Core Viewpoint - Adlai Nortye Ltd. has initiated dosing of the first patient in the U.S. for its Phase 1 clinical trial of AN9025, a pan-RAS (ON) inhibitor, marking a significant milestone in its clinical development strategy [1][3]. Group 1: Clinical Trial Details - The Phase 1 study is a first-in-human, multicenter, open-label trial aimed at assessing the safety, tolerability, pharmacokinetics, and anti-tumor activity of AN9025 in patients with advanced or metastatic solid tumors that have RAS mutations [2]. - This trial is being conducted in collaboration with Jiangsu Aosaikang Pharmaceutical Co. Ltd. as a multi-regional clinical trial, with Adlai Nortye retaining ex-China rights to AN9025 [2]. Group 2: Product Information - AN9025 is an oral small molecule pan-RAS(ON) inhibitor designed to target a wide range of RAS mutations across various tumor types, showing potent and durable efficacy in preclinical studies against pancreatic, lung, and colorectal adenocarcinomas [4]. - The drug demonstrates comparable or superior results relative to benchmark agents in the same class, indicating its potential as a best-in-class therapy [4]. Group 3: Company Overview - Adlai Nortye is a global clinical-stage biotechnology company focused on discovering and developing innovative cancer therapies, with a dual R&D presence in the U.S. and China [5]. - The company is building a robust pipeline that includes next-generation cancer immunotherapies and RAS-targeting therapies, with candidates such as AN8025 and AN4035 alongside AN9025 [5].

Core Viewpoint - Adlai Nortye Ltd. has announced a private investment in public equity financing expected to generate approximately $140 million in gross proceeds, aimed at supporting its innovative cancer therapies [1][3]. Group 1: Financing Details - The company is selling 64,615,386 Class A ordinary shares at a price of $2.1667 per share, equivalent to $6.50 per American Depositary Share (ADS) [2]. - The private placement is co-led by Cormorant Asset Management and Columbia Threadneedle Investments, with participation from both new and existing investors, including Balyasny Asset Management L.P. and Point72 [3]. - Approximately $55 million of Class A ordinary shares will be sold to entities controlled by Yang Lu, the Chairman and CEO of the company [3]. Group 2: Company Overview - Adlai Nortye is a clinical-stage biotechnology company focused on developing innovative cancer therapies, leveraging its R&D presence in the U.S. and China [7]. - The company is building a pipeline of drug candidates in two key areas: next-generation cancer immunotherapies and RAS-targeting therapies [7]. - Key drug candidates include AN8025, a tri-functional fusion protein, and AN4005, a first-in-class oral small-molecule PD-L1 inhibitor, aimed at activating cancer immunity [7].

Core Insights - Adlai Nortye Ltd. is a clinical-stage biotechnology company focused on developing innovative cancer therapies [2] - The company will participate in two upcoming investor conferences, including the Evercore Healthcare Conference and the Oppenheimer Annual Healthcare Life Sciences Conference [1][2] Company Overview - Adlai Nortye operates with a dual R&D presence in the U.S. and China, aiming to build a robust pipeline of drug candidates [2] - The company focuses on two key areas: next-generation cancer immunotherapies and RAS-targeting therapies [2] - Key drug candidates include AN8025, a tri-functional fusion protein, AN4005, a first-in-class oral small-molecule PD-L1 inhibitor, AN9025, an oral pan-RAS(ON) inhibitor, and AN4035, a CEACAM5-targeting ADC [2]

Core Insights - Adlai Nortye Ltd. is a clinical-stage biotechnology company focused on developing innovative cancer therapies and will present at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston from October 22-26, 2025 [1][2] Company Overview - Adlai Nortye operates globally with R&D centers in the U.S. and China, advancing a portfolio of innovative drug candidates in two key therapeutic areas: next-generation PD-1/L1 modulation and RAS-targeted therapies [3] - Key drug candidates include AN8025, a multifunctional fusion protein for T cell and antigen-presenting cell modulation; AN4005, a first-in-class oral small-molecule PD-L1 inhibitor; AN9025, an oral pan-RAS(ON) inhibitor; and AN4035, a novel CEACAM5-targeting antibody-drug conjugate [3]

Group 1 - Adlai Nortye Ltd. announced topline results from its Phase III BURAN trial evaluating buparlisib (AN2025), a PI3K inhibitor, in combination with paclitaxel for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) [1] - The study did not meet the primary endpoint of improving overall survival compared to paclitaxel alone [1] - The safety profile of buparlisib was consistent with previous findings, with no new safety signals observed [1] Group 2 - Detailed results from the Phase III trial will be presented at an upcoming medical conference [2] - AN8025 is a next-generation tri-specific antibody fusion protein derived from an approved PD-L1 antibody, optimized for PD-1-based immunotherapy [2] - Preclinical studies have demonstrated that AN8025 enhances both the quantity and quality of antigen-presenting cells (APCs) while inducing robust PD-L1-dependent T cell activation and anti-tumor efficacy in vivo [3] Group 3 - The company plans to submit the IND application for AN8025 in mid-2025 [3] - AN9025 is an in-house developed oral small molecule pan-RAS(ON) inhibitor designed to target a broad spectrum of RAS mutations across various tumor types [3] - Preclinical studies have shown that AN9025 effectively inhibits RAS-mutant cancers, including pancreatic, lung, and colorectal adenocarcinomas, with potent and durable efficacy [4] Group 4 - The company plans to submit an IND application for AN9025 in the second half of 2025 [4] - AN4005 is an orally available small-molecule PD-L1 inhibitor that demonstrates antitumor activity by blocking PD-1/PD-L1 interaction [4] - Preliminary results from the Dose-Escalation Phase presented at SITC 2024 demonstrated that AN4005 exhibits favorable safety and tolerability in patients with advanced tumors [5]

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on September 27, 2023 Registration No. 333-273465 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 4 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Adlai Nortye Ltd. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Adlai Nortye Ltd. c/o PO Box 309, Ugland H ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on September 12, 2023 Registration No. 333-273465 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 3 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Adlai Nortye Ltd. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Adlai Nortye Ltd. c/o PO Box 309, Ugland H ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on July 27, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Adlai Nortye Ltd. (Exact name of Registrant as specified in its charter) (Primary Standard Industrial Classification Code Number) Cayman Islands 2834 Not Applicable (I.R.S. Employer Identification Number) Adlai Nortye Ltd. c/o PO Box 309, Ugland House Grand Cayman, ...