NEW YORK--(BUSINESS WIRE)--Regulatory News:
Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS) (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.
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
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.
|STATEMENT OF CONSOLIDATED FINANCIAL POSITION|
|(€ in thousands)|
December 31, 2016
March 31, 2017
|Intangible assets||1 274||1 332|
|Property, plant, and equipment||16 033||16 068|
|Other non-current financial assets||656||886|
|Total non-current assets||17 963||18 286|
|Inventories and accumulated costs on orders in process||112||106|
|Trade receivables||3 441||5 035|
|Subsidies receivables||8 276||11 564|
|Other current assets||8 414||11 405|
|Cash and cash equivalent and Current financial assets||276 216||258 527|
|Total current assets||296 459||286 638|
|TOTAL ASSETS||314 422||304 924|
|Share capital||1 767||1 767|
|Premiums related to the share capital||473 306||485 991|
|Treasury share reserve||(307)||(159)|
|Currency translation adjustment||2 501||1 422|
|Retained earnings||(157 695)||(218 505)|
|Net income (loss)||(60 776)||(18 567)|
|Total shareholders’ equity - Group Share||258 795||251 948|
|Non-controlling interests||1 779||1 984|
|Total shareholders’ equity||260 574||253 932|
|Non-current financial liabilities||28||21|
|Total non-current liabilities||560||572|
|Current financial liabilities||1 641||379|
|Trade payables||9 223||12 170|
|Deferred revenues and deferred income||36 931||33 109|
|Other current liabilities||4 930||4 199|
|Total current liabilities||53 288||50 420|
|TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY||314 422||304 924|
|STATEMENT OF CONSOLIDATED OPERATIONS – First quarter|
|(€ in thousands, except per share data)|
For the three-month period
|Revenues and other income|
|Revenues||6 978||6 328|
|Other income||2 521||3 334|
|Total revenues and other income||9 499||9 662|
|Research and development expenses||(18 870)||(18 392)|
|Selling, general and administrative expenses||(10 529)||(9 143)|
|Other operating income and expenses||(76)||(99)|
|Total operating expenses||(29 908)||(28 208)|
|Operating income (loss)||(20 409)||(18 546)|
|Financial gain (loss)||(9 055)||(21)|
|Net income (loss)||(29 464)||(18 567)|
|Attributable to shareholders of Cellectis||(29 464)||(18 567)|
|Attributable to non-controlling interests||
|Basic earnings attributable to shareholders of Cellectis per share (€/share)||(0.84)||(0.53)|
|Diluted earnings attributable to shareholders of Cellectis per share (€/share)||(0.84)||(0.53)|
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|
|(€ in thousands, except per share data)|
For the three-month period
|Net Income (Loss) attributable to shareholders of Cellectis||(29 464)||(18 567)|
|Non-cash stock-based compensation expense||13 414||12 788|
|Adjusted Income (Loss) attributable to shareholders of Cellectis||(16 050)||(5 779)|
|Basic Adjusted Income (Loss) attributable to shareholders of Cellectis (€/share)||(0.46)||(0.16)|
|Weighted average number of outstanding shares, basic (units)||35 195 281||35 289 932|
|Diluted Adjusted Income (Loss) attributable to shareholders of Cellectis (€/share)||(0.46)||(0.16)|
|Weighted average number of outstanding shares, diluted (units)||35 563 743||35 784 930|
Cellectis is a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART). The company’s mission is to develop a new generation of cancer therapies based on engineered T-cells. Cellectis capitalizes on its 17 years of expertise in genome engineering - based on its flagship TALEN® products and meganucleases and pioneering electroporation PulseAgile technology - to create a new generation of immunotherapies. CAR technologies are designed to target surface antigens expressed on 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 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.
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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions and include, but are not limited to, statements regarding the outlook for Cellectis’ future business and financial performance. Forward-looking statements are based on management’s current expectations and assumptions, which are subject to inherent uncertainties, risks and changes in circumstances, many of which are beyond Cellectis’ control. Actual outcomes and results may differ materially due to global political, economic, business, competitive, market, regulatory and other factors and risks. Cellectis expressly disclaims any obligation to update or revise any of these forward-looking statements, whether because of future events, new information, a change in its views or expectations, or otherwise.
1 Translated only for convenience into U.S. dollars at an exchange rate of €1.00=$1.0691, the daily reference rate reported by the European Central Bank (“ECB”) as of March 31, 2017