Sutacimig

July 14, 2026: Hemab Therapeutics (NASDAQ: COAG) presented new ISTH 2026 (Paris) clinical and preclinical updates across sutacimig (HMB-001), plus pipeline highlights for HMB-002 and HMB-003.

Sutacimig (Glanzmann thrombasthenia, GT; also Factor VII deficiency, FVIID): Phase 2 long-term extension (LTE) data in GT (34 patients; median 6.9 months exposure, up to 15.9 months) showed sustained prophylactic bleed reduction. 92% of participants who bled during run-in had reductions in treated bleed rates; mean high-intensity annualized treated bleed event rate fell 62% among those with high-intensity bleeds pre-treatment; mean ATBR reduction was ~84% in the low-dose weekly cohort. Surgical experience: three procedures (two invasive surgeries, one dental) had successful hemostasis; one required a single post-procedure rFVIIa dose. Safety: mostly mild/moderate AEs; no Grade ≥3 related AEs; three Grade 2 thromboembolic events (higher-exposure cohorts/risk factors) managed with anticoagulation and resolved/resolving. Hemab stated FDA alignment on a Phase 3 weekly regimen (0.2 mg/kg Q1 week) with Phase 3 initiation planned in 2H 2026.

FVIID preclinical: disease-mimicking studies showed restored thrombin generation; binding expected for >90% of severe-to-moderate FVIID variants and confirmed in 22/25 tested (88%), supporting an ongoing Phase 2 study.

Natural history (GT360; ATHN Transcends): persistent lifelong bleeding burden and low prophylaxis use (only 14% received any prophylaxis) were reported.