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December 12, 2018
Jean-Fran ois Mouney
Chief Executive Officer
Genfit S.A.
Parc Eurasant
885, avenue Eug ne Avin e
59120 Loos, France
Re: Genfit S.A.
Draft Registration Statement on Form F-1
Submitted November 16, 2018
CIK No. 0001757064
Dear Mr. Mouney:
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
Cover Page
1. Please disclose on the cover page of the preliminary prospectus a bona
fide price range of
the offered securities. If you intend to price the securities based on
the Euronext Paris
price of your ordinary shares, you may disclose a percentage range based
on that price (for
example, 10% of the Euronext price) within which you intend to price the
securities. See
Item 501(b)(3) of Regulation S-K.
Market, Industry and Other Data, page ii
2. Please disclose the information regarding the price history of your
ordinary shares on
Jean-Fran ois Mouney
FirstName LastNameJean-Fran ois Mouney
Genfit S.A.
Comapany12, 2018
December NameGenfit S.A.
December 12, 2018 Page 2
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FirstName LastName
Euronext Paris pursuant to Item 9.A.4 of Form 20-F.
Prospectus Summary
Overview, page 1
3. We note statements throughout your prospectus that describe
elabifranor as being "well-
positioned" as a first-line treatment as a monotherapy and the
backbone of combination
regimens, statements that, "if approved, [you] believe elafibranor
would be among
the first FDA-approved therapies shown to achieve resolution of NASH
without
worsening of fibrosis" and statements that describe your blood-based
IVD test as a novel,
standalone diagnostic that will meet the need for a validated test to
identify NASH
patients as well as your statement on page 112 that describes the
development and
potential regulatory approval of elafibranor as being several years
ahead of your
competitors' drug candidates. These statements imply an expectation of
regulatory
approval and are inappropriate given the stage of development. Please
revise these
statements and all other similar statements to eliminate such
implication.
4. We note statements throughout your prospectus referring to the safety
or efficacy of your
product candidates and diagnostic test. For example, we note your
disclosure on page 3
that elabfibranor "has a differentiated efficacy and safety profile
relative to other drugs in
similar states of development for NASH" and that you "believe
elafibranor has a favorable
safety . . . profile" as well as your conclusions regarding the safety
and efficacy of
elabfibranor on pages 97 to 103 and page 108. Safety and efficacy are
determinations
within the exclusive authority of the FDA or equivalent foreign
regulators, and, because
your product candidates have not yet received approval by the FDA or
equivalent foreign
regulators, it is premature and inappropriate to state conclusions
regarding safety and
efficacy. Please revise these and all similar statements accordingly.
5. Please revise the pipleline chart on page 1 to clarify, if true, that
you are conducting pre-
clinical studies of TGFTX1 for mild to moderate psoriasis. In
addition, we note your
press release that you began your Phase 2 clinical trial of NTZ on
December 3, 2018.
Please revise your pipeline chart to indicate that you have just begun
Phase 2 clinical trials
of NTZ. Also, revise the pipeline chart of your IVD test to disclose
the specific clearance
and approval stages necessary to obtain FDA approval to market your
IVD test. In this
regard, we note your disclosure on pages 121 and 122.
6. We note your disclosure on page 2 that "[i]n [y]our Phase 2b clinical
trial, elafibranor
achieved resolution of NASH without worsening of fibrosis, which is
the primary
endpoint of [y]our ongoing global Phase 3 clinical trial." Please
disclose here and in the
second bullet point on page 3, if true, that you did not achieve
statistical significance on
your prespecified endpoints in your Phase 2b clinical trial. In this
regard, we note your
disclosure on page 15.
7. We note your disclosure on page 2 that "NTZ has shown promising
activity against
fibrosis in [y]our preclinical disease models." As NTZ is in clinical
trials, please limit the
Jean-Fran ois Mouney
FirstName LastNameJean-Fran ois Mouney
Genfit S.A.
Comapany12, 2018
December NameGenfit S.A.
December 12, 2018 Page 3
Page 3
FirstName LastName
prospectus summary discussion of your results to a description of the
endpoints of your
clinical trials and whether they were met.
8. We note your disclosure on page 2 that you believe that, if the test
results from your
interim cohort analysis are positive, you may obtain accelerated
approval from the FDA or
the EMA as early as 2020 for elafibranor in the treatment of NASH.
Please disclose
whether you have received any indication from the FDA or EMA that you
will be granted
accelerated approval. In addition, to the extent that you have not
conducted head-to-head
clinical trials, revise your disclosure throughout your prospectus to
remove comparisons
of your product candidates to other treatments, products and product
candidates. For
example, we note your statements on page 2 that you "believe
elafibranor's unique
mechanism of action can provide benefits for patients with PBC without
the significant
side effects associated with current PBC treatments" and that your IVD
test is better than
the current standard for diagnosis of NASH and your statement on page
3 that
elabfibranor resolves Nash "while also showing a decrease in
cardiovascular risk factors,
an important differentiator . . . ."
Implications of Being an Emerging Growth Company, page 5
9. 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
potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they
retain copies of the communications.
Risk Factors
Risks Related to Our Operations
We increasingly rely on social media, page 40
10. We note your disclosure on page 40 that you "increasingly rely on
social media and new
technologies to communicate to investors." To the extent that you
intend to communicate
with investors on social media, please disclose how investors may
access such
information. For example, please disclose whether you intend to
include such information
in filings on the SEC website and your investor website.
Use of Proceeds, page 66
11. If you do not believe that the anticipated proceeds will be sufficient
to complete all of the
proposed purposes, please disclose an estimate of the additional funds
needed to fully
fund all of the proposed purposes listed on page 66. In addition,
disclose an estimate
of how far the allocated proceeds will allow you to reach in the
development process
of (i) your IVD test and (ii) the research program on the use of
elafibranor as a potential
backbone for combination therapies. If you do not believe that the
amount of funds
allocated for your Phase 3 clinical trial of elafibranor for the
treatment of PBC and for the
completion of your ongoing Phase 3 clinical trial for elafibranor for
the treatment of
NASH will be sufficient to complete these Phase 3 clinical trials,
please provide an
Jean-Fran ois Mouney
FirstName LastNameJean-Fran ois Mouney
Genfit S.A.
Comapany12, 2018
December NameGenfit S.A.
December 12, 2018 Page 4
Page 4
FirstName LastName
estimate of how far the allocated proceeds will allow you to reach.
Business
Overview, page 92
12. We note your disclosure on page 92 that NTZ "has shown promising
activity against
fibrosis in [y]our preclinical disease models." Please revise to
describe here how you
conducted your preclinical disease models of NTZ and the range of the
results of such
tests.
Our Clinical Program for Elafirbranor in the Treatment of NASH, page 98
13. We note your disclosure on pages 99 to 103 of your Phase 1, Phase 2a,
Phase 2b
and Phase 3 clinical trials conducted or about to be conducted with
elabfibranor in
connection with your IND for NASH. For each clinical trial discussed,
please revise your
disclosure as necessary to include a detailed description of how the
clinical trial was or
will be conducted, the endpoints of the trial and, as appropriate,
whether the endpoints
were met, the number of patients that left the trial before
completion, all serious adverse
events, if any, and how many patients experienced serious adverse
events, if any. In
addition, please disclose whether the results from each of the
clinical trials conducted
were statistically significant by describing the specific p-value used
in each and whether
these p-values met the FDA's specified threshold for statistical
significance for the trials.
14. We note your discussions of animal trials on page 102, disease models
indicating that
elafibranor may prevent development of liver cancer on page 102,
disease models of
combination therapies of elafibranor on page 103, studies using
elafibranor as backbone in
in vitro and in vivo NASH models on page 103 and in vivo models in
which you observed
that administration of NTZ significantly attenuated liver fibrosis
development on page
110. Please revise these discussions to include (i) a detailed
description of how the the
animals trials were conducted, including the number of animals tested,
the dose or
doses of elifrabanor used, and the range of the results of such
trials, (ii) a detailed
description of the disease models showing that elafribranor may
prevent development of
liver cancer as well as the disease models using elafibranor as
backbone in NASH,
including the number of times each test was conducted, the products
and product
candidates used in the backbone trials and the range of the results of
the trials, and (iii) a
detailed description of the NTZ trials using in vivo models and the
range of results.
Efficacy Results, page 99
15. Please disclose the total number of patients enrolled in the Phase 2b
trials with only "mild
disease and too low of a NAS," as well as how the results from these
patients affected the
results of the Phase 2b trial.
Jean-Fran ois Mouney
FirstName LastNameJean-Fran ois Mouney
Genfit S.A.
Comapany12, 2018
December NameGenfit S.A.
December 12, 2018 Page 5
Page 5
FirstName LastName
16. We note your chart on page 101 showing the fibrosis change from
baseline in elafibranor
120 mg responders compared to non-responders. Please disclose the
number of patients
that responded and clarify the range of responses. Similarly, please
disclose the number
of patients receiving 120 mg of elafibranor that experienced
improvement of ALP and
how such improvement was measured, as well as the percentage of
patients that met the
secondary endpoints and whether the results were statistically
significant.
IVD Test for the Diagnosis of NASH
Circulating Biomarkers and MicroRNA (miRNA), page 104
17. Please disclose the average and range of time necessary for measuring
miRNA using the
methods you have developed as well as the percentage of accurate
readings in your tests.
In addition, please revise your discussion to explain why your
technique "represents a
significant improvement over" first-generation sequencing technology,
setting forth the
basis for such belief (e.g., head-to-head comparisons). Similarly, we
note your chart on
page 106 comparing the AUROC scores of your IVD test to those of other
tests reported
in literature. To the extent that you did not conduct head-to-head
comparisons in your
trials, please remove this disclosure or tell us why it is
appropriate. In addition, please
disclose the AUROC score of your IVD test as compared to the patient's
initial liver
biopsy. Finally, please disclose here, if known, the specific
clearance and approval stages
necessary to obtain FDA and EMA approval to market your IVD test. In
this regard, we
note your disclosure on pages 121, 122 and 125.
TGFTX1 Program for the Treatment of IL-17-Dependent Autoimmune Diseases, page
110
18. We note your disclosure regarding your preclinical tests of TGFTX1 on
page 110. Please
disclose a detailed description of the your studies, including the
number of mice tested,
the dose or doses used in the tests, the number of tests conducted and
range of results
observed. In addition, we note that you "plan to leverage the
expertise of specialized
pharmaceutical companies with already established franchises in
dermatology and/or
respiratory diseases through collaborations or other strategic
alliances." Please disclose
whether you currently have any such collaborations or strategic
alliances.
Government Regulation
United States Government Regulation, page 115
19. Please describe the process for product candidates pursuant to Section
505(b)(2). In
this regard, we note your disclosure on page 18 that you may seek FDA
approval through
the Section 505(b)(2) regulatory pathway for NTZ. In addition, please
disclose whether
the FDA has given any indication that you may use such pathway for
NTZ.
Certain Relationships and Related Person Transactions, page 152
20. Please file the Shareholders' Agreement as an exhibit to your
registration statement or tell
us why you believe this is not necessary.
Jean-Fran ois Mouney
Genfit S.A.
December 12, 2018
Page 6
Description of American Depositary Shares, page 183
21. Please clarify whether holders of ADSs will receive a double voting
right if the ADS is
held in the name of the same shareholder for at least two years.
Report of Independent Registered Public Accounting Firm, page F-2
22. Financial statements which comply with IAS 1 and an audit report that
complies with
Rule 2-02 of Regulation S-X should be included in the registration
statement for which
you request effectiveness.
3. Summary of Significant Accounting Policies
3.21. Classification of operating expenses, page F-18
23. You state on page F-18 that research and development expenses include
grants to the
endowment fund, The NASH Education Program. You further state on page
85 "We also
make donations to The NASH Education Program, the endowment fund of
which we are a
sponsor" and that the grant is for "the creation of a patient registry
and other disease
awareness initiatives." On page 95, you state "The NASH Education
Program, a public
health initiative we created in 2017, is dedicated to the development
and funding of
NASH awareness and education activities aimed at the medical community
and the
general public." Explain to us why you believe classification of this
expense as research
and development is appropriate and that this expense is not more
appropriately classified
as general and administrative expense. Refer to paragraphs 8, 56, 59,
126 and 127 of IAS
38.
General
24. Please provide us mockups of any pages that include any additional
pictures or graphics to
be presented, including any accompanying captions. Please keep in
mind, in scheduling
your printing and distribution of the preliminary prospectus, that we
may have comments
after our review of these materials.
You may contact Vanessa Robertson at 202-551-3649 or Lisa Vanjoske at
202-551-3614
if you have questions regarding comments on the financial statements and
related
matters. Please contact Sonia Bednarowski at 202-551-3666 or Dietrich King at
202-551-8071
with any other questions.
FirstName LastNameJean-Fran ois Mouney Sincerely,
Comapany NameGenfit S.A.
Division of
Corporation Finance
December 12, 2018 Page 6 Office of
Healthcare & Insurance
FirstName LastName