Adlai Nortye (ANL) Morgan Stanley 24th Annual Global Healthcare Conference summary

Strategic focus and portfolio overview

• Emphasis on two pillars: precision RAS pathway targeted therapies and next-generation PD-L1 pathway modulation.

• Lead assets include AN9025 (oral pan-RAS(ON) inhibitor) and AN4035 (ADC with pan-RAS(ON) payload targeting CEACAM5).

• RAS programs target over 175,000 patients annually in the U.S. with RAS-addicted cancers.

• Proprietary RASiCA platform underpins the ADC pipeline and future expansion.

AN9025 development and clinical strategy

• AN9025 shows 250x higher potency than first-generation molecules, with improved binding and durability in preclinical models.

• Global phase I trial ongoing with both daily (QD) and weekly (QW) dosing arms; QW arm initiated in July.

• Dose escalation and expansion underway; first comprehensive phase I-A data expected in H1 2027.

• Early human data indicate promising PK, tolerability, and preliminary efficacy.

• Combination strategies prioritized, especially for front-line PDAC, with plans to test with chemotherapy regimens GnP and FOLFIRINOX.

AN4035 ADC program and platform innovation

• AN4035 is a first-in-class ADC using a pan-RAS(ON) inhibitor payload, targeting CEACAM5 for enhanced tumor specificity.

• Phase I basket trial enrolling RAS-mutant solid tumors, with both monotherapy and cetuximab combination arms.

• Patient selection leverages CEA enrichment, with further analysis planned on CEACAM5 expression.

• Platform enables rapid development of additional ADCs with diverse payloads and target antigens.

• Expansion cohorts may include post-daraxonrasib patients to assess activity in difficult-to-treat populations.