8-K
Vistagen Therapeutics, Inc. (VTGN)
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): November 12, 2020
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.<br><br><br>South San Francisco, California 94090 | ||
| --- | ||
| (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<br>registered |
|---|---|---|
| Common<br>Stock, par value $0.001 per share | VTGN | Nasdaq<br>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 2.02 Results of Operations and Financial Condition.
On November 12, 2020, VistaGen Therapeutics, Inc. (the “Company”) issued a press release to announce the Company’s financial results for its fiscal year 2021 second quarter ended September 30, 2020. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
Item 7.01. Regulation FD Disclosure.
On November 13, 2020, the Company announced new in vitro electrophysiology data demonstrating that the mechanism of action of PH94B, the Company’s intranasal neuroactive steroid drug candidate, which the Company is preparing for Phase 3 development as a potential acute rapid-onset treatment of anxiety in adults with social anxiety disorder, does not involve direct activation of GABA-A receptors, in distinct contrast to the mechanism of action of benzodiazepines. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.2.
Disclaimer.
The information in this Current Report on Form 8-K, including the information set forth in Exhibits 99.1 and 99.2, are 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 Exhibits 99.1 and 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.
Forward-Looking Statements.
This Current Report on Form 8-K may contain, among other things, certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, (i) statements with respect to the Company's plans, objectives, expectations and intentions; and (ii) other statements identified by words such as "may", "could", "would", should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Index
| Exhibit No. | Description |
|---|---|
| 99.1 | Earnings<br>Release issued by VistaGen Therapeutics, Inc., dated November 12,<br>2020 |
| 99.2 | Press<br>Release issued by VistaGen Therapeutics, Inc., dated November 12,<br>2020 |
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<br>Therapeutics, Inc. | ||
|---|---|---|
| Date:<br>November 13, 2020 | By: | /s/ Shawn K. Singh |
| Shawn<br>K. Singh<br><br><br>Chief<br>Executive Officer |
ex99-1
Exhibit 99.1
VistaGen Therapeutics Reports Fiscal 2021 Second Quarter Financial Results and Provides Highlights on its CNS Pipeline and Business Progress
--
Positive FDA Meeting Sets Key Pathway for Pivotal PH94B Phase 3 Study in the Second Quarter of 2021
Received Over $17.5 Million Net Proceeds from PH94B Upfront License Payment and Public Offering of Common Stock
Positive New Data from Second Preclinical Study of AV-101 in Combination with Probenecid
Positive Preclinical Data Differentiating Mechanism of Action of PH94B from Risk-Ridden Benzodiazepines
--
SOUTH SAN FRANCISCO, Calif., November 12, 2020 – VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) disorders, today reported its financial results for the fiscal 2021 second quarter ended September 30, 2020 and provided an update on its CNS pipeline and business progress.
"We see a significant rise in mental health concerns as the global COVID-19 pandemic continues to impact the daily lives of millions of individuals. We are committed to developing innovative therapies that provide relief to those suffering from anxiety and depression, and we are working diligently towards that goal. We are making significant progress in preparing PH94B for launch of a pivotal Phase 3 study for acute treatment of anxiety in adults with social anxiety disorder in the second quarter of 2021. After reaching consensus with the FDA on the key components of the study design, it will be very similar to the statistically significant Phase 2 study of PH94B in social anxiety disorder. We are also working with the FDA to finalize details for our Phase 2A study of PH94B in adjustment disorder, which we are planning to initiate in early 2021,” said Shawn Singh, Chief Executive Officer of VistaGen.
“Millions of people rely on benzodiazepines and other prescription drugs to manage symptoms of stress and anxiety. While some medications are safe and effective treatments, many in the current treatment paradigm have limited therapeutic benefits and potentially serious side effects and safety concerns. In Phase 2 clinical studies, PH94B produced rapid onset anti-anxiety effects without requiring systemic uptake and distribution. With its rapid-onset pharmacology, lack of systemic exposure and sedation, and its excellent safety profile in all studies to date, we believe PH94B has the potential to displace benzodiazepines in the drug treatment paradigm for anxiety disorders. In addition to social anxiety disorder, we believe PH94B also has potential as a novel treatment for adjustment disorder, postpartum anxiety, post-traumatic stress disorder, preprocedural anxiety, panic, and other anxiety-related disorders, and we look forward to assessing its potential in various controlled Phase 2 clinical studies in parallel with our Phase 3 program to assess its potential as an acute treatment of anxiety in adults with social anxiety disorder,” concluded Mr. Singh.
CNS Pipeline Highlights and Updates:
PH94B
●
VistaGen reached consensus with the FDA on key study design and execution aspects of the Company's initial pivotal Phase 3 study of PH94B for acute treatment of anxiety in adults with social anxiety disorder (SAD):
o
As in the statistically significant (p=0.002) Phase 2 public speaking study of PH94B in SAD, VistaGen's Phase 3 study will involve a laboratory-simulated anxiety-provoking public speaking challenge.
o
The Phase 3 study will be a randomized, double-blind, placebo-controlled, parallel comparison study conducted at approximately 15 sites in North America.
o
The Subjective Units of Distress Scale (SUDS) will be used to assess the primary efficacy endpoint in the study.
o
Dr. Michael Liebowitz, Professor of Clinical Psychiatry at Columbia University, director of the Medical Research Network in New York City, and creator of the Liebowitz Social Anxiety Scale (LSAS), will be the Principal Investigator of the study.
o
Target enrollment (completed subjects) will be approximately 182 adults with SAD.
o
Study expected to initiate recruitment in 2Q 2021.
●
VistaGen is currently preparing for an exploratory Phase 2A clinical study of PH94B for acute treatment of adjustment disorder (AjD), an emotional or behavioral reaction considered excessive or out of proportion to a stressful event or significant life change, occurring within three months of the stressor, and/or significantly impairing a person’s social, occupational and/or other important areas of functioning. Given the diverse impact of the COVID-19 pandemic, including, among other things, fear and anxiety about health and safety, economic loss, unemployment, social isolation, disruption of established education and work practices, VistaGen submitted its preliminary protocol for the study to the FDA through the FDA’s Coronavirus Treatment Acceleration Program (CTAP). Following that submission, the Company has continued its discussions with the FDA’s Division of Psychiatric Products to determine the study's appropriate next steps, including the final study protocol.
o
The Company is planning to conduct the proposed Phase 2A study in New York City and enroll approximately 25 to 30 subjects suffering from adjustment disorder-provoking stressors, including, but not limited to, stressors related to the diverse impact of the COVID-19 pandemic and recent civil unrest in the U.S.
o
The AjD study is expected to initiate patient recruitment in 1Q 2021.
o
The Company is also planning for additional exploratory Phase 2A studies in postpartum anxiety, post-traumatic stress disorder, and pre-procedural anxiety (pre-MRI).
●
VistaGen reported new in vitro electrophysiology data demonstrating that the mechanism of action of PH94B, does not involve direct activation of GABA-A receptors, in distinct contrast to the mechanism of action of benzodiazepines, which act as direct positive modulators of GABA-A receptors.
o
These studies are significant because they indicate that PH94B has no relevant benzodiazepine-like activity, confirming PH94B’s potential to produce rapid-onset benzo-like, anti-anxiety effects, without the risky side effects and safety concerns of benzos.
AV-101
●
VistaGen reported positive new data from the Company's second preclinical study of its oral investigational drug, AV-101, combined with probenecid, an FDA-approved drug for treatment of gout used adjunctively to increase the therapeutic benefit of numerous antibacterial, anticancer and antiviral drugs.
o
The results of this new study complement previous preclinical data demonstrating the combination's potential to substantially increase the brain concentration of AV-101's active metabolite, 7-Cl-KYN, a potent and selective full antagonist of the NMDA receptor glycine co-agonist site, thereby reducing, rather than blocking, NMDA receptor signaling.
Partnering Activity
●
VistaGen received a $5 million non-dilutive upfront license payment from EverInsight Therapeutics (now AffaMed Therapeutics), the Company's strategic partner for Phase 3 development and commercialization of PH94B for anxiety-related disorders in key markets in Asia.
●
Upon successful development and commercialization of PH94B in the licensed territory, VistaGen is eligible to receive up to $172 million in additional development and commercial milestone payments, plus royalties on commercial sales of PH94B.
Capital Resources
●
VistaGen completed an underwritten public offering of common stock resulting in gross proceeds of $14.29 million to the Company, before underwriting discounts and commissions and offering expenses.
Financial Results for the Fiscal Quarter Ended September 30, 2020:
Net loss: Net loss attributable to common stockholders for the fiscal quarter ended September 30, 2020 decreased to approximately $3.7 million compared to $5.7 million for the fiscal quarter ended September 30, 2019. For the six-month period ending September 30, 2020, the net loss attributable to common stockholders was approximately $7.1 million, a decrease from approximately $12.2 million reported in the same period last year.
Revenue: Total revenue for the fiscal quarter ended September 30, 2020 was $334,000, representing the revenue recognition related to its agreement with EverInsight Therapeutics (now AffaMed Therapeutics), pursuant to which the Company received a non-dilutive upfront license fee payment of $5.0 million on August 3, 2020. VistaGen recognized $334,000 in sublicense revenue pursuant to this agreement in the six months ended September 30, 2020 compared to no revenue in the six months ended September 30, 2019. The Company expects to continue recognizing revenue pursuant to this payment in future periods during our fiscal year ending March 31, 2021 and thereafter.
Research and development (R&D) expense: Research and development expense decreased from $4.2 million in the quarter ended September 30, 2019 to $2.4 million for the quarter ended September 30, 2020. Research and development expense also decreased from $8.5 million to $4.1 million for the six months ended September 30, 2019 and 2020, respectively, in both cases, primarily due to the completion of the Company’s Phase 2 study of AV-101 as a potential adjunctive treatment of major depressive disorder in the fourth calendar quarter of 2019. Expenses related to that study and other nonclinical activities related to AV-101 decreased by $4.8 million for the six months ended September 30, 2020 compared to similar expense in the six months ended September 30, 2019. Noncash research and development expenses, primarily stock-based compensation and depreciation in both periods, accounted for approximately $391,000 and $607,000 in the six months ended September 30, 2020 and 2019, respectively.
General and administrative (G&A) expense: General and administrative expense totaled $1.3 million for the three months ended September 30, 2020 as compared to $1.2 million for the same period in the year prior. General and administrative expense decreased to approximately $2.7 million from approximately $3.1 million for the six months ended September 30, 2020 and 2019, respectively. Noncash general and administrative expense, $804,000 in the six months ended September 30, 2020, decreased from $1,044,000 in the six months ended September 30, 2019 primarily due to decreases in stock-based compensation and the noncash components of investor and public relations expense attributable to the amortization of the fair value of equity securities granted to service providers.
Cash Position: At September 30, 2020, the Company had cash and cash equivalents of approximately $15.4 million. During the quarter ended September 30, 2020, the Company received net proceeds totaling approximately $17.5 million from (i) the $5.0 million gross non-dilutive upfront license fee payment from EverInsight Therapeutics (now AffaMed Therapeutics), and (ii) the gross proceeds of approximately $14.29 million from the sale of shares of its common stock in an underwritten public offering.
As of November 12, 2020, the Company had 73,998,057 shares of common stock outstanding.
About VistaGen
VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative medicines with potential to go beyond the current standard of care for anxiety, depression, and other CNS disorders. Each of VistaGen's three drug candidates has a differentiated mechanism of action, an exceptional safety profile in all studies to date, and therapeutic potential in multiple CNS markets. For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.
Forward Looking Statements
Various statements in this release are "forward-looking statements" concerning VistaGen's future expectations, plans and prospects. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: successful development, including, but not limited to Phase 3 development, and approval of one or more of the Company's drug candidates may not be achieved in any market for any indication, and, if approved, may not be differentiated from the standard of care; the FDA and other regulatory authorities may decide that the results of one or more of the Company's development programs are not sufficient for regulatory approval; development of the Company's drug candidates may not be successful in any indication; success in nonclinical studies or in earlier-stage clinical studies may not be repeated or observed in future studies; and other adverse events or market conditions may be encountered, at any stage of development, that negatively impact further development, including entry of competitive products or other technical and unexpected hurdles in the development, manufacture and commercialization of the Company's drug candidates. Additional risks are more fully discussed in the section entitled "Risk Factors" in VistaGen's most recent Annual Report on Form 10-K for the year ended March 31, 2020, and in its subsequent quarterly reports on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in the Company's other filings with the Securities and Exchange Commission. Any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements.
VistaGen Company Contact
Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3600
Email: [email protected]
VISTAGEN THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(Amounts in dollars, except share amounts)
| March 31, | |
|---|---|
| 2020 | |
| (Note 1) | |
| ASSETS | |
| Current<br>assets: | |
| Cash<br>and cash equivalents | $1,355,100 |
| Prepaid<br>expenses and other current assets | 225,100 |
| Deferred<br>contract acquisition costs - current portion | - |
| Total<br>current assets | 1,580,200 |
| Property<br>and equipment, net | 209,600 |
| Right<br>of use asset - operating lease | 3,579,600 |
| Deferred<br>offering costs | 355,100 |
| Deferred<br>contract acquisition cost - non-current portion | - |
| Security<br>deposits and other assets | 47,800 |
| Total<br>assets | $5,772,300 |
| LIABILITIES AND STOCKHOLDERS’ EQUITY<br>(DEFICIT) | |
| Current<br>liabilities: | |
| Accounts<br>payable | $1,836,600 |
| Accrued<br>expenses | 561,500 |
| Current<br>notes payable, including accrued interest | 56,500 |
| Deferred<br>revenue - current portion | - |
| Operating<br>lease obligation - current portion | 313,400 |
| Financing<br>lease obligation - current portion | 3,300 |
| Total<br>current liabilities | 2,771,300 |
| Non-current<br>liabilities: | |
| Non-current<br>portion of notes payable | - |
| Accrued<br>dividends on Series B Preferred Stock | 5,011,800 |
| Deferred<br>revenue - non-current portion | - |
| Operating<br>lease obligation - non-current portion | 3,715,600 |
| Financing<br>lease obligation - non-current portion | 3,000 |
| Total<br>non-current liabilities | 8,730,400 |
| Total<br>liabilities | 11,501,700 |
| Commitments<br>and contingencies | |
| Stockholders’<br>equity (deficit): | |
| Preferred<br>stock, 0.001 par value; 10,000,000 shares authorized at September<br>30, 2020 and March 31, 2020: | |
| Series<br>A Preferred, 500,000 shares authorized, issued and outstanding at<br>September 30, 2020 and March 31, 2020 | 500 |
| Series<br>B Preferred; 4,000,000 shares authorized at September 30, 2020 and<br>March 31, 2020; 1,160,240 shares | |
| issued<br>and outstanding at September 30, 2020 and March 31,<br>2020 | 1,200 |
| Series<br>C Preferred; 3,000,000 shares authorized at September 30, 2020 and<br>March 31, 2020; 2,318,012 shares | |
| issued<br>and outstanding at September 30, 2020 and March 31,<br>2020 | 2,300 |
| Common<br>stock, 0.001 par value; 175,000,000 shares authorized at September<br>30, 2020 and March 31, 2020; | |
| 74,133,722<br>and 49,348,707 shares issued and outstanding at September 30, 2020<br>and March 31, 2020, respectively | 49,300 |
| Additional<br>paid-in capital | 200,092,800 |
| Treasury<br>stock, at cost, 135,665 shares of common stock held at September<br>30, 2020 and March 31, 2020 | (3,968,100) |
| Accumulated<br>deficit | (201,907,400) |
| Total<br>stockholders’ equity (deficit) | (5,729,400) |
| Total<br>liabilities and stockholders’ equity (deficit) | $5,772,300 |
All values are in US Dollars.
Note 1: Derived from audited Consolidated Balance Sheet at March 31, 2020
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Amounts in Dollars, except share amounts) (Unaudited)
| Three Months Ended September 30, | Six Months Ended September 30, | |||
|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | |
| Sublicense<br>revenue | $334,000 | $- | $334,000 | $- |
| Total<br>revenues | 334,000 | - | 334,000 | - |
| Operating<br>expenses: | ||||
| Research<br>and development | 2,358,200 | 4,205,200 | 4,089,400 | 8,519,100 |
| General<br>and administrative | 1,269,500 | 1,146,100 | 2,660,100 | 3,056,200 |
| Total<br>operating expenses | 3,627,700 | 5,351,300 | 6,749,500 | 11,575,300 |
| Loss<br>from operations | (3,293,700) | (5,351,300) | (6,415,500) | (11,575,300) |
| Other<br>income (expenses), net: | ||||
| Interest<br>income (expense), net | (3,900) | 15,400 | (7,100) | 31,900 |
| Other<br>income | - | - | 600 | - |
| Loss<br>before income taxes | (3,297,600) | (5,335,900) | (6,422,000) | (11,543,400) |
| Income<br>taxes | (200) | - | (2,600) | (2,400) |
| Net<br>loss and comprehensive loss | $(3,297,800) | $(5,335,900) | $(6,424,600) | $(11,545,800) |
| Accrued<br>dividends on Series B Preferred stock | (347,200) | (313,800) | (683,000) | (616,300) |
| Net<br>loss attributable to common stockholders | $(3,645,000) | $(5,649,700) | $(7,107,600) | $(12,162,100) |
| Basic<br>and diluted net loss attributable to common | ||||
| stockholders<br>per common share | $(0.05) | $(0.13) | $(0.12) | $(0.29) |
| Weighted<br>average shares used in computing | ||||
| basic<br>and diluted net loss attributable to common | ||||
| stockholders<br>per common share | 67,082,935 | 42,622,965 | 59,245,209 | 42,622,965 |
ex99-2
Exhibit 99.2
VistaGen Reports Positive Preclinical Data Differentiating Mechanism of Action of PH94B from Risk-Ridden Benzodiazepines
New electrophysiological data demonstrate that PH94B does not directly modulate GABA (gamma aminobutyric acid) receptors
SOUTH SAN FRANCISCO, Calif., November 12, 2020 – VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) disorders, today announced new in vitro electrophysiology data demonstrating that the mechanism of action of PH94B, the intranasal neuroactive steroid the Company is preparing for Phase 3 development as a potential acute rapid-onset treatment of anxiety in adults with social anxiety disorder, does not involve direct activation of GABA-A receptors, in distinct contrast to the mechanism of action of benzodiazepines (“benzos”), which act as direct positive modulators of GABA-A receptors.
“We are very pleased with the results of these studies that suggest PH94B’s mechanism of action may not have benzodiazepine-like side effects, such as sedation and cognitive impairment, or abuse liability,” stated Shawn K. Singh, Chief Executive Officer of VistaGen. “While benzodiazepines provide relief for many Americans struggling with anxiety, their extremely risky safety profile does not lend itself to long term use. The mechanism of action contributes to the safety profile. As we have seen in Phase 2 clinical studies, while PH94B is able to produce rapid-onset benzo-like, anti-anxiety effects, this study demonstrates that PH94B does not have a benzo-like mechanism of action. As we approach Phase 3 development of PH94B, especially given the FDA’s recent public announcement about safety concerns associated with benzo use, these new data make us even more excited about PH94B’s potential to change lives without the risky side effects and safety concerns of benzos.”
Recently, the U.S. Food and Drug Administration (FDA) released a Drug Safety Communication (DSC) detailing the risks associated with use of benzodiazepines, a class of drugs commonly prescribed for treatment of anxiety disorders and other conditions. According to the FDA communication, 92 million benzodiazepine prescriptions were filled in 2019. The FDA’s DSC detailed safety concerns regarding the serious risks of abuse, addiction, physical dependence, and withdrawal reactions linked to long-term use of benzodiazepines, and the FDA announced that it is requiring an updated Boxed Warning, the FDA’s most prominent type of safety warning, for all benzodiazepine medications.
“We thought it was important to conduct a study to help differentiate the mechanism of action of PH94B from that of benzodiazepines, therefore, we contracted with EuroFins Discovery to determine whether PH94B has positive modulatory effects on GABA receptors using in vitro patch clamp electrophysiology,” noted Mark A. Smith, M.D., Ph.D., Chief Medical Officer of VistaGen. “Benzodiazepines such as alprazolam and diazepam mediate their anti-anxiety effects by acting as positive modulators at GABA receptors to make them more responsive to GABA and thereby increase inhibitory neuronal activity in the brain. PH94B had no agonist or antagonist effects on GABA receptors. While PH94B may regulate endogenous GABA circuits in the brain, it does not appear to directly bind to or modulate GABA receptors at concentrations <10mM, which differentiates its mechanism of action from benzodiazepines.”
These studies are significant because they indicate that PH94B has no relevant benzodiazepine-like activity. With widespread anxiety-provoking stressors related to the COVID-19 pandemic, civil unrest, election results, the economy, and distance learning during 2020, the number of individuals facing anxiety disorders is rising and a safer treatment alternative to benzodiazepines is imperative. PH94B may have the potential to displace benzodiazepines and become the safer alternative in the drug treatment paradigm for anxiety disorders.
About PH94B
PH94B is an innovative odorless synthetic neuroactive steroid nasal spray with therapeutic potential in a wide range of mental health disorders involving anxiety or phobia. Self-administered in microgram-level doses, PH94B produces rapid onset (within approximately 15 minutes) anti-anxiety effects and does not require systemic uptake and distribution to generate these effects.
VistaGen is currently preparing PH94B for pivotal Phase 3 development as a potential acute treatment of anxiety in adults with Social Anxiety Disorder (SAD). The FDA has granted Fast Track designation for development of PH94B for this indication, believed to be the first such designation by the FDA for a drug candidate for SAD.
With its rapid-onset pharmacology, lack of systemic exposure and sedation, and its excellent safety profile in all studies to date, we believe PH94B has potential to provide a safe alternative to benzodiazepines and other pharmacological alternatives in the drug treatment paradigm for anxiety disorders. View more background information on SAD and a video on PH94B's mechanism of action.
About VistaGen
VistaGen Therapeutics is a clinical-stage biopharmaceutical company developing and commercializing differentiated new generation medicines that go beyond the current standard of care for anxiety, depression and other CNS disorders. Each of VistaGen's three drug candidates has a differentiated mechanism of action, an exceptional safety profile in all studies to date, and therapeutic potential in multiple CNS markets. For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.
Forward Looking Statements
Various statements in this release are "forward-looking statements" concerning VistaGen's future expectations, plans and prospects, including the potential for successful Phase 3 development of PH94B. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: development and approval of PH94B may not be achieved in any market; the FDA may decide that the results of the Company's PH94B Phase 3 clinical program are not sufficient for regulatory approval for acute treatment of anxiety in adult patients with SAD or any other anxiety-related disorder; development of PH94B may not be successful in any indication; success in nonclinical studies or in earlier-stage clinical trials may not be repeated or observed in future studies which may not support further development or be sufficient to gain regulatory approval to market PH94B; adverse events may be encountered at any stage of development that negatively impact further development. Other risks and uncertainties include, but are not limited to, issues related to: adverse healthcare reforms and changes of laws and regulations; general industry and market conditions; manufacturing and marketing risks, which may include, but are not limited to, unavailability of or delays in delivery of raw materials for manufacture of PH94B; inadequate and/or untimely supply of PH94B to meet demand; entry of competitive products; and other technical and unexpected hurdles in the development, manufacture and commercialization of PH94B, as well as those risks more fully discussed in the section entitled "Risk Factors" in VistaGen's most recent Annual Report on Form 10-K for the year ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in either company's other filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements.
VistaGen Company Contact
Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3606
Email: [email protected]