PaxMedica, Inc. Provides First Quarter 2023 Business Update; Phase 3 HAT-301 Top Line Results Expected in Second Half 2023
May 15 2023 - 4:13PM
via NewMediaWire – 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 first
quarter 2023 ended March 31, 2023.
Howard Weisman, Chief Executive Officer of PaxMedica, commented,
“During the first quarter we’ve continued working hard to advance
the ongoing retrospective Phase 3 HAT-301 trial and we continue to
expect to announce top line results in the second half of 2023. The
study, if successful, is expected to lead to the submission of a
New Drug Application (NDA) for PAX-101 to treat the rare tropical
disease, HAT, an important milestone that we expect to trigger a
Priority Review Voucher (PRV) application, which, if granted, we
expect to monetize to advance our work. After our recent multi-day
meeting of our Scientific Advisory Board, which includes several
key opinion leaders on autism spectrum disorder (ASD), we have a
clear path for the next steps needed to test suramin in autism.
Together, these activities are bringing us closer to the expected
2024 filing of an Investigational New Drug Application (IND) with
the Food and Drug Administration (FDA) for a PAX-101 (suramin)
clinical trial for the treatment of ASD in the U.S.”
As of March 31, 2023, PaxMedica had $3.9 million in cash and
remaining access to $17.2 million from the Company’s committed
equity investment agreement for up to $20 million with Lincoln Park
Capital signed in November 2022. PaxMedica had 13,920,234 million
common shares issued and outstanding at March 31, 2023. Subsequent
to quarter end, the Company received proceeds of approximately $1.1
million from the issuance of approximately 0.6 million shares of
the Company’s common stock.
For PaxMedica’s complete financial results for the three-month
period ended March 31, 2023, see the Company’s Quarterly Form 10-Q
that will be filed with the Securities and Exchange Commission on
May 15, 2023.
About the Phase 3 HAT-301 Trial
Launched in November 2022, the Phase 3 HAT-301 trial is a
pivotal, 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 study has been underway at multiple primary HAT
treatment sites in Uganda and Malawi using exclusively licensed,
retrospective clinical data that will be reviewed and compared with
a natural history controlled dataset comprised of exclusively
licensed source data.
The primary objective of the study is to demonstrate that the
standard of care treatment using suramin, as currently practiced in
Uganda and Malawi, leads to better clinical outcomes in patients
with Stage 1 TBR HAT than observed in an untreated natural history
cohort, that had documented illness prior to availability of
suramin. The World Health Organization lists suramin, discovered in
1916, and found to be effective against Stage 1 HAT since at least
1920, as a standard of care for Trypanosoma b. Rhodesiense.
About PaxMedica
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.
For more information, visit www.paxmedica.com.
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 Annual Report on Form 10-K, most recent
quarterly filings and other filings with the U.S. Securities and
Exchange Commission.
Contacts
ir@paxmedica.com
Stephanie PrincePCG Advisorysprince@pcgadvisory.com(646)
863-6341
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