Form 8-K - Current report

 

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): July 9, 2024

 

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)

 

[phone]

(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 ☐

 

 

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Item 8.01. Other Events.

 

On July 9, 2024, Vistagen Therapeutics, Inc. (the “Company”) announced the broadening of its global intellectual property portfolio after receiving multiple new patents related to the use of PH80 for the treatment of migraine. PH80 is the Company’s non-systemic, hormone-free investigational pherine nasal spray in development as a rapid-onset treatment for vasomotor symptoms (hot flashes) due to menopause, with the potential to also treat premenstrual dysphoric disorder, dysmenorrhea, and migraine. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

 

Item 9.01 Financial Statements and Exhibits.

 

(d)Exhibits Index

 

Exhibit No.		Description
99.1		Press Release issued by Vistagen Therapeutics, Inc., dated July 9, 2024, furnished herewith.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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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: July 10, 2024	By:	/s/ Shawn K. Singh
		Shawn K. Singh Chief Executive Officer

 

 

Exhibit 99.1

 

Vistagen Broadens PH80 Global Intellectual Property Portfolio with New Patents for the Treatment of Migraine

 

SOUTH SAN FRANCISCO, Calif, July 9, 2024 - Vistagen (Nasdaq: VTGN), a clinical-stage neuroscience-focused biopharmaceutical company dedicated to the development and commercialization of groundbreaking therapies for psychiatric and neurological disorders based on nose-to-brain neurocircuitry, today announced the broadening of its global intellectual property portfolio after receiving multiple new patents related to the use of PH80 for the treatment of migraine. PH80 is a non-systemic, hormone-free investigational pherine nasal spray in development as a rapid-onset treatment for vasomotor symptoms (hot flashes) due to menopause, with the potential to also treat premenstrual dysphoric disorder, dysmenorrhea, and migraine.

 

The new patents complement previously granted PH80 U.S. Patent No. 11,419,881 and EPO Patent No. 3955933 for the treatment of migraine. All of the new patents are expected to be in effect until 2040, subject to possible patent term extensions on a country-by-country basis.

 

●

Australia: IP Australia issued a Notice of Allowance;

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Hong Kong: The Hong Kong Special Administrative Region – Intellectual Property Department issued Patent No. 40068177;

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Japan: The Japan Patent Office issued Patent No. 7476229; and

●

Mexico: The Mexican Institute of Industrial Property issued a Notice of Allowance.

 

About PH80 Nasal Spray

PH80 is an investigational neuroactive pherine nasal spray with a novel neurocircuitry-focused mechanism of action (MOA) that is fundamentally differentiated from all currently approved treatment options for women’s health indications. PH80’s proposed MOA does not require systemic absorption or direct activity on neurons in the brain. Vistagen is developing PH80 as a potential new hormone-free treatment for the management of vasomotor symptoms (hot flashes) due to menopause, with additional potential in premenstrual dysphoric disorder, migraine, and dysmenorrhea.

 

About Pherines

Pherines are a novel class of synthetic neurocircuitry-focused drug candidates for psychiatric and neurological disorders. They are odorless and tasteless neuroactive steroids, delivered only intranasally, each with a differentiated mechanism of action (MOA) and safety profile from all currently approved drugs. Our neuroactive pherines rapidly activate olfactory system neurocircuitry to achieve therapeutic effects via nose-to-brain neural connections. Through these connections, pherines activate neural circuitry to specific brain regions that impact the neuroscience disorders we are targeting, without requiring systemic absorption or central nervous system (CNS) uptake. As a result of their novel non-systemic MOAs, our pherine drug candidates have demonstrated favorable and differentiated safety profiles in all clinical trials completed to date.

 

About Vistagen

Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a clinical-stage neuroscience-focused biopharmaceutical company dedicated to the development and commercialization of groundbreaking therapies for psychiatric and neurological disorders based on its pioneering approach and deep understanding of nose-to-brain neurocircuitry. Designed exclusively as nasal sprays administered at microgram level doses, Vistagen’s diversified pipeline of pherine product candidates rapidly activate chemosensory neurons in the nasal cavity to impact olfactory system and brain neurocircuitry. Favorable safety profiles have been observed in all clinical studies of Vistagen’s pherine product candidates completed to date. Vistagen’s neuroscience pipeline also includes an oral prodrug with the potential to modulate NMDA receptor activity in multiple neurological conditions, such as levodopa-induced dyskinesia associated with Parkinson’s disease therapy and neuropathic pain. At Vistagen, we are passionate about creating novel and differentiated treatments that set new standards of care for millions of people living with anxiety, depression, and other neurological disorders. Connect at www.Vistagen.com.

 

 

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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 Therapeutics, Inc. (Vistagen or the Company) 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 the scope of protection and enforceability provided by any patents issued for any of the Company’s drug candidates, including PH80, will be sufficient to deter competition, or that any of the Company’s drug candidates, including PH80, will successfully replicate past preclinical studies and/or clinical trials, complete ongoing or future clinical trials, receive regulatory approval or be commercially successful. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to delays in launching, conducting and/or completing ongoing and planned nonclinical studies and clinical trials; the period over which the Company anticipates its available financial resources will fund its operating expense; the timing of completion of preclinical studies and clinical trials and related preparatory work required to apply for and maintain regulatory approval for any of our product candidates; fluctuating costs of materials and other resources and services required to conduct the Company’s ongoing and/or planned clinical and nonclinical 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 product 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, 2024, 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.

 

 

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Investors:

Mark A. McPartland

Vistagen Therapeutics

[e-mail]

 

Media:

Caren Scannell

Vistagen Therapeutics

[e-mail]

 

 

Document And Entity Information	Jul. 09, 2024
Document Information [Line Items]
Entity, Registrant Name	Vistagen Therapeutics, Inc.
Document, Type	8-K
Document, Period End Date	Jul. 09, 2024
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
Amendment Flag	false
Entity, Central Index Key	0001411685

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