Hemab Therapeutics Holdings, Inc.
For the period ended Jun 30, 2026. Filed Aug 11, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 11, 2026
COAG$49.02+7.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-21.
0001193125-26-234386
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001193125-26-344533
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 39 previous paragraphs and 171 current paragraphs.
30 unchanged; 6 reworded; 133 added; 3 removed; 0 previous and 2 current paragraphs rearranged.
Tables are not compared: 38 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (133)
Current report
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Current report
continue to advance the clinical development of our product candidates, including our ongoing clinical development of sutacimig in patients with Glanzmann thrombasthenia and Factor VII deficiency, our ongoing clinical development of HMB-002 in patients with Von Willebrand Disease, as well as HMB-003 and any other product candidates that we may develop;
Current report
advance our clinical-stage product candidates into later-stage clinical trials, including our planned Phase 3 clinical trial of sutacimig in patients with Glanzmann thrombasthenia, which will be required in order to seek marketing approval of our product candidates, and which we expect will be substantially more expensive than our earlier-stage clinical trials;
Current report
continue to advance our research and preclinical activities and seek to discover and develop additional product candidates;
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establish and scale-up manufacturing processes and capabilities, or arrange for a third party to do so on our behalf, to support our clinical trials of our product candidates and commercialization of any of our product candidates for which we obtain marketing approval;
Current report
continue to develop, maintain, expand and protect our intellectual property portfolio (including intellectual property obtained through license agreements) and provide reimbursement of third-party expenses related to our patent portfolio;
Current report
add operational, financial, clinical, quality and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts of our product candidates and our operations as a public company;
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make any milestone, royalty, or other payments to Novo Nordisk A/S, or Novo Nordisk, under our license agreement with Novo Nordisk, or the Novo Nordisk Agreement, to Genmab A/S, or Genmab, under our license agreement with Genmab, or the Genmab Agreement, and to Gubra A/S, or Gubra, under our collaboration agreement with Gubra, or the Gubra Agreement, and under any additional future collaboration or license agreements that we may enter into.
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we are required by the U.S. Food and Drug Administration, the European Medicines Agency, or other regulatory authorities to perform clinical trials or preclinical studies that are in addition to, or different than, those expected;
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Recent Developments
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Sutacimig
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Glanzmann Thrombasthenia
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In July 2026, we announced that sutacimig demonstrated a sustained prophylactic effect in Glanzmann thrombasthenia in the long-term extension portion of our ongoing Phase 2 clinical trial of sutacimig in patients with Glanzmann thrombasthenia. The data enabled identification of a once weekly dose of 0.2 mg/kg for our planned Phase 3 clinical trial, which the FDA has endorsed. This dose has the potential to optimize annualized treated bleed event rate, or ATBR, reduction while avoiding high peak exposures associated with thromboembolism observed in our Phase 1/2 clinical trial of sutacimig in patients with Glanzmann thrombasthenia. We plan to initiate a Phase 3 clinical trial of sutacimig for Glanzmann thrombasthenia in the second half of 2026.
Current report
Factor VII deficiency
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In July 2026, we presented preclinical data for sutacimig in FVIID that demonstrated restoration of thrombin generation under disease-mimicking conditions. The data demonstrated retained binding expected for greater than 90% of severe-to-moderate FVIID database variants and confirmed binding across 22 of 25 tested variants (88%), supporting broad patient applicability for our ongoing Phase 2 clinical trial of sutacimig in Factor VII deficiency. We expect to report data from our Phase 2 clinical trial of sutacimig in Factor VII deficiency in late 2026 or early 2027.
Current report
HMB-002
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In July 2026, we also announced new first-in-human data from VELORA Pioneer, our Phase 1/2 clinical trial of HMB-002 in patients with Von Willebrand Disease. VELORA Pioneer is a three-part protocol: Part A evaluating pharmacokinetics ("PK"), pharmacodynamics ("PD"), and safety of HMB-002 following a single fixed subcutaneous ("SC") dose; Part B evaluating PK, PD, and exploratory efficacy following multiple SC doses; and a newly added Part C evaluating single dose HMB-002 with concomitant IV factor concentrate. All three parts are actively enrolling patients. We believe the data validated our approach of increasing von Willebrand factor, or VWF, and coagulation factor VIII, or FVIII, in Von Willebrand Disease with durable subcutaneous dosing, and a multiple dose assessment is underway. The data announcement reported the following:
Current report
Extended half-life supporting infrequent dosing: PK analysis confirmed dose-dependent increase in Cmax with prolonged duration.
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Dual VWF and FVIII elevation: In all dose cohorts tested, VWF and FVIII were elevated in a dose-dependent manner. In cohort A3 (150 mg), ≥2.4-fold elevation in both VWF and FVIII was achieved and accompanied by restoration of thrombin generation, shortening of APTT, and stable multimer distribution. The pharmacokinetic/pharmacodynamic ("PK/PD") profile supports potential for monthly dosing.
Current report
Emerging safety profile: Most treatment-emergent adverse events, or TEAEs, were mild to moderate in severity, no serious TEAEs occurred, no events were considered related to HMB-002, and no participant discontinued the study due to TEAEs. There were no thromboembolic events, no injection site reactions, no thrombocytopenia, and no hypersensitivity reactions.
Current report
Preliminary clinical observations: The single ascending dose, or SAD, part of the study was not designed to measure efficacy, so clinical observations should be considered descriptive in nature. Three of the four cohorts have completed enrollment with the fourth currently enrolling patients. Across the SAD cohorts, 8 of 9 evaluable patients had zero treated bleeds in the 28 days following HMB-002 dosing, with a mean ATBR of 1.6. Among participants treated with HMB-002, the baseline mean ATBR before HMB-002 treatment was 20.1 reflecting significant disease burden in Type 1 VWD, based on bleed data collected up to 5.5 months.
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HMB-003
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Also in July 2026, we announced that preclinical data for HMB-003 demonstrated that HMB-003 directly inhibited plasmin at its active site and inhibited fibrinolysis across both tPA- and uPA-driven pathways, while showing no effect on thrombin generation, platelet function, or coagulation in nonclinical studies. Additionally, following a single subcutaneous dose in minipigs, HMB-003 achieved peak plasma levels within hours and sustained antifibrinolytic activity for approximately one week. We expect to initiate first-in-human studies of HMB-003 in the second half of 2026 with initial clinical data in mid-2027.
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Corporate Reorganization
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external costs, including expenses incurred under arrangements with third-parties, such as contract manufacturing organizations, or CMOs, contract research organizations, or CROs, providers of sponsored research, consultants and our scientific advisors;
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laboratory and vendor costs related to the execution of preclinical studies and planned and ongoing clinical trials;
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costs related to compliance with regulatory requirements;
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direct costs of conducting internal research and development for our internal preclinical programs;
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acquisition of intellectual property and related future payments should certain development and regulatory milestones be achieved;
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expenses incurred for the procurement of materials, laboratory supplies and non-capital equipment used in the research and development process; and
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depreciation, amortization and other direct and allocated expenses, including rent, insurance, maintenance of facilities and other operating costs, incurred as a result of our research and development activities.
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the scope, progress, costs and results of our current and future preclinical studies and clinical trials for our product candidates;
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the number of clinical trials required for regulatory approval of our current or future product candidates;
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whether we partner our programs with collaborators for later-stage clinical development or commercialization;
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the number and development requirements of any other product candidates we may identify and develop;
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the costs, timing and outcome of regulatory review of our product candidates and any other product candidates we may identify and develop;
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the costs of obtaining clinical and commercial supplies of our product candidates and any other product candidates we may identify and develop;
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our ability to successfully commercialize our product candidates and any other product candidates we may identify and develop;
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the time and cost necessary to respond to technological and market developments;
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the extent to which we may acquire or in-license other product candidates and technologies;
Showing the first 40 of 133 passages. Open the source sections for the rest.
Removed paragraphs (3)
Previous report
Research and Development Expenses
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General and Administrative Expenses
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Other Income (Expense), Net
Reworded paragraphs (6)
Previous wording
We are a clinical-stage biotechnology company developing therapies that reimagine the treatment of blood coagulation disorders to sustain life and human resilience. Our mission is to build the leading coagulation company by discovering, developing, and commercializing innovative therapies for the millions of patients worldwide suffering from serious bleeding and thrombotic diseases, including Glanzmann thrombasthenia, Factor VII deficiency, Von Willebrand Disease and other conditions of abnormal bleeding, all of which can cause significant life-long burden to patients. We are building a comprehensive franchise of investigational therapeutics spanning from Phase 2 clinical development through discovery research. Our assets address critical gaps in the treatment of coagulation disorders, with multiple value-driving clinical data events anticipated in 2026, 2027 and beyond.
Current wording
We are a clinical-stage biotechnology company developing therapies that reimagine the treatment of blood coagulation disorders to sustain life and human resilience. Our mission is to build the leading coagulation company by discovering, developing, and commercializing innovative therapies for the millions of patients worldwide suffering from serious bleeding and thrombotic diseases, including Glanzmann thrombasthenia, Factor VII deficiency, Von Willebrand Disease, heavy menstrual bleeding and other conditions of abnormal bleeding, all of which can cause significant life-long burden to patients. We are building a comprehensive franchise of investigational therapeutics spanning from Phase 2 clinical development through discovery research. Our assets address critical gaps in the treatment of coagulation disorders, with multiple value-driving clinical data events anticipated in 2026, 2027 and beyond.
Previous wording
Our lead asset, sutacimig, is a bispecific antibody currently in Phase 1/2 clinical development for the prophylactic treatment of Glanzmann thrombasthenia and Phase 2 clinical development for the prophylactic treatment of Factor VII deficiency. Our second clinical-stage asset, HMB-002, is a monovalent antibody in Phase 1/2 clinical development for the subcutaneous prophylactic treatment of Von Willebrand Disease. We are also advancing multiple preclinical and discovery-stage assets.
Current wording
Our lead asset, sutacimig, is a bispecific antibody currently in Phase 1/2 clinical development for the prophylactic treatment of Glanzmann thrombasthenia and Phase 2 clinical development for the prophylactic treatment of Factor VII deficiency. Our second clinical-stage asset, HMB-002, is a monovalent antibody in Phase 1/2 clinical development for subcutaneous prophylactic treatment of Von Willebrand Disease. We are also developing HMB-003, an anti-fibrinolytic targeting plasmin inhibition in preclinical development to reduce bleeding across multiple high-unmet-need conditions, beginning with heavy menstrual bleeding. We are also advancing multiple preclinical and discovery-stage assets.
Previous wording
Since our inception in 2020, we have devoted substantially all of our resources to drug discovery, the development of our lead product candidates, sutacimig and HMB-002, along with several preclinical programs focusing on coagulation disorders. In addition to our research and development efforts, our operations to date have been limited to organizing and staffing our company, business planning, raising capital, securing intellectual property rights, in-licensing technology, discovering product candidates, undertaking preclinical studies, conducting clinical trials and providing general and administrative support for these operations.
Current wording
Since our inception in 2020, we have devoted substantially all of our resources to drug discovery, the development of our lead product candidates, sutacimig and HMB-002, along with several preclinical programs focusing on coagulation disorders such as HMB-003. In addition to our research and development efforts, our operations to date have been limited to organizing and staffing our company, business planning, raising capital, securing intellectual property rights, in-licensing technology, discovering product candidates, undertaking preclinical studies, conducting clinical trials and providing general and administrative support for these operations.
Previous wording
We have incurred significant operating losses since inception. Our net losses were $22.7 million and $15.3 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $204.5 million. We expect to continue to incur significant operating expenses and net losses for the foreseeable future.
Current wording
We have incurred significant operating losses since inception. Our net losses were $46.8 million and $27.5 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $228.7 million. We expect to continue to incur significant operating expenses and net losses for the foreseeable future.
Previous wording
As of March 31, 2026, we had cash, cash equivalents and marketable securities of $163.5 million. We believe that our existing cash, cash equivalents and marketable securities, together with net proceeds from the IPO of approximately $317.2 million, will enable us to fund our operating expenses and capital expenditure requirements into 2029. For more information, see the section titled “Liquidity and Capital Resources” below.
Current wording
As of June 30, 2026, we had cash, cash equivalents and marketable securities of $457.5 million. We believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into 2029. For more information, see the section titled “Liquidity and Capital Resources” below.
Previous wording
We anticipate that our general and administrative expenses will increase as we increase our headcount to support our research and development activities and the potential commercialization of our product candidates, if approved. Additionally, these increases will likely include increased costs related to the hiring of additional personnel, among other expenses. We also expect to incur increased expenses associated with being a public company, including increased costs of accounting, audit, legal, regulatory andtax-related services associated with maintaining compliance with Nasdaq listing requirements and the requirements of the Securities and Exchange Commission, or the SEC, director and officer insurance costs, and investor and public relations costs. We also expect to incur additional intellectual property-related expenses as we file patent applications to protect innovations arising from our research and development activities.
Current wording
We anticipate that our general and administrative expenses will increase as we increase our headcount to support our research and development activities and the potential commercialization of our product candidates, if approved. Additionally, these increases will likely include increased costs related to the hiring of additional personnel, among other expenses. We also expect to incur increased expenses associated with being a public company, including increased costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with Nasdaq listing requirements and the requirements of the Securities and Exchange Commission, or the SEC, director and officer insurance costs, and investor and public relations costs. We also expect to incur additional intellectual property-related expenses as we file patent applications to protect innovations arising from our research and development activities.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
personnel-related costs, including salaries, bonuses, benefits and equity-based compensation for employees engaged in research and development functions;
Current report — wording carried from elsewhere
Since our inception, we have incurred significant operating losses. To date, we have financed our operations primarily through private placements of convertible preference shares and issuance of convertible debt and from the sale of common stock in our IPO in May 2026. Through June 30, 2026, we have received aggregate gross proceeds of approximately $692.7 million from such transactions.