Keisei Electric Railway Co. (9009) investor relations material

Pipeline and development milestones

• Obefazimod is in pivotal Phase 3 for ulcerative colitis (UC) and Phase 2b for Crohn's disease (CD), with topline UC induction data read out in July 2025 and maintenance data expected in Q2 2026.

• Phase 2b induction topline results for CD are expected in Q4 2026, with a combination therapy candidate decision and follow-on compound selection anticipated by year-end 2026.

• Obefazimod was co-discovered with CNRS and Institut Curie, initially developed for HIV, and selectively enhances miR-124, a key anti-inflammatory microRNA.

• Preclinical and clinical data show obefazimod reduces inflammatory cytokines and restores immune balance in UC and CD.

• The company is evaluating additional mechanisms for combination therapy, with a candidate to be selected by end of 2026.

Market opportunity and commercial potential

• Worldwide IBD sales are forecasted to reach $41B by 2032, with UC accounting for ~70% of US growth.

• Obefazimod targets a US patient population of up to 800k for CD and 500k for UC, with potential to become a future standard of care in IBD.

• The US alone represents a $15B market opportunity for obefazimod across UC and CD indications.

Clinical efficacy and safety results

• Obefazimod met the FDA primary endpoint for clinical remission in both ABTECT Phase 3 induction trials for UC, with 50mg showing the strongest efficacy.

• Statistically significant improvements were observed in key secondary endpoints, including clinical response, endoscopic improvement, and symptomatic remission, regardless of prior advanced therapy exposure.

• Early and sustained symptomatic improvements were seen from week 1 through week 8, with no plateau.

• Safety profile was favorable, with TEAEs similar to or lower than placebo; headache was the most common adverse event but rarely led to discontinuation.

• No clustering of serious adverse events was observed, and rates of discontinuation were similar across treatment groups.