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United States securities and exchange commission logo
March 13, 2023
Vicky Zhang
Chief Financial Officer
Adlai Nortye Ltd.
c/o PO Box 309, Ugland House
Grand Cayman, KY1-1104
Cayman Islands
Re: Adlai Nortye Ltd.
Amendment No. 1 to
Draft Registration Statement on Form F-1
Submitted February
27, 2023
CIK No. 0001944552
Dear Vicky Zhang:
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
Cover Page
1. We note your response
to our prior comment 5 and we reissue in part. Please specify
on the cover page that
references to we and our cover both the ultimate holding
company and the
subsidiaries in the U.S. and mainland China that conduct daily
operations, as you have
stated in your response letter.
2. We note your response
to our prior comment 6 and we reissue in part. Please further
revise the cover page
to address restrictions on your PRC subsidiary's ability to transfer
funds, as disclosed
elsewhere in the filing, and provide a cross-reference to the
Vicky Zhang
Adlai Nortye Ltd.
March 13, 2023
Page 2
consolidated financial statements. In this regard we note your
statement that "there are
currently no restrictions of transferring funds between our Cayman
Islands holding
company and subsidiaries in the United States and Hong Kong" but you
have not
addressed whether your PRC subsidiary may transfer funds to the Cayman
Islands holding
company.
Overview, page 1
3. We note your response to our prior comment 7 specifying that AN0025's
Phase 1b clinical
trial is in France and the United States, and AN4005's clinical trial
is in China and the
United States. We also note your disclose on page 37 that you "may in
the future conduct
clinical trials for our drug candidates outside the U.S., including in
Europe, Australia,
China or other foreign jurisdictions." Please revise this risk factor
to clarify that you are
already conducting trials outside of the United States in China and
France.
Our company history and team, page 4
4. We note your response to our prior comment 14 and we reissue in part.
To the extent you
believe it is material to investors to highlight the name of specific
large investors, which
appears to be the case as you have included such name and statement in
the Summary of
the prospectus, please revise to make clear that prospective investors
should not rely on
the named investor's investment decision, that this investor may have
different risk
tolerances, and that the referenced financing was conducted at a
significant discount to the
IPO price, if true. In addition, we note that ATCG Holdings Limited is
controlled by Mr.
Hui Shao, one of the company's directors. Please clarify this on pages
4, 5, 105 and 106
where emphasis is placed on this investment.
Prospectus Summary
Our Strengths, page 4
5. We note your response to our prior comment 11 and we reissue the
comment. Please
revise statements throughout your prospectus to eliminate conclusions
or predictions that
the candidates are safe and effective, as determinations of safety and
efficacy are solely
within the authority of the FDA. You may provide an objective summary
of the data that
you used to draw such conclusions. In this regard, we note your
disclosures on page 4
stating that AN2025 demonstrated promising efficacy and safety data.
6. We note your response to our prior comment 15 and we reissue in part.
Please specify the
FirstName LastNameVicky Zhang
non-death types of Serious Adverse Effects (SAEs). In this regard, we
note that
Comapany NameAdlai
the AN2025 plusNortye Ltd.group was 10% higher than the placebo group
for non-death
paclitaxel
March SAEs.
13, 2023 Page 2
FirstName LastName
Vicky Zhang
FirstName LastNameVicky Zhang
Adlai Nortye Ltd.
Comapany
March NameAdlai Nortye Ltd.
13, 2023
March3 13, 2023 Page 3
Page
FirstName LastName
Prospectus Summary
Conventions that apply to this prospectus, page 13
7. We note your response to our prior comment 17 and we reissue in part.
Please clarify that
the legal and operational risks associated with operating in China
also apply to any
operations in Hong Kong and/or Macau.
Business
License and collaboration agreements, page 132
8. We note the supplemental analysis provided in response to our prior
comment 23;
however, we are unable to agree with your conclusion that the
referenced agreements are
not required to be filed pursuant to Item 601(b)(10) of Regulation
S-K. Your response
letter indicates that the Roche and MSD agreements are strictly supply
agreements;
however, your disclosure both in the Summary and Business sections
indicates otherwise.
In addition, your collaboration agreement with Biotime has been your
only source of
revenue to date and includes potential future payments that would
appear to be material to
the company. Please either file each of these agreements as exhibits
or provide further
analysis supporting your position that such filing is not required.
Collaboration Agreement with Roche, page 134
9. We note your response to our prior comment 22 and your statement that
"as of January 19,
2023" you had not entered into a CSA Supplement with Roche that
requires you to pay for
the supplied atezolizumab. Please revise to provide this statement as
of the latest
practicable date or provide the statement as of the date of the
prospectus.
Principal Shareholders, page 169
10. We note your response to our prior comment 26 and we reissue in part.
You have now
disclosed that Industrial and Commercial Bank of China Limited (ICBC)
controls the
voting and/or dispositive power with respect to the shares owned
UNIQUE MARK
VENTURES LIMITED. Please revise your disclosure in footnote 6 on page
169 to clarify
that ICBC is a PRC state-owned bank and to state whether any
individual exercises
investment and/or voting control over the securities held by UNIQUE
MARK
VENTURES LIMITED. In this regard, we note your statement that the
asset management
department of ICBC exercises voting power over the shares. To the
extent voting and
investment decisions in the department are made jointly by three or
more individuals,
please so state, providing support for your belief that no individual
is required to be
named.
History of share capital, page 179
11. We note the revision related to our prior comment 27. Please further
revise to describe the
nature of the relationship between Mr. Lu and Lucy Zhang's father and
the nature of or
Vicky Zhang
Adlai Nortye Ltd.
March 13, 2023
Page 4
reason(s) for the loan facility between the two. Please also address any
related-party
considerations as it relates to your financial statements and related
disclosures.
Notes to the Consolidated Financial Statements
12. Financial Assets at FVTPL, page F-34
12. We note your response to prior comment 31 and the revisions made to the
fair value
disclosures on pages F-49 and F-50. Your current disclosure in Note 12
does not
adequately explain the nature and terms of these financial assets. As
previously requested,
please revise your disclosure to clearly describe the nature and
significant terms of these
products as well as any related risks. For example, clarify whether your
wealth
management product is an investment in a mutual fund and if so, the types
of underlying
investments in which the fund invests. As it relates to your dual
currency structured
deposit, clarify whether this is a compound instrument which combines a
traditional bank
deposit with a foreign currency derivative and discuss the significant
terms.
General
13. Please revise throughout where you discuss the Holding Foreign Companies
Accountable
Act (the "HFCA Act") to reflect the HFCA Act timeline for a potential
trading prohibition
was shortened from three years to two years, as part of the "Consolidated
Appropriations
Act, 2023," signed into law on December 29, 2022.
You may contact Jenn Do at 202-551-3743 or Angela Connell at
202-551-3426 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jimmy McNamara at 202-551-7349 or Laura Crotty at 202-551-7614 with any
other
questions.
Sincerely,
FirstName LastNameVicky Zhang
Division of
Corporation Finance
Comapany NameAdlai Nortye Ltd.
Office of Life
Sciences
March 13, 2023 Page 4
cc: Ke Geng
FirstName LastName