View:
United States securities and exchange commission logo
January 12, 2023
Hartmut Ehrlich, MD
Chief Executive Officer
Abivax SA
7-11 boulevard Haussmann
75009 Paris
France
Re: Abivax SA
Draft Registration
Statement on Form F-1
Submitted on
December 16, 2022
CIK No. 0001956827
Dear Hartmut Ehrlich:
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 on December 16, 2022
Cover Page
1. Please disclose on your
cover page whether your offering is contingent upon final
approval of your Nasdaq
listing. Please ensure the disclosure is consistent with your
underwriting agreement.
Prospectus Summary, page 4
2. We note your disclosure
that you hold a "position as a leader in the development of
therapeutics for
chronic inflammatory diseases." Given that you have a limited operating
Hartmut Ehrlich, MD
FirstName
Abivax SALastNameHartmut Ehrlich, MD
Comapany
January 12,NameAbivax
2023 SA
January
Page 2 12, 2023 Page 2
FirstName LastName
history, no approved products, and no historical product revenues,
please justify this claim
or otherwise advise.
3. We note your footnote under your pipeline table on page 5 where you
state your belief
that you will be able to use the Phase 1 data generated in your UC
trials for your Crohn's
disease indication. Please update your footnote to clarify that the
FDA or other regulators
may require additional trials. In addition, it does not appear that
you have initiated a
Phase 2 trial for Crohn's disease. Please shorten your progress arrow
so it reflects the
current stage of development or otherwise advise.
4. We refer to the last row in your pipeline table where you refer to
ABX711 for an unnamed
inflammatory condition indication. Please expand your disclosure
in your Business
section to provide a more fulsome discussion of this program,
including identifying the
specific indication. Alternatively, please explain to us why this
program is sufficiently
material to your business to warrant inclusion in your pipeline table.
5. We note your disclosure on page 6 that obefazimod "showed a rapid
onset of action and
consistent efficacy[,]" your disclosure on page 29 that the "products
[you] are developing
are likely to provide a therapeutic response[,]" your disclosure on
page 87 that obefazimod
has "demonstrated a favorable safety and tolerability profile[,]" and
your disclosure on
page 88 noting that obefazimod has demonstrated "consistent
efficacy[.]" Please revise
throughout to remove these and any other inferences regarding the
safety and efficacy of
your product candidates. Given that the determination of a product's
safety and efficacy is
solely within the FDA's authority and your product candidates have not
yet completed
clinical trials, these inferences are not appropriate.
6. We note on page 13 that you intend to use the proceeds of the offering
to "fund the
development of obefazimod for ulcerative colitis." Please disclose
here and in your Use
of Proceeds section how far the proceeds from the offering will allow
you to proceed with
the development of obefazimod for the treatment of ulcerative colitis.
Our Team and Investors, page 7
7. We note that you identify a "supported syndicate of leading life
science investors" in your
company in this section, however, some of these investors do not
appear to be among the
principal stockholders that are identified on page 167. Please
relocate this disclosure from
your prospectus summary to your "Principal Stockholder" 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
Hartmut Ehrlich, MD
FirstName
Abivax SALastNameHartmut Ehrlich, MD
Comapany
January 12,NameAbivax
2023 SA
January
Page 3 12, 2023 Page 3
FirstName LastName
shares. In addition to relocating this disclosure, please limit any
textual description of
your pre-IPO investors in your "Principal Stockholders" section to the
investors identified
in that table.
Risks Related to Product Development, Regulatory Approval and
Commercialization, page 25
8. We note your disclosure that currently, "there are no similar
immunological treatments
with marketing authorization granted by competent regulatory
authorities." Given your
disclosure on page 33 that the "current standard of care for treatment
of patients with mild
IBD involves the use of conventional anti-inflammatory therapies[,]"
please reconcile
these statements or otherwise advise.
The war between Ukraine and Russia may affect our business, industry and the
markets in which
we operate., page 42
9. We note your disclosure on page F-10 where you state you "[e]arly
terminated the Phase
2b maintenance study of obefazimod in moderate to severe UC in
Ukraine." Please
update your disclosure here or otherwise advise.
Risks Related to Legal and Compliance, page 49
10. We note your disclosure on page 58 that one of your CROs experienced a
data breach that
involved personal data being compromised. Please clarify if any of
your data was
compromised during this event and if so, please disclose any remedial
measures you have
taken since this event.
Business, page 83
11. We note your inclusion of Figure 4 on page 92. Please clarify where
you believe your
product candidate, if approved, would fit within the treatment
landscape described in
Figure 4 or otherwise advise.
Our Strengths, page 87
12. We note your disclosure here that your lead drug candidate is
"derisked" and "has the
potential to be a first-in-class therapy and alter the inflammatory
treatment paradigm."
Given the development stage of your product candidate and the length
of the drug
approval process, it is premature and inappropriate to speculate or
imply that your product
candidate will ultimately be approved or become first-in-class. Please
remove these
statements.
Clinical Trials, page 93
13. We note your disclosure that the primary endpoint in the induction
Phase 2a trial was
safety, assessed as the rate of treatment emergent adverse events.
Please revise your
disclosure to note the most common treatment emergent adverse events
that were
Hartmut Ehrlich, MD
Abivax SA
January 12, 2023
Page 4
observed in the trial. Additionally, for each of the clinical trials
described in this section,
please disclose whether any serious adverse effects were observed.
Patents, page 114
14. We note your disclosure that all of your patents and patent
applications are "co-owned"
except for certain exceptions. Please disclose the identity or
identities of any co-owners
of the patents and patent applications described in this section.
Collaboration, Research and Development Agreements, page 118
15. We note your disclosure regarding the Evotec Master Services Agreement
entered into
with Evotec in September 2017, including your disclosure that "[you]
are required to pay
Evotec an agreed set of fees." Please revise to clarify your
disclosure to describe the
material terms of the agreement, including the (i) aggregate amounts
paid or received to
date under this agreement, (ii) whether there are any milestone
payments or royalties set
forth in this agreement and (iii) clarify what product candidate(s)
have been discovered
pursuant to this agreement or otherwise advise.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Principal Factors Affecting Our Results of Operations
Acquisition of Prosynergia, page 126
16. You acquired 100% of the share capital of Prosynergia on April 1, 2022
and based on
your disclosure on page F-12 the acquisition did not meet the definition
of a business
under IFRS 3. Thus it appears you have accounted for the acquisition as
an asset
acquisition. You state on pages 122 and 126 that since January 1, 2022,
you have
prepared consolidated financial statements. You also state that on
December 12, 2022,
you completed a merger with Prosynergia and all of Prosynergia's assets
and liabilities
were transferred to you and Prosynergia was dissolved. Please address
the following:
The disclosure relating to you consolidating Prosynergia since
January 1, 2022
conflicts with your disclosure on page F-72 which states that you
consolidated
Prosynergia since the date control was obtained, i.e. April 1, 2022.
Please revise to
clarify when you began consolidating Prospynergia.
If consolidation began prior to the acquisition date and the
acquisition was accounted
for as an asset acquisition, please tell us the guidance you are
relying on for your
accounting treatment.
Please clarify on pages 122 and 163 what you acquired on December
12, 2022. Your
disclosure throughout the filing appears to indicate that you
acquired 100% of the
FirstName LastNameHartmut Ehrlich, MD
share capital of Prosynergia on April 1, 2022.
Comapany NameAbivax
Please clarify SA
in Management's Discussion and Analysis on page 134
the effect the
January 12,acquisition
2023 Page of4 Prosynergia had on your results of operations.
FirstName LastName
Hartmut Ehrlich, MD
FirstName
Abivax SALastNameHartmut Ehrlich, MD
Comapany
January 12,NameAbivax
2023 SA
January
Page 5 12, 2023 Page 5
FirstName LastName
General
17. 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.
You may contact Vanessa Robertson at 202-551-3649 or Mary Mast at
202-551-3613 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Joshua Gorsky at 202-551-7836 or Jason Drory at 202-551-8342 with any
other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Patrick Lyons