Kuvatris Therapeutics (NASDAQ: PXMD) posts Q3 loss and outlines going-private change in control
Kuvatris Therapeutics, Inc. (formerly PaxMedica) reports a much smaller net loss but severe financial strain for the quarter ended September 30, 2024. The company posted a net loss of $0.9 million for the quarter and $7.6 million for the nine months, compared with losses of $5.0 million and $12.4 million in the prior-year periods, mainly because general and administrative and research and development expenses were sharply reduced.
Cash fell to $444,855 from $4.7 million at December 31, 2023, leaving total assets of $0.8 million against liabilities of $2.8 million and a stockholders’ deficit of $(1.9) million. The filing states there is substantial doubt about the company’s ability to continue as a going concern.
Subsequent events radically changed the capital structure. In February 2025, the company issued 114,754,700 common shares to Pax Rescue Vehicle, LLC for $10,000 plus legal fees, giving PRV over 90% of voting power and effecting a change in control as part of a going-private strategy. The company then declared DTC‑held common shares null and void, directed its transfer agent to cancel those shares, and filed a Form 15 to terminate Exchange Act registration.
Positive
- None.
Negative
- Severe financial distress and going‑concern warning: Cash declined to $444,855 against $2.75 million of liabilities and a $(1.93) million stockholders’ deficit, and management discloses substantial doubt about the company’s ability to continue as a going concern.
- Highly dilutive change-in-control going‑private transaction: In February 2025 the company issued 114,754,700 shares for $10,000 plus legal fees to an affiliate that obtained over 90% of voting power, while DTC‑held common shares were later declared null, void and worthless and registration was terminated by Form 15.
Insights
Filing shows effective wipeout of prior equity and going‑concern risk.
The numbers depict a company operating in the zone of insolvency by late 2024. Cash was only
Operations were scaled back rather than grown. General and administrative costs dropped from
Subsequent corporate actions are highly consequential for shareholders. In
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended
OR
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
(formerly PaxMedica, Inc.)
(Exact name of registrant as specified in its charter)
| (State
or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(IRS
Employer Identification No.) |
| (Address Of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| None |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| ☒ | Smaller reporting company | ||
| 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.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As
of January 13, 2026, the Registrant had
EXPLANATORY NOTE
Kuvatris Therapeutics, Inc., formerly known as PaxMedica, Inc., (the “Company,” “we,” “us,” or “our”) is filing this Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024 (this “Quarterly Report”), in order to comply with regulatory requirements set forth and communicated to us by the Financial Industry Regulatory Agency (“FINRA”). As described in a Current Report on Form 8-K we filed on March 7, 2025 and elsewhere in this filing, on February 28, 2025, we entered into a stock purchase agreement with Pax Rescue Vehicle, LLC, a Delaware limited liability company (“PRV”), pursuant to which the Company, on March 3, 2025 (the “Issuance Date”), issued to PRV 114,754,700 shares of its common stock, par value $0.0001 per share (the “common stock”), which constituted over 90% of the Company’s authorized voting securities as of the Issuance Date. This issuance of common stock was made in reliance on the exemption from registration available under Rule 506(c) of Regulation D of the Securities Act of 1933, as amended (the “Securities Act”), and was authorized prior to the Issuance Date by unanimous written consent of the Company’s board of directors (the “Board”) pursuant to Section 141(f) of the Delaware General Corporation Law (the “DGCL”). The issuance of the common stock to PRV represented a change-in-control of the Company.
This action was undertaken in order to facilitate a “going private” transaction of the Company, as the common stock was trading at a market price of $0.0001 during the month of the Issuance Date and was essentially worthless. As an alternative to filing for liquidation under Chapter 7 of the U.S. Bankruptcy Code (“Chapter 7”), we opted to take the Company private, so as to maximize the value of its remaining assets for the benefit of the Company’s remaining stakeholders, particularly its creditors, and to enable its minority common shareholders to realize a taxable event.
In connection with this action, on May 20, 2025, the Company forwarded a letter to the Depositary Trust Company (“DTC”) in which it declared the issued and outstanding shares of common stock, held by DTC on behalf of the beneficial shareholders of the Company to be null, void and worthless. On June 12, 2025, the Company forwarded a letter of instruction to its transfer agent, VStock Transfer, LLC (the “Transfer Agent”), directing the Transfer Agent to cancel all shares of common stock held by DTC. Further, on June 13, 2025, the Company filed a Form 15-12G with the Securities and Exchange Commission (the “SEC”), terminating its registration under Section 12(g) of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), and suspending its obligation to file reports under Sections 13 and 15(d) of the Exchange Act.
Subsequently, FINRA notified the Company that it could not ratify any of the corporate actions referenced in the immediately preceding paragraph, as well as the Company’s change of name to Kuvatris Therapeutics, Inc., which took place on June 6, 2025, until such time as the Company had filed all delinquent periodic SEC reports required under the Exchange Act. For that reason, the Company is filing this Quarterly Report.
KUVATRIS THERAPEUTICS, INC.
Form 10-Q
For the Quarter Ended September 30, 2024
Table of Contents
| Page | ||
| PART I. FINANCIAL INFORMATION | 1 | |
| Item 1. | Financial Statements | 1 |
| Condensed Balance Sheets as of September 30, 2024 (Unaudited) and December 31, 2023 | 1 | |
| (Unaudited) Condensed Statements of Operations for the three- and nine- months ended September 30, 2024 and September 30, 2023 | 2 | |
| (Unaudited) Condensed Statements of Changes in Stockholders’ (Deficit) Equity for the three- and nine- months ended September 30, 2024 and September 30, 2023 | 3 | |
| (Unaudited) Condensed Statements of Cash Flows for the nine months ended September 30, 2024 and September 30, 2023 | 4 | |
| Notes to Unaudited Condensed Financial Statements | 5 | |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 16 |
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 24 |
| Item 4. | Controls and Procedures | 24 |
| PART II. OTHER INFORMATION | 26 | |
| Item 1. | Legal Proceedings | 26 |
| Item 1A. | Risk Factors | 26 |
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 26 |
| Item 3. | Defaults Upon Senior Securities | 26 |
| Item 4. | Mine Safety Disclosures | 26 |
| Item 5. | Other Information | 26 |
| Item 6. | Exhibits | 27 |
PART I. FINANCIAL INFORMATION
| Item 1. | Financial Statements |
KUVATRIS THERAPEUTICS, INC.
CONDENSED
BALANCE SHEETS
(Unaudited)
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash | $ | $ | ||||||
| Prepaid and other current assets | ||||||||
| Total current assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Accrued expenses - compensation | — | |||||||
| Total current liabilities | ||||||||
| Deferred revenue | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 8) | - | - | ||||||
| Stockholders’ (Deficit) Equity | ||||||||
| Preferred stock, par value $ | ||||||||
| Series X preferred shares, | ||||||||
| Common stock, par value $ | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ (deficit) equity | ( | ) | ||||||
| Total liabilities, and stockholders’ (deficit) equity | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed financial statements.
| 1 |
KUVATRIS THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses | ||||||||||||||||
| General and administrative | $ | $ | $ | $ | ||||||||||||
| Research and development | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest expense | — | ( | ) | — | ( | ) | ||||||||||
| Loss on extinguishment of debt | — | ( | ) | — | ( | ) | ||||||||||
| Change in fair value of notes | — | ( | ) | — | ( | ) | ||||||||||
| Other expense | — | ( | ) | |||||||||||||
| Total other income (expense) | ( | ) | ( | ) | ||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Deemed dividend on warrant inducement | ( | ) | - | ( | ) | - | ||||||||||
| Net loss attributable to common stockholders | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Basic and diluted weighted average number of shares outstanding | ||||||||||||||||
| Basic and diluted net loss per share | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
The accompanying notes are an integral part of these unaudited condensed financial statements.
| 2 |
KUVATRIS THERAPEUTICS, INC.
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDER’S (DEFICIT) EQUITY
(Unaudited)
For the Three Months Ended September 30, 2024
| Shares | Amount | Shares | Amount | Capital | Deficit | Equity (Deficit) | ||||||||||||||||||||||
| Series X Preferred Stock | Common Stock | Additional Paid-in | Accumulated | Total Stockholders’ | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Equity (Deficit) | ||||||||||||||||||||||
| Balance at July 1, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Issuance of common stock underlying restricted stock units, net of tax withholding | — | — | — | — | — | — | — | |||||||||||||||||||||
| Issuance of common stock converted from prefunded warrants | — | — | — | — | — | — | — | |||||||||||||||||||||
| Issuance of common stock in connection with warrant inducement, net of fees | — | — | — | |||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | — | — | |||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | ) | ( | ) | |||||||||||||||||||
| Balance at September 30, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
For the Three Months Ended September 30, 2023
| Shares | Amount | Shares | Amount | Capital | Deficit | Equity (Deficit) | ||||||||||||||||||||||
| Series X Preferred Stock | Common Stock | Additional Paid-in | Accumulated | Total Stockholders’ | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Equity (Deficit) | ||||||||||||||||||||||
| Balance at July 1, 2023 | $ | $ | $ | $ | $ | |||||||||||||||||||||||
| Issuance of common stock in connection with equity purchase agreement | — | $ | — | $ | $ | $ | — | $ | ||||||||||||||||||||
| Issuance of common stock warrants in connection with notes payable, net of fees | — | $ | — | $ | $ | $ | — | $ | ||||||||||||||||||||
| Delivery of common stock underlying restricted stock units, net of tax withholding | — | $ | — | $ | $ | ( | ) | $ | — | $ | ( | ) | ||||||||||||||||
| Stock-based compensation | — | $ | — | — | $ | — | $ | $ | — | $ | ||||||||||||||||||
| Net loss | — | $ | — | — | $ | — | $ | — | $ | ( | ) | $ | ( | ) | ||||||||||||||
| Balance at September 30, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
For The Nine Months Ended September 30, 2024
| Shares | Amount | Shares | Amount | Capital | Deficit | Equity (Deficit) | ||||||||||||||||||||||
| Series X Preferred Stock | Common Stock | Additional Paid-in | Accumulated | Total Stockholders’ | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Equity (Deficit) | ||||||||||||||||||||||
| Balance at January 1, 2024 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| Issuance of common stock underlying restricted stock units, net of tax withholding | — | — | ( | ) | — | ( | ) | |||||||||||||||||||||
| Issuance of common stock converted from prefunded warrants | — | — | ( | ) | — | — | ||||||||||||||||||||||
| Issuance of common stock in connection with warrant inducement | — | — | — | |||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | |||||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | ) | ( | ) | |||||||||||||||||||
| Balance at September 30, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
For The Nine Months Ended September 30, 2023
| Shares | Amount | Shares | Amount | Capital | Deficit | Equity (Deficit) | ||||||||||||||||||||||
| Series X Preferred Stock | Common Stock | Additional Paid-in | Accumulated | Total Stockholders’ | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Equity (Deficit) | ||||||||||||||||||||||
| Balance at January 1, 2023 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| Reclassification of shares settled liability to equity | — | $ | — | $ | — | $ | $ | — | $ | |||||||||||||||||||
| Issuance of common stock in connection with equity purchase agreement | — | $ | — | $ | $ | $ | — | $ | ||||||||||||||||||||
| Issuance of common stock warrants in connection with notes payable, net of fees | — | $ | — | $ | $ | $ | — | $ | ||||||||||||||||||||
| Delivery of common stock underlying restricted stock units, net of tax withholding | — | — | ( | ) | — | ( | ) | |||||||||||||||||||||
| Stock-based compensation | — | $ | — | $ | $ | $ | — | $ | ||||||||||||||||||||
| Net loss | — | $ | — | — | $ | — | $ | — | $ | ( | ) | $ | ( | ) | ||||||||||||||
| Balance at September 30, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed financial statements
| 3 |
KUVATRIS THERAPEUTICS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
| Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | ||||||||
| Change in fair value of notes | — | |||||||
| Loss on extinguishment of debt | — | |||||||
| Deferred Revenue | — | |||||||
| Other Expense | — | |||||||
| Changes in assets and liabilities: | ||||||||
| Prepaid and other current assets | ( | ) | ||||||
| Accounts receivable | — | ( | ) | |||||
| Accounts payable | ||||||||
| Accounts payable - related party | — | ( | ) | |||||
| Accrued expenses | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock and warrants, net of fees | ||||||||
| Proceeds from issuance of convertible promissory notes and warrants | — | ( | ) | |||||
| Proceeds from the issuance of common stock in connection with equity purchase agreement | — | |||||||
| Payment of costs from issuance of common stock and warrants | — | — | ||||||
| Payment of costs in connection with equity purchase agreement | — | ( | ) | |||||
| Repayment of convertible promissory notes | — | ( | ) | |||||
| Settlement of shares withheld for payment of employee taxes | ( | ) | ( | ) | ||||
| Net cash provided by financing activities | ||||||||
| Net change in cash | ( | ) | ( | ) | ||||
| Cash, beginning of period | ||||||||
| Cash, end of period | $ | $ | ||||||
| Non-cash financing activities: | ||||||||
| Common stock issued in connection with conversion of notes payable | $ | - | $ | |||||
| Reclassification of shares settled liability | $ | — | $ | |||||
| Unpaid deferred offering costs and financing fees | $ | — | $ | |||||
The accompanying notes are an integral part of these unaudited condensed financial statements.
| 4 |
KUVATRIS THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
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
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 $
Convertible Promissory Note
As
of September 30, 2024, the Company has
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
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 $
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 $
| 5 |
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
The
Reverse Split Amendment provided that, at the Reverse Split Effective Time, every
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
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.
| 6 |
KUVATRIS THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
The Company’s future liquidity and capital funding requirements will depend on numerous factors, including:
| ● | its ability to raise additional funds to finance its operations; | |
| ● | the outcome, costs and timing of clinical trial results for the Company’s current or future product candidates; | |
| ● | the emergence and effect of competing or complementary products; | |
| ● | its ability to maintain, expand and defend the scope of its intellectual property portfolio, including the amount and timing of any payments the Company may be required to make, or that it may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; | |
| ● | its ability to retain its current employees and the need and ability to hire additional management and scientific and medical personnel; and | |
| ● | the terms and timing of any collaborative, licensing or other arrangements that it has or may establish. |
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.
Note 2. Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements
Basis of presentation
The accompanying unaudited condensed financial statements are presented in U.S. dollars and in conformity with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP. In the opinion of management, the unaudited condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. The results of operations for the interim periods presented are not necessarily indicative of results to be expected for any other interim period or for the year as a whole.
The accompanying unaudited condensed financial statements should be read in conjunction with the financial statements for the year ended December 31, 2023 and notes thereto included in the Company’s Annual Report on Form 10-K filed with the SEC on March 11, 2024 (the “2023 Annual Report”).
Use of estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s condensed financial statements relate to the valuation of convertible notes, valuation of warrants, and valuation of equity-based awards. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
| 7 |
KUVATRIS THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
Significant Accounting Policies:
For a detailed discussion about the Company’s significant accounting policies, see Note 3 of the Company’s audited financial statements included in its 2023 Annual Report.
Concentrations of cash, cash equivalents and short-term investments
The
Company considers all highly liquid investments with an original maturity of three months or less at the date of acquisition to be cash
equivalents. As of September 30, 2024 and December 31, 2023, the Company had
Financial instruments that potentially subject the Company to the concentration of credit risk consist primarily of cash. The Company maintains its cash at high credit quality financial institutions, which may at times, be in excess of federal insured limits. The Company believes it is not exposed to any significant losses due to credit risk on cash.
Fair value of financial instruments
The Company accounts for financial instruments under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification 820, Fair Value Measurements (“ASC 820”). This statement defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. To increase consistency and comparability in fair value measurements, ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels as follows:
Level 1 - quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 - observable inputs other than Level 1, quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant value drivers are observable; and
Level 3 - assets and liabilities whose significant value drivers are unobservable.
Observable inputs are based on market data obtained from independent sources, while unobservable inputs are based on the Company’s market assumptions. Unobservable inputs require significant management judgment or estimation. In some cases, the inputs used to measure an asset or liability may fall into different levels of the fair value hierarchy. In those instances, the fair value measurement is required to be classified using the lowest level of input that is significant to the fair value measurement. Such determination requires significant management judgment. During the period ended March 31, 2023, the Company issued a convertible promissory note and a common stock purchase warrant in connection with it. The note was classified as a liability and measured at fair value on the issuance date, with changes in fair value to be recognized as other expense on the statements of operations and disclosed in the condensed financial statements. The carrying amounts of the Company’s financial assets and liabilities, such as accounts payable, approximate fair value due to the short-term nature of these instruments.
| 8 |
KUVATRIS THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
Revenue Recognition
The Company follows the provisions of Accounting Standards Codification 606, Revenue from Contracts with Customers (“ASC 606”). The guidance provides a five-step model to determine how revenue is recognized. In determining the appropriate amount of revenue to be recognized, the Company performs the following steps: (i) identification of the contracts with a customer; (ii) determination of the performance obligations in the contract; (iii) measurement of the transaction price, including potential constraints on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated stand-alone selling prices; and (v) recognition of revenue when (or as) the Company satisfies a performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC 606. Significant management judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations are either completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance or contract-term using the cumulative catch-up method. The Company allocates the total transaction price to each performance obligation based on the relative standalone selling prices of the promised goods or service underlying each performance obligation.
Research and Development
Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received.
Accrued Outsourcing Costs
Substantial portions of the Company’s preclinical studies and clinical trials are performed by third-party laboratories, medical centers, contract research organizations and other vendors (collectively “CROs”). These CROs generally bill monthly or quarterly for services performed, or bill based upon milestone achievement. For preclinical studies, the Company accrues expenses based upon estimated percentage of work completed and the contract milestones remaining. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. The Company outsources a substantial portion of its clinical trial activities, utilizing external entities such as CROs, independent clinical investigators, and other third-party service providers to assist the Company with the execution of its clinical studies. For each clinical trial that the Company conducts, certain clinical trial costs are expensed immediately, while others are expensed over time based on the number of patients in the trial, the attrition rate at which patients leave the trial, and/or the period over which clinical investigators or CROs are expected to provide services. The Company’s estimates depend on the timeliness and accuracy of the data provided by the CROs regarding the status of each program and total program spending. The Company periodically evaluates the estimates to determine if adjustments are necessary or appropriate based on information it receives.
Stock-Based Compensation
The Company expenses stock-based compensation to employees, non-employees and board members over the requisite service period based on the estimated grant-date fair value of the awards and actual forfeitures. The Company accounts for forfeitures as they occur. Stock-based awards with graded vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. All stock-based compensation costs are recorded in general and administrative costs in the statements of operations.
Loss Per Share
Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity. Basic and diluted net loss per common share were the same since the inclusion of common shares issuable pursuant to the exercise of options and warrants in the calculation of diluted net loss per common shares would have been anti-dilutive.
| 9 |
KUVATRIS THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
The following securities were excluded from the computation of diluted net loss per share attributable to common shareholders for the three and nine months ended September 30, 2024 and 2023, because including them would have been anti-dilutive:
Schedule of Securities Excluded from the Computation of Diluted Net Loss Per Share Attributable to Common Shareholders
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Series X preferred stock | ||||||||||||||||
| Unvested restricted stock units | ||||||||||||||||
| Common stock warrants | ||||||||||||||||
| Convertible Notes | — | — | ||||||||||||||
| Total | ||||||||||||||||
Net
loss attributable to common stockholders consists of net loss, as adjusted for deemed dividends. The Company recorded a deemed dividend
for the modification of existing warrants of approximately $
Income taxes
Accounting Standards Codification 740, Income Taxes (“ASC 740”), also provides guidance on derecognition, classification, interest and penalties, accounting in interim period, disclosure and transition. Based on the Company’s evaluation, it has been concluded that there are no significant uncertain tax positions requiring recognition in the Company’s condensed financial statements. The Company believes that its income tax positions and deductions would be sustained on audit and does not anticipate any adjustments that would result in material changes to its financial position.
Critical Accounting Estimates
We prepare our consolidated financial statements in accordance with GAAP, which require our management to make estimates that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the balance sheet dates, as well as the reported amounts of revenues and expenses during the reporting periods. To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations would be affected. We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectations for the future based on available information. We evaluate these estimates on an ongoing basis.
We consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations. There are items within our financial statements that require estimation but are not deemed critical, as defined above.
Recent accounting pronouncements
In November 2023, the FASB issued ASU 2023-07 “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures” to expand the disclosure requirements for reportable segments. The standard expands reportable segment disclosure requirements for public business entities primarily through enhanced disclosures about significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”) and included within each reported measure of segment operating profit (loss). This standard is effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. The Company is currently evaluating the effect that adoption of this standard will have on the Company’s disclosures.
In December 2023, the FASB issued Accounting Standards Update 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard becomes effective for the annual period beginning on January 1, 2025, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its financial statements.
| 10 |
KUVATRIS THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
In November 2024, the FASB issued ASU 2024-03 “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses” which requires public entities to disclose specified information about certain costs and expenses. ASU 2024-03 is effective for the Company’s annual reporting period beginning January 1, 2027 and interim reporting periods beginning January 1, 2028, with early adoption permitted. The Company is currently evaluating the impact that ASU 2024-03 will have on its financial statements.
Correction of Immaterial Classification Error
Certain reclassifications have been made to prior period amounts to conform to the current period financial statement presentation. These reclassifications had no effect on the previously reported results of operations or loss per share.
Note 3. Fair Value Measurements
Convertible Notes
During
the nine months ended September 30, 2023, the Company issued the 2023 Note with a principal balance of $
As of September 30, 2024 and December 31, 2023, the Company did not have any outstanding liabilities measured at fair value on a recurring basis.
A summary of significant unobservable inputs (Level 3 inputs) used in measuring the 2023 Note upon its issuance date is as follows:
Summary of Significant Unobservable Inputs (Level 3 inputs) Used in Measurement upon Issuance Dates
| February 6, 2023 | September
30, 2023 | |||||||
| Dividend yield | — | % | — | % | ||||
| Expected price volatility | % | % | ||||||
| Risk free interest rate | % | % | ||||||
| Expected term (in years) | ||||||||
The following table presents changes in Level 3 liabilities measured at fair value for the nine months ended September 30, 2023. Unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to unobservable (e.g., changes in unobservable long-dated volatilities) inputs.
There were no liabilities measured at fair value on a recurring basis into the fair value hierarchy as of September 30, 2024.
Summary of Changes in Level 3 Liabilities Measured at Fair Value
| Convertible Notes | ||||
| Balance at December 31, 2022 | $ | |||
| Issuance of convertible notes | ||||
| Issuance of common stock in connections with conversion of notes payables | ( | ) | ||
| Repayment of convertible notes | ( | ) | ||
| Loss on extinguishment of debt | ||||
| Change in fair value | ||||
| Balance at September 30, 2023 | $ | |||
| 11 |
KUVATRIS THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
Note 4. Prepaid and other current assets
As
of September 30, 2024, the Company recorded prepaid expenses and other current assets of approximately $
Note 5. Convertible promissory notes
As
of September 30, 2024, the Company has
Note 6. Stock-based compensation
Stock-based Compensation
The following is a summary of stock-based compensation during the three and nine months ended September 30, 2024 and 2023:
Schedule of share-based compensation
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Canceled stock options | $ | — | $ | $ | $ | |||||||||||
| Restricted stock units | — | |||||||||||||||
| Total | $ | — | $ | $ | $ | |||||||||||
Restricted Stock Units
The following is a summary of the restricted stock units during the nine months ended September 30, 2024:
Summary of changes in restricted stock units
| Weighted Average | ||||||||
| Grant-Date | ||||||||
| Number of Units | Fair Value | |||||||
| Unvested as of December 31, 2023 | $ | |||||||
| Granted | — | - | ||||||
| Vested | ( | ) | ||||||
| Unvested as of September 30, 2024 | $ | |||||||
No
restricted stock units (RSUs) were granted during the nine months ended September 30, 2024. During the nine months ended September 30,
2023, the Company granted
During
the nine-month period ended September 30, 2024, the Company recorded stock-based compensation expense related to the RSUs of approximately
$
During
the nine-month period ended September 30, 2023, the Company recorded stock-based compensation expense related to the RSUs of approximately
$
| 12 |
KUVATRIS THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
Performance-based Restricted Stock Units
As
of September 30, 2024, and 2023, there were
As of September 30, 2024, the Company determined that it was not probable that the performance awards would vest, and the Company has not recognized any stock-based compensation expense associated with these awards to date.
Canceled Stock Options
The
Company previously granted options to purchase shares of the Company’s common stock and during the year ended December 31, 2020,
these options were canceled in exchange for RSUs.
During
the three months ended September 30, 2024, the Company recorded no stock-based compensation related to the cancelled stock options and
during the three months ended September 30, 2023, the Company recorded stock-based compensation expense related to the cancelled stock
options of less than $
Note 7. Preferred and common stock
Series X Preferred Stock
There
were
Common Stock
On
November 17, 2022, the Company entered into the Purchase Agreement with 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 $
During
the three months ended September 30, 2024, there were
During
the three and nine months ended September 30, 2024, the Company issued
During
the three months ended September 30, 2024, the Company issued
During
the nine months ended September 30, 2024, the Company issued
| 13 |
KUVATRIS THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
On
September 3, 2024, the Company entered into warrant inducement offers with the holders of approximately
Pursuant
to the terms of the warrant inducement offers, in the event that the exercise of the existing warrants would cause a holder to exceed
the beneficial ownership limitations included therein, the Company would issue the number of shares of common stock that would not cause
a holder to exceed such beneficial ownership limitations and hold the remaining balance of shares of common stock in abeyance. Accordingly,
as of September 30, 2024, the Company held an aggregate of
The
Company accounted for the warrant inducement under ASC 815-40-35, “Issuer’s Accounting for Modifications or Exchanges of
Freestanding Equity-Classified Written Call Options,” and determined that the effect of the modification was directly attributable
to raising additional capital and accounted for the modification as an equity issuance cost. As a result of the warrant inducement offer,
the Company recorded a deemed dividend of approximately $
The modified warrants were valued on the date of the warrant inducement offer using the Black-Scholes model based on the following assumptions:
Summary of warrant inducement
| Dividend yield | — | % | ||||||
| Expected price volatility | % | |||||||
| Risk free interest rate | % | |||||||
| Expected term (in years) |
In
conjunction with the warrant inducement offers, the Company entered into new warrant agreements with the same holders to purchase an
aggregate of
Note 8. Commitments and contingencies
Litigation
As
of September 30, 2024 and December 31, 2023, there was
| 14 |
KUVATRIS THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
Subsequent Event: In January 2025, a complaint was filed against the Company and its Chief Executive Officer, please see Note 10 below.
Note 9. Related party transactions
Expenses
– During the three-month periods ended September 30, 2024 and 2023, the Company expensed $
In April 2023, TardiMed disposed of its equity position in the Company, at which time it ceased to be a related party. Subsequently, in August 2024, the Company and TardiMed mutually terminated the aforementioned rental and consulting agreements. As of the date of this filing, no further obligations remain under these agreements.
Note 10. Subsequent events
In January 2025, a complaint was filed against the Company and its Chief Executive Officer in the U.S. District Court for the Northern District of Ohio. The complaint involves claims by former business partners relating to a prior distribution agreement and certain equity investments. The Company believes these claims are without merit and intends to vigorously dispute and defend against them. The Company maintained Directors and Officers (D&O) liability insurance, including “Side A” coverage, which it believes is applicable to this matter. At this preliminary stage, the Company is unable to predict the outcome of this proceeding or estimate a range of potential loss; however, the Company does not believe the ultimate resolution will have a material adverse effect on its consolidated financial position, results of operations, or cash flows.
On
February 28, 2025, the Company entered into a stock purchase agreement with PRV, pursuant to which the Company, on the Issuance Date
issued to PRV
The
purchase price for the common stock was $
The managing member of PRV is Howard J. Weisman, who is also chief executive officer of the Company and chairman of its Board. 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.
| 15 |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
References to the “Company,” “Kuvatris Therapeutics, Inc.,” “our,” “us,” or “we” herein refer to Kuvatris Therapeutics, Inc, formerly PaxMedica, Inc. The following discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction with the unaudited interim condensed financial statements and the notes thereto contained elsewhere in this Quarterly Report on Form 10-Q (this “Quarterly Report”) and with our audited financial statements for the fiscal year ended December 31, 2023, as included in our annual report on Form 10-K, filed with the SEC on March 11, 2024 (our “Annual Report”). Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties.
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report, as well as information included in oral statements or other written statements made or to be made by us, contain statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Forward-looking statements can be identified by words such as “anticipate,” “believe,” “envision,” “estimate,” “expect,” “anticipate,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “ongoing,” “scheduled to,” “contemplate” and other similar expressions, although not all forward-looking statements contain these identifying words. Examples of forward-looking statements include, among others, statements we make regarding:
| ● | our lack of operating history; | |
| ● | the expectation that we will incur significant operating losses for the foreseeable future and will need significant additional capital, including through future sales and issuances of equity securities, which could also result in substantial dilution to our stockholders; | |
| ● | our current and future capital requirements to support our development and commercialization efforts for our product candidates and our ability to satisfy our capital needs; | |
| ● | our dependence on our product candidates, which are still in preclinical or early stages of clinical development; | |
| ● | our, or our third-party manufacturers’, ability to manufacture cGMP batches of our product candidates as required for pre-clinical and clinical trials and, subsequently, our ability to manufacture commercial quantities of our product candidates; | |
| ● | whether we will be successful in obtaining a priority review voucher, or PRV, for KV-101 and the commercial value to be realized from any such PRV, if any; | |
| ● | our ability to complete required clinical trials for our product candidates and obtain approval from the FDA or other regulatory agencies in different jurisdictions; | |
| ● | our lack of a sales and marketing organization and our ability to commercialize our product candidates if we obtain regulatory approval; | |
| ● | our dependence on third parties to manufacture our product candidates; | |
| ● | our reliance on third-party CROs to conduct our clinical trials; | |
| ● | our ability to obtain, maintain or protect the validity of our intellectual property, including our granted or potential future patents; | |
| ● | our ability to internally develop new inventions and intellectual property; | |
| ● | interpretations of current laws and the passages of future laws; |
| 16 |
| ● | acceptance of our business model by investors; | |
| ● | adverse developments affecting the financial services industry; | |
| ● | the accuracy of our estimates regarding expenses and capital requirements; and | |
| ● | our ability to adequately support organizational and business growth. |
The following discussion should be read in conjunction with our financial statements and related notes and other financial information appearing elsewhere in this report. In addition to historical information, the following discussion and other parts of this report contain forward-looking information that involves risks and uncertainties. Our actual results could differ materially from those anticipated by such forward-looking information due to the factors discussed under Item 1A— “Risk Factors” of our Annual Report and under Item 1A – “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” of this Item 2.
Overview
We are a clinical stage biopharmaceutical company focusing on the development of anti-purinergic drug therapies (“APT”) for the treatment of disorders with intractable neurologic symptoms, ranging from neurodevelopmental disorders, including autism spectrum disorder (“ASD”). APTs have been shown to block the effects of excess production and extracellular receptor activity of adenosine triphosphate (“ATP”), which acts as both the main energy molecule in all living cells and a peripheral and central nervous system neurotransmitter via receptors that are found throughout the nervous system. Excess purinergic signaling can offset homeostasis and trigger immune responses that result in localized and systemic increases in inflammatory chemokines and cytokines, ultimately stimulating ATP production. APTs may also impact immunologic and inflammatory mechanisms that may be causing or exacerbating symptoms in these seemingly unrelated disorders, which may be caused in part by similar mechanisms of ATP overproduction.
One of our primary points of focus is currently the development and testing of our lead program, KV-101, an intravenous formulation of suramin, in the treatment of ASD and for the treatment of Human African Trypanosomiasis, a fatal parasitic infection commonly known as African sleeping sickness (“HAT”).
In February 2021, we announced positive topline data from our Phase 2 dose-ranging clinical trial evaluating KV-101 (commonly known as intravenous suramin) for the treatment of the core symptoms of ASD, as described in more detail below. We also intend to submit data to support a New Drug Application (an “NDA”) for KV-101 under the Tropical Disease Priority Voucher Program of the U.S. Food and Drug Administration (the “FDA”) for HAT, leveraging suramin’s historical use in treating HAT outside of the United States. We have exclusively licensed clinical data from certain academic or international government institutions to potentially accelerate KV-101’s development plans in the United States through this regulatory program and intend to seek approval in the United States for the treatment of East African HAT (as defined below) as early as late 2024 or in the first half of 2025.
We are also pursuing the development of next generation ATP product development candidates for neurodevelopmental indications. These candidates include KV-102, our proprietary intranasal formulation of suramin, as well as other new chemical entities that are more targeted and selective antagonists of particular purine receptor subtypes. We believe our lead drug candidate (suramin), if approved by the FDA, may be a significant advancement in the treatment of ASD.
In July 2023, we announced positive topline results from the KV-101 (intravenous suramin) Phase 3 African Sleeping Sickness Study, PAX-HAT-301. The conclusions of the study confirmed that the retrospective, non-randomized, externally controlled, interventional efficacy and safety study of suramin for the treatment of Stage 1 TBR HAT demonstrated better health outcomes when compared with a natural history control group of patients evaluated and treated from 1900-1910, prior to the availability of suramin in Africa. The adverse event profile of suramin observed in the study was consistent with what has been widely reported in published medical and clinical literature.
On October 26, 2023, we completed a type-B meeting with the FDA, where we discussed the results of our recent data from our PAX-HAT-301 study of suramin in HAT. We received constructive feedback that will aid in the completion of the remaining work necessary to file a NDA for that indication, which is expected to take place in second half of 2026.
| 17 |
On June 27th, 2024, we completed a type-C meeting with the FDA, where we discussed our Chemistry, Manufacturing, and Controls (“CMC”) regulatory guidelines for our KV-101 candidate. We received constructive feedback which will aid in the completion of our remaining work to file a NDA expected in the second half of 2026 or in the second quarter of 2026. Most of the work to achieve this important milestone will focus on completing the production of commercial lots of KV-101 under CMC regulatory guidelines, underway now and scheduled to conclude in early 2026. Additionally, we discussed the implementation and completion of a registry for patients treated with KV-101 for the indication of HAT to be submitted along with the NDA.
On September 4th, 2024, we completed a type-C meeting with the FDA, where we discussed our disease registry study for KV-101 in Malawi. We received constructive feedback on the design of the registry that will address the FDA concerns about heterogeneity in the patient population in Malawi.
We have not generated any revenue to date and through September 30, 2024, we had an accumulated deficit of approximately $59.6 million. To date, we have financed our operations through capital contributions from our prior members when we were a limited liability company, proceeds from our initial public offering, the issuance of convertible notes, our entry into a Simple Agreement for Future Equity (“SAFE”) with an investor, the issuance of Series X preferred stock, par value $0.0001 per share (“Series X preferred stock”), the sale of shares of common stock to LPC (as defined herein) pursuant to the Purchase Agreement, our secondary public offering in November 2023, and a warrant inducement in September 2024, which is described in Note 7 to the financial statements attached hereto. We expect our expenses to increase significantly in connection with our ongoing activities to develop, seek regulatory approval and commercialization of KV-101 and our other product candidates. Furthermore, we expect to incur additional costs associated with operating as a public company. Accordingly, we will likely need substantial additional financing to support our continuing operations. We will seek to fund our operations through public or private equity or debt financings or other sources. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenues to achieve profitability, and we may never do so. Accordingly, there are material risks and uncertainties that raise substantial doubt about our ability to continue as a going concern.
Financial Operations Overview
Revenue
To date, we have not generated any product revenue. Our ability to generate product revenue will depend on the successful development and eventual commercialization of our current, and any potential future, product candidates.
Research and Development Expenses
Research and development expenses consist of costs incurred for the development of KV-101 and our other product candidates, which include:
| ● | the cost of acquiring, developing and manufacturing pre-clinical trial materials; | |
| ● | costs for consultants and contractors associated with developing our product candidates in accordance with CMC guidelines, pre-clinical and clinical activities and regulatory operations; | |
| ● | expenses incurred under agreements with contract research organizations, or CROs, that conduct our pre-clinical studies and clinical trials; and | |
| ● | employee-related expenses, including salaries for those employees involved in the research and development process. |
Research and development costs are expensed as incurred. Costs for certain activities, such as preclinical studies and clinical trials, are generally recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and collaborators.
| 18 |
General and Administrative Expense
Our general and administrative expenses include costs associated with our executive, accounting, information technology and human resources functions. These expenses consist principally of payroll, employee benefits, travel, stock-based compensation and professional services fees such as consulting, audit, tax and legal fees, and general corporate costs. We expense all general and administrative expenses as incurred.
We expect our general and administrative expenses to increase primarily as a result of costs related to us operating as a public company, such as additional legal, accounting, corporate governance, and investor relations expenses, and directors’ and officers’ insurance premiums.
Results of Operations
Comparison of the Three Months Ended September 30, 2024 to the Three Months Ended September 30, 2023
| Three months ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses | ||||||||
| General and administrative | $ | 771,005 | $ | 2,425,849 | ||||
| Research and development | 116,933 | 1,938,672 | ||||||
| Total operating expenses | 887,937 | 4,364,521 | ||||||
| Loss from operations | (887,937 | ) | (4,364,521 | ) | ||||
| Other income (expense), net | 11,295 | (684,697 | ) | |||||
| Net loss | $ | (876,642 | ) | $ | (5,049,218 | ) | ||
Operating expenses
General and administrative
General and administrative expenses were approximately $0.7 million and $2.4 million for the three months ended September 30, 2024 and 2023, respectively. The decrease in general and administrative expenses was primarily due to a decrease in stock compensation of approximately $1.1 million, decrease in salary and benefits of approximately $0.2 million, and a decrease in professional fees of approximately $0.4 million.
Research and Development
Research and development expenses were approximately $0.1 million for the three months ended September 30, 2024 and approximately $1.9 million for the three months ended September 30, 2023. The $1.8 million decrease in research and development expenses was primarily attributable to completion of work with our development activities, including CMC and clinical work.
Of the $0.1 million in research and development expenses incurred during the three months ended September 30, 2024, approximately $0.1 million was associated with activities related to the HAT indication, and less than $0.1 million was associated with activities related to the ASD indication. These activities included, but were not limited to, payments in connection with the recently completed CMC processes and preclinical work.
Of the approximately $1.9 million in research and development expenses incurred during the three months ended September 30, 2023, approximately $1.2 million was associated with activities related to the HAT indication, and approximately $0.7 million was associated with activities related to the ASD indication. These activities included, but were not limited to, payments in connection with the recently completed CMC processes and preclinical work.
The estimated remaining aggregate costs expected to be incurred for the research and development and regulatory filing activities relating to the filing of an NDA for HAT is approximately $2.6 million.
Other Income (expense)
Other income (expense) was less than $0.1 million for the three months ended September 30, 2024, compared with other income (expense) of $(0.7) million for the three months ended September 30, 2023. The decrease in expense was primarily attributable to a reduction on the loss on debt of approximately $0.4 million and the valuation of the 2023 notes of approximately $0.3 million.
| 19 |
Comparison of the Nine months Ended September 30, 2024 to the Nine months Ended September 30, 2023
| Nine months ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses | ||||||||
| General and administrative | $ | 5,557,381 | $ | 8,960,254 | ||||
| Research and development | 2,019,226 | 2,750,192 | ||||||
| Total operating expenses | 7,576,607 | 11,710,446 | ||||||
| Loss from operations | (7,576,607 | ) | (11,710,446 | ) | ||||
| Other income (expense), net | 9,001 | (658,806 | ) | |||||
| Net loss | $ | (7,567,606 | ) | $ | (12,369,252 | ) | ||
Operating expenses
General and administrative
General and administrative expenses were approximately $5.6 million and $9.0 million for the nine months ended September 30, 2024 and 2023, respectively. There was a decrease in general and administrative expenses was primarily due to a decrease in stock compensation of approximately $3.0 million and a decrease in legal and professional fees, and a decrease salaries and benefits of approximately $0.4 million.
Research and Development
Research and development expenses were approximately $2.0 million for the nine months ended September 30, 2024 and approximately $2.8 million for the nine months ended September 30, 2023. The $0.8 million decrease in research and development expenses was primarily attributable to the completion of work in connection with our development activities, including CMC.
Of the $2.0 million in research and development expenses incurred during the nine months ended September 30, 2024, approximately $1.3 million was associated with activities related to the HAT indication, and approximately $0.7 million was associated with activities related to the ASD indication. These activities included, but were not limited to, payments in connection with the recently completed CMC processes and preclinical work.
Of the approximately $2.8 million in research and development expenses incurred during the nine months ended September 30, 2023, approximately $1.8 million was associated with activities related to the HAT indication, and approximately $1.0 million was associated with activities related to the ASD indication. These activities included, but were not limited to, payments in connection with the recently completed CMC processes and preclinical work.
The estimated remaining aggregate costs expected to be incurred for the research and development and regulatory filing activities relating to the filing of an NDA for HAT is approximately $2.3 million.
Other Income (expense)
Other income (expense) was less than $0.1 million for the nine months ended September 30, 2024, compared with other income (expense) of $(0.7) million for the nine months ended September 30, 2023. The decrease in expense was primarily attributable to a reduction on the loss on debt of approximately $0.4 million, the valuation of the 2023 notes of approximately $0.1 million, and the reduction of other expenses of approximately $0.1 million.
Liquidity and Capital Resources
We were formed as a Delaware limited liability company on April 5, 2018 and converted into a Delaware corporation on April 15, 2020. As of September 30, 2024, we had an accumulated deficit since inception of approximately $59.6 million. Since inception, we have not generated revenue from product sales and have incurred net losses and negative cash flows from our operations. From inception through September 30, 2024, we have funded our operations in large part through contributions from an affiliated company, TardiMed Sciences, LLC (“TardiMed”), the issuance of senior secured convertible promissory notes totaling approximately $7.0 million, proceeds from the initial public common stock offering, net of fees, of approximately $6.0 million, our SAFE for $5.0 million, the issuance of shares of our common stock in connection with our Purchase Agreement (as defined herein) of $5.6 million, the proceeds from our secondary public offering, net of fees, of approximately $6.1 million, and the proceeds from a warrant inducement we completed in September 2024, of approximately $0.8 million, net of fees.
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Given our projected operating requirements and existing cash, there is substantial doubt about our ability to continue as a going concern through one year following the date that the condensed financial statements herein are issued (see Note 1).
Equity Purchase Agreement with Lincoln Park Capital
On November 17, 2022, the Company entered into the Purchase Agreement with 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 approximately 0.2 million shares of common stock. As a result of our suspension from trading on the Nasdaq Capital Market, we were no longer permitted to sell shares of the Company’s common stock under the Purchase Agreement. The Purchase Agreement has lapsed as the Maturity Date was reached on June 1, 2025.
Convertible Notes
In February 2023, the 2023 Note with a principal balance of $3.7 million was issued to Lind Global Fund II LP. In connection with the issuance, the Company received proceeds of approximately $3.2 million, net of a $0.5 million discount, incurred fees of approximately $0.5 million and used $0.2 million of proceeds to pay down the remaining balance of already outstanding secured convertible promissory notes.
On November 29, 2023, the Company satisfied in full its obligations under this note.
Vox Nova Exclusive Pharmacy Distribution Agreement
On June 30, 2023, the Company entered into an exclusive specialty benefit manager agreement with Vox Nova, Vox Nova pursuant to which Vox Nova will act as the exclusive United States distributor for the Company’s lead pipeline asset, KV-101 intravenous suramin. Vox Nova will provide 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 provides 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 period after KV-101 is approved by the FDA and made available for distribution.
Secondary Public Offering
On November 20, 2023, the Company entered into an underwriting agreement relating to the secondary public offering of its common stock, par value $0.0001 per share. 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, under the Securities Act of 1933, 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 its public offering the Company issued 5,384,615 warrants to purchase shares of the Company’s common stock with an exercise price of $1.30 per share and issued 215,385 warrants to purchase shares of the Company’s 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 is 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. In November 2023, the Company entered into the secondary public offering described herein in which shares of its common stock were sold at $1.30 per share. As the price of the common stock sold as part of the public offering was below the exercise and conversion price of the 2023 Note and Warrant, the terms of the conversion and exercise price were reset to $1.30, as further described below.
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Warrant Inducement and Issuance
On September 3, 2024, the Company entered into warrant inducement offers with the holders of approximately 4.4 million existing warrants of the Company. The inducement offers provided for the reduction of the exercise price of the warrants from $1.30 to $0.20. The holders immediately exercised those warrants for proceeds of approximately $0.8 million, net of fees. In conjunction with the financing the Company also issued 176,923 warrants, with an exercise price of $0.25, to the underwriter. During the three and nine months ended September 30, 2024, the Company issued 3,099,310 shares of common stock as a result of the warrant exercise.
Pursuant to the terms of the warrant inducement offers, in the event that the exercise of the existing warrants would cause a holder to exceed the beneficial ownership limitations included therein, the Company would issue the number of shares of common stock that would not cause a holder to exceed such beneficial ownership limitations and hold the remaining balance of shares of common stock in abeyance. Accordingly, as of September 30, 2024, the Company held an aggregate of 1,323,770 Abeyance Shares. The Abeyance Shares are evidenced through the holder’s existing warrants, which are deemed to be prepaid. The Abeyance Shares will be held by the Company until the holder sends notice that the remaining balance of shares of common stock may be issued without surpassing the beneficial ownership limitations. Until such time, the Abeyance Shares are evidenced through the holder’s existing warrants and are included in the Company’s outstanding warrants. In October 2024, another 433,000 shares of common stock were issued from the Abeyance Shares.
Operating activities
During the nine months ended September 30, 2024, net cash used in operating activities was $5.0 million, which primarily included our net loss of approximately $7.6 million, adjusted for non-cash stock-based compensation expense of approximately $1.5 million. The net change in operating assets and liabilities was approximately $1.1 million, and was primarily due to decreases in prepaid expenses and other current assets of $0.6 million as well as increases in accounts payable of approximately $1.3 million, partially offset by a decrease in accrued expenses of approximately $0.9 million.
During the nine months ended September 30, 2023, net cash used in operating activities was $8.2 million, which primarily included our net loss of approximately $12.4 million, adjusted for non-cash expenses of approximately $5.6 million including stock-based compensation of approximately $4.5 million and $0.5 million in deferred revenue related to the Vox Nova agreement, offset by the change in fair value of our convertible notes of $0.1 million and the loss on the extinguishment of debt of approximately $0.4 million. The net change in operating assets and liabilities was approximately $1.4 million and was primarily due to decreases in accounts payable and accrued expenses of $1.0 million, and decreases in prepaid and other current assets of $0.5 million.
Investing Activities
There were no investing activities during the nine months ended September 30, 2024 and 2023.
Financing activities
During the nine months ended September 30, 2024, net cash provided by financing activities was approximately $0.7 million, consisting of net proceeds of approximately $0.8 million our September 2024 warrant inducement, offset by cash used for by financing activities of less than $0.1 million for the settlement of shares withheld for payment of employee taxes on vested Restricted Stock Units.
During the nine months ended September 30, 2023, net cash used in operating activities was $8.2 million, which primarily included our net loss of approximately $12.4 million, adjusted for non-cash expenses of approximately $5.6 million including stock-based compensation of approximately $4.5 million, $0.1 million of other expense and $0.5 million in deferred revenue related to the Vox Nova distribution agreement, change in fair value of our convertible notes of $0.1 million, and loss on extinguishment of debt of $0.4 million. The net change in operating assets and liabilities was approximately $1.4 million and was primarily due to decreases in accounts payable and accrued expenses of $1.0 million and decreases in prepaid and other current assets of $0.5 million.
Funding requirements
As of September 30, 2024, we had a cash balance of approximately $0.4 million. Our financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
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We anticipate incurring additional losses for the foreseeable future and may never become profitable. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of product candidates. Furthermore, we expect to continue to incur additional costs as a public company. Accordingly, we will likely need to obtain substantial additional funding. If we are unable to raise capital or otherwise obtain funding when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts. These factors raise substantial doubt about our ability to continue as a going concern. The Company’s future liquidity and capital funding requirements will depend on numerous factors, including:
| ● | the outcome, costs and timing of clinical trial results for the Company’s current or future product candidates; | |
| ● | the emergence and effect of competing or complementary products; | |
| ● | its ability to maintain, expand and defend the scope of its intellectual property portfolio, including the amount and timing of any payments the Company may be required to make, or that it may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; and | |
| ● | its ability to retain its current employees and the need and ability to hire additional management and scientific and medical personnel. |
We will seek to obtain additional capital through the sale of debt or equity financings or other arrangements such as collaborations, strategic alliances and licensing arrangements to fund operations; however, there can be no assurance that we will be able to raise needed capital under acceptable terms, if at all. The sale of additional equity or equity-linked securities may dilute existing stockholders and may contain senior rights and preferences compared to currently outstanding shares of common and preferred stock. Debt securities issued or other debt financing incurred may contain covenants and limit our ability to pay dividends or make other distributions to stockholders. If we are unable to obtain such additional financing, future operations would need to be scaled back or discontinued.
Contractual obligations and commitments
During the next twelve months we have commitments to pay $2.3 million to settle our September 30, 2024 accounts payable, accrued expenses, and other current liabilities.
After the next twelve months, we have a commitment of $0.5 million to provide Vox Nova with exclusive pharmacy distribution rights over KV-101 for up to seven years once approved by the FDA.
Off-balance sheet arrangements
We do not have any relationships with unconsolidated entities or financial partnerships, including entities sometimes referred to as structured finance or special purpose entities that were established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. We do not engage in off-balance sheet financing arrangements. In addition, we do not engage in trading activities involving non-exchange traded contracts. We therefore believe that we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships.
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Critical Accounting Estimates
We prepare our consolidated financial statements in accordance with GAAP, which require our management to make estimates that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the balance sheet dates, as well as the reported amounts of revenues and expenses during the reporting periods. To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations would be affected. We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectations for the future based on available information. We evaluate these estimates on an ongoing basis.
We consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations. There are items within our financial statements that require estimation but are not deemed critical, as defined above.
Recent accounting pronouncements
See Note 2 to our financial statements included in this Quarterly Report for a description of recent accounting pronouncements applicable to our financial statements.
Emerging Growth Company Status
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act (“JOBS Act”), and we may remain an emerging growth company for up to five years following the completion of our initial public offering. For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved and an exemption from compliance with the requirements regarding the communication of critical audit matters in the auditor’s report on financial statements.
Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, we will not be subject to the same new or revised accounting standards as public companies that are not emerging growth companies. As a result of this election, our financial statements may not be comparable to those of companies that are not emerging growth companies.
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.
| Item 4. | Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
With the participation of our principal executive officer and principal financial officer, our management conducted an evaluation of the effectiveness of our disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of the end of the fiscal quarter ended September 30, 2024. Based on this evaluation, our principal executive officer and principal financial officer concluded that during the period covered by this report, our disclosure controls and procedures were not effective as of September 30, 2024 because of a material weakness in our internal control over accounting for complex financial instruments. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected and corrected on a timely basis. Specifically, the Company’s management has concluded that our control around the interpretation and accounting for certain complex features of financial instruments was not effectively designed or maintained. As a result, our management performed additional analysis as deemed necessary to ensure that our financial statements were prepared in accordance with U.S. GAAP. Accordingly, management believes that the financial statements included in this Quarterly Report present fairly, in all material respects, our financial position, result of operations and cash flows of the periods presented. Management understands that the accounting standards applicable to our financial statements are complex and has since the inception of the Company benefited from the support of experienced third-party professionals with whom management has regularly consulted with respect to accounting issues. Management intends to continue to further consult with such professionals in connection with accounting matters.
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Material Weaknesses in Internal Controls over Financial Reporting
In the course of preparing our financial statements for the year ended December 31, 2023, we identified material weaknesses in our internal control over financial reporting relating to the evaluation of complex financial instruments, including earnings per share. The material weaknesses have not been remediated as of September 30, 2024. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis. Our management has concluded that we have not designed, let alone maintained, effective controls over information technology (IT) general controls for information systems that are relevant to the preparation of our financial statements, specifically, with respect to user provisioning and deprovisioning, user access review, passwords, privileged access, cybersecurity, system development lifecycle, and SOC report management review. These IT deficiencies did not result in a misstatement to our financial statements, however, the deficiencies, when aggregated, could impact the effectiveness of IT-dependent controls that could result in misstatements potentially impacting all financial statement accounts and disclosures that would not be prevented or detected. Accordingly, management has determined that these deficiencies in the aggregate constitute a material deficiency. To remediate the above material weaknesses, we have developed a remediation plan with assistance from our IT advisors and have dedicated significant resources and efforts to the remediation and improvement of our internal control.
In addition, we do not have sufficient segregation of duties within our accounting functions, which is a basic internal control. Due to our size, segregation of all duties may not always be possible and may not be economically feasible. However, to the extent possible, the initiation of transactions, the custody of assets, and the recording of transactions should be performed by separate individuals. Our management has weighed the impact of our failure to have a proper segregation of duties on our assessment of our disclosure controls and procedures and has concluded that the resulting control deficiency represented a material weakness. While our management has implemented procedures to ensure that the financial statements balances included herein fairly present, in all material respects, our financial position, results of operations and cash flows for the periods presented, we have not yet hired a sufficient number of additional accounting and finance staff to fully address this material weakness. Until such time as we have hired adequate staff, this material weakness will not be remediated.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting that occurred during the fiscal quarter ended September 30, 2024 covered by this Quarterly Report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II-OTHER INFORMATION
| Item 1. | Legal Proceedings |
From time to time, the Company may become involved in lawsuits and other legal proceedings that arise in the course of business. Litigation is subject to inherent uncertainties, and it is not possible to predict the outcome of litigation with total confidence. The Company is currently not aware of any legal proceedings or potential claims against it whose outcome would be likely, individually or in the aggregate, to have a material adverse effect on the Company’s business, financial condition, operating results, or cash flows.
| Item 1A. | Risk Factors |
Under current SEC rules, as a smaller reporting company, we are not required to provide risk factor disclosure in this Quarterly Report or in any of our periodic reports until such time as we no longer qualify as a smaller reporting company. However, we included a comprehensive set of risk factors in our most recent Annual Report, which can be accessed here. These risk factors remain applicable to our business and operations.
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds. |
None.
| Item 3. | Defaults upon Senior Securities. |
None.
| Item 4. | Mine Safety Disclosures. |
Not applicable.
| Item 5. | Other Information. |
Insider Trading Arrangements
Prior to May 1, 2024, all of our officers, as defined in Rule 16a-1(f) under the Exchange Act, and our directors had engaged in a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Item 408 of Regulation S-K. When our common stock was suspended from trading on the Nasdaq Capital Market beginning on May 2, 2024, our transfer agent terminated each of these arrangements. At this time, there is no viable public market for our common stock and for this reason there is no practical concern that any of our remaining insiders will be able to trade on the basis of material non-public information.
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| Item 6. | Exhibits. |
| Exhibit Number |
Description | |
| 4.1 | Form of Common Stock Purchase Warrant (incorporated by reference from the Current Report on Form 8-K filed on September 6, 2024) | |
| 10.1 | Form of Letter Agreement re Inducement Offer to Exercise Common Stock Purchase Warrants (incorporated by reference from the Current Report on Form 8-K filed on September 6, 2024) | |
| 31.1* | Certification of Chief Executive Officer (Principal Executive Officer) Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| 31.2* | Certification of Chief Financial Officer (Principal Financial and Accounting Officer) Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| 32.1* | Certification of Chief Executive Officer (Principal Executive Officer) Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
| 32.2* | Certification of Chief Financial Officer (Principal Financial and Accounting Officer) Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
| 101.INS | Inline XBRL Instance Document | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| 104 | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) |
| * | These certifications are furnished to the SEC pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing. |
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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.
| Dated: January 14, 2026 | PAXMEDICA, INC. | |
| By: | /s/ Howard J. Weisman | |
| Name: | Howard J. Weisman | |
| Title: | Chairman of the Board and Chief Executive Officer (Principal Executive Officer) | |
| Dated: January 14, 2026 | ||
| By: | /s/ Howard J. Weisman | |
| Name: | Howard J. Weisman | |
| Title: | Chief Financial Officer and Chief Operating Officer (Principal Financial and Accounting Officer) | |
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FAQ
What is Kuvatris Therapeutics, Inc. (PXMD) reporting for the quarter ended September 30, 2024?
Kuvatris Therapeutics reports a quarterly net loss of $876,642, down from $5,049,218 a year earlier. For the nine months ended September 30, 2024, the net loss was $7,567,606 versus $12,369,252 in the prior-year period, mainly due to lower general and administrative and research and development expenses.
What is Kuvatris Therapeutics’ cash position and balance sheet health as of September 30, 2024?
As of September 30, 2024, Kuvatris held $444,855 in cash and total assets of $820,380. Total liabilities were $2,751,950, resulting in a stockholders’ deficit of $(1,931,570). The company states there is substantial doubt about its ability to continue as a going concern.
How did operating expenses change for Kuvatris Therapeutics compared with the prior year?
For the three months ended September 30, 2024, general and administrative expenses were $771,005, down from $2,425,849, largely from lower stock-based compensation, salaries and professional fees. Research and development expenses fell to $116,933 from $1,938,672, reflecting completion of certain CMC and clinical activities.
What major financing and capital structure events does the PXMD 10-Q describe?
The filing highlights a September 2024 warrant inducement, where about 4.4 million warrants had their exercise price cut from $1.30 to $0.20, yielding roughly $0.8 million in proceeds and 3,099,310 new common shares. It also notes prior financings, including a November 2023 secondary public offering that raised about $6.1 million net and the full repayment of a $3.7 million convertible note issued in 2023.
What change-in-control and going-private steps involving Pax Rescue Vehicle, LLC are disclosed?
On February 28, 2025, the company agreed to sell, and on the Issuance Date issued, 114,754,700 common shares to Pax Rescue Vehicle, LLC for $10,000 plus legal fees. This represented over 90% of authorized voting securities and constituted a change in control. The transaction was undertaken to facilitate a going-private strategy instead of a Chapter 7 liquidation, given the company’s zone of insolvency and near-zero market capitalization.
What actions did Kuvatris take regarding its public listing and common shares after the change in control?
The filing states that the company’s common stock was suspended from Nasdaq in May 2024 and has traded on the OTC Expert Market since. In May and June 2025, the company declared DTC‑held common shares null, void and worthless and instructed its transfer agent to cancel those shares. On June 13, 2025, it filed a Form 15-12G, terminating registration under Section 12(g) and suspending its reporting obligations.
What litigation and related-party information is included in the PXMD 10-Q?
The company notes that in January 2025 a complaint was filed in the U.S. District Court for the Northern District of Ohio against Kuvatris and its Chief Executive Officer involving claims by former business partners tied to a prior distribution agreement and equity investments. Kuvatris states it believes the claims are without merit, intends to vigorously defend, and does not currently believe the ultimate resolution will have a material adverse effect. The filing also details historical consulting and rental arrangements with TardiMed Sciences, LLC, which were terminated in August 2024.
