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Evommune, Inc.
Response Received
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Evommune, Inc.
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Evommune, Inc.
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-22 | SEC Comment Letter | Evommune, Inc. | DE | 333-295140 | Read Filing View |
| 2026-04-22 | Company Response | Evommune, Inc. | DE | N/A | Read Filing View |
| 2025-09-10 | SEC Comment Letter | Evommune, Inc. | DE | 377-08010 | Read Filing View |
| 2025-07-30 | SEC Comment Letter | Evommune, Inc. | DE | 377-08010 | Read Filing View |
| 2025-06-10 | SEC Comment Letter | Evommune, Inc. | DE | 377-08010 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-22 | SEC Comment Letter | Evommune, Inc. | DE | 333-295140 | Read Filing View |
| 2025-09-10 | SEC Comment Letter | Evommune, Inc. | DE | 377-08010 | Read Filing View |
| 2025-07-30 | SEC Comment Letter | Evommune, Inc. | DE | 377-08010 | Read Filing View |
| 2025-06-10 | SEC Comment Letter | Evommune, Inc. | DE | 377-08010 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-22 | Company Response | Evommune, Inc. | DE | N/A | Read Filing View |
2026-04-22 - UPLOAD - Evommune, Inc. File: 333-295140
April 22, 2026
Luis Peña
Chief Executive Officer
Evommune, Inc.
1891 Page Mill Road
Palo Alto, CA 94304
Re: Evommune, Inc.
Registration Statement on Form S-1
Filed April 17, 2026
File No. 333-295140
Dear Luis Peña:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Minkyu Park, Esq.
2026-04-22 - CORRESP - Evommune, Inc.
CORRESP 1 filename1.htm CORRESP EVOMMUNE, INC. 1891 Page Mill Road Palo Alto, CA 94304 (925) 247-4487 April 22, 2026 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Information Technologies and Services 100 F Street, N.E. Washington, D.C. 20549 Re: Evommune, Inc. Registration Statement on Form S-1 File No. 333-295140 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the Registration Statement on Form S-1 (File No. 333-295140) (the “Registration Statement”) to become effective on Friday, April 24, 2026, at 4:00 p.m., Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes Minkyu Park of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Minkyu Park of Cooley LLP, counsel to the Registrant, at (212) 479-6588, or in his absence Eric Blanchard of Cooley LLP at (617) 937-2445. Very truly yours, EVOMMUNE, INC. By: /s/ Gregory S. Moss Name: Gregory S. Moss Title: Chief Business & Legal Officer cc: Luis Peña, Evommune, Inc. Minkyu Park, Cooley LLP Eric Blanchard, Cooley LLP
2025-09-10 - UPLOAD - Evommune, Inc. File: 377-08010
September 10, 2025
Luis Peña
Chief Executive Officer
Evommune, Inc.
1841 Page Mill Road, Suite 100
Palo Alto, CA 94304
Re:Evommune, Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted August 29, 2025
CIK No. 0002044725
Dear Luis Peña:
We have reviewed your amended 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 and non-public draft submissions 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.
Amendment No. 2 to Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.Please revise to briefly explain the term "clinically meaningful" in reference to your
trial results from your CIndU Phase 2 trial. Alternatively, please consider replacing
this disclosure, here and throughout your prospectus, with a brief discussion of the
objective results of your CIndU Phase 2 trial without drawing conclusions as to the
safety or efficacy of your product candidates.
Our Clinical Pipeline, page 3
We note your response to prior comment 2 and reissue. Please revise, wherever 2.
September 10, 2025
Page 2
appropriate, to provide a more fulsome discussion of the development activities
conducted related to your EVO756 candidate for “Other Indications.” To the extent
you have not yet conducted any specific development actives for these indications,
please remove them from your pipeline table.
Comparison of the Six Months Ended June 30, 2025 and 2024
Operating Expenses
Research and Development, page 97
3.We note your response to prior comment 3 and we reissue our comment. Please
disclose in more detail the type of or specific programs and/or the nature of the
expenses incurred within the other programs line item.
Business
EVO756, Targeting MRGPRX2 for Chronic Inflammatory Diseases, page 111
4.We note your response to prior comment 4. Please revise the graphic on page 112 to
remove the reference to EVO756 having an "efficient clinical development pathway"
as this statement is speculative given your assertion that you do not intend to rely on
any accelerated approval pathways.
Figure 3: EVO756 FricTest Score Improvements and Other Efficacy Metrics, page 114
5.We note your response to prior comment 6. However, we do not note any revisions on
page 114 and 115 responsive to this comment. Please clarify whether these “other
efficacy metrics” were established endpoints in your EVO756 trial. Please also delete
the reference to “efficacy” in the title for this figure as your disclosure should not
imply that your product candidates will be found to be safe or effective by the FDA or
comparable regulatory bodies.
Our Solution: EVO756, Our MRGPRX2 Antagonist, page 124
6.Please remove the reference to EVO756 being developed as a potential "first-in-class"
candidate as this statement is speculative given the current development status of your
product candidate and improperly implies EVO756 is likely to be approved.
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.
2025-07-30 - UPLOAD - Evommune, Inc. File: 377-08010
July 30, 2025
Luis Peña
Chief Executive Officer
Evommune, Inc.
1841 Page Mill Road, Suite 100
Palo Alto, CA 94304
Re:Evommune, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted July 18, 2025
CIK No. 0002044725
Dear Luis Peña:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.We note the disclosure that was added with regard to the CIndU Phase 2 trial. Please
revise your disclosure to remove your references to "positive" clinical data and
"positive" topline results. Your disclosure should not imply that your product
candidates will be found to be safe or effective by the FDA or comparable regulatory
bodies and should not state conclusions regarding clinical trial data prior to approval.
Our Clinical Pipeline, page 3
We note your response to prior comment 5. Please revise to provide a more fulsome 2.
July 30, 2025
Page 2
discussion of any development activities conducted with regard to EVO756 for "Other
Indications." To the extent you have conducted limited development for these
indications, please explain why they are sufficiently material to your business to
warrant inclusion in your pipeline table. Alternatively, remove any programs that are
not currently material to your business from your pipeline table. Also, please disclose
why the progress bar for chronic inducible urticaria is colored gray.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Comparison of the Three Months Ended March 31, 2025 and 2024
Operating Expenses
Research and Development , page 97
3.We note your revised disclosure in response to prior comment 9 and reissue in part.
Please elaborate on the increase in "other development programs."
Business
EVO756, Targeting MRGPRX2 for Chronic Inflammatory Diseases, page 111
4.We note your response to prior comment 11. Please revise, where appropriate, to
explain your reasoning for characterizing the clinical and regulatory pathway for
EVO756 as "efficient" given your statement appearing on page 162 claiming that you
do not intend to pursue any accelerated approval pathways for your clinical
candidates. Alternatively, remove this statement from the graphic on page 112.
5.We note your response to prior comment 12 and reissue in part. Please revise to
include a brief discussion of the specific third-party studies you reference
as supporting the rationale for targeting MRGPRX2 for chronic inflammatory
diseases.
Figure 3: EVO756 FricTest Score Improvements and Other Efficacy Metrics, page 114
6.We note the addition of Figure 3 and the "Other Efficacy Metrics." Please clarify
whether these "metrics" were established endpoints in the study. Please also delete the
reference to "efficacy" as your disclosure should not imply that your product
candidates will be found to be safe or effective by the FDA or comparable regulatory
bodies.
Our Mission and Strategy, page 118
7.We note your response to prior comment 13 and reissue. Please remove any other
references to EVO756 or EVO301 being potentially "best-in-class" or "first-in-class"
from your registration statement, as these statements imply that your candidates are
expected to receive FDA approval. We would not object to a general statement
claiming, if true, that it is your goal to develop potential first-in-class and/or best-in-
class drug products without specifically referring to your individual candidates.
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.
July 30, 2025
Page 3
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Minkyu Park, Esq.
2025-06-10 - UPLOAD - Evommune, Inc. File: 377-08010
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.
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