Full Press Release Details
PaxMedica Releases 2022 Shareholder Letter
Company Anticipates Multiple Milestones in Next
Tarrytown, NY, February 15, 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 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 ASD in the US. 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 US 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
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, and 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,
Chairman and Chief Executive Officer
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.