Hemab Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $430.2 million as of September 30, 2026, down from $457.5 million as of June 30, 2026, primarily due to cash used in operating activities.
• Research and development expenses were $24.6 million for the three months ended September 30, 2026, compared to $14.6 million for the same period in 2025.
• General and administrative expenses were $5.1 million for the three months ended September 30, 2026, compared to $2.5 million for the same period in 2025.
• Net loss was $27.3 million ($0.58 per share) for the three months ended September 30, 2026, compared to a net loss of $17.1 million ($18.04 per share) for the same period in 2025.
• Net loss per share decreased primarily due to an increase in weighted-average shares outstanding following the initial public offering and the conversion of preferred stock to common stock in May 2026.
• For the nine months ended September 30, 2026, total operating expenses were $79.4 million, with net loss of $74.1 million ($2.84 per share).
• Net cash used in operating activities was $72.5 million for the nine months ended September 30, 2026, compared to $44.8 million in the prior year period.
• Net cash provided by financing activities was $317.2 million for the nine months ended September 30, 2026.
• The Company expects current cash resources to fund operating expenses and capital requirements into 2029.

Business Segments and Product Lines:

• Sutacimig (HMB-001): Initiated the SOLARA pivotal Phase 3 trial for Glanzmann thrombasthenia (GT), an open-label, single-arm, multicenter study enrolling approximately 75 participants. The trial features a 24-week run-in period followed by a 48-week treatment period with once-weekly subcutaneous dosing.
• Sutacimig (HMB-001): Announced first clinical data from the Phase 2b trial in Factor VII deficiency (FVIID), showing prothrombin time shortened by more than 50% in two participants after a single dose, with ~5x accumulation of endogenous FVII(a) in the participant with PK/PD data.
• HMB-002: Presented data from the VELORA Pioneer Phase 1/2 trial in Von Willebrand Disease (VWD) demonstrating a ≥2.4-fold peak increase in VWF and FVIII, normalization of peak thrombin generation, and a durability profile supporting potential monthly subcutaneous dosing.
• HMB-003: Dosed the first participant in the Phase 1 clinical trial for heavy menstrual bleeding in September 2026. Preclinical data in a cynomolgus monkey model showed reduced severe menstrual bleeding.
• Regulatory Designations: Sutacimig holds Fast Track, Orphan Drug, and Breakthrough Therapy Designations from the FDA for GT, and PRIME scheme access from the EMA. It also holds ILAP designation from the UK MHRA.

Market and Competitive Landscape:

• Glanzmann thrombasthenia (GT) is a severe bleeding disorder with no approved prophylactic treatment options; management is currently limited to platelet transfusions, antifibrinolytics, recombinant Factor VIIa, and bone marrow transplantation.
• Heavy menstrual bleeding affects over 23 million women in the U.S. alone, with current treatment options limited by adherence issues or hormonal suitability.
• Von Willebrand Disease is the most common inherited bleeding disorder, affecting approximately 140,000 patients in the U.S., with over 50,000 requiring treatment for bleeding events.
• Factor VII deficiency has a global prevalence of moderate and severe forms estimated at approximately 1 in 500,000.

Risks and Challenges:

• The FDA recommended a randomized controlled design for the SOLARA trial; proceeding with a single-arm design carries the risk that regulatory authorities may not accept the results as substantial evidence supporting approval or may require additional trials.
• Uncertainties exist regarding the initiation and completion of preclinical studies and clinical trials, including patient enrollment and the timing of data results.
• There is a risk that results from preclinical studies and earlier clinical trials may not be predictive of later clinical trial results.
• The Company faces risks regarding the sufficiency of cash resources to fund foreseeable and unforeseeable operating expenses and capital expenditure requirements.

Management Commentary and Tone:

• CEO Benny Sørensen, MD, PhD, expressed excitement regarding the transition to a biotech company with clinical stage programs ranging from Phase 1 to Phase 3.
• Management highlighted the expansion of development efforts into larger, underserved markets, specifically heavy menstrual bleeding, while continuing to serve high-severity populations.
• The tone is forward-looking and confident regarding the advancement of the pipeline and the potential to share additional preclinical and clinical data in the coming months.

Other Key Points:

• Appointed Keli Walbert to the Board of Directors in September; she brings over 20 years of commercial leadership experience, including roles at Horizon Therapeutics, AbbVie, Abbott, and United Healthcare.
• Data from the HMB-003 preclinical monkey model and updated FVIID Phase 2b data will be presented at the 68th ASH Annual Meeting and Exposition in December 2026.
• Additional data from the VELORA Pioneer Phase 1/2 trial of HMB-002 is expected to be reported at the 20th EAHAD Congress in February 2027.
• Initial clinical data from the ongoing Phase 1 trial of HMB-003 is expected in mid-2027.
• The SOLARA trial is the first pivotal trial of a subcutaneous prophylactic treatment in GT, with first participants scheduled to enter the run-in period in the fourth quarter of 2026.