On March 28, 2017 Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, reported financial and operational results for the fourth quarter and year ended December 31, 2016 as well as recent corporate progress (Press release, BioTime, MAR 28, 2017, View Source;p=RssLanding&cat=news&id=2257051 [SID1234518294]).
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"Asterias has achieved substantial progress over the last year, highlighted by previously announced positive interim efficacy and safety results from our ongoing SCiStar Phase 1/2a clinical trial, as well as initiation of operations at our new cGMP manufacturing facility for AST-OPC1," said Steve Cartt, President and Chief Executive Officer. "We are particularly encouraged by the results we have seen to date in the SCiStar trial, which we believe provide solid evidence of the potential for AST-OPC1 to help patients with complete paralysis recover arm, hand and finger function. Such recovery is critically important to increasing both independence and quality of life in patients who suffer complete cervical spinal cord injuries. In 2017, we look forward to completing study enrollment, engaging in discussions with the FDA to determine our optimal clinical path forward, and reporting more efficacy and safety data later in the year as it becomes available."
As of February 28, 2017, Asterias’ cash and cash equivalents totaled $19.9 million and combined with its available-for-sale securities totaled $33.5 million.
"Our cash position is significantly improved from the same time last year, which allows us to continue to advance our programs towards important development milestones," said Ryan Chavez, Chief Financial Officer. "We believe we currently have sufficient capital to fund operations through at least the first quarter of 2018."
2016 and Recent Key Achievements
Presented positive early efficacy data from the first cohort of the SCiStar study testing a dose of AST-OPC1 within the predicted efficacious dose range. In this cohort, 10 million AST-OPC1 cells were delivered to patients with neurologically complete (AIS-A 10) cervical injuries. Patients from this cohort showed improvement in upper extremity motor function at 3-months following administration of AST-OPC1. Asterias subsequently reported efficacy results for five patients from this cohort that showed additional motor function improvement at 6-months and 9-months following administration of AST-OPC1. Earlier this month, Asterias reported that the sixth, and final, patient in this cohort showed additional motor function improvement at 6-months following administration of AST-OPC1. The results suggest a meaningful and favorable difference to date in recovery of arm, hand and finger function in patients treated with the 10 million cell dose of AST-OPC1 versus the level of expected rates of spontaneous recovery shown from historical control data of a closely matched patient population.
Received FDA clearance to expand the SCiStar study to include two additional cohorts of subjects with less severe AIS-B (motor complete, sensory incomplete) injuries.
Commenced dosing of two additional cohorts in the SCiStar study: AIS-B patients treated with 10 million AST-OPC1 cells; and, following clearance by the study’s Data Monitoring Committee, AIS-A patients treated with the higher dose of 20 million AST-OPC1 cells.
Successfully completed the validation and start-up of its internal current Good Manufacturing Practices (cGMP) manufacturing facility at Asterias headquarters in Fremont, CA in preparation for late-stage clinical trials of AST-OPC1.
Reported positive long-term follow-up results from the Phase 1 clinical trial of AST-OPC1.
Received Orphan Drug Designation from FDA for AST-OPC1 for the treatment of acute spinal cord injury.
Successfully completed an End-of-Phase 2 meeting with the FDA for AST-VAC1 in Acute Myeloid Leukemia (AML).
Completed clinical protocol development and the transfer of the manufacturing processes to produce AST-VAC2 to Cancer Research UK (CRUK) as part of the company’s ongoing partnership with CRUK to conduct a Phase 1/2a study for AST-VAC2 in non-small cell lung cancer.
Financial Results
Total revenues were $1.8 million for the fourth quarter and $7.0 million for the year ended December 31, 2016. Revenues were comprised of grant income as well as royalty revenues on product sales by licensees. Research and development expenses were $7.9 million in the fourth quarter and $25.5 million in the year ended December 31, 2016, with the primary driver being expenses associated with our AST-OPC1 program. General and administrative expenses were $2.4 million in the fourth quarter and $15.5 million in the year ended December 31, 2016. Non-cash expenses related to warrants distributed to shareholders other than BioTime earlier in the year, which were included in general and administrative expenses, were $5.3 million.
Net loss was $9.3 million, or $0.20 per share, for the fourth quarter and $35.5 million, or $0.83 per share, for the year ended December 31, 2016. For the year ended December 31, 2016, net cash used in operating activities was $19.0 million and net cash provided from financing activities was $28.5 million.
As of December 31, 2016, Asterias’ cash and cash equivalents totaled $19.8 million and combined with its available-for-sale securities totaled $35.1 million.