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United States securities and exchange commission logo
September 1, 2020
Randall C. Schatzman
Chief Executive Officer
Bolt Biotherapeutics, Inc.
900 Chesapeake Drive
Redwood City, CA 94063
Re: Bolt
Biotherapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted August
10, 2020
CIK No. 0001641281
Dear Dr. Schatzman:
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
Overview, page 1
1. We note your disclosure
that your lead product candidate has a favorable safety and
tolerability profile,
has a favorable preclinical safety profile and has preclinical data
[that] showe[s]
compelling anti-tumor efficacy. We also note your disclosure related to
PD-L1 that you
"observed superior anti-tumor efficacy." Determination as to a drug's
safety and efficacy are
solely within the purview of the FDA or other regulatory body. As
your product candidates
have not received FDA approval, it is premature to suggest or
imply that they are
safe or effective. Please revise your disclosure here and any similar
statements throughout
the prospectus accordingly.
2. We note your disclosure
that in your preclinical studies you "observed complete
Randall C. Schatzman
Bolt Biotherapeutics, Inc.
September 1, 2020
Page 2
regression and durable anti-tumor effects" and "promising anti-tumor
effects." We also
note other similar conclusory statements throughout the filing
regarding your preclinical
studies. Please revise the descriptions of your preclinical studies in
the prospectus
summary and throughout to focus on the specific factual details of the
studies, including
quantitative information regarding the range of results observed. In
addition, in your
prospectus summary, clarify that the preclinical trials involved mice
and non-human
primates. Similarly, in your Business section, please revise to
include more detailed
descriptions of each preclinical trial conducted, including the number
of tests conducted,
the number of mice or non-human primates used in each test and the
range of results
observed.
Our Pipeline, page 4
3. Please revise the pipeline chart to include individual columns for
each of the three phases
of clinical development. Please also advise what you mean by
"Registrational" or,
alternatively, please remove.
Implications of Being an Emerging Growth Company, page 6
4. Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance
on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain,
copies of those
communications. Please contact the staff member associated with the
review of this filing
to discuss how to submit the materials, if any, to us for our review.
Risk Factors
Risks Related to Our Business Operations, Employee Matters and Managing Growth
Our business, operations and clinical development plans and timelines, page 49
5. We note your disclosure on page 49 that your "clinical trials have
been and may continue
to be affected by the COVID-19 pandemic." Please revise the referenced
risk factor to
discuss in greater detail how your clinical trials have been affected.
Risks Related to This Offering and Our Common Stock
Our amended and restated certificate of incorporation , page 60
6. We note your disclosure on pages 60 and 163 that your amended and
restated certificate of
incorporation will include exclusive forum provisions that do not apply
to suits brought to
enforce a duty or liability created by the Exchange Act. Please ensure
that the exclusive
FirstName LastNameRandall C. Schatzman
forum provisions in the governing documents clearly state that they do
not apply to
Comapany NameBolt
actions Biotherapeutics,
arising under Inc.Act, or tell us how you will
inform investors in future
the Exchange
filings
September that the
1, 2020 provisions
Page 2 do not apply to any actions arising under
the Exchange Act.
FirstName LastName
Randall C. Schatzman
FirstName LastNameRandall C. Schatzman
Bolt Biotherapeutics, Inc.
Comapany 1,
September NameBolt
2020 Biotherapeutics, Inc.
September
Page 3 1, 2020 Page 3
FirstName LastName
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, Comparison of the Years Ended December 31, 2018 and
2019, page 75
7. You disclose that research and development expenses and general and
administrative
expenses increased in the year ended December 31, 2019 as compared to
2018 as a result
of higher personnel-related expenses due to increased headcount.
Please revise to disclose
the specific changes in and additions to headcount that contributed to
the increase in
expenses.
8. We see that $12.2 million of the increase in research and development
expenses related
to BDC-1001 and your other preclinical programs due to the completion
of your GLP
toxicology program and the submission of your IND application for
BDC-1001. Please
revise to provide a more detailed discussion of research and
development expenses related
to your product candidates, including a discussion of the nature of
expenses incurred and
the existence of any trends, events or uncertainties that are
reasonably likely to impact
future results of operations or financial position. See Item 303(a)(3)
of Regulation S-K for
further guidance.
Critical Accounting Policies and Significant Judgments and Estimates,
Stock-Based
Compensation Expense, page 82
9. We see that you issued 11.3 million stock options during the year
ended December 31,
2019. Please revise to disclose the fair value of common stock that
was used during the
the fiscal year and any subsequent interim period provided in the
financial statements to
determine the fair value of the stock options. In that regard, provide
us the estimated
offering price or range when it is available and explain to us the
reasons for significant
differences between recent valuations of your common stock and the
estimated offering
price.
Business
License and Collaboration Agreements
License Agreements with Stanford University, page 107
10. Please refer to the fourth paragraph on page 107. We note that you are
obligated to pay
Stanford a percentage based upon consideration received from granting
sublicenses.
Please revise your description of the sublicense percentage to provide
a range that does
not exceed ten percent.
Intellectual Property, page 110
11. Please revise the second paragraph on page 111 to specify the product
candidates or
technologies to which the patents and pending patent applications
relate, and specify
whether each of the listed patents and patent applications are subject
to the 2015 Stanford
Agreement or to the 2018 Stanford Agreement as Stanford has retained
different rights in
each of these agreements. In addition, clarify which of the pending
patent applications are
Randall C. Schatzman
Bolt Biotherapeutics, Inc.
September 1, 2020
Page 4
provisional patent applications.
Executive Compensation
Employment Arrangements
David Dornan, Ph.D., page 142
12. Please file David Dornan's Offer Letter as an exhibit to your
registration statement or tell
us why you believe this is not necessary.
Note 2. Summary of Significant Accounting Policies, Unaudited Pro Forma
Financial
Information, page F-8
13. We reference the discussion of the pro forma balance sheet reflecting
the changes in
capitalization at the closing of the IPO. Please revise to present the
pro forma balance
sheet (excluding effects of offering proceeds) alongside of the
historical balance sheet
giving effect to the change in capitalization.
You may contact Kristin Lochhead at 202-551-3664 or Daniel Gordon at
202-551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Donald Field at 202-551-3680 or Sonia Bednarowski at 202-551-3666 with
any other
questions.
FirstName LastNameRandall C. Schatzman Sincerely,
Comapany NameBolt Biotherapeutics, Inc.
Division of
Corporation Finance
September 1, 2020 Page 4 Office of Life
Sciences
FirstName LastName