UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
Report
of Foreign Private Issuer
Pursuant
to Rule 13a-16 or 15d-16
under
the Securities Exchange Act of 1934
For
the month of February 2026
Commission
File Number: 001-41773
Adlai
Nortye Ltd.
c/o
PO Box 309, Ugland House
Grand
Cayman, KY1-1104
Cayman
Islands
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒
Form 20-F ☐ Form 40-F
Press
Release
On
February 12, 2026, Adlai Nortye Ltd. issued a press release entitled “Adlai Nortye Announces First Patient Enrolled in Global Phase
1 Trial of Pan-RAS (ON) Inhibitor AN9025 for Solid Tumors Harboring RAS Mutations”, a copy of the press release is attached to
this Form 6-K as Exhibit 99.1.
Exhibits
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release, dated February 12, 2026 |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
| |
Adlai
Nortye Ltd. |
| |
|
| |
By: |
/s/
Yang Lu |
| |
Name: |
Yang
Lu |
| |
Title: |
Chief
Executive Officer and Chairman of Board of Directors |
Date:
February 12, 2026
Exhibit 99.1
Adlai
Nortye Announces First Patient Enrolled in Global Phase 1 Trial of Pan-RAS (ON) Inhibitor AN9025 for Solid Tumors Harboring RAS Mutations
SINGAPORE
and NORTH BRUNSWICK, N.J. and HANGZHOU, China, February 12, 2026 – Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or
“Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced
that the first patient has been dosed in the United States in early February in its ongoing Phase 1 clinical trial of AN9025, a pan-RAS
(ON) inhibitor.
The Phase
1 study is a first-in-human, multicenter, open-label trial designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor
activity of AN9025 in patients with advanced or metastatic solid tumors harboring RAS mutations. This trial is being conducted
by Adlai Nortye in collaboration with Jiangsu Aosaikang Pharmaceutical Co. Ltd. (“ASK Pharm”) as a multi-regional clinical
trial (“MRCT”) pursuant to a license agreement , under which Adlai Nortye retains ex-China rights to AN9025, while ASK Pharm
holds rights in mainland China, Hong Kong and Macao.
“Dosing
the first U.S. patient with AN9025, our wholly in-house discovered, oral pan-RAS(ON) inhibitor with best-in-class potential, is a significant
milestone,” said Dr. Archie Tse, Head of Research and Development at Adlai Nortye. “This achievement advances our clinical
strategy to evaluate AN9025 across multiple RAS-mutant solid tumors. We look forward to efficiently progressing its global clinical development
and generating meaningful data to support its future advancement.”
About
AN9025
AN9025 is
an oral small molecule pan-RAS(ON) inhibitor with best-in-class potential, designed to target a broad spectrum of RAS mutations across
various tumor types. Preclinical studies have demonstrated that AN9025 effectively inhibits RAS-mutant cancers with potent and durable
efficacy, including pancreatic, lung, and colorectal adenocarcinomas, and shows comparable or superior results relative to a benchmark
agent of the same class.
About
Adlai Nortye
Adlai Nortye
(NASDAQ: ANL) is a global clinical-stage company at the forefront of discovering and developing innovative cancer therapies. Leveraging
our dual R&D presence in the U.S. and China, we are building a robust pipeline of drug candidates focused on two key areas where we
believe we can make a significant difference. (1) Next-generation cancer immunotherapies: our candidates, AN8025 (a tri-functional fusion
protein of αPD-L1 x CD86 variant x LAG3 variant), a T-cell and antigen-presenting cell modulator, and AN4005 (a first-in-class oral
small-molecule PD-L1 inhibitor), are designed to activate cancer immunity in novel ways. (2) RAS-targeting therapies: we are tackling
RAS-driven cancers with AN9025, an oral pan-RAS(ON) inhibitor, and AN4035, a CEACAM5-targeting ADC delivering a potent pan-RAS(ON) inhibitor
directly to tumors.
Forward-Looking
Statement
This announcement
contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities
Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,”
“anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,”
“potential,” “continue,” “ongoing,” “targets” and similar statements. Among other things,
statements that are not historical facts, including statements about the Company’s beliefs and expectations, the business outlook
and quotations from management in this announcement, as well as the Company’s strategic and operational plans, are or contain forward-looking
statements.
The Company
may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”),
in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking
statements involve inherent risks and uncertainties. Factors that could cause the Company’s actual results to differ materially
from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and
results of the Company’s preclinical studies, clinical trials and other therapeutic candidate development efforts; the Company’s
ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials;
whether the clinical trial results will be predictive of real-world results; the Company’s receipt of regulatory approvals for its
therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market
acceptance of the Company’s therapeutic candidates; the Company’s ability to establish, manage, and maintain corporate collaborations,
as well as the ability of its collaborators to execute on their development and commercialization plans; the implementation of the Company’s
business model and strategic plans for its business and therapeutic candidates; the scope of protection the Company is able to establish
and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing
the intellectual property rights of others; estimates of the Company’s expenses, future revenues, capital requirements and its needs
for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the PRC
and United States or elsewhere. Further information regarding these and other risks is included in the Company’s filings with the
SEC. All information provided in this announcement and in the attachments is as of the date of this announcement, and the Company does
not undertake any obligation to update any forward-looking statement, except as required under applicable law.
Company contact:
Investor Relations
Email: ir@adlainortye.com
