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FREMONT, Calif., Feb. 3, 2017 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced the company is extending the expiration date of certain warrants. The decision to extend the warrants takes into consideration Asterias' recent announcement of positive interim efficacy results from its ongoing SCiStar Phase 1/2a clinical trial that showed additional motor function improvement at 6 months and 9 months following administration of 10 million AST-OPC1 cells in patients with complete cervical spinal cord injuries (AIS-A patients). Further data will become available in the third quarter of 2017 evaluating 12-month safety and efficacy results for this AIS-A 10 million cell cohort, as well as 6-month efficacy and safety data for the currently-enrolling AIS-A 20 million cell and AIS-B 10 million cell cohorts.
"We were excited by the recent positive read-out on the AIS-A 10 million cell cohort in our SCiStar clinical trial. This data reinforced the very positive motor function improvements observed in complete cervical spinal cord injury patients announced in September 2016," said Steve Cartt, Chief Executive Officer of Asterias. "We hope to see continued positive results when we report additional data read-outs later this year. In addition, we expect to make significant progress during 2017 as we complete enrollment in the SCiStar clinical trial and engage in discussions with the FDA to design a new AST-OPC1 randomized-controlled trial that we expect to commence in early 2018."
The company is extending the expiration date of warrants to purchase up to an aggregate of 3,329,035 shares of the company's Series A common stock, par value $0.0001 per share. The expiration date for these warrants, which otherwise would have expired on February 15, 2017, has been extended to 5:00 p.m. New York City time on September 29, 2017. The company is also extending the expiration date of the warrants to purchase up to an aggregate of 409,152 shares of common stock held by Romulus Films Ltd. The expiration date for the warrants held by Romulus has also been extended to 5:00 p.m. New York City time on September 29, 2017.
In addition, Asterias provided an update on its cash position. As of December 31, 2016, the company's cash and cash equivalents totaled $19.8 million (unaudited) and its cash, cash equivalents and available-for-sale securities totaled $35.1 million (unaudited).
"Asterias' cash position at the end of 2016 is significantly improved from the same time last year, and positions us to further advance our development programs through key milestones for the company, including completing enrollment of the SCiStar study, during 2017," said Ryan Chavez, Chief Financial Officer. "Management believes the company's cash, cash equivalents and available-for-sale securities will be sufficient to fund operations through at least the first quarter of 2018."
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company's proprietary cell therapy programs are based on its immunotherapy and pluripotent stem cell platform technologies. 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 undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML) and completing a successful end-of-Phase 2 meeting with the FDA. The company is currently focused on streamlining and modernizing the manufacturing process for AST-VAC1 in advance of a planned initiation of a Phase 2b study designed to set the registration pathway. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic immunotherapy. The company's research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in the second quarter of 2017. 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.
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"We were excited by the recent positive read-out on the AIS-A 10 million cell cohort in our SCiStar clinical trial. This data reinforced the very positive motor function improvements observed in complete cervical spinal cord injury patients announced in September 2016," said Steve Cartt, Chief Executive Officer of Asterias. "We hope to see continued positive results when we report additional data read-outs later this year. In addition, we expect to make significant progress during 2017 as we complete enrollment in the SCiStar clinical trial and engage in discussions with the FDA to design a new AST-OPC1 randomized-controlled trial that we expect to commence in early 2018."
The company is extending the expiration date of warrants to purchase up to an aggregate of 3,329,035 shares of the company's Series A common stock, par value $0.0001 per share. The expiration date for these warrants, which otherwise would have expired on February 15, 2017, has been extended to 5:00 p.m. New York City time on September 29, 2017. The company is also extending the expiration date of the warrants to purchase up to an aggregate of 409,152 shares of common stock held by Romulus Films Ltd. The expiration date for the warrants held by Romulus has also been extended to 5:00 p.m. New York City time on September 29, 2017.
In addition, Asterias provided an update on its cash position. As of December 31, 2016, the company's cash and cash equivalents totaled $19.8 million (unaudited) and its cash, cash equivalents and available-for-sale securities totaled $35.1 million (unaudited).
"Asterias' cash position at the end of 2016 is significantly improved from the same time last year, and positions us to further advance our development programs through key milestones for the company, including completing enrollment of the SCiStar study, during 2017," said Ryan Chavez, Chief Financial Officer. "Management believes the company's cash, cash equivalents and available-for-sale securities will be sufficient to fund operations through at least the first quarter of 2018."
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company's proprietary cell therapy programs are based on its immunotherapy and pluripotent stem cell platform technologies. 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 undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML) and completing a successful end-of-Phase 2 meeting with the FDA. The company is currently focused on streamlining and modernizing the manufacturing process for AST-VAC1 in advance of a planned initiation of a Phase 2b study designed to set the registration pathway. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic immunotherapy. The company's research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in the second quarter of 2017. 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.
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SOURCE Asterias Biotherapeutics, Inc.
