PaxMedica(US:PXMD)2024-05-13 20:46Financial Performance - Paxmedica, Inc. reported an accumulated deficit of approximately $55.7 million as of March 31, 2024, with no revenue generated to date[99]. - Total operating expenses for the three months ended March 31, 2024, were approximately $3.69 million, a decrease from $4.04 million in the same period of 2023[104]. - General and administrative expenses decreased to approximately $3.30 million for the three months ended March 31, 2024, from $3.81 million in 2023, mainly due to reduced stock compensation[105]. - During the three months ended March 31, 2024, net cash used in operating activities was $3.1 million, primarily due to a net loss of approximately $3.7 million[116]. - The Company anticipates incurring additional losses for the foreseeable future and may never become profitable, necessitating substantial additional funding[122]. Research and Development - Research and development expenses increased to approximately $0.39 million for the three months ended March 31, 2024, compared to $0.22 million for the same period in 2023, primarily due to costs associated with clinical trials[106]. - The estimated remaining aggregate costs for research and development and regulatory filing activities related to the NDA for HAT are approximately $3.2 million[109]. - The company is developing PAX-101, an intravenous formulation of suramin, for treating ASD and plans to submit data for a New Drug Application under the Tropical Disease Priority Voucher Program[95]. - Research and development expenses consist primarily of salaries, benefits, and costs related to clinical studies, with significant reliance on third-party contractors[137]. Funding and Liquidity - The Company has financed operations through various means, including approximately $6.0 million from public common stock offerings and $7.0 million from senior secured convertible promissory notes[111]. - As of March 31, 2024, the Company had a cash balance of approximately $1.6 million, indicating ongoing liquidity challenges[121]. - The Company issued the 2023 Note in February 2023 with a principal balance of $3.7 million, receiving proceeds of approximately $3.2 million after a $0.5 million discount[113]. - During the three months ended March 31, 2023, net cash provided by financing activities was approximately $5.1 million, primarily from the issuance of convertible notes and common stock[120]. - The Company satisfied its obligations under a secured convertible promissory note with a final cash payment of $0.2 million, terminating all payment obligations[114]. Regulatory and Strategic Developments - Paxmedica, Inc. completed a type-B meeting with the FDA on October 26, 2023, discussing the PAX-HAT-301 study results and received constructive feedback for the NDA filing expected in the second half of 2024[98]. - The Company entered into an exclusive distribution agreement with Vox Nova for PAX-101, which includes an upfront exclusivity fee of $0.5 million and potential additional payments of up to $2.0 million[115]. - No shares of common stock were issued under the equity purchase agreement with Lincoln Park Capital during the three months ended March 31, 2024, due to suspension from trading on the Nasdaq Capital Market[112]. - The Company has no outstanding contractual obligations or commitments as of March 31, 2024[125]. - The Company does not engage in off-balance sheet financing arrangements, minimizing exposure to financing, liquidity, market, or credit risk[126].