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 set to present its novel CEACAM5-targeting antibody-drug conjugate (ADC), AN4035, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston from October 22-26, 2025 [1][4]. Group 1: AN4035 Development - AN4035 is designed to address the limitations of current pan-RAS(ON) inhibitors by targeting tumors directly, thereby reducing systemic toxicities and widening the therapeutic window [2][3]. - The ADC approach of AN4035 aims to improve efficacy while minimizing on-target, off-tumor toxicities, particularly for RAS-addicted tumors such as colorectal cancer [3][6]. Group 2: Presentation Details - The oral presentation will take place on October 25, 2025, from 11:45 AM to 12:15 PM ET, focusing on novel therapeutic agents [4]. - A poster presentation will also be held on the same day, showcasing the discovery of AN4035 [4]. Group 3: Efficacy and Safety - AN4035 has shown strong intracellular payload retention and significant cytotoxicity in CEACAM5-positive/RAS-addicted cancer cell lines, achieving a 73% objective response rate in a patient-derived xenograft trial with 26 participants [5]. - Preliminary toxicology results in cynomolgus monkeys indicate a favorable safety profile for AN4035 [5]. Group 4: Company Overview - Adlai Nortye is a clinical-stage biotechnology company focused on innovative cancer therapies, with R&D centers in the U.S. and China [7]. - The company is advancing a portfolio that includes next-generation PD-1/L1 modulation and RAS-targeted therapies, highlighting its commitment to developing transformative oncology treatments [7].

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]