VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company committed to developing and commercializing a new generation of medicines with the potential to go beyond the current standard of care for anxiety, depression and other central nervous system (“CNS”) disorders, has reported its financial results for fiscal year ended March 31, 2021; the company also provided a corporate update, noting that its PALISADE-1 phase 3 trial designed to evaluate PH94B for rapid-onset acute treatment of anxiety in adults with social anxiety disorder (“SAD”) is under way. The announcement also noted that the company is preparing to initiate several exploratory phase 2A clinical trials of PH94B in additional anxiety disorders; progress in efforts to initiate a U.S. multicenter phase 2B clinical trial of PH10 as a potential rapid-onset, standalone treatment for major depressive disorder; and begin a phase 1B clinical trial of AV-101 with probenecid, which, if successful, has the potential to support exploratory phase 2A development of the combination in several CNS disorders. “Our fiscal year 2021 was transformative, involving several drug-development, financial and regulatory milestones that fortified the foundation for our very strong start this fiscal year,” said VistaGen CEO and director Shawn K. Singh in the press release. “Notably, we achieved an important consensus with the U.S. Food and Drug Administration regarding our PALISADE phase 3 program for PH94B in social anxiety disorder. Building on that positive meeting, we completed a PH94B collaboration in ex-U.S. markets, strengthened our balance sheet with substantial investment from numerous long-biased, healthcare-focused institutional investors, and advanced several development programs across our CNS pipeline, most notably preparations for PALISADE-1, our U.S. multicenter phase 3 clinical study of PH94B as a potential rapid-onset, acute treatment of anxiety in adults with social anxiety disorder. If successful, PALISADE-1 is designed to be among the studies necessary to support a potential PH94B New Drug Application to the U.S. Food and Drug Administration in 2023. We recently initiated PALISADE-1, moving us closer to our goal of going beyond the current treatment paradigm for social anxiety disorder, not only displacing antidepressants, benzodiazepines and beta blockers but also reaching those in need of support who find those therapies to be undesirable or inadequate. We anticipate topline data from PALISADE-1 in mid-2022. Later this year, we expect to launch PALISADE-2, a second U.S. multicenter phase 3 clinical study of PH94B designed to be substantially similar to PALISADE-1 and equally supportive of our U.S. New Drug Application goal.”
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About VistaGen Therapeutics Inc.
VistaGen Therapeutics is a biopharmaceutical company committed to developing and commercializing innovative medicines with the potential to go beyond the current standard of care for anxiety, depression and other CNS disorders. Each of VistaGen’s drug candidates has a differentiated potential mechanism of action, has been well-tolerated in all clinical studies to date and has therapeutic potential in multiple CNS markets. For more information about the company, please visit www.VistaGen.com.
NOTE TO INVESTORS: The latest news and updates relating to VTGN are available in the company’s newsroom at https://ibn.fm/VTGN
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