MENLO PARK, Calif., May 7, 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 first quarter ended March 31, 2015.
“Asterias remains focused on our two potentially transformative stem cell technology platforms, industry-leading Pluripotent Stem Cells and Allogeneic Dendritic Cell Immunotherapy,” stated Pedro Lichtinger, President and CEO of Asterias. “We are making steady progress on our lead therapeutic programs from each of these platforms that have the potential to address significant unmet medical needs. We have activated the second clinical site in our Phase 1/2a clinical trial of AST-OPC1 in patients with complete cervical spinal cord injury, and expect safety data from the initial low-dose, 2 million cell cohort as well as initiation of the 10 million cell cohort in the third quarter of 2015. In addition, we continue to expect completion and transfer of the manufacturing process of our AST-VAC2 allogeneic dendritic cell-based cancer vaccine to our development partner Cancer Research UK in the second quarter of this year. Importantly, we strengthened our cash position in the first quarter by completing a $5.3 million public offering and private placement of our common stock. In addition, we received $2.3 million in the first quarter from the California Institute of Regenerative Medicine related to clinical development of AST-OPC1.”
Recent Research and Development Highlights:
AST-OPC1 (oligodendrocyte progenitor cells)
- In March, Asterias initiated patient enrollment in the dose-escalation Phase 1/2a clinical trial of AST-OPC1 in patients with complete cervical spinal cord injury (SCI) at Atlanta-based Shepherd Center, one of the nation’s top rehabilitation hospitals for spinal cord injury and brain injury. Asterias activated the second clinical site in April, which has begun patient enrollment for the Phase 1/2a trial. The Company plans to initiate enrollment for the Phase 1/2a trial at up to a total of eight clinical sites by end-2015. The trial is an open-label, single-arm study testing three escalating doses of AST-OPC1 in patients with sub-acute, C-5 to C-7, neurologically complete cervical SCI. The dose escalation will start with three patients being dosed 2 million cells and escalate into two five-patient cohorts at 10 million and 20 million cells, respectively.
- The Company plans to file an Investigational New Drug Application (IND) amendment with the U.S. Food and Drug Administration (FDA), if initial safety data from the 10 million cell cohort is positive, in order to increase the robustness of the proof of concept in the Phase 1/2a clinical trial by expanding enrollment from 13 patients to up to 40 patients. The Company believes these changes will increase the statistical confidence of the safety and efficacy readouts, reduce the risks of the AST-OPC1 program and position the product for potential accelerated regulatory approvals.
- In the first quarter, Asterias received $2.3 million from the California Institute of Regenerative Medicine (CIRM) under the previously announced $14.3 million CIRM grant award for clinical development of AST-OPC1.
AST-VAC2 (antigen-presenting allogeneic dendritic cells)
- Asterias is nearing completion of development and scale-up of the AST-VAC2 manufacturing process. The Company continues to expect to complete transfer of the resulting cGMP-compatible process to development partner Cancer Research UK (CRUK) in the second quarter of 2015. Following completion of the technology transfer, CRUK will, at its own cost, manufacture clinical grade AST-VAC2 and conduct the Phase 1/2a clinical trial in patients with non-small cell lung cancer in the UK, subject to regulatory approval.
AST-VAC1 (antigen-presenting autologous dendritic cells)
- The abstract describing long-term follow-up of patients with acute myelogenous leukemia (AML) from the Phase 2 clinical trial of the Company’s autologous telomerase-based dendritic cell cancer vaccine, AST-VAC1, was selected for an oral presentation at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago, IllinoisMay 29 June 2, 2015.
First Quarter [Unaudited] Financial Results
Total revenues in the first quarter 2015 were $779,060, which were comprised of grant income and royalty revenues on product sales by licensees. Total revenues in the year ago quarter were $61,980. Operating expenses in the first quarter were $5.3 million, compared to $3.7 million in the prior year period. Research and development (R&D) expenses in the first quarter were $3.6 million, compared to $2.6 million in the year ago quarter.
Net loss for the first quarter 2015 was $3.0 million, including a deferred income tax benefit of approximately $1.6 million. Net loss in the first quarter 2014 was $2.3 million, including a deferred income tax benefit of approximately $1.3 million. On a per share basis, net loss for the first quarter was $0.09 per share, compared to a loss of $0.07 per share for the year ago quarter.
Cash and cash equivalents were $7.4 million as of March 31, 2015, compared to $3.1 million as of December 31, 2014. In February 2015, Asterias raised $5.3 million in net proceeds from the public offering and concurrent private placement of its common stock. In addition, the Company held 3.9 million BioTime common shares, with a market value of approximately $19.2 million as of March 31, 2015. For the first quarter, cash burn was $1.7 million, below the Company’s projected cash burn for the quarter, primarily due to higher than anticipated receipts from CIRM in the quarter. The Company continues to expect net cash burn in 2015 to be in the range of $15 million to $17 million.
First Quarter Conference Call and Webcast Details
The Company will host a conference call and webcast today, Thursday, May 7, 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. is 877-407-8291. For participants outside the U.S., the dial-in number is 201-689-8345. 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. The telephone dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. To access the replay for all callers, refer to Conference ID 13608712. An archived webcast will also be available for 30 days, and may be accessed at http://asteriasbiotherapeutics.com/events-presentations/.
Investor Meeting and Webcast to Review AST-OPC1 Clinical Development Strategy for Spinal Cord Injury
Asterias will host a meeting with the investment community tomorrow, Friday, May 8, 2015 to review the clinical development strategy for AST-OPC1 (oligodendrocyte progenitor cells) in spinal cord injury. The program will include presentations by Asterias’ President and Chief Executive Officer Pedro Lichtinger, President of Research and Development Jane S. Lebkowski, Ph.D., and Chief Translational Officer Edward D. Wirth, III, M.D., Ph.D. In addition, John Steeves, Ph.D., Co-Chair of the Spinal Cord Outcomes Partnership Endeavor (SCOPE) and Professor of International Collaboration on Repair Discoveries (ICORD), will discuss clinical foundations for the endpoints and outcome measures in spinal cord injury trials.
A live webcast of the presentations will begin at 9:30 a.m. ET and the webcast will conclude by 12:00 p.m. ET. The live webcast of the event will be available on the Company’s website at: http://asteriasbiotherapeutics.com/events-presentations/. An archived webcast will be available at the same website following the conclusion of the meeting.
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. (NYSE MKT: AST) is a leading biotechnology company in the emerging field of regenerative medicine. The Company’s core technologies center on pluripotent stem cells, which are characterized by the ability to become all cell types in the human body.
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