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February 8, 2019
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
Submitted December 21, 2018
CIK No. 0001760854
Dear Mr. Mauberna:
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 F-1
Overview, page 1
1. We note your disclosure on pages 2 and 80 that preliminary results from
clinical trials of
NBTXR3 in patients with late-stage liver cancers and advanced head and
neck cancers
suggest a "favorable safety profile." Please remove all statements
throughout the filing
that present your conclusions regarding the safety or efficacy of your
product, as these
determinations are within the authority of the FDA, your Notified Body,
or comparable
regulatory bodies. With respect to safety, we will not object to
statements that your
product candidate was well tolerated.
NBTXR3 Development Pipeline, page 3
Philippe Mauberna
FirstName LastNamePhilippe Mauberna
Nanobiotix S.A.
Comapany NameNanobiotix S.A.
February 8, 2019
February 8, 2019 Page 2
Page 2
FirstName LastName
2. We note that the table currently suggests that the Head & Neck Cancers
clinical trial in the
EU has completed Phase 1 testing, but your disclosure states that you
are currently
conducting the Phase I/II clinical trial and that you are seeking a
trial expansion. Please
revise to reflect the status of the Head & Neck Cancers clinical trial
in the EU. Please also
confirm whether you will be providing expected milestones for each
clinical trial in your
pipeline.
3. We note that the table currently states that the Soft Tissue Sarcoma
clinical trial is being
conducted in both the European Union and Asia. However, we do not see
any disclosure
in your filing describing a clinical trial that you or PharmaEngine
are conducting of
NBTXR3 in Asia for patients suffering from soft tissue sarcoma. Please
revise to either
remove the relevant reference to Asia in the pipeline table or to
include a description of
the relevant clinical trial elsewhere in the prospectus.
4. We note your disclosure that based on the preliminary results from the
Phase I/II clinical
trial of NBTXR3 in Europe for patients suffering from locally advanced
head and neck
cancers, you "intend to rapidly develop, and satisfy applicable
pre-marketing regulatory
requirements for, NBTXR3 in locally advanced head and neck cancers."
Please revise to
provide context and a basis for how the preliminary results would
allow you to rapidly
develop and satisfy pre-marketing regulatory requirements, in light of
your disclosure on
page 14 that clinical trials are long, expensive, and unpredictable
processes. Please also
clarify whether you are referring to pre-marketing regulatory
requirements in the
European Union, the United States, or both.
Complete the regulatory requirements to market NBTXR3 ..., page 4
5. We note your disclosure that you expect to complete "in the near
future" the conformity
assessment procedure required for you to be able to market NBTXR3 for
locally advanced
STS in the EU. To provide context, please disclose when you initiated
the conformity
assessment procedure and to give a general timeline within which your
Notified Body will
make a decision as to the issuance of a certificate.
Expand the opportunity for NBTXR3 as a treatment for liver cancers ..., page 4
6. We note your reference to demonstrating the applicability of NBTXR3 to
breast cancer.
Given that breast cancer is a potential cancer indication for
NBTXR3-gel, which is in a
preclinical program and not in your pipeline, please remove the
reference to breast cancer
here.
Implications of Being an Emerging Growth Company, page 5
7. 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 copes of the communications.
Philippe Mauberna
FirstName LastNamePhilippe Mauberna
Nanobiotix S.A.
Comapany NameNanobiotix S.A.
February 8, 2019
February 8, 2019 Page 3
Page 3
FirstName LastName
Risk Factors, page 11
8. We note from your disclosure on page 116 that Dr. Herrera, one of your
supervisory board
members, currently serves as Head of Corporate Development, Managing
Director of
PharmaEngine Europe Sarl. Please revise to disclose the risks of any
conflicts of interest
that may arise from Dr. Herrera's dual roles with you and
PharmaEngine, or tell us why
such disclosure is not useful.
We may not have access to raw materials ..., page 21
9. We note that you have entered into agreements related to the supply of
the raw materials
used in the manufacturing of your nanoparticles and that the supply
could be reduced or
interrupted at any time. Please revise to expand upon the material
terms of your
agreements relating to the supply of such raw materials and to
describe whether the prices
of the raw materials are volatile. Refer to Item 4.B.4 of Form 20-F.
Use of Proceeds, page 46
10. Please expand upon your disclosure regarding the proceeds to be used
to initiate and
conduct additional clinical trials of NBTXR3 in your checkpoint
inhibitor combination
development program to describe how far in the development process you
estimate the
allocated proceeds from this offering will enable you to reach.
Liquidity and Capital Resources, page 60
11. We note your disclosure on page 55 that the amounts of funding you
expect to become
available to you under the EIB loan agreement, in addition to other
factors, leads you to
believe you will have sufficient working capital to fund your
operations to at least the end
of 2019. Please provide more detail on the specified performance
criteria that you must
satisfy in order to have additional tranches of the EIB loan made
available to you.
Results, page 75
12. We note that the graph showing the four fold increase in pathological
complete response
in the higher grade sarcoma group and narrative description does not
include whether the
results of the subgroup were statistically significant. Please revise
to clarify or tell us why
such an explanation is not useful.
Results, page 82
13. Please identify the non-treatment-related adverse events observed.
Additionally, we note
you reference results of seven patients evaluated for best response in
HCC, but state that
nine patients were evaluated. Please clarify the results for the other
two patients.
PharmaEngine, page 86
Philippe Mauberna
FirstName LastNamePhilippe Mauberna
Nanobiotix S.A.
Comapany NameNanobiotix S.A.
February 8, 2019
February 8, 2019 Page 4
Page 4
FirstName LastName
14. We note your disclosure that you are entitled to receive payments for
the supply of
NBTXR3 and "up to double-digit royalties" based on net product sales
by PharmaEngine.
Please revise your disclosure to provide the royalty rate or a range
of royalties to which
you are entitled under this provision.
15. Please provide more detail on the material terms of your license and
collaboration
agreement with PharmaEngine, including the nature and scope of the
intellectual property
transferred, each parties' duties and obligations, the term of the
agreement, and the
termination provisions.
Intellectual Property, page 87
16. We note your reference to "more than 300 issued or pending patents and
patent
applications in over 20 patent families across the world." Please
revise to identify your
material patents or patent applications. Please also include such
information as the
specific product or technology to which the patent relates, the type
of patent protection,
expiration dates, and the applicable jurisdiction.
Government Regulation, Product Approval and Certification, page 88
17. Please revise to describe the regulation of NBTXR3 in Taiwan and the
other Asian-Pacific
countries within which PharmaEngine is responsible for developing and
commercializing
NBTXR3.
Executive Board Compensation, page 105
18. We note footnote four to the executive board compensation table.
Please expand upon
your description of the achievement of strategic goals. Please also
explain what you mean
by "performance on the `work together' of 20%." Refer to Item 6.B.1.
of Form 20-F.
Report of Independent Registered Public Accounting Firm, page F-2
19. Please revise the first paragraph in the basis for opinion to refer to
the Public Company
Accounting Oversight Board (United States) consistent with paragraph
9(g) of AS 3101.
Note 2. General Information, Statement of Compliance and Basis of Presentation,
page F-8
20. In the first paragraph on page F-9, you refer to IFRS as adopted by
the European Union.
Please revise to make an explicit and unreserved statement of
compliance with IFRS as
issued by the International Accounting Standards Board consistent with
paragraph 16 of
IAS 1.
General
21. Please provide us proofs of all graphics, visual, or photographic
information you will
provide in the printed prospectus prior to its use, for example in a
preliminary prospectus.
Please note that we may have comments regarding this material.
Philippe Mauberna
Nanobiotix S.A.
February 8, 2019
Page 5
You may contact Isaac Esquivel at (202) 551-3395 or Kate Tillan at (202)
551-3604 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Coy Garrison at (202) 551-3466 or Tom Kluck at (202) 551-3233 with any
other
questions.
Sincerely,
FirstName LastNamePhilippe Mauberna
Division of
Corporation Finance
Comapany NameNanobiotix S.A.
Office of Healthcare
& Insurance
February 8, 2019 Page 5
cc: Boris Dolgonos
FirstName LastName