United States securities and exchange commission logo
July 16, 2020
Howard J. Weisman
Chief Executive Officer
PaxMedica, Inc.
50 Tice Boulevard, Suite A26
Woodcliff Lake, NJ 07677
Re: PaxMedica, Inc.
Registration
Statement on Form S-1
Filed July 2, 2020
File No. 333-239676
Dear Mr. Weisman:
We have reviewed your registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so
we may better
understand your disclosure.
Please respond to this letter by amending your registration
statement and providing the
requested information. If you do not believe our comments apply to your
facts and
circumstances or do not believe an amendment is appropriate, please tell
us why in your
response.
After reviewing any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1
Prospectus Summary
Our Development Strategy, page 1
1. We note your revised
disclosure in response to comment 1 that you believe there is a
reasonable likelihood
that you will receive approval of PAX-101 for the treatment of
HAT. This statement
conveys an expectation of regulatory approval which is
speculative and
inappropriate given the uncertainty with respect to securing marketing
approval. Please revise
your disclosure accordingly.
PAX-102, page 3
2. We note your response
to comment 5; however, you continue to state conclusions
regarding safety or
efficacy. Please revise your statement here that your proprietary
Howard J. Weisman
FirstName
PaxMedica,LastNameHoward J. Weisman
Inc.
Comapany
July NamePaxMedica, Inc.
16, 2020
July 16,
Page 2 2020 Page 2
FirstName LastName
intranasal formulations and methods of delivering suramin to mammals
have been shown
to dramatically reduce systemic exposure to remove your conclusion
that data
demonstrated safety or efficacy. You may present objective data
resulting from your trials
without including conclusions related to safety or efficacy in the
Business section.
Risk Factors
Risks Related to Product Development, Regulatory Approval, Manufacturing and
Commercialization, page 12
3. We note your response to comment 3, which we reissue in part. Please
revise your
disclosure to highlight the risks associated with UCSD's conduct of
clinical trials
of suramin and the impact UCSD's patent application discussed on page
28, if approved,
may have on your development plans, your patent portfolio and your
business or tell us
why you believe such disclosure is not required.
Use of Proceeds, page 42
4. We note your revised disclosure in response to comment 7. Please
revise your disclosure
to remove the implication that you will be successful in securing
marketing approval
of PAX-101 for the treatment of HAT. Additionally, please revise to
provide more
meaningful and specific disclosure of the intended use of proceeds, as
well as the
approximate amounts intended to be used for each such purpose. This is
required even if
management will have broad discretion in allocating the proceeds. This
section does not
require disclosure of definitive plans and it is acceptable to provide
a quantitative
discussion of preliminary plans. You may also reserve the right to
change the use of
proceeds as indicated in Instruction 7 to Regulation S-K Item 504.
Dilution, page 45
5. The historical net tangible book value of $32,000 and historical net
tangible book value
per share of $0.00 as of March 31, 2020 appears to include the
preferred units in the
mezzanine section of the balance sheet. Please revise the calculations
to exclude the
mezzanine preferred units or advise as to the appropriateness of the
Company's
calculation.
Business
Current Clinical Development Plan, page 56
6. We note your response to comment 10, which we reissue in part. We note
your disclosure
that you intend to conduct preclinical and clinical safety studies of
PAX-101 for the
treatment of HAT yet you present PAX-101 for the treatment of this
indication as
completing Phase 3 clinical trials in your pipeline table on page 56.
Please revise your
pipeline table so that it accurately reflects the necessity to conduct
preclinical studies. We
will not object to explanatory disclosure indicating, if true, that
you intend to rely on data
exclusively licensed by you to support your application for marketing
approval.
Howard J. Weisman
PaxMedica, Inc.
July 16, 2020
Page 3
7. We note your response to comment 11, which we reissue in part. We note
that you have
not provided any additional disclosure regarding preclinical studies
conducted for PAX-
101 for the treatment of FXTAS or for PAX-102. Please provide us with
your analysis as
to why these programs are material to your business and appropriate for
inclusion in the
pipeline table. Please also remove your selective anti-purinergic therapy
program from
your pipeline table. We will not object to a discussion of the program
below the table, but
research and discovery activities that precede the identification of a
product candidate are
too remote to be highlighted in the pipeline table.
Mitochondrial Dysfunction and Implications for the Use of Suramin for
Management of ASD
and FXTAS, page 58
8. We note your revised disclosure in response to comment 13 that a single
dose of suramin
exhibited "promising results" on the core symptoms of ASD. Because a
determination of
efficacy is solely within the FDA's authority, please remove this
reference. You may
present objective data resulting from clinical trials without including
conclusions related
to efficacy. Please revise this statement as well as similar statements
throughout the
prospectus that present conclusions regarding efficacy such as your
disclosure stating
compounds demonstrated "strong early preclinical data."
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Ameen Hamady at 202-551-3891 or Sasha Parikh at
202-551-3627 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Ada D. Sarmento at 202-551-3798 or Christine Westbrook at 202-551-5019
with any
other questions.
Sincerely,
FirstName LastNameHoward J. Weisman
Division of
Corporation Finance
Comapany NamePaxMedica, Inc.
Office of Life
Sciences
July 16, 2020 Page 3
cc: Steven M. Skolnick, Esq.
FirstName LastName