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United States securities and exchange commission logo
July 6, 2021
Robert Azelby
Chief Executive Officer
Eliem Therapeutics, Inc.
23515 NE Novelty Hill Road, Suite B221 #125
Redmond, WA 98053
Re: Eliem Therapeutics,
Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted June 21,
2021
CIK No. 0001768446
Dear Mr. Azelby:
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 on Form S-1 submitted
June 21, 2021
Overview, page 1
1. We note your response
to prior comment 1 and your revised disclosure that "clinically
validated . . . means
there are either products that have received regulatory approval or
product candidates with
these mechanisms of action that have demonstrated statistical
significance on
efficacy endpoints in published randomized, controlled clinical trials." As
currently drafted, this
statement could imply that the FDA has approved, or will more
easily approve, your
products. Although your drugs may target certain pathways that have
been used by other
drugs, we note that your drugs are still distinct from prior drugs that
have been approved by
the FDA and/or the dietary supplement PEA used in prior clinical
trials. While it is
appropriate to say that you are using a similar pathway to help guide
Robert Azelby
Eliem Therapeutics, Inc.
July 6, 2021
Page 2
your development programs, please revise your disclosure to remove any
implication that
your product candidates are more likely to receive FDA approval.
Please also place your
PEA disclosure in appropriate context by disclosing that the FDA has
not, to date,
approved PEA-based therapeutics.
2. We note your response to comment 2. Please revise the summary to make
clear that your
clinical data to date is limited to a small number of healthy
subjects.
3. We note your response to comment 5 and reissue. Please revise your
summary to explain
how you acquired the rights to your products and the material terms of
those transactions.
4. We note your response to comment 6. While you state in correspondence
that you do not
intend to rely on such "precedent favorable clinical activity" but
rather intend to "rely
solely on [your] own clinical data to support an application for
marketing approval," it
does not appear that you changed the language in your summary section,
as page 3 of the
amendment still states that "precedent favorable clinical activity of
PEA . . . put us in
position to progress a robust clinical development program for
ETX-810." Please revise
this statement accordingly.
5. We note your response to comment 8 and re-issue the comment as it
relates to your
amended disclosure that "previous clinical trials of PEA have shown
encouraging safety . .
. data." Safety determinations are solely within the authority of the
FDA and comparable
regulatory bodies. Please revise.
Clinical Experience with PEA in Pain, page 103
6. Please enlarge the table on this page, as its font is too small to be
legible.
Exhibits
7. We note your response to comments 5 and 12 regarding: (1) the
acquisition
agreement with Athenen; (2) the acquisition agreement with Carnot, LLC;
and (3)
the services agreement with Carnot Pharma, LLC and, more specifically,
why you do not
believe these three agreements need to be filed as exhibits. Please
provide us with an
FirstName LastNameRobert Azelby
explanation of why these agreements should not be filed as material
contracts under Item
Comapany NameEliem
601(b)(10). Therapeutics,
Additionally, Inc.
if you believe that these contracts are
immaterial, please
July 6, provide
2021 Pagefurther
2 explanation for this conclusion.
FirstName LastName
Robert Azelby
FirstName LastNameRobert Azelby
Eliem Therapeutics, Inc.
Comapany
July 6, 2021NameEliem Therapeutics, Inc.
July 6,3 2021 Page 3
Page
FirstName LastName
You may contact Sasha Parikh at 202-551-3627 or Vanessa Robertson at
202-551-3649 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Dillon Hagius at 202-551-7967 or Jeffrey Gabor at 202-551-2544 with any
other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Alan Hambelton, Esq.