Conference Call and Webcast Today, November 9, at 4:30 p.m. ET
MENLO PARK, Calif., Nov. 9, 2015 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company focused on the emerging field of regenerative medicine, today reported financial and operating results for the third quarter ended September 30, 2015.
"Asterias continued to achieve solid progress in the third quarter toward advancing the clinical development of our key therapeutic programs," stated Pedro Lichtinger, President and CEO of Asterias. "We completed recruitment for the initial, low-dose safety cohort of the AST-OPC1 Phase 1/2a clinical trial for spinal cord injury. To date, no serious adverse events have been observed in any of the three treated patients. Following recommendation by the Data Monitoring Committee, we started patient enrollment for the second cohort in which patients will be treated with a higher dose of AST-OPC1 that is in the range that we believe to be efficacious and that has the potential to bring benefit to patients. Importantly, the first patient in the initial, low-dose safety cohort has shown steady neurological improvement at both 2-month and 3-month post-injection assessments. Also during the quarter, we announced a strategic collaboration to advance development of large scale manufacturing processes for AST-VAC2, our allogeneic dendritic cell immunotherapy. This manufacturing agreement will streamline and scale manufacturing processes for AST-VAC2 to support advanced clinical trials, including the planned Phase 1/2a clinical trial in lung cancer, and eventual commercialization of AST-VAC2. We anticipate achieving significant additional clinical milestones during the next 12 months."
Recent Corporate Developments
Research and Development Highlights
AST-VAC1 (antigen-presenting autologous dendritic cells)
AST-OPC1 (oligodendrocyte progenitor cells)
AST-VAC2 (antigen-presenting allogeneic dendritic cells)
Third Quarter [Unaudited] Financial Results
Total revenues in the third quarter 2015 were $1.4 million, which were primarily comprised of grant income and royalty revenues on product sales by licensees. Total revenues in the comparable quarter in the prior year were $85,000. Operating expenses in the third quarter were $6.2 million, compared to $4.0 million in the prior year period. Research and development (R&D) expenses in the third quarter were $4.6 million, compared to $2.6 million in the comparable quarter of the prior year. General and administrative (G&A) expenses in the third quarter were $1.6 million, compared to $1.5 million in the comparable quarter of the prior year.
Net loss for the third quarter 2015 was $3.5 million, including a deferred income tax benefit of approximately $1.6 million. Net loss in the third quarter 2014 was $1.7 million, including a deferred income tax benefit of approximately $2.3 million. On a per share basis, net loss for the third quarter was $0.09 per share, compared to a loss of $0.05 per share for the comparable quarter of the prior year.
Cash and cash equivalents were $12.6 million as of September 30, 2015, compared to $3.1 million as of December 31, 2014. At September 30, 2015, the Company held 3.9 million BioTime common shares, with a market value of approximately $11.6 million on that date.
For the third quarter, net cash used in operating activities was $3.6 million. The Company continues to expect net cash burn in 2015 to be in the range of $15 million to $17 million.
Conference Call and Webcast Details
The Company will host a conference call and webcast today, Monday, November 9, 2015, at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the 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 888-378-0320. For international participants outside the U.S./Canada, the dial-in number is 719-325-2435. For all callers, refer to Conference ID 9794791. 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 9794791. Additionally, the archived webcast will be available at http://asteriasbiotherapeutics.com/events-presentations/.
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. (NYSE MKT: AST) 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.
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") 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.
ASTERIAS BIOTHERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
Three Months Ended
Nine Months Ended
Royalties from product sales
Sale of cell lines
Cost of sales
Research and development
General and administrative
Total operating expenses
Loss from operations
Interest expense, net
Other expense, net
Total other expense, net
LOSS BEFORE INCOME TAX BENEFIT
Deferred income tax benefit
BASIC AND DILUTED NET LOSS PER COMMON SHARE
WEIGHTED AVERAGE NUMBER OF COMMON STOCK OUTSTANDING: BASIC AND DILUTED
ASTERIAS BIOTHERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(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
Equipment and furniture, net
Construction in progress
Investment in affiliates
LIABILITIES AND STOCKHOLDERS' EQUITY
Amount due to parent, BioTime, Inc.
Accrued expenses and other current liabilities
Deferred grant income
Deferred tax liabilities, current portion
Total current liabilities
Deferred tax liabilities, net of current portion and deferred tax assets
Deferred rent liability, net of current portion
Commitments and contingencies (see Note 8)
Preferred Stock, $0.0001 par value, authorized 5,000 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, $0.0001 par value; 37,642 and 30,902 shares Series A Common Stock issued and outstanding at September 30, 2015 and December 31, 2014, respectively; no Series B Common Stock issued and outstanding at September 30, 2015 and December 31, 2014
Additional paid-in capital
Accumulated other comprehensive loss on available-for-sale investments
Total stockholders' equity
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
SOURCE Asterias Biotherapeutics, Inc.