MAIA Biotechnology (MAIA) Biotech Showcase 2025 Investor Conference summary

Pipeline and clinical development

• Lead molecule THIO targets telomeres and induces immunogenicity, with pivotal trials starting this year and expansion into multiple cancer types planned for 2025 and beyond.

• THIO-101 is expanding to a pivotal phase 2 trial for accelerated approval in the U.S., focusing on non-small cell lung cancer, with enrollment through 2025.

• THIO-102 and THIO-103 will target colorectal, liver, and small cell lung cancers, with phase 2/3 trials planned for 2026.

• Second-generation telomere targeting agents are advancing, with two candidates nearing IND-enabling study completion and phase 1 trials expected by year-end.

• Multiple FDA orphan drug and rare pediatric disease designations have been secured for THIO in various hard-to-treat cancers.

Efficacy, safety, and mechanism of action

• THIO has shown unprecedented efficacy in third-line non-small cell lung cancer, with disease control rates above 80% and strong response rates.

• Safety profile is superior to chemotherapy and current standard-of-care drugs.

• THIO works by collapsing telomeres in cancer cells, leading to rapid cell death and triggering a robust immune response.

• Preclinical models demonstrated 60%-100% complete response rates and durable immune memory, with no recurrence after re-challenge.

• Dose selection for pivotal trials was based on optimal response rates and safety, with the 180 mg dose chosen for expansion.

Market opportunity and partnerships

• THIO addresses significant unmet needs in cancers with large market potential, such as non-small cell lung cancer ($34B in sales last year).

• Clinical supply agreements are in place with Regeneron (Libtayo) and BeiGene (Tevimbra) for combination trials.

• The checkpoint inhibitor market exceeded $46B in 2023, with THIO positioned to partner with leading agents.

• Comparable oncology companies have achieved $1B–$4B valuations near commercialization.

• Patent portfolio exceeds 30 patents, with exclusivity extending to 2041.