United States securities and exchange commission logo
September 1, 2020
Purnanand D. Sarma, Ph.D.
Chief Executive Officer
Immunome Inc.
665 Stockton Drive, Suite 300
Exton, PA 19341
Re: Immunome Inc.
Draft Registration
Statement on Form S-1
Filed August 12,
2020
File No. 377-03406
Dear Dr. Sarma:
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 filed August 12, 2020
Prospectus Summary , page 1
1. Please add disclosure
to clarify that, while the company has been working on oncology
applications of its
therapeutic platforms for an extended period of time, the infectious
disease applications
needed to develop a therapeutic approach to combat the SARS-CoV-2
virus are a new area of
study. Clarify any significant disparities between the two
applications that you
have already identified, and balance the disclosure by noting any
risks associated with
the shift in focus.
2. Please amend your
disclosure to clarify what makes your platform different from other
research platforms, and
whether any other research currently employs a similar approach.
In particular, explain
what you mean when you say your approach is "unbiased," and
Purnanand D. Sarma, Ph.D.
FirstName
ImmunomeLastNamePurnanand D. Sarma, Ph.D.
Inc.
Comapany 1,
September NameImmunome
2020 Inc.
September
Page 2 1, 2020 Page 2
FirstName LastName
whether that is unique to your company. If it is not unique, contrast
your approach to
those of other companies.
3. Please define hybridoma, immunoglobulins and IL-38 and other terms of
art on first use.
4. Please provide more information about the therapeutic approach to
SARS-CoV2, how it
differs from your approach to oncological disease, and the timing of
anticipated product
candidate development. Clarify early in your disclosure the time that
you anticipate being
required to bring such products to market.
5. Please disclose in the Risk Factors Summary on page 4 that you have on
hand
funds sufficient to fund your operations only into January 2021.
Please make a
conforming revision to the going concern risk factor on page 12.
6. 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 Julia
Griffith at 202-551-
3267 to discuss how to submit the materials, if any, to us for our
review.
Summary Financial Data, page 8
7. Please revise note (1) to reference financial statement Note 2. Also,
please expand this
note to clarify that the EPS data gives effect to the reverse stock
split mentioned on page
7.
Risk Factors, page 10
8. Please refer to the risk factor on page 23 discussing the company's
possible use of
accelerated approval pathways for FDA approval. Please disclose the
specific programs
applicable to products or therapeutic platforms that you are currently
developing.
Strategic Collaborations and License Agreements
IMM-BCP-01 Collaboration with the DoD, page 96
9. Please expand the description of your agreement with the DoD to
disclose the materials
terms of the agreement. In doing so, please address the nature, scope
and ownership
of intellectual property created or transferred through the
collaboration, each parties
rights and obligations, the duration of the agreement, as well as
provisions for future
payments and royalties, if any. Please make conforming revisions to
the description of the
agreement in the prospectus summary.
Purnanand D. Sarma, Ph.D.
Immunome Inc.
September 1, 2020
Page 3
You may contact Tracie Mariner at 202-551-3744 or Al Pavot at
202-551-3738 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Julia Griffith at 202-551-3267 or Dietrich King at 202-551-8071 with
any other
questions.
FirstName LastNamePurnanand D. Sarma, Ph.D. Sincerely,
Comapany NameImmunome Inc.
Division of
Corporation Finance
September 1, 2020 Page 3 Office of Life
Sciences
FirstName LastName