Adlai Nortye (ANL) Corporate Presentation summary

Company overview and mission

• Global biotechnology company focused on innovative cancer therapies, aiming to transform deadly cancer into a chronic and eventually curable disease.

• Operates R&D centers in the U.S. and China, with a team of ~90 dedicated scientists.

• Portfolio includes six drug candidates, three in clinical stages, and one Phase 3 asset with first-to-market potential.

• Strong management team with over 100 years of cumulative industry experience and collaborations with major pharma companies.

• Cash and equivalents of $112 million as of March 31, 2024, providing runway into the second half of 2025.

Lead asset: AN2025 (buparlisib)

• AN2025 is a pan-PI3K inhibitor targeting tumorigenesis and promoting tumor immunosurveillance.

• Addresses a significant unmet need in recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC) after anti-PD-1/PD-L1 therapy.

• Phase 2 BERIL-1 study showed improved progression-free survival (4.6 vs 3.5 months), overall survival (10.4 vs 6.5 months), and ORR (39.2% vs 13.9%) for AN2025 + paclitaxel vs paclitaxel alone.

• Safety profile is manageable, with similar discontinuation rates and tolerability compared to paclitaxel alone.

• Currently in a global Phase 3 BURAN trial (N=322) with primary endpoint of overall survival; readout expected Q4 2024 or Q1 2025.

Market and competitive landscape

• r/m HNSCC after anti-PD-1/PD-L1 therapy represents a >$2B global market opportunity, with AN2025 as the most advanced Phase 3 candidate.

• Fast track designation from FDA and potential to be the first on-label drug for this indication.

• Option agreement with Nippon Kayaku for Japanese market development and commercialization.