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United States securities and exchange commission logo
April 14, 2021
Jeremy Bender, Ph.D., M.B.A.
Chief Executive Officer
Day One Biopharmaceuticals Holding Co LLC
395 Oyster Point Blvd., Suite 217
South San Francisco, CA 94080
Re: Day One
Biopharmaceuticals Holding Co LLC
Draft Registration
Statement on Form S-1
Submitted March 19,
2021
CIK No. 0001845337
Dear Dr. Bender:
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 March 19, 2021
Prospectus Summary
Overview, page 1
1. We note your statement
on page 1 that your lead product candidate has the potential to be
first-in-class and
several other references to first-in-class on pages 2, 3, 104, 121, 126,
and elsewhere in the
prospectus. This term suggest that the product candidate is effective
and likely to be
approved by the FDA. Please delete these references throughout your
registration statement.
To the extent your use of this term was intended to convey your
belief that the product
is based on a novel technology or approach and/or is further along
in the development
process, you may discuss how your technology differs from
technology used by
competitors and, as applicable, that you are not aware of competing
Jeremy Bender, Ph.D., M.B.A.
FirstName LastNameJeremy Bender,
HoldingPh.D., M.B.A.
Day One Biopharmaceuticals Co LLC
Comapany
April NameDay One Biopharmaceuticals Holding Co LLC
14, 2021
April 214, 2021 Page 2
Page
FirstName LastName
products that are further along in the development process. Statements
such as these
should be accompanied by cautionary language that the statements are
not intended to
give any indication that the product candidate has been proven
effective or that it will
receive regulatory approval.
2. We note on page 2 that you plan to further [y]our leadership
position. Please
substantiate this and other claims of leadership throughout the
prospectus or revise them
to state them as your beliefs.
3. Please balance your statements that your portfolio is wholly-owned and
that you hold
worldwide exclusive rights to DAY101 for all oncology indications and
to pimasertib for
all therapeutic areas with reference to your milestone and royalty
obligations under the
Viracta license agreement, as discussed on page 148.
Our Product Candidates, page 3
4. We note your statement on page 20 that you expect that the Phase 2
trial of DAY101 in
pLGG will provide a sufficient dataset to support marketing approval
with only 60
patients. Please revise to state the basis for your claim and your
references to the
FIREFLY-1 trial as pivotal.
5. Please shorten the arrows in the pipeline chart to correspond to the
current stage of
development. For example, neither you nor the investigator has
completed any Phase 2
clinical trial of DAY 101 for pediatric relapsed pLGG or as a
frontline therapy in pLGG.
We will not object to footnote or explanatory disclosure to describe
your anticipated
development plans.
6. The third product candidate disclosed in your pipeline table,
MSC201503B, has not been
associated with a target disease. Please tell us why you believe it is
material to your
business or remove it from your pipeline table. In this regard, we
note that there does not
appear to be any discussion of this product candidate or your
development efforts other
than in the disclosure of your license and patent agreements.
Our Strategy, page 5
7. We note your references to rapidly advancing your lead product
candidate through
clinical development, the potential for expedited clinical
execution and the ability to
rapidly advance clinical development of oncology product
candidates in pediatric
patients. Please revise these statements here and throughout your
registration statement to
remove any implication that you will be successful in commercializing
your product
candidates in a rapid or accelerated manner.
Summary Consolidated Financial Data, page 11
8. Please revise to provide pro forma EPS in your consolidated statements
of operations and
comprehensive loss data which reflects the conversion of your
preferred shares. Refer to
Rule 11 of Regulation S-X.
Jeremy Bender, Ph.D., M.B.A.
Day One Biopharmaceuticals Holding Co LLC
April 14, 2021
Page 3
Risk Factors
Risks related to our common stock and this offering, page 78
9. Please revise the exclusive forum risk factor on page 85 to disclose
that investors cannot
waive compliance with the federal securities laws and the rules and
regulations thereunder
and that there is also a risk that your forum selection provisions may
result in increased
costs for investors to bring a claim.
Business, page 121
10. Revise your graphics throughout this section so that the fonts are
large enough to be
legible.
Clinical trial results for pLGG, page 135
11. We note you have disclosed some treatment emergent adverse events here
and some
adverse events related to the pimasertib study on page 144. Please
revise to identify all
treatment-related serious adverse events and the number of patients
that experienced them
for each clinical trial you discuss.
12. Please tell us whether the MRI images on page 137 are representative
of results observed
in your Phase 1 trial of DAY101. If this graphic is not
representative, please remove it.
Intellectual Property, page 150
13. In the third paragraph, you state you own or co-own a patent portfolio
consisting of seven
patent families, however, in the following paragraph it appears you
only discuss five
patent families. Please revise to clarify. Also, for each patent
family, please disclose the
applicable jurisdictions for your granted patents, rather than
generalizing foreign
patents.
Consolidated Financial Statements
Note 17. Subsequent Events, page F-31
14. Please revise to disclose the key terms for the Series B redeemable
convertible preferred
shares.
General
15. Please 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
FirstName LastNameJeremy Bender, Ph.D., M.B.A.
potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they
Comapany NameDay
retain copies ofOne Biopharmaceuticals Holding Co LLC
the communications.
April 14, 2021 Page 3
FirstName LastName
Jeremy Bender, Ph.D., M.B.A.
FirstName LastNameJeremy Bender,
HoldingPh.D., M.B.A.
Day One Biopharmaceuticals Co LLC
Comapany
April NameDay One Biopharmaceuticals Holding Co LLC
14, 2021
April 414, 2021 Page 4
Page
FirstName LastName
You may contact Li Xiao at (202) 551-4391 or Kevin Kuhar at (202)
551-3662 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Abby Adams at (202) 551-6902 or Christine Westbrook at (202) 551-5019
with any
other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Julia Forbess, Esq.