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