Conference Call and Webcast Today, March 29, at 4:30 p.m. ET
FREMONT, Calif., March 29, 2016 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company focused on the emerging field of regenerative medicine, today reported financial results for the fourth quarter and year ended December 31, 2015, as well as key corporate highlights.
"Asterias has three promising clinical-stage therapeutic programs based on our immunotherapy and pluripotent stem cell platform technologies. These pioneering cell therapy programs have the potential to address areas of very high unmet medical need in the fields of oncology and neurology. We are focused on continuing to advance all three therapeutic programs through clinical development," said Steve Cartt, President and Chief Executive Officer of Asterias.
The Company recently completed the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for AST-VAC1, the company's lead clinical program targeting maintenance of relapse-free-survival in acute myeloid leukemia (AML) patients. Asterias is planning for the initiation of a single pivotal Phase 3 trial that could support an accelerated development pathway towards a potential future biologic license application (BLA) filing.
The company's second clinical-stage program, AST-VAC2, will be investigated in a planned Phase 1/2 trial in non-small cell lung cancer that will be sponsored, managed and funded by the company's development partner, Cancer Research UK (CRUK). This study is expected to begin enrollment in early 2017.
The company's third clinical program, AST-OPC1, has successfully completed the initial 2 million cell safety cohort and is currently enrolling patients for the 10 million cell second cohort in a Phase 1/2a clinical trial in complete cervical spinal cord injury. This trial is being funded in part by a $14.3 million grant from the California Institute of Regenerative Medicine.
"We look forward to achieving further progress on these pioneering cell therapy clinical programs, including important clinical and other development milestones, during the remainder of 2016 and into 2017," Mr. Cartt concluded.
Research and Development Highlights:
Since Asterias released third quarter results in November 2015, the Company has reported the following progress:
AST-VAC1 (antigen-presenting autologous dendritic cells)
AST-VAC2 (antigen-presenting allogeneic dendritic cells)
AST-OPC1 (oligodendrocyte progenitor cells)
Fourth Quarter and Full Year 2015 Financial Results
Cash Position and Usage: Asterias had cash and cash equivalents of $11.2 million as of December 31, 2015, compared to $3.1 million as of December 31, 2014. At December 31, 2015, Asterias held approximately $17 million in available-for-sale securities. For the fourth quarter, net cash used in operating activities was $4.0 million.
Revenues: Total revenues were $608,000 for the fourth quarter and $3.6 million for the full year ended December 31, 2015. Revenues are comprised of grant income as well as royalty revenues on product sales by licensees. Grant income in 2015 was entirely from the California Institute for Regenerative Medicine (CIRM). CIRM is disbursing funds under the grant award to Asterias over four years through 2018 in accordance with a quarterly disbursement schedule, subject to attainment of certain progress and safety milestones.
R&D Expenses: Research and development expenses were $5.4 million for the fourth quarter and $17.3 million for the full year ended December 31, 2015, compared to $5.4 million and $13.3 million for the comparable periods in 2014.
G&A Expenses: General and administrative expenses were $2.8 million for the fourth quarter and $7.9 million for the full year of 2015, compared to $1.2 million and $5.3 million for the comparable periods in 2014.
Net Loss: Net loss was $4.9 million for the three months ended December 31, 2015, or $0.13 per share, including deferred income tax benefits of $2.9 million. For the full year ended December 31, 2015, net loss was $15.0 million or $0.42 per share, including deferred income tax benefits of $7.3 million. For the comparable periods in 2014, fourth quarter net loss was $3.3 million, or $0.11 per share, including deferred income tax benefits of $2.2 million, and full year net loss was $10.1 million or $0.33 per share, including deferred income tax benefits of $7.4 million.
Conference Call and Webcast Details
Asterias will host a conference call and webcast today, Tuesday, March 29, 2016, at 4:30 p.m. ET/1:30 p.m. PT to discuss financial and operating results and recent 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 800-768-6563. For international participants outside the U.S./Canada, the dial-in number is 785-830-7991. For all callers, refer to Conference ID 8993084. To access the live webcast, go to http://asteriasbiotherapeutics.com/events-presentations/.
A replay of the conference call will be available for seven business days 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 8993084. Additionally, the archived webcast will be available at http://asteriasbiotherapeutics.com/events-presentations/.
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a leading biotechnology company in the emerging field of regenerative medicine. The company's proprietary, industry leading platforms are based on its pluripotent stem cell and dendritic cell immunotherapy technologies. Asterias is focused on developing therapies to treat conditions in several medical areas where there is high unmet medical need and inadequate available therapies. 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) has demonstrated promise in a Phase 2 study in acute myelogenous leukemia. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic approach to dendritic cell vaccines. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.
Forward Looking Statements
Statements pertaining to future financial and/or operating 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" and "potential") 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, whether we can obtain regulatory approvals and the timing of such approvals, whether we can attain certain progress and safety milestones required under our grant awards, our 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's filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.
ASTERIAS BIOTHERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
Three months ended December 31,
Year ended December 31,
Royalties from product sales
Sale of cell lines
Cost of sales
Total gross profit
Research and development
General and administrative
Total operating expenses
Loss from operations
Interest expense, net
Other expense, net
Total other expenses
LOSS BEFORE DEFERRED INCOME TAX BENEFIT
Deferred income tax benefit
Available for sales investments: Change in other unrealized gain/(loss), net of taxes
Basic and diluted net loss per common share
Weighted average common shares outstanding used to compute net loss per common share, basic and diluted
ASTERIAS BIOTHERAPEUTICS, INC.
(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)
Cash and cash equivalents
Available-for-sale securities, at fair value
Prepaid expenses and other current assets
Total current assets
Intangible assets, net
Property, plant and equipment, net
Construction in progress
Investment in affiliates
Deferred tax asset
Total noncurrent assets
LIABILITIES AND STOCKHOLDERS' EQUITY
Amount due to parent, BioTime, Inc.
Accrued liabilities and other current liabilities
Capital lease liability
Deferred rent liability
Deferred grant income
Deferred tax liabilities, current portion
Total current liabilities
Capital lease liability
Deferred tax liabilities, net of current portion
Deferred rent liability, net of current portion
Preferred Stock, $0.0001 par value, authorized 5,000,000 shares; none issued and outstanding
Common Stock, authorized 75,000 Series A Common Stock, $0.0001 par value, and 75,000 Series B Common Stock; 38,228 and 30,902 shares Series A Common Stock issued and outstanding at December 31, 2015 and 2014; no Series B Common Stock issued and outstanding at December 31, 2015 and 2014.
Additional paid-in capital
Accumulated comprehensive gain (loss) on available-for-sale investments
Total stockholders' equity
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
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SOURCE Asterias Biotherapeutics, Inc.