First clinical data for sutacimig in Factor VII deficiency (FVIID) shows multi-fold accumulation of endogenous FVII(a) with shortening of prothrombin time after a single subcutaneous dose in initial participants of the Phase 2b study
Preclinical data show HMB-003 reduced severe menstrual bleeding in a cynomolgus monkey model of menstrual bleeding
CAMBRIDGE, Mass. and COPENHAGEN, Denmark, Nov. 04, 2026 (GLOBE NEWSWIRE) -- Hemab Therapeutics (Nasdaq:COAG), a clinical-stage biotechnology company developing therapies that reimagine the treatment of blood coagulation disorders to sustain life and human resilience, today announced two presentations showcasing progress from multiple pipeline programs at the upcoming 68th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, Louisiana, and virtually from December 12–15, 2026.
“We are excited to present the first clinical data for sutacimig in Factor VII deficiency at ASH,” said Benny Sørensen, MD, PhD, CEO of Hemab. “People living with this disease have no approved prophylactic option and face the constant risk of unpredictable, sometimes life-threatening bleeds. Seeing sustained accumulation of Factor VII and a meaningful shortening of prothrombin time after a single dose is an encouraging first step, and it strengthens our belief that sutacimig could bring the freedom of an infrequent, subcutaneous prophylactic treatment to these patients. We are equally energized by the preclinical data for HMB-003, which continue to reinforce our enthusiasm for its potential. Week-long antifibrinolytic activity that returns to baseline between cycles, together with fewer severe bleeding days in a primate model, is exactly the profile we hoped to see as we work toward a non-hormonal, long-acting option for the millions of women living with heavy menstrual bleeding.”
The Company will present the first pharmacokinetic (PK) and pharmacodynamic (PD) results from its ongoing Phase 2b study of sutacimig in congenital FVIID, in which a single subcutaneous dose produced sustained accumulation of endogenous FVII(a) and shortened prothrombin time. For HMB-003, preclinical data will show potent, selective plasmin inhibition with a reduction in severe menstrual bleeding days in a cynomolgus monkey model of menstrual bleeding. HMB-003 is now in a Phase 1 clinical trial, with initial clinical data expected in mid-2027.
Presentation Highlights and Details – The abstracts are now available through the ASH conference website
Sutacimig
The poster reports the first clinical evidence for sutacimig in FVIID, from the single ascending dose cohort of the Phase 2b study, HMB-001-201 (NCT07347249), that is being conducted at a single site in the UK. As of July 24, 2026, two participants with severe congenital FVIID had received a single subcutaneous dose of sutacimig. Adverse events were low grade and assessed as not related to treatment. Both participants had a baseline prothrombin time of ≥180 seconds, which shortened by more than 50% following dosing. In the participant with PK/PD data available to date, sutacimig produced sustained accumulation (~5x) of endogenous total FVII(a), with exposure maintained through Day 22, supporting the potential feasibility of an infrequent dosing regimen pending additional data. Updated data for all dosed participants will be presented at the meeting.
Abstract Number: abs26-10755
Format: Poster
Title: Sutacimig, a subcutaneous FVIIa-targeting bispecific antibody, in congenital factor VII deficiency: First pharmacokinetic and pharmacodynamic results from a Phase 2 study
Date and Time: December 14, 2026, 6:00 PM – 8:00 PM CT
Room: MCCNO - Hall F
HMB-003
In human plasma and whole blood, HMB-003 inhibited fibrinolysis in a concentration-dependent manner, with no observed effect on thrombin generation or platelet aggregation in human plasma. In minipigs, a single subcutaneous dose reached peak plasma levels within hours and had a terminal half-life of 6 to 7 days, with complete ex vivo inhibition of fibrinolysis for up to 7 days followed by a full return to baseline. In a cynomolgus monkey model of menstrual bleeding, HMB-003 reduced the proportion of severe bleeding days and shifted bleeding toward lower intensity compared with the baseline observation phase. These data support HMB-003 as a potential non-hormonal therapy for heavy menstrual bleeding with antifibrinolytic activity intended to cover the heaviest bleeding days. The Phase 1 trial of HMB-003 (NCT07798505) in healthy volunteers is ongoing, with initial clinical data expected in mid-2027.
Abstract Number: abs26-5938
Format: Poster
Title: HMB-003, a novel selective plasmin inhibitor engineered for week-long antifibrinolytic activity, reduced severe menstrual bleeding in cynomolgus monkey
Date and Time: December 13, 2026, 6:00 PM – 8:00 PM CT
Room: MCCNO - Hall F
About Factor VII Deficiency
Factor VII deficiency (FVIID) is a congenital severe bleeding disorder characterized by reduced levels of Factor VII, a naturally circulating blood coagulation protein. Patients with clinically severe FVIID suffer from recurrent, unpredictable, life-threatening or potentially disabling bleeding at critical sites, such as in the central nervous system, gastrointestinal tract and intra-articular locations, as well as recurrent mucocutaneous bleeds of the nose and gums with additional risks for female patients, consisting of heavy menstrual bleeding and potentially life-threatening post-partum hemorrhage.
About Sutacimig (formerly HMB-001)
Sutacimig is a subcutaneously administered bispecific antibody that is designed to bind and stabilize endogenous Factor VIIa with one antibody arm and bind to TLT-1 on activated platelets with the other arm. This mechanism is designed to allow for the accumulation of endogenous Factor VIIa in the body and recruitment of Factor VIIa directly to the surface of the activated platelets, where it amplifies thrombin generation at the platelet surface. Sutacimig is designed to be a first-in-class prophylactic treatment for Glanzmann thrombasthenia (GT) with the potential to treat other debilitating bleeding disorders. The U.S. Food and Drug Administration has granted Fast Track Designation, Orphan Drug Designation, and Breakthrough Therapy Designation to sutacimig for the treatment of GT, and the UK Medicines and Healthcare products Regulatory Agency has awarded sutacimig designation under the Innovative Licensing and Access Pathway (ILAP); it has been designated as an orphan medicinal product in the European Union for the treatment of GT, and the European Medicines Agency (EMA) has granted sutacimig access to the Priority Medicines (PRIME) scheme. For more information, please visit clinicaltrials.gov (NCT06211634).
About Heavy Menstrual Bleeding
Heavy menstrual bleeding is a common condition characterized by excessive menstrual blood loss that disrupts a person’s physical, emotional, social, and daily life, affecting an estimated one in three reproductive-age women, or more than 23 million women in the U.S. alone. The condition is frequently associated with pain, iron-deficiency anemia, and fatigue, and carries a significant social burden, including stigma and substantial lost days from work and school. Current treatment options are limited. Tranexamic acid (TXA), the primary non-hormonal therapy, has a short half-life that requires frequent dosing throughout menstruation, limiting adherence. Hormonal therapies are not suitable, or not preferred, for many women. To date, there remains no approved non-hormonal, customized hemostatic treatment option for heavy menstrual bleeding.
About HMB-003
HMB-003 is a subcutaneously administered peptide-based plasmin inhibitor with a durable half-life — a proven therapeutic target in coagulation medicine — being developed as a novel antifibrinolytic designed to reduce bleeding across multiple settings. Engineered to directly inhibit plasmin at its active site, HMB-003 blocks fibrinolysis independently of the plasminogen activation pathway. HMB-003 is optimized to provide sustained bleed protection across multiple high-unmet-need conditions, ranging from heavy menstrual bleeding and hereditary hemorrhagic telangiectasia to peri-operative bleeding management. For more information, please visit clinicaltrials.gov (NCT07798505).
About Hemab Therapeutics
Hemab Therapeutics Holdings, Inc. is a clinical-stage biotechnology company developing therapies that reimagine the treatment of blood coagulation disorders to sustain life and human resilience. Hemab’s mission is to discover, develop, and commercialize innovative therapies for the millions of patients worldwide suffering from serious bleeding and thrombotic diseases. Hemab is building a franchise of innovative therapeutics designed to address critical gaps in the treatment of coagulation disorders, including sutacimig (HMB-001), a bispecific antibody in clinical development for the prophylactic treatment of Glanzmann thrombasthenia and Factor VII deficiency, HMB-002, a monovalent antibody in clinical development for the prophylactic treatment of Von Willebrand Disease, and HMB-003, an antifibrinolytic targeting plasmin inhibition in clinical development for heavy menstrual bleeding.
Learn more at hemab.com. Follow us on LinkedIn, Facebook, Instagram, and X.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Hemab’s strategy, future operations, prospects and plans, objectives of management, the anticipated presentations and updated data at the ASH Annual meeting, the anticipated timelines for reporting data from Hemab’s clinical trials, the clinical potential of sutacimig, HMB-002 and HMB-003, including the potential for infrequent subcutaneous prophylactic dosing of sutacimig and for HMB-003 to provide a non-hormonal, long-acting treatment for heavy menstrual bleeding, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Hemab may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; the timing of and Hemab’s ability to initiate and enroll patients in clinical trials; whether results from preclinical studies and earlier clinical trials will be predictive of the results of later clinical trials; whether Hemab’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Hemab’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-Q and in subsequent filings Hemab may make with the SEC. In addition, the forward-looking statements included in this press release represent Hemab’s views as of the date of this press release. Hemab anticipates that subsequent events and developments will cause its views to change. However, while Hemab may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Hemab’s views as of any date subsequent to the date of this press release.
Media:
Deerfield Group
Peg Rusconi
peg.rusconi@deerfieldgroup.com
Investors:
Hemab Therapeutics
Mads Behrndt
investors@hemab.com
