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December 18, 2024
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.
Form 20-F for Fiscal Year Ended December 31, 2023
File No. 001-41773
Dear Vicky Zhang:
We have reviewed your filing and have the following comments.
Please respond to this letter within ten business days by providing the
requested
information or advise us as soon as possible when you will respond. If you do
not believe a
comment applies to your facts and circumstances, please tell us why in your
response.
After reviewing your response to this letter, we may have additional
comments.
Annual Report on Form 20-F for Fiscal Year Ended December 31, 2023
Item 3D. Risk Factors
Summary of Risk Factors, page 5
1. In future filings, in your summary of risk factors, please disclose with
greater
specificity the significant regulatory, liquidity and enforcement risks
that your
corporate structure and being based in or having the majority of the
company s
operations in China poses to investors. In particular, describe:
Risks and uncertainties arising from the legal system in China,
including that rules
and regulations in China can change quickly with little advance
notice; and
The risk that the Chinese government may intervene or influence your
operations
at any time, or may exert more control over offerings conducted
overseas and/or
foreign investment in China based issuers, which could result in a
material change
in your operations and/or the value of the securities you are
registering for sale.
Acknowledge any risks that any actions by the Chinese government to
exert more
oversight and control over offerings that are conducted overseas
and/or foreign
investment in China-based issuers could significantly limit or
completely hinder
December 18, 2024
Page 2
your ability to offer or continue to offer securities to investors
and cause the value
of such securities to significantly decline or be worthless.
Item 5. Operating and Financial Review and Prospects
Research and development expenses, page 133
2. We note from the pipeline table on page 70 that you have three clinical
stage drug
product candidates, AN2025, AN0025 and AN4005. Please revise future
filings to
disclose the costs incurred during each period presented for each of
your key research
and development product candidates. If you do not track your research
and
development costs by project, disclose that fact and explain why you do
not maintain
and evaluate research and development costs by project. Also, revise to
provide other
quantitative and qualitative disclosures that give more transparency as
to the type of
research and development expenses incurred (i.e., by nature or type of
expense) which
should reconcile to total research and development expenses on your
Statements of
Operations.
Index to Consolidated Financial Statements, page F-1
3. We note that you have only provided two years of audited financial
statements under
Item 18 of Form 20-F. Please tell us how this presentation is in
accordance with Item
8.A.2 of Form 20-F and its related Instructions.
General
4. We note the changes made to your disclosure appearing in Item 3. Key
Information
and Item 3D. Risk Factor sections relating to legal and operational
risks associated
with operating in China and PRC regulations. It is unclear to us that
there have been
changes in the regulatory environment in the PRC since the prior review
of your
registration statement on Form F-1 that was declared effective by the
SEC on
September 28, 2023 warranting revised disclosure to mitigate the
challenges you face
and related disclosures.
The Sample Letters to China-Based Companies sought specific disclosure
relating to
the risk that the PRC government may intervene in or influence your
operations at any
time, or may exert control over operations of your business, which could
result in a
material change in your operations and/or the value of your securities.
We remind you
that, pursuant to federal securities rules, the term control
(including the terms
controlling, controlled by, and under common control with
) as defined in
Securities Act Rule 405 means the possession, direct or indirect, of
the power to
direct or cause the direction of the management and policies of a
person, whether
through the ownership of voting securities, by contract, or otherwise.
The Sample Letters also sought specific disclosures relating to risks
and uncertainties
regarding the interpretation and enforcement of PRC rules and
regulations, which can
change quickly with little advance notice. We do not believe that your
revised
disclosure regarding the PRC government's "intent to strengthen its
regulatory
oversight" or efforts with respect to the "process of perfecting" the
legal system
adequately conveys the same risks. In future filings, please restore
your disclosures in
December 18, 2024
Page 3
these areas to the disclosures as they existed your registration
statement on Form F-1
declared effective on September 28, 2023. As examples, and without
limitation, we
note that your disclosure in your Annual Report on Form 20-F does not
contain clear
disclosure that (i) in recent statements, the Chinese government has
indicated an intent
to exert more oversight and control over offerings that are conducted
overseas; (ii) the
PRC government has significant oversight and discretion over the conduct
of your
business and may intervene in, exert control over, or influence your
operations at any
time with little or no advance notice, which could result in a material
change in your
operations and/or the value of your securities; and (iii) uncertainties
in the PRC
legal system with respect to the implementation and interpretation of
rules and
regulations, including the possibility of changes thereto with little
advance
notice, may create material risks to the company and its
securityholders, including the
risk of protracted legal proceedings and substantial related costs.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence
of action by the staff.
Please contact Lynn Dicker at 202-551-3616 or Kevin Kuhar at
202-551-3662 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Lauren Sprague Hamill at 303-844-1008 or Alan Campbell at 202-551-4224
with any
other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences