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United States securities and exchange commission logo
November 22, 2021
Joshua B. Cohen, Justin B. Klee
Co-Chief Executive Officers
Amylyx Pharmaceuticals, Inc.
43 Thorndike St.
Cambridge, Massachusetts 02141
Re: Amylyx
Pharmaceuticals, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted October
20, 2021
CIK No, 0001658551
Dear Mr. Cohen:
We have reviewed your amended draft 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 providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. 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 the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Amendment No. 1 to Draft Registration Statement submitted October 20,
2021
Summary, page 1
1. With reference to the
disclosure on page 127, please revise the second paragraph of the
Overview to describe
briefly the type of models that you reference.
2. We note your revised
disclosure in response to prior comment 2. Please revise the
disclosure on pages 1
and 4 to clarify why you plan in Q4 to submit an NDA to FDA
while also commencing
the Phase 3 PHOENIX trial. To the extent that it is atypical to
submit an NDA in
advance of, or in connection with, a Phase 3 trial, the circumstances
and material
discussions with FDA should be highlighted. With reference to disclosures
on pages 21 and 27,
also revise to explain that FDA may determine, among other things,
to not approve your NDA
because it disagrees with your data and rationale, or to require
Joshua B. Cohen, Justin B. Klee
Amylyx Pharmaceuticals, Inc.
November 22, 2021
Page 2
completion of your planned Phase 3 PHOENIX global clinical trial before
issuing an
approval decision.
3. We note your revised disclosure on page 6 in response to prior comment
6. Please revise
the Summary to highlight your disclosure on page 33 indicating that
there are risks
that the Humanitas Mirasole SpA Phase 3 trial could result in a
competitive
commercialized product. Also, revise the disclosure on page 6 to avoid
the implication
that you are collaborating with Humanitas Mirasole SpA, or advise.
Pipeline Overview, page 2
4. We note your revised Pipeline Overview disclosure in response to prior
comment 3.
Please revise the Canadian ALS graphic so that Phase 3 is in grey and
add N/A or
something similar to depict visually that such trial is not required.
5. Please revise to remove the two unidentified neurodegenerative
indications that you added
to the table. In this regard, it appears premature to highlight these
unidentified indications
in the Summary, particularly given that the Business section does not
contain any
discussion regarding these indications or the development work that has
been conducted
to date.
Clinical Development of AMX0035 for Wolfram Syndrome, page 136
6. Please revise to provide support for your statement that AMX0035 has
shown beneficial
effects in a variety of models of Wolfram syndrome, including cellular
models, patient
derived cell lines, and a knockout mouse model.
Intellectual Property, page 141
7. We note your responses to prior comments 6 and 16 and reissue in part.
Please revise
to identify the issued patent having claims that cover the composition
of matter of
AMX0035.
You may contact Christine Torney at (202) 551-3652 and Al Pavot at (202)
551-3738 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Daniel Crawford at (202) 551-7767 or Joe McCann at (202) 551-6262 with
any other
questions.
Sincerely,
FirstName LastNameJoshua B. Cohen, Justin B. Klee
Division of
Corporation Finance
Comapany NameAmylyx Pharmaceuticals, Inc.
Office of Life
Sciences
November 22, 2021 Page 2
cc: Benjamin K. Marsh, Esq.
FirstName LastName