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Asterias Biotherapeutics Reports Fourth Quarter and Full Year 2017 Financial Results and Recent Developments- Achieved Meaningful Progress with Key Clinical Programs - - Anticipate Multiple Data Readouts from SCiStar Study in 2018 into First Quarter of 2019 - - Expect to Enroll First Subject in AST-VAC2 Randomized Clinical Trial in NSCLC in Second Quarter - - Conference Call and Webcast Today, March 15, at 5:00 p.m. ET - FREMONT, Calif., March 15, 2018 (GLOBE NEWSWIRE) -- Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, today reported financial and operational results for the quarter and full year ended December 31, 2017, as well as recent corporate progress. “We have continued to make significant progress in our spinal cord injury clinical program,” commented Michael Mulroy, President and Chief Executive Officer. “The additional results from the SCiStar study that we recently reported further support AST-OPC1’s positive safety profile and its potential to durably engraft and help restore upper extremity motor function improvement to individuals with severe cervical spinal cord injuries. Currently, these severely injured patients have no approved treatment options. We look forward to providing additional data readouts from the SCiStar study in 2018 into the first quarter of 2019.” Mulroy continued, “We are equally excited for the planned start of the first-in-human clinical trial of AST-VAC2, our cancer immunotherapy product candidate, in non-small cell lung cancer (NSCLC). Upon this achievement, Asterias will have two product candidates in clinical trials that are aimed at addressing substantial unmet medical needs.” “On the corporate side, Asterias completed a capital raise in 2017 and significantly improved its cost structure heading into 2018,” said Ryan Chavez, Chief Financial Officer. “The more focused allocation of capital in 2018 allows the company to reduce its cash burn during a period of additional data readouts from the SCiStar study and the start of the AST-VAC2 clinical trial.” Anticipated 2018 Milestones The company intends to report the following AST-OPC1 data readouts later this year:
The company anticipates achieving the following AST-VAC2 milestones in 2018:
Asterias plans to host a conference call to discuss the AST-VAC2 program and its potential as a ready-to-administer, off-the-shelf cancer immunotherapy after the first subject is dosed in the study. 2017 and Recent Key Achievements AST-OPC1:
AST-VAC2:
Corporate:
Financial Results As of December 31, 2017, the combined total of cash, cash equivalents, and available-for-sale securities totaled $21.6 million. In October 2017, Asterias closed the sale of shares of its common stock in a registered direct offering which raised approximately $10.4 million in gross proceeds. Revenue was $4.0 million for the year ended December 31, 2017, comprised of grant income as well as royalty revenue on product sales by licensees. Research and development expenses were $6.4 million in the fourth quarter and $26.6 million in the year ended December 31, 2017. General and administrative expenses were $2.1 million in the fourth quarter and $10.5 million in the year ended December 31, 2017. As a result of the operating cost saving initiatives implemented in 2017, the company expects to reduce its operating costs by approximately 40% in 2018. Asterias believes that its reduced operating costs and cash and cash equivalents as of December 31, 2017 will be sufficient to fund its operations through at least the first quarter of 2019. Net loss was $6.5 million, or $0.12 per share, for the fourth quarter and $28.4 million, or $0.56 per share, for the year ended December 31, 2017. For the year ended December 31, 2017, net cash used in operating activities was $24.4 million and net cash provided from financing activities was $17.2 million. Conference Call and Webcast Details Asterias will host a conference call and webcast today, March 15, 2018, at 5:00 p.m. Eastern / 2:00 p.m. Pacific to discuss the results and corporate developments. For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 888-503-8163. For international participants outside the U.S./Canada, the dial-in number is 719-325-4857. For all callers, refer to Conference ID 9547064. To access the live webcast, go to http://asteriasbiotherapeutics.com/inv_events_presentations.php. A replay of the conference call will be available for one month beginning about two hours after the conclusion of the live call, by calling toll-free (from U.S./Canada) 888-203-1112; international callers dial 719-457-0820. Use the Conference ID 9547064. Additionally, the archived webcast will be available at http://asteriasbiotherapeutics.com/inv_events_presentations.php. About Asterias Biotherapeutics Asterias Biotherapeutics, Inc. is a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with de-myelination and cellular immunotherapies to treat cancer. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is an autologous cancer immunotherapy with promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML). AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The company’s research partner, Cancer Research UK, plans to begin a first-in-human (FIH) clinical trial of AST-VAC2 in non-small cell lung cancer. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com. Forward Looking Statements Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’ filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.
Contacts: Investor Relations (510) 456-3892 [email protected] or EVC Group, Inc. Michael Polyviou/Greg Gin (732) 232-6914 [email protected] |