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 reporting its financial results for the first quarter of 2024, the period ending June 30, 2023; the company also released a corporate update. Highlights of the report include positive top-line results from the company’s phase 3 PALISADE-2 trial of rapid-onset fasedienol (“PH94B”) nasal spray in social anxiety disorder (“SAD”); the staging of itruvone (“PH10”) nasal spray for phase 2B clinical development as a standalone, nonsystemic treatment for major depressive disorder (“MDD”); and optimism for the treatment of moderate to severe vasomotor symptoms, or hot flashes, in women experiencing menopause based on the positive exploratory phase 2A trial of VTGN’s PH80 (“PH80”) nasal spray. In addition, company Q1 2024 financial results show that R&D expenses decreased from $15.3 million to $4.2 million for the quarter; general and administrative expense decreased to $3 million from $4.8 million for the quarter ended June 20, 2022; net loss was approximately $6.9 million compared to $19.8 million for Q1 2022; and cash and cash equivalents for the company total approximately $9.6 million.
“The positive outcome of our PALISADE-2 study demonstrated that fasedienol significantly reduced the mean Subjective Units of Distress Scale score, reducing anxiety during a stressful public-speaking challenge,” said Vistagen CEO Shawn Singh in the press release. “The study outcome is a pivotal achievement for fasedienol and our diverse pherine platform. These results mark the first positive U.S. phase 3 study of an investigational therapy for social anxiety disorder in over 15 years. We believe these results reinforce the promise of our pherine pipeline to address growing unmet treatment needs. We now move forward confidently advancing the phase 3 program for fasedienol in SAD with planning for initiation of additional phase 3 studies in 2024. Our strong understanding of each pherine product candidate’s scientific and therapeutic potential gives us confidence in our ability to continue to innovate for patients and deliver long-term value for shareholders. With a collective body of positive safety and efficacy studies supporting our clinical-stage pipeline, we believe there are many strategic paths to accelerate our progress in achieving key clinical and regulatory milestones for each program over the next 12 months.”
To view the full press release, visit https://ibn.fm/lfa6D
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 prodrug antagonist of the N-methyl-D-aspartate receptor (“NMDAR”). Pherines are neuroactive nasal sprays designed with an innovative proposed 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.
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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