures Act?

Dr. Choulika’s selection as a speaker was based on his contribution to and impact on the global healthcare and life sciences industries through Cellectis’ development and therapeutic application of allogeneic, off-the-shelf CAR T-cell immunotherapies that target cancer. With this process, T-cells from healthy donors are genetically edited with Cellectis’ proprietary TALEN® technology to seek and destroy cancer cells.

The 20^th Annual Milken Institute Global Conference will take place on Sunday, April 30, to Wednesday, May 3, 2017, in Los Angeles, California.
 

For further information, please contact:

Media contacts:

Jennifer Moore, VP of Communications, 917-580-1088, media@cellectis.com
Caitlin Kasunich, KCSA Strategic Communications, 212-896-1241, ckasunich@kcsa.com

IR contact:

Simon Harnest, VP of Corporate Strategy and Finance, 646-385-9008, simon.harnest@cellectis.com

Oral presentation:

Development of Gene Edited Allogeneic CAR T-Cell Therapy
Philippe Duchateau, PhD. Chief Scientific Officer, Cellectis

Session: 300 - Clinical Advancement of Gene Editing-Moving New Science to the Clinic -
Organized by the Clinical Trials and Regulatory Affairs Committee

Friday, May 12, 2017 from 8:35 AM to 9:10 AM EST
Lincoln 2, 3, 4

Poster presentations:

176 - Genome-Wide Analysis of TALEN® Activity in Primary Cells
Brian Busser, Sonal Temburni, Aymeric Duclert, Philippe Duchateau and Laurent
Poirot

Session: Gene Targeting and Gene Correction I
Wednesday May 10, 2017 at 5:30 PM EST
Exhibit Hall A & B South

114 - UCART22: An Allogeneic Adoptive Immunotherapy for Leukemia Targeting
CD22 with CAR T-cells
Anne-Sophie Gautron, Cécile Schiffer-Mannioui, Alan Marechal, Severine Thomas,
Agnes Gouble, Laurent Poirot, Julianne Smith

Session: Cancer-Immunotherapy, Cancer Vaccines I
Wednesday May 10, 2017 from 5:30 PM to 7:30pm EST
Exhibit Hall A & B South

372 - Manufacturing of Gene-Modified Mouse CAR T-Cells
Laurent Poirot, Brian Busser, Sonal Temburni, Philippe Duchateau

Session: Gene Targeting and Gene Correction II
Thursday May 11, 2017 from 5:15 PM to 7:15 PM EST
Exhibit Hall A & B South

For further information, please contact:

Media contacts:
Jennifer Moore, VP of Communications, 917-580-1088, media@cellectis.com
Caitlin Kasunich, KCSA Strategic Communications, 212-896-1241,
ckasunich@kcsa.com

IR contact:
Simon Harnest, VP of Corporate Strategy and Finance, 646-385-9008,
simon.harnest@cellectis.com

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. This press release is being made pursuant to, and in accordance with, Rule 135 under the Securities Act of 1933, as amended. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

For further information, please contact:

Media contacts:
Jennifer Moore, VP of Communications, 917-580-1088, media@cellectis.com
Caitlin Kasunich, KCSA Strategic Communications, 212-896-1241, ckasunich@kcsa.com

IR contact:
Simon Harnest, VP of Corporate Strategy and Finance, 646-385-9008, simon.harnest@cellectis.com

Cellectis presentation:

• UCART22: An Allogeneic Adoptive Immunotherapy for Leukemia Targeting CD22 with CAR T-cells 

Agnès Gouble¹, Cécile Schiffer-Mannioui¹, Séverine Thomas¹, Anne-Sophie Gautron¹, Laurent Poirot¹, Julianne Smith².

¹Cellectis, Paris, France; ²Cellectis, New York, NY

Innate Effectors in Immunity to Cancer session – section 30

April 4, 2017, 8:00 AM - 12:00 PM Eastern Time

Pfizer/Cellectis presentations:

• Allogeneic EGFRvIII Chimeric Antigen Receptor T Cells for Treatment of Glioblastoma

Oi Kwan Wong¹, Mathilde Dusseaux², Jing-Tyan Ma¹, Melinda Au¹, Sophie Leduc², Joyce Chou¹, Jessica M. Yu¹, Marjorie Bateman¹, Thomas Pertel¹, Kevin C. Lindquist¹, Julianne Smith³, Barbra Sasu¹, Shu-Hui Liu¹.

¹Pfizer Inc., South San Francisco, CA; ²Cellectis, Paris, France; ³Cellectis, New York, USA

Innate Effectors in Immunity to Cancer session – section 30

April 4, 2017, 8:00 AM - 12:00 PM Eastern Time

• Differential modulation of the PD-1 pathway impacts the anti-tumor activity of CAR T cells

Regina J. Lin¹, Anne-Sophie Gautron², Laurent Poirot², Oi Kwan Wong¹, Barbra Sasu¹, Bijan Boldajipour¹.

¹Pfizer, South San Francisco, CA; ²Cellectis, Paris, France; ³Cellectis, New York, USA

Late-Breaking Research: Immunology session – section 35

April 4, 2017, 8:00 AM - 12:00 PM Eastern Time

Collaboration with Pfizer

In June 2014, Cellectis and Pfizer began collaborating on a joint clinical development program for UCAR-T therapies, in the field of oncology, directed at numerous targets selected by Pfizer and several targets selected by Cellectis.

Servier is sponsoring the CALM Phase 1 study on UCART19. In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being co-developed by Servier and Pfizer.

The CALM study was initiated in the UK in August 2016. CALM is an open label, dose-escalation study designed to evaluate safety, tolerability and antileukemic activity of UCART19 in patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

The allogeneic UCART19 candidate and CALM protocol were reviewed at the National Institutes of Health's Recombinant DNA Advisory Committee (RAC) meeting on December 14, 2016. Servier submitted an IND application on February 1, 2017, with Pfizer’s support. With this IND clearance, the CALM study will be expanded to include several centers in the U.S., including the MD Anderson Cancer Center in Houston (Texas).

“We are very pleased that Servier’s first IND approval has been granted for such an innovative approach as allogeneic CAR T therapy”, said Dr Patrick Thérasse, Director of Clinical Development Oncology at Servier. “B-ALL is a devastating disease and this study is key to gaining greater insight into the efficacy and safety profile of this new immune-oncology approach in patients with B-ALL.”

“Pfizer is excited by the potential of this investigational CAR T approach to treating ALL and other B-Cell malignancies,” said Barbara Sasu, Vice President, CAR T Research at Pfizer. “We are looking forward to having the opportunity to investigate this approach in the U.S.”

About UCART19

UCART19 is an allogeneic CAR T-cell product candidate being developed for treatment of CD19-expressing hematological malignancies, gene edited with TALEN®. UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I. The current approach with UCART19 is based on the preliminary positive results from clinical trials using autologous products based on the CAR technology. UCART19 has the potential to overcome the limitation of the current autologous approach by providing an allogeneic, frozen, “off-the-shelf” T cell based medicinal product.

In November 2015, Servier acquired the exclusive rights to UCART19 from Cellectis. Following further agreements, Servier and Pfizer began collaborating on a joint clinical development program for this cancer immunotherapy. Pfizer has been granted exclusive rights by Servier to develop and commercialize UCART19 in the United States, while Servier retains exclusive rights for all other countries.

The new board members include Dr Catherine Bollard, Pr Hervé Dombret, Pr Ola Landgren, Dr Marcela Maus and Pr Dietger Niederwieser.

“As Cellectis has recently received IND approval from the U.S. FDA to conduct two Phase 1 clinical trials with UCART123, an allogeneic, ‘off-the-shelf’ CAR T-cell product candidate for acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN), the Company’s Clinical Advisory Board will continue to play a critical role in establishing new and innovative immunotherapies for patients all over the world,” said Dr. Loan Hoang-Sayag, Chief Medical Officer, Cellectis. “As such, we are pleased these five additional hematology leading experts have now joined the Board to further guide us in our efforts to transform cancer treatment through gene editing.”

Professor Catherine Bollard, MBChB, MD, FRACP, FRCPA, is Chief, Division of Allergy and Immunology and Director of the Program for Cell Enhancements and Technologies for Immunotherapy at the Children’s Research Institute, Children's National Health System and The George Washington University. A distinguished hematologist and immunotherapist, Dr. Bollard’s research interests focus on areas that include developing cell and gene therapies for patients with cancer and underlying immune deficiencies.

Professor Hervé Dombret, MD, is Head of the Leukemia Unit at the Hôpital Saint Louis, Paris, and Director of Clinical Research in the Hematology, Immunology and Transplantation Unit, University of Paris Diderot. He is also Director of the University Hematology Research Center in Hôpital Saint-Louis and has a PhD in Oncogenesis. His main fields of interest include clinical and translational research in acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes and chronic myeloid leukemia.

Professor Ola Landgren, MD, is Chief of the Myeloma Service at Memorial Sloan Kettering Cancer Center New York and Professor of Medicine at Weill Cornell Medical College. He is a board-certified hematologist-oncologist whose research focuses on the development of novel treatment strategies and advanced disease monitoring. He has a strong interest in the development of early-treatment clinical trials, targeting high-risk smoldering myeloma. He develops new strategies (including cell-based, molecular-based and imaging-based) and implements advanced MRD testing in clinical trials at MSK.

Doctor Marcela V. Maus, MD, PhD, is Director of Cellular Immunotherapy at the Massachusetts General Hospital in Boston and Assistant Professor at Harvard Medical School. She is a board-certified hematologist-oncologist with extensive research experience in all aspects of pre-clinical and clinical design and use of cell therapies and gene-modified T-cells for cancer. Dr Maus completed undergraduate studies at MIT and her MD and PhD at Penn. As a graduate student, she worked with Dr. Carl June on the biology of human T cell activation. She completed residency training in internal medicine at the University of Pennsylvania Health System, and completed fellowship training in Hematology and Medical Oncology at Memorial Sloan Kettering Cancer Center. Her research focuses on the pre-clinical development and clinical translation of engineered T cell therapies.

Professor Dietger Niederwieser, MD, is Professor of Medicine, Head of the Division of Hematology and Medical Oncology at University of Leipzig and University Hospital. His therapeutic areas of expertise include Clinical Immunology, Hematology and Oncology, and his research is focused on stem cell transplantation, cell therapies and gene therapies. He has extensive experience in health economics, outcomes research, clinical development of innovative drugs and clinical studies.

•  UCART19^[1] Phase I clinical trials ongoing in ALL patients; partial data presented at the NIH’s RAC’s meeting in December 2016

•  Constitution of Cellectis’ Clinical Advisory Board

•  Strong cash position of $291 million^[2] (€276 million) as of December 31, 2016

•  Revenues and other income of $56 million^[3] (€51 million) in 2016

• Excluding non-cash stock based compensation expense, Adjusted net loss^[4] of $9 million^[2] (€8 million) for full year 2016

New York, N.Y. – March 6, 2017 – Cellectis S.A. (Alternext: ALCLS - Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced its results for the three-month period ended December 31, 2016 and for the year ended December 31, 2016.

 ________________________________________

Earnings Call Details

Cellectis will host an earnings call on March 7, 2017 at 8:00am Eastern Time to discuss its financial results and provide a general business update.

Dial-In Numbers:

Live PARTICIPANT Dial-In (Toll-Free US & Canada): 877-407-3104

Live PARTICIPANT Dial-In (International): +1 201-493-6792

Replay Information:

Conference ID #: 13625168

Replay Dial-In (Toll Free US & Canada): 877-660-6853

Replay Dial-In (International): +1 201-612-7415

Expiration Date: 3/21/17

Webcast URL (Archived for 12 months): http://cellectis.equisolvewebcast.com/q4-2016

________________________________________

RECENT CORPORATE HIGHLIGHTS

Cellectis - Therapeutics

UCART123 - Cellectis’ most advanced, wholly owned TALEN® gene-edited product candidate

- Pre-clinical data presented at the 2016 American Society of Hematology (ASH) annual meeting by Dr. Monica Guzman, MD, Weill Cornell, showed long-lasting molecular remission in mice, using UCART123, compared to Cytarabine alone.

- Successful National Institutes of Health’s (NIH) Recombinant DNA Advisory Committee’s (RAC) meeting with unanimous approval of Phase I clinical trials for UCART123 in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).

- Investigational New Drug (IND) approval received from the U.S. Food and Drug Administration (FDA) to conduct Phase I clinical trials in patients with AML and BPDCN.

- First clinical trial approval by the FDA for an allogeneic, “off-the-shelf” gene-edited CAR T-cell product candidate.

- AML clinical program to be led, at Weill Cornell, by Gail J. Roboz, MD, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine.

- BPDCN clinical program to be led, at MD Anderson Cancer Center, by Naveen Pemmaraju, MD, Assistant Professor, and Hagop Kantarjian, MD, Professor and Department Chair, Department of Leukemia, Division of Cancer Medicine.

- Successful cGMP manufacturing runs of UCART123 at large scale, to provide doses for initiating planned Phase I clinical trials in AML and BPDCN patients.

UCART19, exclusively licensed to Servier

- Phase I clinical trials in pediatric and adult ALL patients are ongoing at University College London (UCL) and Kings College London (KCL), UK, sponsored by Servier. Additional sites in other European countries are planned to be opened subject to approval of concerned regulatory bodies.

- Partial data presented on first 7 patients treated with UCART19 at NIH’s Recombinant DNA Advisory Committee (RAC) meeting in December 2016.

- Pfizer, in collaboration with Servier, plans to open sites in the U.S. for the ongoing Phase I clinical trials in adult ALL patients, as presented at the RAC meeting in December 2016.

Scientific Publications

- Publication of a study in Scientific Reports, a Nature Publishing Group journal, describing a novel approach to a CAR design with an integrated environmental signal utilizing oxygen concentration to manipulate the CAR T-cell response.

Clinical Advisory Board

- Formation of a Clinical Advisory Board (CAB) comprising leading experts in the hematologic malignancies / stem cell transplant, immunotherapy and hematology-oncology clinical research fields to serve as a strategic resource to Cellectis in connection with the clinical development of UCART123.

Calyxt – Cellectis’ plant science subsidiary

- Publication of a study in BMC Plant Biology describing the use of genome editing technology to modulate soybean oil composition for increased shelf-life, higher frying stability and improved nutritional characteristics.

- Calyxt completed an expansion of its high-oleic/no trans-fat soybean variety (CAL1501) in the U.S. with a production of 1,200 tons of soybeans.

Financial Results

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“IASB”). The audit procedures have been carried out by the independent auditors and their audit report relating to the certification of the financials is in the process of being issued. The audited report for Cellectis’ consolidated financial statements will be included in the Company’s annual report.

Fourth quarter 2016 Financial Results

Cash: As of December 31, 2016 Cellectis had €276.2 million in total cash, cash equivalents and current financial assets compared to €264.0 million as of September 30, 2016. This increase of €12.2 million notably reflects (i) the receipt of R&D tax credits of €9.2 million, (ii) proceeds of €7.0 million related to the supply agreement with Servier, (iii) the unrealized positive translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €12.1 million, partially offset by (iv) other net cash flows used by operating activities of €15.0 million and (v) fixed assets expenditures of €1.1 million.

Revenues and Other Income: During the quarters ended December 31, 2015 and 2016, we recorded €29.2 million and €12.1 million, respectively, in revenues and other income. This decrease is mainly due to the decrease of €20.0 million in collaboration revenues, notably due to the €18.8 million revenue recorded in 2015 in relation to early exercise by Servier of its option to acquire the exclusive worldwide rights to further develop and commercialize UCART19, partially offset by increases of €1.0 million in research tax credit and €1.3 million in subsidies.

Total Operating Expenses: Total operating expenses for the fourth quarter of 2016 were €30.9 million, compared to €28.0 million for the fourth quarter of 2015. The non-cash stock-based compensation expenses included in these amounts were €13.1 million and €12.6 million, respectively.

R&D Expenses: For the quarters ended December 31, 2015 and 2016, research and development expenses increased by €2.6 million from €16.0 million in 2015 to €18.7 million in 2016. Personnel expenses increased by €0.5 million from €11.2 million in 2015 to €11.6 million in 2016, due to a €1.8 million increase in social charges on stock options, partially offset by a €1.1 million decrease in non-cash stock based compensation expense and a €0.2 million decrease in wages and salaries. Purchases, external expenses and other expenses increased by €2.2 million from €4.3 million in 2015 to €6.5 million in 2016.

SG&A Expenses: During the quarters ended December 31, 2015 and 2016, we recorded €8.1 million and €11.4 million, respectively, of selling, general and administrative expenses. The increase of €3.3 million primarily reflects the increase in personnel expenses from €5.6 million to €8.9 million, attributable to the increase of €1.5 million in non-cash stock-based compensation expense, €1.4 million in social charges on stock options, and €0.4 million in wages and salaries. No material variance has been identified on purchases, external expenses and other expenses.

Financial Gain (Loss): The financial gain was €7.0 million for the fourth quarter of 2015 compared with a financial gain of €6.4 million for the fourth quarter of 2016. The change in financial result was primarily attributable to the increase of €1.3 million in fair value adjustment expense on our foreign exchange derivatives and current financial assets, partially offset by the gain of €0.8 million due to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the quarters ended December 31, 2015 and 2016, we recorded a net gain of €8.2 million (or €0.23 per share on both a basic and a diluted basis) and net loss of €12.5 million (or €0.35 per share on both a basic and a diluted basis), respectively. Adjusted income attributable to shareholders of Cellectis for the fourth quarter of 2016 was €0.6 million (€0.02 per share on both a basic and a diluted basis) compared to adjusted income attributable to shareholders of Cellectis of €20.9 million (€0.59 per share on both a basic and a diluted basis), for the fourth quarter of 2015. Adjusted income (loss) attributable to shareholders of Cellectis for the fourth quarter of 2016 and 2015 excludes non-cash stock-based compensation expense of €13.1 million and €12.6 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.

Full year 2016 Financial Results

Cash: As of December 31, 2016 Cellectis had €276.2 million in total cash, cash equivalents and current financial assets compared to € 314.2 million as of December 31, 2015. This decrease of €38.0 million was primarily driven by (i) €29.6 million of cash used in operating activities, related to our research and development and manufacturing efforts, including the advancement of UCART123, for which an IND was filed in the United States in early 2017, partially offset by payments received from Servier and Pfizer pursuant to our collaboration agreements and R&D tax credit, and (ii) €12.5 million of cash used in investment activities, primarily through Calyxt’s land acquisition and greenhouse construction in an aggregate amount of €9.5 million. The decrease was also partially offset by the positive unrealized translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €4.4 million.

Cellectis expects that its cash, cash equivalents and Current financial assets of €276.2 million as of December 31, 2016 will be sufficient to fund its current operations to 2019.

Revenues and Other Income: During the year ended December 31, 2015 and 2016, we recorded €56.4 million and €51.0 million, respectively, in revenues and other income. This decrease is mainly due (i) to the decrease of €10.4 million in collaboration revenues notably due to revenue recorded in 2015 in relation to early exercise by Servier of its option to acquire the exclusive worldwide rights to further develop and commercialize UCART19 (€18.8 million) partially offset by the revenue from an agreement to provide Servier with raw materials and additional batches of UCART19 products and the achievement of two milestones in 2016 (totaling €11.9 million), (ii) increases of €4.0 million in research tax credit, €0.5 million in licenses fees and €0.4 million in research subsidies.

Total Operating Expenses: Total operating expenses for the year ended December 31, 2016 were €111.8 million, compared to €84.3 million for the year ended December 31, 2015. The non-cash stock-based compensation expenses included in these amounts were €53.0 million and €30.1 million, respectively.

R&D Expenses: For the year ended December 31, 2015 and 2016, research and development expenses increased by €18.5 million from €52.4 million in 2015 to €70.9 million in 2016. Personnel expenses increased by €8.8 million from €35.5 million in 2015 to €44.3 million in 2016, notably due to a €1.6 million increase in wages and salaries, and a €11.5 million increase in non-cash stock based compensation expense, partially offset by a €4.3 million decrease in social charges on stock options and free share grants. Purchases and external expenses increased by €9.8 million from €15.2 million in 2015 to €25.0 million in 2016, due to increased expenses related to UCART123 and other product candidates’ development, including payments to third parties and costs related to preparation of UCART123 clinical trials, purchases of biological materials and expenses associated with the use of laboratories and other facilities.

SG&A Expenses: During the year ended December 31, 2015 and 2016, we recorded €27.2 million and €39.2 million, respectively, of selling, general and administrative expenses. The increase of €12.0 million primarily reflects (i) an increase of €10.7 million in personnel expenses from €19.6 million to €30.3 million attributable to a €0.9 million increase in wages and salaries, an increase of €11.4 million of non-cash stock-based compensation expense, partially offset by a decrease of €1.6 million of social charges on stock options and free share grants, (ii) an increase of €1.9 million in purchases and external expenses and (iii) a decrease of €0.6 in other expenses due to lower business taxes and lower provisions.

Financial Gain (Loss): The financial gain was €7.6 million for the year ended December 31, 2015 and the financial gain was null for the year ended December 31, 2016. The decrease in financial income and expenses between 2016 and 2015 was mainly attributable to the decrease of €5.9 million in net foreign exchange gain, €1.6 million foreign exchange derivatives fair value expense, and €0.9 million current financial assets fair value expenses, partially offset by an increase of €0.5 million in interest income.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the year ended December 31, 2015 and 2016, we recorded a net loss of €20.5 million (or € 0.60 per share on both a basic and a diluted basis) and a net loss of €60.8 million (or €1.72 per share on both a basic and diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the year ended December 31, 2016 was €7.8 million (€0.22 per share on both a basic and a diluted basis) compared to Adjusted income attributable to shareholders of Cellectis of € 9.6 million (€0.28 per share on both a basic and a diluted basis), for the year ended December 31, 2015. Adjusted income (loss) attributable to shareholders of Cellectis for the year ended December 31, 2016 and 2015 excludes non-cash stock-based compensation expense of €53.0 million and €30.1 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.

[1] Cellectis granted Servier an exclusive license to UCART19 product candidate, and Pfizer has been exclusively licensed by Servier for the development and commercialization of UCART19 in U.S.

[2] Translated only for convenience into U.S. dollars at an exchange rate of €1.00=$1.0541, the daily reference rate reported by the European Central Bank (“ECB”) as of December 31, 2016

[3] Translated only for convenience into U.S. dollars at an exchange rate of €1.00=$1.1066, the arithmetic average of the ECB’s monthly average reference rates for the twelve months comprising full year 2016

[4] See the section related to the reconciliation of GAAP to non-GAAP net income. GAAP Net Loss attributable to shareholders amounts to $67 million (€61 million) for the year ended December, 31 2016

To access the live webcast of Cellectis’ presentation, please visit http://www.cellectis.com/en/events. A replay of the webcast will be available on Cellectis’ website for 90 days.

UCART123 is a gene-edited T-cell investigational drug that targets CD123, an antigen expressed at the surface of leukemic cells in AML, tumoral cells in BPDCN. The clinical research for AML will be led, at Weill Cornell, by principal investigator Dr. Gail J. Roboz, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine. The UCART123 clinical program for BPDCN will be led, at the MD Anderson Cancer Center, by Dr. Naveen Pemmaraju, MD, Assistant Professor, and Professor Hagop Kantarjian, MD, Department Chair, Department of Leukemia, Division of Cancer Medicine.

AML is a devastating clonal hematopoietic stem cell neoplasm that is characterized by uncontrolled proliferation and accumulation of leukemic blasts in bone marrow, peripheral blood and, occasionally, in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure and death. In the U.S. alone, there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year.

BPDCN is a very rare and aggressive hematological malignancy that is derived from plasmacytoid dendritic cell precursors. BPDCN is a disease of bone marrow and blood cells but also often affects skin and lymph nodes.

“The FDA’s approval of Cellectis’ UCART123 – the first “off-the-shelf” CAR T-cell product candidate to enter clinical trials in the U.S. – is a major milestone not only for the Company but also for the medical community, global biotech and pharmaceutical industries at large,” said Dr. Loan Hoang-Sayag, Cellectis Chief Medical Officer. “Cellectis’ allogeneic UCART products have the potential to create an important shift with regard to availability, and cost-effectiveness, to make these therapies widely accessible to patient population across the world.”

“After the National Institutes of Health's Recombinant DNA Advisory Committee (RAC)’s unanimous approval of two Phase 1 study protocols for Cellectis’ UCART123 in December 2016, the FDA’s approval of Cellectis’ IND is a new major regulatory milestone achieved, for having UCART123 proceed into clinical development and reaching cancer patients in need,” added Stephan Reynier, Chief Regulatory and Compliance Officer, Cellectis.

Information about ongoing clinical trials are publically available on dedicated websites such as:

www.clinicaltrials.gov in the U.S.

www.clinicaltrialsregister.eu in Europe

January 23, 2017 – New York (N.Y.) – Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced that four new members joined Cellectis’ Clinical Advisory Board (CAB). The CAB serves as a strategic resource to Cellectis as the Company enters the clinical development of allogeneic CAR T immunotherapies lead by its wholly owned product candidate, UCART123.

The CAB initially comprises Pr John Gribben, Lead of the Centre for Hemato-Oncology, Barts Cancer Institute of London, UK; Pr Koen van Besien, Director of the Stem Cell Transplant Program and Professor of Medicine at Weill Cornell Medical College, NYC, USA; Pr Kanti Rai, Professor of Medicine and Molecular Medicine, Hofstra Northwell School of Medicine, Hempstead, USA and Pr Catherine Thieblemont, Professor of Hematology in the Paris VII- University, France and Head of the Hemato-Oncology Unit of St-Louis Hospital in Paris.

"We are honored that these leaders have agreed to join Cellectis’ Clinical Advisory Board as forward-thinking experts, innovators and visionaries in their respective fields,” said Dr. Loan Hoang-Sayag, Chief Medical Officer, Cellectis. “Professors Gribben, van Besien, Rai and Thieblemont are strong supporters of Cellectis’ allogeneic, ‘off-the-shelf’ approach to developing immunotherapies. The in-depth experience of these leading physicians across the hematologic malignancies / stem cell transplant, immunotherapy and hematology-oncology clinical research fields will greatly inform our ongoing work to address the unmet needs of different patient populations globally.”

Professor Gribben holds the Gordon Hamilton Fairley Chair of Medical Oncology at St. Bartholomew's Hospital, Barts Cancer Institute, Queen Mary, University of London, where his research group is currently focused on immunological approaches to the treatment of hematological cancers. He was a research fellow at University College London and Dana-Farber Cancer Institute, Harvard Medical School. He joined the faculty at Harvard Medical School, the Dana-Farber Cancer Institute and Brigham and Women's Hospital in 1992. He is a founding member of the CLL Research Consortium, was Associate Editor of Blood from 2008-2014 and was elected a Fellow of the Academy of Medical Science. He will be President–Elect of The European Hematology Association (EHA) from 2017 to 2019.

Professor van Besien serves as Director of the Stem Cell Transplant Program at Weill Cornell Medical Center and is an Attending Physician at New York Presbyterian Hospital. A graduate of the College ND de la Paix in Namur, Belgium, and University of Leuven, Belgium. Professor van Besien also holds a PhD from the University of Maastricht in the Netherlands. He completed a hematology/oncology fellowship at Indiana University and in Bruges, Belgium, and was a faculty member of the transplant program at MD Anderson Cancer Center. The Professor also directed the transplant program at the University of Illinois and the transplant and lymphoma programs at the University of Chicago. He is Editor-in-chief of Leukemia and Lymphoma.

Professor Rai, an internationally renowned leukemia researcher and hematologist, brings extensive knowledge and experience from his 50-year career spanning groundbreaking clinical leukemia research. He is the Joel Finkelstein Cancer Foundation Professor of Medicine at the Hofstra North Shore-LIJ School of Medicine, where he is also Professor of Molecular Medicine. He is currently Chief of the Chronic Lymphocytic Leukemia (CLL) Research and Treatment Program at Northwell Cancer Institute and an Investigator at The Feinstein Institute for Medical Research.

Professor Thieblemont is Professor of Hematology in the Paris VII- University, France, and Head of the Hemato-Oncology Department in the Hospital Saint-Louis – Paris, France, where she develops specific therapeutic programs for refractory/relapsed lymphomas and chronic lymphocytic leukemia. She belongs to the administrative and scientific committees of the LYSA, the lymphoma study association, to the board of directors of the IELSG, the International extranodal lymphoma study association, and to the Fellowships and Grants Committee of The European Hematology Association (EHA).

“As Cellectis is expected to start the world’s first clinical trial to ever use an allogeneic CAR T therapy in the U.S., the Company’s Clinical Advisory Board will greatly guide us in moving full steam ahead,” added Dr. Hoang-Sayag. “The goal is that the allogeneic CAR T cell approach will lead to a drug that is cost-effective, easily distributed across all geographies and immediately available to patients in need. We are thrilled to have Professors Gribben, van Besien, Rai and Thieblemont onboard as we inch closer to reaching this monumental milestone for cancer patients everywhere and revolutionizing cancer treatment as we know it today.”

January 23, 2017 – New York (N.Y.) – Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced the publication of a study in Scientific Reports, a Nature Publishing Group journal, describing a novel approach to a CAR design with an integrated environmental signal utilizing oxygen concentration to manipulate the CAR T-cell response.

In this report, Alexandre Juillerat, Ph.D. and his collaborators from the Cellectis innovation team designed a new CAR architecture that contains an integrated microenvironment sensor. Low oxygen concentration is recognized as a hallmark of the microenvironment of certain solid tumors. The implementation of the novel oxygen sensitive CAR architecture empowers CAR T-cells with the possibility to auto-regulate (switch on or tune-up) their functions in low oxygen (hypoxic) environments.

With the primary purpose of implementing additional levels of safety to the CAR T-cell technologies, in particular to minimize "on-target / off-tumor” effects, this study demonstrated the possibility to use peculiarities of the tumor microenvironment to create self-decision making CAR T-cells with impaired functions at high oxygen concentration. The results showed that this system also possessed the key feature to be prone to quickly return to its off state in the absence of the inducing signal (hypoxia), a characteristic that is of prime interest to protect healthy tissues distant from the tumor site. Beyond this first in vitro proof of concept, additional studies are expected to fully assess the therapeutic potential of this approach.

Alexandre Juillerat, Ph.D. Innovation Senior Scientist

Dr. Alexandre Juillerat, Ph.D., graduated in Chemistry from the University of Lausanne, Switzerland. After receiving in 2006 his Ph.D. in protein engineering from the École Polytechnique Fédérale de Lausanne (EPFL, Switzerland), he moved to the laboratory of Structural Immunology at the Institut Pasteur in Paris, France, performing structure-function studies on a major adhesin of plasmodium falciparum. In 2010, he joined the R&D department of Cellectis in Paris, France, working on the development and implementation of sequence specific designer nucleases including the transcription activator-like effector nucleases TALEN®. He then joined the Cellectis facility based in New York, NY, USA, leading projects associated with the development of the T-cell chimeric antigen receptor (CAR) technology.

An oxygen sensitive self-decision making engineered CAR T-cell

Alexandre Juillerat, Alan Marechal, Jean Marie Filhol, Yannick Valogne, Julien Valton, Aymeric Duclert, Philippe Duchateau and Laurent Poirot

http://www.nature.com/articles/srep39833

To access the live webcast of Cellectis’ presentation and subsequent breakout session, please visit http://www.cellectis.com/en/events. A replay of the webcast will be available on Cellectis’ website for 90 days.

Pending regulatory clearance, Cellectis plans to initiate Phase 1 clinical trials in the first half of 2017. This is the first IND filing for human clinical applications of a gene edited allogeneic “off-the-shelf” product candidate in the U.S. UCART123 is a gene edited T-cell investigational drug that targets CD123, an antigen expressed at the surface of leukemic cells in AML, as well as on leukemic and other tumoral cells in BPDCN.

The UCART123 program was subject to a public hearing by the National Institutes of Health's Recombinant DNA Advisory Committee (RAC) in December 2016, where it received the unanimous approval of the RAC committee members.

AML is a devastating clonal hematopoietic stem cell neoplasm that is characterized by uncontrolled proliferation and accumulation of leukemic blasts in bone marrow, peripheral blood and, occasionally, in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure and death. In the U.S. alone, there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year.

The clinical research at Weill Cornell will be led by principal investigator Dr. Gail J. Roboz, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine. BPDCN is a very rare and aggressive hematological malignancy that is derived from plasmacytoid dendritic cell precursors. BPDCN is a disease of bone marrow and blood cells but also often affects skin and lymph nodes.

The UCART123 clinical program at MD Anderson will be led by Dr Naveen Pemmaraju, MD, Assistant Professor, and Professor Hagop Kantarjian, MD, Department Chair, Department of Leukemia, Division of Cancer Medicine.

The manufacturing process of Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. Their production can be industrialized and standardized with defined pharmaceutical release criteria.

“Following a Pre-IND meeting with the FDA in August 2016 and a NIH-RAC public hearing in December 2016, filing this IND is an important regulatory milestone for the Company. It represents many years of research and development by a dedicated team focused on developing highly innovative UCART products for the benefit of patients”, stated Stephan Reynier, Chief Regulatory and Compliance Officer, Cellectis.

Chief Medical Officer, Dr. Loan Hoang-Sayag, commented: “UCART123 represents a unique therapeutic approach for patients with unmet medical needs such as relapsed or refractory AML, high risk AML and BPDCN and we are excited to move this experimental product into clinical development. We have designed robust Phase 1 clinical trials to better understand the potential of UCART123 to address the needs of different patient populations.”

Information about ongoing clinical trials are publically available on dedicated websites such as:

www.clinicaltrials.gov in the U.S.

www.clinicaltrialsregister.eu in Europe

The call will be held this Tuesday, December 20, 2016 at 8:30 am Eastern Time and can be accessed with the following dial-in information

Dial-in information:

Participant dial in (Toll Free US & Canada): 877-407-3104

Participant international dial in: +1 201-493-6792

This conference call will be recorded and made available for replay for 14 days as follows:

Conference ID #: 13625168

Replay Dial-In (Toll Free US & Canada): 877-660-6853

Replay Dial-In (International): 201-612-7415

Expiration Date: 1/3/17

Cellectis will host a conference call in the next coming days. The details will be communicated shortly.

The RAC hearing was held on December 14, 2016 during a session dedicated to UCART projects and TALEN® based gene editing. This was the first time that allogeneic CAR T-cell programs gene edited with TALEN® technology were presented during a RAC hearing.

Cellectis expects to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) by the end of 2016 and, pending FDA clearance, plans to initiate Phase 1 clinical trials in the first half of 2017. These programs will be the first therapeutic applications of a gene edited allogeneic “off-the-shelf” product candidate in the U.S.

UCART123 is a gene edited T-cell product candidate that targets CD123, an antigen that is located on CD123-expressing leukemic cells in AML, as well as in leukemic and other tumoral cells in BPDCN.

AML is a devastating clonal hematopoietic stem cell neoplasm that is characterized by uncontrolled proliferation and accumulation of leukemic blasts in bone marrow, peripheral blood and, occasionally, in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure and death. In the U.S. alone, there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year.

The clinical research at Weill Cornell will be led by principal investigator Dr. Gail J. Roboz, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine.

BPDCN is a very rare and aggressive hematological malignancy that is derived from plasmacytoid dendritic cell precursors. BPDCN is primarily a disease of bone marrow and blood cells but also often affects skin and lymph nodes.

The UCART123 clinical program at MD Anderson will be led by Professor Hagop Kantarjian, MD, Department Chair, Department of Leukemia, Division of Cancer Medicine and Professor Naveen Pemmaraju, MD, Assistant Professor.

Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. Their production can be industrialized and standardized with defined pharmaceutical release criteria.

About RAC

The Recombinant DNA Advisory Committee (RAC) is a federal advisory committee that provides recommendations to the NIH Director related to basic and clinical research involving recombinant or synthetic nucleic acid molecules. The NIH, through the RAC, reviews the most innovative clinical study protocols involving a gene therapy product.

New York, N.Y. – November 22, 2016 – Cellectis S.A. (Alternext: ALCLS - Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced its results for the three-month period ended September 30, 2016 and for the nine-month period ended September 30, 2016.

Recent Corporate Highlights

UCART19 in collaboration with Servier / Pfizer

• On June 20, 2016, Cellectis announced that the first patient in Servier’s UCART19 Phase 1 clinical trial had been dosed. The UCART19 Phase 1 clinical trial in ALL and CLL patients is conducted at two clinical sites in the UK – at the Great Ormond Street Hospital (GOSH), part of UCL, for the pediatric arm of the trial, and at Kings College London for the adult arm of the study.

• Interim data from the UCART19 Phase 1 clinical trial is expected to be announced at a scientific meeting in H1 2017.

UCART123

• On November 15, 2016, Cellectis announced the successful completion of large scale production runs of UCART123, according to cGMP standards. Cellectis is planning to file an IND for a Phase 1 clinical trial in AML and BPDCN patients by YE 2016 in collaboration with the Weill Cornell Medical College and the MD Anderson Cancer Center.

• Weill Cornell will present pre-clinical data on UCART123 in an oral presentation at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will be held from December 3 to 6, 2016 in San Diego.

Pfizer Partnership

• Cellectis and Pfizer are making advances in their partnered programs. Notably, Pfizer will present on the “Preclinical Evaluation of Allogeneic Anti-BCMA Chimeric Antigen Receptor T Cells with Safety Switch Domains and Lymphodepletion Resistance for the Treatment of Multiple Myeloma” in an oral presentation at ASH in December 2016.

IP / Patent Portfolio

• Issuance of U.S. patent 9,458,439 – which claims gene inactivation by use of chimeric restriction endonucleases. This patent, granted by the USPTO to the Institut Pasteur and Boston Children's Hospital, naming Dr. André Choulika and Pr. Richard C. Mulligan as co-inventors, is exclusively licensed to Cellectis.

Award

• Cellectis won EuropaBio’s 2016 Most Innovative European Biotech SME Award for the healthcare category. The Awards program is a unique annual initiative that recognizes innovative biotech small- and medium-sized enterprises (SMEs) in Europe and the crucial role that they play in answering some of society’s greatest challenges through biotechnology.

Conferences

• Cellectis will participate in the upcoming Oppenheimer Life Sciences Summit being held in NYC on November 29, 2016 and will be presenting at the Piper Jaffray 28th Annual Health Care Conference on November 30, 2016 in NYC.

Calyxt – Cellectis’ plant science subsidiary

• Calyxt expanded its patent portfolio with U.S. patent 9,458,439, which encompasses broad uses of technologies such as CRISPR/Cas9, Zinc Finger Nucleases and TAL-effector Nucleases for plant gene editing.

• On October 20, 2016 Cellectis hosted, along with its agricultural biotech subsidiary Calyxt, the world’s first dinner made with gene edited foods in New York.

• Calyxt has completed the 2016 expansion of its high-oleic/no trans-fat soybean variety (CAL1501) in the U.S. with a production of 1,200 tons of beans. In Spring 2016, Calyxt planted 942 acres (381 hectares) in six U.S. states – Illinois, Iowa, Michigan, Minnesota, South Dakota and Wisconsin. To date, the Company has harvested approximately 45,000 bushels with the intent to use a substantial portion of the harvest for its first industrial scale crush.

Financial Results

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).

Third Quarter 2016 Financial Results

Cash: As of September 30, 2016, Cellectis had €264.0 million in total cash, cash equivalents and current financial assets compared to €269.7 million as of June 30, 2016. This decrease of €5.7 million notably reflects (i) the net cash flows used in operating activities of €1.7 million, which includes €9.2 million of cash receipts in the third quarter of 2016 in connection with the achievement of two milestones under our collaboration agreement with Servier that occurred during the second quarter of 2016, and (ii) capital expenditures of €2.2 million. The change was also attributable to the unrealized negative translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €1.6 million.

Revenues and Other Income: During the quarters ended September 30, 2015 and 2016, we recorded €10.0 million and €11.3 million, respectively, in revenues and other income. This is mainly due to (i) the increase of €2.5 million in collaboration revenues, notably due to the agreement to provide Servier with raw materials and batches of UCART19 products, partly offset by (ii) the decrease of €0.3 million in research tax credit and €0.8 million in subsidies.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the third quarter of 2016 were €22.9 million, compared to €23.4 million for the third quarter of 2015. The non-cash stock-based compensation expenses included in these amounts were €12.1 million and €9.5 million, respectively.

R&D Expenses: For the quarters ended 2015 and 2016, research and development expenses decreased by €2.3 million from €16.2 million in 2015 to €13.8 million in 2016. Personnel expenses decreased by €1.1 million from €10.3 million in 2015 to €9.2 million in 2016, notably due to a €2.5 million decrease in social charges on stock options and free share grants, partly offset by a €0.4 million increase in wages and salaries, and a €0.9 million increase in non-cash stock based compensation expense. Purchases and external expenses and other expenses decreased by €1.2 million from €5.8 million in 2015 to €4.6 million in 2016.

SG&A Expenses: During the quarters ended 2015 and 2016, we recorded €6.9 million and €8.7 million, respectively, of selling, general and administrative expenses. The increase of €1.8 million primarily reflects (i) an increase of €0.9 million in personnel expenses from €5.7 million to €6.7 million, attributable, among other things, to an increase of €1.7 million of non-cash stock-based compensation expense, partly offset by a decrease of €1.0 million of social charges on stock options and free share grants, and (ii) an increase of €0.9 million in purchases and external expenses and other charges.

Financial Gain (Loss): The financial gain was €0.7 million for the third quarter of 2015 compared with a financial loss of €1.0 million for the third quarter of 2016. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the three months ended September 30, 2015 and 2016, we recorded a net loss of €12.8 million (or €0.36 per share on both a basic and a diluted basis) and net loss of €12.6 million (or €0.36 per share on both a basic and a diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the third quarter of 2016 was €0.5 million (€0.01 per share on both a basic and a diluted basis) compared to adjusted loss attributable to shareholders of Cellectis of €3.3 million (€0.09 per share on both a basic and a diluted basis), for the third quarter of 2015. Adjusted loss attributable to shareholders of Cellectis for the third quarter of 2016 and 2015 excludes non-cash stock-based compensation expense of €12.1 million and €9.5 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.

First Nine Months 2016 Financial Results

Cash: As of September 30, 2016, Cellectis had €264.0 million in total cash, cash equivalents and current financial assets compared to € 314.2 million as of December 31, 2015. This decrease of €50.3 million was primarily driven by (i) €30.8 million of cash used in operating activities, notably in connection with the initiation of industrial Good Manufacturing Practice (“GMP”) production of UCART123, increased expenses in materials required of GMP production of UCART 123 and other targets, a payment of €7.2 million of value added taxes related to proceeds received in the fourth quarter of 2015 from Servier, partly offset by cash receipts of €9.2 million in connection with the achievement of two milestones under our collaboration agreement with Servier that occurred during the second quarter of 2016 and (ii) €11.3 million of cash used in investment activities, primarily through Calyxt’s land acquisition and greenhouse construction in an aggregate amount of €8.9 million. The decrease was also partially attributable to the negative unrealized translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets accounts of €7.4 million.

Cellectis expects that its cash, cash equivalents and Current financial assets of €264.0 million as of September 30, 2016 will be sufficient to fund its current operations through the end of 2018.

Revenues and Other Income: During the nine-month periods ended September 30, 2015 and 2016, we recorded €27.2 million and €38.9 million, respectively, in revenues and other income. This is mainly due to the increase of (i) €9.6 million in collaboration revenues mainly due to both the agreement to provide Servier with raw materials and additional batches of UCART19 products and the achievement of two milestones (totaling €11.7 million) under our collaboration agreement with Servier and (ii) €3.1 million in research tax credit, partly offset by a decrease of €0.9 million in research subsidies, resulting from the termination of research programs.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the nine-month period ended September 30, 2016 were €80.9 million, compared to €56.3 million for the nine months ended September 30, 2015. The non-cash stock-based compensation expenses included in these amounts were €39.9 million and €17.5 million, respectively.

R&D Expenses: For the nine months ended September 30, 2015 and 2016, research and development expenses increased by €15.8 million from €36.4 million in 2015 to €52.2 million in 2016. Personnel expenses increased by €8.4 million from €24.3 million in 2015 to €32.7 million in 2016, notably due to a €1.9 million increase in wages and salaries, and a €12.6 million increase in non-cash stock based compensation expense, partly offset by a €6.1 million decrease in social charges on stock options and free share grants. Purchases and external expenses increased by €7.6 million from €11.0 million in 2015 to €18.6 million in 2016, due to increased expenses related to innovation and platform development, including payments to third parties participating in product development, purchases of biological raw materials and expenses associated with the use of laboratories and other facilities.

SG&A Expenses: During the nine months ended September 30, 2015 and 2016, we recorded €19.1 million and €27.8 million, respectively, of selling, general and administrative expenses. The increase of €8.7 million primarily reflects (i) an increase of €7.4 million in personnel expenses from €14.0 million to €21.4 million, attributable, among other things, to a €0.5 million increase in wages and salaries, and an increase of €9.9 million of non-cash stock-based compensation expense, partly offset by a decrease of €3.0 million of social charges on stock options and free share grants, and (ii) an increase of €1.0 million in purchases and external expenses.

Financial Gain (Loss): The financial gain was €0.5 million for the nine months ended September 30, 2015 compared with financial loss of €6.3 million for the nine months ended September 30, 2016. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the nine months ended September 30, 2015 and 2016, we recorded a net loss of €28.8 million (or € 0.85 per share on both a basic and a diluted basis) and a net loss of €48.3 million (or €1.37 per share on both a basic and diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the nine months ended September 30, 2016 was €8.4 million (€0.24 per share on both a basic and a diluted basis) compared to adjusted loss attributable to shareholders of Cellectis of € 11.3 million (€0.33 per share on both a basic and a diluted basis), for the nine months ended September 30, 2015. Adjusted loss attributable to shareholders of Cellectis for the nine months ended September 30, 2016 and 2015 excludes a non-cash stock-based compensation expense of €39.9 million and €17.5 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.

1 Cash position amounted €264 million and was converted to Dollars using Euro-US Dollar exchange rate as of September 30, 2016: 1.1161

2 Converted from Euro to Dollars using Euro-US Dollar average exchange rate for the 3rd quarter of 2016: 1.1166

3 See the section related to the reconciliation of Gaap to non-Gaap net income. GAAP Net Loss attributable to shareholders amounted to $15 million (€13 million) in the 3rd quarter of 2016

Cellectis will be presenting at the Piper Jaffray 28th Annual Health Care Conference. Cellectis presentation will take place on November 30, 2016 at 8:00AM US Eastern Time in Lotte New York Palace - 455 Madison Ave, Track Three - Holmes 1 - 4th Floor.

A live webcast will be available at http://edge.media-server.com/m/p/xbcsg2nz

The replay is available via the same link.

The cGMP manufacturing of UCART123 clinical batches has been operated with CELLforCURE, a LFB group company and the largest industrial facility for clinical and commercial production of innovative cell and gene therapies in Europe. CELLforCURE is in charge of implementing cGMP manufacturing processes that are designed and developed by Cellectis.

The manufacturing process for Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. Their production can be industrialized and standardized with defined pharmaceutical release criteria.

UCART123 is an engineered T-cell product candidate that targets CD123, an antigen that is located on CD123-expressing leukemic cells in AML as well as leukemic and other tumoral cells in BPDCN. We are planning to file an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) in order to initiate clinical studies. AML is a devastating clonal hematopoietic stem cell neoplasm characterized by uncontrolled proliferation and accumulation of leukemic blasts in the bone marrow, peripheral blood, and occasionally in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure and death. In the U.S. alone, there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year.

Preclinical and translational activities on UCART123 in AML are performed in collaboration with Dr. Monica Guzman, Associate Professor of Pharmacology in Medicine at Weill Cornell Medical College. The clinical research at Weill Cornell will be led by principal investigator Dr. Gail J. Roboz, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine.

BPDCN is a very rare and aggressive hematological malignancy that is derived from plasmacytoid dendritic cell precursors. BPDCN is primarily a disease of the bone marrow and blood cells, but also often affects skin and lymph nodes.

Cellectis collaborates with the MD Anderson Cancer Center on the preclinical development of UCART123 in BPDCN preliminary to the Phase I clinical trial in BPDCN to be activated. The UCART123 clinical program at MD Anderson will be led by Professor Hagop Kantarjian, MD, Department Chair, Department of Leukemia, Division of Cancer Medicine.

“We are proud of achieving this important milestone for UCART123, our first wholly owned product candidate. The successful translation of an R&D concept into a cGMP clinical grade industrial product is one of the key gating factors for us to move into clinical trials,” said Arjan Roozen, Vice President, GMP Solutions and Manufacturing.

“With this work and Cellectis’ breakthrough TALEN®-based gene editing technology, we continue building upon the Company’s milestones as a pioneer in the field, strengthening our pipeline and bringing us closer and closer to finding efficient and cost-effective products for cancer patients across the globe,” added David J.D. Sourdive, Executive Vice President, Corporate Development, Cellectis.

The dinner held on Thursday, Oct. 20, 2016 in New York required a six-month preparation time entrusted to The Lab-Ducasse Conseil’s chefs and experts with a series of trials where the ingredients were cooked and tasted in a variety of ways. Attendees included university professors, doctors, reporters, celebrities, entrepreneurs and key opinion leaders.

The six-course dinner was comprised of a variety of foods that incorporated a selection of Calyxt’s recently harvested gene edited high-oleic soybeans and potatoes. The dinner featured Tofu and soy burgers, Hummus soy, gilt-headbream, lemon, Oven-baked potato pie or Soy with marinated fish and caviar, among other dishes. Calyxt uses its innovative TALEN® technology to create foods with healthier characteristics by making precise deletions in a crop’s DNA, without adding any foreign DNA.

“This dinner – truly a meal of the 21st century – marks a groundbreaking milestone for both Cellectis and Calyxt,” said Dr. André Choulika, Cellectis CEO and Calyxt president. “It not only represents a historic moment for the food, agriculture and biotech industries but also for people all over the world who are in search of an answer to address some of the biggest health issues in today’s society. This meal is a clear indicator of how gene editing will ultimately transform what we put on our plates in the near future. This was the first harvest dinner, and millions of people will be able to experience these same foods in the near future.”

“Gene editing holds an immense potential to improve lives and nutrition while minimizing our environmental footprint through the foods that we produce and eat,” added Federico Tripodi, Calyxt CEO. “We believe that Calyxt’s high-quality food ingredients will meet the challenges that are related to sustainable growth and climate change, while simultaneously addressing societal issues like obesity, diabetes and high cholesterol / blood pressure. The possibilities are endless; every day, consumers are increasingly mindful of the foods that they eat, and our products will be developed to help families meet those needs. This dinner was the first step to achieving this reality and positively impacting consumers’ lives in the months and years to come.”

Photos from the meal and the full menu are available upon request.

October 4, 2016 – New York (NY) – Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced the issuance of U.S. patent 9,458,439 – which claims gene inactivation by use of chimeric restriction endonucleases. This patent granted by the USPTO to the Institut Pasteur and Boston Children's Hospital naming Dr. André Choulika and Pr. Richard C. Mulligan as co-inventors, is exclusively licensed to Cellectis.

This issued U.S. patent 9,458,439 claims the method of introducing chromosomal modifications at a locus by induction of double-stranded DNA cleavage using a chimeric restriction endonuclease and non-homologous end joining recombination (NHEJ). This pivotal invention is at the basis of current nuclease-based precise gene inactivation techniques using chimeric restriction endonuclease such as Cas9/CRISPR (and related families), Zinc finger Nucleases, TAL-Effector Nucleases, Mega-TALEs, some Meganucleases i.e. endonucleases generated by the juxtaposition of specific DNA binding sequences and DNA cleavage domains with a recognition site of at least 12 base pairs. This technology is universal as it can be applied to any types of cells, including human, animal, plant cells or microorganisms.

This new patent follows U.S. patent 8,921,332 issued on December 30th, 2014, which claims the use of chimeric restriction endonucleases for directing chromosomal gene editing in cells by homologous recombination.

This new patent complements Cellectis’ strong portfolio of gene editing technologies that are implemented in its CAR T-cell product candidates, as well as within its Minnesota-based agricultural biotechnology subsidiary, Calyxt, which develops food products with healthier characteristics.

The inventors of this patent are Dr. André Choulika, Chairman & CEO of Cellectis and one of the pioneers in the development of nuclease-based genome editing technologies, and Professor Richard C. Mulligan, Mallinckrodt Professor of Genetics, Emeritus, at Harvard Medical School and a Founding Partner of Sarissa Capital Management. Professor Mulligan is a world-renowned scientist and former member of Cellectis’ Board of Directors whose laboratory has made seminal contributions to the development of fundamental gene transfer and gene therapy technologies.

Claim 1 of the U.S. patent 9,458,439: “A method for attenuating or inactivating an endogenous gene of interest in a cell in vitro comprising: inducing in the cell double stranded cleavage of chromosomal DNA at a genomic site of interest in the specific sequence to be modified, wherein the inducing comprises contacting the genomic site of interest with a chimeric restriction endonuclease, said chimeric restriction endonuclease comprising a DNA binding sequence and a DNA cleavage domain, and said restriction endonuclease recognizing a DNA sequence of at least 12 bp, wherein said restriction endonuclease is introduced as a protein or is encoded by a nucleic acid vector that is expressed, thereby inducing a cellular repair mechanism which leads to highly efficient recombinational events at said genomic site of interest, wherein said recombinational events introduce a mutation into said genomic site of interest, thereby modifying the specific sequence in the chromosomal DNA of the cell and thereby attenuating or inactivating an endogenous gene of interest in said cell.”

Claim 1 of the U.S. patent 8,921,332: “A method of modifying a specific sequence in chromosomal DNA of a cell in vitro comprising: inducing in the cell double stranded cleavage of chromosomal DNA at a genomic site of interest in the specific sequence to be modified, wherein the inducing comprises contacting the genomic site of interest with a chimeric restriction endonuclease, said chimeric restriction endonuclease comprising a DNA binding sequence and a DNA cleavage domain, and said restriction endonuclease recognizing a DNA sequence of at least 12 bp, wherein said restriction endonuclease is introduced as a protein or is encoded by a nucleic acid vector that is expressed; and contacting said cell with a targeting DNA or a nucleic acid vector encoding said targeting DNA in an amount sufficient to produce recombination between said targeting DNA and said chromosomal DNA at the site of interest, wherein said targeting DNA comprises (1) DNA homologous to the region surrounding the genomic site of interest and (2) DNA which modifies the specific sequence upon recombination between said targeting DNA and said chromosomal DNA, thereby modifying the specific sequence in the chromosomal DNA of the cell.”

Cellectis’ selection was based on the Company’s contribution to and impact on the global healthcare and life sciences industries via its development and therapeutic application of allogeneic CAR T-cell immunotherapies that target cancer. In this process, T-cells from healthy donors are genetically edited with Cellectis’ TALEN® technology to seek and destroy cancer cells.

“It is an honor for Cellectis to receive this award for our pioneering gene editing technology and immunotherapies, which will bring cutting-edge cancer treatment globally to patients who have high unmet medical needs,” said Dr. André Choulika, Chairman and Chief Executive Officer, Cellectis. “As we work hard to bring our product candidates to patients, programs like the EuropaBio SME Awards create an environment of strong support and a platform for discussing continuing innovation for bioscience companies across the board.”

“Raising the profile for innovative biotech companies in Europe, both collectively and individually, offers the opportunity to demonstrate the enormous potential of our entrepreneurs in this sector,” added Tom Saylor, Chairman of the EuropaBio SME Platform. “Finalists enjoy the chance to showcase their capabilities to potential partners, investors and collaborators, and past finalists have shown that this award can provide a platform for access to resources and exposure that can contribute to ongoing success in the future.”

New York, N.Y. – September 8, 2016 – Cellectis S.A. (Alternext: ALCLS - Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced its results for the three-month period ended June 30, 2016 and for the six-month period ended June 30, 2016.

Recent Corporate Highlights

Cellectis

• A Phase I study of UCART19 in pediatric acute B lymphoblastic leukemia (B-ALL) was initiated at the University College of London (UCL), with the first dose administered to a patient in June 2016. This UCART19 clinical trial is sponsored by Servier in close collaboration with Pfizer.

• Cellectis employees presented important scientific presentations: o An intrinsic safeguard Chimeric Antigen Receptor architecture for T-cell immunotherapy, presented by Julien Valton at ASCO, Chicago; o Allogeneic TCRα/CD38 double knockout T-cells bearing an anti-CD38 Chimeric Antigen Receptor (CAR): an improved immunotherapy for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and multiple myeloma (MM), presented by Mathilde Dusseaux at EHA, Copenhagen, Denmark.

• The MIT Technology Review has named the Company on its Annual List of 50 Smartest Companies for the second year in a row.

• Cellectis has been selected as a 2016 World Economic Forum Technology Pioneer, a credential that is awarded annually to the most innovative and impactful companies developing new technologies around the world.

Calyxt – Cellectis’ plant science subsidiary

• Appointment of former Monsanto Corporation executive Federico A. Tripodi to the role of Chief Executive Officer, a key hire for the execution of the commercial business plan and market launch of lead programs.

• Completed the expansion of its high-oleic / no-trans-fat (HO) soybean variety in Argentina, as part of its counter-season seed production. Thirty tons of HO soybean seeds have been shipped to production sites in the United States for further expansion, in preparation for an initial commercial launch expected in 2018.

• Calyxt hosted an R&D Day in New York City on May 26. Speakers reviewed advancements made in the plant science community with a focus on Calyxt’s plant engineering platform. Additionally, management provided an overview of Calyxt’s crop programs.

Financial Results

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).

Second Quarter 2016 Financial Results

Cash: As of June 30, 2016 Cellectis had €269.7 million in total cash, cash equivalents and current financial assets compared to €276.5 million as of March 31, 2016. This decrease of €6.8 million notably reflects (i) the net cash flows used in operating activities of €7.6 million and (ii) fixed assets expenditure of €2.4 million. The change was also attributable to the unrealized positive translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €5.8 million.

Revenues and Other Income: During the quarters ended June 30, 2015 and 2016, we recorded €8.0 million and €18.1 million, respectively, in revenues and other income. This is mainly due to the increase of (i) €8.6 million in collaboration revenues, notably due to the achievement of two milestones under our collaboration agreement with Servier and (ii) €1.5 million in research tax credit.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the second quarter of 2016 were €28.2 million, compared to €20.1 million for the second quarter of 2015. The non-cash stock-based compensation expenses included in these amounts were €14.4 million and €7.1 million, respectively.

R&D Expenses: For the quarters ended June 30, 2015 and 2016, research and development expenses increased by €6.7 million from €12.8 million in 2015 to €19.5 million in 2016.Personnel expenses increased by €2.4 million from €9.3 million in 2015 to €11.6 million in 2016, notably due to a €0.5 million increase in wages and salaries, and a €4.5 million increase in non-cash stock based compensation expense, partly offset by a €2.6 million decrease in social charges on stock options and free share grants. Purchases and external expenses increased by €4.3 million from €3.2 million in 2015 to €7.5 million in 2016, due to increased expenses related to innovation and platform development, including payments to third parties participating in product development, purchases of biological raw materials and expenses associated with the use of laboratories and other facilities.

SG&A Expenses: During the quarters ended June 30, 2015 and 2016, we recorded €6.9 million and €8.6 million, respectively, of selling, general and administrative expenses. The increase of €1.7 million primarily reflects (i) an increase of €1.9 million in personnel expenses from €4.6 million to €6.5 million, attributable, among other things, to an increase of €2.7 million of non-cash stock-based compensation expense, partly offset by a decrease of €0.9 million of social charges on stock options and free share grants, and (ii) a decrease of €0.3 million in purchases and external expenses.

Financial Gain (Loss): The financial loss was €10.0 million for the second quarter of 2015 compared with a financial gain of €3.8 million for the second quarter of 2016. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the three months ended June 30, 2015 and 2016, we recorded a net loss of €22.2 million (or €0.63 per share on both a basic and a diluted basis) and net loss of €6.3 million (or €0.18 per share on both a basic and a diluted basis), respectively. Adjusted income attributable to shareholders of Cellectis for the second quarter of 2016 was €8.1 million (€0.23 per share on both a basic and a diluted basis) compared to Adjusted loss attributable to shareholders of Cellectis of €15.0 million (€0.43 per share on both a basic and a diluted basis), for the second quarter of 2015. Adjusted income (loss) attributable to shareholders of Cellectis for the second quarter of 2016 and 2015 excludes non-cash stock-based compensation expense of €14.4 million and €7.2 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.

First Half Year 2016 Financial Results

Cash: As of June 30, 2016 Cellectis had €269.7 million in total cash, cash equivalents and current financial assets compared to €314.2 million as of December 31, 2015. This decrease of €44.5 million was primarily driven by (i) €27.2 million of cash used in operating activities in connection with the initiation of industrial Good Manufacturing Practice (“GMP”) production of UCART123, increased expenses in materials required of GMP production and a payment of €7.2 million of value added taxes related to proceeds received in the fourth quarter of 2015 from Servier, and (ii) €10.8 million of cash used in investment activities, primarily through Calyxt’s land acquisition and greenhouse construction in an aggregate amount of €8.9 million. The decrease was also partially attributable to the negative unrealized translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets accounts of €5.8 million.

Cellectis expects that its cash, cash equivalents and Current financial assets of €269.7 million as of June 30, 2016 will be sufficient to fund its current operations through the end of 2018.

Revenues and Other Income: During the six months ended June 30, 2015 and 2016, we recorded €17.2 million and €27.6 million, respectively, in revenues and other income. This is mainly due to the increase of (i) €7.1 million in collaboration revenues notably due to the achievement of two milestones under our collaboration agreement with Servier and (ii) €3.4 million in research tax credit.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the first half of 2016 were €58.1 million, compared to €32.9 million for the first half of 2015. The non-cash stock-based compensation expenses included in these amounts were €27.8 million and €8.0 million, respectively.

R&D Expenses: For the six months ended June 30, 2015 and 2016, research and development expenses increased by €18.2 million from €20.2 million in 2015 to €38.4 million in 2016. Personnel expenses increased by €9.5 million from €13.9 million in 2015 to €23.5 million in 2016, notably due to a€1.4 million increase in wages and salaries, and a €11.6 million increase in non-cash stock based compensation expense, partly offset by a €3.5 million decrease in social charges on stock options and free share grants. Purchases and external expenses increased by €8.5 million from €5.7 million in 2015 to €14.2 million in 2016, due to increased expenses related to innovation and platform development, including payments to third parties participating in product development, purchases of biological raw materials and expenses associated with the use of laboratories and other facilities.

SG&A Expenses: During the six months ended June 30, 2015 and 2016, we recorded €12.2 million and €19.2 million, respectively, of selling, general and administrative expenses. The increase of €6.9 million primarily reflects (i) an increase of €6.5 million in personnel expenses from €8.3 million to €14.8 million, attributable, among other things, to an increase of €8.2 million of non-cash stock-based compensation expense, partly offset by a decrease of €2.0 million of social charges on stock options and free share grants, and (ii) an increase of €0.4 million in purchases and external expenses.

Financial Gain (Loss): The financial loss was €0.2 million for the first half year of 2015 compared with financial loss of €5.3 million for the first half year of 2016. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the six months ended June 30, 2015 and 2016, we recorded a net loss of €16.0 million (or €0.48 per share on both a basic and a diluted basis) and a net loss of €35.7 million (or €1.01 per share on both a basic and diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the first half of 2016 was €7.9 million (€0.22 per share on both a basic and a diluted basis) compared to Adjusted income attributable to shareholders of Cellectis of €8.0 million (€0.24 per share on both a basic and a diluted basis), for the first half of 2015. Adjusted loss attributable to shareholders of Cellectis for the first half of 2016 and 2015 excludes a non-cash stock-based compensation expense of €27.8 million and €8.0 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.

1 Euro-US Dollar exchange rate as of June 30, 2016: 1.1102

² Euro-US Dollar average exchange rate for the 2nd quarter 2016: 1.1293

3 See the section related to the reconciliation of gaap to non-gaap net income. GAAP Net Loss attributable to shareholders amounts to $7 million (€6 million) in the 2nd quarter of 2016

MIT Technology Review listed immune engineering as one of its 10 Breakthrough Technologies of 2016, a field that Cellectis has continued to shape and impact via the Company’s development and therapeutic application of allogeneic CAR T-cell immunotherapies targeting cancer. In this process, T-cells from healthy donors are genetically edited with Cellectis’ proprietary TALEN® technology to seek and destroy cancer cells.

In late 2015 and early 2016, two groundbreaking compassionate care cases have been reported with UCART19, an “off-the-shelf” gene edited T-cell product that has been designed and manufactured by Cellectis. What’s more is that earlier this month, Cellectis also announced that the first patient has been dosed in a Phase I UCART19 study for Leukemia.

“We are honored that MIT Technology Review has once again selected Cellectis for this award and it is truly gratifying to be recognized among such innovative and pioneering industry leaders,” said Dr. André Choulika, Chairman and Chief Executive Officer of Cellectis. “At Cellectis, we make it our mission to not only push the boundaries for what’s possible in the global healthcare and life sciences spaces but also work to redefine what standard cancer treatment looks like for patients in need all over the world.”

Cellectis’ selection was based on its contribution to and impact on the global healthcare and life sciences industries via the Company’s development and therapeutic application of allogeneic CAR T-cell immunotherapies targeting cancer. In this process, T-cells from healthy donors are genetically edited with Cellectis’ proprietary TALEN® technology to seek and destroy cancer cells.

In late 2015 and early 2016, two groundbreaking compassionate care cases have been reported with UCART19, an “off-the-shelf” gene edited T-cell product that has been designed and manufactured by Cellectis.

“We are thrilled to be recognized for our achievements and honored to share this title alongside other global creators, innovators, scientists and business leaders who are constantly raising the bar with their expertise, ideas and technologies,” said Dr. André Choulika, Chairman and Chief Executive Officer, Cellectis. “This collaboration, facilitated by the World Economic Forum, is an important building block for the future of scientific and technological breakthroughs and fits perfectly into Cellectis’ strategy of developing innovative products in an effort to eradicate cancer.”

“The World Economic Forum's Technology Pioneers community recognizes companies from around the world that are involved in the design, development and deployment of new technologies that are poised to have a significant impact on business and society,” said Fulvia Montresor, Head of Technology Pioneers, World Economic Forum. “Technology Pioneers are companies that develop and apply the most innovative and transformational technologies in diverse fields, and the work that’s undertaken by these companies holds the promise of significantly affecting the way that business and societies operate. Each innovation is another step in society's attempt to harness, adapt and utilize technology to change and improve our world.”

The pediatric Phase I is an open label, non-comparative, monocenter study to evaluate the safety and ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukemia ahead of planned allogeneic haematopoeitic stem cell transplantation (allo-HSCT).

Cellectis will receive a milestone payment from Servier of an undisclosed amount.

About UCART19

UCART19 is an allogeneic CAR T-cell product candidate developed for treatment of CD19-expressing hematological malignancies, gene edited with TALEN®. UCART19 is initially being developed in chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL). Cellectis’ approach with UCART19 is based on the preliminary positive results from clinical trials using autologous products based on the CAR technology, and has the potential to overcome the limitation of the current autologous approach by providing an allogeneic, frozen, “off-the-shelf” T cell based medicinal product.

In November 2015, Servier acquired the exclusive rights to UCART19 from Cellectis. Following further agreements, Servier and Pfizer began collaborating on a joint clinical development program for this cancer immunotherapy. Pfizer has exclusive rights from Servier to develop and commercialize UCART19 in the United States, while Servier retains exclusive rights for all other countries.

At the meeting, during which more than 62% of voting rights were exercised, 21 of 22 resolutions were adopted.

Each of the 21 resolutions, adopted in accordance with the recommendation of the board of directors, received more than 75% votes in favor. Resolution No. 22, regarding a capital increase reserved for members of a company savings plan, was rejected in accordance with the recommendation of the board of directors.

The resolutions adopted by Cellectis' shareholders included:

• The approval of the financial statements for the financial year ended December 31, 2015

• The approval of specified related-party agreements

• The reappointment of Mr. Mathieu Simon to the board of directors

• Authorization of a share repurchase plan and authorization of the retirement of the shares acquired through it

• Delegations of authority given to the board of directors to increase share capital up to specified limits

• Resolutions authorizing Cellectis to grant its executive officers, employees, consultants and directors equity compensation up to specified limits

The full results of the vote can be examined on the company’s website (www.cellectis.com).

New York, N.Y. – May 11, 2016 – Cellectis S.A. (Alternext: ALCLS - Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), today announced its results for the three-month period ended March 31, 2016.

“We are excited to monitor the results presented by Great Ormond Street Hospital – University College of London describing clinical application of allogeneic, off-the-shelf CAR T-cells in young ALL patients with high medical need who exhausted all other treatment options. We are looking forward to seeing more data updates from our partners and bringing our CAR T-cell programs into the clinic, starting with UCART123 for AML patients” said André Choulika, CEO, Cellectis.

Recent Corporate Highlights

• New agreement with CELLforCURE for the cGMP manufacturing of clinical batches of UCART123, Cellectis’ lead product candidate, and for the implementation of cGMP manufacturing processes designed and developed by Cellectis.

• Supply and license agreement with Takara Bio Inc. for recombinant human fibronectin fragment RetroNectin® to support Cellectis’ manufacturing processes and production capabilities.

• Publication in Scientific Reports, part of Nature Publishing Group, describing the design and development of a new CAR architecture with an integrated switch-on system that allows control over CAR T-cell functions.

• Research collaboration and license agreement with MabQuest SA for the development of a new class of anti PD-1 monoclonal antibodies.

• Cellectis gave a presentation at the Cowen and Company 36th Annual Health Care Conference on March 9, 2016 in Boston, MA.

• Scientific presentations at AACR, New Orleans:

• Allogeneic TCRα/CS1 double knockout T-cell bearing an anti-CS1 chimeric antigen receptor: an improved immunotherapy approach for the treatment of Multiple Myeloma, presented by Roman Galetto, Cellectis.
• Improved safety by a non-lethal switch to control CAR activity at the T-cell surface membrane, presented by Laurent Poirot, Cellectis.

• Appointment of Dr. Loan Hoang-Sayag to the role of Chief Medical Officer. Dr. Hoang-Sayag joined Cellectis from Quintiles Transnational, where she was most recently Senior Director of Medical Science.

• Calyxt, Cellectis’ plant science subsidiary, has purchased a 10-acre parcel in the St. Paul suburb of Roseville, MN, to build a new greenhouse and company headquarter.

Financial Results

As previously announced, commencing with this report of first quarter results Cellectis will now publish quarter-over-quarter comparative figures.

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).

First Quarter 2016 Financial Results

Cash: As of March 31, 2016 Cellectis had €276.5 million in total cash, cash equivalents and current financial assets compared to €314.2 million as of December 31, 2015. This notably reflects (i) the initiation of industrial GMP UCART123 production, (ii) increased expenses in GMP materials (iii) payment of €7.2 million of Value Added Taxes related to the proceeds received in the fourth quarter of 2015 from Servier and (iv) Calyxt’s acquisition of a 10-acre parcel for €5.2 million. The change was also attributable to the unrealized translation effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts.

Revenues and Other Income: During the three months ended March 31, 2015 and 2016, we recorded €9.2 million and €9.5 million, respectively, in revenues and other income.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the first quarter of 2016 were €29.9 million, compared to €12.8 million for the first quarter of 2015. The non-cash stock-based compensation expenses included in these amounts were €13.4 million and €0.8 million, respectively.

R&D Expenses: For the three months ended March 31, 2015 and 2016, research and development expenses increased by €11.4 million from €7.4 million in 2015 to €18.9 million in 2016. Personnel expenses increased by €7.2 million from €4.7 million in 2015 to €11.9 million in 2016, notably due to a €1.0 million increase in wages and salaries, and a €7.2 million increase in non-cash stock based compensation expense, partly offset by a €1.0 million decrease in social charges on stock option and free shares grants. Purchases and external expenses increased by €4.2 million from €2.4 million in 2015 to €6.6 million in 2016, due to increased expenses related to innovation and platform development, including payments to third parties participating in product development, purchases of biological raw materials and expenses associated with the use of laboratories and other facilities.

SG&A Expenses: During the three months ended March 31, 2015 and 2016, we recorded €5.4 million and €10.5 million, respectively, of selling, general and administrative expenses. The increase of €5.2 million primarily reflects (i) an increase of €4.5 million in personnel expenses from €3.7 million to €8.3 million, attributable, among other things, to an increase of €5.4 million of non-cash stock-based compensation expense, partly offset by a decrease of €1.1 million of social charges on stock options and free share grants, and (ii) an increase of €0.8 million in purchases and external expenses.

Financial gain (loss): The financial gain was €9.9 million for the first quarter of 2015 compared with financial loss of €9.1 million for the first quarter of 2016, which does not reflect actions undertaken to mitigate the impact of currency exchange rate fluctuations that were adopted at the end of the first quarter of 2016. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts.

Net Loss Attributable to Shareholders of Cellectis: During the three months ended March 31, 2015 and 2016, we recorded a net income of €6.3 million (or €0.20 per share on a basic basis and €0.19 per share on a diluted basis) and a loss of €29.5 million (or €0.84 per share on both a basic and diluted basis), respectively. Adjusted net loss attributable to shareholders of Cellectis for the first quarter of 2016 was €16.1 million (€0.46 per share on both a basic and a diluted basis) compared to adjusted net income attributable to shareholders of Cellectis of €7.0 million (€0.22 per share on both a basic and a diluted basis), for the first quarter of 2015. Adjusted net income (loss) attributable to shareholders of Cellectis for the first quarter of 2016 and 2015 excludes a non-cash stock-based compensation expense of €13.4 million and €0.8 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income to adjusted net income.

Financial Guidance: Cellectis expects that its cash, cash equivalents and Current financial assets of €276.5 million as of March 31, 2016 will be sufficient to fund its current operations through 2018.

The meeting will be held from May 4 to May 7, 2016 in Washington, DC, USA.

Allogeneic CAR T-Cells Targeting CD123 Effectively Eliminate Myeloid Leukemia Cells
Presentation by Julianne Smith, Ph.D., Vice President CART Development at Cellectis
Poster Session: Cancer-Immunotherapy, Cancer Vaccines II
Session Time: Thursday, May 5, 2016, 5:45 PM
Room: Exhibit Hall C & B South
Final abstract number: 397

An Engineered CAR T-Cell Platform for Allogeneic Combination Immunotherapy
Presentation by Philippe Duchateau, Ph.D., Chief Scientific Officer of Cellectis
Poster Session: Cancer-Targeted Gene and Cell Therapy II
Session Time: Friday, May 6, 2016, 6:00 PM - 8:00 PM
Room: Exhibit Hall C & B South
Final abstract number: 676

Integration of Dual Signal Input Strategies in Novel Chimeric Antigen Receptors to Control the CAR T-Cell Functions
Presentation by Alexandre Juillerat, Ph.D., Senior Scientist at Cellectis
Poster Session: Cancer-Immunotherapy, Cancer Vaccines III
Session Time: Friday May 6, 2016 6:00 PM - 8:00 PM
Room: Exhibit Hall C & B South
Final abstract number: 651

Posters will be posted on Cellectis’ website on May 7, 2016.

Access to Takara Bio Inc.’s RetroNectin will secure Cellectis’ manufacturing processes and expand the Company’s UCART production capabilities. Under the terms of the agreement, RetroNectin, which is used for cell engineering, may be applied in the production of both R&D- and GMP-grade Cellectis’ UCART product candidates.

Financial terms of the agreement are not disclosed.

“This agreement with Takara Bio will not only secure the manufacturing of Cellectis’ robust product pipeline but also strengthen our key assets and capabilities in the cell engineering space” said Dr David Sourdive, EVP Corporate Development at Cellectis. “The partnership ultimately furthers our effort to provide universal CAR-Ts for immunotherapy patients all over the world.”

“We are very grateful to provide RetroNectin for Cellectis’ UCAR T-cell manufacturing process, which is one of the world’s most advanced program in immunotherapy” added Dr. Yoh Hamaoka, Senior Executive Officer of Business Development at Takara Bio Inc. “We are pleased that RetroNectin contributes to the development of the emerging gene and cell therapy.”

The action of these PD-1 antibodies is to promote the recovery of T-cells from exhaustion through a new mechanism of action. This new class of antibodies differs from currently approved anti-PD-1 mAbs in that they do not block the PD-1-PD-L1 interaction. These anti-PD-1 mAbs have potential uses for multiple indications in immunotherapy, including notably treatments for a variety of cancers. Cellectis plans to use this new class of anti-PD-1 antibodies either in combination therapy with its gene-edited UCART product candidates or single-agent or in combination with other already approved immunotherapy drugs.

In vitro studies have shown that the combination of these novel PD-1 mAbs with currently approved anti-PD-1 mAbs enhances the recovery of T-cells from exhaustion. Due to their new mechanism of action, these anti-PD-1 mAbs may be used in combination with other PD-1/PD-L1 inhibitors, such as Nivolumab and Pembrolizumab, or other checkpoints inhibitors and immunotherapy approaches for boosting the therapeutic effects of single therapy. Furthermore, this novel class of anti-PD-1 mAbs may represent an alternative and effective therapeutic intervention in those cancer patients with tumors expressing low levels of PD-L1, with respect to the currently approved anti-PD-1 mAbs. In addition, Cellectis intend to combine these PD-1 mAbs with its gene-edited UCART product candidates to enhance their activity and increase their half-life.

The agreement includes a collaboration phase funded by Cellectis whereby Cellectis and MabQuest will jointly pursue preclinical research on several candidate antibodies; and a clinical development and commercialization phase of the best selected antibodies which will be led by Cellectis.

Under the agreement, MabQuest has granted an exclusive option to Cellectis. Upon exercise of the option, Cellectis would be granted worldwide exclusive rights over the family of PD-1 antagonist antibodies developed under the collaboration for all fields, and further potential derivatives of these antibodies.

“We are very pleased to have signed this agreement with MabQuest, with founders and lead scientists who have great expertise in the field of immunology and monoclonal antibodies,” said André Choulika, Chairman and Chief Executive Officer of Cellectis. “This collaboration is an important building block for our gene-edited UCART product candidates and for our immunotherapy franchise. This new partnership fits perfectly into Cellectis’ strategy of expanding our focus in the cancer immunotherapy space with our CAR T-cell based approaches.”

“The collaboration agreement with Cellectis is a tremendous opportunity for MabQuest to move into clinical development with this new class of anti-PD-1 mAbs. This collaboration will also boost MabQuest’s discovery program to develop additional antibody-based strategies to modulate the host immune system,” said Dr. Giuseppe Pantaleo, President of MabQuest and Professor of Medicine and Chief of the Service of Immunology and Allergy at the Lausanne University Hospital, Lausanne, Switzerland.

New York, N.Y. – March 14, 2016 – Cellectis (Alternext: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART), today reported business highlights and financial results for the fourth quarter and year ended December 31, 2015.

“In 2015, Cellectis has reached a key inflection point by applying the first in-human off-the-shelf UCART product candidate. The production of UCART19 in GMP conditions was the gating factor to the filing of the Clinical Trial Application. We believe that our UCART product candidates have the potential to turn an individualized CAR T therapy into universal off-the-shelf products, bringing hope to patients with unmet medical needs. Our U.S. IPO in March 2015 strengthened our financial position to fund our operations over the next years. Our collaborations with Servier and Pfizer are on a strong momentum, and we are forward looking to generating clinical data.” said André Choulika, Chairman and Chief Executive Officer of Cellectis.

Earnings Call Details

Cellectis will host an earnings call on March 15, 2016 at 8:30am Eastern Time to discuss its financial results and provide a general business update.

Dial-In Numbers: Live PARTICIPANT Dial-In (Toll-Free US & Canada): 877-407-3104

Live PARTICIPANT Dial-In (International): +1 201-493-6792

Replay Information: Conference ID #: 13625168

Replay Dial-In (Toll Free US & Canada): 877-660-6853

Replay Dial-In (International): +1 201-612-7415
Expiration Date: 3/22/16

Webcast URL (Archived for 12 months): http://cellectis.equisolvewebcast.com/q4-2015

Recent Corporate Highlights

Cellectis

Manufacturing:

• January 2016 – Start of technology transfer for GMP manufacturing of UCART123 clinical batches, Cellectis’ wholly-owned lead product candidate targeting AML and BPDCN, to CELLforCURE, which will be in charge of implementing GMP manufacturing processes designed and developed by Cellectis.
• October 2015 – Successful completion of a series of three production runs of UCART19, Cellectis’ lead TALEN® gene-edited product candidate, confirming the implementation of Cellectis’ manufacturing process in GMP conditions.

Clinical:

• December 2015 – Submission of a Clinical Trial Application (CTA) to the Medicines & Healthcare products Regulatory Agency (MHRA) requesting approval to initiate Phase I clinical trial of UCART19 product candidate in acute lymphoblastic leukemia (ALL) in the United Kingdom.
• November 2015 – Treatment by physicians at University College London’s Great Ormond Street Hospital (GOSH) of a young patient suffering from aggressive ALL using UCART19 product candidate on a compassionate use basis in June 2015. The encouraging data of this first-in-human clinical use of UCART19 was subsequently presented at the 57th American Society of Hematology (ASH) Annual Meeting in December 2015.

➢ IND filing for first wholly-owned product candidate, UCART123, expected by year end 2016, which would be followed by UCARTCS1.

Corporate:

• November 2015 – Early exercise of Servier’s option on UCART19 product candidate and announcement by Servier and Pfizer of a new global license and collaboration agreement between them. Cellectis received €35.6 million ($38.5 million) upfront from Servier and may receive up to €895 million ($974 million) in further potential option exercise fees and development, clinical and sales milestones, in addition to royalties on sales and research and development costs reimbursements.
• April 2015 – Opening of R&D labs and offices in New York City with staff of 16.
• March 2015 – Completion of Cellectis’ U.S. IPO on the Nasdaq, raising more than $228 million of gross proceeds.

➢ Strong year end 2015 cash position of $342 million (€314 million), which we believe will be sufficient to fund operations until year end 2018.

➢ Alliances remain strong, creating economies of scale in manufacturing costs.

Medical and R&D:

• January 2016 – Appointment of Dr. Loan Hoang-Sayag as Chief Medical Officer. Dr. Hoang-Sayag was Senior Director of Medical Science at Quintiles Transnational prior to joining Cellectis.
• January 2016 – Publication of a study in Scientific Reports, a Nature Publishing Group journal, describing the design and development of a new CAR architecture with an integrated switch-on system that provides control over CAR T-cell functions.
• September 2015 – Entry into a research and development alliance with MD Anderson Cancer Center aimed at bringing novel cellular immunotherapies to patients suffering from different types of liquid tumors.
• June 2015 – Entry into a research and development alliance with The Weill Cornell Medical College (WCMC) aimed at bringing novel cellular immunotherapies to patients suffering from acute myeloid leukemia.

➢ Cellectis continues to be on the forefront of R&D with multiple publications on gene-editing applications and proprietary CAR constructs.

Calyxt, Inc. (“Calyxt”)

• March 2016 – Acquisition of land for new headquarters facility. The new facility will incorporate office space, research labs, green houses as well as land for field trials.
• December 2015 – Confirmation by the USDA that Calyxt’s powdery mildew-resistant wheat product candidate falls outside the scope of plant regulation.
• December 2015 –Research collaboration and licensing agreement signed with Plant Bioscience Limited for trait development in wheat, rice and corn. This new collaboration expands the relationship between Calyxt and Plant Bioscience Limited, boosts the trait development pipeline at Calyxt for gluten-reduced wheat, and provides access to traits in two new crops: rice and corn.
• November 2015 – Completion of first field trial of Calyxt’s cold-storable potato product candidate in Minnesota, Wisconsin and Michigan.
• November 2015 – Harvest of over one ton of high oleic soybean product candidate, after completion of second year of field trial.
• July 2015 – Exclusive worldwide license granted to Calyxt by University of Minnesota under the patent rights of the PCT/US2013/046495 patent family entitled “Gene Targeting Using Replicating DNA Molecules.”
• July 2015 – Calyxt named among the “50 Smartest Companies in 2015” by MIT Technology Review.
• June 2015 – New wheat program added to Calyxt’s pipeline. The trait provides endogenous resistance to powdery mildew of wheat.
• June 2015 – Announcement of alfalfa seed collaboration with S&W Seed Company.
• April 2015 – Confirmation by the USDA that two Calyxt soybean breeds, high oleic and low linolineic, fall outside the scope of plant regulation.
• April 2015 – Exclusive worldwide license granted to Calyxt by University of Minnesota under the patent rights of the WO/2014/144155 patent family entitled “Engineering Plant Genomes Using CRISPR/Cas Systems”.

➢ Calyxt (formerly Cellectis Plant Sciences, Inc.) is positioning its capacities to target a full scale market launch of its soybean program in 2018.

➢ Power of TALEN® technology would enable development of a new plant trait in as few as six years from conception to commercialization at a cost of approximately $6 million.

➢ Maintains a strong intellectual property portfolio. ➢ Positioned to become a leader in the agricultural biotechnology space

Financial Results

Since Cellectis did not have consolidated financial statements for individual quarters during fiscal year 2014, no comparative quarterly 2014 figures will be presented during 2015. Cellectis will publish quarter-over-quarter comparative figures starting with the first quarter of 2016. The audited report for Cellectis’ consolidated financial statements will be included in the Company’s annual report.

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).

Cellectis reclassified certain expenses related to the year ended December 31, 2015 from SG&A expenses to R&D expenses in the fourth quarter of 2015. Personnel and other costs related to information technology, human resources, business development, legal, intellectual property and general management that were initially reported during the first three quarters of 2015 in SG&A have been reclassified as R&D costs based on the time that employees spent contributing to R&D activities versus general and administrative activities. This allocation change is effective starting in 2015, and is due to the increased level of efforts towards our R&D activities in order to develop product candidates and work toward clinical phases. We approved the reallocation in the fourth quarter of 2015 and assess the performance of the Group based on this new classification.

Except for information related to the year ended December 31, 2014, which is based on reported figures, all 2015 information below is based on these reclassified figures.

Fourth Quarter 2015 Financial Results

Cash Position: As of December 31, 2015 Cellectis had €314.2 million in cash and cash equivalents compared to €112.3 million as of December 31, 2014. This increase is primarily attributable to the $228 million of proceeds from Cellectis’ U.S. initial public offering in March 2015 and €42.8 million proceeds in the fourth quarter of 2015 received from Servier in connection with the early exercise of its option to acquire the exclusive worldwide rights to further develop and commercialize UCART19 (including €7.2 million of Value Added Taxes which were repaid in January 2016), partly offset by €39.5 million of net cash flows used in operating activities (excluding the €42.8 million of proceeds from Servier mentioned above), €3.9 million of acquisitions of tangible assets, and the repurchase for €3.5 million of 25% of the minority shares of Cellectis Bioresearch S.A.S, in each case during 2015.

Revenues and Other Income: Total revenues and other income were €29.2 million for the fourth quarter of 2015 and were primarily comprised of €26.8 million of collaboration revenues (including €18.8 million in revenue recorded in relation to the early option exercise by Servier in November 2015), €0.2 million of license revenues (which include Calyxt’s negative adjustments on license revenues related to prior years for €0.7 million) and €2.2 million of research tax credit revenues.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the fourth quarter of 2015 were €28.0 million, which includes non-cash stock-based compensation expenses of €12.6 million.

R&D Expenses: Research and development expenses for the fourth quarter of 2015 were €16.0 million which includes personnel expenses of €11.1 million as well as external purchases and other expenses of €4.9 million. Research and development expenses for the fourth quarter notably reflected the impact of non-cash stock-based compensation expense of €8.2 million.

SG&A Expenses: Selling, general and administrative expenses for the fourth quarter of 2015 were €8.1 million, which includes personnel expenses of €5.6 million as well as external purchases and other expenses of €2.5 million. SG&A expenses for the fourth quarter reflected the impacts of non-cash stock-based compensation expense of €4.4 million.

Financial Gain: Financial gain was €7.0 million for the fourth quarter of 2015, which is primarily attributable to an overall net favorable Euro-Dollar exchange rate applied to U.S. dollar-denominated cash and cash equivalents during this period.

Net income Attributable to Shareholders of Cellectis: Net income attributable to shareholders of Cellectis was €8.2 million (€0.23 per share on both a basic and a diluted basis), for the fourth quarter of 2015. This reflects €18.8 million of revenue recorded in relation to the early option exercise on UCART19 by Servier in November 2015, partly offset by the impact of non-cash stock-based compensation of €12.6 million. Adjusted net income attributable to shareholders of Cellectis for the fourth quarter of 2015, which excludes the non-cash stock-based compensation expense of €12.6 million, was €20.9 million, (€0.59 per share on both a basic and a diluted basis). Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliations of GAAP net income to adjusted net income.

Full Year 2015 Financial Results

Revenues: Revenues for the years ended December 31, 2015 and 2014, were €50.3 million and €21.6 million, respectively. The increase of €28.7 million primarily reflects an increase of €36.4 million in revenues under our collaboration agreements with Servier and Pfizer which was partially offset by a decrease in in-license revenue of €5.3 million, a decrease in R&D services revenue of €1.3 million and a decrease in Product and Services revenue of €1.1 million. Revenues related to collaboration non-cash upfront amortization revenue amounted to €21.3 million in 2015 compared to €13.3 million in 2014.

Other Income: Other income was €6.0 million in 2015 and €4.8 million in 2014. The increase of €1.2 million primarily reflects an increase of €1.7 million in research tax credit, offset by a decrease of €0.5 million in research subsidies.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income were €84.3 million in 2015 and €31.7 million in 2014), which includes (i) non-cash stock-based compensation expenses of €30.1 million and €0.5 million, respectively and (ii) social charges related to free shares and stock-options granted of €12.2 million and €0.2 million, respectively.

R&D Expenses: Research and development expenses were €52.4 million in 2015 and €14.4 million in 2014. These amounts include personnel expenses of €35.5 million and €6.4 million in 2015 and in 2014, respectively, as well as purchases and external expenses and other expenses of €17.0 million and €8.0 million, respectively. The increase of €38.0 million in research and development expenses reflects (i) increased expenditures in 2015 for the development of UCART programs toward their entry into Phase 1 clinical trials, (ii) expenses in 2015 related to the opening of our facility in New York, (iii) non-cash stock-based compensation expense of €18.5 million in 2015 and €0.2 million in 2014 and (iv) social charges on stock-options and free share grants of €7.7 million in 2015 and €0.1 million in 2014.

SG&A Expenses: SG&A expenses were €27.2 million in 2015 and €13.1 million in 2014. SG&A expenses included personnel expenses of €19.6 million in 2015 compared to €5.5 million in 2014, as well as purchases and external expenses and other expenses of €7.7 million in 2015 compared to €7.6 million in 2014. The increase of €14.1 million primarily reflects an increase of €14.1 million in personnel expenses attributable, among other things, to (i) €11.6 million of non-cash stock-based compensation expense in 2015 from €0.3 million in 2014, (ii) €4.5 million of social charges on stock-options and free share grants in 2015 from €0.1 million in 2014, and an increase in professional costs, in each case in connection with our U.S. IPO in March 2015.

Financial gain: Financial gain was €7.6 million in 2015 compared to €7.1 million in 2014. The increase was primarily attributable to a favorable Euro-Dollar exchange rate applied to increased U.S. dollar-denominated cash and cash equivalents during 2015.

Net Income (Loss) Attributable to Shareholders of Cellectis: Net loss attributable to shareholders of Cellectis was of €20.5 million, or €0.60 per share, in 2015, compared to net income attributable to shareholders of Cellectis of €20,000, or €0.11 per share, in 2014. Adjusted net income attributable to shareholders of Cellectis in 2015 was €9.6 million (€0.28 per share on both a basic and a diluted basis) compared to adjusted net income attributable to shareholders of Cellectis of €0.6 million (€0.02 per share on both a basic and a diluted basis), in 2014. Adjusted net income attributable to shareholders of Cellectis in 2015 and 2014 excludes a non-cash stock-based compensation expense of €30.1 million and €0.5 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income to adjusted net income.

The Cellectis presentation will take place on Wednesday, March 9, 2016, from 09:20-09:50 AM US Eastern Time in the Provincetown room, 4th Floor, followed by a breakout session from 10:00-10:30 AM US Eastern Time in the Nantucket room, 4th Floor, at the The Boston Marriott Copley Place Hotel, 110 Huntington Ave, Boston, MA.

A live webcast will be available at http://wsw.com/webcast/cowen30/clls

The new facility, which should be operational around mid-2017, will be comprised of a 35,000 square-foot office and lab building, with greenhouses and outdoor research plots.

Calyxt, Inc., is a Minnesota-based company focused on developing healthier food products to benefit both consumers and growers.

To find out more about Calyxt, please visit their website: www.calyxt.com

Following the recent successful production of UCART19, pursuant to this second agreement CELLforCURE will be responsible for the manufacturing of cGMP clinical batches for UCART123, the lead engineered T-cell product candidate in Cellectis’ wholly owned portfolio. UCART123 targets CD123, an antigen expressed on the surface of cancer cells in malignancies, such as acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cells neoplasm (BPDCN).

UCARTs (Universal Chimeric Antigen Receptor T-cells) are “off-the-shelf” allogeneic product candidates. Their production can be industrialized and standardized with consistent pharmaceutical release criteria, over time and from batch to batch.

Peripheral Blood Monoculear Cells from healthy donors are transduced and genetically edited with Cellectis’ TALEN® technology to seek and destroy cancer cells. This approach could lead to a drug that would be cost-effective, made readily available - “off the shelf” - to broad patient populations in hospitals without need for local CAR-T processing facilities and easily distributed across all geographies.

Dr. David J.D. Sourdive, Executive Vice President Corporate Development, Cellectis, stated: “The manufacturing campaign for UCART123 consolidates Cellectis’ GMP processes and our expertise in its industrialization while allowing Cellectis to further enhance and improve the manufacturing of its UCART product candidates.”

Dr. André Choulika, Chairman & CEO, Cellectis, added: “We are very pleased with our continued collaboration with CELLforCURE, a unique industrial platform dedicated to cell and gene therapies and equipped with a state-of-the-art cGMP manufacturing facility to foster the clinical development of UCART123. Cellectis’ cGMP manufacturing of allogeneic CAR T-cells is a paradigm change in cancer adoptive immunotherapies, for the patient's benefit.”

Pierre-Noël Lirsac, CEO of CELLforCURE stated: “The technical and pharmaceutical experience of the CELLforCURE team is a real asset, bringing its expertise to manufacture Cellectis’ cost-effectively CAR T-cell products, thus helping to make them broadly and immediately available to patients.”

Leopold Bertea, Head of the Global bioproduction division of the LFB group, added: “This new agreement confirms the excellence of the collaboration between Cellectis and CELLforCURE. We are proud to contribute to such an exciting challenge.”

New York, January 11, 2016 – Cellectis (Alternext: ALCLS – Nasdaq: CLLS) today announced the publication of a study in Scientific Reports, a Nature Publishing Group journal, describing the design and development of a new CAR architecture with an integrated switch-on system that permits control over CAR T-cell functions.

This integrated switch-on system offers the advantages of controllable CAR T-cells for safety while allowing for the possibility of multiple cytotoxicity cycles using a small molecule drug.

The possibility to control spatially and temporally the CAR T activity is very desirable to mitigate potential unwanted risks, such as cytokine-release syndrome (CRS)¹ and the “on-target, off-tumor” effect². To date, few strategies are available and mostly rely on suicide mechanisms that ultimately lead to a complete eradication of the engineered T-cells, thus resulting in a premature end of the treatment. Consequently, implementing non-lethal, spatio-temporal control of gene edited CAR T-cells represents an important advancement in improving the CAR T-cell technology.

In this report, Alexandre Juillerat, Ph.D., and his collaborators engineered a system directly integrated within the CAR architecture. In particular, they showed that such system turns a CAR T-cell from an off-state to an on-state upon addition of a small molecule, inducing the cytolytic properties of the gene edited T-cell. Overall, this non-lethal system not only offers the advantage of a temporal control of activation to mitigate the risk of CAR-induced toxicities but also enables opportunities for spatial activation of the engineered CAR T-cells using local targeted drug delivery.

Alexandre Juillerat, Ph.D. Innovation Senior Scientist

Dr. Alexandre Juillerat, Ph.D., graduated in Chemistry of the University of Lausanne, Switzerland. After receiving in 2006 his Ph.D. in protein engineering from the École Polytechnique Fédérale de Lausanne (EPFL, Switzerland), he moved to the laboratory of Structural Immunology at the Institut Pasteur in Paris, France, performing structure-function studies on a major adhesin of plasmodium falciparum. In 2010, he joined the R&D department of Cellectis in Paris, France, working on the development and implementation of sequence specific designer nucleases including the transcription activator-like effector nucleases (TALEN®). He then joined the Cellectis facility based in New York, NY, USA, leading projects associated with the development of the T-cell chimeric antigen receptor (CAR) technology.

Design of chimeric antigen receptors with integrated controllable transient functions

Alexandre Juillerat, Alan Marechal, Jean-Marie Filhol, Julien Valton, Aymeric Duclert, Laurent Poirot and Philippe Duchateau

http://www.nature.com/articles/srep18950

1 CAR T-cell therapy can cause several worrisome side effects, including the cytokine-release syndrome. The infused T-cells release cytokines, which are chemical messengers that help the T-cells carry out their duties. With cytokine-release syndrome, there is a rapid and massive release of cytokines into the bloodstream, which can lead to dangerously high fevers and precipitous drops in blood pressure.

2 Off-tumor/on-target toxicities are the recognition of normal tissues expressing the tumor-associated antigen.

“Dr. Hoang-Sayag’s experience in oncology clinical development – specifically in strategy and delivery in all phases in the pharmaceutical, biotechnology and clinical research spaces – enables her to lead Cellectis’ strategy and generate awareness around the breakthrough work that we are doing as a leader and innovator in the field,” said Dr. André Choulika, Ph.D., Chairman and Chief Executive Officer of Cellectis. “Her relationship-building and communication skills, deep understanding of the global environment in oncology clinical research and close relationships with regulatory and business development units add a high caliber of talent and depth to our current leadership team. This will be extremely beneficial as Cellectis continues to build upon its brand and expand our product candidates into clinical stage development.”

“Dr. Hoang-Sayag’s impressive and extensive professional background makes her a perfect fit for the Cellectis team, as her clinical development expertise will play a key role in helping us to achieve our goals and strategic priorities in 2016 and beyond,” added Dr. Mathieu Simon, MD, Executive Vice President and Chief Operating Officer of Cellectis. “At Cellectis, we have always made it our mission to bring the best and brightest leaders on board, especially at the senior management level, and Dr. Hoang-Sayag fits the bill.”

Dr. Hoang-Sayag is a board-certified physician in hematology and medical oncology with 23 years of experience – eight years in the hospital / university setting and 15 years in oncology clinical development. In her most recent role, she was at Quintiles Transnational for 10 years where she held the positions of Associate Medical Director, Medical Director and Senior Director of Medical Science. Prior to Quintiles, she was at Pierre Fabre Oncology, serving as the oncology project leader in charge of a variety of clinical studies for this France-based pharmaceutical company. Additionally, Dr. Hoang-Sayag was a medical manager at Hoffmann La Roche in France where she was responsible for clinical development and medical affairs activities for several new oncology drugs. Dr. Hoang-Sayag will report to Mathieu Simon, MD, Executive Vice President and Chief Operating Officer of Cellectis.

“CAR T-cell therapy presents great potential to improve cancer patient treatment in a profound way. I am pleased and proud to join Cellectis, which is, by its unique pioneering approach, one of the most highly science-driven, innovative and dynamic biotech company,” said Dr. Hoang-Sayag, Chief Medical Officer at Cellectis.

This study aims to include CD19-positive Acute Lymphoblastic Leukemia (ALL) patients. Other eligibility criteria to enter clinical trials will be assessed by the investigators.

“It has been a privilege preparing this application with our team, partners, investigators and subcontractors, in close interaction with MHRA, rewarding many years of intense work to overcome the challenges that are inherent to advanced therapy medicinal products. This achievement marks an important step toward making UCART19 available to patients,” said Stephan Reynier, Chief Regulatory and Compliance Officer, Cellectis.

"The UCART19 CTA filing is a great recognition for the Company’s preclinical and manufacturing accomplishments in developing a therapeutic for Acute Lymphoblastic Leukemia. We are all pleased with Cellectis’ progress to date with UCART19, including the filing of this CTA, and we look forward to following the progress of this program through the course of its clinical development," said Dr. Mathieu Simon, EVP, Chief Operating Officer, Cellectis.

About UCART19

UCART19 is a potential best-in-class allogeneic TALEN® gene edited T-cell product for treatment of CD19 expressing hematological malignancies, initially developed in Chronic lymphocytic leukemia (CLL) and Acute lymphoblastic leukemia (ALL). Engineered allogeneic CD19 CAR T-cells currently stand out as a real therapeutic innovation for treating various types of leukemia and lymphoma. Cellectis’ approach with UCART19 is based on the preliminary positive results from clinical trials using products based on the CAR technology and has the potential to overcome the limitation of the autologous current approach by providing an allogeneic frozen, “off the shelf” T-cell based medicinal product.

On November 18, 2015 Servier exercised its worldwide option to license UCART19 and entered into a global development and commercialization collaboration with Pfizer on UCART19. According to their recent agreement, Cellectis will hand over the clinical development of UCART19 to Servier and their US partner Pfizer. Due to the early exercise, Cellectis is no longer responsible for funding the UCART19 Phase I clinical program.

Information about ongoing clinical trials are publically available on dedicated websites such as:

www.clinicaltrials.gov in the U.S.

www.clinicaltrialsregister.eu in Europe

The Cellectis presentation will take place on Thursday, January 14, 2016, at 10:30AM Pacific Time, followed by a Q&A session at 11:00AM Pacific Time, at the Westin St. Francis Hotel, San Francisco, California.

November 19, 2015 – New York (USA) and Suresnes (France) – Cellectis (Alternext: ALCLS; Nasdaq: CLLS) and Servier today announced that they signed an amendment to their existing collaboration agreement from February 2014 especially for UCART19, a TALEN® gene-edited allogeneic Chimeric Antigen Receptor T-cell (CAR-T) immunotherapy.

Under this amendment, Servier early exercises its option to acquire the exclusive worldwide rights to further develop and commercialize UCART19, which is about to enter Phase 1 development for chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL).

In addition, Pfizer Inc. (NYSE: PFE) and Servier have entered into an exclusive global license and collaboration agreement to co-develop and commercialize UCART19. Under the terms of the agreement, Pfizer and Servier will work together on a joint clinical development program for UCART19 and share development costs. Pfizer will be responsible for potential commercialization of UCART19 in the United States, and Servier will retain marketing rights in countries outside the United States. Pfizer’s collaboration with Servier on UCART19 is distinct from the collaboration with Cellectis that Pfizer announced in June 2014, which did not include UCART19.

UCART19 utilizes Cellectis’ proprietary, allogeneic approach to develop CAR-T therapies that engineer T-cells from non-patient donors for use in multiple patients. This is different from autologous approaches, which engineer a patient’s own T-cells.

Cellectis will receive from Servier a payment of $38.2 million upon signature. In addition, Cellectis is eligible for over $300 million of milestone payments, R&D financing, and royalties on sales from Servier, based on annual net sales of commercialized products. Financial terms for the Servier agreement with Pfizer were not disclosed.

“Servier’s early option exercise is a strong recognition of the potential value of UCART19 for patients, as the first allogeneic CAR-T therapy expected to move into clinical development that utilizes Cellectis’ TALEN® gene editing technologies,” said Dr. André Choulika, Ph.D., chairman and chief executive officer of Cellectis. “Cellectis aims to provide cancer patients with highly innovative best-in-class allogeneic CAR-T therapies across all geographies, and we are proud to collaborate on this license agreement with Servier and Pfizer to foster access for patients.”

“The partnership between Pfizer and Servier is a major step in the development of UCART19 and our ambition to provide innovative drugs for patients in oncology, as it has been envisioned by Servier’s president, Olivier Laureau,” said Emmanuel Canet, M.D., president, Research and Development at Servier.

“This collaboration on the development of the UCART19 asset builds on Pfizer’s position in the CAR-T space and our growing portfolio of investigational immuno-oncology assets, which is a major priority for our oncology business,” said Mikael Dolsten, M.D., Ph.D., president, Worldwide Research and Development at Pfizer. “This work with Servier and Cellectis underscores our companies’ shared commitment to developing unique cancer therapies that may benefit patients around the world.”

Recent Corporate Highlights

Cellectis

- Completed a series of three production runs of UCART19, its lead TALEN® gene edited product candidate, confirming the implementation of Cellectis’ manufacturing process in GMP conditions.

- Announced that Great Ormond Street Hospital (GOSH) and University College London (UCL) will present, during the 2015 American Society of Hematology Annual Meeting (ASH) in December, data from the first in man clinical use of Cellectis’ TALEN® gene edited allogeneic UCART19 product candidate.

- Announced that a poster and an oral presentation on its engineered allogeneic CAR T-cell product candidates, UCARTCS1 and UCART123, will be presented in December during the 2015 American Society of Hematology Annual Meeting (ASH).

Calyxt

- Completion of field trials of its non-regulated status cold storable potato product and high oleic soybean product.

Financial Results

Since Cellectis did not have consolidated financial statements for individual quarters during fiscal year 2014, no comparative quarterly 2014 figures will be presented during 2015. Cellectis will publish quarter-over-quarter comparative figures starting with the first quarter of 2016.

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).

Third Quarter and First Nine Months 2015 Financial Results

Cash Position: As of September 30, 2015 Cellectis had €279.4 million in cash and cash equivalents compared to €112.3 million as of December 31, 2014. This increase is primarily attributable to the $228 million of proceeds from Cellectis’ U.S. initial public offering in March 2015, partly offset by €22 million of cash flows used in operating activity, €3.3 million of acquisitions of tangible assets, and the repurchase for €3.5 million of 25% of the minority shares of Cellectis Bioresearch S.A.S, in each case during the first nine months of 2015.

Revenues and Other Income: Total revenues and other income were €10.0 million for the third quarter of 2015 and primarily comprised €7.1 million of collaboration revenues, €0.5 million of license revenues, €1.0 million of grant revenues and €1.5 million of research tax credit revenues. Total revenues and other income were €27.2 million for the nine-month period ended September 30, 2015 and primarily comprised €21.7 million of collaboration revenues, €1.6 million of license revenues, €1.1 million of grant revenues and €2.8 million of research tax credit revenues.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the third quarter of 2015 were €23.4 million, which includes non-cash stock-based compensation expenses of €9.5 million. Total operating expenses and other operating income for the nine-month period ended September 30, 2015 were €56.3 million, which includes non-cash stock-based compensation of €17.5 million.

R&D Expenses: Research and development expenses for the third quarter of 2015 were €13.5 million, including personnel expenses of €8.2 million and external purchases and other expenses of €5.3 million. Research and development expenses for the third quarter notably reflected the impacts of (i) non-cash stock-based compensation expense of €4.5 million and (ii) social charges related to stock-options granted during the third quarter of €1.8 million. Research and development expenses for the nine-months ended September 30, 2015 were €29.6 million, including personnel expenses of €19.2 million and external purchases and other expenses of €10.4 million. Research and development expenses for the nine-month period ended September 30, 2015 notably reflected the impacts of (i) non-cash stock-based compensation expense of €8.2 million and (ii) social charges related to free shares and stock-options granted during this period of €5.9 million.

SG&A Expenses: Selling, general and administrative expenses were €9.6 million for the third quarter of 2015, and included personnel expenses of €7.9 million and external purchases and other expenses of €1.7 million. SG&A expenses for the third quarter notably reflected the impacts of (i) non-cash stock-based compensation expense of €5.0 million and (ii) social charges related to stock-options granted during the third quarter of €1.8 million. Selling, general and administrative expenses were €25.9 million for the nine-month period ended September 30, 2015, and included personnel expenses of €19.1 million and external purchases and other expenses of €6.8 million. SG&A expenses for this nine-month period notably reflected the impacts of (i) non-cash stock-based compensation expense of €9.3 million and (ii) social charges related to free shares and stock-options granted during this period of €6.3 million.

Financial Gain: Financial gain was €0.7 million for the third quarter of 2015 and €0.5 million for the nine-month period ended September 30, 2015, which, in each case, is primarily attributable to an overall net favorable Euro-Dollar exchange rate applied to U.S. dollar-denominated cash and cash equivalents during the applicable periods.

Net Loss Attributable to Shareholders of Cellectis: Net loss attributable to shareholders of Cellectis was €12.8 million, or €0.36 per share, for the third quarter of 2015. This notably reflects the impact of (i) non-cash stock-based compensation of €9.5 million and (ii) social charges on stock-based compensation of €3.6 million. Adjusted net loss attributable to shareholders of Cellectis for the third quarter of 2015, which excludes the non-cash stock-based compensation expense of €9.5 million, was €3.3 million, or €0.09 per share. Net loss attributable to shareholders of Cellectis was €28.8 million or €0.85 per share, for the nine-month period ended September 30, 2015. This notably reflects the impact of (i) non-cash stock-based compensation of €17.5 million and (ii) social charges on stock-based compensation of €12.2 million. Adjusted net loss attributable to shareholders of Cellectis for the nine-month period ended September 30, 2015, which excludes the non-cash stock-based compensation expense of €17.5 million, was €11.3 million, or €0.33 per share.

Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income to adjusted net income.

Earnings Call Details

Cellectis will host an earnings call on November 17, 2015 at 8am Eastern Time to discuss its financial results and provide a general business update.

Dial-In Numbers:

Live PARTICIPANT Dial-In (Toll-Free US & Canada): 877-407-3104

Live PARTICIPANT Dial-In (International): +1 201-493-6792

Replay Information:

Conference ID #: 13625168

Replay Dial-In (Toll Free US & Canada): 877-660-6853

Replay Dial-In (International): +1 201-612-7415

Expiration Date: 11/24/15

Webcast URL (Archived for 12 months): http://cellectis.equisolvewebcast.com/q3-2015

Note Regarding Use of Non-GAAP Financial Measures

Cellectis S.A. provides non-GAAP net income and non-GAAP net income per share measures that include adjustments to figures presented in accordance with GAAP. In presenting non-GAAP net income, GAAP net income is adjusted to exclude non-cash stock-based compensation expense. Cellectis believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Cellectis' financial performance. The non-GAAP financial measures used by Cellectis may be calculated differently, and therefore may not be comparable to similarly titled non-GAAP financial measures used by other companies. Please refer below for a reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.

First Clinical Application of Talen Engineered Universal CAR19 T Cells in B-ALL

Gene Therapy and Transfer

Program: Oral and Poster Abstracts

Session: 801. Gene Therapy and Transfer:

Poster I Saturday, December 5, 2015, 5:30 PM-7:30 PM

Hall A, Level 2 (Orange County Convention Center)

Waseem Qasim, MBBS PHD1*, Persis Jal Amrolia2*, Sujith Samarasinghe, MD, PhD3*, Sara Ghorashian, MD, PhD, FRCPath1*, Hong Zhan, PhD4*, Sian Stafford, PHD1*, Katie Butler, PHD1*, Gul Ahsan5*, Kimberly Gilmour5*, Stuart Adams, PHD5*, Danielle Pinner5*, Robert Chiesa5*, Steve Chatters, PHD5*, Sue Swift, PHD1*, Nicholas Goulden, MD, PhD3, Karl Peggs, MBBChir, MRCP, FRCPath6*, Adrian J Thrasher, MD, PhD1*, Paul Veys2* and Martin Pule, PhD7*

1 INSTITUTE OF CHILD HEALTH, UCL, London, United Kingdom

2 Bone Marrow Transplantation Department, Great Ormond Street Hospital, London, United Kingdom

3 Department of Haematology, Great Ormond Street Hospital For Children, London, United Kingdom

4 Institute of Child Health / Molecular and Cellular Immunology Unit, University College London, London, United Kingdom

5 GREAT ORMOND STREET HOSPITAL, London, United Kingdom

6 CANCER INSTITUTE, UCL, London, United Kingdom

7 Cancer Institute, University College London, London, United Kingdom

The manufacturing process for Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, allogeneic, engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. The TALEN®-based gene editing (knock-out of the TCR-alpha and CD52 genes) is designed to suppress T-cell alloreactivity and confer resistance to alemtuzumab to the T-cells. This important milestone shows that UCARTs can be manufactured in GMP conditions. It also demonstrates the industrial production of UCART19, as well as the capacity of Cellectis’ pipeline of UCART product candidates to be manufactured for clinical investigations.

“It is very exciting to lead a novel allogeneic gene therapy platform at the critical time when a R&D concept is translated into a GMP clinical grade industrial product to be investigated in clinical studies,” said Arjan Roozen, Vice President, GMP Solutions and Manufacturing.

“Cellectis has reached a critical milestone both for the Company and our industry, creating new opportunities for patients. Historically, cell-based therapies have grown in the world of individual grafts. With TALEN®-based gene editing they have now started moving toward that of industrial pharmaceutical products broadly available to patients, and Cellectis, as a leading company in the field of gene editing, is at the forefront of this evolution,” added David J.D. Sourdive, Executive Vice President, Corporate Development.

About UCART19

UCART19 is a potential best-in-class allogeneic engineered T-cell product for treatment of CD19 expressing hematologic malignancies, initially developed in Chronic lymphocytic leukemia (CLL) and Acute lymphoblastic leukemia (ALL). Servier has an option under the collaboration agreement to acquire the exclusive rights to further develop and commercialize UCART19. Engineered allogeneic CD19 T-cells currently stand out as a real therapeutic innovation for treating various types of leukemia and lymphoma. Cellectis’ approach with UCART19 is based on the preliminary positive results from clinical trials using products based on the CAR technology and has the potential to overcome the limitation of the autologous current approach by providing an allogeneic frozen, “off-the-shelf” T-cell based medicinal product.

Arjan Roozen, Vice President GMP Solutions and Manufacturing

Arjan Roozen received a BSc degree in molecular microbiology from Larenstein, Velp in The Netherlands. Arjan joined Cellectis in March 2015. In his present position of VP GMP Solutions & Manufacturing, he is responsible for all GMP pharmaceutical manufacturing activities including the biological raw materials.

Before joining Cellectis, Arjan worked for over 20 years at different biotechnology departments at Centocor, Solvay Pharmaceuticals, Biogen Idec, Crucell, Proxy laboratories and Pharmacell and gained significant experience in QC, QA and manufacturing GMP aspects. The last 4 years within Pharmacell, Arjan Roozen was responsible for GMP operations involved in significant number of cell therapy technology transfer projects as well as responsible for cell therapy commercial products. He was also involved in regulatory audit and filings for EMA and FDA.

Recent Corporate Highlights

- Completed U.S. IPO in March 2015 raising more than $228 million of proceeds.

- Opened U.S. research facility at the Alexandria Center in New York City, with more than 12,000 sq. ft. of state-of-the-art laboratories and 15 full time staff, in proximity to Cellectis’s U.S. partners and investors.

- Entered into a strategic collaboration with Weill Cornell Medical College to accelerate the development of targeted immunotherapy for patients with acute myeloid leukemia (AML). This alliance will foster the development of our lead product candidate, UCART123, for treatment of AML.

- Achieved a significant milestone under our collaboration agreement with Servier.

- Entered into a broad preclinical and clinical strategic alliance with MD Anderson Cancer Center to pursue the development of Cellectis’ candidate products UCARTCS1, UCART22, UCART38 in T-cell ALL and UCART123 in a rare non curable disease BPDCN.

Development Update

- Ongoing manufacturing of GMP-compatible CAR T-cell batches in line.

- Presented additional study results on gene-edited allogeneic (“off-the-shelf”) CAR T-cells, strengthening the pre-clinical proof of concept in lead development programs. In particular, Cellectis presented the following results at ASCO and ASGCT:

o “UCART19, an allogeneic “off-the-shelf” adoptive T-cell immunotherapy against CD19+ B-cell leukemias”

o “Adoptive immunotherapy of acute myeloid leukemia (AML) with allogeneic CAR T-cells targeting CD123”

o “A multidrug resistant engineered CAR T-cell for allogeneic combination immunotherapy”

- Publication of a study in Molecular Therapy, a Nature Publishing Group journal, describing the development of the next generation of engineered CAR T-cells compatible with allogeneic adoptive transfer immunotherapy.

- Publication of an article in Cancer Research describing the applicability of TALEN®-mediated genome editing to a scalable process, enabling the manufacturing of non-alloreactive T-cells from third-party donors in a robust, scalable process, thus allowing "off-the-shelf" CAR T-cell immunotherapies.

- Our plant sciences subsidiary, which changed its name to Calyxt, Inc., continues to show promising developments and commenced field trials of cold storable potatoes in the United States of America and high oleic/low transfat soybean varieties in Argentina and the United States of America.

Financial Results

Since Cellectis did not have consolidated financial statements for individual quarters during fiscal year 2014, no comparative quarterly 2014 figures will be presented during 2015. Cellectis will publish quarter-over-quarter comparative figures starting with the first quarter of 2016.

Cellectis’s consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).

Second Quarter 2015 Financial Results

Cash Position: As of June 30, 2015 Cellectis had €283.9 million in cash and cash equivalents compared to €112.3 million as of December 31, 2014. This increase is primarily attributable to the $228 million of proceeds from the U.S. initial public offering in March 2015. Revenues and Other Income: Total revenues and other income were €8.0 million for the second quarter 2015 and primarily comprised €6.6 million of collaboration revenues and €0.9 million of license revenues.

Total Operating Expenses and Other Operating Income: Total operating expenses for the second quarter of 2015 were €20.1 million, which includes non-cash stock-based compensation expenses of €7.2 million.

R&D Expenses: Research and development expenses for the second quarter of 2015 were €10.6 million, including personnel expenses of €7.6 million and external purchases and other expenses of €3.0 million. Research and development expenses for the second quarter notably reflected the impacts of (i) non-cash stock-based compensation expense of €3.3 million and (ii) social charges related to free shares granted during the second quarter of €1.8 million.

SG&A Expenses: Selling, general and administrative expenses were €9.1 million for the second quarter of 2015, and included personnel expenses of €6.3 million and external purchases and other expenses of €2.8 million. SG&A expenses for the second quarter notably reflected the impacts of (i) non-cash stock-based compensation expense of €3.8 million and (ii) social charges related to free shares granted during the second quarter of €1.8 million. Financial Loss: Financial loss was €10.0 million for the second quarter of 2015, which is primarily attributable to an unfavorable Euro-Dollar exchange rate applied to U.S. dollar-denominated cash and cash equivalents during the quarter.

Net Loss Attributable to Shareholders of Cellectis: Net loss attributable to shareholders of Cellectis was €22.2 million, or €0.63 per share, for the second quarter of 2015. The decrease of €28.3 million in net earnings, compared to the first quarter 2015 net gain attributable to shareholders of Cellectis of €6.1 million, notably reflects the effects of unfavorable Euro-Dollar exchange rates with respect to our U.S. Dollar cash and cash equivalent accounts and to a lesser extent the impact of non-cash stock-based compensations during the second quarter of 2015. Adjusted net loss attributable to shareholders of Cellectis for the second quarter of 2015, which excludes a non-cash stock-based compensation expense of €7.1 million, was €15.0 million, or €0.43 per share. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income to adjusted net income.

First Half Year 2015 Financial Results

Revenues and Other Income: During the six months ended June 30, 2015 and 2014, Cellectis recorded €17.2 million and €10.3 million, respectively, in revenues and other income. The increase of €7.1 million primarily reflects an increase of €13.2 million in revenues under our collaboration agreements with Servier and Pfizer which were partially offset by a decrease in license, R&D services and Product and Services revenues.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the first half of 2015 was €32.9 million (€15.3 million for the same period in 2014). Total operating expenses and other operating income for first half of 2015 and 2014 include non-cash stock-based compensation expenses of €8.0 million and €0.4 million, respectively.

R&D Expenses: Cellectis recorded research and development expenses of €16.2 million in the first half of 2015 and €7.7 million in the first half of 2014. These amounts include personnel expenses of €11.1 million and €3.1 million in 2015 and in 2014, respectively, and purchases and external expenses and other expenses of €5.1 million and €4.6 million, respectively. The increase in research and development expenses also reflects expenditures for the development of UCART programs toward their entry into Phase 1 clinical trials, expenses related to the opening of our facility in New York, non-cash stock-based compensation expense of €3.8 million and social charges on stock options and free share grants of €4.1 million in 2015.

SG&A Expenses: SG&A expenses were €16.3 million in the first half year of 2015 compared to €6.2 million in the corresponding period of 2014. SG&A expenses included personnel expenses of €11.2 million in 2015 compared to €3.0 million in 2014, and purchases and external expenses and other expenses of €5.1 million in 2015 compared to €3.2 million in 2014. The increase in SG&A expenses in 2015 was attributable, among other things, to €4.3 million of non-cash stock-based compensation expense, €4.6 million of social charges on stock options and free share grants and an increase in professional costs, in each case in connection with our U.S. IPO in March 2015.

Financial result: Financial loss was €0.2 million for the first half year of 2015 compared to €16,000 financial gain for the corresponding period in 2014. This increase was primarily attributable to an unfavorable Euro-Dollar exchange rate applied to U.S. dollar-denominated cash and cash equivalents during 2015.

Net Loss Attributable to Shareholders of Cellectis: Net loss attributable to shareholders of Cellectis was of €16.0 million, or €0.48 per share, for the first half year of 2015 compared to a net loss attributable to shareholders of Cellectis of €7.4 million, or €0.32 per share, for the corresponding period in 2014. Adjusted net loss attributable to shareholders of Cellectis for the first half year of 2015 was €8.2 million, or €0.25 per share, compared to adjusted net loss attributable to shareholders of Cellectis of €7.1 million, or €0.31 per share, for the corresponding period in 2014. Adjusted net loss attributable to shareholders of Cellectis for the first half year of 2015 and 2014 excludes a non-cash stock-based compensation expense of €7.9 million and €0.3 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income to adjusted net income. 

The alliance is aimed at developing novel cancer immunotherapies based on Cellectis’ allogeneic chimeric antigen receptor (CAR) platform. MD Anderson Cancer Center’s leukemia and myeloma teams will work with Cellectis to bring better treatments to patients suffering from cancers with high unmet needs, particularly multiple myeloma (MM), acute lymphocytic leukemia (ALL), T-cell acute lymphocytic leukemia (ALL) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The alliance will build on MD Anderson’s outstanding translational and state-of-the-art preclinical and clinical teams in leukemia and myeloma, coupled with Cellectis’ first-in-class allogeneic CAR T-cell therapy approach and manufacturing capabilities, to pursue the development of Cellectis’ candidate products UCARTCS1, UCART22, UCART38 in T-cell ALL and UCART123 in a rare non curable disease BPDCN. Cellectis has built an allogeneic CAR T-cell approach based on proprietary gene editing technologies, aimed at developing off-the-shelf cellular therapies for cancer treatment.

At MD Anderson, the alliance will be brought forward under the direction of Hagop Kantarjian, MD, Chair, Department of Leukemia, and Robert Orlowski, MD, PhD, Department Ad Interim Chair, Department of Lymphoma/Myeloma. MD Anderson’s Leukemia Department is known for its clinical trials and patient treatment using chemotherapies, tyrosine kinase inhibitors and monoclonal antibodies.

“We are extremely proud to have our research teams partnering with MD Anderson as we aim to address treatments for different types of liquid tumors,” said Mathieu Simon, MD, Executive Vice President and Chief Operating Officer at Cellectis. “This alliance could potentially drive to 5 clinical developments within a time horizon of 3 years. Together, we are confident that we will quickly bring new therapeutic solutions to patients.”

“Our efforts are always focused on providing more effective care for our patients,” said Kantarjian. “Alliances such as this one are one more way that we can explore how to bring the latest therapies to the patients who need them.”

“Significant unmet medical need exists in many types of liquid tumors. Cellectis is committed to changing patient expectations as we're building a portfolio of candidate products in immune-oncology through our own research and key collaborations such as with MD Anderson,” said André Choulika, Ph.D., Chief Executive Officer and Chairman of Cellectis. “We're highly encouraged by the potential of our product candidate pipeline to deliver innovative, best-in-class treatment options to patients.”

“Immunotherapy is increasingly a significant element in cancer treatment,” said Orlowski. “It is my hope that patients with multiple myeloma and other cancers will benefit through this alliance.”

New York, August 26, 2015 – Cellectis (Alternext: ALCLS – Nasdaq Global Market: CLLS), a pioneering gene-editing company employing proprietary technologies to develop best-in-class products in the emerging field of immuno-oncology, today announced that pre-clinical data on its engineered allogeneic CAR T-cells will be featured during several conferences in the coming weeks.

The Immunotherapy and Vaccine Summit

August 24th to 28th, 2015, Boston, USA

• André Choulika, Ph.D., Chairman and CEO of Cellectis, will be presenting in the panel "Advantages and Disadvantages of Different Gene Editing Technologies" on Thursday, August 27th at 11:45AM.

• Dr Choulika will also give a presentation entitled "Allogeneic Universal CAR-T Cells Engineered With TALEN®" during the session "Merging Gene Editing and Immunotherapy" on Thursday, August 27th at 3:05PM.

• Julien Valton, Ph.D., Senior Scientist at Cellectis, will give a presentation entitled "A Multidrug Resistant Engineered CAR T-Cell for Allogeneic Combination Immunotherapy" during the session "Chimeric Antigen Receptors" on Thursday, August 27th at 11:15AM.

CRI-CIMT-EATI-AACR Immunotherapy Conference

September 16th to 19th, 2015, New York, USA

• Laurent Poirot, Head of Early Discovery at Cellectis, to present a poster entitled "Targeted genome modifications for Improved Adoptive Immunotherapy" on Wednesday, September 16.

• Philippe Duchateau, Chief Scientific Officer at Cellectis, to present a poster entitled "Design of a chimeric antigen receptor (CAR) with controllable function via small molecule" on Friday, September 18.

• Julianne Smith, VP CAR T Development at Cellectis, to present a poster entitled "Allogeneic CAR T-cells for Adoptive Immunotherapy" on Friday, September 18.

Phacilitate Cell & Gene Therapy

September 29th to 30th, 2015, Barcelona, Spain

• Stéphan Reynier, Chief Regulatory and Compliance Officer at Cellectis, to present as a chairperson during the session: "What is the most realistic, practicable supply chain solution for this particular class of products in Europe? What would be most feasible for rare vs. common indications?" This roundtable discussion will take place on Wednesday, September 30th, from 4:20 to 5:30PM.

Adoptive immunotherapy using autologous T-cells endowed with chimeric antigen receptors or CARs has emerged as a powerful means of treating cancer. However, a limitation of this approach is that autologous CAR T-cells must be generated on a custom-made basis. To overcome the limitations of patient-derived CAR T-cell therapies, TALEN® mediated gene inactivation can be used to generate non-alloreactive T-cells from third-party donors in a robust, scalable manufacturing process, thus allowing "off-the-shelf" CAR T-cell immunotherapies.

Laurent Poirot Ph.D. and his collaborators use this TALEN®-mediated editing approach to develop a process for the large-scale manufacturing of T-cells deficient in expression of both their T-cell receptor (TCR) and CD52, a protein targeted by alemtuzumab, a chemotherapeutic agent. Functionally, T-cells manufactured with this process do not mediate graft-versus-host reactions, and are rendered resistant to destruction by alemtuzumab. These characteristics enable the administration of alemtuzumab concurrently or prior to engineered T-cells, supporting their engraftment. Furthermore, endowing the TALEN®-engineered cells with a CD19 CAR led to efficient destruction of CD19+ tumor targets even in the presence of the chemotherapeutic agent. CAR T-cell immunotherapies can therefore be used in an “off-the-shelf” manner akin to other biological immunopharmaceuticals.

Laurent Poirot, Ph.D., Head of Early Discovery

Dr. Laurent Poirot studied physics and biology at the Ecole Polytechnique in France, before earning his Ph.D. at the Strasbourg University (France) and the Harvard Medical School in Boston. He then joined the Genomics Institute of the Novartis research foundation in San Diego as a postdoctoral fellow, where he studied the development of high throughput in vivo and in vitro approaches for the study of gene functions in immune cells. He joined Cellectis in 2009 as a Project Leader, and has been working as Head of Early Discovery since 2013.

Multiplex genome edited T-cell manufacturing platform for “off-the-shelf” adoptive T-cell immunotherapies

Laurent Poirot¹, Brian Philip², Cécile Schiffer Mannioui¹, Diane Le Clerre¹, Isabelle Chion-Sotinel¹, Sophie Derniame¹, Pierrick Potrel¹, Cécile Bas¹, Laetitia Lemaire¹, Roman Galetto¹, Céline Lebuhotel¹, Justin Eyquem¹,³, Gordon Weng-Kit Cheung², Aymeric Duclert¹, Agnès Gouble¹, Sylvain Arnould¹, Karl Peggs², Martin Pule², Andrew M. Scharenberg⁴ and Julianne Smith¹

¹ Cellectis, Paris, France

² Department of Haematology, UCL Cancer Institute, University College London, London, UK

³ Current address: Memorial Sloan-Kettering Cancer Center, New York, NY

⁴ Current address: Department of Pediatrics, University of Washington, Seattle Children's Research Institute, Seattle, WA

Under the terms of the Company's collaboration agreement with Servier, Cellectis is eligible to an undisclosed payment.

The collaboration announced in February 2014, is focused on research, development, and potentially commercialization of five product candidates targeting leukemia and solid tumors.

“We are very pleased with the productivity of this alliance enabling us to accelerate our development in the field of solid tumors”, commented Mathieu Simon, MD, EVP Chief Operating Officer of Cellectis.

“We believe that immunotherapy will dramatically change the management of metastatic cancers. Our goal at Servier is to make these new technologies available for the largest number of cancer patients”, commented Jean-Pierre Abastado, MD, Director Oncology Innovation Therapeutic Pole of Servier.

New York, June 10, 2015 – Cellectis (Alternext: ALCLS – Nasdaq Global Market: CLLS), the gene-editing company employing proprietary technologies to develop best-in-class CAR T-cell products in adoptive immunotherapy for cancer, today announced the publication of a study in Molecular Therapy, a Nature Publishing Group Journal, describing the development of the next generation of engineered CAR T-cells compatible with allogeneic adoptive transfer immunotherapy.

Study Highlights

• The adoptive transfer of allogeneic CAR T-cells represents a promising strategy to fight multiple cancers worldwide.

• Cellectis has streamlined an engineering process to generate CAR T-cells that could be compatible with allogeneic adoptive transfer in combination with nucleoside analogues lymphodepleting drugs.

When allogeneic CAR T-cell infusion is considered, host versus graft and graft versus host reactions must be avoided to prevent rejection of adoptively transferred cells, host tissue damages and to elicit significant antitumoral outcome. In this report, Julien Valton Ph.D. and his collaborators addressed these requirements by developing a multidrug resistant TCRαβ-deficient CAR T-cell. This engineered T-cell displayed efficient antitumor activity and significant resistance to purine and pyrimidine nucleoside analogues, which are currently used clinically in preconditioning lymphodepleting regimens. Their properties could prevent their alloreactivity and enable control over engraftment in patients. In addition, they are compatible in combination therapy, an approach likely to improve clinical outcomes. By providing a basic framework to develop a universal T-cell compatible with allogeneic adoptive transfer, Cellectis is laying the foundation for the large-scale utilization of CAR T-cell immunotherapies.

Julien Valton, Ph.D. Innovation Senior Scientist

Dr. Julien Valton obtained his Ph.D. degree at Université Joseph Fourier in Grenoble (France) where he was trained as enzymologist. He then joined the Yale School of Medicine to apply his knowledge to therapeutic research, by investigating the mechanism of inhibition of receptor tyrosine kinases involved in the development of gastrointestinal cancer. In 2009, he moved a step further into the field of applied science by joining the R&D Department of Cellectis, where he actively participated to set, improve and use meganucleases and TALEN® for targeted gene therapy and genome engineering purposes. He is now part of the NYC based Cellectis, Inc.

A Multidrug Resistant Engineered CAR T-Cell for Allogeneic Combination Immunotherapy

Julien Valton, Valérie Guyot, Alan Marechal, Jean Marie Filhol, Alexandre Juillerat, Aymeric Duclert, Philippe Duchateau and Laurent Poirot

http://dx.doi.org/10.1038/MT.2015.104

Cellectis previously published consolidated financial statements for the first six months of 2014 and for the full year 2014. Cellectis did not have consolidated financial statements for the 1st and 3rd quarters 2014. Therefore, no comparative 2014 figures will be presented for 1st and 3rd quarters in 2015. Cellectis will publish full quarterly comparative figures starting 2016.

Consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).

First Quarter 2015 Financial Results

● Revenues and Other Income: Total revenues and other income were of €9.2 million for the first quarter 2015 (€26.5 million for FY2014) and mainly comprised €7.9 million of collaboration revenues (€11.9 million for FY2014) and €0.4 million of license revenues (€7.3 million for FY2014).

● Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the first quarter of 2015 were of €12.8 million (€31.7 million for FY2014).

● R&D Expenses: Research and development expenses for the first quarter of 2015 were of €5.6 million (€14.4 million for FY2014). These expenses mainly consisted of personnel expenses (€3.5 million), external purchases and other expenses (€2.1 million). Research and development expenses for the first quarter also reflect the impact of social charges related to stock-options and free shares granted during the first quarter (€1.9 million).

● SG&A Expenses: Selling, general and administrative expenses were of €7.2 million for the first quarter 2015 (€13.1 million for FY2014). These expenses mainly related to personnel expenses (€4.9 million), and to external purchases and other expenses (€2.3 million). Selling, general and administrative expenses for the first quarter also reflect the impact of social charges related to stock-options and free shares granted during the first quarter (€3.3 million). For the first three months 2015, the non–recurring IPO expenses amounted to €0.5 million.

● Financial Gain: Financial gain was of €9.9 million for the first quarter 2015 (€7.1 million for FY2014), which is mainly attributable to a favorable Euro-Dollar exchange rate applied to U.S. dollar-denominated cash and cash equivalents during the first quarter of 2015.

● Net Income (Loss): Net income was of €6.3 million, or €0.23 per share, for the first quarter of 2015 (net loss of €1.0 million, or €0.00 per share, for FY2014). Adjusted net income for the first quarter of 2015 was €7.1 million, or €0.23 per share. Adjusted net income for the first quarter of 2015 excludes a non-cash stock-based compensation expense of €0.8 million. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income to adjusted net income.

● Cash Position: Cash and cash equivalents include cash, bank accounts, money market funds and fixed bank deposits that meet the definition of a cash equivalent. As of March 31, 2015, Cellectis had €118.4 million in cash and cash equivalents compared to €112.3 million as of December 31, 2014. Our initial public offering closed on March 30, 2015 and as of March 31, 2015, the €196.8 million of net proceeds from the initial public offering are classified under Other Current Assets. We believe that our cash and cash equivalents, together with the net proceeds from our initial public offering and our cash flow from operations (including payments we expect to receive pursuant to our collaboration agreements) and government funding of research programs will be sufficient to fund our operations through at least 2017. However, we may require additional capital for the further development of our existing product candidates and may also need to raise additional funds sooner to pursue other development activities related to additional product candidates.