<SEC-DOCUMENT>0000000000-20-008328.txt : 20201106
<SEC-HEADER>0000000000-20-008328.hdr.sgml : 20201106
<ACCEPTANCE-DATETIME>20200903150614
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-20-008328
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20200903

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Shattuck Labs, Inc.
		CENTRAL INDEX KEY:			0001680367
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				812575858
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		1018 W. 11TH STREET
		CITY:			AUSTIN
		STATE:			TX
		ZIP:			78703
		BUSINESS PHONE:		919-864-2700

	MAIL ADDRESS:	
		STREET 1:		1018 W. 11TH STREET
		CITY:			AUSTIN
		STATE:			TX
		ZIP:			78703
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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<TEXT>
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
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