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United States securities and exchange commission logo
September 29, 2023
Zachary Hornby
President and Chief Executive Officer
Boundless Bio, Inc.
9880 Campus Point Drive, Suite 120
San Diego, CA 92121
Re: Boundless Bio, Inc.
Draft Registration
Statement on Form S-1
Submitted September
1, 2023
CIK No. 0001782303
Dear Zachary Hornby:
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 September 1, 2023
Prospectus Summary
Overview, page 1
1. We note your disclosure
here and throughout your Prospectus stating, among other things,
that your product
candidates demonstrated potent inhibition and showed "substantial . . .
anti-tumor activity[.]"
Please revise these and similar statements throughout your
prospectus to eliminate
conclusions or predictions that your product candidates are
effective, as
determinations of efficacy are solely within the authority of the FDA. You
may provide an
objective summary of the data that you used to draw such conclusions.
2. Please revise pages 2
and 103 to provide the basis for your belief that you are the world s
Zachary Hornby
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leading ecDNA experts and that Dr. Paul Mischel is the globally
recognized leader in
the ecDNA field.
3. Please revise to define synthetic lethal the first time it is
used.
4. We note your disclosure that since your inception, you have raised
"$252.1 million from
leading life science investors, including [y]our 5% or greater
stockholders, ARCH
Venture Partners, Fidelity Management & Research Company LLC, RA
Capital
Management, Leaps by Bayer, Nextech Invest, and Vertex Ventures HC, as
well as other
investors." Please relocate this disclosure from your prospectus
summary to your
"Principal Stockholders" section. We note in this regard that the
identification of the pre-
IPO investors in your prospectus summary may appear to suggest that
potential investors in your public offering consider investments made
by the pre-
IPO investors as a factor in making an investment decision without
knowing, among other
things, the amount of each pre-IPO investor s investment in total or
on a per share basis,
their investment strategies or whether those investors will continue
to hold their shares in
the future, as some of the pre-IPO investors may not be subject to the
reporting
requirements of Section 16 of the Exchange Act, and investors in your
public offering will
not necessarily know when some of the pre-IPO investors decide to sell
any of their
shares.
Our Pipeline and Platform, page 2
5. Please revise your pipeline tables on pages 2, 103 and 121 to make the
following changes:
Remove your BBI-098 program as it appears your disclosure on page
135 indicates
you are not currently developing this product candidate or,
alternatively, please
advise;
revise the presentation of your ecDNA diagnostic row so it does
not appear to
indicate the completion of phase 3 clinical trials; and
clarify here, and elsewhere as appropriate, whether the ecDNA
diagnostic is a
medical device that will need to be approved for use by the FDA.
Our Strategy, page 4
6. Please revise here to include an equally prominent discussion of the
challenges and
uncertainties involved in executing your business strategy.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Estimates and Judgments
Stock-Based Compensation Expense, page 98
7. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the initial public offering and the estimated offering price.
This information will help
facilitate our review of your accounting for equity issuances
including stock
Zachary Hornby
FirstName LastNameZachary Hornby
Boundless Bio, Inc.
Comapany 29,
September NameBoundless
2023 Bio, Inc.
September
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compensation. Please discuss with the staff how to submit your
response.
Business
Our Strategy, page 104
8. Please revise pages 105 and 144 to disclose the significance of the
FDA s determination
that your ecDNA diagnostic is a non-significant risk device. Please
clarify whether
your companion diagnostic will require FDA medical device approval as
you appear to
suggest on page 27.
Our Lead ecDTx: BBI-355 CHK1 Inhibitor, page 122
9. We note your disclosure that your lead product, BBI-355, is being
studied in the Phase 1/2
POTENTIATE clinical trial in patients with oncogene amplified cancers.
Please revise
your disclosure here and on page 132 to specify the cancer indications
being evaluated in
this clinical trial.
BBI-355 Clinical Development Plan, page 132
10. Please revise to disclose how many patients are currently enrolled in
the POTENTIATE
clinical trial.
11. We note your disclosure on page 133 stating that, depending on
clinical trial results, you
would seek to engage with the FDA and other global regulatory
bodies to discuss
potential registrational paths." Please revise your disclosure to note
that even if "any
cohort of the trial demonstrate[s] compelling signs of clinical
anti-tumor activity" and
"acceptable safety and tolerability" is demonstrated in this trial,
the FDA and other similar
regulatory agencies may require further clinical trials to be
completed prior to having
discussions with you about "potential registrational paths" regarding
your product
candidate.
12. We note your disclosure on page 133 that you have entered into
clinical trial collaboration
and supply agreements with each of Eli Lily and Taiho Oncology. Please
revise your
disclosure to describe the material terms of those agreements
including, but not limited to,
the term and termination provisions as well as any milestone or
royalty payment
provisions.
Addressable Patient Populations for BBI-355, page 134
13. Please revise the graphics on pages 135 and 142 to remove any
indications that you are
not currently pursuing.
BBI-825 In Vitro Preclinical Data, page 137
14. Please revise your graphic on page 138 to provide the p-value or state
whether the results
of the BBI-825 in vitro tests are statistically significant. Likewise,
revise your discussion
of your third ecDTx program to indicate whether the preclinical
results disclosed in the
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Boundless Bio, Inc.
September 29, 2023
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graphic on page 143 are statistically significant.
Our Third ecDTx Program, page 142
15. We note your disclosure on page 143 that you "preclinically validated
[a] target both in
vitro and in vivo across multiple ecDNA models[.]" Please revise your
disclosure to
clarify the meaning of the phrase "preclinically validated" in this
instance.
Intellectual Property, page 145
16. Please revise your intellectual property disclosure starting on page
145 to disclose all
foreign jurisdictions where you have pending patents for each program
and disclose when
you expect the patents associated with your Precision Medicine Program
to expire.
Principal Stockholders, page 190
17. Please revise footnote 6 on page 192 to identify the natural persons
comprising the
investment committee established by VVM.
Description of Capital Stock
Choice of Forum, page 197
18. We note that your forum selection provision identifies the Court of
Chancery of the State
of Delaware as the exclusive forum for certain litigation, including
any derivative
action. Please revise here and your risk factor on page 70 to
disclose whether this
provision applies to actions arising under the Exchange Act. In that
regard, we note that
Section 27 of the Exchange Act creates exclusive federal jurisdiction
over all suits brought
to enforce any duty or liability created by the Exchange Act or the
rules and regulations
thereunder.
General
19. 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
FirstName LastNameZachary Hornby
behalf, have presented or expect to present to potential investors in
reliance on Rule
Comapany
163BNameBoundless
of the SecuritiesBio,
Act,Inc.
whether or not you retained, or intend to
retain, copies of those
communications.
September 29, 2023 Page 4
FirstName LastName
Zachary Hornby
FirstName LastNameZachary Hornby
Boundless Bio, Inc.
Comapany 29,
September NameBoundless
2023 Bio, Inc.
September
Page 5 29, 2023 Page 5
FirstName LastName
You may contact Ibolya Ignat at 202-551-3636 or Vanessa Robertson at
202-551-3649 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Daniel Crawford at 202-551-7767 or Joshua Gorsky at 202-551-7836 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Matthew Bush, Esq.