Vistagen and Fuji Enter Exclusive Negotiation Agreement for a Potential License to Develop and Commercialize Vistagen’s Investigational Menopausal Hot Flash Therapy, PH80 Nasal Spray, in Japan

Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, and Fuji Pharma Co., Ltd. (“Fuji”) (TSE: 4554), a pharmaceutical company specializing in development, manufacture and marketing in the fields of women’s healthcare and acute medical care, today announced they have entered into a time-limited (up to approximately eighteen months) agreement to negotiate exclusively with each other regarding a potential license to develop and commercialize Vistagen’s PH80 in Japan, including for the acute treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause and potentially other indications. Vistagen’s PH80 neuroactive nasal spray demonstrated statistically significant efficacy versus placebo in an exploratory double-blind, placebo-controlled Phase 2A study in women diagnosed with menopausal hot flashes. Fuji will make a non-refundable payment of $1.5 million to secure the time-limited exclusive negotiation rights for the Japanese market.

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“As we have seen across our neuroactive pherine nasal spray pipeline, PH80 offers exciting potential to transform a significant segment of a major healthcare market, including the current treatment landscape for women’s healthcare,” said Shawn Singh, CEO of Vistagen. “Menopausal hot flashes affect millions of women worldwide. We share Fuji Pharma’s long-standing commitment to deliver innovative treatment options with potential to enable women to improve their physical, mental and social well-being. As we continue to advance our PH80 development program in the U.S., we look forward to continuing our ongoing discussions with Fuji regarding a potential development and commercialization collaboration in Japan.”

“Our core mission at Fuji Pharma centers on helping people lead healthy lives by offering excellent pharmaceutical solutions. We believe that PH80 will provide new treatment options to improve the quality of life and further strengthen our position as one of the best Japanese specialty pharmaceutical companies in women’s health,” said Takayuki Iwai, President & CEO of Fuji. “We will continue to engage in dialogue with Vistagen, anticipating that successful development of PH80 will contribute to women's health in Japan.”