New results from HMB-002 first-in-human data validate proof of mechanism in Von Willebrand disease (VWD), elevating Von Willebrand Factor (VWF) and Factor VIII (FVIII) levels with subcutaneous dosing; multiple dose assessment underway
New program announced as HMB-003, a potent peptide plasmin inhibitor with a durable half-life designed as a novel antifibrinolytic to reduce bleeding across multiple settings; initiating first-in-human studies in 2H 2026 and preparing for studies in heavy menstrual bleeding in 2027
Long-term extension (LTE) data for sutacimig demonstrate sustained reduction in annualized treated bleeding rate (ATBR) in Glanzmann thrombasthenia (GT)
Sutacimig granted FDA Breakthrough Therapy and EMA Priority Medicines (PRIME)
designations; Phase 3 initiation planned 2H 2026
Total of nine presentations reflect the breadth and momentum of Hemab’s pipeline of assets designed to address critical gaps in the treatment of multiple coagulation disorders
CAMBRIDGE, Mass. and COPENHAGEN, Denmark, June 26, 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 nine presentations showcasing progress from multiple pipeline programs at the upcoming International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris, France, on July 11-15, 2026.
“People living with serious coagulation disorders remain profoundly underserved, with few targeted preventive treatment options, leaving them to face the relentless burden of unpredictable, disruptive bleeding, with substantial medical, social, psychological, and quality-of-life impact,” said Benny Sørensen, MD, PhD, CEO of Hemab. “We’re advancing three programs with the potential to change that. We are progressing sutacimig to Phase 3 in GT, strengthening the clinical validation of HMB-002 in VWD, and introducing HMB-003, a novel long-acting peptide-based inhibitor of plasmin, a proven therapeutic target in coagulation medicine, central to bleeding in conditions ranging from heavy menstrual bleeding and hereditary hemorrhagic telangiectasia to peri-operative bleeding management. Our presentations at ISTH 2026 demonstrate our momentum and progress across our pipeline.”
For sutacimig, Phase 2 LTE data show sustained reductions in ATBR in GT and describe successful use in the surgical setting and are complemented by real-world and natural-history analyses that help quantify disease burden. Additionally, preclinical data for sutacimig will be presented supporting expansion into Factor VII deficiency (FVIID) where a Phase 2b study is currently in progress. For HMB-002, new first-in-human data validate the approach of simply increasing VWF and FVIII in VWD with durable subcutaneous dosing, and a multiple dose assessment is underway. For HMB-003, preclinical findings describe a novel fatty acid conjugated peptide antifibrinolytic designed for potent plasmin inhibition with durable half-life and subcutaneous dosing allowing the potential for use in multiple high-unmet-need bleeding conditions including heavy menstrual bleeding.
Presentation Highlights and Details – The abstracts are now available through the ISTH conference website
Sutacimig
Sutacimig showed sustained prophylaxis in GT (meaningful reduction in ATBR and high-intensity treatment events and use in surgical setting) in LTE portion of ongoing Phase 2 trial, with real-world and natural-history data underscoring the unmet need, and preclinical validation supporting expansion into FVIID with a Phase 2 proof-of-concept study underway; data expected late 2026 or early 2027.
Presentation Number: OC 57.3
Format: Oral
Title: Sutacimig Prophylaxis in Glanzmann Thrombasthenia: Results from a Phase 2 Long-Term Extension
Date and Time: July 14, 2026, 10:00 AM - 10:15 AM CEST
Presentation Number: OC 12.4
Format: Oral
Title: Elucidating Sutacimig’s Dual Mechanism in Factor VII Deficiency: TF-Pathway Enhancement via FVIIa Accumulation as the Significant Driver of Hemostatic Activity
Date and Time: July 12, 2026, 10:00 AM - 10:15 AM CEST
Presentation Number: PB3513
Format: Poster
Title: Persistent Weekly Bleeding Burden Across the Lifespan in Glanzmann Thrombasthenia: Analysis of the GT360 Patient Survey
Date and Time: July 14, 2026, 1:45 PM CEST
Presentation Number: PB3523
Format: Poster
Title: Elevated Depression Prevalence and Psychological Burden Associated with Bleeding Frequency in Glanzmann Thrombasthenia
Date and Time: July 14, 2026, 1:45 PM CEST
Presentation Number: PB3495
Format: Poster
Title: Substantial Bleeding Burden and Limited Prophylaxis Use in Glanzmann Thrombasthenia: Prospective Real-World Data from ATHN Transcends
Date and Time: July 14, 2026, 1:45 PM CEST
HMB-002
HMB-002’s first-in-human data from an ongoing Phase 1/2 clinical trial support a non-replacement subcutaneous approach that elevates endogenous VWF and FVIII, with sustained hemostatic elevations and no thromboembolic events observed; multiple dose assessment is currently underway to enable a potential new prophylaxis paradigm in VWD.
Presentation Number: OC 12.5
Format: Oral
Title: First-in-human investigation of HMB-002: a subcutaneous antibody for prophylactic management of Von Willebrand disease
Date and Time: July 12, 2026, 10:15 AM - 10:30 AM CEST
HMB-003
HMB-003 is a potent subcutaneous plasmin inhibitor with a durable half-life that blocks fibrinolysis independently of the plasminogen activation pathway (tPA or uPA). HMB-003 inhibited fibrinolysis with greater potency than tranexamic acid in a human whole-blood flow model and demonstrated long half-life in preclinical models, supporting infrequent dosing with potential across multiple high-unmet-need conditions; first-in-human studies are planned for the second half of 2026.
Presentation Number: OC 05.1
Format: Oral
Title: A long-acting peptide plasmin inhibitor with extended antifibrinolytic activity enabling once-per-cycle subcutaneous treatment for heavy menstrual bleeding: Preclinical development of HMB-003
Date and Time: July 11, 2026, 1:00 PM - 1:15 PM CEST
Presentation Number: OC 09.5
Format: Oral
Title: HMB-003, a long-acting peptide plasmin inhibitor, potently inhibits fibrinolysis and localizes with fibrin in a human whole blood microfluidic flow model
Date and Time: July 11, 2026, 2:00 PM - 2:15 PM CEST
Presentation Number: PB1414
Format: Poster
Title: Optimization of the Halo Fluorescence Fibrinolysis Assay: How Plasma Overlay and Timing Influence Antifibrinolytic Assessment
Date and Time: July 12, 2026, 1:45 PM CEST
About Glanzmann Thrombasthenia
Glanzmann thrombasthenia (GT) is a severe bleeding disorder marked by debilitating, sometimes life-threatening bleeding episodes. Results from an international natural history study (Glanzmann's 360) revealed the substantial burden of this disease: 88% of the 117 participants reported at least one bleed in the previous week with 65% requiring a bleed-related hospital visit in the prior six months. These bleeding episodes significantly impacted patients' mental health and quality of life, with over 80% having missed work or school, over 50% facing limitations in attending social events, and over 50% experiencing restrictions in travel. To date, there are no approved prophylactic treatment options for GT.
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 facilitates hemostatic plug formation. 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 Priority Medicines (PRIME) designation. For more information, please visit clinicaltrials.gov (NCT06211634).
About Von Willebrand Disease
Von Willebrand Disease (VWD) is the most common inherited bleeding disorder, characterized by quantitative or qualitative defects in Von Willebrand Factor (VWF), often resulting in frequent mucocutaneous bleeding events and heavy menstrual bleeding in women. The severity of bleeding ranges from low-volume events to potentially life-threatening hemorrhages. Chronic blood loss frequently leads to iron deficiency anemia, exacerbating the disease burden and reducing quality of life, particularly for those with clinically understated subtypes. Despite its prevalence, current treatment options for VWD primarily focus on managing symptoms rather than addressing the underlying biology of the disease.
About HMB-002
HMB-002 is a monovalent human antibody being developed as the first-in-class subcutaneous prophylactic treatment for Von Willebrand Disease targeting the underlying cause of the disease, a condition driven by a deficiency or defect in Von Willebrand Factor (VWF), a key regulator of hemostasis. By specifically targeting the C-terminal CK domain of VWF, which is distinct from regions critical to its essential interactions, HMB-002 shields the protein from degradation, boosting endogenous levels without compromising its function. Clinical and nonclinical data suggest strong potential for meaningful therapeutic benefit. For more information, please visit clinicaltrials.gov (NCT06610201 and NCT06754852).
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.
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 anti-fibrinolytic targeting plasmin inhibition in preclinical development for multiple high-unmet-need conditions, ranging from heavy menstrual bleeding and hereditary hemorrhagic telangiectasia to peri-operative bleeding management.
Learn more at hemab.com. Follow us on LinkedIn, Facebook, Instagram, and X.
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 timelines for reporting data from Hemab’s clinical trials, the anticipated timelines for initiating a Phase 3 clinical trial of sutacimig and first-in-human studies of HMB-003, the clinical potential of sutacimig, HMB-002 and HMB-003, Hemab’s plans to expand its pipeline, and the sufficiency of Hemab’s cash resources for the period anticipated, 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
mads@hemab.com
