Hemab Therapeutics Holdings, Inc.
For the period ended Sep 30, 2026. Filed Nov 10, 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.
Sep 30, 2026 · Filed Nov 10, 2026
COAG$38.77-9.4%Stored close · as of Nov 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious 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 OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-10.
0001193125-26-455376
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 171 previous paragraphs and 170 current paragraphs.
121 unchanged; 38 reworded; 10 added; 12 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 7 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 (10)
Current report
In November 2026, we initiated SOLARA, a pivotal, open-label, single-arm, multicenter Phase 3 clinical trial of once-weekly subcutaneous sutacimig for Glanzmann thrombasthenia, which is expected to enroll approximately 75 participants aged 12 to 70. Participants must have had at least four treated bleeding events in the 12 months before screening. The trial consists of a 24-week run-in period, during which participants continue their current on-demand standard of care, without sutacimig, while treated bleeding events are prospectively recorded, followed by a 48-week treatment period during which participants receive sutacimig at a dose of 0.2 mg/kg by subcutaneous injection once weekly, such that each participant serves as their own control. The primary endpoint is annualized treated bleed rate, or ATBR, during sutacimig prophylaxis compared with the run-in period. Secondary endpoints include high-intensity ATBR, annualized treated bleed days, ATBR by bleed type and cause, the proportion of participants with reductions in ATBR, and safety, tolerability, immunogenicity and pharmacokinetics. The trial is being conducted at sites in the United States and other countries, and enrollment of adolescents will be gated by the data safety monitoring committee. Participants who complete the treatment period will have the opportunity to continue sutacimig treatment in a separate open-label extension study. The first participants have been consented and are scheduled to enter the run-in period in the fourth quarter of 2026. SOLARA is being conducted under our active investigational new drug application. The FDA has recommended that we consider a randomized controlled design. However, the FDA acknowledged our concerns about the feasibility of randomization in Glanzmann thrombasthenia. In light of the substantial variability in treated bleeding rates, the heterogeneity of the patient population, and the practical challenges of randomized trials in a rare disease, we have determined to proceed with a single-arm trial.
Current report
In November 2026, we announced the first clinical data for sutacimig from the single ascending dose cohort of our ongoing Phase 2b clinical trial of sutacimig in Factor VII deficiency (NCT07347249) that is being conducted at a single site in the U.K. As of July 24, 2026, two participants with severe congenital Factor VII deficiency 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 at least 180 seconds, which shortened by more than 50% following dosing. In the participant with pharmacokinetic, or PK, and pharmacodynamic, or PD, data available to date, sutacimig produced sustained accumulation (approximately five-fold) of endogenous total Factor VII(a), with exposure maintained through Day 22. Updated data for all dosed participants will be presented in a poster at the 68th Annual Meeting and Exposition of the American Society of Hematology, or ASH, in December 2026.
Current report
VWF, and coagulation factor VIII in Von Willebrand Disease with durable subcutaneous dosing, and a multiple dose assessment is underway. We plan to report additional data from the Phase 1/2 clinical trial at the 20th European Association for Haemophilia and Allied Disorders Congress in February 2027.
Current report
In September 2026, we dosed the first participant in our Phase 1 clinical trial of HMB-003 in healthy volunteers, an investigational therapy for management of heavy menstrual bleeding (NCT07798505). The trial is a randomized, placebo-controlled, single-ascending-dose escalation trial designed to evaluate the safety, tolerability, PK, and PD of HMB-003 in healthy adult volunteers. Results from this trial are expected to inform dose selection and clinical development plans for HMB-003 across additional high-unmet-need bleeding conditions.
Current report
In November 2026, we announced additional preclinical data for 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 six to seven days, with complete ex vivo inhibition of fibrinolysis for up to seven 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.
Current report
We plan to announce these data at ASH in December 2026 and expect to report initial clinical data from our Phase 1 clinical trial of HMB-003 in mid-2027.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
External research and development expenses related to sutacimig for the nine months ended September 30, 2026 and 2025 were $18.5 million and $15.1 million, respectively. The increase of $3.4 million for the nine months ended September 30, 2026 was primarily driven by increased start-up activities related to the initiation of the SOLARA Phase 3 clinical trial of sutacimig in Glanzmann thrombasthenia.
Current report
Other income (expense), net for the nine months ended September 30, 2026 and 2025 was net income of $6.1 million and $5.0 million, respectively. The $1.1 million increase was primarily due to a $6.4 million increase in interest income, driven by higher balances of cash, cash equivalents and marketable securities following the IPO and the related accretion income on our available-for-sale debt securities. This increase was partially offset by a $5.3 million unfavorable change in other income (expense) from net income of $4.0 million for the nine months ended September 30, 2025 to net expense of $1.4 million for the nine months ended September 30, 2026. The unfavorable change was primarily due to foreign currency exchange losses in 2026 compared with foreign currency exchange gains in 2025, as well as net realized foreign currency gains of $0.9 million on the maturity of available-for-sale debt securities in 2025, compared with net realized foreign currency losses of $0.2 million in 2026.
Current report
In September 2023, we entered into a non-cancelable operating lease for approximately 4,274 rentable square feet of office space on the 12th floor at 101 Main Street, Cambridge, Massachusetts, or the Existing Premises, which was scheduled to expire in October 2026. In August 2026, we amended the lease to relocate our offices to approximately 11,312 rentable square feet of office space on the 11th floor of the same building, or the New Premises, and to extend the lease term. Our lease of the Existing Premises will continue until 15 days after the date on which the landlord delivers the New Premises with its build-out, or the Landlord’s Work, substantially complete, or the New Premises Commencement Date, which we currently expect to occur in early 2027. The lease of the New Premises has a term of 66 months from the New Premises Commencement Date, with an option to extend, and aggregate base rent of approximately $3.7 million, reflecting an 18-month base rent abatement. We are also required to pay our proportionate share of operating expenses and real estate taxes and to contribute approximately $1.4 million toward the cost of the Landlord’s Work, payable in installments as construction progresses. We accounted for the extension of the Existing Premises lease term as a lease modification and, in August 2026, remeasured the related operating lease liability using our incremental borrowing rate as of the modification date, which increased both the operating lease liability and the right-of-use asset by approximately $0.1 million.
Removed paragraphs (12)
Previous report
continue to advance our research and preclinical activities and seek to discover and develop additional product candidates;
Previous report
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.
Previous report
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.
Previous report
Extended half-life supporting infrequent dosing: PK analysis confirmed dose-dependent increase in Cmax with prolonged duration.
Previous report
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.
Previous 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.
Previous 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.
Previous report
External research and development expenses related to HMB-002 for the three months ended June 30, 2026 and 2025 were $3.0 million and $1.8 million, respectively. The increase of $1.2 million for the three months ended June 30, 2026 was primarily driven by clinical development costs related to the ongoing Phase 1/2 clinical trial of HMB-002 during the three months ended June 30, 2026 as compared to start-up costs during the three months ended June 30, 2025.
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report
Other income (expense), net for the six months ended June 30, 2026 and 2025 were net income of $3.0 million and $4.9 million, respectively. The $1.9 million decrease was primarily related to foreign currency losses recognized due to unfavorable movements between the currencies which we regularly transact in, including DKK, Euros, British Pounds and our functional currency, the U.S. Dollar, and the higher cash balance in marketable securities from proceeds of the IPO. This was offset by an increase in interest income of $3.3 million due to an increase in accretion income related to our available-for-sale debt securities.
Previous report
continue to advance our research and preclinical activities and seek to discover and develop additional product candidates;
Previous report
In September 2023, we entered into a non-cancelable operating lease for office space in Cambridge, Massachusetts. The lease requires us to pay annual base rent of approximately $0.4 million, which is subject to a 2% annual increase over the term of the lease. The lease expires in October 2026 and contains a two-year renewal option.
Reworded paragraphs (38)
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, 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.
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 3 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 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.
Current wording
Our lead asset, sutacimig, is a bispecific antibody currently in Phase 3 clinical development for the prophylactic treatment of Glanzmann thrombasthenia and Phase 2b 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 Phase 1 clinical development for 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 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.
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, HMB-002, and HMB-003 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.
Previous wording
We have no approved products, and we have not generated any revenue from product sales. On May 4, 2026, we closed our initial public offering ("IPO") of 19,262,500 shares of common stock, which included the exercise in full by the underwriters of their option to purchase additional shares of common stock. The net proceeds from the IPO were approximately $317.2 million, after deducting underwriting discounts and commissions and offering expenses payable by us. Prior to our IPO, we financed our operations primarily through private placements of convertible preference shares and issuance of convertible debt. Since our inception through June 30, 2026, we have received aggregate gross proceeds of approximately $692.7 million from such transactions.
Current wording
We have no approved products, and we have not generated any revenue from product sales. On May 4, 2026, we closed our IPO of 19,262,500 shares of common stock, which included the exercise in full by the underwriters of their option to purchase additional shares of common stock. The net proceeds from the IPO were approximately $317.2 million, after deducting underwriting discounts and commissions and offering expenses payable by us. Prior to our IPO, we financed our operations primarily through private placements of convertible preference shares and issuance of convertible debt. Since our inception through September 30, 2026, we have received aggregate gross proceeds of approximately $692.7 million from such transactions.
Previous 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.
Current wording
We have incurred significant operating losses since inception. Our net losses were $74.1 million and $44.6 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $256.0 million. We expect to continue to incur significant operating expenses and net losses for the foreseeable future.
Previous wording
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 wording
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, HMB-002 in patients with Von Willebrand Disease, HMB-003 in patients with heavy menstrual bleeding, and any other product candidates that we may develop;
Previous wording
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 wording
advance our clinical-stage product candidates into later-stage clinical trials, including our ongoing SOLARA Phase 3 clinical trial of sutacimig in patients with Glanzmann thrombasthenia, which we expect will be substantially more expensive than our earlier-stage clinical trials;
Previous 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.
Current wording
As of September 30, 2026, we had cash, cash equivalents and marketable securities of $430.2 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
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 wording
In July 2026, we 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 PK, PD, and safety of HMB-002 following a single fixed subcutaneous, or SC, dose; Part B evaluating PK, PD, and exploratory efficacy following multiple SC doses; and 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
Previous wording
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.
Current wording
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.
Previous wording
We record accruals for estimated ongoing research costs and receive updated estimates of costs and amounts owed on a monthly basis from our third-party service providers. When evaluating the adequacy of the prepaid expenses and accrued liabilities, we analyze progress of the studies, including the phase or completion of events, invoices received and contracted cost estimates from its third-party service providers. Estimates are made in determining the balances at the end of any reporting period.
Current wording
We record accruals for estimated ongoing research costs and receive updated estimates of costs and amounts owed on a monthly basis from our third-party service providers. When evaluating the adequacy of the prepaid expenses and accrued liabilities, we analyze progress of the studies, including the phase or completion of events, invoices received and contracted cost estimates from our third-party service providers. Estimates are made in determining the balances at the end of any reporting period.
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 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.
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 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.
Previous wording
Total research and development expenses were $20.3 million for the three months ended June 30, 2026, compared to $12.9 million for the three months ended June 30, 2025. The $7.4 million increase in research and development expenses for the three months ended June 30, 2026 was primarily due to an increase of $3.3 million in external research and development costs for our drug product candidates, a $3.2 million increase in personnel-related costs and equity-based compensation and an increase of $0.9 million in discovery and other costs related to adding consultancy resources for medical and clinical operations.
Current wording
Total research and development expenses were $24.6 million for the three months ended September 30, 2026, compared to $14.6 million for the three months ended September 30, 2025. The $10.1 million increase in research and development expenses for the three months ended September 30, 2026 was primarily due to an increase of $4.8 million in external research and development costs for our drug product candidates, a $2.7 million increase in personnel-related costs and equity-based compensation and an increase of $2.6 million in discovery and other costs related to adding consultancy resources for medical and clinical operations.
Previous wording
External research and development expenses related to sutacimig for the three months ended June 30, 2026 and 2025 were $5.4 million and $4.7 million, respectively. The increase of $0.7 million for the three months ended June 30, 2026 was primarily driven by increased Chemistry, Manufacturing, and Controls, or CMC, costs.
Current wording
External research and development expenses related to sutacimig for the three months ended September 30, 2026 and 2025 were $7.4 million and $4.5 million, respectively. The increase of $2.9 million for the three months ended September 30, 2026 was primarily driven by increased start-up activities related to the initiation of the SOLARA Phase 3 clinical trial of sutacimig in Glanzmann thrombasthenia and Chemistry, Manufacturing, and Controls, or CMC, costs.
Previous wording
External research and development expenses related to sutacimig for the six months ended June 30, 2026 and 2025 were $11.2 million and $10.6 million, respectively. The increase of $0.6 million for the six months ended June 30, 2026 was primarily driven by increased CMC costs.
Current wording
External research and development expenses related to HMB-002 for the three months ended September 30, 2026 and 2025 were $3.7 million and $3.1 million, respectively. The increase of $0.6 million for the three months ended September 30, 2026 was primarily driven by CMC-related activities.
Previous wording
External research and development expenses related to HMB-003 for the three months ended June 30, 2026 and 2025 were $1.9 million and $0.5 million, respectively. The increase of $1.4 million for the three months ended June 30, 2026 was primarily driven by increased non-clinical and CMC development related to the HMB-003 program during the three months ended June 30, 2026 as compared to primarily pre-clinical development costs in the three months ended June 30, 2025.
Current wording
External research and development expenses related to HMB-003 for the three months ended September 30, 2026 and 2025 were $2.2 million and $0.9 million, respectively. The increase of $1.3 million for the three months ended September 30, 2026 was primarily driven by the initiation of our Phase 1 clinical trial of HMB-003 during the three months ended September 30, 2026 as compared to primarily pre-clinical development costs in the three months ended September 30, 2025.
Previous wording
Personnel-related expenses and equity-based compensation increased by $2.5 million and $0.8 million in the three months ended June 30, 2026, respectively, compared to the three months ended June 30, 2025, primarily driven by a significant increase in average headcount across clinical development, CMC, and clinical operations related to the pursuit of identifying and developing product candidates.
Current wording
Personnel-related expenses and equity-based compensation increased by $2.1 million and $0.7 million in the three months ended September 30, 2026, respectively, compared to the three months ended September 30, 2025, primarily driven by a significant increase in average headcount across clinical development, CMC, and clinical operations related to the pursuit of identifying and developing product candidates.
Previous wording
Discovery and other costs increased by $0.9 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025, primarily driven by an increase in discovery activities and consultancy expense related to clinical operations, clinical research, and regulatory research.
Current wording
Discovery and other costs increased by $2.6 million for the three months ended September 30, 2026 compared to the three months ended September 30, 2025, primarily driven by an increase in discovery activities and consultancy expense related to clinical operations, clinical research, and regulatory research.
Previous wording
Total general and administrative expenses were $5.7 million for the three months ended June 30, 2026, compared to $3.2 million for the three months ended June 30, 2025. The $2.5 million increase was primarily due to an increase in personnel-related costs and equity-based compensation of $0.2 million and $0.7 million, respectively, driven by an increase in average headcount as well as an increase in professional service fees and other administrative fees of $1.6 million.
Current wording
Total general and administrative expenses were $5.1 million for the three months ended September 30, 2026, compared to $2.5 million for the three months ended September 30, 2025. The $2.6 million increase was primarily due to an increase in personnel-related costs and equity-based compensation of $0.4 million and $1.0 million, respectively, driven by an increase in average headcount as well as an increase in professional service fees of $1.2 million.
Previous wording
Other income (expense), net for the three months ended June 30, 2026 and 2025 were net income of $2.0 million and $3.8 million, respectively. The $1.8 million decrease was primarily related to foreign currency losses recognized due to unfavorable movements between the currencies which we regularly transact in, including DKK, Euros, British Pounds and our functional currency, the U.S. Dollar, and the higher cash balance in marketable securities from proceeds of the IPO. This was offset by an increase in interest income of $2.5 million due to an increase in accretion income related to our available-for-sale debt securities.
Current wording
Other income (expense), net for the three months ended September 30, 2026 and 2025 was net income of $3.1 million and $0.1 million, respectively. The $3.1 million increase was primarily due to a $3.2 million increase in interest income, driven by higher balances of cash equivalents and marketable securities following the IPO, partially offset by a $0.1 million unfavorable change in other income (expense), net, primarily due to a $0.5 million realized foreign currency loss upon the maturity of a DKK-denominated available-for-sale debt security, partially offset by favorable movements between the currencies we regularly transact in, including DKK, Euros, British Pounds and our functional currency, the U.S. Dollar.
Previous wording
Total research and development expenses were $39.8 million for the six months ended June 30, 2026, compared to $27.0 million for the six months ended June 30, 2025. The $12.8 million increase in research and development expenses for the six months ended June 30, 2026 was primarily due to an increase of $3.8 million in external research and development costs for our drug product candidates inclusive of a $3.1 million increase in HMB-003 costs, a $5.9 million increase in personnel-related costs and equity-based compensation and an increase of $3.1 million in discovery and other costs related to adding consultancy resources for medical and clinical operations.
Current wording
Total research and development expenses were $64.4 million for the nine months ended September 30, 2026, compared to $41.5 million for the nine months ended September 30, 2025. The $22.9 million increase in research and development expenses for the nine months ended September 30, 2026 was primarily due to an increase of $8.6 million in external research and development costs for our drug product candidates inclusive of a $4.4 million and $3.4 million increase in HMB-003 and sutacimig costs, respectively, an $8.6 million increase in personnel-related costs and equity-based compensation and an increase of $5.6 million in discovery and other costs related to adding consultancy resources for medical and clinical operations.
Previous wording
External research and development expenses related to HMB-002 for the six months ended June 30, 2026 and 2025 were $6.5 million and $6.4 million, respectively. The increase of $0.1 million for the six months ended June 30, 2026 was primarily driven by clinical development costs related to the ongoing Phase 1/2 clinical trial of HMB-002 during the six months ended June 30, 2026 as compared to the six months ended June 30, 2025.
Current wording
External research and development expenses related to HMB-002 for the nine months ended September 30, 2026 and 2025 were $10.3 million and $9.5 million, respectively. The increase of $0.8 million for the nine months ended September 30, 2026 was primarily driven by CMC-related activities.
Previous wording
External research and development expenses related to HMB-003 for the six months ended June 30, 2026 and 2025 were $3.9 million and $0.8 million, respectively. The increase of $3.1 million for the six months ended June 30, 2026 was primarily driven by increased non-clinical and CMC development related to the HMB-003 program during the six months ended June 30, 2026 as compared to primarily pre-clinical development costs in the six months ended June 30, 2025.
Current wording
External research and development expenses related to HMB-003 for the nine months ended September 30, 2026 and 2025 were $6.1 million and $1.7 million, respectively. The increase of $4.4 million for the nine months ended September 30, 2026 was primarily driven by the initiation of our Phase 1 clinical trial of HMB-003 in addition to increased non-clinical and CMC development related to the HMB-003 program during the nine months ended September 30, 2026 as compared to primarily pre-clinical development costs in the nine months ended September 30, 2025.
Previous wording
Personnel-related expenses and equity-based compensation increased by $4.8 million and $1.2 million in the six months ended June 30, 2026, respectively, compared to the six months ended June 30, 2025, primarily driven by a significant increase in average headcount across clinical development, CMC, and clinical operations related to the pursuit of identifying and developing product candidates.
Current wording
Personnel-related expenses and equity-based compensation increased by $6.8 million and $1.8 million in the nine months ended September 30, 2026, respectively, compared to the nine months ended September 30, 2025, primarily driven by a significant increase in average headcount across clinical development, CMC, and clinical operations related to the pursuit of identifying and developing product candidates.
Previous wording
Discovery and other costs increased by $3.1 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025, primarily driven by an increase in discovery activities and consultancy expense related to clinical operations, clinical research, and regulatory research.
Current wording
Discovery and other costs increased by $5.6 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025, primarily driven by an increase in discovery activities and consultancy expense related to clinical operations, clinical research, and regulatory research.
Previous wording
Total general and administrative expenses were $9.9 million for the six months ended June 30, 2026, compared to $5.6 million for the six months ended June 30, 2025. The $4.3 million increase was primarily due to an increase in personnel-related costs and equity-based compensation of $0.5 million and $1.2 million, respectively, driven by an increase in average headcount as well as an increase in professional service fees and other administrative fees of $2.6 million.
Current wording
Total general and administrative expenses were $15.0 million for the nine months ended September 30, 2026, compared to $8.1 million for the nine months ended September 30, 2025. The $6.9 million increase was primarily due to an increase in personnel-related costs and equity-based compensation of $0.8 million and $2.2 million, respectively, driven by an increase in average headcount as well as an increase in professional service fees of $2.4 million and other administrative fees of $1.5 million.
Previous wording
During the six months ended June 30, 2026, net cash used in operating activities was $44.2 million, due to a net loss of $46.8 million, which was partially offset by changes in operating assets and liabilities that provided $1.0 million in cash and net non-cash expenses of $1.6 million.
Current wording
During the nine months ended September 30, 2026, net cash used in operating activities was $72.5 million, due to a net loss of $74.1 million and changes in operating assets and liabilities that used $1.5 million in cash, partially offset by net non-cash expenses of $3.1 million.
Previous wording
During the six months ended June 30, 2025, net cash used in operating activities was $28.4 million, due to a net loss of $27.6 million, in addition to changes in operating assets and liabilities that used $0.9 million in cash, partially offset by net non-cash expenses of $0.1 million.
Current wording
During the nine months ended September 30, 2025, net cash used in operating activities was $44.8 million, due to a net loss of $44.6 million and changes in operating assets and liabilities that used $1.1 million in cash, partially offset by net non-cash expenses of $0.9 million.
Previous wording
During the six months ended June 30, 2026, net cash used in investing activities was $123.3 million, which primarily consisted of purchases of marketable securities and property and equipment, which were partially offset by maturities of marketable securities.
Current wording
During the nine months ended September 30, 2026, net cash used in investing activities was $93.2 million, which consisted of $148.2 million of purchases of marketable securities and $0.2 million of purchases of property and equipment, partially offset by $40.2 million of maturities and $15.0 million of proceeds from sales of marketable securities.
Previous wording
During the six months ended June 30, 2025, net cash provided by investing activities was $15.5 million, which primarily consisted of maturities of marketable securities, which were partially offset by purchases of marketable securities.
Current wording
During the nine months ended September 30, 2025, net cash provided by investing activities was $15.5 million, which consisted of $35.5 million of maturities of marketable securities, partially offset by $19.9 million of purchases of marketable securities.
Previous wording
During the six months ended June 30, 2026, net cash provided by financing activities was $317.2 million related to proceeds from the issuance of common stock in the IPO after deducting underwriting discounts and commissions and offering expenses of $29.6 million.
Current wording
During the nine months ended September 30, 2026, net cash provided by financing activities was $317.2 million related to proceeds from the issuance of common stock in the IPO after deducting underwriting discounts and commissions and offering expenses of $29.6 million.
Previous wording
During the six months ended June 30, 2025, net cash used in financing activities was less than $0.1 million, related to principal payments on finance lease obligations.
Current wording
During the nine months ended September 30, 2025, net cash used in financing activities was $0.1 million, related to principal payments on finance lease obligations.
Previous wording
We expect our expenses to increase substantially in connection with our ongoing and planned activities, particularly as we advance sutacimig into late-stage clinical development in patients with Glanzmann thrombasthenia and continue its clinical development in patients with Factor VII deficiency, continue the clinical development of HMB-002 in patients with Von Willebrand Disease, and initiate clinical trials of HMB-003 in heavy menstrual bleeding, continue research and development and initiate additional clinical trials of, and seek marketing approval for, these and other product candidates. In addition, if we obtain marketing approval for our product candidates and any other product candidates we may identify and pursue, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution. Furthermore, we expect to incur additional costs associated with operating as a public company. As a result, we expect to continue to incur significant operating expenses and net losses for the foreseeable future.
Current wording
We expect our expenses to increase substantially in connection with our ongoing and planned activities, particularly as we continue the clinical development of sutacimig in patients with Glanzmann thrombasthenia and Factor VII deficiency, continue the clinical development of HMB-002 in patients with Von Willebrand Disease and continue the clinical development of HMB-003 in patients with heavy menstrual bleeding, continue research and development and initiate additional clinical trials of, and seek marketing approval for, these and other product candidates. In addition, if we obtain marketing approval for our product candidates and any other product candidates we may identify and pursue, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution. Furthermore, we expect to incur additional costs associated with operating as a public company. As a result, we expect to continue to incur significant operating expenses and net losses for the foreseeable future.
Previous wording
As of June 30, 2026, we had total 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. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Current wording
As of September 30, 2026, we had total cash, cash equivalents and marketable securities of $430.2 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. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Previous wording
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 wording
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, HMB-002 in patients with Von Willebrand Disease, HMB-003 in patients with heavy menstrual bleeding, and any other product candidates that we may develop;
Previous wording
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 wording
advance our clinical-stage product candidates into later-stage clinical trials, including our ongoing SOLARA Phase 3 clinical trial of sutacimig in patients with Glanzmann thrombasthenia, which we expect will be substantially more expensive than our earlier-stage clinical trials;
Previous wording
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;
Current wording
we are required by the FDA, 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;
Previous wording
For additional information on our future commitments relating to our leasing obligations, see Note 9, “Leases” of the “Notes to Consolidated Financial Statements” in the audited consolidated financial statements for the year ended December 31, 2025 and notes thereto, included in our final prospectus filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on May 1, 2026.
Current wording
For additional information on our future commitments relating to our leasing obligations, see Note 9, “Leases” of the “Notes to Consolidated Financial Statements” in the audited consolidated financial statements for the year ended
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
December 31, 2025 and notes thereto, included in our final prospectus filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on May 1, 2026.