PR Newswire
FREMONT, Calif., Nov. 14, 2016
FREMONT, Calif., Nov. 14, 2016 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today reported financial results for the third quarter ended September 30, 2016. In addition, the Company disclosed that there has been a recent acceleration in AST-OPC1 SCiStar study enrollment with three patients having been dosed over the past week. In addition to the previously completed dosing of the 2 million and 10 million cell AIS-A cohorts, Asterias has now treated two AIS-A patients with the maximum dose of 20 million AST-OPC1 cells and two AIS-B patients with 10 million AST-OPC1 cells.
The significant enrollment progress has also met requirements for an additional $2.5 million grant payment to the company under the Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.
AIS-A patients are characterized by cervical spinal cord injuries resulting in complete loss of motor and sensory function below the cervical injury site, while AIS-B patients have similar cervical injuries and complete motor loss but retain some sensory function. The company believes AIS-B patients may be particularly responsive to AST-OPC1 due to the larger amount of intact spinal tissue remaining in these patients at the injury site.
"Since mid-September, when we presented promising early data from AIS-A patients dosed with 10 million cells, our clinical team has continued to make excellent progress enrolling additional patients in the SCiStar study," said Steve Cartt, President and Chief Executive Officer. "We have now dosed two patients each in both the AIS-A 20 million cell cohort and the AIS-B 10 million cell cohort. The early efficacy data presented in September for AST-OPC1 was very encouraging, and we look forward to presenting the six-month efficacy and safety results for this cohort in January 2017. We also look forward to Dr. Kurpad and his patient joining our conference call this afternoon to share their experience with AST-OPC1."
Asterias management will be joined on the conference call by Shekar N. Kurpad, MD, PhD, Professor of Neurosurgery, Director, Spinal Cord Injury Center Medical College of Wisconsin and a clinical investigator for the SCiStar study. Dr. Kurpad will discuss his experience to date with AST-OPC1 at his institution, and will be joined on the call by one of his patients who received AST-OPC1.
Recent Research and Development Highlights
AST-OPC1 (oligodendrocyte progenitor cells)
AST-VAC1 (antigen-presenting autologous dendritic cells)
AST-VAC2 (antigen-presenting allogeneic dendritic cells)
Third Quarter Financial Update
Total revenues were $2.1 million for the third quarter, and $5.2 million for the nine months ended September 30, 2016. Revenues were comprised of grant income as well as royalty revenues on product sales by licensees. Research and development expenses were $5.2 million for the third quarter and $17.6 million for the nine months ended September 30, 2016, with the primary driver being expenses associated with our AST-OPC1 program. General and administrative expenses were $4.2 million for the third quarter and $13.1 million for the nine months ended September 30, 2016. Non-cash expenses related to warrants distributed to shareholders earlier in the year and which were included in general and administrative expenses were $2.1 million for the third quarter and $5.3 million for the nine months ended September 30, 2016. Net loss was $10.6 million, or $0.24 per share, for the third quarter and $26.1 million, or $0.63 per share, for the nine months ended September 30, 2016. For the nine months ended September 30, 2016 net cash used in operating activities was $15.1 million and net cash provided from financing activities was $22.4 million.
As of September 30, 2016, the company's cash, cash equivalents and available-for-sale securities totaled $33.9 million, which management believes will be sufficient to fund operations through the third quarter of 2017.
Conference Call and Webcast Details
Asterias will host a conference call and webcast today, November 14, 2016 at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the results and corporate developments. Company management will be joined by Shekar N. Kurpad, MD, PhD, Professor of Neurosurgery, Director, Spinal Cord Injury Center Medical College of Wisconsin and a clinical investigator for the SCiStar study. Dr. Kurpad will discuss his experience to date with AST-OPC1 at his institution, and will be joined on the call by one of his patients who received AST-OPC1. To access a video that includes Dr. Kurpad, other clinical investigators, as well as patients who have been treated with AST-OPC1, please click on the following link: http://asteriasbiotherapeutics.com/.
For both "listen-only" participants and those participants who wish to take part in the question-and-answer session, the call can be accessed by dialing 877-719-9799 (U.S./Canada) or 719-325-4838 (international) five minutes prior to the start of the call and providing the Conference ID 5481738. 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 dialing 888-203-1112 (U.S./Canada) or 719-457-0820 (international) and providing the Conference ID 5481738. Additionally, the archived webcast will be available at http://asteriasbiotherapeutics.com/events-presentations/.
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 after demonstrating promise in 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 confirmatory phase 2b 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 the first half 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.
| ASTERIAS BIOTHERAPUTICS, INC. | ||||||||||||
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| CONDENSED STATEMENTS OF OPERATIONS | ||||||||||||
| (IN THOUSANDS, EXCEPT PER SHARE DATA) | ||||||||||||
| |||||||||||||
| | | Three Months Ended | | Nine Months Ended | ||||||||
| | | 2016 | | 2015 | | 2016 | | 2015 | ||||
| REVENUE | | | | | | | | | | | | |
| Royalties from product sales | | $ | 218 | | $ | 353 | | $ | 337 | | $ | 528 |
| Sale of cell lines | | | - | | | - | | | - | | | 40 |
| Grant income | | | 1,858 | | | 1,070 | | | 4,865 | | | 2,406 |
| Total revenue | | | 2,076 | | | 1,423 | | | 5,202 | | | 2,974 |
| Cost of sales | | | (59) | | | (176) | | | (118) | | | (265) |
| Total gross profit | | | 2,017 | | | 1,247 | | | 5,084 | | | 2,709 |
| | | | | | | | | | | | | |
| EXPENSES | | | | | | | | | | | | |
| Research and development | | | (5,232) | | | (4,629) | | | (17,594) | | | (11,918) |
| General and administrative | | | (4,210) | | | (1,554) | | | (13,081) | | | (5,071) |
| Total operating expenses | | | (9,442) | | | (6,183) | | | (30,675) | | | (16,989) |
| | | | | | | | | | | | | |
| Loss from operations | | | (7,425) | | | (4,936) | | | (25,591) | | | (14,280) |
| | | | | | | | | | | | | |
| OTHER INCOME/(EXPENSE) | | | | | | | | | | | | |
| Change in fair value on warranty liability | | | (3,995) | | | - | | | (2,368) | | | - |
| Interest expense, net | | | (128) | | | (126) | | | (413) | | | (197) |
| Other expense, net Werbung Mehr Nachrichten zur Asterias Biotherapeutics Aktie kostenlos abonnieren
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