8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) of the SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): September 1, 2023

Vistagen Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Nevada	000-54014	20-5093315
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification Number)

343 Allerton Ave.

South San Francisco, California 94080

(Address of principal executive offices)

(650) 577-3600

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	VTGN	Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2)

Emerging Growth Company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☐

Item 1.01 Entry into a Materially Definitive Agreement.

On September 1, 2023, Vistagen Therapeutics, Inc. (the “Company”) entered into an Exclusive Negotiation Agreement (the “Negotiation Agreement”) by and among the Company and Fuji Pharma Co., Ltd. (“Fuji Pharma”), a Tokyo Stock Exchange listed, Japan-based pharmaceutical company. Pursuant to the terms and conditions of the Negotiation Agreement, the Company agreed, for a limited period of time (described below), to negotiate exclusively with Fuji Pharma a potential license to develop and commercialize the Company’s PH80 product candidate in Japan, including for the acute treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause and potentially other indications. The Negotiation Agreement provides for a term of the later to occur of (i) fourteen (14) months beginning on the date of receipt of the Purchase Price (defined below) by the Company or (ii) ninety (90) days from the date that the U.S. Food and Drug Administration accepts an Investigational New Drug application for PH80 for the treatment of vasomotor symptoms (hot flashes) due to menopause (“Exclusive Negotiation Period”).

As consideration for the Exclusive Negotiation Period provided by the Company to Fuji Pharma under the Negotiation Agreement, Fuji Pharma has agreed to make a payment to the Company of $1,500,000 (“Purchase Price”) upon confirmation from the Company stating that a contract development and manufacturing organization has been selected by the Company for toxicity studies for PH80. The Purchase Price is not refundable, except upon a material breach of the Negotiation Agreement by the Company. Should the Company and Fuji Pharma enter into a definitive license agreement during the Exclusive Negotiation Period for the development and commercialization of PH80 in Japan (a “Potential Definitive Agreement”), the Purchase Price will be creditable against the signing fee for such agreement. Neither the Company nor Fuji Pharma is obligated to enter into the Potential Definitive Agreement, and if the Company and Fuji Pharma have not entered into the Potential Definitive Agreement on or before the end of the Exclusive Negotiation Period, either the Company or Fuji Pharma may terminate any further negotiations.

On September 5, 2023, the Company issued a press release announcing the Negotiation Agreement, a copy of which is attached to this Current Report on Form 8-K as Exhibit 99.1.

The foregoing description of the Negotiation Agreement is subject to and is qualified in its entirety by reference to the full text of the form of the Negotiation Agreement, a copy of which is attached hereto as Exhibit 10.1.

Item 7.01 Regulation FD Disclosure.

On September 8, 2023, the Company began utilizing a new corporate presentation, a copy of which is attached to this Current Report on Form 8-K as Exhibit 99.2.

The information in this Current Report on Form 8-K, including the information set forth in Exhibit 99.2, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall Exhibit 99.2 filed herewith be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

See Item 8.01 regarding the Company’s issuance of a press release announcing the Negotiation Agreement.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits Index

Exhibit No.	Description
10.1	Exclusive Negotiation Agreement by and between Fuji Pharma Co., Ltd. and Vistagen Therapeutics, Inc., dated September 1, 2023.
99.1	Press Release issued by Vistagen Therapeutics, Inc., dated September 5, 2023.
99.2	Vistagen Therapeutics, Inc. Corporate Presentation, dated September 2023.
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

Signatures

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	Vistagen Therapeutics, Inc.
Date: September 8, 2023	By:	/s/ Shawn K. Singh
		Shawn K. Singh Chief Executive Officer

EX-10.1

Exhibit 10.1

EXCLUSIVE NEGOTIATION AGREEMENT

This Exclusive Negotiation Agreement (“Agreement”) is made and entered into on September 1, 2023 (the “Effective Date”) by and between Vistagen Therapeutics, Inc., a Nevada corporation, having an address at 343 Allerton Avenue, South San Francisco, California 94080, USA (“Vistagen”), and Fuji Pharma Co., Ltd., a company organized and existing under the laws of Japan and having an address at 5-7 Sanban-cho, Chiyoda-ku, Tokyo 102-0075, Japan (“Fuji Pharma”). Vistagen and Fuji Pharma are sometimes referred to separately as a “Party” and collectively as the “Parties.

RECITALS

WHEREAS, Vistagen and Fuji Pharma wish to negotiate, on an exclusive basis, a definitive strategic development and commercialization agreement with regard to the Product (as defined below) in Japan (“Commercialization Agreement”).

NOW THEREFORE, in consideration of the mutual covenants, representations, and agreements set forth herein, the Parties, intending to be legally bound, agree as follows:

AGREEMENT

1.         Exclusive Negotiation Right. During the Exclusive Negotiation Period (as defined below), Fuji Pharma has the exclusive right to negotiate with Vistagen the terms of the potential Commercialization Agreement (“Exclusive Negotiation Right”) in accordance with this Agreement.

2.         Commercialization Agreement. If negotiated and signed by the Parties, the Commercialization Agreement will, upon its effective date, grant Fuji Pharma an exclusive license in Japan under Vistagen Technology (as defined below) to develop, use for development or commercialization, promote, sell, offer for sale and/or import for development or commercialization, and use of the Product (“Proposed Transaction”). If it is negotiated and signed, the Commercialization Agreement will include industry-standard provisions that may be agreed to by the Parties.

3.         Product. Product means a pharmaceutical product containing Vistagen’s investigational pherine drug candidate, PH80, as an active ingredient, whether alone or combined with other active ingredients, and indicated for the treatment of vasomotor symptoms (hot flashes) due to menopause, premenstrual disphoric disorder, migraine, and all other human therapeutic uses.

4.         Vistagen Technology. For purposes of this Agreement and the Commercialization Agreement, Vistagen Technology means, to the extent applicable to Japan, the preclinical, clinical study and manufacturing data, know-how, patents, and other intellectual property, and other information owned or controlled by Vistagen that is necessary or reasonably useful for Fuji Pharma to successfully apply for an investigational new drug application (“IND”) in Japan for the Product for any therapeutic indication and to conduct clinical studies. Vistagen will use its best commercial efforts to preserve, protect, and enhance Vistagen Technology in contemplation of a potential transfer of the Vistagen Technology to Fuji Pharma in the event the Parties enter into the Commercialization Agreement.

5.          Payment. Upon the terms and subject to the conditions set forth herein, Vistagen hereby sells, and Fuji Pharma hereby purchases the Exclusive Negotiation Right for One Million Five Hundred Thousand U.S. Dollars (US$1,500,000) (“Purchase Price”). The Purchase Price is due upon Fuji Pharma’s receipt of a confirmation letter from Vistagen stating that a contract development and manufacturing organization has been selected by Vistagen for toxicity studies for the Product (“Payment Event”). The confirmation letter shall be in writing (but not email) and accompany the contemplated timeline for such toxicity studies as agreed upon between Vistagen and such selected contract development and manufacturing organization. The Purchase Price shall be delivered to Vistagen by wire transfer of immediately available funds, net of any taxes or withholdings, no later than fifteen (15) days from the date of the Payment Event. The Purchase Price is not refundable except for the case of a material breach by Vistagen of this Agreement. However, if the Parties negotiate and enter into the Commercialization Agreement, the Purchase Price will be creditable against the signing fee for the Commercialization Agreement.

6.          Exclusive Negotiation Period. The exclusive negotiation period will begin on the date of Payment Event and expire upon the later to occur of (i) fourteen (14) months from the date of Payment Event or (ii) ninety (90) days from the date that the U.S. Food and Drug Administration (“FDA”) accepts an IND for the Product for the treatment of vasomotor symptoms (hot flashes) due to menopause (“Exclusive Negotiation Period”). Neither Party is obligated to enter into the Commercialization Agreement, and if the Parties have not entered into the Commercialization Agreement before the end of the Exclusive Negotiation Period, then either Party may cancel any further negotiations.

7.           [Intentionally Omitted]

8.           Consultations.

(a)         At the written request of Fuji Pharma at any time during the Exclusive Negotiation Period, the Parties will negotiate the Proposed Transaction in good faith and attempt to agree upon the provisions of the Commercialization Agreement.

(b)         During the Exclusive Negotiation Period, Vistagen shall not, and shall not permit any directors, officers, employees, agents, advisors, or representatives (collectively, “Representatives”) of itself or its affiliates to, directly or indirectly, engage in any discussions or negotiations with any third party other than Fuji Pharma, or enter into any agreement (including a letter of intent, memorandum of understanding and the like, whether or not legally binding) with any third party other than the Fuji Pharma, in each case relating to (i) the Proposed Transaction or any similar arrangement or transaction in Japan or (ii) any arrangement or transaction that reasonably would be expected to prevent, impede, delay or otherwise conflict with the Exclusive Negotiation Right or attempts by Fuji Pharma to negotiate and attain the Commercialization Agreement. Without limiting the foregoing, Vistagen shall not sell, license, mortgage, or encumber in any way any rights to Vistagen Technology to the extent applicable to Japan during the Exclusive Negotiation Period.

(c)         During the Exclusive Negotiation Period, Vistagen and Fuji Pharma will consult with each other periodically to evaluate development and commercialization opportunities for the Product and to facilitate obtaining favorable regulatory and prescriber perspectives regarding the Product in Japan.

(d)         For the avoidance of doubt, nothing in this Agreement will prevent Vistagen, in any manner, from discussing, negotiating, or entering into one or more option, collaboration, development, commercialization, or any other kind of agreements for the Product or involving the Vistagen Technology in any territory other than Japan. For the avoidance of doubt, nothing in this Agreement grants any rights to Fuji Pharma under the Vistagen Technology.

9.           Representations.

(a)         Vistagen represents that no agreements between any third party and Vistagen prevent the exercise of the Exclusive Negotiation Right by Fuji Pharma in the manner contemplated by this Agreement.

(b)         Vistagen and Fuji Pharma represent that they have all requisite corporate power and authority to execute and deliver this Agreement and perform its obligations hereunder. The execution and delivery by each Party of this Agreement and the consummation of the transactions contemplated hereby have been duly and validly authorized by all necessary corporate actions.

(c)         Vistagen represents that it will use its best commercial efforts to submit an IND for the Product for the treatment of vasomotor symptoms (hot flashes) due to menopause; however, Fuji Pharma acknowledges that there is no guarantee that the US FDA will accept such an IND or ultimately approve the Product for marketing.

(d)         Vistagen and Fuji Pharma make no other representations or warranties in connection with this Agreement other than as specified above.

10.          Limitation of Liability. NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE, OR EXEMPLARY DAMAGES OR ANY LOSS OF REVENUE OR PROFITS ARISING OUT OF, IN CONNECTION WITH, THIS AGREEMENT REGARDLESS OF WHETHER SUCH PARTY HAS BEEN ADVISED OF OR IS AWARE THAT SUCH DAMAGES HAVE BEEN OR MAY BE INCURRED.

11.          Miscellaneous.

(a)         Governing Law. This Agreement and any dispute arising from the performance or breach hereof shall be governed by, construed, and enforced in accordance with the laws of the State of California as applied to disputes involving parties located entirely within the State and without reference to the State’s conflicts of laws principles.

(b)         Dispute Resolution. All disputes arising out of, or in connection with, this Agreement shall be finally settled by arbitration administered by the Singapore International Arbitration Centre (“SIAC”) in accordance with the rules of the SIAC for the time being in force (the “SIAC Rules”), which rules are deemed to be incorporated by reference into this Section 11(b). Any arbitral tribunal appointed pursuant to this Section 11(b) shall consist of three arbitrators to be appointed in accordance with the SIAC Rules. The place of arbitration shall be Singapore. The language of the arbitration shall be English. The Parties undertake to keep confidential all awards in their arbitration, together with all materials in the proceedings created for the purpose of the arbitration and all other documents produced by the other Party in the proceedings not otherwise in the public domain, save and to the extent that disclosure may be required of a Party by legal duty, to protect or pursue a legal right or to enforce or challenge an award in bona fide legal proceedings before a state court or other judicial authority.

(c)         Preliminary Injunctions. Notwithstanding any provision to the contrary set forth in this Agreement, in the event of an actual or threatened breach of a Party’s obligations under this Agreement, a Party may seek a temporary restraining order or a preliminary injunction from any court of competent jurisdiction in order to prevent immediate and irreparable injury, loss, or damage on a provisional basis.

(d)         Waiver. Neither Party may waive or release any of its rights or interests in this Agreement except in writing. The failure of either Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition.

(e)         Assignability. Neither Party may assign its rights under this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld. Notwithstanding the foregoing, either Party may assign its rights under this Agreement to a successor in connection with a merger, consolidation, spin-off, or sale of all or substantially all of its assets or that portion of its business pertaining to the Product without the prior written consent of the other Party.

(f)         Notices. All notices, requests and other communications hereunder shall be in writing and shall be personally delivered or sent by courier or by registered or certified mail, return receipt requested, postage prepaid, in each case to the respective address specified below, or such other address as may be specified in writing to the other Parties hereto:

Vistagen Therapeutics, Inc.

343 Allerton Avenue

South San Francisco, CA 94080 USA

Email:

ATTN: Shawn K. Singh, J.D., Chief Executive Officer

Fuji Pharma Co., Ltd.

5-7 Sanban-cho,

Chiyoda-ku, Tokyo 102-0075, Japan

Email:

ATTN: Chaudhary Kushendra, General Manager of Business Development

(g)         Force Majeure. Neither Party shall be liable to the other for failure or delay in the performance of any of its obligations under this Agreement for the time and to the extent such failure or delay is caused by riots, civil commotions, wars, hostilities between nations, embargoes, actions by a government or any agency thereof, acts of God, storms, fires, accidents, sabotage, explosions or other similar or different contingencies, the damage or harm resulting from any or all of which, in each case, shall be beyond the reasonable control of the Party invoking this Section 11(g) and not attributable to the negligence or willful misconduct of the Party invoking this Section 11(g).

(h)         Disclosure of the Agreement and Use of Name. The Parties acknowledge that Vistagen may be required to disclose this Agreement pursuant to applicable rules and regulations of the U.S. Securities and Exchange Commission or the Nasdaq Capital Market, or both. Either Party may announce the existence of this Agreement, use the name of the other Party for such purpose and for regulatory compliance purposes, and as otherwise may be required by law.

(i)         Severability. If any provision of this Agreement becomes or is declared by the SIAC or by a court of competent jurisdiction to be illegal, unenforceable, or void, this Agreement shall continue in full force and effect without said provision so long as this Agreement, taking into account said voided provision(s), continues to provide the Parties with the same practical economic benefits as the Agreement containing said voided provision(s) did on its Effective Date. If, after considering said voided provision(s), the Parties are unable to realize the practical economic benefit contemplated on the Effective Date, the Parties shall negotiate in good faith to amend this Agreement to reestablish the practical economic benefit provided the Parties on the Effective Date.

(j)         Complete Agreement. This Agreement will constitute the entire agreement, both written and oral, between the Parties with respect to the subject matter hereof, and all prior agreements or discussions respecting the subject matter hereof, either written or oral, expressed or implied, are merged and canceled and are null and void and of no effect. No amendment or change hereof or addition hereto shall be effective or binding on either of the Parties hereto unless reduced to writing and duly executed on behalf of both Parties.

(k)         Headings. The captions to the sections and articles in this Agreement are not a part of this Agreement and are included merely for the convenience of reference only and shall not affect its meaning or interpretation.

(l)         Counterparts and Signatures. This Agreement may be executed in counterparts, or facsimile versions, each of which shall be deemed to be an original, and both shall be deemed one and the same agreement. Signatures to this Agreement transmitted by facsimile transmission, by electronic mail in “portable document format” (“.pdf”) form, by DocuSign, or by any other electronic means intended to preserve the original graphic and pictorial appearance of a document will have the same effect as physical delivery of the paper document bearing the original signature.

(m)         Binding Effect. This Agreement shall be binding upon and shall inure to the benefit of Vistagen, Fuji Pharma, and their successors and permitted assigns.

(n)         Advice of Counsel and Expenses. Vistagen and Fuji Pharma have each consulted with counsel of their choice regarding this Agreement, and each acknowledges and agrees that this Agreement shall not be deemed to have been drafted by one party or another and will be construed accordingly. Except as may otherwise expressly be provided in this Agreement, each Party shall pay the fees and expenses of its respective attorneys and all other expenses and costs incurred by such Party incidental to the negotiation, preparation, execution, and delivery of this Agreement.

(o)         Intellectual Property Matters. During the Exclusive Negotiation Period, Vistagen will use its best commercial efforts to preserve, protect and enhance patents and any other intellectual property rights that are relevant to the Commercialization Agreement.

(p)         Further Assurance. Each Party shall perform all further acts and execute and deliver such further documents as may be necessary or as the other Party may reasonably require to give effect to this Agreement.

IN WITNESS WHEREOF, the undersigned have caused this Agreement to be duly executed and delivered by their proper and duly authorized officers as of the date and year first written above.

Vistagen Therapeutics, Inc.

By:   /s/ Shawn K. Singh

Name:  Shawn K. Singh, J.D.

Title: Chief Executive Officer

Fuji Pharma Co., Ltd.

By:      /s/ Takayuki Iwai

Name: Takayuki Iwai

Title:    President and CEO

EX-99.1

Exhibit 99.1

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 to receive $1.5 million and Fuji to obtain time-limited exclusive negotiation period for the Japanese market

Recently reported exploratory Phase 2A study in women diagnosed with menopausal hot flashes demonstrated PH80’s statistically significant reduction in the number of hot flashes and the severity, disruption in function, and sweating related to hot flashes as compared with placebo

SOUTH SAN FRANCISCO, Calif. & TOKYO--(BUSINESS WIRE)--Sep. 5, 2023-- 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.

“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.”

About 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. 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. 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.

About Vasomotor Symptoms (Hot Flashes) due to Menopause

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. 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.

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

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

About 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'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). 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. Connect at www.Vistagen.com.

About Fuji

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

Forward-looking Statements

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. 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. 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. 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, conducting and/or completing ongoing and planned clinical trials; the scope and enforceability of the Company’s patents, including patents related to PH80 and the Company’s other pherine drug candidates; fluctuating costs of materials and other resources and services required to conduct the Company’s ongoing and/or planned clinical and non-clinical trials; market conditions; the impact of general economic, industry or political conditions in the United States or internationally; and other technical and unexpected hurdles in the development, manufacture and commercialization of the Company’s drug candidates. These risks are more fully discussed in the section entitled "Risk Factors" in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended March 31, 2023, and in the Company’s most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the U.S. Securities and Exchange Commission (SEC). The Company’s SEC filings are available on the SEC’s website at www.sec.gov. Additionally, you should not place undue reliance on these forward-looking statements in the future, because they apply only as of the date of this press release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements, other than as may be required by law. If the Company does update one or more forward-looking statements, no inference should be made that the Company will make additional updates with respect to those or other forward-looking statements.

Investors:

Vistagen
Mark McPartland
Senior Vice President, Investor Relations
(650) 577-3606
markmcp@vistagen.com

Fuji Pharma Co., Ltd.
Corporate Communication Section, Corporate Planning Department, Corporate Strategy Division
fsks@fujipharma.jp

Media:
Nate Hitchings
SKDK
nhitchings@skdknick.com

Source: Vistagen

EX-99.2

Exhibit 99.2

XML

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Document Information [Line Items]
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Document, Type	8-K
Document, Period End Date	Sep. 01, 2023
Entity, Incorporation, State or Country Code	NV
Entity, File Number	000-54014
Entity, Tax Identification Number	20-5093315
Entity, Address, Address Line One	343 Allerton Ave.
Entity, Address, City or Town	South San Francisco
Entity, Address, State or Province	CA
Entity, Address, Postal Zip Code	94080
City Area Code	650
Local Phone Number	577-3600
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	VTGN
Security Exchange Name	NASDAQ
Entity, Emerging Growth Company	false
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Entity, Central Index Key	0001411685