<SEC-DOCUMENT>0000000000-21-003031.txt : 20210513
<SEC-HEADER>0000000000-21-003031.hdr.sgml : 20210513
<ACCEPTANCE-DATETIME>20210312173006
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-21-003031
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20210312

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Biomea Fusion, Inc.
		CENTRAL INDEX KEY:			0001840439
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		726 MAIN STREET
		CITY:			REDWOOD CITY
		STATE:			CA
		ZIP:			94063
		BUSINESS PHONE:		(650) 980-9099

	MAIL ADDRESS:	
		STREET 1:		726 MAIN STREET
		CITY:			REDWOOD CITY
		STATE:			CA
		ZIP:			94063
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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<TYPE>TEXT-EXTRACT
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<FILENAME>filename2.txt
<TEXT>
United States securities and exchange commission logo





                             March 12, 2021

       Thomas Butler
       Chief Executive Officer
       Biomea Fusion, Inc.
       726 Main Street
       Redwood City, CA 94063

                                                        Re: Biomea Fusion, Inc.
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted February
12, 2021
                                                            CIK No. 0001840439

       Dear Mr. Butler:

              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

       Prospectus Summary
       Overview, page 1

   1.                                                   Please remove your
statement that you believe that your capabilities and platform
                                                        uniquely position you
to be a leader in developing irreversible small molecules. Given the
                                                        number of product
candidates that never receive FDA approval, the time required to
                                                        obtain approval and
your current stage of development, this statement is not appropriate.
                                                        Please remove any
similar statements throughout the prospectus.
   2.                                                   We note that you have
included in your pipeline table two programs with undisclosed
                                                        targets which appear to
be in the discovery phase. Given the early-stage development of
 Thomas Butler
FirstName  LastNameThomas Butler
Biomea Fusion,  Inc.
Comapany
March      NameBiomea Fusion, Inc.
       12, 2021
March2 12, 2021 Page 2
Page
FirstName LastName
         these programs, please explain why each program is sufficiently
material to your business
         to warrant inclusion in your pipeline table. Please also explain what
is involved in
         "Optimization" and why you believe this is a separate and distinct
development phase, as
         opposed to part of IND-Enabling.
Our FUSION System discovery platform, page 2

3.       Please remove the reference to the transaction value for Pharmacyclics
from this section.
         This is not appropriate disclosure for the Prospectus Summary where
full and proper
         context is not provided. We note several references to the management
team's experience
         developing ibrutinib. Please balance this disclosure throughout the
prospectus by noting
         that past experiences are no guarantee of future success.
Our Product Candidates, page 4

4.       We note your statements throughout your filing that you believe
BMF-219 is a potentially
         "first-in-class" irreversible menin inhibitor. These statements imply
an expectation of
         regulatory approval and are inappropriate given the length of time and
uncertainty with
         respect to securing marketing approval. Please remove the phrase
"first-in-
         class" throughout your filing, including, but not limited to, on pages
107 and 108 in your
         Business section.
Our Strategy, page 4

5.       We note your disclosure here and in the Business section that your
strategy is to "rapidly
         advance" BMF-219 into and through clinical development and to evaluate
opportunities to
         "accelerate" development timelines. Please revise this disclosure to
remove any
         implication that you will be successful in commercializing your
product candidates in a
         rapid or accelerated manner as such statements are speculative.
Risk Factors
If we are unable to obtain, maintain, enforce and adequately protect our
patents and other
intellectual property rights, page 55

6.       You state here that you rely upon a combination of patents, trade
secret protection and
         confidentiality agreements to protect the intellectual property
related to your technology
         and product candidates, but you later disclose on page 125 that you
currently do not own
         or in-license any issued patents with respect to any of your product
candidates, including
         BMF-219. Please revise this risk factor accordingly.
Our amended and restated certificate of incorporation and amended and restated
bylaws will
provide for an exclusive forum, page 73

7.       Please revise this risk factor to disclose that there is also a risk
that your exclusive forum
         provision may result in increased costs for investors to bring a
claim.
 Thomas Butler
Biomea Fusion, Inc.
March 12, 2021
Page 3
Competition, page 123

8.     Please disclose the basis for your belief that you are the only company
with the ability to
       discover and develop irreversible binders specifically against menin.
Please also revise
       your disclosure regarding the encouraging clinical benefit and strong
pharmacologic
       validation of menin from preliminary Phase 1 results of other product
candidates to avoid
       any suggestion that such product candidates have demonstrated safety or
efficacy.
       Findings of safety and efficacy are solely within the authority of the
FDA and are assessed
       throughout all clinical trial phases.
Intellectual Property, page 124

9.     Please revise to disclose the specific product candidates or
technologies to which the
       patent applications relate and the type of patent protection you are
trying to obtain
       (composition of matter, use or process). Please also briefly explain
what an ex-U.S. patent
       application is. If that is meant to refer to a foreign patent
application, please identify the
       jurisdiction.
Principal Stockholders, page 157

10.    Please revise to disclose how the entities listed in footnote 4 are
affiliated with the
       Tavistock Group.
General

11.    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.
       You may contact Eric Atallah at 202-551-3663 or Daniel Gordon at
202-551-3486 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Dillon Hagius at 202-551-7976 or Ada D. Sarmento at 202-551-3798 with
any other
questions.



                                                               Sincerely,
FirstName LastNameThomas Butler
                                                               Division of
Corporation Finance
Comapany NameBiomea Fusion, Inc.
                                                               Office of Life
Sciences
March 12, 2021 Page 3
cc:       Miles P. Jennings, Esq.
FirstName LastName
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
