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 6 drug candidates, 3 in clinical stages, and over 250 patent applications.

• Management team has over 100 years of cumulative industry experience and strong 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.

• Phase 3 asset for recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC) after anti-PD-1/PD-L1 therapy, with fast track designation from FDA.

• Completed Phase 2 (BERIL-1) showed improved progression-free survival (4.6 vs 3.5 months), overall survival (10.4 vs 6.5 months), and higher response rate (39.2% vs 13.9%) compared to paclitaxel alone.

• Safety profile manageable, with similar discontinuation rates and expected adverse events.

• Ongoing global Phase 3 BURAN trial (N=322) compares AN2025 + paclitaxel vs paclitaxel alone in r/m HNSCC post PD-1/PD-L1 therapy; primary endpoint is overall survival.

Market opportunity and competitive landscape

• r/m HNSCC after anti-PD-1/PD-L1 therapy represents a sizable market, with over 15,000 U.S. and 50,000 7MM annual incidences projected for 2028.

• Global market for this indication expected to exceed $2.0 billion.

• AN2025 is the most advanced drug candidate in Phase 3 for this setting, with no approved therapies currently available.

• Multi-regional clinical trials underway at ~180 sites globally, with a licensing option agreement in place for Japan with Nippon Kayaku.