-FDA Clears Expansion of AST-OPC1 Clinical Trial in Spinal Cord Injury-
-Capital Resources Now in Place to Fund AST-OPC1 Clinical Trial Expansion and Continue Progress on Cancer Immunotherapy Programs-
-Conference Call and Webcast Today, May 16, at 4:30 p.m. ET-
FREMONT, Calif., May 16, 2016 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company with three clinical-stage development programs focused on the emerging field of regenerative medicine, today reported financial results for the first quarter ended March 31, 2016. The company also announced plans to expand the AST-OPC1 Phase 1/2a trial in spinal cord injury patients following recent clearance for the expansion by the U.S. Food and Drug Administration (FDA) based on the favorable safety profile observed so far with AST-OPC1 in the current study.
"Recent FDA clearance for expanding the AST-OPC1 clinical study in spinal cord injury patients and the recent capital raise needed to fund this expansion are key developments for Asterias," said Steve Cartt, President and Chief Executive Officer. "This important trial expansion should increase the statistical confidence of the safety and efficacy readouts, expand the range of spinal cord injury patients being evaluated, and better position the product for a potential accelerated regulatory pathway should we observe positive efficacy signals and continued safety in the study."
Mr. Cartt continued, "In addition, the capital we recently raised, despite the very challenging capital markets, significantly strengthened our cash position. Combined with continued non-dilutive funding from leading scientific institutions, this will allow Asterias to immediately progress our three clinical-stage programs toward important milestones targeted for late 2016 and into 2017."
As of May 15, 2016, the company's cash, cash equivalents and available-for-sale securities totaled over $33 million. This includes a recent $2.5 million grant payment from the California Institute of Regenerative Medicine (CIRM) related to progress in the ongoing AST-OPC1 study.
Research and Development Highlights
AST-OPC1 (oligodendrocyte progenitor cells)
AST-VAC1 (antigen-presenting autologous dendritic cells)
AST-VAC2 (antigen-presenting allogeneic dendritic cells)
First Quarter Financial Update
Total revenues were $1.6 million for the first quarter. Revenues are comprised of grant income as well as royalty revenues on product sales by licensees. Research and development expenses were $6.3 million for the first quarter. General and administrative expenses were $6.3 million for the first quarter. Net loss was $10.3 million for the three months ended March 31, 2016, or $0.27 per share, including a deferred income tax benefit of $902,000. For the first quarter, net cash used in operating activities was $4.2 million.
Conference Call and Webcast Details
Asterias will host a conference call and webcast today, May 16, 2016 at 4:30 p.m. Eastern / 1:30 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 888-572-7025. For international participants outside the U.S./Canada, the dial-in number is 719-325-2463. For all callers, refer to Conference ID 3554654. 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 3554654. 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 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 oncology and neurology. AST-VAC1 (antigen-presenting autologous dendritic cells) demonstrated promise in a Phase 2 study in acute myelogenous leukemia (AML) and completed a successful end-of-Phase 2 meeting with the FDA in advance of initiating planning for a single pivotal Phase 3 AML study. 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 2017. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. 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") 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 March 31, (unaudited)
Royalties from product sales
Cost of sales
Total gross profit
Research and development
General and administrative
Total operating expenses
Loss from operations
Interest expense, net
Total other expenses
LOSS BEFORE INCOME TAX BENEFIT
Deferred income tax benefit
Other comprehensive loss, net of tax: Unrealized gain (loss) on available-for-sale securities, net of taxes
Basic and diluted net loss per common share
Weighted average common shares outstanding: basic and diluted
ASTERIAS BIOTHERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)
March 31, 2016 (unaudited)
December 31, 2015
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
Investment in affiliates
Deferred tax asset
LIABILITIES AND STOCKHOLDERS' EQUITY
Amount due to parent, BioTime, Inc.
Accrued expenses and other current liabilities
Capital lease 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
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; 38,557 and 38,228 shares Series A Common Stock issued and outstanding at March 31, 2016 and December 31, 2015, respectively, no Series B Common Stock issued and outstanding at March 31, 2016 and December 31, 2015, respectively.
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.