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United States securities and exchange commission logo
May 27, 2021
Joshua B. Cohen, Justin B. Klee
Co-Chief Executive Officers
Amylyx Pharmaceuticals, Inc.
43 Thorndike St.
Cambridge, Massachusetts 02141
Re: Amylyx
Pharmaceuticals, Inc.
Draft Registration
Statement on Form S-1
Submitted April 26,
2021
CIK No, 0001658551
Dear Mr. Cohen:
We have reviewed your 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.
Draft Registration Statement on Form S-1
Summary, page 1
1. Please revise to
explain the term foundational therapy.
2. Please revise the
disclosure on page 1 to explain why FDA has requested that you conduct
an additional trial in
support of a New Drug Application. Identify the type(s) of topline
data that you seek from
the Phase 3 trial to support the NDA submission.
3. Please address the
following with respect to your pipeline table:
revise to clearly
demarcate where each phase or column begins and ends;
revise the first
arrow to clarify that you did not conduct a Phase 3 trial, or advise; and
include upcoming
milestones for the bottom two indications, or advise.
Joshua B. Cohen, Justin B. Klee
FirstName LastNameJoshua B. Cohen, Justin B. Klee
Amylyx Pharmaceuticals, Inc.
Comapany
May NameAmylyx Pharmaceuticals, Inc.
27, 2021
May 27,
Page 2 2021 Page 2
FirstName LastName
4. Please revise the Pipeline Overview to clarify that the PB and TURSO
molecules are not
proprietary and to clarify more specifically what is proprietary.
5. With reference to the risk factor disclosure on page 27, please revise
the disclosure on
page 3 to explain that the EU and Canadian authorizations you are
seeking may be limited
or subject to restrictions, or advise.
6. Please revise the Summary, where appropriate, to highlight:
your disclosure on page 33 that you are aware of one ongoing
clinical study in
Europe which is evaluating the effects on ALS of TURSO, one of the
two
components in AMX0035, and
your disclosure on page 69 that there is uncertainty as to whether
claims in your
pending patent applications, including those claims covering the
composition of
matter of AMX0035, will be considered patentable by the USPTO or
by patent
offices in foreign countries.
The Offering, page 9
7. Please disclose on page 10 whether the number of shares of your common
stock to be
outstanding after this offering includes or excludes shares of your
common stock that may
be issuable upon conversion of the $27.3 million of convertible
promissory notes you
issued and sold to investors in January 2021.
Clinical Development of AMX0035 for ALS, page 130
8. Please revise here and on page 3 to explain who conducted and funded
the survey and its
purpose. Present in the Business section all material information
concerning how the trial
was conducted and its results.
9. Please revise to present the full open label extension results or
advise.
Clinical Development Plan of AMX0035 in ALS, page 135
10. We note your disclosure concerning the size and duration of the
planned Phase 3 trial.
Please revise to identify the primary endpoint(s) or revise to
clarify, if true, that the
endpoint(s) are yet to be determined.
Clinical Development of AMX0035 for Alzheimers Disease, page 136
11. Please revise to qualitatively and/or quantitatively discuss each of
the key endpoints.
Commercialization, page 138
12. Please revise the discussion to explain in greater detail your plans
for obtaining coverage
and reimbursement for AMX0035 to treat ALS in the U.S., Canada and the
EU. For
instance, please discuss, if material, whether your plan is to obtain
coverage and
reimbursement that is similar to the two currently approved ALS
treatments cited on page
139. Explain what you would need to demonstrate in order to achieve
orphan drug-like
Joshua B. Cohen, Justin B. Klee
Amylyx Pharmaceuticals, Inc.
May 27, 2021
Page 3
prices in ALS in specific geographies. As applicable, discuss
reimbursement codes and
the dollar values associated with them.
13. Revise to discuss the duration of patient treatments. For instance, we
note that your
CENTAUR trial measured median survival rates.
14. With reference to your disclosure on page 167, please discuss when you
would need to
decide whether expensive pharmacoeconomic studies will or will not be
necessary to
demonstrate medical necessity and cost-effectiveness of AMX0035.
Intellectual Property, page 142
15. Please expand your disclosure to address the following:
for each of your patent families, disclose the foreign
jurisdictions where you have
been issued or granted patents and where you have patent
applications pending;
for your second and third patent families, disclose any pending
patent applications
you have and the jurisdiction(s), thereof.
In this regard, it may be useful to provide tabular disclosure.
16. With reference to the disclosure on page 69, please revise your
intellectual property
discussion to address the significance of composition of matter
patents to each patent
family. With reference to your disclosures on pages 128-129, discuss
whether these or
other patents cover specific ratios of PB and TURSO. Also identify
your one issued
composition of matter patent and describe your issued European Patent,
EP2978419 in
greater detail.
Certain Relationships and Related Party Transactions
2021 Convertible Promissory Note Financing, page 190
17. Please expand your disclosure to describe the material terms of the
2021 Notes, including
the terms of their conversion.
Principal Stockholders, page 193
18. Please identify the natural person(s) with voting and/or dispositive
power over the shares
owned by ALS Invest 1 B.V. and Morningside Venture Investments
Limited.
General
19. Please provide us with copies of all written communications, as defined
in Rule 405 under
FirstName LastNameJoshua B. Cohen, Justin B. Klee
the Securities Act, that you, or anyone authorized to do so on your
behalf, present to
Comapany NameAmylyx
potential Pharmaceuticals,
investors in Inc. 5(d) of the Securities Act,
whether or not they
reliance on Section
May 27,retain
2021copies
Page 3of the communications.
FirstName LastName
Joshua B. Cohen, Justin B. Klee
FirstName LastNameJoshua B. Cohen, Justin B. Klee
Amylyx Pharmaceuticals, Inc.
Comapany
May NameAmylyx Pharmaceuticals, Inc.
27, 2021
May 27,
Page 4 2021 Page 4
FirstName LastName
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 David Gessert at (202) 551-2326 or Joe McCann at (202) 551-6262 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Benjamin K. Marsh, Esq.