Humacyte Inc.

03/27/2026 | Press release | Distributed by Public on 03/27/2026 14:46

Annual Report for Fiscal Year Ending December 31, 2025 (Form 10-K)

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

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

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:

•
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;
•
obtain marketing approval for our 6 millimeter ATEV in additional indications involving vascular repair, reconstruction and replacement, including in AV access for hemodialysis;
•
scale out our manufacturing facility to the extent required to satisfy potential market demand for Symvess in the United States and our product candidates, following receipt of any regulatory approval;
•
continue our preclinical and clinical development efforts;
•
maintain, expand and protect our intellectual property portfolio;
•
add operational, financial and management information systems and personnel to support, among other things, our product development and commercialization efforts and operations; and
•
continue operating as a public company, which includes higher costs associated with hiring additional personnel, director and officer insurance premiums, audit and legal fees and expenses for compliance with public company reporting requirements under the Exchange Act and rules implemented by the SEC and The Nasdaq Stock Market LLC ("Nasdaq").

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.

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:

•
salaries and related overhead expenses for personnel in research and development functions, including stock-based compensation and benefits;
•
fees paid to CROs and consultants, including in connection with our clinical trials, and other related clinical trial fees, such as for clinical site fees and investigator grants related to patient screening and treatment, conduct of clinical trials, laboratory work and statistical compilation and analysis;
•
allocation of facility lease and maintenance costs;
•
depreciation of leasehold improvements, laboratory equipment and computers;
•
costs related to purchasing raw materials and producing our product candidates for clinical trials;
•
costs related to compliance with regulatory requirements;
•
costs related to our manufacturing development and expanded-capabilities initiatives; and
•
license fees related to in-licensed technologies.

The 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:

•
the scope, rate of progress, expense and results of our preclinical development activities, our ongoing clinical trials and any additional clinical trials that we may conduct, and other research and development activities;
•
successful patient enrollment in and the initiation and completion of clinical trials;
•
the timing, receipt and terms of any marketing approvals from applicable regulatory authorities including the FDA and non-U.S. regulators;
•
the extent of any required post-marketing approval commitments to applicable regulatory authorities;
•
development and refinement of clinical and commercial manufacturing capabilities or making arrangements with third-party manufacturers in order to ensure that it or its third-party manufacturers are able to successfully manufacture our product;
•
obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
•
significant and changing government regulations;
•
launching commercial sales of Symvess and our product candidates, if approved, whether alone or in collaboration with others;
•
the degree of market acceptance of Symvess and any product candidates that obtain marketing approval; and
•
maintaining a continued acceptable safety profile following approval of Symvess in the vascular trauma indication and in any other indications for which approval may be granted, or for any of our product candidates, if approved.

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.

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.

Results of Operations

Comparison of the Years Ended December 31, 2025 and 2024

Year Ended December 31,

Change

($ in thousands)

2025

2024

$

%

Revenue

Product revenue, net

$

1,389

$

-

$

1,389

100

%

Contract revenue

649

-

649

100

%

Total revenue

2,038

-

2,038

100

%

Operating expenses:

Cost of goods sold

9,702

-

9,702

100

%

Research and development

69,302

88,599

(19,297

)

(22

)%

General and administrative

31,171

25,799

5,372

21

%

Total operating expenses

110,175

114,398

(4,223

)

(4

)%

Loss from operations

(108,137

)

(114,398

)

6,261

(5

)%

Other income (expense), net

Interest income

2,587

4,104

(1,517

)

(37

)%

Change in fair value of Contingent Earnout Liability

59,469

(33,045

)

92,514

(280

)%

Interest expense

(11,250

)

(9,277

)

(1,973

)

21

%

Change in fair value of derivatives

38,765

3,915

34,850

890

%

Loss on extinguishment of debt

(22,267

)

-

(22,267

)

N/A

Total other expense, net

67,304

(34,303

)

101,607

(296

)%

Net loss

$

(40,833

)

$

(148,701

)

$

107,868

(73

)%

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.

Research and Development Expenses

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

Year Ended December 31,

Change

($ in thousands)

2025

2024

$

%

Direct Expenses

Vascular Trauma

$

892

$

2,181

$

(1,289

)

(59

)%

AV Access

5,944

6,620

(676

)

(10

)%

PAD

0

143

(143

)

(100

)%

Total

6,836

8,944

(2,108

)

(24

)%

Unallocated Expenses

External services

5,241

7,071

(1,830

)

(26

)%

Materials and supplies

16,173

21,765

(5,592

)

(26

)%

Payroll and personnel expenses

33,380

36,537

(3,157

)

(9

)%

Other research and development expenses

7,672

14,282

(6,610

)

(46

)%

Total

62,466

79,655

(17,189

)

(22

)%

Total research and development expenses

$

69,302

$

88,599

$

(19,297

)

(22

)%

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

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

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

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

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 than
1 year

1 - 3 years

3 - 5 years

More than
5 years

Finance leases

$

61,165

$

2,428

$

2,199

$

7,180

$

49,358

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;
•
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,

($ in thousands)

2025

2024

Net loss

$

(40,833

)

$

(148,701

)

Non-cash adjustments to reconcile net loss to net cash used in operating activities(a):

(40,814

)

50,268

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

Net increase (decrease) in cash, cash equivalents and restricted cash

$

(44,440

)

$

14,489

Cash, cash equivalents and restricted cash at the beginning of the period

$

95,290

$

80,801

Cash, cash equivalents and restricted cash at the end of the period

$

50,850

$

95,290

(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.

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,

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.

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

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.

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