Isofol Medical (ISOFOL) Investor Update summary

Recent milestones and financial position

• Successfully completed an oversubscribed rights issue, raising SEK 84 million, strengthening the cash position for ongoing studies.

• Secured investment from Japanese partner, enabling expansion of clinical studies in Japan and globally.

• Received FDA confirmation that the current study program is acceptable, allowing progression to formal IND and US clinical trials.

• Announced a new European patent for Arfolitixurin, extending exclusivity to at least 2043 and supporting long-term commercial potential.

• Enhanced study design with a third arm and broader patient population, increasing the value and robustness of results.

Clinical development and study updates

• Ongoing phase 1B/2 study in metastatic colorectal cancer, with validated new dosing sequence and higher, well-tolerated doses.

• Expanded phase 2 study to include a standard-of-care arm (Leucovorin) for direct comparison.

• Broadened patient eligibility to better reflect real-world populations and treatment regimens.

• Japanese studies will contribute to global regulatory filings, increasing the robustness of the clinical program.

• Safety committee has approved escalation to higher dose cohorts, with no unexpected side effects observed.

Scientific rationale and evidence

• Arfolitixorin offers higher and more effective MTHF levels in tumors compared to Leucovorin, with a clear dose-response relationship.

• Previous phase 3 study showed non-inferiority to Leucovorin, but suboptimal dosing and timing limited efficacy; post-hoc analyses suggest better outcomes with optimized dosing.

• New studies demonstrate that higher doses and optimized timing significantly improve TS inhibition and potential clinical outcomes.

• Multiple preclinical and clinical studies confirm the safety and efficacy of higher doses.

• The product targets large unmet needs in high-mortality cancers, with potential applications beyond colorectal cancer.