<SEC-DOCUMENT>0000000000-21-007108.txt : 20210908
<SEC-HEADER>0000000000-21-007108.hdr.sgml : 20210908
<ACCEPTANCE-DATETIME>20210609073010
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-21-007108
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20210609

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Eliem Therapeutics, Inc.
		CENTRAL INDEX KEY:			0001768446
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				832273741
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		23515 NE NOVELTY HILL ROAD
		STREET 2:		SUITE B221 #125
		CITY:			REDMOND
		STATE:			WA
		ZIP:			98053
		BUSINESS PHONE:		425-276-2300

	MAIL ADDRESS:	
		STREET 1:		23515 NE NOVELTY HILL ROAD
		STREET 2:		SUITE B221 #125
		CITY:			REDMOND
		STATE:			WA
		ZIP:			98053
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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United States securities and exchange commission logo





                             June 8, 2021

       Robert Azelby
       Chief Executive Officer
       Eliem Therapeutics, Inc.
       23515 NE Novelty Hill Road, Suite B221 #125
       Redmond, WA 98053

                                                        Re: Eliem Therapeutics,
Inc.
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted May 12,
2021
                                                            CIK No. 0001768446

       Dear Mr. Azelby:

              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 submitted May 12, 2021

       Prospectus Summary
       Overview , page 1

   1.                                                   Please revise to
clarify what you mean by "clinically validated mechanisms of action" and
                                                        whether you believe
this description refers to PEA. If this "clinically validated"
                                                        description does not
apply to all of your product candidates, please make
                                                        appropriate revisions.
Please also place your disclosure in appropriate context by
                                                        disclosing that the
U.S. Food and Drug Administration (FDA) or European Medicines
                                                        Agency (EMA) has not,
to date, approved PEA-based therapeutics. Additionally, please
                                                        revise your disclosure
to remove any implication that you are presently successful or are
                                                        likely to be successful
in securing marketing approval for any of your product candidates.
 Robert Azelby
FirstName  LastNameRobert Azelby
Eliem Therapeutics, Inc.
Comapany
June 8, 2021NameEliem Therapeutics, Inc.
June 8,
Page 2 2021 Page 2
FirstName LastName
2.       We note your statement on page 2 that "PEA...that has shown activity
in more than 30
         published clinical studies in over 3,000 patients across a variety of
pain indications,
         including approximately 1,500 patients in randomized, controlled
studies, where it has
         demonstrated marked reductions in pain intensity and attractive
tolerability and safety
         data." Given that it is within the sole authority of the FDA or
similar foreign regulator to
         determine the efficacy of a drug and that efficacy is determined by
reference to the
         indication being treated, it is inappropriate to state or imply that
PEAs have established
         therapeutic benefits. Please delete this and similar statements
throughout your prospectus,
         including in the Business section. You may replace these statements
with a description of
         a publicly available clinical trials conducted to assess efficacy and
the resulting data. The
         accompanying disclosures should identify the party performing the
trial and include the
         number of participants and dosing information but should not draw
conclusions about
         efficacy from the data. Please also revise the summary to make clear
that your
         clinical data to date is limited to a small number of healthy
subjects.
3.       The pipeline table on pages 2 and 93 should reflect the actual, and
not the anticipated,
         status of your pipeline candidates as of the latest practicable date.
The table currently
         suggests that the ETX-810 trial is in the midst of Phase 2 but your
disclosure indicates that
         you are actively enrolling DPNP and LSR patients. Please revise to
show the actual status
         or advise.
4.       Please revise the pipeline table on pages 2 and 93 to highlight your
market opportunity for
         the initial indications rather than the broader market opportunity.
5.       Expand your summary to explain how you acquired the rights to your
products. Did you
         develop them in house or acquire them from other parties? If acquired,
please describe
         your acquisition or licensing agreements and all material terms.
Please either file the
         agreements or provide us with an analysis supporting your
determination that the
         agreements are not required to be filed.
ETX-810, page 2

6.       We note your statement that "precedent favorable clinical activity of
PEA...puts [you] in a
         position to progress a robust clinical development program for
ETX-810." Please tell
         us whether you expect to be able to rely on such "precedent favorable
clinical activity" to
         support an application for marketing approval. Please also clarify
whether "encouraging
         precedent clinical data" only studied PEA in its dietary supplement
formulation or
         whether these trials also studied PEA in pharmaceutical formulations.
         Additionally, disclose whether any of the precedent clinical trial
data specifically studied
         diabetic peripheral neuropathic pain and/or pain associated with
lumbosacral
         radiculopathy.
7.       Please balance your disclosure in the summary section that "[i]n one
randomized, placebo-
         controlled study in over 600 chronic low back pain patients, PEA
demonstrated
         statistically significant reductions in pain versus placebo including
a greater than 50%
 Robert Azelby
FirstName  LastNameRobert Azelby
Eliem Therapeutics, Inc.
Comapany
June 8, 2021NameEliem Therapeutics, Inc.
June 8,
Page 3 2021 Page 3
FirstName LastName
         reduction in pain intensity in 82% of patients" with a warning about
relying on this cross-
         trial comparison as an indicative of the the efficacy of ETX-810.
Additionally, please add
         risk factor disclosure concerning the "precedent body of data for PEA"
and the
         generalized risks associated with cross-trial comparisons.
8.       We note your disclosure here and elsewhere implying safety and
efficacy of your product
         candidates, although none of your candidates have received regulatory
approval to date.
         As determinations of safety and efficacy are solely within the
authority of the U.S. Food
         and Drug Administration (FDA) and comparable regulatory bodies, please
revise your
         disclosure throughout the prospectus to remove all claims of safety
and efficacy. Note
         that we will not object to a discussion of objective data resulting
from your trials without
         safety and efficacy conclusions.
Our Team and Investors, page 6

9.       We note that you identify certain entities as investors in your
company; however, some do
         not appear to be among your principal stockholders as disclosed on
page 167. If material,
         please expand your disclosure to describe the nature of each named
entity's investment in
         you and explain to us why including this information is appropriate.
Please also explain
         in your response your plans to update investors about any changes
these entities make
         with respect to their investments in the company.
Risk Factors
Our amended and restated certificate of incorporation will designate the Court
of Chancery of the
State of Delaware..., page 62

10.      Please revise this risk factor to disclose that there is also a risk
that your exclusive forum
         provision may result in increased costs for investors to bring a
claim.
Intellectual Property, page 122

11.      Please clarify the type of patent protection applicable to your U.S.
patent and pending
         patent applications for ETX-810. Please also specify which
international jurisdictions in
         which you have granted patents or pending patent applications for
ETX-155.
Relationship with Carnot, LLC, page 164

12.      Please provide a brief description of the material terms of your
services agreement with
         Carnot Pharma, LLC and file the agreement as an exhibit to the
registration statement or
         tell us why such agreement is not required to be filed. Refer to Item
601(b)(10) of
         Regulation S-K.
Principal Stockholders, page 166

13.      Please identify the natural person or persons who directly or
indirectly exercise sole or
         shared voting and/or dispositive power with respect to the common
stock held by the
         entities identified in the table. Refer to Item 403 of Regulation S-K.
 Robert Azelby
Eliem Therapeutics, Inc.
June 8, 2021
Page 4
General

14.   Please supplementally provide us with copies of all written
communications, as defined in
      Rule 405 under the Securities Act, that you, or anyone authorized to do
so on your behalf,
      present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
      not they retain copies of the communications
       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,
FirstName LastNameRobert Azelby
                                                            Division of
Corporation Finance
Comapany NameEliem Therapeutics, Inc.
                                                            Office of Life
Sciences
June 8, 2021 Page 4
cc:       Alan Hambelton
FirstName LastName
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
