Announcement • Jul 25
Kringle Pharma, Inc. Advances the Registrational Program for Oremepermin Alfa in Japan with Initiation of Additional Phase 3 in Acute Spinal Cord Injury Kringle Pharma, Inc. announced the initiation of an additional Phase 3 clinical study evaluating oremepermin alfa, recombinant human hepatocyte growth factor (HGF), for the treatment of patients with acute spinal cord injury (SCI) in Japan. Patient enrollment is expected to begin after site activation at participating study sites. The additional Phase 3 study is a multicenter, open-label, single-arm clinical trial designed to evaluate the efficacy and safety of oremepermin alfa in patients with acute cervical SCI. A total of 10 patients are planned for enrollment across three national SCI hospitals in Japan. Eligible patients are adults aged 18 to 89 years who are diagnosed with AIS grade A cervical SCI and remain neurologically complete at 72 hours (±6 hours) following injury. Participants will receive 0.6 mg of oremepermin alfa administered intrathecally once weekly for five consecutive weeks. The primary endpoint is the proportion of patients whose neurological status improves to AIS grade C or better six months after treatment initiation. Based on analyses of prior clinical studies and discussions with the PMDA, the Japanese regulatory agency,
the additional Phase 3 study incorporates refined eligibility criteria to enrich for responders. Patients with severe structural spinal cord damage on magnetic resonance imaging (MRI), including spinal cord compression of 70% or greater and cases strongly suggestive of spinal cord transection, are excluded. By reducing heterogeneity among AIS grade A patients, the study aims to more accurately assess the therapeutic effects of oremepermin alfa in patients with retained recovery potential. Acute SCI is a devastating neurological condition that can result in permanent motor, sensory, and autonomic dysfunction. Although advances in acute care and rehabilitation have improved outcomes, no widely established regenerative pharmacotherapy exists to restore neurological function, underscoring a substantial unmet medical need. Announcement • Jun 28
Kringle Pharma, Inc. to Report Q3, 2026 Results on Aug 10, 2026 Kringle Pharma, Inc. announced that they will report Q3, 2026 results on Aug 10, 2026 Reported Earnings • May 13
Second quarter 2026 earnings released: JP¥42.92 loss per share (vs JP¥43.84 loss in 2Q 2025) Second quarter 2026 results: JP¥42.92 loss per share. Net loss: JP¥314.2m (loss widened 5.0% from 2Q 2025). 
