November 15, 2016
By Mark Terry, BioSpace.com Breaking News Staff
South San Francisco-based VistaGen Therapeutics released its second-quarter financial records yesterday, with cash runway a top concern.
VistaGen is a clinical-stage biotech company that’s focused on treatments for depression and other central nervous system disorders. It has AV-101 currently in Phase II trials as adjunctive treatment of major depressive disorder (MDD) in patients who haven’t responded to U.S. Food and Drug Administration (FDA)-approved antidepressants.
AV-101 is in a Phase IIa monotherapy trial for MDD. It is fully funded by the U.S. National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health (NIH). And it is in a Phase IIb trial as adjunctive treatment in MDD, which it hopes to advance to in the first half of next year.
Various near-term milestones include the submission of an Investigational New Drug (IND) application for a Phase IIb study of AV-101, the launch of the AV-101 Phase IIb in the first half of next year, FDA Fast Track designation for the drug as an adjunctive treatment of MDD in the first half of 2017, and topline results from the Phase IIa MDD monotherapy study in the first half of next year.
In terms of financials, it reported a net loss of about $3.1 million in the second quarter of fiscal year 2017, which ended September 30, 2016. Research and development expenses were $1.61 million for the quarter, a decrease of 3 percent from the same period last year. General and administrative expense dropped to $1.5 million from $3.7 million in the same quarter last year. These are the result of a drop in noncash stock compensation expenses related to option and fully-vested warrant grants to employees, board members and consultants.
VistaGen indicates it has about $6.3 million in cash and cash equivalents, which should fund operations through the first half of 2017.
VistaGen also appointed Mark Smith as chief medical officer. Smith was formerly clinical lead for neuropsychiatry at Teva Pharmaceuticals . Mark McPartland was appointed vice president, corporate development and investor relations. Previously he was vice president of corporate development and communications for Stellar Biotechnologies.
In its SEC filing, VistaGen indicates that, “In addition to clinical development of AV-101, we are advancing potential commercial applications of our human pluripotent stem cell (hPSC) technology platform, including drug rescue and regenerative medicine (RM). Our small molecule drug rescue and regenerative medicine involve using CardioSafe 3D, our customized cardiac bioassay system, to develop new chemical entities (NCEs) for our internal pipeline. Potential RM applications include using blood, cartilage, heart and/or liver cells derived from hPSCs for (A) cell-based therapy, (B) cell repair therapy, and/or (C) tissue engineering. We may pursue these drug rescue and RM applications in collaboration with third-parties.”
On the financial front, it stated, “Although we may seek additional collaborations that could generate revenue, as well as new government grant awards, no assurance can be provided that any such collaborations or awards will occur in the future. … Substantial additional funding may not be available to us on a timely basis, on acceptable terms, or at all. If we are unable to obtain substantial additional financing on a timely basis in the near term, our business, financial condition, and results of operations may be harmed, the price of our stock may decline, we may be required to reduce, defer, or discontinue certain of our research and development activities and we may not be able to continue as a going concern.”
