United States securities and exchange commission logo

                               September 27, 2023

       Zhengbin (Bing) Yao, Ph.D.
       Chief Executive Officer
       ArriVent Biopharma, Inc.
       18 Campus Boulevard, Suite 100
       Newtown Square, PA 19073

                                                        Re: ArriVent Biopharma,
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted August
25, 2023
                                                            CIK 0001868279

       Dear Zhengbin (Bing) Yao:

              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

             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

       Draft Registration Statement on Form S-1

       Prospectus Summary
       Overview, page 1

   1.                                                   We note that
furmonertinib is currently approved in China to treat classical EGFRm
                                                        NSCLC. Please revise to
clarify all statements related to safety and efficacy to clarify that
                                                        they only relate to
classical EGFRm NSCLC and are based on NMPA's authority to
biopharmaceutical products in China. Remove all other statements related to
                                                        safety and efficacy
from your registration statement. Such conclusions are within the sole
                                                        authority of the FDA or
equivalent foreign regulator. Such statements include, but are not
                                                        limited to, the
                                                            "Furmonertinib. .
..has demonstrated compelling efficacy and safety results in clinical
 Zhengbin (Bing) Yao, Ph.D.
FirstName LastNameZhengbin   (Bing) Yao, Ph.D.
ArriVent Biopharma, Inc.
Comapany 27,
September NameArriVent
              2023       Biopharma, Inc.
Page 2    27, 2023 Page 2
FirstName LastName
             trials in NSCLC patients across a broader set of EGFR mutations
(EGFRm) than are
             currently served by approved AGFR TKKIs." (pages 1 and 95);
             "In clinical trials to date, across a patient population of over
700 patients,
             furmonertinib has demonstrated compelling activity against a broad
range of EGFRm
             NSCLC, including both classical and uncommon EGFRm. . ." (page 2);
             "Furmonertinib retains many of the key advantages of
third-generation EGFR TKIs
             compared to first- and second-generation EGFR TKIs including
overcoming T790M
             mutations that confer resistance, while also targeting a broader
set of EGFRm." (page
             "Furmonertinib is potentially differentiated from third-generation
             approved for classic EGFRm NSCLC by its observed clinical activity
against exon 20
             insertions in FAVOUR clinical trial and compelling preclinical
data against PACC
             mutations." (page 108).
         You may reference your trial observations that are described in more
detail elsewhere
         without drawing a conclusion that a product candidate that has not yet
been approved is
2.       Please revise the description of clinical trials to describe the
objective results, rather than
         your conclusions. For example, rather than indicating that the FAVOUR
         demonstrated a 79% overall response rate, identify the clinical
endpoints that lead you or
         Allist to conclude that it was a positive response and indicate the
number of such
         observations. For instance, was the overall response rate intended to
indicate an
         elimination of all tumors, a reduction in the number of tumors, a
reduction in size of the
         tumors, a decline in growth in the number of size of tumors, or some
other measure?
3.       Please balance your discussion of the results of the ongoing Phase 1b
clinical trial (the
         FAVOUR trial) with disclosure that these are interim results are
subject to change. We
         note disclosure to this effect on pages 24 and 121.
4.       We note your reference to "compelling" safety results. It is
inappropriate to state or imply
         that a product that is still in clinical trials is safe. Generally, we
will allow statements that
         there have been no serious adverse events. However, we note your
disclosure indicating
         that there were treatment-related adverse events that resulted in
trial participants
         discontinuing their participation in the FAVOUR trial; 5.6% of FURLONG
         participants experienced Grade 3 treatment-related adverse events; and
6 FAVOUR trial
         participants experiencing serious adverse events and 12 participants
experiencing Grade 3
         or higher treatment-related events. We note that Grade 3 events are
generally defined as
         severe or medically significant, requiring hospitalization or
prolongation of
         hospitalization, or disabling. A serious adverse event is generally
defined as one resulting
         in death, life threatening situation, hospitalization (initial or
prolonged), disability or
         permanent damage. Please revise your summary to quantify the number of
events that
         met the definition of serious adverse events and quantify the number
of occurrences.
         Similarly, revise your risk factor titled "Use of furmonertinib or any
future product
         candidates could be associated with adverse side events or other
safety risks, which could
 Zhengbin (Bing) Yao, Ph.D.
ArriVent Biopharma, Inc.
September 27, 2023
Page 3
         delay or preclude regulatory approval..." appearing on page 21 to
describe the number of
         events that meet the definition of serious adverse event, including
all events that require
         hospitalization or result in a prolonged hospitalization, and the
number of each type of
         event, and quantify the number of participants who discontinued their
participation due to
         treatment-related adverse events.
Our Pipeline, page 2

5.       We note your pipeline table currently indicates you have completed
Phase 1 and Phase 2
         clinical trials for 1L NSCLC EGFR Exon 20 INS Mutations. However, it
appears that the
         FURTHER and FAVOUR clinical trials are Phase 1b trials for Exon 20 and
         Additionally, there is no disclosure of your Phase 2 trial for 1L
         Ins Mutations. Please explain why you believe the table reflects the
current status of your
         development of 1L NSCLC EGFR Exon 20 Ins Mutations. If you have
conducted a Phase
         2 trial, please describe it and the objective results of the trial.
Our Furmonertinib Development Initiative, page 3

6.       The sub-heading states that this is "[y]our Furmonertinib Development
Initiative" and that
         you "have designed a robust global clinical development plan[]," but
we note that the table
         includes clinical trials sponsored by third-parties Allist and
InnoCare that appear unrelated
         to your current pipeline. Please clarify how these clinical trials
related to your
         furmonertinib programs. To the extent they relate to separate Allist
and Innocare
         programs, unrelated your current pipeline, explain why they are part
of your development
         initiative and why it is appropriate for you to include them in this
table. Alternatively,
         remove them from the clinical trial table. Please also define the
terms "1L" and "2L+"
         used in the table included in this section.
7.       Additionally, explain what additional information this table provides.
It appears the table
         is largely redundant of your pipeline table, but in a different
format. For example, with
         respect to your Furvent trial, your pipeline table already indicates
you are in Phase 3 trials
         related to the treatment of 1L NSCLC EGFR Exon 20 Ins Mutations, and
your next
         milestone is topline data. With respect to the additional data, such
as the information
         about the FURLONG trial, it is not clear how it relates to your
candidates in development.
Our Team and Approach , page 4
FirstName LastNameZhengbin (Bing) Yao, Ph.D.
8.     Please limit the disclosure of specific investors on this page to those
identified in the
Comapany   NameArriVent
       Principal StockholderBiopharma,   Inc. 173. Unlike the other investors
mentioned on this
                              table on page
September    General  Catalyst
                2023 Page  3 does not appear to be included in the Principal
Stockholder table.
FirstName LastName
 Zhengbin (Bing) Yao, Ph.D.
FirstName LastNameZhengbin   (Bing) Yao, Ph.D.
ArriVent Biopharma, Inc.
Comapany 27,
September NameArriVent
              2023       Biopharma, Inc.
Page 4    27, 2023 Page 4
FirstName LastName
Risk Factors
Several of the ongoing clinical trials for our lead product candidate,
furmonertinib, are being
conducted outside the United States. . ., page 23

9.       Please specify which ongoing clinical trials for furmonertinib are
being conducted outside
         of the United States.
If we are required by the FDA to obtain approval of a companion diagnostic in
connection with
approval of any of our product candidates..., page 36

10.      To the extent you have any reason to believe the approval of a
companion diagnostic
         device will be required in connection with any of your product
candidates, please expand
         your disclosure to discuss the circumstances. For example, given that
many of your
         programs are studying the efficacy of furmonertinib for NSCLC in
patients with specific
         mutations, is it likely that a companion diagnostic will be required
to determine whether a
         patient has the specific mutation or a diagnostic test to make such a
determination readily
Use of Proceeds, page 87

11.      As you are advancing your development of furmonertinib for three
different NSCLC
         indications, please revise your use of proceeds to discuss the
proceeds you intend to use to
         advance each of these programs and specify how far in the clinical
development process
         you expect to reach with the proceeds of this offering.
12.      We note that you intend to devote proceeds from the offering to
pre-commercial and
         commercial activities of furmonertinib. Please clarify if this use is
with respect to
         furmonertinib 1L NSCLC EGFR Exon m20 Ins Mutations. Additionally,
clarify that
         these activities are contingent on successful completion of Phase 3
trials. Clarify that any
         commercial activities are contingent on receiving regulatory approval.
Management's Discussion and Analysis of Financial Condition and Results of
Results of Operations
Research and Development, page 98

13.      You disclose here that you track outsourced clinical and preclinical
study costs and other
         external research and development costs associated with your lead
product candidate,
         furmonertinib. You also disclose elsewhere that furmonertinib is
currently being evaluated
         in multiple clinical trials across a range of epidermal growth factor
receptor (EGFR)
         mutations in non-small cell lung cancer (NSCLC), including a pivotal
Phase 3 clinical
         trial in exon 20 insertion mutations. Please revise to further
disclose the research and
         development expenses you tracked for furmonertinib by each individual
         indication, or if you do not track by indication, disclose that fact.
Please also expand your
         fluctuation disclosures here to provide more robust quantitative or
qualitative discussions
         about change drivers, trend and uncertainties. Refer to Item 303(b)(2)
of Regulation S-X.
 Zhengbin (Bing) Yao, Ph.D.
ArriVent Biopharma, Inc.
September 27, 2023
Page 5
Liquidity and Capital Resources
Cash Flows, page 102

14.      You disclose here that your net cash used in operating activities for
2021 includes a $42.9
         million non-cash charge for acquired in-process research and
development related to the
         Allist License Agreement. Since $40.0 million of the $42.9 million was
a cash payment,
         revise to quantify the amount of cash versus non-cash payments in the
Critical Accounting Policies, Significant Judgments and Use of Estimates
Determination of Fair Value of Our Common Stock, page 104

15.      Once you have an estimated offering price or range, please explain to
us how you
         determined the fair value of the common stock underlying your equity
issuances and the
         reasons for any differences between the recent valuations of your
common stock leading
         up to the initial public offering and the estimated offering price.
This information will
         help facilitate our review of your accounting for equity issuances,
including stock
         compensation. Please discuss with the staff how to submit your
Overview, page 107

16.      Delete your statement that furmonertinib has the potential to become
the standard of care
         in first-line EGFRm NSCLC patients with PACC mutations given
preclinical activity
         observed against these mutations together with its safety results in
clinical trials. Such
         statements inappropriately assume regulatory approval and results
relative to alternative
Our Furmonertinib Development Initiative, page 109

17.      Please clarify whether anti-tumor activity is a reduction in tumors or
no growth in tumors.
         Additionally, quantify the low rate of discontinuation due to
treatment-related adverse
Our Strategy, page 111

18.    We note your statement that "the data obtained as of June 15, 2023 in
your Phase 1b
       FAVOUR clinical trial. . .supports the use of furmonertinib as a first
line therapy." We
       also note that, according to your table appearing on pages 3 and 109,
this Phase 1b is still
FirstName LastNameZhengbin (Bing) Yao, Ph.D.
       ongoing, is intended to be a proof of concept trial, and the use of
furmonertinib has not yet
       beenNameArriVent     Biopharma,
             approved for exon          Inc.delete this statement and all
similar statements of
                                20. Please
September   27, 2023 Page 5
FirstName LastName
 Zhengbin (Bing) Yao, Ph.D.
FirstName LastNameZhengbin   (Bing) Yao, Ph.D.
ArriVent Biopharma, Inc.
Comapany 27,
September NameArriVent
              2023       Biopharma, Inc.
Page 6    27, 2023 Page 6
FirstName LastName
FAVOUR - Ongoing Phase 1b Clinical Trial in NSCLC Patients with EGFR Exon 20
Mutations, page 120

19.      Please explain the meaning of the following:
             "ORR per RECIST 1.1 by BICR;" and
         Additionally, quantify the secondary end points and provide data from
the trials so that a
         reader will be able to determine if the end points were met.
20.      Please clarify the meaning of ECOG in the table on page 121.
FURLONG - Completed Phase 3 Clinical Trial in Classical EGFRm First-Line NSCLC
page 125

21.      With respect to the FURLONG clinical trial in China, please confirm
the trial was a head-
         to-head trial with gefitnib. Alternatively, remove the comparisons to
Licenses, Partnerships and Collaborations, page 128

22.      Please revise this section to include your collaboration with Beijing
InnoCare Pharma Co.,
         Ltd. This disclosure should:
             describe the collaboration goal(s);
             identify the pipeline assets related to the collaboration, and;
             describe and quantify the benefits and obligations under any
              agreement, including quantifying payments made to date, aggregate
              milestone payments, royalty rates or applicable ranges, and term
and termination
         If there is a written agreement underlying this collaboration, please
file this agreement as
         an exhibit to the registration statement. Refer to Item 601(b)(10) of
Regulation S-K.
23.      Please clarify when your obligation to pay royalties for all licensed
products expires.
Aarvik Research Collaboration Agreement, page 130

24.      Please clarify how the research agreement is funded.
25.      Please quantify the amount of the "one-time non-refundable payment,"
that you would
         need to make to Aarvik if you exercised the Option.
26.      Disclose when the obligation to pay royalties will expire if you
exercise the Option.
Manufacturing, page 131

27.      Please specify whether your two third-party contract manufacturers,
Zhejiang Raybow
         Pharmaceutical Company., Ltd. and WuXi SynTheAll Pharmaceutical
company, Ltd., are
         located in China.
 Zhengbin (Bing) Yao, Ph.D.
FirstName LastNameZhengbin   (Bing) Yao, Ph.D.
ArriVent Biopharma, Inc.
Comapany 27,
September NameArriVent
              2023       Biopharma, Inc.
Page 7    27, 2023 Page 7
FirstName LastName
Principal Stockholders, page 173

28.      Please identify in a footnote to the table all natural persons who
have voting and/or
         investment power over the shares held by LAV Fund VI, L.P. and the
entities affiliated
         with Octagon Capital Advisors LP and Hillhouse Investment Management,
Financial Statements
Note 7. Convertible Preferred Stock and Common Stock
Convertible Preferred Stock, page F-12

29.      You report the Series A and B convertible preferred stocks as
permanent equity. Please
         respond to the following comments:

                Provide us with your analysis of the applicable guidance to
support your conclusion
              that these convertible preferred stocks should not be classified
as temporary
              equity following ASC 480-10-S99-3A. In that regard, we note your
Certificate of
              Incorporation as filed under Exhibit 3.1 includes redemption
clauses under situations
              including deemed liquidation.
                Revise to expand your disclosures to include all key terms for
these convertible
              preferred stocks, including any redemption features, as well as
any adjusting
              mechanism for their conversion price.
                Revise to disclose in the equity section of the statement of
financial position the
              aggregate amount of liquidation preference of these convertible
preferred stocks if
              considerably in excess of the par or stated value of the shares.
Refer to ASC 505-10-
Note 11. Allist License Agreement, page F-17

30.      Please revise to address the following:
             Revise this section and elsewhere as appropriate to disclose the
             arrangements under the Joint Clinical Collaboration Agreement,
including how costs
             and profit are shared between parties.
             Tell us your consideration whether the agreement is subject to ASC
             Collaborative Arrangements.
             If so, please revise to provide all the required disclosures under
ASC 808-10-50,
             including any profit sharing arrangement.
             For the research and development expenses related to the Clinical
Collaboration with
             Allist as you disclosed here, please also revise to disclose the
nature of the costs and
             their related global clinical studies.
 Zhengbin (Bing) Yao, Ph.D.
FirstName LastNameZhengbin   (Bing) Yao, Ph.D.
ArriVent Biopharma, Inc.
Comapany 27,
September NameArriVent
              2023       Biopharma, Inc.
Page 8    27, 2023 Page 8
FirstName LastName

31.      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 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


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