Completed Initial Public Offering in
Granted Breakthrough Therapy Designation for sutacimig in Glanzmann thrombasthenia
“As a public company we continue our journey to accelerate progress and broaden impact for people living with serious coagulation disorders with strong momentum across our clinical programs,” said
Corporate Highlights
In
Recent Business Highlights and Anticipated Milestones
Sutacimig: Sutacimig, a bispecific antibody, is the Company's most advanced product candidate. The Company is advancing the clinical development of sutacimig for two indications: Glanzmann thrombasthenia (GT) and Factor VII Deficiency.
Glanzmann Thrombasthenia:
GT is a serious inherited bleeding disorder with a prevalence of between 1 in 350,000 and 1 in 600,000 in
- The Company is conducting a Phase 1/2 clinical trial of sutacimig in patients with GT. Part B of the trial, which evaluated the safety and tolerability profile of sutacimig and explored clinical efficacy over three months at multiple dose levels, is complete, and patients are continuing treatment with sutacimig in the long-term extension portion of the trial.
- In March, sutacimig received Breakthrough Therapy Designation from the
US Food and Drug Administration (FDA) for GT, a designation awarded to medicines that treat serious or life-threatening conditions where preliminary clinical evidence suggests the potential for a substantial improvement over the current standard of care. - The Company is preparing for a planned Phase 3 pivotal clinical trial in patients with GT that it anticipates initiating in the second half of 2026.
- Sutacimig has received Orphan Drug Designation from both the FDA and the
European Medicines Agency (EMA) for the treatment of GT.
Factor VII Deficiency
Factor VII deficiency is a serious inherited coagulation disorder affecting approximately 1 in 500,000 people globally, that is characterized by impaired blood clotting and increased bleeding risk.
- The Company is conducting an ongoing Phase 2 clinical trial of sutacimig for Factor VII deficiency. The Company expects to report data from the trial in late 2026 or early 2027.
HMB-002 - Von Willebrand Disease
HMB-002 is a novel monovalent antibody designed for subcutaneous prophylactic treatment of Von Willebrand Disease (VWD), one of the most common inherited bleeding disorders affecting approximately 140,000 patients.
- The Company is evaluating HMB-002 in an ongoing Phase 1/2 clinical trial. The Company expects to report data from the trial in late 2026 or early 2027.
Pipeline Expansion
The Company is also advancing multiple preclinical and discovery-stage assets focused on coagulation disorders with the goal of addressing critical gaps in the treatment landscape.
First Quarter 2026 Financial Results
- Cash Position and Cash Runway: Cash, cash equivalents, and marketable securities totaled
$163.5 million as ofMarch 31, 2026 , compared to$185.5 million as ofDecember 31, 2025 . The Company believes its current cash, cash equivalents, and marketable securities, together with net proceeds from the initial public offering completed inMay 2026 of approximately$317.2 million , will enable it to fund its operating expenses and capital expenditure requirements into 2029. - Research and Development Expenses: Research and development expenses were
$19.5 million for the three months endedMarch 31, 2026 , compared to$14.1 million for the three months endedMarch 31, 2025 , reflecting advancement of clinical programs and regulatory activities. - General and Administrative Expenses: General and administrative expenses were
$4.2 million for the three months endedMarch 31, 2026 , compared to$2.5 million for the three months endedMarch 31, 2025 , including costs associated with preparing for and completing the initial public offering. - Net Loss: Net loss was
$22.7 million , or$23.98 per share, for the three months endedMarch 31, 2026 , compared to a net loss of$15.3 million , or$16.18 per share, for the three months endedMarch 31, 2025 .
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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, 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
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Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (Unaudited) | |||||||
| Three Months Ended | |||||||
| 2026 | 2025 | ||||||
| Operating expenses | |||||||
| Research and development | $ | 19,461 | $ | 14,101 | |||
| General and administrative | 4,151 | 2,459 | |||||
| Total operating expenses | 23,612 | 16,560 | |||||
| Loss from operations | (23,612 | ) | (16,560 | ) | |||
| Other income (expense), net: | |||||||
| Interest income | 1,219 | 473 | |||||
| Other (expense) income, net | (282 | ) | 591 | ||||
| Total other income, net | 937 | 1,064 | |||||
| Loss before income tax expense | (22,675 | ) | (15,496 | ) | |||
| Income tax (expense) benefit | (12 | ) | 190 | ||||
| Net loss | $ | (22,687 | ) | $ | (15,306 | ) | |
| Net loss per share, basic and diluted | $ | (23.98 | ) | $ | (16.18 | ) | |
| Weighted average ordinary shares outstanding, basic and diluted | 946,000 | 946,000 | |||||
| Other comprehensive (loss) income: | |||||||
| Net loss | (22,687 | ) | (15,306 | ) | |||
| Net unrealized gain (loss) on available-for-sale debt securities | (614 | ) | 974 | ||||
| Total comprehensive loss | $ | (23,301 | ) | $ | (14,332 | ) | |
Selected Consolidated Balance Sheets Data (In thousands) (Unaudited) | |||||||
| 2026 | 2025 | ||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 49,860 | $ | 87,974 | |||
| Marketable securities | 113,671 | 97,511 | |||||
| Prepaid expenses and other current assets | 5,900 | 7,066 | |||||
| Property and equipment, net | 648 | 609 | |||||
| Operating right-of-use assets | 939 | 1,092 | |||||
| Other non-current assets | 4,240 | 531 | |||||
| Total assets | 175,258 | 194,783 | |||||
| Liabilities and stockholders’ deficit | |||||||
| Accounts payable | 5,682 | 5,734 | |||||
| Operating lease liabilities | 544 | 647 | |||||
| Operating lease liabilities, net of current portion | 519 | 573 | |||||
| Accrued expenses and other current liabilities | 6,963 | 4,296 | |||||
| Total liabilities | 13,708 | 11,250 | |||||
| Total convertible preferred stock and convertible preference shares | 360,168 | 360,168 | |||||
| Total stockholders’ deficit | $ | (198,618 | ) | $ | (176,635 | ) | |
Selected Consolidated Statements of Cash Flows Data (In thousands) (Unaudited) | |||||||
| Three Months Ended | |||||||
| 2026 | 2025 | ||||||
| Net cash used in operating activities | (21,584 | ) | (13,033 | ) | |||
| Net cash used in investing activities | (15,847 | ) | (5,994 | ) | |||
| Net cash used in financing activities | (460 | ) | (29 | ) | |||
| Effect of foreign exchange rate changes on cash and cash equivalents | (223 | ) | - | ||||
| Net decrease in cash and cash equivalents | $ | (38,114 | ) | $ | (19,056 | ) | |
Source: