Isofol Medical (ISOFOL) investor relations material

Disease focus and medical need

• Focus on metastatic colorectal cancer, the third most common cancer globally with 1.9 million new cases and 900,000 deaths annually.

• Current standard treatments have limited efficacy, with less than half of patients responding meaningfully.

• 95% of metastatic colorectal cancer patients receive cytostatic-based first-line therapy, representing a large addressable population.

• The need for improved therapies is expected to persist for at least the next 10–15 years.

Product innovation and clinical evidence

• Arfolitixorin is a next-generation, direct-acting folate drug that bypasses metabolic conversion, achieving higher active substance levels in tumor tissue than leucovorin.

• Demonstrates a strong dose-response relationship, with efficacy not plateauing at higher doses, unlike leucovorin.

• Interim results from the ongoing phase 1b/2 trial show all patients have responded, with up to 50% tumor reduction and some becoming eligible for surgery, including in RAS-mutated mCRC.

• No dose-limiting toxicities or significant new side effects observed at higher, optimized doses.

• Previous phase III trial showed efficacy on par with standard of care, with new dosing strategies expected to improve outcomes.

Clinical development and operational strategy

• Ongoing phase 1b/2 clinical trial in Europe and Japan aims to optimize dosing and confirm efficacy in first-line mCRC, with results expected through 2027.

• Current challenge is slow patient recruitment, being addressed by expanding to more hospitals and broadening patient criteria.

• Collaborations established with leading hospitals and a global advisory board of oncology experts.

• Key partnerships in place with Merck and Solasia, and licensing agreements for Japan and Canada to expand market reach.

• Safety remains a focus; higher doses are being tested with no significant new side effects so far.