View:
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