PaxMedica Provides Company Update and Continues to Advance PAX-101 Regulatory Strategy

TARRYTOWN, New York, May 07, 2024 (GLOBE NEWSWIRE) — via IBN — PaxMedica, Inc. (OTC:PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, provided a corporate update in light of its transition off the NASDAQ stock market, emphasizing this change will not affect the company’s commitment to advancing treatments for neurological disorders.

Howard Weisman, CEO of PaxMedica, affirmed, “Our determination to progress with the NDA submission for PAX-101 remains unaffected, as does our commitment to our clinical program to further explore the potential for  anti-purinergic therapies to address the core symptoms of autism spectrum disorder (ASD).”

The company is preparing to file a New Drug Application (NDA) with the FDA for the use of suramin in treating Human African Trypanosomiasis (HAT) as it has previously reported. Suramin has been recognized for nearly a century as a standard treatment for HAT in East Africa.

In April 2024, PaxMedica responded to an urgent request from Malawi for an emergency release of suramin, underscoring the company’s commitment to addressing global health crises.

“We are not just continuing; we are intensifying our efforts to achieve significant milestones for these programs by the end of this year,” Weisman added. “We are on track to submit an NDA for PAX-101, and potentially secure an FDA Priority Review Voucher if approved.”

This proactive approach illustrates PaxMedica’s dedication to advancing healthcare solutions globally.

About PaxMedica

PaxMedica, Inc. is a forward-looking clinical-stage biopharmaceutical firm specializing in cutting-edge anti-purinergic drug therapies (APT) aimed at addressing a range of challenging neurologic disorders. Our comprehensive portfolio encompasses a spectrum of conditions, including neurodevelopmental disorders such as Autism Spectrum Disorder (ASD), as well as other critical areas within the neurology field. Additionally, we intend to provide the rest of the world with an additional, reliable source of suramin, the accepted standard of care for Stage 1, Trypanosoma Brucei Rhodesiense.

We are dedicated to the continuous development and evaluation of our pioneering program, PAX-101, an intravenous suramin formulation that lies at the heart of our efforts, particularly focused on innovative ASD treatment solutions. Our ongoing research initiatives not only prioritize the needs of ASD patients, but also extend to exploring potential therapeutic applications for related conditions. To learn more about our transformative work, please visit www.paxmedica.com.

Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at https://www.paxmedica.com/email-alerts and by following PaxMedica on Twitter and LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking statements.” Forward-looking statements reflect our current view about future events. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “could,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “propose,” “potential,” “continue” or similar expressions. These forward-looking statements include our anticipated clinical program, the timing and success of our anticipated data announcements, pre-clinical and clinical trials and regulatory filings, and distribution and demand for our product candidates. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Such risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of the Company’s product development and clinical trials, risk of insufficient capital resources, cash funding and cash burn, regulatory approvals and risks associated with intellectual property and infringement claims. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results described in the Company’s “Risk Factors” section and other sections in its most recent Annual Report on Form 10-K, and subsequent quarterly and other filings with the U.S. Securities and Exchange Commission.

Contacts

PaxMedica, Inc.
 303 S Broadway,
 Suite 125.
 Tarrytown, NY 10591
 www.paxmedica.com

Media Contact
 media@paxmedica.com

Investor Contact
 Scott McGowan
 InvestorBrandNetwork (IBN)
 Phone: 310.299.1717
 ir@paxmedica.com
 www.paxmedica.com/investors

SOURCE: PaxMedica, Inc.