Adlai Nortye Ltd.

Adlai Nortye Announces Oral Presentation for AN4035 Program Update at the Upcoming 38th EORTC-NCI-AACR Symposium

Adlai Nortye announced a late-breaking oral presentation of AN4035 program data at the 38th EORTC-NCI-AACR Symposium in Barcelona on November 19. The presentation will cover translational and EGFR-combination data for AN4035, a first-in-class CEACAM5-targeting ADC armed with a proprietary pan-RAS(ON) inhibitor payload, now in a global Phase I trial across Australia, the U.S., and China. This is the second ENA oral selection for the program -- a visibility positive for the pipeline, though no new clinical results are disclosed in this release.

•5d ago

Adlai Nortye Enters into Clinical Collaboration with Lilly and Merck KGaA, Darmstadt, Germany to Evaluate Combination of AN4035 and Cetuximab

Adlai Nortye signed clinical trial collaboration and supply agreements with Eli Lilly and Merck KGaA, Darmstadt, Germany, for the anti-EGFR antibody cetuximab (ERBITUX). Both partners will supply cetuximab at no cost — Lilly for U.S. trial sites and Merck KGaA for Australia and China sites — supporting the ongoing global Phase I trial of AN4035, a first-in-class pan-RAS(ON) inhibitor-based ADC targeting CEACAM5. The trial evaluates AN4035 as monotherapy and in combination with cetuximab in CEACAM5-enriched RAS-addicted solid tumors, including colorectal, pancreatic, and lung cancers; big-pharma participation is a modest validation signal for the early-stage asset.

•17d ago

Adlai Nortye Announces First Patient Dosed in Australia and U.S. FDA IND Clearance for AN4035, a First-in-Class Pan-RAS(ON) Inhibitor-Based ADC

Adlai Nortye dosed the first patient in Australia with AN4035, a first-in-class CEACAM5-targeting ADC armed with a pan-RAS(ON) inhibitor, initiating a global Phase I trial in patients with CEACAM5-enriched RAS-addicted solid tumors. The company also received a Study-May-Proceed letter from the U.S. FDA on its IND application, clearing the path to expand the trial into the United States, and is filing an IND application with China's NMPA. The Phase I trial will evaluate AN4035 as monotherapy and in combination with cetuximab across colorectal, pancreatic, and lung cancers, with management on track to report full Phase Ia data in the second half of 2027.

•1mo ago

 Adlai Nortye Ltd. Reports Unaudited First Half 2026 Financial Results and Highlights Recent Operational Progress

Adlai Nortye reported first-half 2026 revenue of $13.1 million, its first ever, driven by the AN9025 license agreement, while narrowing its net loss by 71% to $5.3 million. The company ended the period with a robust cash position of $231.9 million, bolstered by $290 million raised in two oversubscribed private placements earlier this year. Operationally, the first patient was dosed in the QW arm of the AN9025 Phase I trial and AN4035 received regulatory approval in Australia, though the company deprioritized AN4005 monotherapy.

•2mo ago

Adlai Nortye Announces Clinical Trial Notification Submission and HREC Approval for the Phase I Clinical Trial of Pan-RAS(ON) Inhibitor ADC AN4035 in Australia

Adlai Nortye received HREC approval in Australia to commence a Phase I trial for AN4035, a first-in-class CEACAM5-targeting pan-RAS(ON) inhibitor ADC. The global trial will evaluate the safety, tolerability, and preliminary efficacy of AN4035 as monotherapy and in combination with cetuximab for treating RAS-addicted solid tumors. Patient dosing is expected to begin in the second half of 2026, with IND submissions currently underway with the U.S. FDA and China NMPA.

•2mo ago

Adlai Nortye Announces First Patient Dosed in Intermittent Weekly Dosing Arm of Global Phase 1 Trial of Pan-RAS(ON) Inhibitor AN9025

Adlai Nortye has dosed the first patient in the intermittent weekly arm of the global Phase 1 trial for AN9025, its oral pan-RAS(ON) inhibitor targeting advanced solid tumors with RAS mutations. The company believes the weekly dosing schedule could widen the therapeutic window, and both the daily and weekly arms of the study are now actively enrolling patients. Adlai Nortye retains ex-China rights to AN9025 while collaborating with ASK Pharm, with initial dose escalation data from the daily arm expected in the first half of 2027.

•3mo ago

Adlai Nortye Expands Scientific Advisory Board with Appointment of Two Leading Medical Oncologists

Adlai Nortye expanded its Scientific Advisory Board with the appointments of Dr. David S. Hong and Dr. Piro Lito, two leading experts in oncology and RAS biology. The new advisors will provide scientific guidance for the company's pipeline, which includes the pan-RAS(ON) inhibitor AN9025 and the CEACAM5-targeting ADC AN4035. Dr. Hong serves at The University of Texas MD Anderson Cancer Center, while Dr. Lito is at Memorial Sloan Kettering Cancer Center and contributed to the FDA approval of first-in-class KRAS G12C inhibitors.

•3mo ago