SEC Comment Letter for Evommune, (EVMN) — Jun 10, 2025
Evommune, Inc.
Date: June 10, 2025 · CIK: 0002044725 · Accession: 0000000000-25-006098
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June 10, 2025
Luis Peña
Chief Executive Officer
Evommune, Inc.
1841 Page Mill Road, Suite 100
Palo Alto, CA 94304
Re:Evommune, Inc.
Draft Registration Statement on Form S-1
Submitted May 14, 2025
CIK No. 0002044725
Dear Luis Peña:
We have reviewed your draft registration statement and have the following comments.
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 a comment applies 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 this letter and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.We note your disclosure here and throughout your prospectus stating, among other
things, that your product candidates are “potent” and have "consistently and robustly
inhibited degranulation" across all tested ligands. Please revise these and similar
statements throughout your prospectus to eliminate conclusions or predictions that
your product candidates are effective, as determinations of efficacy are solely within
the authority of the FDA.
We note your statements claiming that chronic inflammation is the "number one
healthcare problem in the world" and that it contributes to "three out of every five
deaths worldwide." Please balance these statements by clarifying what conditions are 2.
June 10, 2025
Page 2
covered by the term "chronic inflammation." Please also revise to clearly disclose at
the outset which chronic inflammation indications you currently intend to treat with
your existing product candidates.
Our Approach to Drug Development and Chronic Inflammation, page 2
3.Please remove your statement claiming that you will focus on clinical candidates with
a "high probability of success" as it improperly implies that your candidates will
receive regulatory approval.
Our Clinical Pipeline, page 2
4.We note your disclosure that you are initially developing EVO756 for the treatment of
chronic spontaneous urticaria and atopic dermatitis. Please clarify whether you are
continuing to develop EVO756 for the treatment of chronic inducible urticaria. In
addition, we note the inclusion of “Other Chronic Inflammatory Diseases” for
undisclosed indications in the fourth row of the table. Given the limited disclosure
regarding the targeted indications, it seems premature to highlight these programs
prominently in your pipeline table. Please remove them from the table or advise.
5.We note the inclusion of EVO301 for Crohn's Disease in your pipeline table. Given
the limited disclosure related to this indication, please explain why it is sufficiently
material to your business to warrant inclusion in your pipeline table. If it is material,
please expand your disclosure in the Business section to provide a more fulsome
discussion of any development activities conducted. Alternatively, remove any
programs that are not currently material from your pipeline table on page 2 and 105.
Founding Members, Management Team and Investors, page 4
6.Please limit the disclosure of specific investors both here and on page 110 to those
identified in your Principal Stockholders table on page 182. Please also provide
balancing disclosure that prospective investors should not rely on such investors’
investment decisions, that these investors may have different risk tolerances and that
the shares purchased by these investors may have been conducted at a significant
discount to the IPO price, if true.
Risk Factors
We rely on third-party manufacturers, CROs, CDMOs and suppliers to supply, develop and
test components of our product candidates..., page 44
7.We note your disclosure regarding the proposed BIOSECURE Act on page 44 and
that you "currently rely on foreign CROs and CDMOs" for manufacturing and
development activities. Please clarify whether you currently contract with any of the
Chinese biotechnology companies of concern named in the BIOSECURE Act.
Use of Proceeds, page 82
Please revise to disclose how far in your development of EVO756 for chronic
spontaneous urticarias and atopic dermatitis and your development of EVO301 for
atopic dermatitis and inflammatory bowel diseases, the proceeds from this offering
will allow you to reach, including specific phases of clinical trials. If material amounts
of other funds are expected to be necessary to accomplish the specified purposes for 8.
June 10, 2025
Page 3
which net proceeds are intended to be used, provide an estimate of the amounts of
such other funds and the sources thereof.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Operating Expenses
Research and Development, page 95
9.Please address the following in revised disclosure with regards to the changes in your
research and development expenses:
•Specify what occurred in the current period from the prior period that increased
your expense of EVO756 program;
•Identify the license agreement and the cost incurred related to the agreement for
your EVO301 program; and
•Identify the reasons for the decrease in your other early-stage development
programs.
Business, page 104
10.We note disclosure on page 24 that you are presently conducting clinical trials in
Australia, New Zealand, Japan, Canada and the EU. Please revise your Business
section where appropriate to disclose all the jurisdictions where you are currently
conducting clinical trials.
EVO756, Targeting MRGPRX2 for Chronic Inflammatory Diseases, page 106
11.We note the graphic on page 106 references an "efficient clinical & regulatory
pathway" for developing EVO756. Please revise here, or wherever appropriate, to
clarify if you are intending to pursue a specific accelerated approval pathway for this
candidate.
12.You state on page 108 that "studies have demonstrated increased mast cell density,
elevated MRGPRX2 expression and neuroinflammation also present in lesional AD
skin, supporting the rationale for targeting MRGPRX2 to both resolve skin lesions
and relieve symptoms." Please include a discussion of the studies referenced here and
state whether such studies were conducted by you or a third-party.
Our Mission and Strategy, page 110
13.We note your statements claiming that EVO756 has the potential to be "best-in-
class" and "first-in-class for the treatment of CSU and AD and that EVO301 is a
potential "best-in-class" molecule for chronic inflammatory and autoimmune diseases.
These statements appear to be speculative given the current development status of
your product candidates. Please remove these and any other references to EVO756 or
EVO301 being potentially "best-in-class" or "first-in-class" from your registration
statement.
Intellectual Property, page 133
14.Please revise to disclose the type of patent protection (e.g., composition of matter, use
or process) for each material patent or patent family discussed in this section.
June 10, 2025
Page 4
Strategic Collaborations and License Agreements, page 134
15.Please revise to quantify the upfront license fee paid to Dermira, Inc., disclose the
aggregate amount paid to date under this agreement and limit any royalty rate ranges
to ten percentage points. Please also revise to briefly discuss the terms governing your
ability to sublicense EVO756 to third parties. In addition please clarify whether this
offering will be a Qualified Financing pursuant to the license agreement.
16.Please describe the material terms of the agreements with Maruho, AprilBio and
Accutar. Please revise your registration statement to provide the following
information for each of your agreements:
•Describe each parties' rights and obligations under the agreement;
•Provide quantified disclosure of all amounts paid and/or received to date;
•Provide quantified disclosure of all potential regulatory milestone payments;
•Provide quantified disclosure of potential sales based milestone payments, if any;
•Describe any royalty provisions, including the royalty rate within a ten point
range and disclose when the royalty provisions expire; and
•Disclose the term and termination provisions.
Management
Executive Officers, page 153
17.Please briefly discuss the specific experience, qualifications, attributes or skills that
led to the conclusion that Eugene A. Bauer, M.D. should serve as a director. Refer to
Item 401 of Regulation S-K for guidance.
General
18.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.
Please contact Tara Harkins at 202-551-3639 or Sasha Parikh at 202-551-3627 if you
have questions regarding comments on the financial statements and related matters. Please
contact Tyler Howes at 202-551-3370 or Chris Edwards at 202-551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Minkyu Park, Esq.