HUMA 10-K & 10-Q changes, risk factors and insider trading

•We have never generated product revenue and have incurred significant losses to date. We expect to continue to incur losses for the foreseeable future and may never generate significant product revenue or be profitable. We will need to raise additional capital to finance our operations, which we may not be able to do on acceptable terms or at all.

•Our near-term prospects are dependent on the success of Symvess, our sole FDA-approved product, and if we are unable to successfullyincrease commercialize itsales in the vascular trauma indication and obtain regulatory approval for Symvess in additional indications, our business, operating results and financial condition will be materially harmed.

•Symvess and our product candidates, if approved, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

•We face and will continue to face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do, which may adversely affect our ability to successfully market or commercialize Symvess or our product candidates.

•If our clinical trials fail to demonstrate safety and efficacy to the satisfaction of the FDA or similar regulatory authorities outside the United States or do not otherwise produce favorable results, we may incur significant additional costs or experience significant delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

•We may experience delays or difficulties in the enrollment of patients in our clinical trials, which may delay or prevent additional clinical trials and our receipt of necessary marketing approvals.

•Lack of experience by investigators and surgeons with our ATEVs can lead to incorrect implantation or follow-up procedures which could harm the results of our clinical trials and market acceptance of Symvess and our product candidates, if approved.

•We may not be successful in our efforts to use our proprietary scientific technology platform to build a pipeline of additional product candidates.

•The sizes of the market opportunities for Symvess and our product candidates have not been established with precision and are estimates that management believes to be reasonable. If these market opportunities are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the relevant patient population, our revenue and ability to achieve profitability might be materially and adversely affected.

•Our distribution agreement with Fresenius Medical Care imposes obligations on us that may restrict our ability to operate our business in ways we believe to be in our long-term best interest.

•If we receive approval for a product candidate that is not subject to our distribution agreement with Fresenius Medical Care, and we are unable to establish our own marketing, sales and distribution capabilities or are unable to enter into agreements with third parties to do so, we may not be able to generate product revenue and will have to alter our development and commercialization plans.

•The manufacture of Symvess and our product candidates is complex, we have limited experience manufacturing commercial product, and we have in the past and may in the future encounter difficulties in production. If we or any third-party manufacturer encounter such difficulties, our ability to supply Symvess for commercial sale or Symvess and our product candidates for clinical trials could be delayed or halted entirely.

•The terms of the PurchaseLoan Agreement (defined below) may limit our ability to incur future debt.

•We rely on third parties to conduct and support our clinical trials, and those third parties may not perform satisfactorily, including by failing to adhere to regulatory requirements or our stated protocols or to meet deadlines for the completion of such trials.

•We rely on third-party suppliers, including sole source suppliers, to provide certain components for our product candidates. Any failure by a third-party supplier to supply these components for manufacture may delay or impair our ability to complete our clinical trials and to commercialize our product candidates.

•We intend to rely on our strategic, global partnership with Fresenius Medical Care to undertake, or assist with, the marketing, sale and distribution of certain of our product candidates in certain markets if we receive marketing approval from relevant regulatory authorities. Disruption of this arrangement could materially adversely affect our business, prospects, operating results and financial condition.

•Our ability to successfully commercialize Symvess and our product candidates may be impaired if we are unable to obtain and maintain effective intellectual property rights for our proprietary scientific technology platform and product candidates.

•We may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on our financial condition, results of operations and stock price, which could cause you to lose some or all of your investment.

Our near-term prospects are dependent on the success of Symvess, our sole FDA-approved product, and if we are unable to successfullyincrease commercialize itsales in the vascular trauma indication and obtain regulatory approval for Symvess in additional indications, our business, operating results and financial condition will be materially harmed.

Our business currently depends heavily on our ability to successfullyincrease commercializesales of Symvess in the United States and in other jurisdictions where we may obtain marketing approval. Symvess currently is our only product approved for sale in the US and, while we are developing a number of product candidates, we have invested and continue to invest a substantial portion of our efforts and financial resources in the development of Symvess. None of our remaining product geometries and modifications have advanced beyond preclinical development. As a result, in the near term we are dependent on the success of Symvess, and if we are unable to successfullyincrease commercialize itsales in the vascular trauma indication and obtain regulatory approval for Symvess in additional indications, our business, along with our operating results and financial condition, will be materially harmed. We may never be able to successfullyincrease commercializesales of Symvess or our product candidates or meet our expectations with respect to revenues for a number of reasons, including:

•a lack of acceptance of Symvess by physicians, patients, third-party payors and other members of the medical community;

•our limited experience in marketing, selling and distributing Symvess or any other product;

•our limited experience in the commercial manufacturing of Symvess or any other product;

•reimbursement and coverage policies of government and private payors such as Medicare, Medicaid, group purchasing organizations, insurance companies, health maintenance organizations and other plan administrators;

•our ability to expand the current FDA-approved indications for Symvess into treatment of pediatric patients, treatment of a broader set of traumas, or indications outside of trauma;

•emergence of new AEs associated with Symvess once the product is in commercial use or data suggesting that known AEs are more frequent or severe than originally thought;

•changed or increased regulatory restrictions in the United States, EUEU, Israel and other foreign territories; and a lack of adequate financial or other resources to commercialize Symvess successfully.

There is no guarantee that the infrastructure, systems, processes, policies, relationships, and materials we have built for the launch and commercialization of our approved product in the United States will be sufficient for us to achieve success at the levels we expect. Even ourOur ability to generateincrease product revenuesales and become profitable from Symvess depends on our assumptions regarding the relevant market opportunity and the degree of market acceptance for Symvess, and if approved, our other products, for which our estimates may prove inaccurate, and market acceptance in any approved indication, which may never occur.

The commercial success of Symvess and our product candidates will depend, in part, on the acceptance of physicians, patients and health care payors, as medically necessary, cost-effective and safe. Symvess and any other product that we commercialize may not gain acceptance by physicians, patients, health care payors and others in the medical community due to ethical, social, medical, costcost, reputational and legal concerns. If these products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become profitable.

•the efficacy and potential advantages of Symvess or our product candidates compared with alternative products or methods, including convenience and ease of administration;

•the prices we charge for Symvess or our other products, if approved;

•the availability of third-party coverage and adequate reimbursement;

•the willingness of the target patient population to try new products and methods and of physicians to use these products and methods;

•the strength of marketing and distribution support;

•the availability of the product and our ability to meet market demand;

•the prevalence and severity of any side effects, or the emergence of new, previously unknown side effects; and any restrictions on the use of Symvess and our other products, if approved.

A number of factors may impact the timing of our preclinical and clinical programs and the development and commercialization of our product candidates. These include factors such as inability to recruit sufficient numbers of patients, delays in obtaining IRB approval for planned trials, or disagreements with regulatory agencies on clinical trial design and/or imposition of clinical holds. For instance, our proposed CABG clinical trial currently is on a clinical hold until we can provide batch testing data to the FDA for our smaller diameter ATEV. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all, or that they will be successful. Any inability to successfully complete development of our product candidates would likely result in significant additional costs to us, create delays in filing a BLA for regulatory approval of our product candidates and impair our ability to generate revenue.

We believe the novelty of our research and development efforts, which are focused on the development of bioengineered human, acellular, tissue-based vessels for use across a wide spectrum of applications in vascular surgery, augments this uncertainty. The scientific discoveries that form the basis for our efforts to develop our product candidates are relatively new, and the scientific evidence to support the feasibility of developing product candidates based on these discoveries is both preliminary and limited. At this time, Symvess has been approved in the United States in an initial indication, and none of our other product candidates have been approved in the United States, EuropeEurope, Israel, or in any other jurisdiction. The clinical trial requirements of the FDA and other regulatory agencies and the criteria these regulators use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential product. In addition, because of the nature of the ATEVs, many of our clinical trials are “open label,” meaning that both the patient and the investigator know whether the patient is receiving the investigational product candidate. These studies often require the use of historical control arms consisting of patients previously treated with alternative therapies in the normal course of medical care. Use of open label study designs further complicates the clinical development process. Because of these and other factors, we may experience substantial difficulties in agreeing with FDA and other regulatory authorities on clinical trial design.

Additionally, even though we received FDA approval for Symvess in certain types of trauma, we may face a number of difficulties if the results of our clinical trials for additional Symvess indications or for our product candidates are unfavorable, inconclusive, or only modestly favorable or if there are safety concerns, such as AEs or SAEs, which could include clotting, mechanical failure, immunological rejection or infection, that could outweigh potential benefits associated with such product candidates. This could result in:

•obtaining approval for indications or patient populations that are not as broad as intended or desired;

•obtaining approval with, or later becoming subject to, labelling that includes significant use or distribution restrictions or significant safety warnings;

•being subject to a REMS or equivalent requirement from a comparable foreign regulatory agency, to ensure that the benefits of a biological product outweigh its risks or to change the way the product is used;

•being required to perform additional clinical trials to support approval or comparability or being subject to additional post-marketing testing requirements;

•having regulatory authorities withdraw their approval of the product;

•being sued; or suffering damage to our reputation.

We are currently enrolling patients in several clinical trials, including in our V012 trial, which is a Phase 3 clinical trial comparing the safety and efficacy of our 6 millimeter ATEV to AV fistula for hemodialysis access in women.women, and may in the future enroll patients in other clinical trials. Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends in part on the rate at which we can recruit patients to participate in such trials. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA and other regulatory authorities, and as such our product candidates could be delayed or otherwise adversely affected. Patient enrollment and trial completion is affected by many factors including the:

•size of the patient population and process for identifying subjects;

•design of the trial protocol;

•inclusion and exclusion criteria;

•safety profile to date of the product candidate under study;

•perceived risks and benefits of the product candidate under study;

•availability of competing therapies and clinical trials;

•severity of the disease under investigation;

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our accompanying consolidated financial statements and related notes contained in Part II, Item 8 of this Annual Report on Form 10-K. Unless the context indicates otherwise, references in this Annual Report on Form 10-K to the “Company,” “Humacyte,” “we,” “us,” “our” and similar terms refer to Humacyte, Inc. (formerly known as Alpha Healthcare Acquisition Corp.) and its consolidated subsidiaries (including Humacyte Global, Inc.) following the Merger (defined below); references to “Legacy Humacyte” refer to Humacyte, Inc. prior to the Merger; and references to “AHAC” refer to Alpha Healthcare Acquisition Corp. prior to the Merger.

We are initially using our proprietary, scientific technology platform to engineer and manufacture ATEVs. On December 19, 2024, the FDA granted full approval for the ATEV under the brand name SymvessTMSymvess® for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible. Our ATEVs are designed to be easily implanted into any patient without inducing a foreign body response or leading to immune rejection. We are developing a portfolio, or “cabinet”, of ATEVs with varying diameters and lengths. The ATEV cabinet would initially target the vascular repair, reconstruction and replacement market, including use in vascular trauma, AV access for hemodialysis, and PAD. We are also developing a smaller diameter blood vessel, the ATEVCTEV for CABG and pediatric heart surgery. Over the longer term, we are developing our ATEV for the delivery of cellular therapies, including pancreatic islet cell transplantation to treat Type 1 diabetes (our BVP). We will continue to explore the application of our technology across a broad range of markets and indications, including the development of urinary conduit, trachea, esophagus and other novel cell delivery systems.

As of December 31, 2024,2025, our ATEVs have been implanted in approximately 601636 patients.patients in clinical studies as well as additional patients following the U.S. commercial launch of Symvess in the vascular trauma indication. In addition to extremity vascular trauma, we and our collaborators are currently conducting a Phase 3 and Phase 2 trialstrial of our 6 millimeter ATEV in AV access for hemodialysishemodialysis, and previously completed Phase 2 trials in PAD. We were granted Fast Track designation by the FDA for our 6 millimeter ATEV for use in AV access for hemodialysis in 2014. We also received the first RMAT designation from the FDA, for the creation of vascular access for performing hemodialysis, in March 2017. In May 2023, we were granted the RMAT designation for the ATEV for urgent arterial repair following extremity vascular trauma, and in June 2024, we were granted the RMAT designation for the ATEV for patients with advanced PAD. In addition, in 2018 our ATEV product candidate was assigned a priority designation by the Secretary of Defense under Public Law 115-92, enacted to expedite the FDA’s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel.

In September 2023, we announced positive topline results from our V005 Phase 2/3 trial in vascular trauma, and in December 2023, we filed a BLA for urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and autologous vein use is not feasible. In February 2024, the FDA accepted the BLA filing and granted priority review and set a PDUFA date of August 10, 2024. On August 9, 2024, the FDA informed us that it required additional time to complete its review of the BLA for the vascular trauma indication. On December 19, 2024, the FDA granted full approval for Symvess (acellular tissue engineered vessel-tyod) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. In February 2025, the FDA completed its required review of commercial batch information for Symvess and has authorized us to commence commercial shipments. We commenced commercial sales of Symvess in the vascular trauma indication in the first quarter of 2025.

WeSince its inception in 2004, we have generated no product revenue and incurred operating losses and negative cash flows from operations in each year since our inception in 2004.year. As of December 31, 20242025 and 2023,2024, we had an accumulated deficit of $686.0$726.8 million and $537.3$686.0 million, respectively, and working capital of $27.9$49.4 million and $64.8$27.9 million, respectively. Our operating losses were approximately $114.4$108.1 million and $100.0$114.4 million for the years ended December 31, 20242025 and 2023,2024, respectively. Net cash flows used in operating activities were $98.1$105.0 million and $73.3$98.1 million during the years ended December 31, 20242025 and 2023,2024, respectively. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We expect to incurcontinue incurring substantial operating losses and to experience negative cash flows from operations for the foreseeable future as we beginscale tothe commercializecommercialization of Symvess and advance our product candidates.

As of December 31, 2024,2025, we had cash and cash equivalents of $44.9$50.5 million and restricted cash of $50.4$0.4 million. SubsequentThe to December 31, 2024, in March 2025 we completed a public offering of common stock which provided approximately $46.6 million in net proceeds. We believe our cash and cash equivalents on handCompany will benot have sufficient liquidity to fund its operations forbeyond atone least 12 monthsyear from the date of this Annual Report on Form 10-K.10-K if the Company is unable to generate sufficient cash flows from commercial sales on a timely basis and/or obtain additional capital. See Note 1 —1, Organization and Description of BusinessBusiness, in the notes to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for additional information regarding this assessment.

Our need for additional capital will depend in part on the scope and costs of our development and commercial manufacturing activities,activities and on the results of our ongoing commercial sales efforts. WeSince recently receivedreceiving FDA approval to commercialize Symvess,Symvess butin the vascular trauma indication, we have not generated any$1.4 million in product revenue fromfor the saleyear ofended commercializedDecember products31, to date.2025. Our ability to generate sufficient product revenue to finance our operations will depend on the successful development and commercialization of Symvess and the advancement of our product candidates. Until such time, if ever, we expect to finance our operations primarily through the use of existing cash and cash equivalents, theprivate saleor ofpublic equity orfinancings, debt,debt borrowingsfinancings, underdebt credit facilities,refinancings or through potentialrestructurings, collaborations, other strategic transactionsalliances, and marketing, distribution or governmentlicensing and other grants.arrangements. Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we couldplan beto forcedimplement a program to delay, reduce, suspend or cease our planned capital expenditures, research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. See “Risk Factors” for additional information.

•commercializecontinue to generate revenue from sales of Symvess viain U.S.the marketUnited launchStates for indicationsthe indication in vascular trauma and, if approved, via U.S. market launch for the indication in AV access for hemodialysis;

•obtain marketing approval for our 6 millimeter ATEV in additional indications involving vascular repair, reconstruction and replacement, including in AV access for hemodialysis;

•scale out our manufacturing facility to the extent required to satisfy potential market demand for Symvess in the United States and our product candidates, following receipt of any regulatory approval;

•continue our preclinical and clinical development efforts;

•maintain, expand and protect our intellectual property portfolio;

•add operational, financial and management information systems and personnel to support, among other things, our product development and commercialization efforts and operations; and continue operating as a public company, which includes higher costs associated with hiring additional personnel, director and officer insurance premiums, audit and legal fees and expenses for compliance with public company reporting requirements under the Exchange Act and rules implemented by the SEC and The Nasdaq Stock Market LLC (“Nasdaq”).

OnAlso on March 25,19, 2025,2026, we entered into ancertain underwritingsecurities agreementpurchase withagreements, TDpursuant Securitiesto (USA)which LLC,we Barclaysagreed Capitalto Inc.issue and BTIG, LLC, as representatives of the several underwriters named therein, relatingsell to thecertain issuance and saleinvestors in ana underwrittenregistered direct offering (the “Public Offering”) of 25,000,000 shares of Common Stock, at a price to the public of $2.00 per share (the “Firm Shares”). The Company also granted the underwriters a 30-day option to purchase up to an additional 3,750,000 shares of Common Stock at the samea price asof the$0.80 Firmper Shares.share. The net proceeds to us from the Public Offering were approximately $46.6$18.4 millionmillion, after deducting underwritingthe discountsplacement andagent’s commissionsfees and estimated Publicoffering Offeringexpenses expenses.payable by us. The Public Offeringoffering closed on March 27,20, 2025.2026.

ToDuring date,the fiscal year of 2025, we have notgenerated generated$1.4 million in product revenue from the sale of anySymvess. products.The Allremainder of our revenue has been derived from government and other grants.contracts. From inception through December 31, 2024,2025, we have been awarded grants, including grants from the California Institute of Regenerative Medicine (“CIRM”), NIH, and the DoD, to support our development, production scaling and clinical trials of our product candidates. We may generate revenue in the future from government and other grants, payments from future license or collaboration agreements and, if any of our product candidates receive marketing approval, from product sales. We expect that any revenue we generate will fluctuate from quarter to quarter. If we fail to complete the development of, or obtain marketing approval for, our product candidates in a timely manner, our ability to generate future revenue, and our results of operations and financial position, would be materially adversely affected.

SincePrior to our inception,recent shift in focus to the sale of Symvess for the vascular trauma indication, we have focusedhistorically focused, and continue to focus a substantial portion of our resources on our research and development activities, including conducting preclinical studies and clinical trials, developing and refining our manufacturing process and activities related to regulatory filings for our product candidates. We recognize research and development expenses as they are incurred. Our research and development expenses consist primarily of:

•salaries and related overhead expenses for personnel in research and development functions, including stock-based compensation and benefits;

•fees paid to CROs and consultants, including in connection with our clinical trials, and other related clinical trial fees, such as for clinical site fees and investigator grants related to patient screening and treatment, conduct of clinical trials, laboratory work and statistical compilation and analysis;

•allocation of facility lease and maintenance costs;

•depreciation of leasehold improvements, laboratory equipment and computers;

•costs related to purchasing raw materials and producing our product candidates for clinical trials;

•costs related to compliance with regulatory requirements;

•costs related to our manufacturing development and expanded-capabilities initiatives; and license fees related to in-licensed technologies.

•the scope, rate of progress, expense and results of our preclinical development activities, our ongoing clinical trials and any additional clinical trials that we may conduct, and other research and development activities;

•successful patient enrollment in and the initiation and completion of clinical trials;

•the timing, receipt and terms of any marketing approvals from applicable regulatory authorities including the FDA and non-U.S. regulators;

•the extent of any required post-marketing approval commitments to applicable regulatory authorities;

•development and refinement of clinical and commercial manufacturing capabilities or making arrangements with third-party manufacturers in order to ensure that it or its third-party manufacturers are able to successfully manufacture our product;

•obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;

•significant and changing government regulations;

•launching commercial sales of Symvess and our product candidates, if approved, whether alone or in collaboration with others;

•the degree of market acceptance of Symvess and any product candidates that obtain marketing approval; and maintaining a continued acceptable safety profile following approval of Symvess in the vascular trauma indication and in any other indications for which approval may be granted, or for any of our product candidates, if approved.

Total other income (expense), net consists of (i) the change in fair value of the Contingent Earnout Liability that was accounted for as a liability as of the date of the Merger,Merger and is remeasured to fair value at each reporting period, resulting in a non-cash gain or loss, (ii) interest income earned on our cash and cash equivalents and short-term investments, (iii) interest expense incurred on theour PurchaseTerm AgreementLoan (defined below),Facility, finance leases, and our former loanPurchase agreement with SVBAgreement during the periods each were outstanding, (iv) the change in fair value of our derivative liabilities and assetassets, including the private placement Common Stock warrant liabilities related to the Private Placement Warrants, which we assumed in connection with the Merger; Common Stock warrant liabilities related to our Registered Direct Offerings; the warrant liability related to the Loan Agreement; the former contingent derivative liability related to the terminated Purchase Agreement; a former liability related to a freestanding option agreement related to the terminated Purchase Agreement; a derivative liability related to our agreement with JDRF; (defineda below)derivative liability related to the Loan Agreement; and a derivative asset related to our Common Stock Purchase Agreement (defined below),Agreement, all of which are subject to remeasurement to fair value at each balance sheet date each liability is outstanding, resulting in a non-cash gain or loss, and (v) a loss on debt extinguishment related to the prepaymenttermination of ourthe loanPurchase agreement with Silicon Valley BankAgreement in MayDecember 2023, and (vi) an employee retention credit we recognized in June 2023.2025.

General and administrative expenses were $25.8$31.2 million and $23.5$25.8 million for the years ended December 31, 20242025 and 2023,2024, respectively. The increase in general and administrative expenses during the year ended December 31, 20242025 of $2.3$5.4 million, or 10%,21%, compared to the year ended December 31, 20232024 was primarily driven by preparation for our plannedthe commercial launch of the ATEV in vascular trauma.Symvess. Major changes in expenses included a $2.6$5.3 million increase in salaries and benefits due to the recruitment and hiring of a sales force for Symvess and other expansion of the commercial team, and a $1.3$0.8 million increase in professional fees, partially offset by a $1.8$1.4 million decrease in non-cashexternal stockservices compensationand expense.consulting expenses.

Total other expense,income, net was $67.3 million for the year ended December 31, 2025, compared to net expense of $34.3 million for the year ended December 31, 2024, compared to net expense of $10.7 million for the year ended December 31, 2023.2024. The increase in net expenseincome of $23.6$101.6 million primarily resulted from a $23.0$127.4 million increase in the non-cash lossgains resultingconsisting fromof thea $92.5 million fair value remeasurement of the Contingent Earnout Liability duringand each$34.9 year.million fair value remeasurement of derivative liabilities, partially offset by $22.3 million loss on extinguishment of debt related to the Purchase Agreement termination.

Although we are a commercial-stage biotechnology platform company, we have a single product approved for commercial sale and have generated $1.4 million in product revenue for the period ended December 31, 2025. We have historically financed our operations primarily through the sale of equity securities and convertible debt, including pursuant to the Offering (as defined below) and Registered Direct Offerings we completed in October and November 2024, proceeds from the Merger and related PIPE Financing (as defined in Note 14 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K), borrowings under loan facilities, including the Term Loan Facility, the Purchase Agreement (defined below),Agreement, and, to a lesser extent, through grants from governmental and other agencies. Since our inception, we have incurred significant operating losses and negative cash flows. As of December 31, 20242025 and 2023,2024, we had an accumulated deficit of $686.0$726.8 million and $537.3$686.0 million, respectively.

As of December 31, 20242025 and 2023, we had working capital of $27.9 million and $64.8 million, respectively. As of December 31, 2024 and 2023,2024, we had cash and cash equivalents of $44.9$50.5 million and $80.4$44.9 million, respectively, and restricted cash of $50.4$0.4 million and $0.4$50.4 million, respectively. We funded the restricted cash account on August 14, 2024, in accordance with ourthe amendedsecond amendment to the Purchase Agreement (definedthe below“Purchase Agreement Amendment”), of which $50.0 million iswas not subject to our unilateral control. On September 17, 2025, in connection with the Purchase Agreement Amendment, we made a $50.0 million repayment under the Purchase Agreement (the “Purchase Agreement Amendment Payment”), funded from the restricted cash previously maintained for the benefit of the Agent. As a result of the Purchase Agreement Amendment Payment, we were no longer obligated to maintain $50.0 million of restricted cash in an account for the benefit of the Agent.

On May 12, 2023, we entered into a Revenue Interestthe Purchase Agreement (with the “PurchasePurchasers Agreement”)and withanother two purchasers (the “Purchasers”), both affiliatesaffiliate of Oberland Capital Management LLC (“Oberland”), and another affiliate of Oberland,LLC, as agent for the Purchasers (the “Agent”), to obtain financing in respect to the further development and commercialization of our ATEV, to repay our then outstanding credit facility with SVB, and for other general corporate purposes.Agent. Pursuant to the Purchase Agreement, and subject to customary closing conditions, the Purchasers purchased certain revenue interests (the “Revenue Interests”) from us in exchange for an aggregate investment amount of up to $150.0 million (the “Investment Amount”).million. Under the terms of the Purchase Agreement, $40.0 million of the Investmentinvestment Amount,amount, less certain transaction expenses, was funded on May 12, 2023, whichand was used to repay in full all and retire our indebtedness under our loan agreement with SVB,Silicon Valley Bank, with the remaining proceeds funded to the Company. On March 11, 2024, an additional $20.0 million of the Investment Amount was funded to the Company.Company under the Purchase Agreement. On May 8, 2024, we agreed with the Purchasers to amend the Purchase Agreement to remove requirements related to the leasehold mortgage, and, in connection therewith, on August 14, 2024, we funded an account in the amount of $54.0 million, over which the Agent had certain consent and other rights to $50.0 million of the funds. On September 17, 2025, we entered into an amendment to the Purchase Agreement pursuant to which we made a $50.0 million repayment under the Purchase Agreement, funded from restricted cash maintained for the benefit of the Agent. On December 19, 2024, the FDA granted full approval forof our BLA for the vascular trauma indication, and we didelected not elect to draw the additional $40.0 million that became available under the Purchase Agreement. As of and subsequent to December 31, 2024, we arewere not entitled to draw on any further installments under the Purchase Agreement. SeeOn NoteDecember 615, 2025, we entered into a payoff letter with the Purchasers and the Purchasers’ agent pursuant to ourwhich accompanyingthe consolidatedPurchase financialAgreement statementsand the related Option Agreement were terminated in Parttheir II,entirety. ItemAs 8consideration for the termination of thisthese Annualagreements Reportand onthe Formsatisfaction 10-Kof forall additionalobligations detailsthereunder, aboutwe thispaid financing$38.0 transaction.million in cash and issued 5,725,190 shares of our Common Stock to the Purchasers.

On February 29, 2024, we entered into an underwriting agreement with TD Cowen and Company, LLC and Cantor & Fitzgerald & Co., as representatives of the several underwriters named therein, relating to the issuance and sale in an underwritten offering (the “Offering”) of 15,410,000 shares of our Common Stock at a price to the public of $3.00 per share. The net proceeds to us from the Offering were approximately $43.0 million, after deducting underwriting discounts and commissions and Offering expenses. The Offering closed on March 5, 2024.

On September 24, 2024, we entered into the Common Stock Purchase Agreement with Lincoln Park for an equity line financing, which provides that, subject to the terms and conditions set forth in the Common Stock Purchase Agreement, we have the sole right, but not the obligation, to sell to Lincoln Park shares of Common Stock having an aggregate value of up to $50.0 million over a 24-month period. We control the timing and amount of any sales to Lincoln Park. As of December 31, 2024,2025, we had completed sales of shares under the Common Stock Purchase Agreement that provided $2.5 million in gross proceeds. As of MarchDecember 31, 2025, we had $47.5 million in remaining availability for sales of our Common Stock under our Common Stock Purchase Agreement with Lincoln Park.

On October 4, 2024, we entered into a securities purchase agreement with an institutional investor pursuant to which the investor purchased approximately $30.0 million worth of Common Stock and warrants in the October 2024 Registered Direct Offering (as defined belowin Note 10). The net proceeds to us from the October 2024 Registered Direct Offering were approximately $28.0 million, after deducting placement agent’s fees and offering expenses of approximately $2.0 million. The October 2024 Registered Direct Offering closed on October 7, 2024.

Our risk factors are disclosed in Part I, Item 1A of our Annual Report. The risk factors set forth below supplement those disclosures and should be read together with the risk factors in our Annual Report. Except as set forth below, there have been no material changes to the risk factors previously disclosed in our Annual Report during the threesix months ended MarchJune 31,30, 2026 .

On MayJuly 4,31, 2026, we received a letter from the staff of The Nasdaq Stocknotifying Market LLC providing notificationus that, for the 30 consecutive business days ended MayJuly 1,30, 2026, the closing bid price forof the Company’sour Common Stock had closedwas below the minimum $1.00 per share requirement for continued listing on The Nasdaq Global Select Market under Nasdaq Listing Rule 5450(a)(1). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been provided an initial period of 180 calendar days, or until NovemberJanuary 2,27, 2026,2027, to regain compliance. To regain compliance, the closing bid price of theour Common Stock must be $1.00 per share or more for a minimum of 10 consecutive business days at any time before NovemberJanuary 2,27, 2026.2027. ThisThe notice has no immediate effect on the listing of theour Common Stock, which continues to trade on The Nasdaq Global Select Market under the symbol “HUMA,” or on our business operations or reporting obligations with the SEC. If we regain compliance, Nasdaq will provide us with written confirmation and will close the matter.

If we do not regain compliance during the initial compliance period, Nasdaq may issue a delisting determination with respect to our Common Stock, which could result in the delisting of our Common Stock from Nasdaq. We intend to monitor the bid price of the Common Stock and will consider options available to us to achieve compliance. However, there can be no assurance that we will regain compliance within the applicable compliance period or otherwise maintain compliance with Nasdaq’s continued listing requirements. Additionally, it is possible that the Public Warrants will be subject to delisting by Nasdaq if they do not satisfy applicable Nasdaq requirements. If our Common Stock or the Public Warrants areis delisted from Nasdaq, the market liquidity for our Common Stock or the Public Warrants could be adversely affected and the trading price of our Common Stock or the Public Warrants could decline. A delisting could also make it more difficult for us to raise additional capital on acceptable terms, or at all, which could adversely affect our business, financial condition and results of operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q (“Quarterly Report”) and with our audited financial statements and the notes thereto included in our Annual Report. In addition, you should read the “Risk Factors” and “Information Regarding Forward-Looking Statements” sections of this Quarterly Report and our Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

We are initially using our proprietary, scientific technology platform to engineer and manufacture ATEVs. On December 19, 2024, the FDA granted full approval for the ATEV under the brand name Symvess® for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. Our ATEVs are designed to be easily implanted into any patient without inducing a foreign body response or leading to immune rejection. We are developing a portfolio, or “cabinet,” of ATEVs with varying diameters and lengths. The ATEV cabinet would initially target the vascular repair, reconstruction and replacement market, including use in vascular trauma, AV access for hemodialysis and PAD. We are also developing the ATEV for coronary artery bypass grafting (“CABG”) and pediatric heart surgery. Over the longer term, we are developing our ATEV for the delivery of cellular therapies, including pancreatic islet cell transplantation to treat Type 1 diabetes (our BioVascular Pancreas or BVP). We will continue to explore the application of our technology across a broad range of markets and indications, including the development of urinary conduit, trachea, esophagus and other novel cell delivery systems.

In addition to extremity vascular trauma, we and our collaborators are currently conducting Phase 3 and Phase 2 trials of our 6 millimeter ATEV in AV access for hemodialysis and PAD. We were granted Fast Track designation by the FDA for our 6 millimeter ATEV for use in AV access for hemodialysis in 2014. We also received the first Regenerative Medicine Advanced Therapy (“RMAT”) designation from the FDA, for the creation of vascular access for performing hemodialysis, in March 2017. In May 2023, we were granted the RMAT designation for the ATEV for urgent arterial repair following extremity vascular trauma, and in June 2024, we were granted the RMAT designation for the ATEV for patients with advanced PAD. In addition, in 2018 our ATEV product candidate was assigned a priority designation by the Secretary of Defense under Public Law 115-92, enacted to expedite the FDA’s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel.

In April 2023, we announced completion of enrollment of our V007 Phase 3 trial of the ATEV for use in AV access for hemodialysis. In July 2024, we announced positive topline results from our V007 Phase 3 trial,trial of the ATEV for use in AV access, where the ATEV met the primary endpoints in the study. IfIn theJune 2026, we announced positive interim results from our ongoing V012 Phase 3 trial in womenwomen, areshowing positive,that wethe ATEV achieved superior catheter-free days compared to AV fistula, the primary endpoint in the study. We plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026.

On April 21, 2026, we entered into the Third Amendment to our distribution agreement with Fresenius Medical Care. Pursuant to the amendment, we have the sole right to develop and commercialize, and conduct all regulatory matters relating to, the Distribution Product (as defined in the distribution agreement, as amended) on a worldwide basis. In connection with the reversion of ex-U.S. rights to us, we will pay Fresenius Medical Care low-single-digit royalties on net sales of the Distribution Product outside the United States, subject to a two-year royalty-free period following launch of the Distribution Product in each applicable country. We will continue to pay royalties on net sales of the Distribution Product in the United States at rates ranging from mid-single digits to low double digits, and Fresenius Medical Care remains obligated to support adoption of the Distribution Product as a standard of care in hemodialysis patients for which such use is supported by clinical results and health economic analyses.

We have incurred operating losses and negative cash flows from operations in each year since our inception in 2004. As of MarchJune 31,30, 2026 and December 31, 2025, we had an accumulated deficit of $744.5$781.3 million and $726.8 million, respectively, and working capital of $47.4$77.8 million and $49.4 million, respectively. Our operating losses were approximately $28.9$55.9 million and $23.2$52.9 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively.

Net cash flows used in operating activities were $25.1$47.2 million and $28.6$55.0 million during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations. We expect to incur substantial operating losses and negative cash flows from operations for the foreseeable future as we begincontinue to commercialize Symvess and advance our product candidates.

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $48.5$79.9 million and restricted cash of $0.4 million.

Our need for additional capital will depend in part on the scope and costs of our development and commercial manufacturing activities and on the results of our ongoing commercial sales efforts. Since receiving FDA approval to commercialize Symvess in the vascular trauma indication, we generated $0.5product revenue of $0.4 million and $0.9 million for the three and six months ended June 30, 2026, respectively, and $1.4 million in product revenue for the three months ended March 31, 2026, and twelve months ended December 31, 2025, respectively.2025. Our ability to generate sufficient product revenue to finance our operations will depend on the successful commercialization of Symvess and the advancement of our product candidates. Until such time, if ever, we expect to finance our operations primarily through the use of existing cash and cash equivalents, private or public equity financings, debt financings, debt refinancings or restructurings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements. Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we plan to implement a program to delay, reduce, suspend or cease our planned capital expenditures, research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. See “Risk Factors” for additional information.

As further disclosed in Note 12, Subsequent Events, to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report, onOn April 21, 2026, we entered into the Third Amendment to the distribution agreement with Fresenius Medical Care. Pursuant to the amendment, we have the sole right to develop and commercialize, and conduct all regulatory matters relating to, the Distribution Product (as defined in the distribution agreement, as amended) on a worldwide basis. In connection with the reversion of ex-U.S. rights to us, we will pay Fresenius Medical Care low-single-digit royalties on net sales of the Distribution Product outside the United States, subject to a two-year royalty-free period following launch of the Distribution Product in each applicable country. We will continue to pay royalties on net sales of the Distribution Product in the United States at rates ranging from mid-single digits to low double digits, and Fresenius Medical Care remains obligated to support adoption of the Distribution Product as a standard of care in hemodialysis patients for which such use is supported by clinical results and health economic analyses.

Also, as further disclosed in Note 12, inIn May 2026, we implemented a plan to reduce our workforce by approximately 45 employees, defer additional planned new hires, and reduce other operating expenses. These reductions have been implemented thoughtfully, and we have retained key personnel, resources, and initiatives to meet our key corporate goals and milestones. We estimate that we will incur aggregate charges of approximately $0.8 million representing one-time cash expenditures for severance and other employee termination benefits, of which the majority ishas expected to bebeen incurred during the second quarter of 2026. We estimate net savings due to the workforce reductions and operating cost reductions, net of termination severance and benefits, totaling approximately $14.3 million during the remainder of 2026.million.

Prior to the recent commercialization of the ATEVs in the vascular trauma indication, all of our revenue was derived from government and other grants. During the three and six months ended MarchJune 31,30, 2026 and 2025,2026, we have generated $0.5$0.4 million and $0.1$0.9 million, respectively, in product revenue from the salesales of Symvess.Symvess, compared with $0.1 million and $0.2 million, respectively, for the three and six months ended June 30, 2025. The remainder of our revenue has been derived from contracts. From inception through MarchJune 31,30, 2026, we have been awarded grants, including grants from the California Institute of Regenerative Medicine, the National Institutes of Health, and the Department of Defense, to support our development, production scaling and clinical trials of our product candidates.

Cost of goods sold consists of manufacturing costs associated with the production of Symvess, including materials, direct labor and manufacturing-related overhead. Cost of goods sold also includes royalty expense related to product sales, overhead associated with unused production capacity, and inventory reserves recorded to adjust inventory to its estimated net realizable value. Prior to FDA approval of Symvess for the vascular trauma indication in December 2024, manufacturing and material costs incurred in connection with product development were expensed as research and development costs as incurred, as commercialization and future economic benefit were not yet considered probable. Beginning in 2025, following commercialization of Symvess, certain manufacturing-related payroll and overhead costs previously included within research and development expenses were capitalized to inventory and recognized in cost of goods sold as product is sold. During the three and six months ended MarchJune 31,30, 2026, we recorded an inventory reserve to adjust certain inventory balances to the estimated net realizable value, which is reflected within cost of goods sold in the condensed consolidated statements of operations and comprehensive (loss) income.

The majority of our research and development resources are currently focused on our Phase 2 and 3 clinical trials for our 6 millimeter ATEV andATEV, other work needed to obtain marketing approval for our 6 millimeter ATEV for use in AV access in hemodialysishemodialysis, and PADpreparation for a planned Phase 2a study of the 3.5 millimeter coronary tissue engineered vessel (CTEV) in thecoronary Unitedartery States.bypass grafting (CABG). We have incurred and expect to continue to incur significant expenses in connection with these and our other clinical development efforts, including expenses related to regulatory filings, trial enrollment and conduct, data analysis, patient follow up and study report generation for our Phase 2 and Phase 3 clinical trials.

Direct expenses for our vascular trauma,trauma and AV access for hemodialysis and PAD indications include costs related to our clinical trials, including fees paid to CROs, consultants, clinical sites and investigators. Costs related to development activities which broadly support multiple programs using our technology platform, including personnel, materials and supplies, external services costs, and other internal expenses, such as facilities and overhead costs, are not allocated to individual research and development programs. Other research and development expenses include direct costs not identifiable with a specific product candidate, including costs associated with our research and development platform used across programs, process development, manufacturing analytics and preclinical research and development for prospective product candidates and new technologies.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Total revenue was $0.5$0.4 million for the three months ended MarchJune 31,30, 2026, compared towith $0.5$0.3 million revenue for the three months ended MarchJune 31,30, 2025. Revenue for the three months ended MarchJune 31,30, 2026 consisted primarily of product revenue from sales of Symvess in the United States. Revenue for the three months ended MarchJune 31,30, 2025 consisted of $0.1 million of product revenue from sales of Symvess in the United States and $0.4$0.2 million of revenue earned related to research and development services pursuant to a research contract with a large medical technology company.

Cost of goods sold was $2.0$1.2 million for the three months ended MarchJune 31,30, 2026, compared to $0.1$0.2 million for the three months ended MarchJune 31,30, 2025. During the three months ended MarchJune 31,30, 2026, cost of goods sold included a $1.6$0.7 million inventory reserve recorded to reduce certain inventory balances to theirits estimated net realizable valuevalue, $0.1 million in connectioncosts associated with the initial commercialization of Symvess, excess capacity recorded as an expense,capacity, and royaltyroyalties expense related toon product sales.

The following table discloses the breakdown ofpresents research and development expenses for the periods indicated:

Research and development expenses were $19.5$18.1 million for the three months ended MarchJune 31,30, 2026, representinga an increasedecrease of $4.0$3.9 million, or 26%,18%, fromcompared $15.4with $22.0 million for the three months ended MarchJune 31,30, 2025. The increasedecrease was primarily drivenattributable to a $4.9 million reduction in materials and supplies expense, which was higher in the prior-year period due to non-commercial manufacturing production runs. The decrease was partially offset by a $4.3$1.5 million increase in materials,other research and development expenses, primarily from non-commercial manufacturing runs associated with the CTEV and process improvement designeddue to reducea cost of goods sold going forward, and supplies expense, partially offset by $0.8$1.6 million decrease in externalthe services.capitalization of manufacturing overhead costs in the current-year period resulting from fewer manufacturing runs compared to the prior-year period.

General and administrative expenses were $7.9comparable at $8.0 million and $8.1$7.8 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively, and were relatively flat year-over-year.respectively.

Total other income,expense, net was $11.3$9.8 million for the three months ended MarchJune 31,30, 20262026, compared towith total other income, net of $62.3$7.9 million for the three months ended MarchJune 31,30, 2025. The $51.0$1.9 million decreaseexpense in other income, netincrease was primarily drivenattributable to a $4.4 million increase in the non-cash loss from the fair value remeasurement of derivative liabilities, partially offset by lowera $2.8 million non-cash gains, including a $45.0 million decreasegain from the fair value remeasurement of the Contingent Earnout Liability and a $6.4 million decrease from the fair value remeasurement of derivative liabilities.Liability.

Although we are a commercial-stage biotechnology platform company, we have a single product approved for commercial sale and have generated $0.5$0.4 million and $1.4$0.9 million,million respectively, inof product revenue from the salesales of Symvess during the three months ended March 31, 2026 and twelvesix months ended DecemberJune 31,30, 20252026, respectively.respectively, compared with $0.1 million and $0.2 million, respectively, for the three and six months ended June 30, 2025.

We have historically financed our operations primarily through the sale of equity securities and convertible debt, borrowings under loan facilities, including the Term Loan Facility, the Purchase Agreement, and, to a lesser extent, through grants from governmental and other agencies. Since our inception, we have incurred significant operating losses and negative cash flows. As of MarchJune 31,30, 2026 and December 31, 2025, we had an accumulated deficit of $744.5$781.3 million and $726.8 million, respectively.

As of MarchJune 31,30, 2026 and December 31, 2025, we had working capital of $47.4$77.8 million and $49.4 million, respectively. As of MarchJune 31,30, 2026 and December 31, 2025, we had cash and cash equivalents of $48.5$79.9 million and $50.5 million, respectively, and restricted cash of $0.4 million as of both dates.

We will not have sufficient liquidity to fund our operations beyond one year from the issuance of these interim financial statements if we are unable to generate sufficient cash flows from commercial sales on a timely basis and/or obtain additional capital. These factors raise substantial doubt about our ability to continue as a going concern. Our future viability is dependent on our ability to generate cash flows from the sale of Symvess and raise additional capital to finance our operations. As further disclosed in Note 12,10, in May 2026, we implemented a plan to reduce our workforce by approximately 45 employees, defer additional planned new hires, and reduce other operating expenses. These reductions have been implemented thoughtfully, and we have retained key personnel, resources, and initiatives to meet our key corporate goals and milestones. We plan to seek additional funding through private or public equity financings, debt financings, debt refinancings or restructurings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements. Adequate additional capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we plan to implement a program that delays, reduces, suspends or ceases certain of our planned capital expenditures, research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. The accompanying unaudited condensed consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q have been prepared assuming that we will continue as a going concern and contemplate the realization of assets and the satisfaction of liabilities in the normal course of business. The accompanying condensed consolidated financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities or any other adjustments that might be necessary should we be unable to continue as a going concern. See Note 1, Organization and Description of Business, to our accompanying condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information regarding this assessment.

On September 24, 2024, we entered into the Common Stock Purchase Agreement with Lincoln Park for an equity line financing, which provides that, subject to the terms and conditions set forth in the Common Stock Purchase Agreement, we have the sole right, but not the obligation, to sell to Lincoln Park shares of Common Stock having an aggregate value of up to $50.0 million over a 24-month period. We control the timing and amount of any sales to Lincoln Park. As of MarchJune 31,30, 2026, we had completed sales of shares under the Common Stock Purchase Agreement that provided $2.5 million in gross proceeds, and as of MarchJune 31,30, 20262026, we had $47.5 million in remaining availability for sales of our Common Stock under our Common Stock Purchase Agreement with Lincoln Park.

On December 15, 2025, we entered into the Loan Agreement with Avenue Venture Opportunities Fund II, L.P., as administrative agent and collateral agent for the lenders, which provides for a Term Loan Facility of up to $77.5 million in the aggregate that matures on December 1, 2029. The Term Loan AgreementFacility consists of (i) an initial term loan of $40.0 million, which was fully funded on December 15, 2025, (ii) a $12.5 million delayed draw term loan which will be made available between October 1, 2026 and March 31, 2027, subject to the satisfaction of certain revenue, regulatory approval and liquidity conditions, and (iii) a $25.0 million delayed draw term loan which will be made available at the discretion of the lenders between July 1, 2027 and June 30, 2028, subject to the satisfaction of certain revenue, regulatory approval and liquidity conditions. The proceeds from the initial term loan were used primarily to repay the remaining obligations under the Purchase Agreement, as discussed below.

On September 1, 2022, we entered into a sales agreement with Jefferies LLC, acting as sales agent (the “Jefferies ATM Sales Agreement”), for the sale from time to time of up to $80.0 million of shares of Common Stock (the “Jefferies ATM Facility”). During the threesix months ended MarchJune 31,30, 2025, we sold an aggregate of 75,7931,299,870 shares of Common Stock under the Jefferies ATM Facility at an average price of $5.04$2.86 per share for net proceeds of approximately $0.4$3.6 million after deducting sales commissions of approximately $0.1 million. On November 21, 2025, we delivered a notice to Jefferies LLC terminating the Jefferies ATM Sales Agreement, which termination became effective 10 days thereafter.

On December 16, 2025, we entered into a sales agreement with TD Cowen, acting as sales agent (the “TD Cowen ATM Facility”), pursuant to which we may sell shares of Common Stock from time to time up to an aggregate offering price of $60.0 million. During the threesix months ended MarchJune 31,30, 2026, we sold an aggregate of 4,018,497 shares of Common Stock under the TD Cowen ATM Facility at an average price of $1.16 per share for net proceeds of approximately $4.6 million. All such sales occurred during the first quarter of 2026. On March 19, 2026, we suspended and terminated the ATM Prospectus pursuant to which shares had been sold under the TD Cowen ATM Facility.

Our known material cash requirements include: (1) the purchase of supplies and services that are primarily for research and development; (2) manufacturing and commercialization expenditures; (3) employee wages, benefits, and incentives; (4) financingfinance lease payments (for additional information see below),; and (5) debt service obligations under our senior secured Term Loan Facility (for additional informationinformation, see below and Note 6, Debt, to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report). We have also entered into contracts with CROs primarily for clinical trials. These contracts generally provide for termination upon limited notice, and therefore we believe that our non-cancellable obligations under these agreements are not material. Moreover, we may be subject to additional material cash requirements that are contingent upon the occurrence of certain events, for example, legal contingencies, uncertain tax positions, and other matters.

As of MarchJune 31,30, 2026, we had non-cancellable purchase commitments of $27.8$22.3 million for supplies and services that are primarily for research and development. We have existing license agreements with Duke University and Yale University, a distribution agreement with Fresenius Medical Care and our JDRF Agreement. The amount and timing of any potential milestone payments, license fee payments, royalties and other payments that we may be required to make under these agreements are unknown or uncertain at MarchJune 31,30, 2026. For additional information regarding our agreement with Fresenius Medical Care, see Note 11, Related Party Transactions, to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report. For additional information regarding our agreements with Duke University, Yale University and JDRF, see Note 10 to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report.

Our finance lease relates to our headquarters facility containing our manufacturing, research and development and general and administrative functions, which was substantially completed in June 2018. Our future contractual obligations under our lease agreement as of MarchJune 31,30, 2026 are as follows:

We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) continue to sell Symvess for the vascular trauma indication and seek marketing approval for Symvess in additional indications and for our product candidates in the United States and to obtain marketing approval for our 6 millimeter ATEV outside of the United States,States; (ii) continue clinical development of our 6 millimeter ATEV for use in AV access for hemodialysis and submit a BLA for FDA approval of an indication in AV access for hemodialysis,hemodialysis; (iii) advance our pipeline in major markets, including PAD Phase 3 trials and continue preclinical development and advance to planned clinical studies in CABG and BVP for diabetes,diabetes; and (iv) scale out our manufacturing facility as required to satisfy market demand. We will need additional funding in connection with these activities.

Until such time, if ever, as we are able to successfully commercialize Symvess and to develop and commercialize our product candidates, we expect to continue financing our operations through theequity salefinancings, of equity, debt,debt financings, debt refinancings or restructurings or through potential collaborations with other companies, other strategic transactions or government or other grants. Adequate capital may not be available to us when needed or on acceptable terms. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures. Debt financing would also result in additional fixed payment obligations. If we are unable to raise capital, we plan to implement a program that delays, reduces, suspends or ceases our planned capital expenditures, research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition.

Our principal use of cash in recent periods has been primarily to fund our operations, including the clinical and preclinical development of our product candidates. Our future capital requirements, both short-term and long-term, will depend on many factors, including the progress and results of our clinical trials and preclinical development, timing and extent of spending to support development efforts, cost and timing of future commercialization activities, and the amount and timing of revenues that we receive from commercial sales.