Conference Call and Webcast Today, August 10, at 4:30 p.m. ET
MENLO PARK, Calif., Aug. 10, 2015 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a leading biotechnology company in the emerging field of regenerative medicine, today reported financial and operating results for the second quarter ended June 30, 2015.
"In the second quarter, we continued to make progress on multiple fronts toward advancing the clinical development of our key therapeutic programs," stated Pedro Lichtinger, President and CEO of Asterias. "We presented new, long-term follow-up Phase 2 clinical data of AST-VAC1 in acute myelogenous leukemia, the most common form of acute leukemia in adults, which showed potential for prolonged relapse-free survival in the overall study population, as well as in the sub-population of adults 60 years and older for which there remains a major unmet need. Based on the promising clinical data observed with AST-VAC1, we are pursuing opportunities to fund a focused clinical development plan for potential commercialization of AST-VAC1 through partnerships or non-dilutive funding."
Mr. Lichtinger continued, "In addition, we dosed the first patient in our Phase 1/2a clinical trial of AST-OPC1 for complete cervical spinal cord injury, a trial which is designed to evaluate the product at the doses and in the population where it has the maximum potential to bring benefit to patients. Importantly, we were successful in our efforts to further strengthen our balance sheet during the quarter by increasing our cash position by approximately $8 million, which has enhanced our financial flexibility to continue to execute our strategic plan through mid-2016. At the same time, during the quarter we completed some administrative tasks, namely the registration of all unregistered Asterias outstanding shares, including those shares held by our parent company BioTime. BioTime remains our largest shareholder and it is important to note that BioTime has not sold any of its position in Asterias since the June 10, 2015 effective date of the registration statement."
Recent Research and Development Highlights:
AST-VAC1 (antigen-presenting autologous dendritic cells)
AST-OPC1 (oligodendrocyte progenitor cells)
AST-VAC2 (antigen-presenting allogeneic dendritic cells)
Other Corporate Developments:
Second Quarter [Unaudited] Financial Results
Total revenues in the second quarter 2015 were $772,000, which were primarily comprised of grant income and royalty revenues on product sales by licensees. Total revenues in the year ago quarter were $21,000. Operating expenses in the second quarter were $5.5 million, compared to $4.3 million in the prior year period. Research and development (R&D) expenses in the second quarter were $3.7 million, compared to $2.7 million in the year ago quarter. General and administrative (G&A) expenses in the second quarter were $1.8 million, compared to $1.5 million in the year ago quarter.
Net loss for the second quarter 2015 was $3.6 million, including a deferred income tax benefit of approximately $1.2 million. Net loss in the second quarter 2014 was $2.8 million, including a deferred income tax benefit of approximately $1.5 million. On a per share basis, net loss for the second quarter was $0.10 per share, compared to a loss of $0.09 per share for the year ago quarter.
Cash and cash equivalents were $15.6 million as of June 30, 2015, compared to $3.1 million as of December 31, 2014. In May 2015, Asterias received total proceeds of $11.7 million resulting from the exercise of all outstanding common share purchase warrants originally issued in June 2014. In addition, Asterias raised approximately $2.8 million in gross proceeds through the Company's at-the-market (ATM) equity offering program during the second quarter of 2015. At June 30, 2015, the Company held 3.9 million BioTime common shares, with a market value of approximately $14.0 million on that date. For the second quarter, net cash used in operating activities was $4.7 million. The Company continues to expect net cash burn in 2015 to be in the range of $15 million to $17 million.
Second Quarter Conference Call and Webcast Details
The Company will host a conference call and webcast today, Monday, August 10, 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 participate in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 888-389-5988. For participants outside the U.S./Canada, the dial-in number is 719-457-2648. For all callers, refer to Conference ID 3175112. 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 3175112. 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 allogeneic dendritic cell technologies. Pluripotent stem cells are characterized by the ability to become all cell types in the human body. Asterias is focused on developing therapies based on pluripotent stem cells 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 June 30,
Six months ended June 30,
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:
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)
June 30, 2015 (unaudited)
December 31, 2014
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
Total noncurrent assets
LIABILITIES AND STOCKHOLDERS' EQUITY
Amount due to parent, BioTime, Inc.
Accrued liabilities 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 5,000,000 shares; none issued and outstanding
Common Stock, authorized 75,000,000 Series A Common Stock, $0.0001 par value, and 75,000,000 Series B Common Stock, $0.0001 par value; 37,602,180 and 30,902,152 shares Series A Common Stock issued and outstanding at June 30, 2015 and December 31, 2014, respectively, no Series B Common Stock issued and outstanding at June 30, 2015 and December 31, 2014
Additional paid-in capital
Accumulated comprehensive loss on available-for-sale investments
Deficit accumulated during the development stage
Total stockholders' equity
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
SOURCE Asterias Biotherapeutics, Inc.