Adlai Nortye Ltd.

Adlai Nortye Ltd. announced the submission of a Clinical Trial Notification (CTN) to Australia's TGA and received Human Research Ethics Committee (HREC) approval to begin a Phase I clinical trial for AN4035. AN4035 is a first-in-class CEACAM5-targeting, pan-RAS(ON) inhibitor-based antibody drug conjugate (ADC) designed for CEACAM5-enriched RAS-addicted solid tumors. The company is also preparing IND submissions for the U.S. FDA and China NMPA, with patient dosing anticipated to start in the second half of 2026.

Adlai Nortye announced that its first-in-class pan-RAS(ON) ADC, AN4035, has received approval from Australia's Human Research Ethics Committee (HREC) and submitted a Clinical Trial Notification (CTN) to the Therapeutic Goods Administration (TGA) to commence a Phase I clinical trial. This global trial will evaluate AN4035 for CEACAM5-enriched RAS-addicted solid tumors, both as monotherapy and in combination with cetuximab. The company is also filing Investigational New Drug (IND) applications with the U.S. FDA and China NMPA, with patient dosing expected to begin in the second half of 2026.

Adlai Nortye Ltd. announced that the first patient has been dosed in the intermittent weekly dosing (QW) arm of its global Phase 1 clinical trial for AN9025, a pan-RAS(ON) inhibitor. This milestone advances the company's strategy to evaluate AN9025 with a differentiated approach, as preclinical data suggests weekly dosing could widen the therapeutic window and improve tolerability. Both the daily (QD) and weekly (QW) dose escalation arms are now actively enrolling patients, with initial data from the QD arm anticipated in the first half of 2027.

Adlai Nortye Ltd. announced the expansion of its Scientific Advisory Board (SAB) with the appointments of Dr. David S. Hong and Dr. Piro Lito. These leading medical oncologists will provide critical scientific guidance to shape the company's R&D strategy and clinical development priorities. Their expertise in clinical development, translational oncology, RAS biology, and targeted therapeutic strategies is expected to support the advancement of Adlai Nortye's innovative cancer therapies.

Adlai Nortye Ltd. announced an oversubscribed private investment in public equity (PIPE) financing, expected to generate approximately $150.0 million in gross proceeds. The company is selling 11,320,755 ADSs at a price of $13.25 per ADS to a mix of new and existing institutional investors. This capital infusion will support the development of its innovative RAS-targeting therapies and next-generation ADC payload platform, RASiCA", as the company aims to transform cancer treatment.