SOUTH SAN FRANCISCO, Calif. & TOKYO--(BUSINESS WIRE)--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.

南旧金山，加利福尼亚州和东京-（商业线）-Vistagen（纳斯达克股票代码：VTGN），一家临床阶段的生物制药公司，旨在改变患有焦虑，抑郁和其他中枢神经系统（CNS）疾病的个人的治疗环境，以及专门从事开发的制药公司富士制药有限公司（“富士”）（TSE:4554），今天，在妇女保健和急诊医疗领域的制造和营销宣布，他们已经签订了一项有时限（长达约18个月）的协议，专门就在日本开发和商业化Vistagen PH80的潜在许可进行谈判，包括用于更年期和潜在的其他适应症引起的中度至重度血管舒缩症状（潮热）的急性治疗。

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..

Vistagen的PH80神经活性鼻喷雾剂在诊断为绝经期潮热的女性的探索性双盲，安慰剂对照2A期研究中显示出与安慰剂相比具有统计学显着的功效。富士将收取150万美元的全额退款，以确保日本市场的限时独家谈判权。。

“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.

Vistagen首席执行官Shawn Singh说：“正如我们在神经活性pherine鼻喷雾剂管道中看到的那样，PH80为改变主要医疗保健市场的重要部分提供了令人兴奋的潜力，包括目前妇女医疗保健的治疗领域。“更年期潮热影响全球数百万女性。

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.”.

我们分享富士制药公司长期致力于提供创新的治疗方案，使女性能够改善身心健康。随着我们继续推进我们在美国的PH80开发计划，我们期待继续与富士公司就日本潜在的开发和商业化合作进行持续讨论。

“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.

“我们在富士制药中心的核心使命是通过提供优质药物解决方案帮助人们过上健康的生活。我们相信PH80将为提高生活质量提供新的治疗方案，并进一步加强我们作为日本最好的专业制药公司之一的地位。富士总裁兼首席执行官岩井隆之说。

“We will continue to engage in dialogue with Vistagen, anticipating that successful development of PH80 will contribute to women's health in Japan.”.

“我们将继续与Vistagen进行对话，预计PH80的成功发展将有助于日本妇女的健康。”。

About PH80

大约PH80

PH80 is a rapid-onset neuroactive pherine nasal spray product candidate designed to be used in a manner analogous to a rescue inhaler for asthma, taken by patients as-needed up to multiple times daily. Several pharmacokinetic and toxicokinetic studies show that PH80 administered intranasally is below the level of detection in plasma of human subjects and laboratory animals.

PH80是一种快速起效的神经活性pherine鼻喷雾剂候选产品，设计用于类似于哮喘救援吸入器的方式，由患者根据需要每天服用多次。几项药代动力学和毒代动力学研究表明，鼻内给药的PH80低于人类受试者和实验动物血浆中的检测水平。

Based on other studies conducted by Vistagen, pherine molecules have no detectable uptake in the brain and do not absorb systemically. All these data, along with the minimal adverse events reported in all clinical studies to date, demonstrate the excellent safety profile of this new class of molecules.

根据Vistagen进行的其他研究，pherine分子在大脑中没有可检测的摄取，也不能全身吸收。所有这些数据，以及迄今为止所有临床研究中报告的最小不良事件，证明了这类新分子的优异安全性。

In a placebo-controlled exploratory Phase 2A clinical trial, PH80 demonstrated an excellent safety profile and potential as a new treatment for moderate to severe vasomotor symptoms (hot flashes) associated with menopause..

在安慰剂对照的探索性2A期临床试验中，PH80表现出优异的安全性和作为与绝经相关的中度至重度血管舒缩症状（潮热）的新疗法的潜力。。

About Vasomotor Symptoms (Hot Flashes) due to Menopause

关于更年期引起的血管舒缩症状（潮热）

Hot flashes are vasomotor symptoms (VMS) commonly experienced by women in menopause and are accompanied by hallmark symptoms such as sudden feelings of warmth, night sweats and flushed skin. Presentation of hot flashes is directly linked to changes in hormone levels due to menopause, or to menopause induced by other medical treatments or co-existing conditions, and the causal mechanism is unclear.

潮热是更年期妇女常见的血管舒缩症状（VMS），并伴有标志性症状，如突然感觉温暖，盗汗和皮肤潮红。潮热的表现与更年期激素水平的变化或其他药物治疗或共存条件引起的更年期直接相关，其致病机制尚不清楚。

Hot flashes are the most common symptom of the menopausal transition, affecting about 75% of menopausal women and about 40% of women in perimenopause. Current pharmacotherapies to treat hot flashes include hormonal therapy (estrogen with or without progesterone, or a synthetic progestin), gabapentins, certain antidepressants, clonidine and fezolinetant, a neurokinin 3 (NK3) receptor antagonist, all of which are associated with certain side effects..

潮热是绝经过渡期最常见的症状，影响约75%的绝经期妇女和约40%的围绝经期妇女。目前治疗潮热的药物疗法包括激素疗法（含或不含黄体酮的雌激素或合成孕激素），加巴喷丁，某些抗抑郁药，可乐定和fezolinetant，神经激肽3（NK3）受体拮抗剂，所有这些都与某些副作用有关。。

About Exploratory Phase 2A Study of PH80 in Vasomotor Symptoms (Hot Flashes) due to Menopause

关于PH80在更年期血管舒缩症状（潮热）中的探索性2A期研究

In a randomized, double-blind, placebo-controlled exploratory Phase 2A clinical study of PH80 (n=36) designed to explore the efficacy, safety and tolerability of intranasal administration of PH80 for the acute management of menopausal hot flashes in women, PH80 induced significant reduction in the daily number of hot flashes compared to placebo at the end of the first week of treatment, and the improvement was maintained through each treatment week until the end of the treatment period.

在一项针对PH80（n=36）的随机，双盲，安慰剂对照探索性2A期临床研究中，旨在探讨鼻内给予PH80治疗女性更年期潮热的疗效，安全性和耐受性，PH80在治疗的第一周结束时，与安慰剂相比，诱导每日潮热次数显着减少，并且在每个治疗周保持改善直至治疗期结束。

At baseline, subjects reported a mean daily number of hot flashes of 7.7 (PH80, n=18) and 8.0 (placebo, n=18). After one week of treatment, the number of hot flashes dropped to 2.8 (PH80) and 6.4 (placebo) (p<0.001) and after four weeks of treatment the number of hot flashes dropped to 1.5 (PH80) and 5.1 (placebo) (p<0.001).

在基线时，受试者报告平均每日潮热次数为7.7（PH80，n=18）和8.0（安慰剂，n=18）。治疗一周后，潮热次数降至2.8（PH80）和6.4（安慰剂）（p<0.001），治疗四周后，潮热次数降至1.5（PH80）和5.1（安慰剂）（p<0.001）。

PH80 treatment also significantly reduced the severity, disruption in function and sweating related to hot flashes during the treatment period as compared with placebo. This exploratory Phase 2A study of PH80 was conducted in a real-world setting in Mexico and was sponsored by Pherin Pharmaceuticals (Pherin), now a wholly owned subsidiary of Vistagen, prior to Vistagen’s acquisition of Pherin in February 2023.

与安慰剂相比，PH80治疗还显着降低了治疗期间与潮热相关的严重程度，功能中断和出汗。PH80的这项探索性2A期研究是在墨西哥的现实环境中进行的，由Vistagen的合资子公司Pherin Pharmaceuticals（Pherin）赞助，于2023年2月Vistagen收购Pherin。

Ellen Freeman, Ph.D. of the University of Pennsylvania served as the Principal Investigator of the study..

宾夕法尼亚大学的Ellen Freeman博士担任该研究的首席研究员。。

About Vistagen

关于Vistagen

Vistagen (Nasdaq: VTGN) is a clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. Vistagen is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns, than those currently available for the treatment of anxiety, depression and multiple CNS disorders.

Vistagen（纳斯达克股票代码：VTGN）是一家临床阶段的生物制药公司，旨在改变焦虑，抑郁和其他中枢神经系统疾病患者的治疗环境。Vistagen正在推进治疗方法，与目前可用于治疗焦虑症，抑郁症和多种中枢神经系统疾病的药物相比，具有更快的疗效，更少的副作用和安全性问题。

Vistagen's pipeline includes six clinical-stage product candidates, including fasedienol (PH94B), itruvone (PH10), PH80, PH15, and PH284, with each of these being an investigational agent belonging to a new class of drugs known as pherines, as well as AV-101, which is an oral prodrug of an antagonist of the N-methyl-D-aspartate receptor (NMDAR).

Vistagen的管道包括六个临床阶段候选产品，包括法舒地诺（PH94B），伊曲酮酮（PH10），PH80，PH15和PH284，其中每一个都是属于一类新药物的研究药物，称为pherines，以及AV-101，它是N-甲基-D-天冬氨酸受体（NMDAR）拮抗剂的口服前药。

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 absorption or direct activity on 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.

Pherines是神经活性鼻腔喷雾剂，其设计具有创新的提出的作用机制，其激活鼻腔中的化学感应神经元，并且可以有益地影响大脑中的关键神经回路，而没有全身吸收或直接活动大脑中的神经元。Vistagen热衷于改变精神卫生保健并重新定义治疗焦虑，抑郁和其他几种中枢神经系统疾病的可能性。

Connect at www.Vistagen.com..

Connect at www.Vistagen.com..

About Fuji

关于富士

Fuji is a Tokyo Stock Exchange (TSE) listed, Japan-based pharmaceutical company mainly engaged in the manufacture and sale of prescription based pharmaceutical products. Since our establishment in 1965, Fuji has promoted corporate philosophy that 'We help people lead healthy lives by offering excellent pharmaceuticals.' and 'Our corporate growth is proportional to our personal growth.' Fuji focuses on the field of women's health care with a wide variety of new and generic drugs for women's specific diseases such as infertility, dysmenorrhea, endometriosis, contraception, and menopausal disorders.

富士是东京证券交易所（TSE）上市公司，日本制药公司主要从事处方药产品的制造和销售。自1965年成立以来，富士一直倡导企业理念，“我们通过提供优质药品帮助人们过上健康的生活”和“我们的公司增长与我们的个人增长成正比。”富士专注于妇女保健领域，为妇女的特定疾病，如不孕症，痛经，子宫内膜异位症，避孕和更年期疾病提供各种各样的新药和仿制药。

Fuji aims to be a leading company in women's healthcare and support health of women of all ages. https://www.fujipharma.jp.

富士的目标是成为女性保健和支持各年龄段女性健康的领先公司。https://www.fujipharma.jp.

Forward-looking Statements

前瞻性声明

This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions.

本新闻稿包含联邦证券法含义内的某些前瞻性声明。这些前瞻性陈述涉及难以预测的已知和未知风险，包括所有非历史事实的事项。在某些情况下，您可以使用诸如“may”，“can”，“expect”，“project”，“outlook”，“strategy”，“interpret”，“plan”，“seek”，“expect”，“相信”，“估计”，“预测”，“潜力”，“努力”，“目标”继续，“可能”，“将会”以及这些术语和类似术语的变体表达式，或这些术语或类似表达式的否定值。

Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization, and actual results or development may differ materially from those projected or implied in these forward-looking statements.

这种前瞻性陈述必然基于估计和假设，虽然Vistagen及其管理层认为合理，但本质上是不确定的。与所有药品一样，开发和商业化过程中存在重大风险和不确定性，实际结果或开发可能与这些前瞻性声明中预测或暗示的结果或开发有很大差异。

Among other things, there can be no guarantee that any of the Company’s drug candidates will successfully complete ongoing or future clinical trials, receive regulatory approval or be commercially successful, or that the Company will be able to successfully replicate the result of past studies of its product candidates, including PH80.

除其他外，不能保证任何公司的候选药物将成功完成正在进行的或未来的临床试验，获得监管部门批准或商业成功，或者公司将能够成功复制其过去研究结果。产品候选人，包括PH80。

Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to the Company’s ability to secure adequate financing for its operations, including financing or collaborative support for continued clinical development of the Company’s product candidates; other risks and uncertainties related to delays in launching.

可能导致这种差异的其他因素包括但不限于与公司为其运营获得足够融资的能力相关的风险和不确定性，包括为公司产品候选人的持续临床开发提供融资或合作支持；与发射延误有关的其他风险和不确定性。