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United States securities and exchange commission logo
June 12, 2021
Benjamin J. Zeskind, Ph.D.
Chief Executive Officer
Immuneering Corporation
245 Main Street, Second Floor
Cambridge, MA 02142
Re: Immuneering
Corporation
Draft Registration
Statement on Form S-1
Submitted May 13,
2021
CIK No. 0001790340
Dear Dr. Zeskind:
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
Industry and Other Data, page ii
1. Your statements that
(i) third party sources do not guarantee the accuracy or completeness
of the information
presented in the prospectus, (ii) you have not had third party
information
independently verified by any independent sources and (iii) no independent
source has verified
your internal research and market definitions may imply inappropriate
disclaimers of
responsibility with respect to this information. Please either delete these
statements or
specifically state that you are liable for such information.
Benjamin J. Zeskind, Ph.D.
FirstName LastNameBenjamin J. Zeskind, Ph.D.
Immuneering Corporation
Comapany
June NameImmuneering Corporation
12, 2021
June 12,
Page 2 2021 Page 2
FirstName LastName
Prospectus Summary
Overview, page 1
2. Please provide us with the basis for your claims that you have more
than a decade of
leadership in translational bioinformatics and that you have an
established track record of
generating insights into drug mechanisms of action and patient
treatment responses.
Our Wholly Owned Pipeline, page 2
3. Please revise your pipeline table to combine the lead optimization
column with the
discovery column. A textual discussion of the program is a more
appropriate place to
make distinctions regarding different segments within a particular
phase. With the
exception of IMM-1-104, it appears that all of your product candidates
are in the
discovery phase. Given the early stage of development of these
programs, please explain
why each program is sufficiently material to your business to warrant
inclusion in your
pipeline table
Dual-MEK Program, page 4
4. We note statements in the Summary and Business sections regarding the
performance of
your product candidates. For example, we note statements that you have
observed
therapeutic activity with improved tolerability of IMM-1-104 in
preclinical studies as
compared to current FDA-approved drugs and similar statements. Please
revise the first
paragraph on page 4 and similar statements throughout the prospectus
to revise all
performance claims so that the basis for each statement is clear.
Safety and efficacy
determinations are the exclusive authority of the FDA or comparable
foreign regulators.
You may provide a summary of the data that you used to draw these
conclusions, but not
the conclusions or predictions that the product candidates are safe or
effective.
Our Strategy, page 5
5. We note your disclosure here and elsewhere in the prospectus
referencing your plans to
"rapidly advance" the development of IMM-1-104. Please revise this
disclosure and
similar disclosure throughout the prospectus to remove any implication
that you will be
successful in developing your product candidates in a rapid or
accelerated manner as such
statements are speculative.
6. We note your statements here and in the Business section claiming that
your platform
allows you to leverage human biological data in new and creative ways
which provide
counterintuitive insights that are not constrained by inherent
limitations of conventional
approaches or prevailing scientific views. However, translational
bioinformatics appears
to be a growing field with numerous researchers and participants.
Please revise your
disclosure to explain why your approach in particular is
counterintuitive and why you are
able to leverage data in ways that others cannot.
Benjamin J. Zeskind, Ph.D.
FirstName LastNameBenjamin J. Zeskind, Ph.D.
Immuneering Corporation
Comapany
June NameImmuneering Corporation
12, 2021
June 12,
Page 3 2021 Page 3
FirstName LastName
Our Team, page 5
7. We note that you identify certain entities as investors in your
company here and on page
98. However, certain of these entities do not appear to be among your
principal
stockholders as disclosed on page 153. If material, please expand your
disclosure to
describe the nature of each such entity's investment in you and
explain to us why
including this information is appropriate. Please also explain in the
response your plans to
update investors about any changes these entities make with respect to
their investments in
your company.
Summary Risk Factors, page 5
8. Please revise to add the risk that your approach to the discovery and
development of
product candidates is unproven, and you may not be successful in your
efforts to use and
expand your DCT platform to build a pipeline of product candidates
with commercial
value.
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company, page 7
9. 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.
Use of Proceeds, page 75
10. Please update the second bullet in Use of Proceeds, when possible, to
disclose how far in
the development of these programs you estimate that the proceeds from
this offering will
allow you to reach, including how many additional programs and how
many of your
current programs you will be able to pursue and for how many programs
you estimate that
you will be able to begin or complete IND-enabling studies.
Critical Accounting Policies
Equity-based Compensation, page 91
11. It appears from your Outstanding Equity Awards table on page 144 that
you did not grant
any options or other equity awards to the three named executive
officers (NEOs) during
2020. Please confirm for us that none of the equity-based awards
granted in 2020 as
presented in the table on page 92 were granted to NEOs or revise your
disclosure
accordingly.
12. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the initial public offering and the estimated offering price.
This information will help
facilitate our review of your accounting for equity issuances
including stock compensation
Benjamin J. Zeskind, Ph.D.
FirstName LastNameBenjamin J. Zeskind, Ph.D.
Immuneering Corporation
Comapany
June NameImmuneering Corporation
12, 2021
June 12,
Page 4 2021 Page 4
FirstName LastName
and beneficial conversion features. Please discuss with the staff how
to submit your
response.
Business, page 94
13. We note your disclosure on page 49 that you own pending patent
applications in the
United States related to your platform technologies and pending patent
applications
related to your product candidates. Please revise your Business
section to include a
discussion of your intellectual property coverage, including the
specific products, product
groups and technologies to which the patent applications relate, the
type of patent
protection you are seeking, the applicable jurisdictions and the
potential patent expiration
dates.
Our Bioinformatics Approach, page 99
14. We note your statement that your approach has already yielded programs
that have
exhibited preclinical activity against a broad range of clinically
challenging solid tumors
and are advancing towards the clinic. Please revise your disclosure to
clarify that the
majority of your product candidates have yet to advance to
IND-enabling studies.
Our Differentiated Approach to Tackling Some the Most Challenging Cancers, page
101
15. Please provide the basis for your claim that your insights derived
from your translational
bioinformatics platform have "substantiated" your belief that
leveraging signaling
dynamics against tumor addiction will result in better drugs. This
statement appears to be
premature given the current stage of development of your product
candidates.
Trifecta-MEK Program, page 110
16. We note your statement that you are developing "potentially
first-in-class" therapies that
are designed to uniquely engage MEK. Given your current stage of
development, it
appears to be premature to make this claim. Please revise your
disclosure to remove this
statement.
Executive and Director Compensation
Executive Compensation Arrangements, page 143
17. When available, please revise this section to describe the material
terms of your new
employment agreements with your named executive officers and file the
agreements as
exhibits to your registration statement.
Description of Capital Stock
Registration Rights, page 156
18. Please quantify the number of shares of your common stock that will
have registration
rights following the offering.
Benjamin J. Zeskind, Ph.D.
Immuneering Corporation
June 12, 2021
Page 5
You may contact Jenn Do at 202-551-3743 or Angela Connell at
202-551-3426 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Alan Campbell at 202-551-4224 or Ada D. Sarmento at 202-551-3798 with
any other
questions.
Sincerely,
FirstName LastNameBenjamin J. Zeskind, Ph.D.
Division of
Corporation Finance
Comapany NameImmuneering Corporation
Office of Life
Sciences
June 12, 2021 Page 5
cc: Nathan Ajiashvili, Esq.
FirstName LastName