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August 18, 2023
Marc de Garidel
Chief Executive Officer
Abivax SA
7-11 boulevard Haussmann
75009 Paris
France
Re: Abivax SA
Amendment No. 1 to
Draft Registration Statement on Form F-1
Submitted July 28,
2023
CIK No. 0001956827
Dear Marc de Garidel:
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.
Amendment No. 1 to Draft Registration Statement on Form F-1, submitted
July 28, 2023
Our Pipeline, page 3
1. We note your response
to prior comment 4 and your revisions to the pipeline table. Please
revise your pipeline
table further to remove the row labeled "Obefazimod Follow-on." In
this regard we note
your disclosure that the first follow-on drug candidate in the Follow-
On Compounds Program is
not expected to be selected and enter into preclinical
development until 2024.
Alternatively, please explain how the Follow-On Compounds
Program is sufficiently
material to include in your pipeline table.
Marc de Garidel
FirstName
Abivax SALastNameMarc de Garidel
Comapany
August 18, NameAbivax
2023 SA
August
Page 2 18, 2023 Page 2
FirstName LastName
Our Strategy, page 6
2. We note your disclosure on page 6 that your drug candidate has
displayed the potential for
"durable efficacy and tolerability" in your Phase 2 trials. Please
remove references here,
and elsewhere as appropriate, to your drug candidate's safety and
efficacy as those
determinations are solely within the purview of the FDA and other
similar regulators.
Overview of Primary Endpoints of Induction Phase 2a Clinical Trial with
Obefazimod for
Treatment of UC, page 126
3. We note your response to prior comment 13 and your revised disclosure
on page 126
noting that the most frequently reported adverse events reported in
your Phase 2a trial
included "GI disorders." Please revise your disclosure to describe
with more specificity
the events that were observed in this regard or otherwise advise.
Evotec Drug Discovery Services Agreement, page 158
4. We note your response to prior comment 15 and your revised disclosure
regarding the
material terms of the Evotec Drug Discovery Services Agreement. Please
revise your
disclosure further to state the total aggregate amount of fees that
could be due to Evotec
for services provided under the agreement.
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: Ryan Sansom