Full Press Release Details
PaxMedica, Inc. Provides
Business Update and Reports Fourth Quarter 2022 Financial Results
-Phase 3 Results for
HAT-301 Retrospective Trial Expected in Second Half 2023-
Fourth Quarter 2022 Highlights
Tarrytown, N.Y. March 29, 2023 - PaxMedica, Inc.
(Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies ("APT")
for the treatment of disorders with intractable neurologic symptoms, today provided a business update and reported financial results for
the fourth quarter and year ended December 31, 2022.
Howard Weisman, Chief Executive Officer of PaxMedica,
commented, "The fourth quarter capped a strong year for PaxMedica. Most importantly, we initiated a pivotal Phase 3 HAT-301 trial
in November that is a retrospective, controlled analysis of suramin for the treatment of the rare and fatal tropical disease, Stage 1
Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis (Stage 1 TBR HAT). The final results are expected to be announced in the
second half of 2023."
"To support our work, we signed a committed
equity investment agreement for up to $20 million, also in November, and in February 2023, raised an additional $2.5 million in growth
capital. During the year ahead we also expect to complete any remaining necessary pre-clinical, non-clinical and clinical studies to support
our NDA submission for the HAT indication. All of this work is to advance us toward the achievement of our most important objective -
the submission of an IND to the FDA for a PAX-101 (suramin) clinical trial for the treatment of ASD in the U.S. which we intend to submit
in 2024," concluded Mr. Weisman.
For PaxMedica's complete financial results
for the twelve-month period ended December 31, 2022, see the Company's Annual Form 10-K filed with the Securities and Exchange Commission
PaxMedica is a clinical stage biopharmaceutical
company focusing on the development of anti-purinergic drug therapies ("APT") for the treatment of disorders with intractable
neurologic symptoms, ranging from neurodevelopmental disorders, including Autism Spectrum Disorder ("ASD"), to Myalgic Encephalomyelitis/Chronic
Fatigue Syndrome ("ME/CFS"), a debilitating physical and cognitive disorder believed to be viral in origin and now with rising
incidence globally due to the long term effects of SARS-CoV-2 ("COVID-19"). One of PaxMedica's primary points of focus
is the development and testing of its lead program, PAX-101, an intravenous formulation of suramin, in the treatment of ASD and the advancement
of the clinical understanding of using that agent against other disorders such as ME/CFS and Long COVID-19 Syndrome, a clinical diagnosis
in individuals who have been previously infected with COVID-19.
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, statements about the strength of our balance sheet. 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 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 Registration Statement, most recent quarterly filings and other filings with
the U.S. Securities and Exchange Commission.