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, with a lead indication in 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 arfolitixorin is safe, well-tolerated, and effective, with comparable or superior efficacy to standard of care in post-hoc analyses.

• Ongoing phase Ib/II trial is optimizing dosing and administration timing to maximize efficacy.

Market opportunity and commercialization

• 5-FU plus folate is the backbone for 95% of mCRC patients, and arfolitixorin could replace leucovorin across major regimens.

• Global CRC pharmaceutical market projected to reach $17 billion by 2030, with mCRC at $7.3 billion.

• Blockbuster revenue potential in the US alone, with gross yearly sales for mCRC estimated at $1 billion.

• Additional opportunities exist in other solid tumors and international markets, with licensing partnerships in Japan and Canada.