Vistagen Therapeutics Inc

CONDENSED CONSOLIDATED BALANCE SHEETS

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’** EQUITY**

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’** EQUITY**

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. Description of Business

Vistagen Therapeutics, Inc., a Nevada corporation (Vistagen, theCompany,we,our, orus), is a clinical-stage biopharmaceutical company pioneering neuroscience to deliver first-in-class therapies for psychiatric and neurological disorders. Five of our six clinical-stage product candidates – fasedienol (PH94B), itruvone (PH10), PH15, PH80 and PH284 – belong to a new class of drugs known as pherines, which have the potential to rapidly deliver meaningful efficacy with a differentiated safety profile. Pherines are investigational neuroactive nasal sprays with innovative proposed mechanisms of action that activate chemosensory neurons in the nasal passages to impact fundamental neural circuits in the brain without the need for systemic absorption or binding to receptors in the brain. Our sixth clinical-stage product candidate, AV-101, is an investigational oral drug candidate with the potential to inhibit, but not block, NMDA receptor activity. Vistagen is passionate about transforming what is possible in the treatment of anxiety, depression, and other neuroscience disorders.

2. Basis of Presentation, Principles of Consolidation and Summary of Significant Accounting Policies

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) applicable to interim financial information and pursuant to the instructions of the Securities and Exchange Commission (SEC) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Further, the results of our operations for any interim periods are not necessarily indicative of the results that may be expected for any other interim period or the full fiscal year. In the opinion of management, all normal and recurring adjustments considered necessary for a fair presentation have been included. The condensed consolidated balance sheet at March 31, 2023, has been derived from our audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The report of our independent auditors included an explanatory paragraph in their opinion on our consolidated financial statements as of and for the fiscal year ended March 31, 2023, that states that our ongoing losses raised substantial doubt about our ability to continue as a going concern. Because all of the disclosures required by U.S. GAAP for complete financial statements are not included herein, these unaudited condensed consolidated financial statements and the accompanying notes should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended March 31, 2023 (ourAnnual Report).

The accompanying unaudited condensed consolidated financial statements include the accounts of Vistagen and its subsidiaries. All intercompany accounts and transactions have been eliminated.

On June 6, 2023, we implemented a stockholder-approved one-for-thirty (1-for-30) reverse split of our common stock (theReverse Stock Split). All share and per share data for all periods presented in the accompanying condensed consolidated financial statements and related disclosures in this Report have been adjusted retrospectively to reflect the Reverse Stock Split. Refer to Note 5,Capital Stock, for additional information.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue and expense during the reporting period. Significant estimates include those relating to revenue recognition, share-based compensation, right-of-use assets and lease liabilities and assumptions that have been used historically to value warrants and warrant modifications. Actual results could differ from those estimates. Changes in estimates are reflected in the reported results in the period in which they become known.

Liquidity

We have incurred significant losses and negative cash flows from operations since inception. As of December 31, 2023, we had an accumulated deficit of $346.7 million. We expect that operating losses and negative cash flows will continue for the foreseeable future as we continue to develop our product candidates. We currently expect that our cash and cash equivalents of $126.6 million as of December 31, 2023 will be sufficient to fund operating expenses and capital requirements for more than 12 months from the date the unaudited condensed consolidated financial statements are issued.

Recently Issued Accounting Pronouncements

There were no significant updates not already disclosed in the Company’s audited consolidated financial statements for the years ended March 31, 2023, and 2022, to the recently issued accounting standards for the nine months ended December 31, 2023.

3. Fair Value Measurements

We have certain financial assets that are measured at fair value on a recurring basis, which consist of cash held in money market funds. These assets, which are classified within Level 1 of the fair value hierarchy and are reflected as a component of cash and cash equivalents on the condensed consolidated balance sheets, totaled $120.8 million and $5.0 million at December 31, 2023 and March 31, 2023, respectively. We hadno financial liabilities measured at fair value on a recurring basis at December 31, 2023 or March 31, 2023.

4. Note Payable

In May 2023, we executed a 7.43% promissory note in the principal amount of $0.9 million in connection with certain insurance policy renewal premiums. The note was payable in monthly installments of $0.1 million, including principal and interest, through February 2024. We paid this note in full in August 2023.

In May 2022, we executed a 3.88% promissory note in the principal amount of $1.1 million in connection with certain insurance policy premiums. The note was payable in monthly installments of $0.1 million, including principal and interest, and we paid this note in full in April 2023.

5. Capital Stock

Common Stock

Reverse Split of Common Stock

On June 6, 2023, we implemented the stockholder-approved one-for-thirty (1-for-30) Reverse Stock Split. The number of shares and exercise prices of outstanding options to purchase common stock granted under our stockholder-approved equity compensation plans and common stock purchase warrants issued prior to June 6, 2023, have been adjusted proportionately to reflect the Reverse Stock Split. Following the Reverse Stock Split, authorized shares of our common stock remain unchanged at 325,000,000 and authorized shares of our preferred stock remain unchanged at 10,000,000. The par value of our common stock and preferred stock remains at $0.001 per share. All issued and outstanding shares of common stock, options exercisable for common stock and common stock purchase warrants issued prior to June 6, 2023, and per share amounts for all periods presented in the accompanying condensed consolidated financial statements have been adjusted retrospectively to reflect the Reverse Stock Split.

Open Market Sale Agreement

In May 2021, we entered into an Open Market Sale Agreement SM (theSales Agreement) with Jefferies LLC (Jefferies) pursuant to which we may, in our sole discretion, offer and sell, from time to time, shares of our common stock having an aggregate offering price of up to $75.0 million. During the nine months ended December 31, 2023, we sold an aggregate of 4,698,495 shares of our common stock under the Sales Agreement and received net cash proceeds of $36.2 million. We did not sell any shares under the Sales Agreement during the three months ended December 31, 2023.

October2023 Public Offering**

On October 2, 2023*,* we completed an underwritten public offering (theOctober 2023 Public Offering), whereby we offered and sold, for gross proceeds of approximately $100,000,000, a total of 15,010,810 shares of our common stock and, to certain investors,3,577,240 pre-funded warrants to purchase up to 3,577,240 shares of common stock in lieu of shares of common stock (thePre-Funded Warrants). Each share of common stock and/or Pre-Funded Warrant was issued together with a ratably allocated portion of both warrants to purchase up to 9,294,022 shares of common stock (or pre-funded warrants to purchase up to 9,294,022 shares of common stock in lieu thereof) with an exercise price of $5.38 per share (theT1 Warrants) and warrants to purchase 11,265,086 shares of common stock (or pre-funded warrants to purchase up to 11,265,086 shares of common stock in lieu thereof) with an exercise price of $8.877 per share (theT2 Warrants). The combined offering price for each share of common stock, accompanying T1 Warrant and accompanying T2 Warrant was $5.38. The combined offering price per Pre-Funded Warrant, accompanying T1 Warrant and accompanying T2 Warrant was $5.379. The securities were issued pursuant to our effective shelf registration statement on Form S-3 (FileNo. 333-254299) and a related prospectus supplement filed with the Securities and Exchange Commission on October 3, 2023. The October 2023* Public Offering closed on October 4, 2023.*The net proceeds to us from the October 2023 Public Offering were approximately $93.5 million, after deducting expenses related to the offering, including commissions, legal expenses and other offering costs.

The Pre-Funded Warrants, T1 Warrants and T2 Warrants are exercisable, only at the option of the holder, at any time after October 4, 2023. Holders of Pre-Funded Warrants, T1 Warrants, and T2 Warrants are entitled to receive dividends, if declared, on an as-if-converted-to-common-stock basis, and in the same form as dividends actually paid on shares of the common stock. We may not effect the exercise of any Pre-Funded, T1 Warrant, or T2 Warrant, and a holder will not be entitled to exercise any portion of any Pre-Funded, T1 or T2 Warrant, which, upon giving effect to such exercise, would cause the aggregate number of shares of common stock beneficially owned by the holder of such warrant (together with its affiliates) to exceed 9.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise. However, any holder may increase or decrease such percentage to any other percentage (not to exceed 19.99% if exceeding such percentage would result in a change of control under Nasdaq Listing Rule 5636(b) or any successor rule) upon at least 61 days’ prior notice from the holder to us subject to the terms of the respective warrant agreement.

We evaluated the terms of the warrants issued and determined that they should be classified as equity instruments within additional paid-in capital.

Common Stock Warrants

At December 31, 2023, the following common stock warrants were outstanding:

The weighted average exercise price of all outstanding warrants at December 31, 2023 is $6.24 per share.

On May 1, 2020, we filed a Registration Statement on Form S-3 covering the resale of the shares underlying all of the currently outstanding warrants at that time (theWarrant Registration Statement). The SEC declared the Warrant Registration Statement effective on May 13, 2020. No outstanding warrant, including the warrants issued in connection with the October 2023 Public Offering, is subject to any down-round anti-dilution protection feature.

6. Stock-Based Compensation

The following table summarizes stock-based compensation expense included in operating expense:

7. Net Loss per Common Share

Basic net loss per common share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period, without consideration for common stock equivalents. The Pre-Funded Warrants associated with the October 2023 Public Offering (see Note 5 above) are considered outstanding shares in the basic earnings per share calculation given their nominal exercise price. Dilutive common stock equivalents for the periods presented include warrants for the purchase of common stock and common stock options outstanding under the Company’s equity compensation plans. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.

The following table summarizes the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because their inclusion would be anti-dilutive:

8. Sublicensing and Collaborative Agreements

We recognized sublicense and other revenue of $0.4 million and $0.9 million for the three and nine months ended December 31, 2023, respectively, and $0.2 million and $(0.4) million for the three and nine months ended December 31, 2022, respectively.

The following table presents changes in contract assets and liabilities during the nine months ended December 31, 2023.

The following summarizes the terms of our collaboration arrangements:

AffaMed Agreement

In June 2020, we entered into a license and collaboration agreement (theAffaMed Agreement) with EverInsight Therapeutics Inc., a company incorporated under the laws of the British Virgin Islands, now AffaMed Therapeutics, Inc. (AffaMed), pursuant to which we granted AffaMed an exclusive license to develop and commercialize fasedienol for social anxiety disorder (SAD) and potentially other anxiety-related disorders in Greater China, South Korea and Southeast Asia (which includes Indonesia, Malaysia, Philippines, Thailand and Vietnam) (collectively, theTerritory). We retain exclusive development and commercialization rights for fasedienol in the U.S. and throughout the rest of the world outside the Territory.

Under the terms of the AffaMed Agreement, AffaMed paid to us a non-refundable upfront license payment of $5.0 million in August 2020. Additionally, upon successful development and commercialization of fasedienol in the Territory, we are eligible to receive milestone payments of up to $172.0 million. Further, we are eligible to receive royalty payments on a country-by-country basis on net sales for the later of ten years or the expiration of market or regulatory exclusivity in the jurisdiction, except that payments will be reduced on a country-by-country basis in the event that there is no market exclusivity in the period. Royalty payments may also be reduced if there is generic competitive product in the Territory in the period.

We have determined that we have one combined performance obligation for the license to develop and commercialize fasedienol in the Territory and related development and regulatory services. In addition, AffaMed has an option that will create manufacturing obligations for us during development upon exercise by AffaMed. This option for manufacturing services was evaluated and determined not to include a material right.

Development and commercialization milestones were not considered probable at inception and therefore, were excluded from the initial transaction price. The royalties were excluded from the initial transaction price because they relate to a license of intellectual property and are subject to the royalty constraint.

We recognize revenue as the combined performance obligation is satisfied over time using an output method. The measure of progress is stand-ready straight-line over the period in which we expect to perform the services related to the license of fasedienol.

Significant management judgment is required to determine the level of effort attributable to the performance obligation included in the AffaMed Agreement and the period over which we expect to complete our performance obligation. The performance period or measure of progress is estimated at the inception of the arrangement and re-evaluated in subsequent reporting periods. This re-evaluation may shorten or lengthen the period over which we recognize revenue. At September 30, 2022, we extended the date in our estimate to complete the performance obligation. As a result of the change in our estimate of the time required to complete our performance obligation, we recorded a cumulative catch-up adjustment at September 30, 2022 resulting in derecognition of $892,500 of previously recognized revenue.

As of December 31, 2023 and March 31, 2023, we had short-term deferred revenue of $0.8 million and $0.7 million, respectively, and long-term deferred revenue of $1.6 million and $2.3 million, respectively, related to the AffaMed Agreement. During the three and nine months ended December 31, 2023, we recognized revenue of $0.2 million and $0.7 million, respectively, under the AffaMed Agreement, which was included in the contract liability balance as of March 31, 2023. The remaining deferred revenue under the AffaMed Agreement will be recognized over the expected remaining contractual term.

The AffaMed Agreement will expire on a jurisdiction-by-jurisdiction basis upon the latest to occur of expiration of the last valid claim under a licensed patent of fasedienol in such jurisdiction, the expiration of regulatory exclusivity in such jurisdiction or ten years after the first commercial sale of fasedienol in such jurisdiction.

Fuji Pharma Agreement

On September 1, 2023, we entered into an Exclusive Negotiation Agreement (theNegotiation Agreement) with 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, we agreed, for a limited period of time, to negotiate exclusively with Fuji Pharma for a potential exclusive license agreement to develop and commercialize our PH80 product candidate in Japan (thePotential Definitive Agreement). The Negotiation Agreement provides for an exclusive negotiation period beginning on the date of formal written notice being received by Fuji Pharma that we have selected a contract development and manufacturing organization to conduct preclinical toxicology studies for the product candidate (thePayment Event), and terminating on the later to occur of (i) fourteen (14) months from the date of the Payment Event 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, Fuji Pharma agreed to make a payment to us of $1.5 million (Purchase Price), payable upon occurrence of the Payment Event. The Payment Event occurred in October 2023, and we received payment of the Purchase Price in full in November 2023. The Purchase Price is non-refundable, except upon a material breach of the Negotiation Agreement by the Company; however, should the Company and Fuji Pharma enter into the Potential Definitive Agreement, the Purchase Price will be creditable against any upfront fee due in connection with the execution of 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.

As of December 31, 2023, we had short-term deferred revenue of $1.0 million and long-term deferred revenue of $0.3 million related to the Negotiation Agreement. During the three and nine months ended December 31, 2023, we recognized $0.2 million of revenue under the Negotiation Agreement. The remaining deferred revenue under the Negotiation Agreement will be recognized over the expected remaining estimated contractual term.

9. Related Party Transactions

In August 2023, in connection with his retirement, we entered into a consulting agreement with our former Chief Financial Officer, Jerrold D. Dotson, to assist in transition matters related to the employment of our new Chief Financial Officer. Pursuant to the agreement, Mr. Dotson received an initial payment of $100,000 and $10,000 per month from September 2023 through August 2024. During the three and nine months ended December 31, 2023, we recorded expense of $30,000 and $140,000, respectively.

In January 2022, we entered into a consulting agreement with FitzPatrick Co. LLC, a consulting firm for which Margaret FitzPatrick, an independent member of our Board of Directors, is Managing Director, to provide corporate development and public relations advisory services. The consulting agreement, as amended, was set to expire on December 31, 2023. However, the Company and FitzPatrick Co. LLC mutually agreed to conclude the term of the FitzPatrick Co. Consulting Agreement effective October 1, 2023, as all matters set forth in the statement of work were completed as of that date. We recorded expense of $0 and $70,000 for the three and nine months ended December 31, 2023, respectively, as compared to $45,000 and $135,000 for the three and nine months ended December 31, 2022, respectively.

In November 2022, Ann Cunningham resigned as our Chief Commercial Officer to serve full-time as Managing Partner of i3 Strategy Partners, a pharmaceutical consulting firm founded by Ms. Cunningham. i3 Strategy Partners began providing commercial planning advisory services to us pursuant to a consulting agreement, dated November 2022. The initial term of the consulting agreement will expire on March 31, 2024. During the three and nine months ended December 31, 2023, we recorded expense under the consulting agreement of $52,000 and $117,000, respectively, as compared to $120,000 for the three and nine months ended December 31, 2022. Ms. Cunningham remains a member of our Board of Directors.

10. Commitments and Contingencies

From time to time, we may be party to litigation, arbitration or other legal proceedings in the course of our business. The outcome of any such legal proceedings, regardless of the merits, is inherently uncertain. In addition, litigation and related matters are costly and may divert the attention of our management and other resources that would otherwise be engaged in other activities. If we were unable to prevail in any such legal proceedings, our business, results of operations, liquidity, and financial condition could be adversely affected.