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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,
Inc.
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
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 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
approve
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
following:
"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.
September
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
108);
"Furmonertinib is potentially differentiated from third-generation
EGFR TKIs
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
effective.
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
trial
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
trial
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
PACC.
Additionally, there is no disclosure of your Phase 2 trial for 1L
NSCLC EGFR Exon 20
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
page,27,
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.
September
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
available?
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
Operations
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
clinical
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
total.
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
response.
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
treatments.
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
events.
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
Comapany
beenNameArriVent Biopharma,
approved for exon Inc.delete this statement and all
similar statements of
20. Please
efficacy.
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.
September
Page 6 27, 2023 Page 6
FirstName LastName
FAVOUR - Ongoing Phase 1b Clinical Trial in NSCLC Patients with EGFR Exon 20
Insertion
Mutations, page 120
19. Please explain the meaning of the following:
"ORR per RECIST 1.1 by BICR;" and
"OS."
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
Patients,
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
gefitnib.
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
collaboration
agreement, including quantifying payments made to date, aggregate
potential
milestone payments, royalty rates or applicable ranges, and term
and termination
provisions.
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.
September
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,
Ltd.
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-
50-4.
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
financial
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
808,
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.
September
Page 8 27, 2023 Page 8
FirstName LastName
General
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
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: John Rudy