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United States securities and exchange commission logo
January 10, 2021
Scott Carmer
Chief Executive Officer
NexImmune, Inc.
9119 Gaither Road
Gaithersburg, MD 20877
Re: NexImmune, Inc.
Draft Registration
Statement on Form S-1
Submitted December
14, 2020
CIK No. 0001538210
Dear Mr. Carmer:
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
Overview, page 1
1. Please revise your
disclosure on page 2 and on page 106 to provide the basis for your
statement that your
AIM-activated T cells are potent and can effectively distinguish
between tumor cells and
healthy cells. With reference to your disclosures on page 116, it
appears that these two
claims are based on your preclinical work.
2. We note your statements
on pages 2 and 3 indicating that you have observed initial
indicators of
immunologic response in your Phase I/II trial of NEXI-001. Please balance
your disclosure here
and in the Business section to clarify, if true, that this portion of the
trial is exploratory
and that your claims are not supported by statistically significant trial
results.
Scott Carmer
FirstName LastNameScott Carmer
NexImmune, Inc.
Comapany
January 10,NameNexImmune,
2021 Inc.
January
Page 2 10, 2021 Page 2
FirstName LastName
3. Please revise the Summary presentation, where appropriate, to address
the following:
You plan to initially target a small patient population with your
product candidates
(page 35);
Only limited human study data is available for your AIM
technology, and it remains
not fully known as to what kind of cytokines may be released (page
18); and
The cost to manufacture your modified cell product candidates is
generally higher
than traditional small molecule chemical compounds, and the
manufacturing process
is less reliable and is more difficult to reproduce (page 30).
Our Pipeline, page 4
4. With reference to your disclosures on pages 140-141, please revise the
pipeline
presentation to include all three development phases or advise. With
respect to your
ongoing NEXI-001 and NEXI-002 trials, tell us your basis for
characterizing these as
"Phase I/II" trials. We further note that it does not appear that the
second or "Phase II" part
of either trial has commenced because your disclosure in the second
paragraph on page
124 indicates that you have yet not determined a "Phase II dose" for
NEXI-001 and your
disclosure on page 131 suggests that you have not commenced the
expansion cohort for
NEXI-002. As applicable, please also revise your Summary discussion of
these trials on
pages 2-3.
5. Please explain to us why your AIM ACT product candidate and AIM INJ
product
candidates should be highlighted in the pipeline table. To the extent
that these programs
are material to your business, please revise the Business section to
explain these programs
in greater detail, including a discussion of relevant pre-clinical
work conducted or in
process. In this regard, your disclosure in the Business section
concerning the preclinical
work should support the positioning of the arrows in your pipeline
table.
Our Approach, page 5
6. We note your Summary disclosures claiming that you are a platform for
"rapid" product
development, you intend to "rapidly" advance NEXI-001 and NEXI-002 and
that you will
"accelerate" development of your AIM INJ modality. Please remove these
statements or
revise to provide appropriate balance and context so that these
statements do not
imply that you will be successful in developing and progressing your
product candidates
in a rapid or accelerated manner. In this regard, we note your page 24
disclosure
that Phase 3 clinical trials typically involve hundreds of patients,
have significant costs
and take years to complete.
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company, page 7
7. 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 copes of the communications.
Scott Carmer
NexImmune, Inc.
January 10, 2021
Page 3
Risk Factors
Our bylaws to be effective upon the consummation of this offering designate
certain courts...,
page 76
8. Please revise your disclosure here and on page 185 to clarify that
Section 22 of the
Securities Act creates concurrent jurisdiction for federal and state
courts over all suits
brought to enforce any duty or liability created by the Securities Act
or the rules and
regulations thereunder and that there is uncertainty as to whether a
court would enforce an
exclusive forum provision for actions arising under the Securities
Act.
Capitalization, page 84
9. Please revise to reflect the redeemable convertible preferred stock
outside of permanent
equity consistent with your interim balance sheet on page F-29.
Research and Development Expenses, page 94
10. We note that you have multiple drug candidates in varying stages of
development and
clinical testing and that research and development is a significant
aspect of your business.
Please revise to provide more detail for your research and development
expenses for each
period presented, including but not limited to by product candidate as
well as by the
nature of the expenses. To the extent that you do not track expenses
by product candidate,
please disclose as such.
Business
Our Approach, page 110
11. We note your statement that your current clinical trials of NEXI-001
and NEXI-002
utilize the HLA-A2 allele, which is expressed by more than 40% of the
Caucasian
population. Please revise to discuss in greater detail your plans for
developing other HLA
allele subtypes and how your exclusive use of the HLA-A2 allele in the
present
trials impacts, if at all, the regulatory pathway and timeline to
commercialization. For
instance, please discuss whether this limitation impacts your ability
to advance these
product candidates to a registrational trial or to obtain Breakthrough
Therapy Designation.
Also, discuss if a lack of data concerning other HLA allele subtypes
and patient
populations could impact the design of future clinical trials.
Our Strategy, page 111
12. We note your use of the term significant unmet medical need . This
term may imply that
FirstName LastNameScott Carmer
your product candidates have been granted fast track designation or
priority review by the
Comapany
FDANameNexImmune, Inc.certain serious unmet medical needs. Please
revise or
for products that treat
Januaryotherwise
10, 2021 explain
Page 3 why you believe use of this term is appropriate.
FirstName LastName
Scott Carmer
FirstName LastNameScott Carmer
NexImmune, Inc.
Comapany
January 10,NameNexImmune,
2021 Inc.
January
Page 4 10, 2021 Page 4
FirstName LastName
AIM ACT T cell Characterization, page 116
13. We note your non-clinical comparison of the killing activity of WT-1
transduced T cells
and your AIM-expanded T cells. Given your disclosure that the models
were not identical
and these results are not a head-to-head comparison, please tell us,
and revise to discuss, if
applicable, whether there were material differences between the models
that could
materially impact the comparison and conclusions presented.
Preliminary Data from the Phase I/II Clinical Trial, page 124
14. We note your statement on page 125 and on page 2 that the initial
three patients in your
Phase I/II clinical trial of NEXI-001 experienced "rapid and robust"
lymphocyte
reconstitution. Given your disclosure that normal return to baseline
ALC takes 1-3
months, explain to us how you were able to conclude that the
lymphocyte reconstitution
was both rapid and robust. In this regard, the results for two of the
three patients in the
NEXI-001 trial appear to be within the bounds of normal lymphocyte
recovery-to-baseline
timelines.
15. Please revise to disclose where your ongoing clinical trials are
conducted and indicate
whether there are established endpoints for assessing safety and
efficacy.
Johns Hopkins License Agreement, page 137
16. Please update your description of your exclusive license agreement as
follows:
Disclose separately the aggregate amount of all potential
clinical and regulatory,
diagnostic and non-clinical milestone payments;
Describe the circumstances that would lead to you being
required to pay royalties on
therapeutic products, diagnostic products and non-clinical
products;
Quantify the potential increases in the minimum annual royalty
payments in the
future;
Revise your description of the non-royalty sublicense
consideration to provide a
range that does not exceed ten percent; and
Disclose when the royalty provisions expire.
Intellectual Property, page 138
17. Please revise your intellectual property subsection to indicate
whether any of the material
patents cover a specific technology or product candidate and identify
the type of patent
protection.
Description of Capital Stock, page 181
18. In this section, and elsewhere in your prospectus, you state that your
outstanding shares of
preferred stock, including shares of preferred stock issuable upon the
automatic
Scott Carmer
NexImmune, Inc.
January 10, 2021
Page 5
conversion of all of your outstanding convertible promissory notes, will
automatically
convert into 196,970,172 shares of common stock upon the completion of
the offering.
However, in Dilution, Principal Stockholders, and Shares Eligible for
Future Sale, you
indicate that your outstanding shares of preferred stock, including
automatic conversion of
all outstanding convertible promissory notes, will convert into
201,162,009 shares of
common stock. Please revise or explain to us how your disclosures are
consistent.
Exhibits
19. We note that item 10.11 in your exhibit index refers to an exclusive
license agreement by
and between you and Johns Hopkins University dated June 21, 2011.
Elsewhere in the
prospectus, you statement that this agreement was amended and restated in
January 2017.
Please file the amended and restated agreement as an exhibit to your
registration
statement.
You may contact Gary Newberry at (202) 551-3761 or Kevin Kuhar at (202)
551-3662 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Alan Campbell at (202) 551-4224 or Joe McCann at (202) 551-6262 with
any other
questions.
Sincerely,
FirstName LastNameScott Carmer
Division of
Corporation Finance
Comapany NameNexImmune, Inc.
Office of Life
Sciences
January 10, 2021 Page 5
cc: John T. Rudy
FirstName LastName