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United States securities and exchange commission logo
March 28, 2021
Pierluigi Paracchi
Chief Executive Officer
Genenta Science S.r.l.
Via Olgettina No. 58
20132 Milan, Italy
Re: Genenta Science
S.r.l.
Draft Registration
Statement on Form F-1
Submitted March 1,
2021
CIK No. 0001838716
Dear Mr. Paracchi:
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 submitted March 1, 2021
Prospectus Summary, page 1
1. We note references to
preclinical and preliminary data that treatment with Temferon
resulted in an
"anti-tumor effect," "changes in the immune system" and similar statements
indicating findings of
efficacy. Additionally, we also note your statement on page 4 that
you believe that the
addition of your product candidates to other cancer therapies "will
enhance the durability
and efficacy of the existing therapies...." Please revise to remove
any statements that
suggest the efficacy of your product candidates, as these
determinations are the
exclusive authority of the FDA or other regulators. Also, please
limit the prospectus
summary discussion of preclinical studies and trial results to an
objective description
of the endpoints of your studies and trials and whether they were
Pierluigi Paracchi
FirstName LastNamePierluigi Paracchi
Genenta Science S.r.l.
Comapany
March NameGenenta Science S.r.l.
28, 2021
March2 28, 2021 Page 2
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met. For example, rather than stating that Temferon triggered an
anti-tumor
effect, present your trial observations without concluding that
Temferon caused the
observations. Similarly revise the disclosure throughout your filing.
Research and Development Pipeline, page 3
2. Please revise your product pipeline table on pages 3 and 90 to clearly
break out each stage
or phase of clinical development and include a column for Phase 3. In
addition, it appears
that the asterisked footnote that appears in your pipeline table on
page 90 is missing from
the table on page 3. Finally, we note that you have included in your
pipeline table various
TEMs immuno-gene therapy programs that are in pre-clinical
development. Given the
early-stage development of these programs, please explain why these
programs are
sufficiently material to your business to warrant inclusion in your
pipeline table. If they
are material, please expand your disclosure in the Business section to
provide a more
fulsome discussion of these programs, including a description of
preclinical studies or
other development activities conducted. Alternatively, remove any
programs that are not
currently material from your pipeline table.
Company History and Management Team, page 6
3. Please remove the reference to "first-in-class" as this statement
implies an expectation of
regulatory approval and is inappropriate given the length of time and
uncertainty with
respect to securing marketing approval.
Risk Factors
Our gene therapy product candidates and the process for administering our
product candidates
may cause undesirable side effects..., page 16
4. We note your statement that two recent cases of myelodysplastic
syndrome and acute
myeloid leukemia relating to a third-party's product "are unlikely
related to the LVV...."
Please revise to provide the basis for this statement.
We may need to license intellectual property from third parties..., page 45
5. We note that you may need to license intellectual property from third
parties. Discuss, if
known, whether there are existing intellectual property rights,
including patent rights, that
are important or necessary to the development or manufacture of your
product candidates
that could prevent or negatively impact commercialization.
Use of Proceeds, page 70
6. Please revise to specify how far in the development of Temferon, for
each indication, you
expect to reach with the proceeds of the offering. If any material
amounts of other funds
are necessary to accomplish the specified purposes for which the
proceeds are to be
obtained, state the amounts and sources of such other funds needed for
each such specified
purpose and the sources thereof. Refer to Instruction 3 of Item 504 of
Regulation S-K.
Pierluigi Paracchi
Genenta Science S.r.l.
March 28, 2021
Page 3
Critical Accounting Policies
Share-based Compensation, page 85
7. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the quota underlying your equity
issuances and the reasons
for any differences between the recent valuations of your quota
leading up to the IPO and
the estimated offering price with consideration of the conversion of
quotas into ordinary
shares. This information will help facilitate our review of your
accounting for equity
issuances including compensation.
Business
Clinical Development of Temferon in GBM
Preliminary Interim Results, page 105
8. Please revise here and throughout to remove conclusory statements
regarding the
preliminary interim results of your phase 1/2a clinical trial, and
provide detailed
disclosure regarding the tests conducted, including the number of
tests conducted, an
explanation of the analysis performed, the range of results observed
in each, whether the
results were statistically significant and the p-value used to
determine statistical
significance. For example, we note your disclosure on page 106 that
you "analyzed the
peripheral blood of the patients from cohorts 1 and 2. In these
patients, the peripheral
blood showed a change in the T cell immune repertoire post treatment,
revealing
expansion of tumor-associated clones, which suggested that changes in
the immune
system are occurring."
Business
Intellectual Property, page 111
9. We note "it is [your] understanding" that Telethon granted OSR a
worldwide exclusive
license, with the right to sublicense, its rights in the patent
families. Please revise to
clarify whether Telethon granted OSR a worldwide exclusive license
with the right to
sublicense or advise.
10. Please revise your intellectual property disclosure to describe on an
individual basis the
type of patent protection granted for each technology (composition of
matter, use, or
process).
11. Please revise here to disclose the type of intellectual property right
protection applicable
to your "proprietary platform." In your revised disclosure, please
clarify the source of
FirstName LastNamePierluigi Paracchi
protection for your "proprietary" platform, explain why the platform is
"proprietary," and
Comapany NameGenenta
disclose Science
the applicable S.r.l. and the duration of the underlying
intellectual
jurisdictions
March property
28, 2021 protection.
Page 3
FirstName LastName
Pierluigi Paracchi
FirstName LastNamePierluigi Paracchi
Genenta Science S.r.l.
Comapany
March NameGenenta Science S.r.l.
28, 2021
March4 28, 2021 Page 4
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License Agreement with Ospedale San Raffaele, page 112
12. With respect to the OSR License Agreement and applicable amendments,
please clearly
disclose the duration of the agreement and the royalty term, the
aggregate amounts paid to
date under the agreement and additional amounts that you are subject
to pay in the future,
including aggregate future potential milestone payments. Please also
clarify, if accurate,
that under the agreement you are required to file an IND regarding
Temferon for GBM
prior to February 2022. In addition, with respect to the Sponsored
Research Agreement
with OSR, please disclose the duration of the agreement and the
aggregate amounts paid
to date under the agreement.
Know-How License Agreement with Fondazione Telethon, page 114
13. Please file the Telethon License Agreement and the Sponsored Research
Agreement with
OSR as exhibits or provide your analysis identifying how you
determined that the
agreements did not need to be filed. Please refer to Item 601(b)(10)
of Regulation S-K.
Related Party Transactions
Employment, Consulting and Services Agreements, page 143
14. We note that there are several service, consulting, directorship, and
employment
agreements discussed in this section. Please file these agreements as
exhibits or provide
your analysis identifying how you determined that the agreements did
not need to be filed.
Please refer to Item 601(b)(10) of Regulation S-K.
Statement of Operations and Comprehensive Loss, page F-3, page F-3
15. Please present the historical earnings per quota information as well
as provide related
disclosures pursuant to ASC 260.
Note 11. Related parties
OSR - San Raffaele Hospital, page F-21
16. In regards to your Agreements with OSR, please address the following:
We note the various disclosures in the filing related to your OSR
License
Agreements, which include multiple amendments. Please clearly
state the amounts
paid since inception under the license agreements, the amounts
currently due, and
additional amounts that you are subject to pay in the future.
Please clearly state the
total milestone and other payments you are currently subject to
based on current
indications;
We note that OSR is a co-founder of the Company. Please also
clarify in your
disclosures whether OSR has any current ownership interests in
your company and if
so, the extent to which it does; and
Please help us reconcile the disclosures provided in the notes to
the financial
statements to those provided on page 143. The disclosures in the
notes to the
Pierluigi Paracchi
Genenta Science S.r.l.
March 28, 2021
Page 5
financial statements indicate that OSR provided certain services
free of charge;
whereas, on page 143, it appears you paid OSR amounts for these
services. We also
remind you that all costs of doing business should be reflected in
your historical
financial statements.
Note 12. Commitments and Contingencies
Legal Proceedings, page F-24
17. We note your disclosures on page 132 state that you are not currently a
party to any legal
proceedings that, in the opinion of our management, are likely to have a
material adverse
effect on your business and have not been notified of any claims in
respect thereof, other
than a possible infringement matter. The audited financial statements for
the year ended
December 31, 2019 indicate that you are not currently party to any
material legal
proceedings. It is not clear if you gave consideration to this possible
infringement matter
disclosed on page 132 in making this determination and determining
additional
disclosures pursuant to ASC 450 do not need to provided. Please advise or
provide
additional disclosures related to this matter pursuant to ASC 450-20-50.
General
18. 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 copies of the communications.
You may contact Nudrat Salik at 202-551-3692 or Jeanne Baker at
202-551-3691 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Kasey Robinson at 202-551-5880 or Jeffrey Gabor at 202-551-2544 with
any other
questions.
Sincerely,
FirstName LastNamePierluigi Paracchi
Division of
Corporation Finance
Comapany NameGenenta Science S.r.l.
Office of Life
Sciences
March 28, 2021 Page 5
cc: Mitchell S. Nussbaum, Esq.
FirstName LastName