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United States securities and exchange commission logo
December 9, 2020
John Celebi
President and Chief Executive Officer
Sensei Biotherapeutics, Inc.
620 Professional Drive
Gaithersburg, MD 20879
Re: Sensei
Biotherapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted November
12, 2020
CIK No. 0001829802
Dear Mr. Celebi:
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 November 12, 2020
Prospectus Summary
Company Overview, page 1
1. We note your statements
throughout the prospectus that SNS-301 has been "well-tolerated
and has shown promising
anti-tumor activity" and you characterize the results received to
date as positive.
However, given that only nine patients have been evaluated to date,
please revise your
disclosure in the Summary to present a balanced view of the ongoing
clinical trial and the
meaning of the results. In addition, please include a risk factor
discussing the limited
nature of the data received to date and the potential for diverging
data once the patient
population is expanded.
John Celebi
Sensei Biotherapeutics, Inc.
December 9, 2020
Page 2
2. Please remove all references to "Phase 1/2" and "Phase 2/3" clinical
trials throughout the
prospectus and instead reference either phase 1, 2, or 3 distinctly or
tell us the basis for
your belief that have been approved to conduct a Phase1/2 trial and
that you will be
eligible to conduct a Phase 2/3 trials for your SNS3-1 product
candidates and revise your
disclosure as appropriate. Our concern is that the references as
currently disclosed may be
read to imply a shorter clinical trial process or further progress
than has actually been
made, and may skew a potential investor's understanding of the process
applicable to the
company's product candidates. Please ensure your references throughout
the document are
consistent with your disclosure regarding Government Regulation
beginning on page 113.
3. We note the following statements on pages 1, 89 and 94 : "ImmunoPhage
is not only
capable of driving T cell responses, but also generates strong B cell
mediated antibody
responses. We believe that the unique features of ImmunoPhage,
including the flexibility
of antigen design, the ease of platform engineering, its large
antigenic capacity, the low
cost of goods and the high speed of manufacturing, as well as the
enduring stability of our
product candidates, have the potential to lead to a paradigm shift in
cancer
immunotherapies." Given your early stage of development and limited
clinical data
received to date it does not appear these claims are supported. Please
remove in each place
in which they appear.
4. Please remove all references to "positive FDA feedback" received, as
this may be read to
imply approval by the FDA and assured progression in the clinical
trial process which is
not known or within the company's control.
5. We note your statement that you believe that the addition of SNS-301
has the "potential to
generate and expand ASPH specific anti-tumor T cells and thereby
enhance the efficacy
of PD-1 blockade." Please remove all references to efficacy in
relation to your product
candidates, as the determination of both safety and efficacy is solely
within the purview of
the FDA, which has not yet determined SNS-301 to be safe or effective.
Our Pipeline, page 3
6. Please revise your pipeline table to include a column for the
discovery phase prior to the
preclinical phase and separate the columns depicting clinical trials
to distinctly show
phases 1, 2 and 3. In addition, adjust your bar graph for each
candidate to accurately show
its progression in relation to each phase once the table has been
revised. In this regard we
note the pipeline table shown on your website.
FirstName LastNameJohn Celebi
Please also remove the rows relating to SNS-CoV2 and "multiple
pathogens", as it does
Comapany NameSensei
not appear Biotherapeutics,
from your Inc.
disclosure elsewhere that these categories are
material to the
company's
December 9, 2020business
Page 2 at this time.
FirstName LastName
John Celebi
FirstName LastNameJohn
Sensei Biotherapeutics, Inc.Celebi
Comapany9,
December NameSensei
2020 Biotherapeutics, Inc.
December
Page 3 9, 2020 Page 3
FirstName LastName
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation
Fair Value of Common Stock, page 86
7. 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 IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances including stock
compensation and
beneficial conversion features. Please discuss with the staff how to
submit your response.
Business, page 89
8. Where appropriate, please disclose any human capital measures or
objectives that the
company focuses on in managing its business. See Item 101(c)(2)(ii) of
Regulation S-K.
9. We note your discussion of collaborations with AstraZeneca for future
Phase 2 clinical
trials for SNS-301 and the University of Washington for your SNS-401
program. As each
of these product candidates appear material to the business, for each
collaboration please
disclose the company's rights and/or obligations, termination
provisions and expiration
terms, and quantify the amounts paid to date (including upfront
payments and milestone
payments already paid), the aggregate potential milestone payments to
be paid or
received, and any applicable royalty rates. Please also file each as
an exhibit. Please also
revise to disclose that status of any collaboration with the
manufacturer of pembrolizumab
or include risk factor disclosure as appropriate.
Our Approach to Immunotherapy, page 94
10. Please revise your disclosure to provide support for the statements
under the above
heading relating to the functionality of your ImmunoPhage platform and
its components.
To the extent you have clinical data to support the statements please
include a summary
thereof. If you have no clinical data to support the statements,
please clearly state this in
the disclosure.
Targeting ASPH, page 101
11. Please clarify the purpose of the graphics on page 101 entitled
"Tumors Stained Highly
Positive for ASPH", namely what the four individual images are meant
to convey (i.e., a
progression of ASPH over time, four separate patient samples, etc.).
Intellectual Property, page 109
12. Please revise your intellectual property discussion to disclose on an
individual basis the
jurisdiction of each foreign patent and pending patent application.
John Celebi
Sensei Biotherapeutics, Inc.
December 9, 2020
Page 4
License Agreement with Fred Hutch, page 112
13. Please revise your reference to the annual license maintenance fee due
under the Fred
Hutch Agreement from the mid-single digit thousands to "low six figures"
to a more
clearly defined range. Please also confirm that the 1,429,412 shares
issued by Alvaxa to
Fred Hutch (and subsequently exchanged for 2,191,514 shares of the
company's stock) is
the only payment that has been made to date under the agreement.
Principal Stockholders, page 151
14. Please include footnotes to your table that disclose the natural persons
who
have beneficial ownership of the shares held by the entities listed in
your table.
General
15. 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.
16. We note the statements on the company's website that SNS-301 has shown
"excellent
safety and clinical benefit in Phase 1 patient trials, and is currently
in Phase 2 at multiple
clinical sites across the USA", that SNS-301 has "successfully completed
a Phase 1
clinical study", that ImmunoPhage has been "proven" "safe and tolerable
in phase 1 and 2
clinical trials", and that it may solicit a "complete" immune response.
Although we note
that the information contained on your website is not incorporated by
reference into the
prospectus, the information cited above appears to be different from the
disclosure in the
prospectus. Please explain.
17. We note your disclosure throughout the prospectus that you are a smaller
reporting
company; however, you have not indicated this status by checking the box
on the cover
page of the registration statement. Please address this in your next
filing.
You may contact Christine Torney at 202-551-3652 or Angela Connell at
202-551-3426
if you have questions regarding comments on the financial statements and
related matters.
Please contact Laura Crotty at 202-551-7614 or Tim Buchmiller at 202-551-3635
with any other
questions.
Sincerely,
FirstName LastNameJohn Celebi
Division of
Corporation Finance
Comapany NameSensei Biotherapeutics, Inc.
Office of Life
Sciences
December 9, 2020 Page 4
cc: Michael E. Tenta, Esq.
FirstName LastName