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United States securities and exchange commission logo
November 15, 2023
Zhengbin (Bing) Yao, Ph.D.
Chief Executive Officer
ArriVent Biopharma, Inc.
18 Campus Boulevard, Suite 100
Newtown Square, PA 19073
Re: ArriVent Biopharma,
Inc.
Amendment No. 2 to
Draft Registration Statement on Form S-1
Submitted October
31, 2023
CIK 0001868279
Dear Zhengbin (Bing) Yao:
We have reviewed your amended draft registration statement and have
the following
comments.
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 a comment applies 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 this
letter and your amended
draft registration statement or filed registration statement, we may
have additional comments.
Amendment No. 2 to Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1. We note your disclosure
that you received Breakthrough Therapy Designation from the
FDA in October 2023.
Please include balancing disclosure in the Prospectus Summary
that this Designation
does not increase the likelihood that furmonertinib will ultimately
receive FDA approval
for any indication.
Furmonertinib, page 2
2. We note your response
to comment 3 and re-issue in part. Please balance your disclosure
on pages 3 and 4 that
furmonertinib "has been observed to be generally well tolerated" in
multiple clinical
trials with a description of all serious adverse events and quantify the
number of each type of
event.
Zhengbin (Bing) Yao, Ph.D.
ArriVent Biopharma, Inc.
November 15, 2023
Page 2
3. Please include clarifying disclosure in the Prospectus Summary that your
statements about
the FURLONG trial relate to a clinical trial in China conducted by
Allist, which resulted
in the approval of furmonertinib in China as a first-line therapy in
patients with locally
advanced or metastatic NSCLC with classical EGFRm.
Our Pipeline, page 2
4. Please revise the block of text under your pipeline table to more clearly
explain which
programs each note applies to. As currently drafted, it is not clear how
the text applies to
the above pipeline table and to which programs it applies. For example,
it is not clear if
the first row of the pipeline table corresponds to the sentence in the
below text block
concerning the FAVOUR and FURVENT trials. We would not object to the use
of a key.
Our Strategy, page 3
5. We note your revised disclosure in response to comment 5, specifically
that your
investigation of NSCLC EGFR exon 20 insertion mutations as a first-line
therapy is based
on the ongoing FAVOUR Phase 1b study and the ongoing FURVENT Phase 3
study. We
also note your revised disclosure that no Phase 2 study has been
conducted for this
indication. Please expand your discussion of the Phase 3 FURVENT clinical
trial in the
Prospectus Summary to include disclosure that clinical development
announcements by
Allist in the ongoing FAVOUR Phase 1b study may adversely affect your
clinical
development plan. We note risk factor disclosure to this effect on page
31. Ensure that this
discussion also discloses when the final results of this Phase 1b trial
are expected and
whether you intend to complete a Phase 2 trial for this indication.
Director Independence, page 162
6. Please reconcile your disclosure concerning director independence with
your revised
disclosure on page 164 that Dr. Carl Gordon does not meet the
requirements of
independence applicable to audit committee members of a listed issuer
under Rule 10A-3
under the Exchange Act.
Please contact Li Xiao at 202-551-4391 or Kevin Vaughn at 202-551-3494
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Dillon Hagius at 202-551-7967 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
FirstName LastNameZhengbin (Bing) Yao, Ph.D.
Division of
Corporation Finance
Comapany NameArriVent Biopharma, Inc.
Office of Life
Sciences
November 15, 2023 Page 2
cc: John Rudy
FirstName LastName