Item 7. Management’s Discussion and Analysis of 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 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 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.
Cautionary Statement Regarding Forward-Looking Statements
In addition to historical information, some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business, future financial performance, expense levels and liquidity sources, includes forward-looking statements that involve risks and uncertainties. You should read the sections of this Annual Report on Form 10-K titled “Forward-Looking Statements” and “Risk Factors” 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.
Overview
We are a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, and in the first quarter of 2025 commenced the United States commercial launch of our first FDA-approved product. We are pioneering the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues, advanced tissue constructs and organ systems with the goal of improving the lives of patients and transforming the practice of medicine. We believe our regenerative medicine technology has the potential to overcome limitations in existing standards of care and address the lack of significant innovation in products that support tissue repair, reconstruction and replacement. We are leveraging our novel, scalable technology platform to develop proprietary bioengineered, acellular human tissues for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas.
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 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 CTEV 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.
For the ATEV, we believe there is substantial clinical demand for safe and effective vascular conduits to replace and repair blood vessels throughout the body. Vascular injuries resulting from trauma are common in civilian and military populations, frequently resulting in the loss of either life or limb. Existing treatment options in the vascular repair, reconstruction and replacement market include the use of autologous vessels and synthetic grafts, which we believe suffer from significant limitations. For example, the use of autologous veins to repair traumatic vascular injuries can lead to significant morbidity associated with the surgical wounds created for vein harvest and prolonged times to restore blood flow to injured limbs, leading to an increased risk of complications such as amputation and reperfusion injury. In addition, in many instances of vascular trauma the patient may not have adequate vein available, or the time between injury and treatment is too long to make autologous graft repair feasible. Synthetic grafts are often contraindicated in the setting of vascular trauma due to wound contamination that contributes to higher infection risk that can lead to prolonged hospitalization and limb loss. Given the competitive advantages
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our ATEVs are designed to have over existing vascular substitutes, we believe that ATEVs have the potential to become the standard of care and lead to improved patient outcomes and lower healthcare costs.
As of December 31, 2025, our ATEVs have been implanted in approximately 636 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 are currently conducting a Phase 3 trial of our 6 millimeter ATEV in AV access for hemodialysis, 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.
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.
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, where the ATEV met the primary endpoints in the study. Dependent upon interim results from our ongoing V012 Phase 3 trial in women, 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.
Since its inception in 2004, we have incurred operating losses and negative cash flows from operations in each year. As of December 31, 2025 and 2024, we had an accumulated deficit of $726.8 million and $686.0 million, respectively, and working capital of $49.4 million and $27.9 million, respectively. Our operating losses were approximately $108.1 million and $114.4 million for the years ended December 31, 2025 and 2024, respectively. Net cash flows used in operating activities were $105.0 million and $98.1 million during the years ended December 31, 2025 and 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 continue incurring substantial operating losses and to experience negative cash flows from operations for the foreseeable future as we scale the commercialization of Symvess and advance our product candidates.
As of December 31, 2025, we had cash and cash equivalents of $50.5 million and restricted cash of $0.4 million. The Company will not have sufficient liquidity to fund its operations beyond one year from the date of this Annual Report on Form 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, Organization and Description of Business, 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 and on the results of our ongoing commercial sales efforts. Since receiving FDA approval to commercialize Symvess in the vascular trauma indication, we have generated $1.4 million in product revenue for the year ended December 31, 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
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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.
We expect to continue to incur significant expenses and to increase operating losses for at least the next several years. We anticipate that our expenses will increase substantially as we seek to:
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continue to generate revenue from sales of Symvess in the United States for the indication in vascular trauma and, if approved, via U.S. market launch for the indication in AV access for hemodialysis;
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obtain marketing approval for our 6 millimeter ATEV in additional indications involving vascular repair, reconstruction and replacement, including in AV access for hemodialysis;
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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;
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continue our preclinical and clinical development efforts;
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maintain, expand and protect our intellectual property portfolio;
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add operational, financial and management information systems and personnel to support, among other things, our product development and commercialization efforts and operations; and
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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”).
Recent Developments
On March 4, 2026, we received a minimum purchase commitment of approximately $1.48 million of the Symvess ATEV to enable the education of surgeons, and the evaluation of Symvess by hospitals, in the Kingdom of Saudi Arabia (the “KSA”). The evaluation of Symvess is planned to be conducted in parallel with ongoing negotiations with a KSA-based entity for establishment of a joint venture and license to commercialize Symvess within the country. We have agreed to not engage in negotiation of commercialization rights within the KSA with any other party through July 2, 2026. Although the purchase commitment described above is binding, the establishment of a joint venture and license and the finalization of definitive terms are subject to further negotiation between the parties as well as the execution of definitive agreements between the KSA-based entity and us.
On March 16, 2026, we filed a Marketing Authorization Application (“MAA”) with the Ministry of Health of the State of Israel for approval of Symvess for the vascular trauma indication. In response to requests from surgeons, we are also pursuing methods of making Symvess available on a hospital-by-hospital basis in advance of any future MAA approval in Israel.
On March 19, 2026, we delivered written notice to TD Securities (USA) LLC, as agent (“TD Cowen”), that we were suspending and terminating the prospectus, dated December 16, 2025 (the “ATM Prospectus”), relating to the sale of up to $60 million of Common Stock, that may be issued and sold pursuant to the Sales Agreement, dated as of December 16, 2025, by and between us and TD Cowen (the “Sales Agreement”). We will not make any further sales of Common Stock pursuant to the Sales Agreement unless and until a new prospectus, prospectus supplement or registration statement is filed. Other than the suspension and termination of the ATM Prospectus, the Sales Agreement remains in full force and effect.
Also on March 19, 2026, we entered into certain securities purchase agreements, pursuant to which we agreed to issue and sell to certain investors in a registered direct offering 25,000,000 shares of Common Stock at a price of $0.80 per share. The net proceeds to us were approximately $18.4 million, after deducting the placement agent’s fees and estimated offering expenses payable by us. The offering closed on March 20, 2026.
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Components of Results of Operations
Revenue
During the fiscal year of 2025, we have generated $1.4 million in product revenue from the sale of Symvess. The remainder of our revenue has been derived from contracts. From inception through December 31, 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.
Cost of goods sold
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 2025, 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 consolidated statements of operations and comprehensive loss.
Research and Development Expenses
Prior to our recent shift in focus to the sale of Symvess for the vascular trauma indication, we have historically 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:
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salaries and related overhead expenses for personnel in research and development functions, including stock-based compensation and benefits;
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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;
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allocation of facility lease and maintenance costs;
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depreciation of leasehold improvements, laboratory equipment and computers;
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costs related to purchasing raw materials and producing our product candidates for clinical trials;
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costs related to compliance with regulatory requirements;
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costs related to our manufacturing development and expanded-capabilities initiatives; and
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license fees related to in-licensed technologies.
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The majority of our research and development resources are currently focused on our Phase 2 and 3 clinical trials for our 6 millimeter ATEV and other work needed to obtain marketing approval for our 6 millimeter ATEV for use for in AV access in hemodialysis in the United States. 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, 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.
The successful development of our preclinical and clinical product candidates is highly uncertain. At this time, we cannot estimate with any reasonable certainty the nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of any of our preclinical or clinical product candidates or the period, if any, in which material net cash inflows from these product candidates may commence. This is due to the numerous risks and uncertainties associated with the development of our product candidates, including:
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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;
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successful patient enrollment in and the initiation and completion of clinical trials;
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the timing, receipt and terms of any marketing approvals from applicable regulatory authorities including the FDA and non-U.S. regulators;
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the extent of any required post-marketing approval commitments to applicable regulatory authorities;
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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;
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obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
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significant and changing government regulations;
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launching commercial sales of Symvess and our product candidates, if approved, whether alone or in collaboration with others;
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the degree of market acceptance of Symvess and any product candidates that obtain marketing approval; and
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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.
A change in the outcome of any of these variables could lead to significant changes in the costs and timing associated with the development of our product candidates. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate being required to conduct in order to complete the clinical development of any of our product candidates, or if we experience significant delays in the enrollment or the conduct of any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.
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General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related costs for employees in executive, finance, human resources, commercialization, and administrative support functions, which also include stock-based compensation expenses and benefits for such employees. Other significant general and administrative expenses include facilities costs, professional fees for accounting and legal services and expenses associated with obtaining and maintaining patents.
We expect our general and administrative expenses will continue to increase for the foreseeable future to support our expanded infrastructure and increased costs of operating as a public company and as we commercialize Symvess in the United States and seek marketing approval for Symvess outside of the United States. These increases are expected to include increased employee-related expenses, increased sales and marketing expenses, and increased 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, as well as Nasdaq rules.
Other Income (Expense), Net
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 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 our Term Loan Facility, finance leases, and our former Purchase Agreement during the periods each were outstanding, (iv) the change in fair value of our derivative liabilities and assets, 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; a derivative liability related to the Loan Agreement; and a derivative asset related to our Common Stock Purchase 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 termination of the Purchase Agreement in December 2025.
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Results of Operations
Comparison of the Years Ended December 31, 2025 and 2024
Year Ended December 31, Change
Revenue
Operating expenses:
Other income (expense), net
Loss on extinguishment of debt (22,267 ) — (22,267 ) N/A
Costs of Goods Sold
Cost of goods sold was $9.7 million for the year ended December 31, 2025, compared to $0 for the year ended December 31, 2024. The increase was primarily driven by an $8.9 million inventory reserve recorded during 2025 to reduce certain inventory balances to their estimated net realizable value in connection with the initial commercialization of Symvess. The remaining $0.8 million of cost of goods sold was attributable to the commencement of commercial sales of Symvess in the first quarter of 2025. Prior to commercialization, manufacturing costs incurred in connection with product development were expensed as research and development. As a result, cost of goods sold in 2025 reflects inventory costs capitalized subsequent to commercialization, manufacturing-related overhead associated with unused production capacity, royalty expense related to product sales, and the aforementioned reserve. There was no cost of goods sold recognized during 2024, as Symvess had not yet been commercialized and manufacturing costs incurred prior to approval were expensed as research and development.
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Research and Development Expenses
The following table discloses the breakdown of research and development expenses for the periods indicated:
Year Ended December 31, Change
Direct Expenses
Unallocated Expenses
Research and development expenses were $69.3 million for the year ended December 31, 2025, representing a decrease of $19.3 million, or 22%, from $88.6 million for the year ended December 31, 2024. The decrease primarily reflects our transition from late-stage development activities to commercial operations following FDA approval of Symvess in December 2024.
Beginning in 2025, following the commercialization of Symvess, certain unallocated manufacturing-related payroll and overhead costs that had been included within research and development expenses were capitalized to inventory. These capitalized costs, which will be recognized in cost of goods sold as product is sold, resulted in reductions across laboratory materials and supplies, payroll and personnel, and other research and development expenses. In addition, our direct expenses related to clinical studies decreased by $2.1 million, primarily due to reduced spending on vascular trauma trials as this clinical program was completed.
General and Administrative Expenses
General and administrative expenses were $31.2 million and $25.8 million for the years ended December 31, 2025 and 2024, respectively. The increase in general and administrative expenses during the year ended December 31, 2025 of $5.4 million, or 21%, compared to the year ended December 31, 2024 was primarily driven by the commercial launch of Symvess. Major changes in expenses included a $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 $0.8 million increase in professional fees, partially offset by a $1.4 million decrease in external services and consulting expenses.
Total Other Income (Expense), net
Total other 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. The increase in net income of $101.6 million primarily resulted from a $127.4 million increase in non-cash gains consisting of a $92.5 million fair value remeasurement of the Contingent Earnout Liability and $34.9 million fair value remeasurement of derivative liabilities, partially offset by $22.3 million loss on extinguishment of debt related to the Purchase Agreement termination.
Liquidity and Capital Resources
Sources of Liquidity
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
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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 December 31, 2025 and 2024, we had an accumulated deficit of $726.8 million and $686.0 million, respectively.
As of December 31, 2025 and 2024, we had working capital of $49.4 million and $27.9 million, respectively. Subsequent to December 31, 2025, on March 20, 2026, we issued and sold to certain investors in a registered direct offering 25,000,000 shares of Common Stock at a price of $0.80 per share (the “March 2026 Registered Direct Offering”). Net proceeds to the Company from the March 2026 Registered Direct Offering were approximately $18,400,000, after deducting the placement agent’s fees and estimated expenses payable by the Company. Also, from January 1, 2026 until March 17, 2026, we sold an aggregate of 4,018,497 shares of Common Stock under the TD Cowen ATM Facility (defined below) at an average price of $1.16 per share for net proceeds of approximately $4.6 million. On March 19, 2026, we suspended and terminated the ATM Prospectus (defined below), pursuant to which shares had been sold under the TD Cowen ATM Facility.
As of December 31, 2025 and 2024, we had cash and cash equivalents of $50.5 million and $44.9 million, respectively, and restricted cash of $0.4 million and $50.4 million, respectively. We funded the restricted cash account on August 14, 2024, in accordance with the second amendment to the Purchase Agreement (the “Purchase Agreement Amendment”), of which $50.0 million was 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.
The Company will not have sufficient liquidity to fund its operations beyond one year from the issuance of these financial statements if the Company is unable to generate sufficient cash flows from commercial sales on a timely basis and/or obtain additional capital. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The future viability of the Company is dependent on its ability to generate cash flows from the sale of Symvess and raise additional capital to finance its operations. The Company plans 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 the Company when needed or on acceptable terms. If the Company is unable to raise capital, the Company plans to implement a program that delays, reduces, suspends or ceases certain of its planned capital expenditures, research and development programs or any future commercialization efforts, which would have a negative impact on its business, prospects, operating results and financial condition. The accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K have been prepared assuming that the Company 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 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 the Company be unable to continue as a going concern. See Note 1, Organization and Description of Business to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for additional information regarding our assessment.
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 the Term Loan Facility of up to $77.5 million in the aggregate that matures on December 1, 2029. The Loan Agreement 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 May 12, 2023, we entered into the Purchase Agreement with the Purchasers and another affiliate of Oberland Capital
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Management LLC, as the Agent. Pursuant to the Purchase Agreement, and subject to customary closing conditions, the Purchasers purchased certain revenue interests from us in exchange for an aggregate investment amount of up to $150.0 million. Under the terms of the Purchase Agreement, $40.0 million of the investment amount, less certain transaction expenses, was funded on May 12, 2023, and was used to repay in full and retire our indebtedness under our loan agreement with Silicon Valley Bank, with the remaining proceeds funded to the Company. On March 11, 2024, an additional $20.0 million was funded to the 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 of our BLA for the vascular trauma indication, and we elected not to draw the additional $40.0 million that became available under the Purchase Agreement. As of and subsequent to December 31, 2024, we were not entitled to draw any further installments under the Purchase Agreement. On December 15, 2025, we entered into a payoff letter with the Purchasers and the Purchasers’ agent pursuant to which the Purchase Agreement and the related Option Agreement were terminated in their entirety. As consideration for the termination of these agreements and the satisfaction of all obligations thereunder, we paid $38.0 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, 2025, we had completed sales of shares under the Common Stock Purchase Agreement that provided $2.5 million in gross proceeds. As of December 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 in 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.
On November 13, 2024, we entered into a securities purchase agreement with an institutional investor pursuant to which the investor purchased approximately $15.0 million worth of Common Stock and warrants in the November 2024 Registered Direct Offering (as defined in Note 10). The net proceeds to us from the November 2024 Registered Direct Offering were approximately $14.9 million after deducting offering expenses of approximately $0.1 million. The November 2024 Registered Direct Offering closed on November 15, 2024.
On March 25, 2025, we entered into an underwriting agreement with TD Securities (USA) LLC, Barclays Capital Inc. and BTIG, LLC, as representatives of the several underwriters named therein, relating to the issuance and sale in the public offering of 25,000,000 shares of Common Stock, at a price to the public of $2.00 per share. We also granted the underwriters a 30-day option to purchase up to an additional 3,750,000 shares of Common Stock at the same price per share, which was not exercised by the underwriters. The net proceeds to us from the public offering were approximately $46.7 million after deducting underwriting discounts and commissions and estimated public offering expenses. The public offering closed on March 27, 2025.
On October 6, 2025, we entered into a securities purchase agreement with institutional investors pursuant to which the investors purchased approximately $60.0 million worth of Common Stock and October 2025 RDO Warrants in the October 2025
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Registered Direct Offering. The net proceeds to us from the October 2025 Registered Direct Offering were approximately $56.5 million, after deducting placement agent’s fees and offering expenses of approximately $3.5 million. The October 2025 Registered Direct Offering closed on October 8, 2025.
On March 19, 2026, we entered into certain securities purchase agreements, pursuant to which we agreed to issue and sell to certain investors in a registered direct offering 25,000,000 shares of Common Stock at a price of $0.80 per share. The net proceeds to us were approximately $18.4 million, after deducting the placement agent’s fees and estimated offering expenses payable by us. The offering closed on March 20, 2026.
ATM Facilities
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”). In December 2024, we sold an aggregate of 1,333,596 shares of Common Stock under the Jefferies ATM Facility at an average price of $5.26 per share for net proceeds of approximately $6.8 million. In the year ended December 31, 2025, the Company completed sales of shares under the Jefferies ATM Facility that provided net proceeds of approximately $10.0 million. On November 21, 2025, the Company delivered a notice to Jefferies LLC terminating the Jefferies ATM Sales Agreement, which termination became effective 10 days thereafter. As of December 31, 2025, no shares remained available for issuance under the Jefferies ATM Facility.
On December 16, 2025, we entered into a sales agreement with TD Securities (USA) LLC (“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. As of December 31, 2025, no shares had been sold under the TD Cowen ATM Facility. From January 1, 2026 until March 17, 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. On March 19, 2026, we suspended and terminated the ATM Prospectus pursuant to which shares had been sold under the TD Cowen ATM Facility.
Material Cash Requirements
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) financing and operating lease payments (for additional information see below and Note 9, Leases to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K); (5) debt service obligations under our senior secured Term Loan Facility (for additional information see below and Note 8, Debt to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K); and (6) payments under our JDRF Agreement (for additional information see Note 14, Commitments and Contingencies to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K). 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.
On December 15, 2025, we entered into a payoff letter with the Purchasers and the Agent, pursuant to which the Purchase Agreement and the related Option Agreement were terminated in their entirety. As consideration for the termination of these agreements and the satisfaction of all obligations thereunder, we paid $38.0 million in cash and issued 5,725,190 shares of our Common Stock measured at fair value of $7.5 million at time of issuance to the Purchasers. The cash payment was funded with proceeds from the Term Loan Facility (see Note 8 to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K). The termination of the Purchase Agreement released all liens and security interests previously granted to the Purchasers and their agent and relieved the Company of any further obligations to the Purchasers. See Note 7, Revenue Interest Purchase Agreement to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K.
Under the senior secured Term Loan Facility, we are required to make monthly interest payments beginning in January 2026
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at a variable rate equal to the greater of 11.50% or the Wall Street Journal Prime Rate plus 4.50%. We are not required to make scheduled principal payments until December 1, 2027, or December 1, 2028 if the second tranche is funded, after which principal will be repaid in equal monthly installments through maturity in December 2029. In addition, the facility includes a contractual final payment fee of $2.4 million due at maturity. Because the interest rate is variable, our future interest expense and related cash interest payments may increase or decrease based on changes in rates. The Loan Agreement contains customary affirmative and negative covenants, certain liquidity requirements and customary events of default, and is secured by substantially all of our assets. See Note 8 to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K.
As of December 31, 2025, we had non-cancellable purchase commitments of $31.5 million for supplies and services that are primarily for research and development. We have existing license agreements with Duke University and Yale University, a distribution agreement with Fresenius Medical Care and our JDRF Agreement. The amount and timing of any potential milestone payments, license fee payments, royalties and other payments that we may be required to make under these agreements are unknown or uncertain at December 31, 2025. For additional information regarding our agreements with Duke University, Yale University, and Fresenius Medical Care, and the nature of payments that could become due thereunder, see the sections in this Annual Report on Form 10-K titled “Business — Distribution” and “Business — Intellectual Property.” For additional information about our JDRF Agreement, see Note 14 to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K.
Leases
Our finance lease relates to our headquarters facility containing our manufacturing, research and development and general and administrative functions, which was substantially completed in June 2018. On September 29, 2025, we executed a Sixth Amendment to our lease agreements that extended the lease term and modified key financial terms. See Note 9 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for further information regarding our leases.
Our future contractual obligations under our lease agreement as of December 31, 2025 are as follows:
($ in thousands) Total Less than1 year 1 – 3 years 3 – 5 years More than5 years
Future Funding Requirements
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, (ii) continue clinical development of our 6 millimeter ATEV for use in hemodialysis AV access and submit a BLA for FDA approval of an indication in hemodialysis AV access, (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, and (iv) scale out our manufacturing facility as required to satisfy market demand. We will need additional funding in connection with these activities.
Our future funding requirements, both short-term and long-term, will depend on many factors, including:
•
the cost and timing of our ongoing sales and future commercialization activities, including product manufacturing, marketing and distribution for Symvess in the United States, and any other product candidate for which we receive marketing approval in the future;
•
the amount and timing of revenues, which we receive from commercial sales of Symvess and any product candidates for which we receive marketing approval;
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•
the progress and results of our clinical trials and interpretation of those results by the FDA and other regulatory authorities;
•
the cost, timing and outcome of regulatory review of our product candidates, particularly for marketing approval of Symvess outside of the United States and of our product candidates in the United States;
•
the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our additional product candidates;
•
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and
•
the costs of operating as a public company, including hiring additional personnel as well as increased 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 Nasdaq.
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 the sale of equity, debt, borrowings under credit facilities, 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 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, if any, that we receive from commercial sales. See “Risk Factors” for additional risks associated with our substantial capital requirements.
Cash Flows
The following table shows a summary of our cash flows for each of the periods shown below:
Year Ended December 31,
Changes in operating assets and liabilities: (23,395 ) 311
Net cash used in operating activities (105,042 ) (98,122 )
Net cash used in investing activities (884 ) (1,572 )
Net cash provided by financing activities 61,486 114,183
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(a) Primarily includes depreciation; amortization related to our leases; stock-based compensation expense; non-cash interest expense related to our revenue interest liability, our JDRF Award liability (defined below), and our Term Loan Facility; the changes in fair value of our Contingent Earnout Liability and our derivative liabilities and asset; and an immaterial amount of loss on disposal of property and equipment. In 2025, this also includes a loss on extinguishment of debt and inventory write-down to net realizable value.
Cash Flow from Operating Activities
The increase in net cash used in operating activities from 2024 to 2025 primarily reflects higher spending on preclinical and commercial activities, increased payroll and personnel costs, continued expansion of clinical development of the ATEV for use in AV access, and activities associated with the commercial launch of Symvess. Operating cash flows for the year ended December 31, 2025 were further impacted by the capitalization of $22.5 million of inventory following the commencement of commercialization of Symvess. These cash outflows were partially offset by non-cash charges, including a $22.3 million loss on extinguishment of the Purchase Agreement and an $8.9 million inventory reserve, which reduced net income but did not affect operating cash flows.
Cash Flow from Investing Activities
Net cash used in investing activities for the years ended December 31, 2025 and 2024 consisted of purchases of property and equipment.
Cash Flow from Financing Activities
Net cash provided by financing activities for the year ended December 31, 2025 consisted primarily of $56.5 million of net proceeds from our Registered Direct Offering we completed in October 2025, $46.7 million of net proceeds from our Public Offering we completed in March 2025, $39.0 million of net proceeds from the Term Loan Facility we entered into in December 2025, and $10.0 million of net proceeds from issuance of shares of Common Stock under the Jefferies ATM Facility, which was partially offset by a $88.0 million repayment of the Purchase Agreement. Net cash provided by financing activities for the year ended December 31, 2024 consisted primarily of $43.1 million of net proceeds from our Registered Direct Offerings we completed in October and November 2024, $43.0 million of net proceeds from our Public Offering we completed in March 2024 and $19.5 million of net proceeds from our Purchase Agreement.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in SEC rules and regulations.
Critical Accounting Estimates
Our discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of our consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses, and disclosure of contingent liabilities. We base our estimates and assumptions on historical experience and other factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Although we believe that our estimates, assumptions, and judgments are reasonable, they are based upon information presently available. Actual results may differ significantly from these estimates based on different assumptions, judgments, or conditions.
An accounting estimate or assumption is considered critical if both (a) the nature of the estimate or assumption involves a significant level of estimation uncertainty, and (b) the impact within a reasonable range of outcomes of the estimate and assumption is material to our financial condition. Our critical accounting policies are summarized below.
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Contingent Earnout Liability
In connection with the Reverse Recapitalization, Legacy Humacyte equity holders are entitled to receive as additional merger consideration of up to 15,000,000 shares of our common stock in the aggregate, in two equal tranches of 7,500,000 shares of common stock per tranche, for no consideration upon the occurrence of certain triggering events, including a change of control event, that is not solely indexed to the common stock. In accordance with ASC 815-40, as the Contingent Earnout Shares were not indexed to the common stock, they were accounted for as a liability at the Reverse Recapitalization date and subsequently remeasured at each reporting date with changes in fair value recorded as a component of other income (expense), net in the consolidated statements of operations and comprehensive loss.
The estimated fair value of the Contingent Earnout Shares was determined using a Monte Carlo simulation valuation model using a distribution of potential outcomes on a monthly basis over a 10-year period prioritizing the most reliable information available. The assumptions utilized in the calculation were based on the achievement of certain stock price milestones, including the expected volatility and expected term, as well as certain data inputs, including the Company’s common stock price, risk-free interest rate, and expected dividend yield. See Note 10 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for further information regarding the assumptions used in the valuations at December 31, 2025 and 2024.
The Contingent Earnout Shares are categorized as a Level 3 fair value measurement (see “Fair Value of Financial Instruments” accounting policy described in Note 2, Summary of Significant Accounting Policies to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K) because we estimated projections over a ten-year period utilizing unobservable inputs. Contingent earnout payments involve certain assumptions requiring significant judgment and actual results can differ from assumed and estimated amounts.
Revenue Interest Liability
On May 12, 2023, we entered into the Purchase Agreement to obtain financing in respect to the further development and commercialization of our ATEV, to repay our credit facility with SVB, and for other general corporate purposes. We recorded a revenue interest liability related to the Purchase Agreement on our consolidated balance sheet on the date we entered into the Purchase Agreement, which is presented net of issuance costs and a debt discount. We imputed interest expense associated with this liability using the interest method.
At December 31, 2024, the revenue interest liability was calculated using our current estimate of forecasted global net sales of our products, and impacted by a debt discount comprising the estimated fair value of a bifurcated derivative liability related to the Purchasers’ put option under the Purchase Agreement, the estimated fair value of a freestanding option agreement related to the Purchase Agreement, and issuance and transaction costs incurred.
The fair value of the contingent derivative liability was valued using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the individual embedded derivative. The difference between the entire instrument with the embedded derivative compared to the instrument without the embedded derivative was the fair value of the contingent derivative liability. The estimated probability and timing of underlying events triggering the exercisability of the contingent derivative liability bifurcated from within the Purchase Agreement, forecasted cash flows and the discount rate were significant unobservable inputs used to determine the estimated fair value of the entire instrument with the embedded derivative.
On December 15, 2025, we entered into a payoff letter with the Purchasers and the Purchasers’ Agent pursuant to which the Purchase Agreement and the Option Agreement were terminated in their entirety. In connection with the termination of the Purchase Agreement, the embedded derivative was extinguished and derecognized. See Note 7 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for further details.
Inventory valuation
Inventory is stated at the lower of cost or net realizable value. The Company records reserves for excess quantities,
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obsolescence, and declines in net realizable value based on estimates of future demand, expected product shelf life, regulatory considerations, manufacturing performance, and other commercialization-related factors.
The estimation of net realizable value requires significant judgment, particularly as the Company commenced commercialization of Symvess in 2025 and has limited historical experience forecasting commercial demand for its products. Changes in demand forecasts, market acceptance, manufacturing scale, or product shelf life could result in material adjustments to inventory reserves in future periods.
Stock-Based Compensation
Stock-based compensation expense represents a significant non-cash expense and is based on the grant-date fair value of equity awards. The Company grants stock options and restricted stock units under its equity incentive plans. The grant-date fair value of stock options is estimated using the Black-Scholes option-pricing model.
The determination of the grant date fair value of stock options using an option pricing model is affected principally by our estimated fair value of shares of our common stock and requires management to make a number of other assumptions, including the expected term of the option, the volatility of the underlying shares, the risk-free interest rate and expected dividends. The assumptions used in our Black-Scholes option-pricing model represent management’s good faith estimates at the time of measurement. These estimates are complex, involve a number of variables, uncertainties and assumptions and the application of management’s judgment, as they are inherently subjective. If any assumptions change, our stock-based compensation expense could be materially different in the future.
These assumptions are estimated as follows:
•
Fair Value of Common Stock. The fair value of our Common Stock has been determined based on the closing price of the shares on Nasdaq.
•
Expected Term. The expected term represents the period that stock options are expected to be outstanding. We calculated the expected term using the simplified method for options, which is available where there is insufficient historical data about exercise patterns and post-vesting employment termination behavior. The simplified method is based on the vesting period and the contractual term for each grant, or for each vesting-tranche for awards with graded vesting. The mid-point between the vesting date and the maximum contractual expiration date is used as the expected term under this method. For awards with multiple vesting-tranches, the times from grant until the mid-points for each of the tranches may be averaged to provide an overall expected term.
•
Expected Volatility. The expected volatility was determined based on a blended approach using the historical share volatility of our Common Stock and that of several publicly traded peer companies over a period of time equal to the expected term of the options, as we have limited trading history. For purposes of identifying these peer companies, we considered the industry, stage of development, size and financial leverage of potential comparable companies.
•
Risk-Free Interest Rate. The risk-free interest rate was based on the yields of U.S. Treasury zero-coupon securities with maturities similar in duration to the expected term of the options.
•
Expected Dividend Yield. We have not paid dividends on our Common Stock nor do we expect to pay dividends in the foreseeable future. Accordingly, we have estimated the dividend yield to be zero.
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Common Stock Warrants
Public and Private Placement Warrants
Under the Merger, we assumed 5,000,000 publicly-traded warrants (“Public Warrants”) and 177,500 private placement warrants issued to AHAC in connection with AHAC’s initial public offering (“Private Placement Warrants” and, together with the Public Warrants, the “Common Stock Warrants”). We account for the Common Stock Warrants in accordance with the guidance contained in ASC Topic 480, “Distinguishing Liabilities from Equity” (“ASC 480”) and ASC Topic 815, “Derivatives and Hedging” (“ASC 815”).
We accounted for the Private Placement Warrants in accordance with the guidance contained in ASC 815, under which the warrants did not meet the criteria for equity treatment and must be recorded as liabilities. As the Private Placement Warrants met the definition of a derivative under ASC 815, we recorded these warrants as liabilities on the consolidated balance sheet at fair value, with subsequent changes in their respective fair values recognized in the consolidated statements of operations and comprehensive loss at each reporting date. The fair value of the warrants was estimated using a Monte Carlo simulation value model utilizing assumptions including our current common stock price, expected volatility, risk-free rate, expected term and expected dividend yield. The fair value of the Private Placement Warrants is based on significant unobservable inputs, which represent Level 3 fair value measurements within the fair value hierarchy (see “Fair Value of Financial Instruments” accounting policy described in Note 2 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K). Determining the fair value of the Private Placement Warrants involves certain assumptions requiring significant judgment and actual results can differ from assumed and estimated amounts.
The Public Warrants are considered to be “indexed to the Company’s own stock” and as we have a single class of common stock, a qualifying cash tender offer of more than 50% of Common Stock will always result in a change-in-control and would not preclude permanent equity classification of the Public Warrants. Based on this evaluation, we concluded that the Public Warrants met the criteria to be classified within stockholders’ equity.
Registered Direct Offering Warrants
We accounted for the common stock warrants issued in the Registered Direct Offerings in accordance with the guidance contained in ASC 480 and ASC 815. The Registered Direct Offering Warrants (as defined in Note 2 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K) did not meet the criteria for equity treatment and must be recorded as liabilities. As the Registered Direct Offering Warrants meet the definition of a derivative under ASC 815, we recorded these warrants as liabilities on the consolidated balance sheet at fair value, with subsequent changes in their respective fair values recognized in the consolidated statements of operations and comprehensive loss at each reporting date. The fair value of the warrants was estimated using a Black-Scholes valuation model utilizing assumptions including our current common stock price, expected volatility, risk-free rate, expected term and expected dividend yield. The fair value of the Registered Direct Offering Warrants is based on significant unobservable inputs, which represent Level 3 fair value measurements within the fair value hierarchy (see “Fair Value of Financial Instruments” accounting policy described in Note 2 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K). Determining the fair value of the Registered Direct Offering Warrants involves certain assumptions requiring significant judgment and actual results can differ from assumed and estimated amounts.
Loan Agreement Warrants
We accounted for the Loan Agreement Warrants issued in connection with the Loan Agreement in accordance with the guidance contained in ASC 480 and ASC 815. The Loan Agreement Warrants (as defined in Note 10 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K) did not meet the criteria for equity treatment and must be recorded as liabilities. As the Loan Agreement Warrants meet the definition of a derivative under ASC 815, we recorded these warrants as liabilities on the consolidated balance sheet at fair value, with subsequent changes in their fair value recognized in the consolidated statements of operations and comprehensive loss at each reporting date. The fair value of the Loan Agreement Warrants was estimated using a Black-Scholes valuation model utilizing assumptions including our
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current common stock price, expected volatility, risk-free rate, expected term and expected dividend yield. The fair value of the Loan Agreement Warrants is based on significant unobservable inputs, which represent Level 3 fair value measurements within the fair value hierarchy (see “Fair Value of Financial Instruments” accounting policy described in Note 2 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K). Determining the fair value of the Loan Agreement Warrants involves certain assumptions requiring significant judgment and actual results can differ from assumed and estimated amounts.
Loan Agreement Conversion Derivative Liability
We accounted for the conversion feature embedded in the Loan Agreement in accordance with the guidance contained in ASC 815. The Loan Agreement conversion feature (as defined in Note 2 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K) required bifurcation from the host debt instrument and is recorded as a derivative liability. Accordingly, we recorded the Loan Agreement conversion derivative liability on the consolidated balance sheet at fair value, with subsequent changes in its fair value recognized in the consolidated statements of operations and comprehensive loss at each reporting date. The fair value of the Loan Agreement conversion derivative liability was estimated using a Black-Scholes valuation model utilizing assumptions including our current common stock price, expected volatility, risk-free rate, expected term and expected dividend yield. The fair value of the Loan Agreement conversion derivative liability is based on significant unobservable inputs, which represent Level 3 fair value measurements within the fair value hierarchy (see “Fair Value of Financial Instruments” accounting policy described in Note 2 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K). Determining the fair value of the Loan Agreement conversion derivative liability involves certain assumptions requiring significant judgment and actual results can differ from assumed and estimated amounts.
Smaller Reporting Company Status
We are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K under the Exchange Act (“Regulation S-K”). Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company if (1) the market value of Common Stock held by non-affiliates is less than $250 million as of the last business day of the second fiscal quarter, or (2) our annual revenues in our most recent fiscal year completed before the last business day of its second fiscal quarter are less than $100 million and the market value of Common Stock held by non-affiliates is less than $700 million as of the last business day of the second fiscal quarter.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
We qualify as a smaller reporting company, as defined by Item 10 of Regulation S-K and, thus, are not required to provide the information required by this Item.
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Item 8. Financial Statements and Supplementary Data.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
HUMACYTE, INC.
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID 238) 127
Notes to Consolidated Financial Statements 133
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Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Humacyte, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Humacyte, Inc. and its subsidiaries (the “Company”) as of December 31, 2025 and 2024, and the related consolidated statements of operations and comprehensive loss, of changes in stockholders' equity (deficit) and of cash flows for the years then ended, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred operating losses and negative cash flows from operations since inception that raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
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Contingent Earnout Liability
As described in Notes 2 and 3 to the consolidated financial statements, the Company’s contingent earnout liability was $11.5 million as of December 31, 2025. Pursuant to the merger agreement, following the closing of the 2021 merger, Legacy Humacyte equity holders are entitled to receive additional merger consideration of up to 15,000,000 additional shares of common stock (the “contingent earnout shares”), comprised of two separate tranches of 7,500,000 shares per tranche, for no consideration upon the occurrence of certain triggering events. The contingent earnout shares were accounted for as a liability (the “contingent earnout liability”) and are remeasured at each reporting date. The estimated fair value of the contingent earnout liability was determined using a Monte Carlo simulation using a distribution of potential outcomes on a monthly basis over a 10-year period prioritizing the most reliable information available. Management’s assumptions utilized in the calculation were based on the achievement of certain stock price milestones, including the expected volatility and expected term, as well as certain data inputs, including the Company’s common stock price, risk-free interest rate, and expected dividend yield.
The principal considerations for our determination that performing procedures relating to the contingent earnout liability is a critical audit matter are (i) the significant judgment by management when developing the fair value estimate of the contingent earnout liability; (ii) a high degree of auditor judgement, subjectivity, and effort in performing procedures and evaluating management’s significant assumptions related to expected volatility and expected term; and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included, among others (i) testing the completeness and accuracy of underlying data provided by management and (ii) the involvement of professionals with specialized skill and knowledge to assist in evaluating the reasonableness of management’s estimate by (a) developing an independent range of estimated contingent earnout liability using independently developed assumptions related to expected volatility and expected term and (b) comparing the independent range of estimated contingent earnout liability to management’s estimate.
/s/ PricewaterhouseCoopers LLP
Raleigh, North Carolina
March 27, 2026
We have served as the Company’s auditor since 2013.
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HUMACYTE, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands except for share and per share amounts)
As of December 31,
ASSETS
Current assets
Accounts receivable 441 —
Prepaid expenses and other current assets 3,268 2,922
Finance lease right-of-use assets, net 29,146 15,490
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Finance lease obligation, current portion 2,428 2,917
Revenue interest liability, current portion — 885
Other current liabilities — 238
Revenue interest liability — 63,354
Finance lease obligation, net of current portion 26,974 13,620
Contingent derivative liability — 2,415
Other long-term liabilities 1,583 983
Commitments and contingencies (Note 13)
Stockholders’ equity (deficit)
Total stockholders’ equity (deficit) 3,109 (52,669 )
Total liabilities and stockholders’ equity (deficit) $ 116,366 $ 137,872
The accompanying notes are an integral part of these financial statements.
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HUMACYTE, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands except for share and per share amounts)
Year Ended December 31,
Revenue
Product revenue, net $ 1,389 $ —
Contract revenue 649 —
Total revenue 2,038 —
Operating expenses:
Cost of goods sold 9,702 —
Other income (expense), net
Change in fair value of Contingent Earnout Liability 59,469 (33,045 )
Change in fair value of derivatives 38,765 3,915
Loss on extinguishment of debt (22,267 ) —
Net loss and comprehensive loss $ (40,833 ) $ (148,701 )
The accompanying notes are an integral part of these financial statements.
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CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
(in thousands except for share amounts)
Common Stock AdditionalPaid-in Accumulated TotalStockholders’
Shares Amount Capital Deficit Equity (Deficit)
Stock-based compensation — — 6,137 — 6,137
Proceeds from the exercise of stock options 19,614 — 61 — 61
The accompanying notes are an integral part of these financial statements.
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CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year Ended December 31,
Cash flows from operating activities
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense 9,753 6,137
Change in fair value of Contingent Earnout Liability (59,469 ) 33,045
Change in fair value of derivatives (38,765 ) (3,915 )
Loss on disposal of property and equipment 5 4
Loss on extinguishment of debt 22,267 —
Inventory reserve 8,897 —
Non-cash operating lease costs 44 53
Changes in operating assets and liabilities:
Accounts receivable (261 ) —
Prepaid expenses and other current assets (527 ) 88
Operating lease obligation (44 ) (53 )
Net cash used in operating activities (105,042 ) (98,122 )
Cash flows from investing activities
Purchase of property and equipment (884 ) (1,572 )
Net cash used in investing activities (884 ) (1,572 )
Cash flows from financing activities
Proceeds from the Term Loan Facility 39,783 —
Payments of transaction costs related to the Loan Agreement (774 ) —
Payments of costs related to public offering (340 ) (350 )
Payments on revenue interest liability (45 ) —
Repayment of the Purchase Agreement (88,000 ) —
Proceeds from the Purchase Agreement, net of issuance costs — 20,000
Payments of transaction costs related to the Purchase Agreement — (500 )
Proceeds from sale of stock under the Common Stock Purchase Agreement — 2,530
Proceeds from the exercise of stock options 61 1,511
Proceeds from the JDRF Agreement 175 240
Payments of finance lease principal (2,754 ) (2,579 )
Net cash provided by financing activities 61,486 114,183
Supplemental disclosure of noncash activities:
Unpaid transaction costs related to the Loan Agreement $ 446 $ —
Accrual of transaction costs associated with public offering $ 156 $ —
Debt discount from embedded contingent derivative liability $ — $ 1,552
The accompanying notes are an integral part of these financial statements.
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1. Organization and Description of Business
Organization
Humacyte, Inc. and subsidiaries (unless the context indicates otherwise, collectively, the “Company”) is pioneering the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues, advanced tissue constructs and organ systems with the goal of improving the lives of patients and transforming the practice of medicine. The Company is leveraging its regenerative medicine technology platform to develop proprietary product candidates for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas.
On August 26, 2021 (the “Closing Date”), Alpha Healthcare Acquisition Corp. (“AHAC”) consummated a merger pursuant to a Business Combination Agreement, dated as of February 17, 2021 (the “Merger Agreement”), by and among Humacyte, Inc. (“Legacy Humacyte”), AHAC and Hunter Merger Sub, Inc. (“Merger Sub”), a wholly owned subsidiary of AHAC. As contemplated by the Merger Agreement, Merger Sub merged with and into Legacy Humacyte, with Legacy Humacyte continuing as the surviving corporation and as a wholly-owned subsidiary of AHAC (such transactions, the “Merger,” and, collectively with the other transactions described in the Merger Agreement, the “Reverse Recapitalization”). On the Closing Date, AHAC changed its name to Humacyte, Inc. and Legacy Humacyte changed its name to Humacyte Global, Inc. (“Global”). The Merger was accounted for as a reverse recapitalization in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and under this method of accounting, AHAC was treated as the acquired company for financial reporting purposes and Legacy Humacyte was treated as the acquirer. Operations prior to the Merger are those of Legacy Humacyte.
Liquidity and Going Concern
Since its inception in 2004, the Company has incurred operating losses and negative cash flows from operations in each year. To date, the Company has financed its operations primarily through the sale of equity securities and convertible debt, proceeds from the Reverse Recapitalization, borrowings under loan facilities, proceeds from a revenue interest purchase agreement and, to a lesser extent, through product revenue, governmental and other grants. At December 31, 2025 and December 31, 2024, the Company had an accumulated deficit of $726.8 million and $686.0 million, respectively. The Company’s operating losses were $108.1 million and $114.4 million for the years ended December 31, 2025 and 2024, respectively. Net cash flows used in operating activities were $105.0 million and $98.1 million during the years ended December 31, 2025 and 2024, respectively. Substantially all of the Company’s operating losses resulted from costs incurred in connection with the Company’s research and development programs and from general and administrative costs associated with the Company’s operations. The Company expects to incur substantial operating losses and negative cash flows from operations for the foreseeable future as the Company advances its product candidates.
As of December 31, 2025, the Company had available cash and cash equivalents of $50.5 million. Subsequent to December 31, 2025, on March 20, 2026, we issued and sold to certain investors in a registered direct offering 25,000,000 shares of Common Stock at a price of $0.80 per share (the “March 2026 Registered Direct Offering”). Net proceeds to the Company from the March 2026 Registered Direct Offering were approximately $18,400,000, after deducting the placement agent’s fees and estimated expenses payable by the Company. Also, from January 1, 2026 until March 17, 2026, we sold an aggregate of 4,018,497 shares of Common Stock under the TD Cowen ATM Facility (defined in Note 10) at an average price of $1.16 per share for net proceeds of approximately $4.6 million. On March 19, 2026, we suspended and terminated the ATM Prospectus (defined in Note 10), pursuant to which shares had been sold under the TD Cowen ATM Facility.
As further disclosed in Note 7, Revenue Interest Purchase Agreement, on May 12, 2023, Humacyte, Inc. and Global entered into a Revenue Interest Purchase Agreement (the “Purchase Agreement”) with two purchasers, both affiliates of Oberland Capital Management LLC (the “Purchasers”), and another affiliate of Oberland Capital Management LLC (“Oberland”), as agent for the Purchasers (the “Agent”), to obtain financing with respect to the further development and commercialization of the
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Company’s ATEV, to repay the Company’s then-existing credit facility with Silicon Valley Bank (“SVB”), and for other general corporate purposes.
The Purchase Agreement contained customary representations and warranties and affirmative covenants for transactions of this type, including, among others, the provision of financial and other information to the Purchaser, notice to the Purchaser upon the occurrence of certain material events, and compliance with applicable laws. The Purchase Agreement also contained customary negative covenants, including certain restrictions on the ability to incur indebtedness and grant liens or security interests on assets. On February 18, 2024, the Company reached an agreement with the Purchasers and the Agent to waive certain breaches related to, and extend the deadline for certain post-closing obligations under, the Purchase Agreement, including the requirement for the Company to deliver a leasehold mortgage in favor of the Agent over the Company’s headquarters. On May 8, 2024, the Company agreed with the Purchasers to amend the Purchase Agreement to remove requirements related to the leasehold mortgage. In exchange for removing this requirement, the Company agreed to fund 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. The Company funded an account with the required $54.0 million on August 14, 2024. On September 17, 2025, the Company and Humacyte Global, Inc. (“Humacyte Global”) entered into a second amendment to the Purchase Agreement (the “Purchase Agreement Amendment”) with the Purchasers and the Agent to amend the Purchase Agreement. In connection with the Purchase Agreement Amendment, the Company 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, the Company was no longer obligated to maintain $50.0 million of restricted cash in an account for the benefit of the Agent. As of December 31, 2025 and 2024, $0.0 million and $50.0 million, respectively, related to the Purchase Agreement was classified as restricted cash on the accompanying consolidated balance sheets.
On December 15, 2025, the Company entered into a payoff letter with the Purchasers and the Purchasers’ Agent pursuant to which the Purchase Agreement and the Option Agreement were terminated in their entirety. As consideration for the termination of these agreements and the satisfaction of all obligations thereunder, the Company paid $38.0 million in cash and issued 5,725,190 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”), to the Purchasers. The cash payment was funded with proceeds from the Term Loan Facility (see Note 8, Debt). Pursuant to the Loan Agreement, the proceeds of the Term Loan Facility are required to be used to repay outstanding indebtedness under the Purchase Agreement and for other general corporate purposes. The funding of the first tranche of the Term Loan Facility was conditioned upon delivery of a payoff letter with respect to all indebtedness outstanding under the Purchase Agreement and evidence that the liens securing such indebtedness would be released. The extinguishment of the Purchase Agreement was accounted for as a debt extinguishment under ASC 470-50. The termination of the Purchase Agreement released all liens and security interests previously granted to the Purchasers and their agent and relieved the Company of any further obligations to the Purchasers. The shares issued to the Purchasers in connection with the payoff are discussed in more detail in Note 10, Stockholders’ Equity (Deficit) and Warrants. As of December 31, 2025 and 2024, $0.0 million and $64.2 million, respectively, was recorded as a revenue interest liability on the accompanying consolidated balance sheets. See Note 7, Revenue Interest Purchases Agreement, for further discussion
On September 24, 2024, the Company entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”) for an equity line financing (the “Common Stock Purchase Agreement”). The Common Stock Purchase Agreement provides that, subject to the terms and conditions set forth therein, the Company has 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 (the “Purchase Shares”) over a 24-month period. The Company controls the timing and amount of any sales of Purchase Shares to Lincoln Park pursuant to the Common Stock Purchase Agreement in its sole discretion. As of December 31, 2025, the Company had $47.5 million in remaining availability for sales of Common Stock under the Common Stock Purchase Agreement. There were no purchases under the Common Stock Purchase Agreement during the fiscal year ended December 31, 2025. As of December 31, 2024, the Company had completed sales of shares under the Common Stock Purchase Agreement that provided $2.5 million in gross proceeds. See Note 10 for further discussion.
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
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Facility”). In December 2024, we sold an aggregate of 1,333,596 shares of Common Stock under the Jefferies ATM Facility at an average price of $5.26 per share for net proceeds of approximately $6.8 million. In the year ended December 31, 2025, the Company completed sales of shares under the Jefferies ATM Facility that provided net proceeds of approximately $10.0 million. On November 21, 2025, the Company delivered a notice to Jefferies LLC terminating the Jefferies ATM Sales Agreement, which termination became effective 10 days thereafter. As of December 31, 2025, no shares remained available for issuance under the Jefferies ATM Facility.
The Company will not have sufficient liquidity to fund its operations beyond one year from the issuance of these financial statements if the Company is unable to generate sufficient cash flows from commercial sales on a timely basis and/or obtain additional capital. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The future viability of the Company is dependent on its ability to generate cash flows from the sale of Symvess and raise additional capital to finance its operations. The Company plans 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 the Company when needed or on acceptable terms. If the Company is unable to raise capital, the Company plans to implement a program that delays, reduces, suspends or ceases certain of its planned capital expenditures, research and development programs or any future commercialization efforts, which would have a negative impact on its business, prospects, operating results and financial condition. The accompanying consolidated financial statements have been prepared assuming that the Company 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 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 the Company be unable to continue as a going concern.
2. Summary of Significant Accounting Policies
Basis of Presentation
The Company has prepared the accompanying financial statements in conformity with U.S. GAAP. The Company’s consolidated financial statements reflect the operations of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in the financial statements include stock-based compensation costs, right-of-use assets, accruals for research and development activities, contingent earnout liability, revenue interest liability, derivatives, fair value of common stock warrants and income taxes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates.
Reclassifications
Certain prior year amounts have been reclassified to conform to the current year presentation. In the accompanying consolidated balance sheets, amounts previously included within “Other current liabilities” as of December 31, 2024 have been reclassified to separately present the current portion of the “Revenue interest liability, current portion.” These reclassifications were made to enhance the clarity and comparability of the Company’s financial statement presentation and had no impact on previously reported total assets, total liabilities, stockholders’ deficit, or net loss.
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Segments
The Company is developing proprietary, bioengineered, acellular human tissues, advanced tissue constructs and organ systems that are designed to be used in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. The Company’s operations are managed and reported to its Chief Executive Officer, the Company’s chief operating decision maker (“CODM”), on a consolidated basis. The CODM evaluates financial performance, allocates resources and monitors budget versus actual results based on the Company’s consolidated statements of operations and comprehensive loss. The measure of segment assets provided to and reviewed by the CODM is reported on the consolidated balance sheets as total assets. Segment asset information is not used by the CODM to evaluate performance, allocate resources or make strategic decisions. Under the current organizational and reporting structure, the Company operates and manages its business on a consolidated basis as one reportable and operating segment.
As a single reportable segment entity, the Company’s segment performance measure is consolidated net loss. Consolidated net loss is used to monitor the budget versus actual results and to help make key operating decisions such as the allocation of budget between research and development and general and administrative expenses. Significant segment expenses within net loss include cost of goods sold, research and development, and general and administrative expenses, which are each separately presented on the Company’s consolidated statements of operations and comprehensive loss. Other segment items within net loss include interest income, interest expense, the change in fair value of the Company’s Contingent Earnout Liability and the change in fair value of derivatives.
Additional disaggregated significant segment expenses that are not separately presented on the Company’s consolidated statements of operations and comprehensive loss are presented below.
Research and Development Expenses
Year Ended December 31,
Direct Expenses
Unallocated Expenses
Other research and development expenses 7,672 14,282
Total research and development expenses $ 69,302 $ 88,599
Direct expenses for the Company’s vascular trauma, AV access for hemodialysis and PAD indications include costs related to the Company’s clinical trials, including fees paid to CROs, consultants, clinical sites and investigators. Costs related to development activities which broadly support multiple programs using the Company’s 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 reported in the table above include direct costs not identifiable with a specific product candidate, including costs associated with the Company’s research and
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development platform used across programs, process development, manufacturing analytics and preclinical research and development for prospective product candidates and new technologies.
Non-cash Operating Expenses
Year Ended December 31,
Inventory
The Company capitalizes inventory when it concludes that commercialization and future economic benefit from the sale of products is probable. Prior to this conclusion, the Company expenses inventory as research and development expense in the condensed consolidated statements of operations and comprehensive loss in the period incurred. The determination to capitalize inventory costs is based on various factors, including the product’s historical shelf life, the product’s current status in the development and regulatory approval process, results from related clinical trials, results from meetings with relevant regulatory agencies, potential obstacles to the approval process and viability of commercialization and market trends.
In early 2025, based on the Company’s assessment of the legal and regulatory process related to Symvess, the Company concluded that it met the criteria to capitalize expenditures as inventory. The Company capitalized $22.5 million of inventory as of December 31, 2025 and none as of December 31, 2024.
Inventory is stated at the lower of cost or net realizable value. The Company’s inventory is valued under the first in, first out method. Cost includes direct materials, direct labor and an allocation of manufacturing overhead. Raw and intermediate materials that may be used for either research and development or commercial purposes are classified as inventory until the material is consumed or otherwise allocated for research and development. If the material is used for research and development, it is expensed as research and development once that determination is made.
The Company evaluates inventory for excess, obsolete or slow-moving items based on historical and forecasted demand, product shelf life, regulatory considerations and other factors that may affect the recoverability of inventory. When necessary, the Company records a reserve to reduce inventory to its estimated net realizable value. The determination of any required inventory reserve involves significant judgment and is based on estimates of future sales volumes, expected market acceptance and demand for the Company’s products. As the Company commenced commercialization of Symvess in 2025 and has limited commercial sales history, actual future demand may differ from current estimates. Changes in demand forecasts, market conditions, manufacturing performance or other factors could result in additional inventory write-downs in future periods.
During the year ended December 31, 2025, the Company recorded an inventory reserve of $8.9 million to adjust certain inventory to its estimated net realizable value. Provision for inventory reserves and write-downs is recorded within cost of goods sold in the consolidated statements of operations and comprehensive loss. Cost of goods sold was $9.7 million for the year ended December 31, 2025, which includes the $8.9 million inventory reserve, overhead related to unused production capacity, and royalty expense related to product sales. No cost of goods sold was recognized during the year ended December 31, 2024.
Revenue Recognition
Revenue from Customers
Under Accounting Standards Codification 606, “Revenue from Contracts with Customers” (“ASC 606”), revenue is recognized when a customer obtains control of promised goods or services and is recognized in an amount that reflects the consideration that an entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity
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satisfies a performance obligation. ASC 606 also impacts certain other areas, such as the accounting for costs to obtain or fulfill a contract.
In addition, ASC 606 requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers.
For contracts where the period between when the Company transfers a promised good or service to the customer and when the customer pays is one year or less, the Company has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component.
Product Revenue
The Company’s current source of product revenue has been from U.S. sales of Symvess. The Company recognizes product revenue upon delivery of Symvess to the customer. Revenue is recognized based on the price stated in the approved contract or purchase order. There are no contractual rights of returns and replacements for damaged products are provided free of charge. Accounts receivable related to product sales were approximately $0.4 million as of December 31, 2025. There were no accounts receivable related to product sales as of December 31, 2024.
Contract Revenue
Contract revenue consists of revenue related to a single contract with a customer to recover contract expenses. The expenses incurred related to the contract are primarily classified as research and development expenses on the Company’s condensed consolidated statements of operations and comprehensive loss. The Company recognizes revenue associated with each performance obligation as the research and development services are provided using an input method, according to the actual costs incurred compared to the total costs expected to be incurred to satisfy the performance obligation. The transfer of control occurs as the program expenses are incurred and, in management’s judgment, is the best measure of progress towards satisfying each performance obligation. The transaction price is determined based on the milestones within the contract and there is no variable consideration. Accounts receivable related to the Company’s contract revenue were insignificant and $0.2 million as of December 31, 2025 and December 31, 2024, respectively.
Cost of Goods Sold
Cost of goods sold consists of manufacturing costs, transportation and freight, depreciation, indirect overhead costs (including salary related and stock-based compensation expenses) associated with the commercial manufacturing and distribution of Symvess, and third-party royalties payable on our net product revenue. Cost of goods sold may also include period costs related to excess, dated or obsolete inventory adjustment charges, unabsorbed manufacturing and other overhead costs.
Interest Expense
Interest expense is recognized using the effective interest method, which reflects a constant rate of interest over the estimated term of the related financing arrangement. Interest expense includes stated interest, as well as the amortization of original issue discounts, issuance costs, premiums, and other amounts that are economically part of the borrowing. Debt is initially recorded at the proceeds received, net of any discounts and issuance costs, and subsequently amortized and accreted to the contractual repayment amount over the estimated term of the arrangement. Changes in the timing or amount of expected cash flows, when applicable, are accounted for in accordance with U.S. GAAP and reflected prospectively through amortization and accretion into interest expense. Interest expense is recorded in interest expense in the consolidated statements of operations and comprehensive loss.
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Comprehensive Loss
Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. There was no difference between net loss and comprehensive loss for the years ended December 31, 2025 and 2024.
Concentration of Credit Risk
Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, including amounts classified as restricted cash. Total cash balances exceeded insured balances by the Federal Deposit Insurance Corporation as of December 31, 2025 and December 31, 2024. The Company believes it mitigates this risk by monitoring the financial stability of the institutions holding material cash and cash equivalents balances. The Company maintains the majority of these balances at a Global Systemically Important Bank, as designated by the Financial Stability Board. The Company has cash equivalents that are invested in highly rated money market funds that are invested only in obligations of the U.S. government and its agencies. The Company has not experienced any credit loss relating to its cash and cash equivalents.
The Company believes that credit risks associated with its customers and contractual partners are not significant and has not recorded an allowance for credit loss as of December 31, 2025.
Cash and Cash Equivalents
The Company considers all short-term, highly liquid investments, including certificates of deposit (“CDs”) purchased with an original maturity of three months or less at the date of purchase, to be cash equivalents. Cash deposits are held with financial institutions with investment-grade ratings in the U.S. Cash deposits typically exceed federally insured limits. As of December 31, 2025 and 2024, cash and cash equivalents consisted of cash on deposit with banks denominated in U.S. dollars and investments in money market funds.
Restricted Cash
The Company classifies as restricted cash all cash pledged as collateral to secure long-term obligations and all cash whose use is otherwise limited by contractual provisions. As of December 31, 2025 and 2024, the Company classified$0.2 million in funds maintained in a separate deposit account to secure a letter of credit for the benefit of the lessor of the Company’s headquarters lease, and $0.1 million in cash balances held as collateral for the Company’s employee credit card program as restricted cash. As of December 31, 2024, the Company classified $50.0 million as stipulated under the Purchase Agreement as restricted cash. The Purchase Agreement was terminated during the year ended December 31, 2025. See Note 7, Revenue Interest Purchase Agreement for further details.
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets to the total of the amounts shown in the consolidated statements of cash flows as of December 31, 2025 and 2024.
As of December 31,
Restricted cash included in prepaid expenses and other current assets 144 144
Restricted cash included in long-term assets 209 50,209
Total cash, cash equivalents and restricted cash $ 50,850 $ 95,290
Revenue Interest Liability
On May 12, 2023, Humacyte, Inc. and Global entered into the Purchase Agreement (as defined in Note 1) with the Purchasers and another affiliate of Oberland, as agent for the Purchasers. The revenue interest liability associated with the Purchase Agreement was presented net of a debt discount comprised of issuance costs, transaction costs, the fair value of a
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freestanding option agreement related to the Purchase Agreement, and the fair value of embedded derivatives requiring bifurcation on the consolidated balance sheets. The Company imputed interest expense associated with this liability.
On December 15, 2025, the Company entered into a payoff letter with the Purchasers and the Purchasers’ Agent pursuant to which the Purchase Agreement and the Option Agreement were terminated in their entirety. As consideration for the termination of these agreements and the satisfaction of all obligations thereunder, the Company paid $38.0 million in cash and issued 5,725,190 shares of Common Stock to the Purchasers. The shares were measured at their fair value of $7.5 million, based on the closing market price of the Company's common stock on the settlement date, which was included as a component of the loss on extinguishment of debt on the consolidated statements of operations and comprehensive loss. The shares issued to the Purchasers in connection with the payoff are discussed in more detail in Note 10. The cash payment was funded with proceeds from a senior secured term loan facility with Avenue Venture Opportunities Fund II, L.P. (see Note 8, Debt). Pursuant to the Loan Agreement, as defined in Note 8, the proceeds of the Term Loan Facility, as defined in Note 8, were required to be used to repay outstanding indebtedness under the Purchase Agreement and for other general corporate purposes. The funding of the first tranche of the Term Loan Facility was conditioned upon delivery of a payoff letter with respect to all indebtedness outstanding under the Purchase Agreement and evidence that the liens securing such indebtedness would be released. The extinguishment of the Purchase Agreement was accounted for as a debt extinguishment under ASC 470-50. The termination of the Purchase Agreement released all liens and security interests previously granted to the Purchasers and their agent and relieved the Company of any further obligations to the Purchasers. See Note 7 for further details.
Derivative Liabilities
The Company evaluates debt instruments and other hybrid contracts for embedded features that may be required to be separated and accounted for as derivative instruments in accordance with ASC Topic 815, “Derivatives and Hedging” (“ASC 815”), and, when applicable, ASC Topic 480, “Distinguishing Liabilities from Equity” (“ASC 480”).
In evaluating whether an embedded equity-linked feature qualifies for a derivative scope exception, the Company considers the guidance in ASC 815-40, “Contracts on an Entity’s Own Equity” (“ASC 815-40”), including whether the feature is indexed to the Company’s own stock and meets the related equity classification conditions.
When the Company concludes that an embedded conversion feature must be bifurcated, the Company records the bifurcated embedded feature as a derivative liability at fair value on the issuance date (or modification date, as applicable). The host debt instrument is accounted for under the applicable debt guidance, with the proceeds allocated between the host and the bifurcated derivative, which generally results in a debt discount that is amortized to interest expense over the term of the related debt using the effective interest method.
The derivative liability is subsequently remeasured to fair value at each reporting date, with changes in fair value recognized in earnings within Change in fair value of derivatives in other income (expense), net. The Company estimates fair value using valuation techniques appropriate to the terms of the instrument, which may include option-pricing models, such as Black-Scholes option pricing model, that require highly volatile assumptions and data inputs, including the Company’s common stock price, expected volatility, expected term, risk-free interest rate, and expected dividend yield.
The Company performs its embedded derivative assessment at contract inception and upon modification and also evaluates, each reporting period, whether changes in facts and circumstances affect the accounting for, classification of, or required disclosures related to derivative liabilities.
Contingent Derivative Liability
The Put Option under the Purchase Agreement, as defined in Note 7, exercisable by the Purchasers upon certain contingent events, was determined to be an embedded derivative requiring bifurcation and separately accounted for as a single compound derivative instrument (the “Contingent derivative liability”). In connection with the termination of the Purchase Agreement in December 2025, the embedded derivative was extinguished and derecognized.See Note 7 for further details.
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Loan Agreement Conversion Derivative Liability
On December 15, 2025, the Company entered into the Loan Agreement (as defined in Note 8), providing for the Term Loan Facility (as defined in Note 8) of up to $77.5 million in aggregate. Under the Loan Agreement the Lenders (as defined in Note 8), may convert up to $2.5 million of outstanding principal into shares of the Common Stock at a contractually specified price, subject to ownership limitations and customary conditions. The Company evaluated the conversion feature in accordance with ASC 815 and concluded that it does not qualify for the scope exception for contracts indexed to the Company’s own equity. Certain provisions, including those that affect the economics of settlement upon a change in control, result in outcomes that are not consistent with the settlement of a fixed-for-fixed equity instrument. Accordingly, the conversion feature is bifurcated from the host debt and accounted for as a derivative liability at fair value, with subsequent changes in fair value recognized in earnings. At issuance, the Company recognized the bifurcated conversion feature as a derivative liability (the “Loan Agreement conversion derivative liability”), with a corresponding debt discount recorded against the carrying amount of the related term loan. See Note 10 for additional information.
Net Loss per Share Attributable to Common Stockholders
Basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period without consideration of potentially dilutive shares of Common Stock. Diluted net loss per share attributable to common stockholders reflects the potential dilution that could occur if securities or other contracts to issue Common Stock were exercised or converted into Common Stock or resulted in the issuance of Common Stock that then shared in the earnings of the Company unless inclusion of such shares would be anti-dilutive. As the Company has incurred losses for the years ended December 31, 2025 and 2024, basic and diluted net loss per share is the same for each period.
The following potential shares of Common Stock were excluded from the computation of diluted net loss per share for each period because including them would have had an antidilutive effect:
Year Ended December 31,
Exercise of RSUs under stock plan 1,985,390 —
Conversion shares issuable under the Loan Agreement 2,500,000 —
Exercise of option by underwriters 308,219 —
The 15,000,000 Contingent Earnout Shares (defined below) are excluded from the anti-dilutive table for all periods presented, as such shares are contingently issuable until the share price of the Company exceeds specified thresholds that have not yet been achieved, or upon the occurrence of a change in control. The Option Agreement, as defined in Note 7, was excluded from the anti-dilutive table for the year ended December 31, 2024, based on the Company’s assumption that the Option Agreement would not be exercised unless the Company’s stock price exceeded $7.50 per share, the minimum purchase price under the Option Agreement. In connection with the termination of the Purchase Agreement in December 2025, the Option Agreement was terminated in its entirety, and as a result, was excluded from the anti-dilutive table for the year ended December 31, 2025. See Note 7 for further details.
Fair Value of Financial Instruments
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants at the measurement date. ASC 820, Fair Value Measurement and Disclosures, establishes a hierarchy whereby inputs to valuation techniques used in measuring fair value are prioritized, or the fair value hierarchy. There are three levels to the fair value hierarchy based on reliability of inputs, as follows:
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Level 1 — Observable inputs that reflect unadjusted quoted prices for identical assets or liabilities in active markets.
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Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
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Level 3 — Unobservable inputs in which little or no market data exists, therefore requiring the Company to develop its own assumptions.
The Company evaluates assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them for each reporting period, utilizing valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The determination requires significant judgments to be made by the Company.
Property and Equipment, Net
Property and equipment, net are recorded at cost less accumulated depreciation. Expenditures for major additions and improvements are capitalized and minor replacements, maintenance, and repairs are charged to expense as incurred. When property and equipment are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet accounts and any resulting gain or loss is included in the results of operations for the respective period. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets.
The estimated useful lives for significant asset categories are as follows:
Property and equipment Estimated UsefulLives (Years)
Scientific equipment 5 – 7
Computer equipment 5
Software 3
Furniture and fixtures 5 – 7
Leasehold improvements Lesser of useful life or life of lease
Construction in progress N/A
Impairment of Long-Lived Assets
The Company reviews the carrying value of property and equipment for indicators of possible impairment whenever events and circumstances indicate that the carrying value of an asset or asset group may not be recoverable from the estimated future net undiscounted cash flows expected to result from its use and eventual disposition. In cases where estimated future net undiscounted cash flows are less than the carrying value, an impairment loss is recognized equal to an amount by which the carrying value exceeds the fair value of the asset or asset group. The factors considered by management in performing this assessment include current operating results, trends and prospects, the manner in which the property is used, and the effects of obsolescence, demand, competition, and other economic factors. Based on this assessment, during the years ended December 31, 2025 and 2024, respectively, the Company concluded there were no such events or changes in circumstances requiring review of the carrying amount of the Company’s long-lived assets and there was no impairment during the years ended December 31, 2025 and 2024.
Income Taxes
Income taxes are computed using the asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s financial statements. A valuation allowance is recorded, if necessary, to reduce net deferred tax assets to their realizable values if management does not believe it is more likely than not that the net deferred tax assets will be realized. As of December 31, 2025 and 2024, the Company has recorded a full valuation allowance against its deferred tax assets.
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The Company applies the accounting guidance for uncertainties in income taxes, which prescribes a recognition threshold and measurement process for recording uncertain tax positions taken, or expected to be taken, in a tax return in the financial statements. Additionally, the guidance also prescribes the treatment for derecognition, classification, accounting in interim periods and disclosure requirements for uncertain tax positions. The Company accrues for the estimated amount of taxes for uncertain tax positions if it is more likely than not that the Company would be required to pay such additional taxes.
The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit can be recognized. Assessing an uncertain tax position begins with the initial determination of the sustainability of the position and is measured at the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed. Additionally, the Company must accrue interest and related penalties, if applicable, on all tax exposures for which reserves have been established consistent with jurisdictional tax laws.
The Company has analyzed its filing positions in all significant Federal and state jurisdictions where it is required to file income tax returns, as well as open tax years in these jurisdictions. As of December 31, 2025 and 2024, the Company has determined that no uncertain tax positions would have a material impact on the financials statements of the Company. The Company is no longer subject to Federal, state, and local tax examinations by tax authorities for years before 2021 although carry-forward attributes that were generated prior to 2021 may still be adjusted upon examination by the taxing authorities if they either have been or will be used in a future period. No income tax returns are currently under examination by taxing authorities.
As of December 31, 2025 and 2024, the Company had not recorded any amounts for unrecognized tax benefits. The Company’s policy is to recognize interest and penalties related to uncertain tax positions in the provision for income taxes. As of December 31, 2025 and 2024, the Company had no accrued interest or penalties related to uncertain tax positions, and no amounts had been recognized in the Company’s statements of operations and comprehensive loss.
Intellectual Property
The Company seeks to protect its intellectual property by filing patent applications in the United States and abroad related to novel technologies and product candidates that it views as important to its business. The patent positions of biotechnology companies generally, including the Company’s patent positions, is highly uncertain and involves complex legal and factual questions for which legal principles remain unresolved. Patent costs have been expensed as incurred as general and administrative expense.
Research and Development
The Company expenses research and development costs as operating expenses as incurred. Research and development expenses consist primarily of:
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salaries and related overhead expenses for personnel in research and development functions, including stock-based compensation and benefits;
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fees paid to CROs and consultants, including in connection with 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;
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allocation of facility lease and maintenance costs;
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depreciation of leasehold improvements, laboratory equipment and computers;
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costs related to purchasing raw materials for and producing product candidates for clinical trials;
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costs related to compliance with regulatory requirements;
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costs related to the manufacturing scale-out initiative; and
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license fees related to in-licensed technologies.
Accrued Research and Development
The Company has entered into various agreements with CROs, which conduct preclinical studies and clinical trials. The Company’s research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued expenses on the balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets until the services are rendered.
Stock-Based Compensation
The Company accounts for stock-based awards to employees and non-employees in accordance with ASC 718, Compensation - Stock Compensation. Stock-based awards are measured at the grant date based on the award’s fair value and recognized as compensation expense over the requisite service period, which is generally the vesting period.
For awards with graded vesting schedules, the Company recognized compensation expense on a straight-line basis over the requisite period for each separately vesting tranche. For awards with performance-based vesting conditions, compensation expense is recognized over the requisite service period using the accelerated attribution method to the extent achievement of the performance-based condition is probable. The Company does not recognize compensation expense related to awards with performance-based vesting conditions until it is probable that the performance-based vesting condition will be achieved. Forfeitures are accounted for as they occur.
Stock Options
The Company recognizes stock-based compensation expense of stock options based on the grant-date fair value of the awards estimated using the Black-Scholes option-pricing model. Option valuation models, including the Black-Scholes option-pricing model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility, the expected term of the award, and the fair value of the underlying Common Stock on the date of grant. Forfeitures are accounted for as they occur.
Restricted Stock Units (“RSUs”)
The fair value of RSUs is measured on the grant date based on the closing market price of Common Stock on the grant date. Compensation cost related to RSUs is recognized on a straight-line basis over the requisite service period and is adjusted for forfeitures as they occur.
Common Stock Warrants
The Company evaluates warrants and other freestanding equity-linked financial instruments to determine the appropriate classification as equity or liabilities in accordance with the guidance ASC 480 and ASC 815. In performing this assessment, the Company considers, among other factors, whether the warrant is a freestanding financial instrument, whether the warrant is required to be classified as a liability under ASC 480, and whether the warrant qualifies for the scope exception from derivative accounting for contracts on an entity’s own equity under ASC 815, including whether the warrant is indexed to the Company’s common stock and meets the related equity classification conditions. This assessment requires the use of judgment and is performed at the time of issuance, upon modification, and at the end of each reporting period while warrants remain outstanding.
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Equity-classified warrants are classified in stockholders’ equity and are initially recorded at fair value at the issuance date or at the modification date, as applicable. Equity-classified warrants are not subsequently remeasured, unless the warrants are modified and such modification results in reclassification or other accounting consequences.
Warrants that do not meet all criteria for equity classification are recorded as warrant liabilities on the consolidated balance sheets at fair value on the issuance date. Warrant liabilities are subsequently remeasured at fair value at each reporting date, with changes in fair value recognized in earnings in the consolidated statements of operations and comprehensive loss.
The fair value of warrant liabilities is estimated using valuation techniques that are appropriate to the terms of the instruments, which may include option-pricing models, such as Black-Scholes option pricing model, that require highly volatile assumptions and data inputs, including the Company’s common stock price, expected volatility, expected term, risk-free interest rate, and expected dividend yield. Warrant liabilities are classified as Level 3 in the fair value hierarchy due to unobservable inputs. See Note 10, Stockholders’ Equity (Deficit) and Warrants for more details on the Company's outstanding warrants.
Contingent Earnout Liability
Pursuant to the Merger Agreement, following the closing of the Merger (the “Closing”), Legacy Humacyte equity holders are entitled to receive additional merger consideration of up to 15,000,000 additional shares of Common Stock (the “Contingent Earnout Shares”), comprised of two separate tranches of 7,500,000 shares per tranche, for no consideration upon the occurrence of certain triggering events, including a change of control event that is not solely indexed to the Common Stock. In accordance with ASC 815-40, as the earnout shares were not indexed to the common stock, they were accounted for as a liability (“Contingent Earnout Liability”) at the Reverse Recapitalization date and subsequently remeasured at each reporting date with changes in fair value recorded as a component of other income (expense), net in the consolidated statements of operations and comprehensive loss.
The estimated fair value of the Contingent Earnout Liability was determined using a Monte Carlo simulation using a distribution of potential outcomes on a monthly basis over a 10-year period prioritizing the most reliable information available. The assumptions utilized in the calculation were based on the achievement of certain stock price milestones, including the expected volatility and expected term, as well as certain data inputs, including the Common Stock price, risk-free interest rate, and expected dividend yield.
The Contingent Earnout Shares are categorized as a Level 3 fair value measurement (see “Fair Value of Financial Instruments” accounting policy described above) because the Company estimated projections over a 10-year period utilizing unobservable inputs. Contingent earnout payments involve certain assumptions requiring significant judgment and actual results can differ from assumed and estimated amounts.
Leases
The Company accounts for its leases under ASC 842, Leases. The Company determines if an arrangement is or contains a lease and the classification of that lease at inception of a contract. The Company’s operating lease assets are included in “other long-term assets”, and the current and non-current portions of the operating lease liabilities are included in “other current liabilities”, and “other long-term liabilities”, respectively, on the consolidated balance sheets. The Company’s finance lease assets are included in “finance lease right-of-use assets, net”, and the current and non-current portions of the finance lease liabilities are included in “finance lease obligation, current portion”, and “finance lease obligation, net of current portion”, respectively, on the consolidated balance sheets.
Under this guidance, arrangements meeting the definition of a lease are classified as operating or finance leases, and are recorded on the consolidated balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease right-of-use assets and lease obligations are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Operating lease right-of-use assets are adjusted for (i) payments made at or before the commencement date, (ii) initial direct costs incurred, and (iii) tenant incentives under the lease. As the implicit rate for the operating leases were
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not determinable, the Company used an incremental borrowing rate based on the information available at the respective lease commencement dates in determining the present value of future payments. The incremental borrowing rate represents the interest rate the Company would expect to incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of a lease. The Company determined the incremental borrowing rate by considering various factors, such as its credit rating, interest rates of similar debt instruments of entities with comparable credit ratings, the lease term and the currency in which the lease was denominated. The Company considers a lease term to be the noncancelable period that it has the right to use the underlying asset, including any periods where it is reasonably certain the Company will exercise any option to extend the contract.
Lease expenses for minimum lease payments for operating leases are recognized on a straight-line basis over the lease term. Amortization expense of the right-of-use asset for finance leases is recognized on a straight-line basis over the lease term and interest expense for finance leases is recognized based on the incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right of use asset is amortized over the lease term.
In calculating the right-of-use assets and lease liabilities, the Company has elected to combine lease and non-lease components for all asset classes. The Company excludes short-term leases, if any, having initial terms of 12 months or less from the guidance under ASC 842 as an accounting policy election, and recognizes rent expense on a straight-line basis over the lease term.
During the third quarter of 2025, the Company executed an amendment to its lease agreements that extended the lease term and modified key financial terms, including rent and related provisions. The amendment also resulted in a remeasurement of the related lease liability and right-of-use asset as of September 30, 2025, using the Company’s incremental borrowing rate at that date. See Note 9, Leases for additional details regarding the amendment and its impact to the condensed consolidated financial statements.