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~~May 2025

Commission File Number: 001-41773

Adlai Nortye Ltd.

c/o PO Box 309, Ugland House ~~Grand Cayman, KY1-1104 Cayman Islands~~

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

CONTENT

~~Changes~~Announcement of Topline Results of Phase III BURAN Trial Evaluating Buparlisib (AN2025) in ~~Company’s~~Combination ~~Certifying~~with ~~Accountant.~~Paclitaxel for Recurrent or Metastatic HNSCC

Adlai Nortye Ltd. (athe “Company” or “Adlai Nortye”) announced ~~Dismissal of~~topline ~~Independent~~results ~~Registered~~from its Phase III BURAN trial evaluating buparlisib (AN2025), a PI3K inhibitor, in combination with paclitaxel ~~Public~~for ~~Accounting~~the ~~Firm~~treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

OnThe ~~February~~study ~~14,~~did ~~2025,~~not meet the ~~Audit~~ ~~Committee~~ primary endpoint of improving overall survival ~~Adlai~~compared ~~Nortye~~to ~~Ltd~~paclitaxel ~~(Nasdaq:~~alone. ~~ANL)~~The ~~(the~~safety ~~“Company”)~~profile ~~dismissed~~of ~~Forvis~~buparlisib ~~Mazars~~was consistent with previous findings, ~~LLP~~with ~~(“Forvis~~no ~~Mazars”)~~new assafety ~~the~~signals ~~Company’s~~observed. ~~independent~~Detailed ~~registered~~results ~~public~~will ~~accounting~~be ~~firm~~presented at an upcoming medical conference.

~~From~~“We ~~June~~are 1,disappointed ~~2024~~with ~~through February 14, 2025,~~ the ~~period~~outcome ~~during~~of ~~which Forvis Mazars was engaged as~~ the ~~Company’s~~phase ~~independent~~III ~~registered~~BURAN study,” ~~public~~said ~~accounting~~Carsten ~~firm~~Lu, ~~there~~CEO ~~were~~and ~~no disagreements~~Chairman ~~with Forvis Mazars on any matter~~ of ~~accounting~~Adlai ~~principles~~Nortye. or“While ~~practices,~~the ~~financial~~outcome ~~statement~~is ~~disclosure or auditing scope or procedure, which disagreements, if~~ not ~~resolved~~what towe ~~the~~hoped ~~satisfaction of Forvis Mazars~~for, ~~would~~we ~~have~~are ~~caused~~deeply ~~Forvis Mazars to make reference~~grateful to the ~~subject~~patients, ~~matter~~investigators, ofand ~~the~~research ~~disagreements~~teams aswhose ~~defined~~commitment ~~in Item 16F(a)(1)(iv) of Form 20-F~~ and ~~related~~contributions ~~instructions~~made tothis ~~Item 16F~~global oftrial ~~Form 20-F in~~possible. ~~connection~~Based ~~with~~on ~~any~~these results, ~~reports~~we ~~it would~~ have ~~issued,~~decided ~~and~~to ~~there~~discontinue ~~were~~further nodevelopment ~~“reportable events” as such term is described in Item 16F(a)(1)(v)~~ of ~~Form 20-F~~buparlisib. ~~Forvis~~ ~~Mazars~~We ~~did~~will, ~~not~~however, ~~issue~~continue ~~any~~to ~~reports~~analyze on the ~~Company’s~~data ~~financial consolidated~~to ~~statements~~better ~~during~~ understand the ~~period~~findings ~~which~~and ~~Forvis~~to ~~Mazars~~inform ~~was~~future ~~engaged~~drug asdevelopment ~~the~~in ~~Company’s independent registered public accounting firm~~HNSCC.”

“The Company ~~has~~expects ~~provided~~to ~~Forvis~~make ~~Mazars~~near-term ~~with a~~changes ~~copy~~to ofits ~~the~~business operations ~~foregoing~~and ~~disclosure,~~to ~~and~~reduce ~~requested~~its ~~that~~workforce ~~Forvis~~in ~~Mazars~~order ~~furnish~~to ~~the~~preserve ~~Company~~cash, ~~with~~including abut ~~letter~~not ~~addressed~~limited to: ~~the~~optimizing ~~Securities~~workforce structure and compensation, ~~Exchange~~pursuing ~~Commission~~strategic ~~stating~~business ~~whether~~development oropportunities, ~~not~~and itexpanding ~~agrees~~our ~~with~~financing ~~such~~options,” ~~disclosure.~~Carsten ALu ~~copy~~added. of“We ~~the~~will ~~letter~~refocus our ~~from~~resources ~~Forvis~~and ~~Mazars~~efforts ~~addressed~~on toadvancing ~~the~~AN8025 ~~Securities~~ and ~~Exchange~~AN9025, ~~Commission~~together ~~dated~~with ~~February~~our ~~14,~~emerging ~~2025~~candidates, iswhich ~~filed~~we ~~as Exhibit~~believe ~~99.1~~ have strong potential to ~~this~~address ~~current~~unmet ~~report~~needs onacross ~~Form 6-K~~multiple tumor types, and deliver transformative therapies to patients worldwide.”

~~(b) Engagement~~About ofPhase ~~New~~III ~~Independent Registered~~BURAN ~~Public Accounting Firm~~Trial

The ~~Company’s~~BURAN ~~Audit~~study ~~Committee~~is ~~approved~~a randomized (2:1), open-label Phase III study to ~~and~~assess the ~~Company’s~~treatment ~~Board~~effect of ~~Directors~~buparlisib ~~(the~~in ~~“Board”~~combination with paclitaxel compared to weekly paclitaxel alone in patients with recurrent and metastatic HNSCC that have progressed after anti-PD-(L)1-based ~~ratified,~~treatment. ~~the~~A ~~engagement~~total of ~~BDO~~487 ~~China~~patients ~~Shu~~were ~~Lun~~enrolled ~~Pan~~globally. ~~Certified~~The ~~Public~~primary ~~Accountants~~endpoint ~~LLP~~of (the ~~“New Auditor”~~trial was overall survival (OS), ~~and~~with ~~appointed~~secondary ~~the~~endpoints ~~New Auditor as~~including ~~the~~progression-free ~~Company’s~~survival ~~independent~~(PFS), ~~registered~~objective response ~~public~~rate ~~accounting~~(ORR), ~~firm~~and toduration ~~audit~~of ~~the~~response ~~Company’s~~(DoR). ~~consolidated~~This ~~financial~~Phase ~~statements~~III astrial ofbuilds ~~and~~on ~~for~~positive Phase II data, where the ~~fiscal~~buparlisib-paclitaxel ~~year~~combination demonstrated ~~ended~~improvements ~~December~~in 31ORR, ~~2024~~ PFS, ~~effective~~and ~~February~~OS 14compared to paclitaxel alone. Notably, ~~2025~~these Phase II findings preceded the establishment of anti-PD-(L)1 therapies as the cornerstone treatment for recurrent/metastatic HNSCC.

~~During~~About ~~the~~AN8025 past two fiscal years ended December 31, 2022 and 2023, and the subsequent period through February 14, 2025, neither the Company nor anyone on the Company’s behalf consulted with the New Auditor with respect to either (i) the application of accounting principles to a specified transaction, either completed or proposed, or (ii) the type of audit opinion that might be rendered on financial statements, and no written report nor oral advice was provided to the Company that the New Auditor concluded was an important factor that the Company consider in reaching a decision as to any accounting, auditing or financial reporting issue, or (iii) any matter that was the subject of a disagreement as defined in Item 16F(a)(1)(iv) of Form 20-F and related instructions to Item 16F of Form 20-F, or any reportable events as described in Item 16F(a)(1)(v) of Form 20-F.

AN8025 is a next-generation tri-specific antibody fusion protein in particular PD-1-based immunotherapy, derived from an approved αPD-L1 antibody and fused with functionally optimized CD86 and LAG3 variants. Designed to modulate T cell and antigen-presenting cell (APC) functions, preclinical studies have demonstrated that AN8025 enhances both the quantity and quality of APCs while also inducing robust PD-L1-dependent T cell activation and anti-tumor efficacy in vivo. The Company plans to submit the IND application in mid-2025.

About AN9025

AN9025 is an in-house developed 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. The company plans to submit an IND application in the second half of 2025.

About AN4005

AN4005 is an orally available, small-molecule PD-L1 inhibitor that demonstrates antitumor activity by the blockade of PD-1/PD-L1 interaction. Preliminary results from the Dose-Escalation Phase, presented at SITC 2024, demonstrated that AN4005 exhibits favorable safety and tolerability in patients with advanced tumors. Encouraging preliminary efficacy was observed in a tumor type known to respond to anti-PD-(L)1 therapy. The trial has now advanced to the Expansion Phase, evaluating two doses of AN4005 in checkpoint inhibitor-naïve patients. Proof-of-concept data from the Expansion Phase is expected by the end of 2025.

~~EXHIBIT~~About ~~INDEX~~Adlai Nortye

Exhibit No.		Description
99.1		Letter of Forvis Mazars, LLP dated February 14, 2025

Adlai Nortye (NASDAQ: ANL) is a global clinical-stage company focused on the development of innovative cancer therapies, with global R&D centers in the U.S. and China, the Company is advancing a robust oncology pipeline. We are advancing multiple drug candidates including AN8025, a multifunctional fusion protein acting as a T cell and antigen-presenting cell (“APC”) modulator, AN9025, an oral small molecule pan-RAS(ON) inhibitor, and AN4005, an oral small molecule PD-L1 inhibitor.

Forward-Looking ~~and Cautionary Statements~~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~~ 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 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~~ 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~~ 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~~ 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.

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~~May 1430, 2025

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