MAIA Biotechnology (MAIA) Investor presentation summary

Scientific and clinical innovation

• Lead molecule ateganosine (THIO) targets telomeres and induces immunogenicity, showing a dual mechanism of action for cancer therapy.

• THIO is the only direct telomere-targeting anticancer agent in clinical development, with multiple ongoing and planned trials in NSCLC, CRC, SCLC, and HCC.

• Preclinical studies demonstrate high efficacy, including 60–100% complete response rates and durable anticancer immune memory in various tumor models.

• THIO activates both innate and adaptive immune responses, enhancing the effect of checkpoint inhibitors.

• Second-generation telomere-targeting agents are in preclinical and IND-enabling stages.

Clinical development and trial progress

• Phase 2 (THIO-101) and pivotal Phase 3 (THIO-104) trials in third-line NSCLC are ongoing, with THIO + Libtayo showing a median overall survival of 17.8 months, three times higher than standard of care.

• THIO-104 is designed with high statistical power and a 99% probability of technical success at final analysis.

• Additional Phase 2 trials (THIO-102) are planned for CRC, SCLC, and HCC, leveraging clinical supply agreements with BeOne Medicines and Roche.

• Regulatory achievements include three FDA Orphan Drug Designations, one Rare Pediatric Disease Designation, and one Fast Track Designation.

Market opportunity and exclusivity

• Targeting large, high-mortality cancer markets: NSCLC ($34B), CRC ($20B), HCC ($3.8B), and SCLC ($2.8B).

• THIO has robust exclusivity: 5–7 years in the US (with additional designations), 10 years in EU/Japan, and a growing patent portfolio covering key innovations through 2044.

• Checkpoint inhibitor market exceeds $50B, with NSCLC representing over 30% of sales.