On November 7, 2019 VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, reported financial results for its fiscal year 2020 second quarter ended September 30, 2019 (Press release, VistaGen Therapeutics, NOV 7, 2019, View Source [SID1234550704]).
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"During the quarter, we achieved several important milestones intended to advance development of each of our three differentiated CNS drug candidates," stated Shawn Singh, Chief Executive Officer of VistaGen. "We recently achieved target enrollment and completed patient dosing in our randomized, double-blind, placebo-controlled Phase 2 ELEVATE study of AV-101, our novel oral NMDA receptor antagonist, in major depressive disorder. In addition, for development of AV-101 in suicidal ideation, with emphasis on U.S. Military Veterans, our collaborators at Baylor University recently completed dosing in their Phase 1b target engagement study in healthy volunteer Veterans, a study funded by the U.S. Department of Veteran’s Affairs. We are also encouraged by post-Phase 2 feedback from the FDA earlier this year regarding our Phase 3 development plan for PH94B, our first-in-class, rapid-acting neuroactive nasal spray, in social anxiety disorder. We expect the coming months to be equally active and potentially transformative, as we look forward to topline readouts from two studies involving AV-101 before the end of 2019, and potential regulatory milestones involving PH94B before the end of fiscal 2020."
Financial Results for the Fiscal Quarter Ended September 30, 2019:
Net loss attributable to common stockholders for the fiscal quarter ended September 30, 2019 decreased to approximately $5.7 million compared to $7.7 million for the fiscal quarter ended September 30, 2018, primarily attributable to research and development activities relating to the Company’s CNS drug development programs.
Research and development expense decreased to $4.2 million for the fiscal quarter ended September 30, 2019, compared with $5.3 million for the fiscal quarter ended September 30, 2018. Expense for the quarter ended September 30, 2018 included $2.25 million noncash expense associated with the Company’s acquisition of its exclusive worldwide license to develop and commercialize PH94B and an option to acquire an exclusive worldwide license to develop and commercialize PH10, the Company’s first-in-class, rapid-onset neuroactive nasal spray in Phase 2 development for major depressive disorder, which option was subsequently exercised. Offsetting this noncash expense in the quarter ended September 30, 2019 are increased expenses for the ELEVATE study and various nonclinical activities across the Company’s CNS pipeline.
General and administrative expense decreased to approximately $1.1 million in the fiscal quarter ended September 30, 2019, compared to approximately $2.2 million in the fiscal quarter ended September 30, 2018. Noncash expense of $272,000 in the quarter ended September 30, 2019, decreased from $792,000 in the quarter ended September 30, 2018, primarily due to decreases in stock-based compensation and other expenses.
At September 30, 2019, VistaGen had cash and cash equivalents of $4.1 million, compared to $13.1 million at March 31, 2019.
As of November 6, 2019, there were 43,222,965 shares of common stock outstanding.
VistaGen’s CNS Pipeline
VistaGen is developing three new generation clinical-stage CNS drug candidates, AV-101, PH10 and PH94B, each with a differentiated mechanism of action, an exceptional safety profile in all clinical studies to date, and therapeutic potential in multiple CNS markets where current treatments are inadequate to meet high unmet patient needs.
AV-101 belongs to a new generation of investigational medicines in neuropsychiatry and neurology known as NMDA (N-methyl-D-aspartate) receptor modulators. The NMDA receptor is a pivotal receptor in the brain and abnormal NMDA function is associated with numerous CNS diseases and disorders. AV-101 is an oral prodrug of 7-Cl-KYNA, a potent and selective full antagonist of the glycine co-agonist site of the NMDA receptor. Based on several positive preclinical studies and its exceptional safety profile in all preclinical and clinical studies to date, AV-101 has potential to be a new at-home, non-sedating treatment for multiple large market CNS indications, including major depressive disorder, neuropathic pain, suicidal ideation, epilepsy and dyskinesia associated with levodopa therapy for Parkinson’s disease. The FDA has granted Fast Track designation for development of AV-101 as both a novel potential adjunctive treatment for MDD and a non-opioid treatment for neuropathic pain.
PH10 is a first-in-class, odorless, rapid-onset CNS neuroactive nasal spray in development for treatment of major depressive disorder. Administered in microgram doses, PH10 activates nasal chemosensory receptors that, in turn, engage neural circuits that lead to rapid antidepressant effects without psychological side effects, systemic exposure or safety concerns often associated with current oral antidepressants and ketamine-based therapies (intravenous ketamine or esketamine nasal spray). In an exploratory (n=30) randomized, double-blind, placebo-controlled Phase 2a clinical study in major depressive disorder, at microgram doses, rapid-onset antidepressant effects were observed and sustained for 8 weeks, without psychological side effects or systemic exposure. VistaGen is preparing for planned Phase 2b clinical development of PH10 for major depressive disorder.
PH94B is a first-in-class, odorless, rapid-onset (approximately 10 to 15 minutes) CNS neuroactive nasal spray with the potential to be the first FDA-approved, as-needed, on-demand treatment for millions of Americans who suffer from social anxiety disorder, with additional potential in peripartum anxiety, pre/postoperative anxiety, post-traumatic stress disorder, panic disorder and generalized anxiety disorder. Administered at microgram doses, PH94B activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety associated with everyday social and work or performance situations. Following successful Phase 2 development, VistaGen is preparing for Phase 3 clinical development of PH94B for social anxiety disorder.