Vistagen Therapeutics (NASDAQ: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (“CNS”) disorders, is releasing its 2023 fiscal year report. Highlights of the report include positive results reported in the company’s phase 3 open label study of fasedienol (“PH94B”) in social anxiety disorder (“SAD”) as well as the positive feedback received from the U.S. Food and Drug Administration (“FDA”) regarding the use of the Liebowitz Social Anxiety Scale (“LSAS”) as the primary efficacy endpoint in phase 3 studies planned for fasedienol. In addition, Vistagen’s successful itruvone (“PH10”) U.S. phase 1 study supports previous successful phase 1 studies and a positive phase 2A study in major depressive disorder (“MDD”) as well as the anticipated next-step U.S. phase 2B development. The report noted that the company’s clinical-stage pipeline has grown to six differentiated product candidates and that the company is actively working to pursue key global and regional strategic development and commercialization partnerships designed to accelerate milestones across the CNS pipeline. Financial highlights included a $9 million increase in research and development, with R&D expense reaching $44 million for the year, up from $35.4 million in the previous year; a $1.2 million increase in general and administrative expenses, which totaled $14.7 million for the 2023 fiscal year; a net loss attributable to common stockholders for the year of $59.2 million; and cash and cash equivalents of approximately $16.6 million.
The company noted that it currently has 7,872,479 shares of common stock outstanding as a result of its recent 1-for-30 reverse stock split, which enabled Vistagen to regain full compliance with NASDAQ listing requirements. “We continue to make significant progress across our CNS pipeline, which now includes six innovative clinical-stage product candidates, each with a differentiated mechanism of action, a favorable safety profile and substantial potential to improve millions of lives affected by anxiety, depression, hot flashes due to menopause and several other large market CNS disorders without therapeutic options that adequately satisfy patient needs,” said Vistagen CEO Shawn Singh in the press release. “Our deep understanding of the science and therapeutic potential underlying each of our product candidates provides a firm foundation for our confidence in our future. Given the collective body of positive safety and efficacy studies supporting our clinical-stage pipeline, now is the opportune time to amplify our efforts with multiple global and regional strategic development and commercialization partnerships across our portfolio to accelerate achieving key clinical and regulatory milestones within each program.”
To view the full press release, visit https://ibn.fm/oQN8X
About Vistagen Therapeutics Inc.
Vistagen Therapeutics is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. The company is advancing therapeutics with the potential to be faster acting and with fewer side effects and safety concerns than treatments that are currently available for treatment of anxiety, depression and multiple CNS disorders. Vistagen’s pipeline includes six clinical-stage product candidates, including fasedienol (“PH94B”), itruvone (“PH10”), PH15, PH80 and PH284, each an investigational agent belonging to a new class of drugs known as pherines, as well as AV-101, which is an oral antagonist of the N-methyl-D-aspartate receptor (NMDAR). Pherines, which are administered as low-dose nasal sprays, are designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal cavity and can beneficially impact key neural circuits in the brain without systemic uptake or direct activity on CNS neurons in the brain. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression and several other CNS disorders. For more information about the company, please visit www.Vistagen.com.
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