United States securities and exchange commission logo
September 3, 2020
Taylor Schreiber
Chief Executive Officer
Shattuck Labs, Inc.
1018 W. 11th Street, Suite 100
Austin, TX 78703
Re: Shattuck Labs, Inc.
Draft Registration
Statement on Form S-1
Submitted August 7,
2020
CIK 0001680367
Dear Dr. Schreiber:
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 submitted August 7, 2020
Prospectus Summary
Overview, page 1
1. We note your statements
here and throughout your document that your product candidates
are designed or have
the potential to be "best-in-class." This term suggests that
your product candidates
are effective and likely to be approved, particularly given your
claims regarding your
pioneering the development of dual-sided fusion proteins. Please
delete these references
throughout your document. If your use of the term was designed to
convey your belief that
your product candidates are based on a differentiated technology
or approach, you may
further discuss how your technology or approach differs from those
of your competitors.
Taylor Schreiber
FirstName LastNameTaylor Schreiber
Shattuck Labs, Inc.
Comapany 3,
September NameShattuck
2020 Labs, Inc.
September
Page 2 3, 2020 Page 2
FirstName LastName
2. Please balance your discussion of the key advantages of your product
candidates with an
equally prominent discussion of any detriments. In particular, we note
your disclosure
elsewhere in your document that your dual-sided fusion protein product
candidates have
not been tested before in humans and may have properties that
negatively impact
safety and efficacy, and that previous attempts to simultaneously
complement the
administration of checkpoint inhibitors with the stimulation of
costimulatory receptors
have not been successful in clinical trials.
3. We note your use of the terms "unmet medical need" and "significant
unmet clinical need"
here and elsewhere in the document. Such terms might imply that your
product
candidates are eligible for fast track designation or priority review
granted by the FDA for
products that treat certain serious unmet medical needs. Please remove
your use of these
terms throughout or otherwise please explain why you believe use of
these terms are
appropriate.
Our Pipeline, page 4
4. Your disclosure here indicates that you have initiated a Phase 1
clinical trial of SL-172154
for CSCC and HNSCC. However, your disclosure elsewhere in the
prospectus (including
pages 103 and 116) indicates that the Phase 1 trial has not yet
commenced. Please revise
your disclosure to indicate the current status of this trial,
including any necessary
update to the progress bar in the pipeline chart.
5. We note that none of the programs disclosed in your table on page 5
are discussed in the
body of the prospectus. As such, it appears that it may be premature
to include these
programs in your prospectus summary. Please revise or provide us your
analysis as to why
these programs are sufficiently material to highlight in your
prospectus summary.
Risks Associated with Our Business, page 6
6. We note your disclosure on page 15 that you have actually experienced
delays in your
clinical trial of SL-279252 as a result of the ongoing pandemic. If
the pandemic has
actually impacted your clinical trials in a material way, please
update your disclosure in
this section as appropriate.
Implications of Being an Emerging Growth 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 copies of the communications.
Taylor Schreiber
FirstName LastNameTaylor Schreiber
Shattuck Labs, Inc.
Comapany 3,
September NameShattuck
2020 Labs, Inc.
September
Page 3 3, 2020 Page 3
FirstName LastName
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies
Estimating the Fair Value of Common Stock, page 97
8. Once you have an estimated offering price range, please explain to us
the reasons for any
differences between recent valuations of your common shares leading up
to the planned
offering and the midpoint of your estimated offering price range. This
information will
help facilitate our review of your accounting for equity issuances,
including stock
compensation.
Business
Our Strategy, page 103
9. We note your statement that if your clinical data is compelling,
accelerated registration
paths and other regulatory designations will be discussed with
regulatory agencies. Please
revise your statement to clarify that any such determination will be
in the solely in the
discretion of such regulatory agencies and that there can be no
guarantee that any of your
product candidates will be granted a differentiated regulatory path or
designation.
Clinical Development Strategy, page 122
10. We note your disclosure in the first paragraph of this section that
one of the secondary
objectives of your Phase 1 trial includes the anti-tumor activity of
SL-279252. Please
expand your disclosure in the second paragraph of this section to
briefly indicate how you
intend to evaluate any anti-tumor activity.
11. Please update your disclosure in this section to discuss the delays
experienced so far in
your ongoing Phase 1 clinical trial of SL-279252 as well as any
anticipated future delays
and the patients in your clinical trials who have chosen to forgo one
or more doses and the
reasons given for declining doses.
12. We note your disclosure that SL-279252 has been well-tolerated with no
dose-limiting
toxicities observed to date. Please update your disclosure to discuss
whether any adverse
or serious adverse events have been observed that were deemed related
to SL-279252 and
the nature of any such events.
Collaboration Agreement with Takeda, page 123
13. We note your disclosure in the second paragraph of this section that
you will conduct
preclinical and Phase 1 clinical trials for two molecules,
PD-1-Fc-OX40L and CSF1R-Fc-
CD40L, under the Takeda agreement. Please update your prospectus, as
appropriate, to
address the status of your obligation to develop CSF1R-Fc-CD40L.
14. We refer to the disclosure in the second paragraph on page 124. Please
clarify if Takeda
will be obligated to develop, manufacture or commercialize any of the
ARC compounds
that it may license. Please separately disclose the aggregate amount
potentially receivable
Taylor Schreiber
Shattuck Labs, Inc.
September 3, 2020
Page 4
in license fees, and the aggregate amount potentially receivable from the
development,
regulatory and sales milestones. Also disclose the duration of the
royalty term during
which you might be eligible to receive tiered royalty payments and, in
the next paragraph,
the duration of the "option term" for the optioned molecules.
Heat License Agreement, page 124
15. We note your disclosure that, pursuant to the terms of the Heat License
Agreement, you
are obligated to use commercially reasonable efforts to diligently
research and develop at
least one product covered by the Fusion Protein Patent Rights. Please
revise to clarify if
any of the products you currently have in development satisfies this
obligation.
Manufacturing and Supply, page 125
16. Please update your disclosure in this section to include a discussion of
the novel
manufacturing and purification process (along with the potential delays
in manufacturing
scale-up and higher costs) for your product candidates and the drug
substance stability
challenges described on page 24 of the prospectus.
We further note your disclosure discussing your reliance on a
single-source supplier for
bulk drug substance. To the extent you are substantially dependent on any
agreements
with this supplier, please describe the material terms of such agreements
and file the
agreements as exhibits. If you believe you are not substantially
dependent on the
agreements, please provide us with an analysis supporting your belief.
Principal Stockholders, page 169
17. 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.
You may contact Franklin Wyman at 202-551-3660 or Kevin Vaughn at
202-551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Alan Campbell at 202-551-4224 or Tim Buchmiller at 202-551-3635 with
any other
questions.
Sincerely,
FirstName LastNameTaylor Schreiber
Division of
Corporation Finance
Comapany NameShattuck Labs, Inc.
Office of Life
Sciences
September 3, 2020 Page 4
cc: Branden C. Berns, Esq.
FirstName LastName