United States securities and exchange commission logo





                             June 2, 2023

       Michael Henderson, M.D.
       Chief Executive Officer
       Apogee Therapeutics, LLC
       221 Crescent St., Building 17, Suite 102b
       Waltham, MA 02453

                                                        Re: Apogee
Therapeutics, LLC
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted April 28,
2023
                                                            CIK No. 0001974640

       Dear Michael Henderson:

              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 April 28, 2023

       Cover Page

   1.                                                   Revise you cover page
to clearly disclose whether your offering is contingent on final
                                                        approval of your Nasdaq
listing. Please ensure the disclosure is consistent with your
                                                        underwriting agreement
and disclosure elsewhere in the registration statement.
       Summary, page 1

   2.                                                   Please revise your
summary to limit the discussion to an overview of the key aspects of
                                                        your offering,
including a brief identification of your material product candidates, the
                                                        indication(s) and the
current stage of development. Move the discussion of the pre-
                                                        clinical trials and
competing products and competing product candidates to the Business
 Michael Henderson, M.D.
FirstName  LastNameMichael
Apogee Therapeutics, LLC Henderson, M.D.
Comapany
June 2, 2023NameApogee Therapeutics, LLC
June 2,
Page 2 2023 Page 2
FirstName LastName
         section where the information can be put in proper context. Please see
Item 503 of
         Regulation S-K.
Overview, page 1

3.       Delete the discussions of DUPIXENT, ADBRY, Lebrikizumab, Amlitelimab
and
         rocatinlimab clinical trial results here and throughout your
registration statement. It
         appears that the FDA and/or equivalent foreign regulator(s) are
requiring you to conduct
         clinical trials for your product candidates. Therefore, it is not
appropriate for you to
         include these results which may imply that your candidates may
experience similar results
         with respect to safety and/or efficacy.
4.       We note you intend to indicate when you anticipate initiating a Phase
1 clinical trial of
         APG777 and APG808. Please revise to indicate whether you have filed an
IND for each
         candidate. If you have not, indicate when you plan to file them.
5.       Please delete your statement anticipating when you expect to initiate
your Phase 2 trials.
         Given that you have not initiated your Phase 1 trials, the statements
are speculative.
6.       Please clarify that while your candidates may target monoclonal
antibodies in the same
         manner as some products that have already received FDA approval and
others that are
         further along in the regulatory approval process, you cannot conclude
that your clinical
         trial results will be the similar to the products and product
candidates that target the same
         monoclonal antibodies with respect to safety and/or efficacy. Revise
your Business
         section to describe the preclinical trials you conducted, including
your head to head trials.
         Your preclinical trial discussion should include an objective
description of your trial
         observations, while avoiding drawing conclusions relating to safety
and efficacy.
Our Approach, page 2

7.       We note your disclosure on page 2 that your antibody engineering
programs are designed
         to generate assets with potentially best-in-class profiles. The term
"best-in-class" suggests
         that your product candidates are effective and likely to be approved.
Given the early
         stages of development for each of your candidates, the term appears
speculative. Please
         revise to delete these references here and throughout your
registration statement.
Our Pipeline, page 3

8.       Please revise your table to combine the Lead Optimization and
IND-Enabling columns
         into one column representing the preclinical trial development phase.
9.       Please limit the items included in your pipeline table to those that
are currently material to
         you and your operations. We note the lack of disclosure related to
APG777 Additional
         I&I indication, APG990 and APG222. Please delete these items from your
table.
         Alternatively, identify the additional I&I indication related to
APG777 and expand your
         disclosures related to these programs throughout your registration
statement to provide
         more information.
 Michael Henderson, M.D.
FirstName  LastNameMichael
Apogee Therapeutics, LLC Henderson, M.D.
Comapany
June 2, 2023NameApogee Therapeutics, LLC
June 2,
Page 3 2023 Page 3
FirstName LastName
Biologics have Transformed Treatment of I&I Diseases, page 5

10.      You may disclose the market for products to treat indications you are
developing product
         candidates to treat and the market for products you intend to compete
with, but please
         delete the statements related to the aggregate market for I&I product
revenues and
         revenues for products that your candidates are not currently being
developed to compete
         with. The discussion of the market is too broad to be meaningful to
investors. Make
         similar revisions to the Business section.
AD Background and Current Treatment Limitations, page 6

11.      Please disclose the basis for your statement that 20% of patients
discontinue treatment
         with DUPIXENT within six months of starting therapy.
Our Strategy, page 7

12.      Your discussion indicating that you are leveraging
"clinically-validated mechanisms"
         appears to indicate that your candidates have already been proven
effective. Based on
         your current disclosure, that you are planning to conduct clinical
trials, we believe your
         use of this terminology is not appropriate. Please revise your
discussion accordingly.
Our Team, Investors and Paragon Collaborators, page 7

13.      Please revise to identify Paragon Therapeutics as a related party.
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company, page 9

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.
We rely on collaborations and licensing arrangements with third parties...,
page 24

15.      Please revise your discussion to clarify that Paragon is a related
party, which owns more
         than 5% of your capital stock and is controlled by Fairmont Funds
Management LLC,
         which owns more than 5% of your capital stock and has two seats on
your Board of
         Directors.
Business, page 72

16.      Please delete the statement on page 72 indicating "our two most
advanced programs,
         APG777 and APG808, bind to the same epitopes, or binding sites,...as
lebrikizumab and
         DUPIXENT, respectively, and are thereby expected to retain their
clinical outcomes."
         This must be proven in your clinical trials, your statement about your
expectations is not
         appropriate.
 Michael Henderson, M.D.
Apogee Therapeutics, LLC
June 2, 2023
Page 4
Our Pipeline , page 75

17.   According to your pipeline table APG777, APG990 and APG222 are all being
developed
      to treat contact dermatitis. Please discuss your strategy of developing
products that it
      appears will compete with each other and consider including a risk factor
discussing the
      the possibility that your products will compete with each other.
Exclusive Forum Selection Clause, page 156

18.   Please revise your disclosure regarding your exclusive forum provision to
note that the
      provision may result in increased costs to bring a claim, which may
further limit investors'
      ability to bring a claim.
Financial Statements
Note 10- Equity-Based Compensation, page F-19

19.   We note your disclosure stating that the fair value of each incentive
unit grant is estimated
      on the grant using either an option pricing method (   OPM   ), or a
hybrid method, both of
      which used market approaches to estimate your enterprise value. Please
expand your
      disclosure to include the significant assumptions used to estimate the
fair value of your
      unit-based compensation awards according to ASC 718-10-50-2(f)2.
       You may contact Tracie Mariner at 202-551-3744 or Daniel Gordon at
202-551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Arzhang Navai at 202-551-4676 or Suzanne Hayes at 202-551-3675 with any
other
questions.



                                                            Sincerely,
FirstName LastNameMichael Henderson, M.D.
                                                            Division of
Corporation Finance
Comapany NameApogee Therapeutics, LLC
                                                            Office of Life
Sciences
June 2, 2023 Page 4
cc:       Melanie Neary
FirstName LastName