Adlai Nortye (NASDAQ: ANL) cuts H1 2025 loss, updates oncology pipeline

Rhea-AI Filing Summary

Adlai Nortye reported unaudited first half 2025 results showing a smaller loss and lower cash burn while advancing its oncology pipeline. Net loss for the six months ended June 30, 2025 narrowed to $18.3M from $27.7M a year earlier, as research and development expenses fell 41.4% to $15.2M and general and administrative costs declined to $4.1M. Net cash used in operating activities was $15.1M, compared with $28.4M in the prior-year period.

Cash and cash equivalents were $44.1M as of June 30, 2025, plus $18.2M of restricted cash, while shareholders’ equity stood at $7.9M. The company highlighted progress across multiple drug candidates: phase I for AN8025 is ongoing; AN4005 has moved into expansion cohorts with proof-of-concept data planned for 2026; AN0025’s phase II ARTEMIS study is under way; and first-in-human or IND-enabling steps for AN9025 and AN4035 are targeted around 2026.

Insights

Biotech equity analyst

Adlai Nortye cut its H1 2025 loss and cash burn while progressing an early-stage oncology pipeline.

Adlai Nortye remains a pre-revenue, clinical-stage company, but its first half 2025 results show tighter spending. Loss for the six months ended June 30, 2025 decreased to $18.3M from $27.6M, driven mainly by a 41.4% reduction in research and development expenses to $15.2M. Operating cash outflow improved to $15.1M from $28.4M, indicating a slower burn rate as projects sit in earlier, less costly stages.

On the balance sheet, cash and cash equivalents of $44.1M plus restricted cash of $18.2M supported total assets of $72.0M as of June 30, 2025. However, interest-bearing bank borrowings rose to $44.1M and shareholders’ equity declined to $7.9M, reflecting cumulative losses. This capital structure underscores continued dependence on external funding.

Pipelined assets are advancing but remain largely in early development. AN8025 is in an ongoing phase I trial, AN4005 has entered its expansion phase with proof-of-concept data planned for a 2026 conference, and the ARTEMIS phase II study of AN0025 continues with a futility analysis expected by the first quarter of 2026. Plans to initiate a phase I study for AN9025 in the first quarter of 2026 and submit an IND for AN4035 in mid-2026 point to a busy upcoming clinical schedule, with future updates likely to come through subsequent company disclosures.

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 December 2025

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

CONTENT

Adlai Nortye Ltd. (the “Company”) Reports Unaudited First Half 2025 Financial Results and Highlights Recent Operational Progress

Business Highlights

Pipeline updates 

 

1

AN8025

AN8025 is a next-generation tri-specific antibody fusion protein derived from an approved αPD-L1 antibody and fused with functionally optimized CD86 variant and LAG3 variant. 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 clinical phase I study of AN8025 is currently ongoing.

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. The Company expects to initiate the phase I clinical study in the first quarter of 2026.

AN4035

AN4035 is a proprietary CEACAM5-targeting antibody drug conjugate (ADC) designed to deliver potent anti-tumor activity with an improved therapeutic window. It is armed with highly potent pan-RAS(ON) inhibitor payload, which effectively target a broad spectrum of CEACAM5-expressing, RAS-driven cancers. The Company expects to submit IND in the middle of 2026.

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 to be presented in a conference in 2026.

AN0025

AN0025 is a small molecule EP4 antagonist designed to modulate the tumor microenvironment. In the phase Ib study of preoperative AN0025 and radiotherapy/chemoradiotherapy combination in rectum cancer, preliminary efficacy results (20% clinical complete response (cCR) and 16% pathologic complete response (pCR)) are encouraging. ARTEMIS (Augmenting RadioTherapy in REctal Cancer to Minimise Invasive Surgery) phase II study of preoperative AN0025 and radiotherapy/chemoradiotherapy combination in rectum cancer is ongoing. The futility analysis result is expected by the first quarter of 2026. 

Financial Highlights for the Six Month Period Ended June 30, 2025

The consolidated financial statements of the Company are prepared in accordance with IFRS as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in US dollars, the Company’s functional and presentation currency.

As of June 30, 2025, cash and cash equivalents totaled US$44.1 million compared to US$60.9 million on December 31, 2024. As of June 30, 2025, restricted cash totaled US$18.2 million compared to nil on December 31, 2024.

2

Net cash used in operating activities for the six months ended June 30, 2025 was US$15.1 million, compared to US$28.4 million for the six months ended June 30, 2024.

Research and development expenses decreased by 41.4% from US$26.0 million for the six months ended June 30, 2024 to US$15.2 million for the six months ended June 30, 2025. The decrease was primarily because the Company’s current projects are still at relatively early stages compared to the same period last year, resulting in lower service fees incurred to date.

General and administrative expenses decreased by 13.8% from US$4.7 million for the six months ended June 30, 2024 to US$4.1 million for the six months ended June 30, 2025, primarily attributable to a decrease in share-based compensation expenses resulting from the vesting schedule of certain stock options.

Other gains decreased by 45% from US$2.6 million for the six months ended June 30, 2024 to US$1.4 million for the six months ended June 30, 2025, primarily attributable to a reduction in government grants received in 2025. 

For the reasons described above, the Company’s net loss for the period ended June 30, 2025 decreased by 33.6% from US$27.7 million for the six months ended June 30, 2024 to US$18.3 million for the six months ended June 30, 2025.

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 

3

ADLAI NORTYE LTD.

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(All amounts in thousands, except share and per share data, or as otherwise noted)

		Six Months Ended
		June 30, 2024				June 30, 2025
		$’000				$’000
REVENUE			—				—
Other operating income, net			1,490				140
Administrative expenses			(4,717	)			(4,066	)
Research and development expenses			(26,016	)			(15,248	)
Total operating loss			(29,243	)			(19,174	)
Other gains, net			2,575				1,461
Investment income			2				98
Share of profits of investments accounted for using the equity method			—				(4	)
Fair value loss on financial liabilities at FVTPL			—				—
Finance costs			(946	)			(716	)
LOSS BEFORE TAX			(27,612	)			(18,335	)
Income tax expense			—				—
LOSS FOR THE PERIOD			(27,612	)			(18,335	)
Attributable to:
Ordinary Equity Holders of the Parent			(27,612	)			(18,335	)
OTHER COMPREHENSIVE LOSS
Exchange differences on translation of the financial statements of subsidiaries			(92	)			82
Other comprehensive loss for the period, net of tax			(92	)			82
TOTAL COMPREHENSIVE LOSS FOR THE PERIOD			(27,704	)			(18,253	)
Attributable to:
Ordinary Equity Holders of the Parent			(27,704	)			(18,253	)
LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT
Basic and diluted
Loss for the period ($ per share)			(0.35	)			(0.19	)
Weighted average common shares outstanding			78,385,007				95,862,790

4

ADLAI NORTYE LTD.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(All amounts in thousands, except share and per share data, or as otherwise noted)

		Six Months Ended June 30,
		2024				2025
		$’000				$’000
Net cash flows used in operating activities			(28,371	)			(15,121	)
Net cash flows used in investing activities			27,514				(18,181	)
Net cash flows from financing activities			7,510				16,584
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS			6,653				(16,718	)
Cash and cash equivalents at beginning of the period			91,492				60,902
Effect of foreign exchange rate changes, net			(165	)			34
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD			97,980				44,218

5

ADLAI NORTYE LTD.

UNAUDITED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(All amounts in thousands, except share and per share data, or as otherwise noted)

		As of
		December 31, 2024				June 30, 2025
		$’000				$’000
ASSETS
Current assets
Cash and cash equivalents			60,902				44,138
Restricted cash			—				18,240
Financial assets at FVTPL			7				7
Prepayments, other receivables and other assets			3,141				3,078
Other receivables -related party			14				14
Total current assets			64,064				65,477
Non-current assets
Property, plant and equipment			1,743				1,499
Right-of-use assets			962				636
Other intangible assets			40				29
Other receivables and other assets			304				231
Long-term equity investments			4,157				4,173
Long-term investments at amortized cost			—				—
Total non-current assets			7,206				6,568
Total assets			71,270				72,045
LIABILITIES
Current liabilities
Trade payables			10,146				9,678
Contract Liabilities			5,000				5,000
Other payables and accruals			3,413				4,879
Interest-bearing bank borrowings			26,330				44,053
Lease liabilities			471				257
Total current liabilities			45,360				63,867
Non-current liabilities
Lease liabilities			425				257
Total non-current liabilities			425				257
Total liabilities			45,785				64,124
SHAREHOLDERS’ EQUITY
Class A Ordinary shares (par value of $0.0001 per share; 93,710,803 shares outstanding as of December 31, 2024 and June 30, 2025)			9				9
Class B Ordinary shares (par value of $0.0001 per share; 16,990,000 shares outstanding as of December 31, 2024 and June 30, 2025)			2				2
Share premium			439,016				439,173
Share based payments reserve			20,311				20,843
Exchange fluctuation reserve			(4,535	)			(4,453	)
Accumulated deficit			(429,318	)			(447,653	)
Total shareholders’ equity			25,485				7,921
Total liabilities and shareholders’ equity			71,270				72,045

6

ADLAI NORTYE LTD.

UNAUDITED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(All amounts in thousands, except share and per share data, or as otherwise noted)

		Attributable to owners of the parent
		Ordinary Shares				Additional paid-in capital				Share option reserve				Exchange fluctuation reserve				Accumulated losses				Total deficits
		$’000				$’000				$’000				$’000				$’000				$’000
At January 1, 2024			11				438,707				18,018				(4,241	)			(373,092	)			79,403
Loss for the period			—				—				—				—				(27,612	)			(27,612	)
Other comprehensive income for the period:
Exchange differences on translation of the financial statements of subsidiaries			—				—				—				(92	)			—				(92	)
Share-based compensation			—				—				1,669				—				—				1,669
At June 30, 2024			11				438,707				19,687				(4,333	)			(400,704	)			53,368
At January 1, 2025			11				439,016				20,311				(4,535	)			(429,318	)			25,485
Loss for the period			—				—				—				—				(18,335	)			(18,335	)
Vesting of restricted shares			—				157				(157	)			—				—				—
Other comprehensive income for the period:
Exchange differences on translation of the financial statements of subsidiaries			—				—				—				82				—				82
Share-based compensation			—				—				689				—				—				689
At June 30, 2025			11				439,173				20,843				(4,453	)			(447,653	)			7,921

7

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: December 29, 2025

8

FAQ

How did Adlai Nortye (ANL) perform financially in the first half of 2025?

For the six months ended June 30, 2025, Adlai Nortye reported a net loss of $18.3M, an improvement from $27.7M in the same period of 2024. Operating cash outflow also declined to $15.1M from $28.4M, reflecting lower spending.

What is Adlai Nortye’s cash position as of June 30, 2025?

As of June 30, 2025, the company held $44.1M in cash and cash equivalents and $18.2M in restricted cash. Total shareholders’ equity was $7.9M, compared with $25.5M at December 31, 2024.

Why did Adlai Nortye’s research and development expenses decrease in H1 2025?

Research and development expenses fell 41.4% to $15.2M in the first half of 2025 from $26.0M a year earlier. The company attributes this to its current projects being at relatively early stages compared to the prior period, which led to lower service fees incurred.

What progress did Adlai Nortye report on its cancer drug pipeline?

The company reported that phase I for AN8025 is ongoing, AN4005 has advanced to an expansion phase with proof-of-concept data expected at a 2026 conference, and the phase II ARTEMIS trial of AN0025 is ongoing with a futility analysis expected by the first quarter of 2026. It also expects to start phase I for AN9025 in the first quarter of 2026 and submit an IND for AN4035 in mid-2026.

Does Adlai Nortye generate any revenue in the first half of 2025?

The company reported no revenue for the six months ended June 30, 2025, consistent with its status as a clinical-stage biopharmaceutical company. It recorded $0.1M of other operating income and $1.5M of other gains for the period.

How did Adlai Nortye’s operating expenses change year over year?

For the six months ended June 30, 2025, research and development expenses decreased to $15.2M from $26.0M, and administrative expenses declined to $4.1M from $4.7M. Other gains also decreased to $1.5M from $2.6M, mainly due to lower government grants.