Adlai Nortye (ANL) Investor Presentation summary

Study background and rationale

• AN0025 is a selective EP4 antagonist targeting the PGE2-EP4 pathway to modulate immunosuppressive myeloid cells in the tumor microenvironment.

• Preclinical and prior clinical data suggest synergistic antitumor effects when combined with radiotherapy or chemoradiotherapy.

• Previous trials in rectal cancer showed promising response rates, supporting further development in esophageal cancer.

Study design and patient characteristics

• Phase 1b, open-label study in unresectable, locally advanced or recurrent esophageal cancer, conducted at three sites in China.

• Dose escalation with AN0025 at 250 mg and 500 mg QD, combined with definitive chemoradiotherapy.

• Twelve patients enrolled: median age 61.5 years, all Asian, majority male, all with squamous cell carcinoma.

Safety and tolerability

• All patients experienced at least one treatment-emergent adverse event; 83% had Grade ≥3 events.

• 92% had at least one AN0025-related adverse event, with 17% experiencing Grade ≥3 AN0025-related events.

• No dose-limiting toxicities observed; maximum tolerated dose not reached.

• Serious adverse events occurred in 58% but were not attributed to AN0025.