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United States securities and exchange commission logo
July 2, 2020
Philippe Mauberna
Chief Financial Officer
Nanobiotix S.A.
60, rue de Wattignies
75012 Paris, France
Re: Nanobiotix S.A.
Draft Registration
Statement on Form F-1/A
Filed June 5, 2020
CIK No. 0001760854
Dear Mr. Mauberna:
We have reviewed your amended 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 F-1/A, filed on June 5, 2020
Summary
NBTXR3 Development Pipeline, page 4
1. We note your response
to prior comment 1 that there are no immediate plans to pursue
application for market
approval for NBTRX3 in soft tissue sarcoma in Asia. Please clarify
this fact in your
pipeline table here and in the Business section. Please also clarify your
disclosure regarding
whether Hensify has been commercialized or if commercialization is
pending.
2. Please ensure that your
pipeline table accurately reflects the stages of your trials. For
example, you state on
page 3 that you "intend to initiate" the Phase III Study 312 once the
Philippe Mauberna
FirstName
NanobiotixLastNamePhilippe Mauberna
S.A.
Comapany
July 2, 2020NameNanobiotix S.A.
July 2,2 2020 Page 2
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FirstName LastName
FDA determines that your trial may proceed, and accordingly, please
revise the line in
your pipeline table for Study 312 here and in the Business section so
that it extends no
further than Phase II. Similarly, revise the lines in the table here
and in the Business
section for lung cancer and esophageal cancer to the beginning of the
IND phase as you
state on page 6 that MD Anderson is preparing to submit IND
applications to the FDA for
these trials, and revise the line for the pancreatic trial to reflect
that the Phase I trial has
not yet begun. Additionally, we note your statement that the FDA has
accepted available
data from your Study 102 Escalation for its evaluation of Study 312,
but please explain
whether you expect to need to provide any additional data before
proceeding to Phase III,
including any data from your ongoing Phase 1 Study 102 Expansion
trial, which you state
will produce final data in mid-2021.
Our Competitive Strengths, page 5
3. We refer to your revised disclosure that none of the patents covering
your NBTXR3
technology is expected to expire until at least 2036. However, the
table on page 107
relating to your owned patents appears to indicate earlier expiration
dates for your
NanoXray technology. Please revise your disclosure to address this
discrepancy, and also
revise your intellectual property disclosure in the Business section
to clarify which patents
are relevant to the NBTXR3 technology, the type of patent protection
provided by the
various patents (e.g., composition of matter), and their applicable
expiration dates.
Business
Our Clinical Programs
Locally Advanced Head and Neck Cancers, page 90
4. We refer to the newly included table on page 91 referencing published
results from other
head and neck trials and your statement on page 92 comparing
preliminary data to these
results. Please revise your disclosures to remove this comparison as
your results are
preliminary, your comparisons are not based on a head-to-head study,
and you
acknowledge on page 96 that the data "cannot be compared."
Dose Escalation Results, page 93
5. Please revise the second chart on page 94 so that all information is
legible.
6. We refer to your revised disclosure on page 96 regarding serious
adverse events, and your
examples of certain of these events. Please revise to identify the
other serious adverse
events. In addition, to the extent there are any, please also identify
any serious adverse
events for the other trials you describe elsewhere, such as the trials
for liver cancer and
prostate cancer.
Liver Cancers
Phase I/II Trial Design ( Study 103 ), page 97
7. We refer to your revised disclosure on page 97 that your preliminary
results showed a
Philippe Mauberna
FirstName
NanobiotixLastNamePhilippe Mauberna
S.A.
Comapany
July 2, 2020NameNanobiotix S.A.
July 2,3 2020 Page 3
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FirstName LastName
"favorable safety and tolerability profile," and that there were
"positive signs of
efficacy." As we have previously noted, safety and efficacy
determinations are within the
authority of the FDA or comparable regulatory authorities, and such
statements are not
appropriate. Please remove all such statements in your registration
statement.
Significant Collaborations and Research Agreements
NBTXR3 Clinical Collaboration with MD Anderson, page 104
8. We note your revised disclosure in response to prior comment 6. Please
further revise to
disclose the aggregate amount of milestone payments that may be
payable.
Other Collaborations, page 105
9. In your revised disclosure, you refer to partnerships with various
research institutions to
conduct preclinical research that contributed to the rationale for the
I-O program you are
developing. Please disclose the ownership and rights to the research
conducted in
collaboration with these partners.
Intellectual Property, page 106
10. You state that there are material patents and patent applications in
co-ownership. Please
revise to disclose the co-owner(s) and any material terms of such
co-ownership.
Note 4. Significant Transactions
4.2 Financing Agreement with the European Investment Bank, page F-15
11. You disclose that you agreed to pay EIB an additional fee based on the
consolidated
forecasted sales generated by the company. Please clarify
whether the contractual
royalties are based on actual sales or forecasted sales.
Note 12. Financial Liabilities, page F-31
12. Please disclose how the company accounts for subsequent changes in the
estimated
amount of royalties owed on the EIB loan. Refer to IFRS 7.21. Tell us
whether you apply
paragraph B5.4.6 of IFRS 9.
Note 14. Financial Instruments Included in the Statement of Financial Position
and Impact on
Income
Fair Value, page F-38
13. Consistent with IFRS 13.97, please disclose how you determined the
fair value of your
non-current financial liabilities as shown on page F-36.
Exhibits
14. On page 130, you refer to employment agreements with Mr. Philippe
Mauberna
and Ms. Anne-Juliette Hermant. Please file such agreements as exhibits
to your
Philippe Mauberna
Nanobiotix S.A.
July 2, 2020
Page 4
registration statement. Additionally, we note you filed summaries of
various equity plans
with your latest amendment. Please revise to file the plans or explain
why it is not
necessary. See Item 601(b)(10) of Regulation S-K and Item 8.a of Form
F-1.
You may contact David Burton at 202-551-3626 or Kate Tillan at
202-551-3604 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Paul Fischer at 202-551-3415 or Dorrie Yale at 202-551-8776 with any
other questions.
Sincerely,
FirstName LastNamePhilippe Mauberna
Division of
Corporation Finance
Comapany NameNanobiotix S.A.
Office of Life
Sciences
July 2, 2020 Page 4
cc: Peter Devlin, Esq.
FirstName LastName