- PaxMedica’s total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $7 million
- The company intends to use the proceeds to pay an outstanding promissory note, advance development programs, and general corporate purposes
- PaxMedica received constructive feedback from its type-B meeting with the FDA, which will aid in completing the remaining paperwork necessary to file a New Drug Application
- The company is currently working on commercial lots of PAX-101, which are expected during the first half of 2024, for the New Drug Application, which is expected to be filed during the second half of 2024
PaxMedica (NASDAQ: PXMD), a clinical-stage biopharmaceutical company focused on the development of novel anti-purinergic therapies (“APTs”) for the treatment of Autism Spectrum Disorder (“ASD”) and other serious conditions with intractable neurologic symptoms, recently reported the closing of its public offering. PaxMedica’s total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $7 million. H.C. Wainwright & Co. acted as the exclusive placement agent for the offering (https://ibn.fm/XEIiL).
The previously announced public offering is an aggregate of 5,384,615 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to 5,384,615 shares of common stock at a public offering price of $1.30 per share and accompanying warrant. The warrants have an exercise price of $1.30 per share and are exercisable immediately upon issuance – with an expiration of five years from the initial exercise date.
The company intends to use the net proceeds from this offering to repay an outstanding $0.2 million convertible promissory note held by Lind Global Fund II LP to advance PaxMedica’s development programs and for general corporate purposes.
Part of PaxMedica’s pipeline includes using suramin sodium in Stage One Human African Sleeping Sickness, which will help further the company’s efforts to develop therapies for ASD and other neurological symptoms. PaxMedica recently completed a type-B meeting with the FDA regarding the positive data results from its PAX-HAT-301 study.
The PAX-HAT-301 study is a retrospective, non-randomized, externally controlled, interventional efficacy and safety study comparing medical records data from a cohort of patients with Stage 1 Trypanosoma Brucei Rhodesiense (African Sleeping Sickness). These patients were treated from about 2000 to 2020 at a medical site in Uganda and two medical sites in Malawi. Medical records data from a cohort of patients from 1900 to 1910 from the TBR HAT epidemic in Uganda were also evaluated. The study aimed to determine if the treatments with suramin sodium from 2000 to 2020 were more effective at treating the disease than the outcomes observed in the epidemic over 100 years ago.
PaxMedica received constructive feedback, which will aid in completing the remaining paperwork necessary to file a New Drug Application (“NDA”), expected in the second half of 2024. Most of the work to achieve this milestone will focus on completing the production of commercial lots of PAX-101 under CMC regulatory guidelines, which are underway now and expected to conclude in the first half of 2024.
“This is an important turning point for our young company, and we are very pleased with the guidance that the FDA has provided us in this meeting,” said Howard Weisman, CEO and Chairman of PaxMedica (https://ibn.fm/CjaxD). “We look forward to urgently completing the necessary steps in the coming months to clear the path to submit our first NDA for PAX-101.”
For more information, visit the company’s website at www.PaxMedica.com.
NOTE TO INVESTORS: The latest news and updates relating to PXMD are available in the company’s newsroom at https://ibn.fm/PXMD