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 released a
2022 shareholder letter discussing its recent accomplishments and
upcoming milestones.
Dear Shareholders and Stakeholders,
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
(suramin) clinical trials for the treatment of Autism Spectrum
Disorder (ASD) 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 (IPO) 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, (sometimes
referred to as HATr, Human African Trypanosomiasis
rhodesiense). 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.
In the months leading up to the IPO and since, we have also been
working to build out our management team and Board of
Directors.
During 2022, we filled two important roles on the management
team. We appointed Stephen D. Sheldon as Chief Financial Officer in
July, and in October, we appointed Stefan Schwabe MD, PhD as Chief
Medical Officer. Mr. Sheldon is a seasoned pharmaceutical
entrepreneur and executive, with extensive international business
development experience. Dr. Schwabe has over 30 years of experience
in the pharmaceutical industry and is responsible for directing all
of the product development activities, including pre-clinical,
clinical, regulatory and pharmaceutical sciences, for PaxMedica’s
pipeline products.
We were excited to announce the appointment of Chuck Casamento
to the Board of Directors and as Chair of the Audit Committee in
October. Chuck is well known in the specialty pharma industry, has
built several pharmaceutical companies, and serves as an
independent director at several public companies. Dr. John
Coelho also joined our board in 2022, joining Zach Rome and Michael
Derby, our co-founders, along with Karen LaRochelle and me.
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.
I’d like to close by thanking the team and the Board of
Directors for their hard work and insight in our first year as a
public company. I’d also like to thank our shareholders and other
stakeholders for their interest and support in the work that
PaxMedica is doing to find treatments for disorders with
intractable neurologic symptoms, including Autism Spectrum Disorder
and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
(“ME/CFS”).
Thank you and best wishes for a successful year,Howard
WeismanChairman and Chief Executive Officer
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, please visit:
www.paxmedica.com
Forward-Looking Statements
This press release contains “forward-looking statements.”
Statements contained in this press release other than statements of
historical fact are forward-looking statements, including but not
limited to statements regarding our anticipated development and
operating plan, achievement of anticipated milestones, planned
research and development efforts and other matters regarding
the Company’s business strategy, use of capital, and plans and
objectives for future operations. Forward-looking statements
reflect our current view about future events. 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. 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. 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 in the Company’s
registration statement, most recent quarterly reports, 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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