Financial Performance - Kuvatris Therapeutics, Inc. reported a net loss of approximately $876,642 for the three months ended September 30, 2024, compared to a net loss of $5,049,218 for the same period in 2023, indicating a significant reduction in losses [128]. - Total operating expenses for the three months ended September 30, 2024, were approximately $887,937, down from $4,364,521 in the same period of 2023, reflecting a decrease of about 80.7% [128]. - General and administrative expenses for the nine months ended September 30, 2024, were approximately $5.6 million, down from $9.0 million in 2023, a decrease of about 37% [136]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $5.0 million, compared to $8.2 million for the same period in 2023 [152][153]. - The company reported an accumulated deficit of approximately $59.6 million since inception, with no revenue generated from product sales [142]. Research and Development - Research and development expenses decreased to approximately $116,933 for the three months ended September 30, 2024, from $1,938,672 in 2023, a reduction of approximately 93% [130]. - Research and development expenses for the nine months ended September 30, 2023, totaled approximately $2.8 million, with $1.8 million related to HAT and $1.0 million to ASD [139]. - The estimated remaining aggregate costs for research and development and regulatory filing activities related to the NDA for Human African Trypanosomiasis (HAT) are approximately $2.6 million [133]. - Estimated remaining costs for the NDA filing for HAT are approximately $2.3 million [140]. - The company is pursuing the development of next-generation ATP product candidates, including KV-102, an intranasal formulation of suramin [116]. Future Outlook and Funding - The company expects to incur significant additional costs associated with the development and commercialization of KV-101 and other product candidates [122]. - The company anticipates incurring additional losses and may never become profitable, indicating a need for substantial additional funding [158]. - As of September 30, 2024, the company had a cash balance of approximately $0.4 million, raising substantial doubt about its ability to continue as a going concern [157]. - The company has commitments to pay $2.3 million for accounts payable and accrued expenses over the next twelve months [160]. Regulatory and Market Activities - A type-B meeting with the FDA was completed on October 26, 2023, discussing the PAX-HAT-301 study results, with NDA filing expected in the second half of 2026 [118]. - An exclusive distribution agreement with Vox Nova for KV-101 includes an upfront exclusivity fee of $0.5 million and potential additional payments of up to $2.0 million upon FDA approval [147]. - The company entered into a secondary public offering on November 20, 2023, selling 5,384,615 shares at $1.30 per share, resulting in net proceeds of approximately $6.1 million [148]. Shareholder Information - The company issued approximately 3.1 million shares of common stock due to warrant exercises during the nine months ended September 30, 2024 [150]. - The company is classified as a smaller reporting company under Rule 12b-2 of the Exchange Act and is not obligated to provide the detailed disclosures typically required for market risk [168].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading Symbol(s) | Name of each exchange on which | | --- | --- | --- | | | | registered | | Comm ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41475 PAXMEDICA, INC. (Exact name of registrant as specified in its charter) Delaware 85-0870387 (State or other jurisdiction of inc ...

As filed with the U.S. Securities and Exchange Commission on November 16, 2023. Registration No. 333-275416 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 2834 85-0870387 303 South Broadway, Suite 125 Tarrytown, NY 10591 (914) 987-2876 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 PAXMEDICA, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorpora ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to PAXMEDICA, INC. (Exact name of registrant as specified in its charter) | Delaware | 001-41475 | 85-0870387 | | --- | --- | --- | | (State or oth ...

FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 PAXMEDICA, INC. As filed with the U.S. Securities and Exchange Commission on November 9, 2023. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classification Code Number) Identification No.) Delaware 2834 85-0870387 303 South Broadway, Suite 125 Tarrytown, NY 10591 (914) 987-2876 (Address, i ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 PAXMEDICA, INC. (Exact name of registrant as specified in its charter) Delaware 001-41475 85-0870387 (State or other jurisdiction of incorporation or organization) (Commission File Number) (IRS Employer Identification No.) 303 South Broadway, Suite 125 Tarrytown, NY 10591 (Address Of Principal Executive Offices) (Zip Cod ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to PAXMEDICA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 001-4 ...

FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 PAXMEDICA, INC. (Exact name of registrant as specified in its charter) As filed with the Securities and Exchange Commission on May 3, 2023. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 (State or Other Jurisdiction (Primary Standard Industrial (I.R.S. Employer of Incorporation or Organization) Classification Code Number) Identification No.) Delaware 2834 85-0870387 303 South Broadway, Suite 125 Tar ...

Table of Contents | UNITED STATES | | | --- | --- | | SECURITIES AND EXCHANGE COMMISSION | | | Washington, D.C. 20549 | | | FORM 10-K | | | ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | | For the year ended December 31, 2022 | | | OR | | | ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | | For the transition period from to | | | Commission File Number: 001-41475 | | | PAXMEDICA, INC. | | | (Exact name of registrant as ...