Isofol Medical (ISOFOL) Corporate presentation summary

Strategic focus and mission

• Oncology-focused biotech developing arfolitixorin, a next-generation folate drug to enhance 5-FU-based chemotherapy for solid tumors, especially metastatic colorectal cancer (mCRC).

• Aims to address high unmet medical need by improving efficacy and outcomes in cancers where current treatments are insufficient.

• Seeks to create significant value for patients, healthcare providers, shareholders, and society.

Drug candidate and clinical evidence

• Arfolitixorin is the first direct-acting folate, bypassing metabolic activation required by leucovorin, resulting in higher MTHF levels in tumors.

• Demonstrates a unique dose-response relationship, with efficacy increasing at higher doses, unlike leucovorin.

• Earlier studies show safety, tolerability, and efficacy, with higher MTHF levels and tumor response rates.

• Phase III AGENT trial showed comparable efficacy to standard of care, with post-hoc analyses suggesting superior efficacy outside Japan when protocol deviations are excluded.

• Ongoing phase Ib/II trial shows promising interim results, including significant tumor shrinkage and surgical eligibility in difficult-to-treat patients.

Market opportunity and commercialization

• 5-FU plus folate is the backbone for 95% of mCRC patients, with arfolitixorin positioned as the only new first-line replacement for leucovorin.

• Global CRC pharmaceutical market projected to reach $16.9B by 2030, with mCRC at $7.3B.

• Blockbuster sales potential in the US alone, with $1B gross yearly sales estimated for mCRC; additional upside from other indications and markets.

• Licensing partnerships established in Japan (Solasia) and Canada (Knight Therapeutics), with significant investment and royalty agreements.