COAG 10-K & 10-Q changes, risk factors and insider trading
Hemab Therapeutics Holdings, Inc. · Nasdaq · Biological Products, (No Diagnostic Substances) · CIK 2114044 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Comparison not available: Not available: fewer than two 10-K filings on EDGAR to compare..
What changed in the latest 10-Q
Risk Factors
Removed heading “Our business is subject to numerous risks. You should carefully consider the risks and uncertainties described below together with all of the other information contained in this Quarterly Report on Form”
Removed heading “Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc.”
Largest changes
In recent years, a significant number of pharmaceutical and biotechnology companies have been the target of inquiries and investigations by various federal and state regulatory, investigative, prosecutorial and administrative entities in connection with the promotion of products for unapproved uses and other sales practices, including the Department of Justice and various U.S. Attorneys’ Offices, the Office of Inspector General of the Department of Health and Human Services, the FDA, the Federal Trade Commission, or the FTC, and various state Attorneys General offices. These investigations have alleged violations of various federal and state laws and regulations, including claims asserting antitrust violations, violations of the Federal Food, Drug and Cosmetic Act, or FDCA, the False Claims Act, the Prescription Drug Marketing Act and anti-kickback laws and other alleged violations in connection with the promotion of products for unapproved uses, pricing and Medicare and/or Medicaid reimbursement. Many of these investigations originate as “qui tam” actions under the False Claims Act. Under the False Claims Act, any individual can bring a claim on behalf of the government alleging that a person or entity has presented a false claim or caused a false claim to be submitted to the government for payment. The person bringing a qui tam suit is entitled to a share of any recovery or settlement. Qui tam suits, also commonly referred to as “whistleblower suits,” are often brought by current or former employees. In a qui tam suit, the government must decide whether to intervene and prosecute the case. If it declines, the individual may pursue the case alone. For example, in September 2025, President Trump issued a Memorandum directing the U.S. Department of Health and Human Services, or HHS, to “ensure transparency and accuracy in direct-to-consumer prescription drug advertising, including by increasing the amount of information regarding any risks associated with the use of any such prescription drug required to be provided in prescription drug advertisements.” To that end, the FDA announced that it is initiating a rulemaking process “to eliminate the ‘adequate provision’ loophole that allows pharmaceutical advertisements to hide safety information by placing it in another format or location.” In this context, the FDA declared that it will no longer tolerate what it characterized as “deceptive practices” in prescription drug advertising and that the FDA would “aggressively deploy” its available enforcement tools, with “heightened scrutiny” of fair balance and disclosures in social media promotions. The FDA also issued a generic “notice letter” directing companies to “remove any noncompliant advertising and bring all promotional communications into compliance.” The FDA has subsequently increased its enforcement scrutiny over prescription drug advertising, particularly direct-to-consumer product promotion and advertising. If the FDA finds any of our promotional communications or advertising to be violative, we may receive an untitled or warning letter, requests for corrective advertising, or fines, amongst other enforcement tools available to the FDA.see in full comparison
“In recent years, a significant number of pharmaceutical and biotechnology companies have been the target of inquiries and investigations by various federal and state regulatory, investigative, prosecutorial and administrative entities in connection with the promotion of products for unapproved uses and other sales practices, including the Department of Justice and various U.S. Attorneys’ Offices, the Office of Inspector General of the Department of Health and Human Services, the FDA, the Federal Trade Commission, or the FTC, and various state Attorneys General offices. …”see in full comparison
“President Trump subsequently invoked Section 122 of the Trade Act of 1974, or Section 122, to impose a 10% tariff, which could be raised to 15%, on nearly all foreign imports. The tariffs imposed under Section 122 expired in July 2026. In addition, the U.S. Trade Representative has conducted two investigations under Section 301 of the Trade Act of 1974, or Section 301, which have resulted in additional tariffs. …”see in full comparison
“Neither the U.S. Supreme Court’s decision nor the Executive Order revoking the IEEPA tariffs addressed refunds, leaving the issue to renewed proceedings before the U.S. Court of International Trade, where importers may need to pursue administrative remedies and/or litigation amid continued uncertainty. …”see in full comparison
“The reciprocal tariffs and the fentanyl tariffs were imposed pursuant to the International Emergency Economic Powers Act, or the IEEPA. These tariffs were found to be unconstitutional by multiple federal courts in the spring and summer of 2025. On February 20, 2026, the U.S. Supreme Court held that the IEEPA does not authorize the U.S. President to impose tariffs, invalidating both the reciprocal tariffs and the drug trafficking tariffs. …”see in full comparison
“Separately, in April 2025, the Department of Commerce announced an investigation under Section 232 of the Trade Expansion Act of 1962, or Section 232, into imports of pharmaceuticals and pharmaceutical ingredients, including finished products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items. On September 25, 2025, via a post on Truth Social, President Trump announced that, beginning October 1, 2025, all branded or patented drugs imported in the United States would face a 100% tariff. …”see in full comparison
Full comparison: every changed paragraph (346)
Our business is subject to numerous risks. You should carefully consider the risks and uncertainties described below together with all of the other information contained in this Quarterly Report on Form
Our business is subject to numerous risks. You should carefully consider the risks and uncertainties described below together with all of the other information contained in this Quarterly Report on Form 10-Q, or this Quarterly Report, including our condensed consolidated financial statements and the related notes thereto in evaluating our company. The risks described below are not the only risks facing our company. The occurrence of any of the following risks, or of additional risks and uncertainties not presently known to us or that we currently believe to be immaterial, could cause our business, prospects, operating results and financial condition to suffer materially.
We are a clinical-stage biopharmaceutical company with a limited operating history. Since our inception, we have devoted substantially all of our financial resources and efforts to research and development, including clinical trials and preclinical studies of our product candidates, sutacimig and HMB-002, along with several preclinical programs focusing on coagulation disorders, such as HMB-003, and have incurred significant operating losses. Our net losses were $22.7$46.8 million for the threesix months ended MarchJune 31,30, 2026 and $63.9 million for the year ended December 31, 2025. As of MarchJune 31,30, 2026, we had an accumulated deficit of $204.5$228.7 million. We have no approved products, and we have not generated any revenue from product sales. We have financed our operations primarily through private placements of convertible preference shares, issuances of convertible debt and, most recently, from the sale of common stock in our initial public offering, or IPO, in May 2026. We are still continuing to research and develop our product candidates, and we have not yet completed the development of any of our product candidates. We expect to continue to incur significant operating expenses and net losses for the foreseeable future. Our operating expenses and net losses may fluctuate significantly from quarter to quarter and year to year. Accordingly, our stockholders should not rely upon the results of any particular quarterly or annual period as indications of future operating performance. Because of the numerous risks and uncertainties associated with developing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if at all. Even if we become profitable, we may not be able to sustain or increase our profitability on a quarterly or annual basis.
We anticipate that our expenses will increase substantially,substantially if and as,as we:
continue to advance the clinical development of our clinical-stage product candidates, including our ongoing Phase 1/2 clinical trial of sutacimig in patients with Glanzmann thrombasthenia, our ongoing Phase 2 clinical trial of sutacimig in patients with Factor VII deficiency, and our ongoing Phase 1/2 clinical trial of HMB-002 in patients with Von Willebrand Disease, as well as any other product candidates that we may develop, including HMB-003 in patients with heavy menstrual bleeding;
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;
continue to advance our research and preclinical activities and seek to discover and develop additional product candidates, including HMB-003;
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;
seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials;
ultimately establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any products for which we may obtain marketing approval;
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;
acquire or in-license products, product candidates or technologies;
establish or maintain collaborations;
maintain, expand, enforce, defend and protect our intellectual property;
hire additional clinical, medical, regulatory, quality control, manufacturing and other scientific and technical personnel;
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;
incur additional audit, legal, regulatory, tax and other expenses with being a public company; and 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, and 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, and under any additional future collaboration or license agreements that we may enter into.
we are required by the U.S. Food and Drug Administration, or the FDA, the European Medicines Agency, or the EMA, or other regulatory authorities to perform clinical trials or preclinical studies that are in addition to, or different than, those expected;
there are any delays in completing our clinical trials or preclinical studies or the development of any of our product candidates; or there are any third-party challenges to our intellectual property or we need to defend against any intellectual property-related claim.
Our operations have consumed substantial amounts of cash since inception. Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approvals and achieve product sales. We expect to devote substantial financial resources to our ongoing and planned activities, particularly as we commence our planned Phase 3 clinical trial of sutacimig in patients with Glanzmann thrombasthenia and continue our ongoing Phase 1/2 clinical trial of sutacimig in patients with Glanzmann thrombasthenia, Phase 2 clinical trial of sutacimig in patients with Factor VII deficiency and Phase 1/2 trial of HMB-002 in patients with Von Willebrand Disease, and progress HMB-003 into first-in-human studies 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. We expect our expenses to increase substantially in connection with our ongoing and planned activities, particularly as we advance our preclinical activities and clinical trials of and potentially seek marketing approval for our product candidates and other product candidates we may identify, and if and as we expand our research and development and scale-up and manufacture our product candidates for our current and future indications. We will be required to incur substantial costs and may experience delays in completing, or ultimately be unable to complete, the development and commercialization of any product candidates.
As of MarchJune 31,30, 2026, we had cash, cash equivalents and marketable securities of $163.5$457.5 million. We believe that our cash, cash equivalents and marketable securities as of MarchJune 31,30, 2026, together with net proceeds from the IPO of approximately $317.2 million,2026 will enable us to fund our operating expenses and capital expenditure requirements into 2029. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. As a result, we could deplete our capital resources sooner than we currently expect and could be forced to seek additional funding sooner than planned. We would be required to obtain substantial additional funding in order to initiate and conduct registrational and other clinical trials for our product candidates.
the scope, progress, costs and results of our current and future preclinical studies and clinical trials for our product candidates;
the number of clinical trials required for regulatory approval of our current or future product candidates;
whether we partner our programs with collaborators for later-stage clinical development or commercialization;
the number and development requirements of any other product candidates we may identify and develop;
the costs, timing and outcome of regulatory review of our product candidates and any other product candidates we may identify and develop;
the costs of obtaining clinical and commercial supplies of our product candidates and any other product candidates we may identify and develop;
our ability to successfully commercialize our product candidates and any other product candidates we may identify and develop;
the manufacturing, selling and marketing costs associated with our product candidates and any other product candidates we may identify and develop, including the cost and timing of establishing sales and marketing capabilities;
the scope, progress, costs and results of any post-marketing studies that could be required by regulatory authorities;
the amount and timing of sales and other revenues from our product candidates and any other product candidates we may identify and develop, including the sales price and the availability of coverage and adequate third-party reimbursement;
the time and cost necessary to respond to technological and market developments;
the extent to which we may acquire or in-license other product candidates and technologies;
our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements;
milestone payments and other collaboration-based payments, if any;
our ability to attract, hire and retain qualified personnel;
our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors;
the effect of macroeconomic trends including inflation, foreign exchange rate, interest rates and tariffs; and the costs and timing of preparing, filing and prosecuting patent applications, maintaining, enforcing and protecting our intellectual property and proprietary rights and defending any intellectual property-related claims.
We are heavily dependent on the success of sutacimig and HMB-002, which are our only clinical-stage product candidates.candidates, and HMB-003, which is in preclinical development.
We currently have no products that are approved for commercial sale and may never be able to develop marketable products. We expect that a substantial portion of our efforts and expenditures over the next several years will be devoted to sutacimig and HMB-002, which are currently our only clinical-stage product candidates.candidates, and HMB-003, which is in preclinical development. Accordingly, our business currently depends heavily on the successful development, marketing approval and commercialization of these product candidates. We cannot be certain that sutacimigsutacimig, HMB-002 or HMB-003 will receive marketing approval, be approved for the indications that we may seek or be successfully commercialized even if we receive marketing approvals. If we were required to discontinue development of sutacimigsutacimig, HMB-002 or HMB-003 or if any of these product candidates do not receive marketing approvals or fail to achieve significant market acceptance, we would be delayed by many years in our ability to achieve profitability, if ever, and may not be able to generate sufficient revenue to continue our business.
To date, we have invested a majority of our efforts and financial resources in the preclinical and clinical development of our product candidates, including our ongoing Phase 1/2 clinical trial of sutacimig in patients Glanzmann thrombasthenia, Phase 2 clinical trial of sutacimig in patients with Factor VII deficiency and our ongoing Phase 1/2 clinical trial of in patients with Von Willebrand Disease.candidates. We have not yet initiated a Phase 3 trial of any product candidate. Our future success is heavily dependent on our ability to successfully develop, obtain marketing approval for and ultimately commercialize our product candidates. We cannot be certain that our product candidates will be successful in clinical trials or receive marketing approval.
successfully completing clinical trials;
acceptance by the FDA or other regulatory agencies of regulatory filings for our product candidates;
expanding and maintaining a workforce of experienced scientists and others to continue to develop our product candidates;
obtaining and maintaining intellectual property protection and regulatory exclusivity for our product candidates;
making arrangements with third-party manufacturers for, or establishing, commercial manufacturing capabilities;
establishing sales, marketing and distribution capabilities and successfully launching commercial sales, if and when approved, whether alone or in collaboration with others;
acceptance of the products, if and when approved, by patients, the medical community and third-party payors;
further chemistry, manufacturing and controls, manufacturing or development and optimization of the formulation and presentation of our product candidates;
effectively competing or successfully being administered with other approved therapies;
obtaining and maintaining coverage, adequate pricing and adequate reimbursement from third-party payors, including government payors;
patients’ willingness to pay out of pocket for our products in the absence of coverage and/or adequate reimbursement from third-party payors;
maintaining, enforcing, defending and protecting our rights in our intellectual property portfolio;
not infringing, misappropriating or otherwise violating others’ intellectual property or proprietary rights; and maintaining a continued acceptable safety and tolerability profile following receipt of any marketing approvals.
Although we are planning to conduct a multinational, multicenter, Phase 3, single-arm, open-label clinical trial evaluating sutacimig as a prophylactic therapy in adults with Glanzmann thrombasthenia, the FDA may determine that a randomized controlled clinical trial is necessary to support filing and approval of our Biologics License Application, or BLA. We intend to schedule a Type D meeting with the FDA in the coming months to obtain the FDA’s feedback on, and seek alignment regarding, our proposed Phase 3 trial design. A Type D meeting is intended to facilitate focused discussion on a limited number of specific issues, but there can be no assurance that the FDA will agree with our proposed approach. If the FDA requires us to conduct a randomized controlled Phase 3 clinical trial, we could incur additional costs and delays, to the extent any such trial is more complex, time-consuming and/or expensive to design, initiate and complete. A randomized trial may require a larger number of patients, longer enrollment and follow-up periods, and additional clinical sites, which could delay the timing of any regulatory submission and potential approval. In addition, the use of a control arm may introduce ethical, operational and recruitment challenges, particularly if patients or investigators are reluctant to participate in a study where treatment assignment is randomized. There is also a risk that a randomized trial could fail to meet its primary or secondary endpoints, even if a single-arm study might have demonstrated favorable results, which could materially and adversely affect our ability to obtain regulatory review and approval and commercialize our product candidate.
The small patient populations in the indications we are pursuing, such as Glanzmann thrombasthenia and Factor VII deficiency (which we estimate to be approximately 10,000 patients in the aggregate in the geographies where we intend to commercialize sutacimig, including the United States, the European Union, Japan, the Gulf Cooperation Council, or GCC, countries and other select regions), may make it challenging to enroll a sufficient number of patients in our clinical trials for sutacimig.
The variability in bleeding phenotypes and disease severity in these conditions can make it difficult to demonstrate statistical significance in clinical endpoints.
The lack of validated biomarkers and endpoints in blood disorders requires us to develop novel endpoints, which may not be accepted by regulatory authorities.
Patients with coagulation disorders may be geographically dispersed, requiring multi-national clinical trials with associated regulatory complexity.
Recruitment of patients for our clinical trials may be slower than anticipated due to the low prevalence of certain of these conditions, competition for patients from other clinical trials and the burden of our clinical trials on patients, including due to the duration of our clinical trials, the need for a higher degree of oversight by principal investigators, and the requirement of patient adherence to strict electronic bleed diary protocol requirements.
Management's Discussion & Analysis (MD&A)
New heading “Recent Developments”
New heading “Glanzmann Thrombasthenia”
New heading “Factor VII deficiency”
New heading “Comparison of the Six Months Ended June 30, 2026 and 2025”
New heading “Research and Development Expenses”
New heading “General and Administrative Expenses”
New heading “Other Income (Expense), Net”
New heading “License Agreement with Gubra”
Largest changes
“our ability to attract, hire and retain qualified personnel; and the effect of macroeconomic trends including inflation, foreign exchange rate, interest rates and tariffs.”see in full comparison
Full comparison: every changed paragraph (109)
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 DiseaseDisease, 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.
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 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.
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.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.
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 MayJune 21,30, 2026, we have received aggregate gross proceeds of approximately $692.7 million from such transactions.
We have incurred significant operating losses since inception. Our net losses were $22.7$46.8 million and $15.3$27.5 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $204.5$228.7 million. We expect to continue to incur significant operating expenses and net losses for the foreseeable future.
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;
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;
continue to advance our research and preclinical activities and seek to discover and develop additional product candidates;
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;
seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials;
ultimately establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any products for which we may obtain marketing approval;
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;
acquire or in-license products, product candidates or technologies;
establish or maintain collaborations;
maintain, expand, enforce, defend and protect our intellectual property;
hire additional clinical, medical, regulatory, quality control, manufacturing and other scientific and technical personnel;
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;
incur additional audit, legal, regulatory, tax and other expenses with being a public company; and 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.
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;
there are any delays in completing our clinical trials or preclinical studies or the development of any of our product candidates; or there are any third-party challenges to our intellectual property or we need to defend against any intellectual property-related claim.
As of MarchJune 31,30, 2026, we had cash, cash equivalents and marketable securities of $163.5$457.5 million. We believe that our existing cash, cash equivalents and marketable securities, together with net proceeds from the IPO of approximately $317.2 million,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.
Recent Developments
Sutacimig
Glanzmann Thrombasthenia
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.
Factor VII deficiency
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.
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:
Extended half-life supporting infrequent dosing: PK analysis confirmed dose-dependent increase in Cmax with prolonged duration.
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.
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.
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.
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.
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;
laboratory and vendor costs related to the execution of preclinical studies and planned and ongoing clinical trials; costs related to compliance with regulatory requirements;
direct costs of conducting internal research and development for our internal preclinical programs;
acquisition of intellectual property and related future payments should certain development and regulatory milestones be achieved;
personnel-related costs, including salaries, bonuses, benefits and equity-based compensation for employees engaged in research and development functions;
expenses incurred for the procurement of materials, laboratory supplies and non-capital equipment used in the research and development process; and 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.
the scope, progress, costs and results of our current and future preclinical studies and clinical trials for our product candidates;
the number of clinical trials required for regulatory approval of our current or future product candidates;
whether we partner our programs with collaborators for later-stage clinical development or commercialization;
the number and development requirements of any other product candidates we may identify and develop;
the costs, timing and outcome of regulatory review of our product candidates and any other product candidates we may identify and develop;
the costs of obtaining clinical and commercial supplies of our product candidates and any other product candidates we may identify and develop;
our ability to successfully commercialize our product candidates and any other product candidates we may identify and develop;
the time and cost necessary to respond to technological and market developments;
the extent to which we may acquire or in-license other product candidates and technologies;
our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements;
milestone payments and other collaboration-based payments, if any;
our ability to attract, hire and retain qualified personnel; and the effect of macroeconomic trends including inflation, foreign exchange rate, interest rates and tariffs.
Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025
Total research and development expenses were $19.5$20.3 million for the three months ended MarchJune 31,30, 2026, compared to $14.1$12.9 million for the three months ended MarchJune 31,30, 2025. The $5.4$7.4 million increase in research and development expenses for the three months ended MarchJune 31,30, 2026 was primarily due to an increase of $2.3$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 $2.2$0.9 million in discovery and other costs related to adding consultancy resources for medical and clinical operations.
External research and development expenses related to sutacimig for the three months ended MarchJune 31,30, 2026 and 2025 were $5.8$5.4 million and $6.0$4.7 million, respectively. The decreaseincrease of $0.2$0.7 million for the three months ended MarchJune 31,30, 2026 was primarily driven by reducedincreased Chemistry, Manufacturing, and Controls, or CMC, costs.
External research and development expenses related to HMB-002 for the three months ended MarchJune 31,30, 2026 and 2025 were $3.5$3.0 million and $4.6$1.8 million, respectively. The decreaseincrease of $1.1$1.2 million for the three months ended MarchJune 31,30, 2026 was primarily driven by start-upclinical development costs related to the ongoing Phase 1/2 clinical trial of HMB-002 during the three months ended MarchJune 31,30, 20252026 as compared to start-up costs during the three months ended MarchJune 31,30, 2026.2025.
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.
Other external research and development expenses increased by $1.8 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025, primarily driven by continued CMC activities related to our preclinical programs and other increased preclinical development costs.
Personnel-related expenses and equity-based compensation increased by $2.3$2.5 million and $0.4$0.8 million in the three months ended MarchJune 31,30, 2026, respectively, compared to the three months ended MarchJune 31,30, 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.
Discovery and other costs increased by $2.1$0.9 million for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025, primarily driven by an increase in discovery activities and consultancy expense related to clinical operations, clinical research, and regulatory research.
Total general and administrative expenses were $4.2$5.7 million for the three months ended MarchJune 31,30, 2026, compared to $2.5$3.2 million for the three months ended MarchJune 31,30, 2025. The $1.7$2.5 million increase was primarily due to an increase in personnel-related costs and equity-based compensation of $0.3$0.2 million and $0.5$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 $0.8$1.6 million.
COAG insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 5 Form 4 filings (4 insiders, 11 trade dates, 2,970,541 shares, about $55.5M) and open-market sales in 0 filings. Net open-market shares: 2,970,541 (purchases minus sales); net value about $55.5M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-06-16 | Ra Capital Management, L.p. |
Open-market purchase | 61,523 | $24.98 | $1.5M |
| 2026-06-15 | Ra Capital Management, L.p. |
Open-market purchase | 6,146 | $24.89 | $153.0K |
| 2026-05-20 | Ra Capital Management, L.p. |
Open-market purchase | 996 | $24.94 | $24.8K |
| 2026-05-19 | Ra Capital Management, L.p. |
Open-market purchase | 3,802 | $24.97 | $94.9K |
| 2026-05-12 | Kolchinsky Peter |
Open-market purchase | 6,387 | $24.90 | $159.0K |
| 2026-05-11 | Ra Capital Healthcare Fund Lp |
Open-market purchase | 25,720 | $25.00 | $643.0K |
| 2026-05-11 | Ra Capital Healthcare Fund Lp |
Open-market purchase | 14,149 | $24.47 | $346.2K |
| 2026-05-08 | Ra Capital Healthcare Fund Lp |
Open-market purchase | 1,483 | $24.98 | $37.0K |
| 2026-05-07 | Ra Capital Healthcare Fund Lp |
Open-market purchase | 1,985 | $24.95 | $49.5K |
| 2026-05-07 | Ra Capital Healthcare Fund Lp |
Open-market purchase | 7,921 | $24.34 | $192.8K |
| 2026-05-06 | Shah Rajeev M. |
Open-market purchase | 53,407 | $24.83 | $1.3M |
| 2026-05-06 | Shah Rajeev M. |
Open-market purchase | 14,611 | $23.77 | $347.3K |
| 2026-05-05 | Shah Rajeev M. |
Open-market purchase | 10,268 | $25.00 | $256.7K |
| 2026-05-05 | Shah Rajeev M. |
Open-market purchase | 87,143 | $24.59 | $2.1M |
| 2026-05-04 | Shah Rajeev M. |
Conversion | 3,607,846 | — | — |
| 2026-05-04 | Shah Rajeev M. |
Open-market purchase | 133,750 | $18.00 | $2.4M |
| 2026-05-04 | Shah Rajeev M. |
Open-market purchase | 2,541,250 | $18.00 | $45.7M |
| 2026-05-04 | Shah Rajeev M. |
Conversion | 221,188 | — | — |
| 2026-05-04 | Shah Rajeev M. |
Conversion | 1,009,052 | — | — |
| 2026-05-04 | Novo Holdings A/s |
Conversion | 4,180,550 | — | — |
| 2026-05-04 | Maraganore John |
Conversion | 17,974 | — | — |
| 2026-05-04 | Maraganore John |
Conversion | 17,974 | — | — |
Well-known investors holding COAG (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 523,450 | $19.2M | 0.01% | New position |
| Soros Fund Management | 2026-06-30 | 25,000 | $918.2K | 0.01% | New position |
| Two Sigma Investments | 2026-06-30 | 5,680 | $208.6K | 0.0% | New position |