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PaxMedica anticipates multiple milestones in next 12-14 months
The Fly

PaxMedica anticipates multiple milestones in next 12-14 months

PaxMedica released a 2022 shareholder letter, which read in part, "2022 was an exciting year for PaxMedica. We reached several important milestones, and anticipate several others as we progress through 2023. PaxMedica’s most important objective is to initiate PAX-101 clinical trials for the treatment of Autism Spectrum Disorder in the U.S. To achieve that primary objective, we are following a well-thought-out strategic path, comprised of key goals that will help accelerate us towards our primary objective. The past year was highlighted by our transition to a public company, after our Initial Public Offering in August 2022. This was an important milestone that will increase our corporate visibility, broaden awareness of PaxMedica in the investment community, and provide trading liquidity for our common stock. Thanks to our IPO, we raised $6.8 million in new capital. We have continued to raise capital for future operations and in November the company executed an equity investment agreement with Lincoln Park Capital, which will potentially provide up to an additional $20 million in working capital, giving the company a cash runway into 2025 based on our current operating plan, assuming we utilize the entire capacity of the Lincoln Park Capital facility. An important part of our strategy is to pursue an FDA program that provides valuable incentives for achieving an initial NDA approval as an orphan designated drug. One of the most critical steps in this process is a Phase 3 trial for HAT-301, that we initiated in November. This trial, which uses existing retrospective data that PaxMedica has exclusively licensed from key hospitals in Malawi and Uganda, is expected to advance PAX-101 towards FDA submission for the treatment of Stage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis. This rare and fatal form of sleeping sickness has been the clinical target indication for suramin since it was first discovered in the early 1900s. We expect final results for the HAT-301 study in the second half of 2023. This is important because, if this trial is successful, we expect to seek accelerated approval for an NDA for PAX-101 as the first treatment for HATr approved under the U.S. Rare Tropical Disease Priority Review Voucher program. The Company expects to monetize a Priority Review Voucher, if received. We believe that this has the potential to be the fastest route to generate funding to complete a comprehensive clinical program for the use of PAX-101 for core symptoms of autism spectrum disorder and other neurodevelopmental conditions. We are in the process of establishing a commercial supply chain for PAX-101, which we expect to use for future regulatory filings, and future clinical needs…As you can see, PaxMedica made great strides in 2022 and we’re poised to achieve a number of additional milestones over the next 12-24 months. With a strong management team, a lean cost structure, ample flexible funding, and a clear path forward, we believe that PaxMedica is well-positioned to achieve its goals."

Published first on TheFly

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