Cellectis Reports 4th Quarter and Full Year 2016 Financial Results

•  FDA approval to conduct Phase I clinical trials for UCART123 in AML & BPDCN patients

•  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.

 

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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

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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.

 

 

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[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