Note 1. Organization and description of business operations

The Company is a clinical stage biopharmaceutical company organized as a Delaware limited liability company on April 5, 2018 to focus on the development of drug candidates for the treatment of autism spectrum disorder (ASD), Fragile X syndrome tremor-ataxia (FXTAS) and Human African Trypanosomiasis (HAT). The Company converted into a Delaware corporation on April 15, 2020.

Going concern, liquidity and capital resources

The Company has no product revenues, has incurred operating losses since inception, and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. The Company had an accumulated deficit of approximately $59.6 million at September 30, 2024, a net loss of approximately $7.6 million, and approximately $5.0 million of net cash used in operating activities for the nine months ended September 30, 2024.

Equity Purchase Agreement with Lincoln Park Capital

On November 17, 2022, the Company entered into an equity purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), which provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company could sell to LPC, at its discretion, up to $20.0 million of shares of its common stock over the 30-month term of the Purchase Agreement (See Note 7). During the nine months ended September 30, 2024 there were no shares of common stock issued in connection with the Purchase Agreement. During the nine months ended September 30, 2023, the Company received approximately $5.4 million from the issuance of 0.2 million shares of common stock to LPC. Due to the suspension of the Company from trading on the Nasdaq Capital Market, it was no longer permitted to sell shares of the Company’s common stock under the Purchase Agreement. The Purchase Agreement has since lapsed as the Maturity Date was reached on June 1, 2025.

Convertible Promissory Note

As of September 30, 2024, the Company has no outstanding convertible promissory notes. In February 2023, the Company issued a secured convertible promissory note with a principal balance of $3.7 million to Lind Global Fund II LP, together with a common stock purchase warrant to purchase 800,000 shares of common stock (the “2023 Note and Warrant”).

On November 29, 2023, the Company satisfied in full the obligations under this note.

Secondary Public Offering

On November 20, 2023, the Company entered into an underwriting agreement relating to the secondary public offering of its common stock. The Company agreed to sell 5,384,615 shares of its common stock with the offering price to the public of $1.30 per share, pursuant to the Company’s registration statement on Form S-1 (File No. 333-275416), as amended, that was filed by the Company under Rule 462(b) under the Securities Act. On November 22, 2023, the Company received net proceeds from its public offering of approximately $6.1 million, net of underwriter fees and commissions of approximately $0.6 million, and offering costs of approximately $0.3 million. In connection with this public offering the Company issued 5,384,615 warrants to purchase shares of common stock with an exercise price of $1.30 per share and issued 215,385 warrants to purchase shares of common stock with an exercise price of $1.625.

The 2023 Note and Warrant contained a price adjustment clause where the exercise and conversion price of the 2023 Note and Warrant would be adjusted to the selling price of an offering if the Company’s common stock is sold at a price below the conversion or exercise price, respectively. As the price of the common stock sold as part of the secondary public offering described herein was below the exercise and conversion price of the Note and Warrant, the terms of the conversion and exercise price were reset to $1.30.

Vox Nova Exclusive Pharmacy Distribution Agreement

On June 30, 2023, the Company entered into an exclusive specialty benefit manager agreement with Vox Nova, LLC (“Vox Nova”) pursuant to which Vox Nova would act as the exclusive United States distributor for the Company’s lead pipeline asset, KV-101 intravenous suramin. Vox Nova provided certain distribution management, pharmacy benefit management, sales and supply monitoring services to the Company with respect to KV-101, in the event KV-101 receives FDA approval. The distribution agreement also provided for an exclusivity fee payable to the Company of up to $2.0 million, payable in installments based on various time and regulatory approval parameters. Vox Nova paid $0.5 million of the exclusivity fee upfront in connection with the signing of the distribution agreement when the distribution right was transferred to Vox Nova. The remaining $1.5 million is due in four equal installments over a one-year 1period after KV-101 is approved by the FDA and made available for distribution.

KUVATRIS THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

Reverse Stock Split

On October 30, 2023, we filed a Certificate of Amendment to our Certificate of Incorporation (the “Reverse Split Amendment”) with the Secretary of State of the State of Delaware to affect a 1-for-17 reverse stock split of our outstanding common stock (the “Reverse Stock Split”). The Amendment became effective October 30, 2023 (the “Reverse Split Effective Time”). The Reverse Split Amendment was authorized by our stockholders at our special meeting of stockholders on September 26, 2023.

The Reverse Split Amendment provided that, at the Reverse Split Effective Time, every 17 shares of our issued and outstanding common stock were automatically combined into one issued and outstanding share of common stock, without any change in par value per share. The Reverse Stock Split affected all of our shares of common stock outstanding immediately prior to the Reverse Split Effective Time. As a result of the Reserve Stock Split, proportionate adjustments have been made to the per share exercise price and/or the number of shares issuable upon the exercise or vesting of all stock options and warrants issued and outstanding immediately prior to the Reverse Split Effective Time, which resulted in a proportionate decrease in the number of shares of our common stock reserved for issuance upon exercise or vesting of such stock options and warrants, and, in the case of stock options and warrants, a proportionate increase in the exercise price of all such stock options and warrants. In addition, the number of shares reserved for issuance under our Amended and Restated 2020 Equity Incentive Plan immediately prior to the Reverse Split Effective Time has been reduced proportionately.

No fractional shares were issued as a result of the Reverse Stock Split. Stockholders of record who would otherwise have been entitled to receive a fractional share received a number of shares rounded up to the next whole share in lieu thereof. The Reverse Stock Split affected all stockholders proportionately and did not affect any stockholder’s percentage ownership of our common stock (other than the nominal effect of the treatment of fractional shares).

Our common stock began trading on The Nasdaq Capital Market on a split-adjusted basis when the market opened on October 31, 2023.

All share and per share information referenced throughout this Form 10-Q has been retroactively adjusted to reflect the Reverse Stock Split.

Delisting and Subsequent Events

As disclosed in a current report on Form 8-K filed on May 1, 2024, the Company’s common stock was suspended from trading on the Nasdaq Capital Market beginning on May 2, 2024. Since May 2, 2024, the Company’s common stock has been trading on the OTC Expert Market.

On February 28, 2025, the Company entered into the stock purchase agreement with PRV, pursuant to which the Company, on the Issuance Date, issued to PRV 114,754,700 shares of its common stock, which constituted over 90% of the Company’s authorized voting securities as of the Issuance Date. The managing member of PRV is Howard J. Weisman, who is also Chief Executive Officer and Chairman of the Board of the Company. As a holder of greater than ninety percent (90%) of the issued and outstanding voting shares of the Company, PRV intends to execute a short-form merger of the remaining issued and outstanding shares of common stock pursuant to Section 251(h) of the DGCL. Once the short-form merger is complete, the Company will continue to exist as a wholly-owned subsidiary of PRV.

Going Concern

The accompanying condensed financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern.

KUVATRIS THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

The Company’s future liquidity and capital funding requirements will depend on numerous factors, including:

The Company will likely need to raise substantial additional funds through one or more of the following: issuance of additional debt or equity, or the completion of a licensing transaction for one or more of the Company’s pipeline assets. If the Company is unable to maintain sufficient financial resources, its business, financial condition and results of operations will be materially and adversely affected. This could affect future development and business activities and potential future clinical studies and/or other future ventures. Failure to obtain additional equity or debt financing will have a material, adverse impact on the Company’s business operations. There can be no assurance that the Company will be able to obtain the needed financing on acceptable terms or at all. Additionally, equity or convertible debt financings will likely have a dilutive effect on the holdings of the Company’s existing stockholders. Accordingly, there are material risks and uncertainties that raise substantial doubt about the Company’s ability to continue as a going concern for the next twelve months from the issuance of these condensed financial statements.