Isofol Medical (ISOFOL) Status Update summary

AGENT study and results

• Phase III AGENT enrolled 490 patients with first-line mCRC across 90 sites on 4 continents; final data were available in Q4 2022.

• Neither the primary ORR endpoint nor the key secondary PFS endpoint was met.

• Arfolitixorin showed a trend toward worse OS, with 11% higher death risk; no patient subgroup showed a difference, and arfolitixorin was not superior to leucovorin.

• Two external expert groups agreed with the data interpretation; one saw no path forward with arfolitixorin plus 5-FU in oncology, while the other saw a possible path but did not define its requirements.

• The selected Phase III regimen was 120 mg/m² as two 60 mg/m² bolus injections, following earlier dose studies and FDA Special Protocol Assessment review.

Development prospects

• A new dose regimen was assessed to require Phase I, Phase II and pivotal Phase III studies, based on Phase I/IIa safety data, the AGENT mortality signal and stricter FDA dose-optimization requirements.

• Further development was estimated to take at least 6–8 years and cost at least SEK 500m; remaining patent life was assessed as too short for commercial attractiveness.

• The board assessed a low likelihood of commercial success for arfolitixorin with 5-FU regimens and viewed financing further studies as very challenging.

Cost actions and strategic review

• Cost reductions included ending precommercial and nonessential activities, terminating suppliers not directly tied to AGENT, and reducing employee and consultant numbers.

• The board explored value-creating transactions, including a reverse merger; fragmented ownership significantly hindered securing advance shareholder support and negotiations.