Basis of Presentation

The Company has prepared the accompanying condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Company’s condensed 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, right-of-use assets and lease liabilities, accruals for research and development activities, inventory valuation, the fair value of Contingent Earnout Liability, derivative liabilities (including 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.

Unaudited Interim Condensed Consolidated Financial Statements

The accompanying interim condensed consolidated financial statements and the related footnote disclosures are unaudited. These unaudited interim financial statements have been prepared on the same basis as the audited financial statements and, in management’s opinion, include all adjustments, consisting of only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2026 and its results of operations for the three months ended March 31, 2026 and 2025, and cash flows for the three months ended March 31, 2026 and 2025. The results of operations for the three months ended March 31, 2026 are not necessarily indicative of the results to be expected for the year ending December 31, 2026 or any other period. The December 31, 2025 year-end condensed consolidated balance sheet was derived from audited annual financial statements but does not include all disclosures from the annual financial statements.

Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2025 and the related notes included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 27, 2026, which provides a more complete discussion of the Company’s accounting policies and certain other information. There have been no significant changes to the significant accounting policies disclosed in Note 2 of the audited consolidated financial statements as of and for the years ended December 31, 2025 and 2024 included in the Company’s Annual Report.

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 condensed consolidated statements of operations and comprehensive (loss) income. The measure of segment assets provided to and reviewed by the CODM is reported on the condensed 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) income. Consolidated net (loss) income 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 selling, general and administrative expenses. Significant segment expenses within net income (loss) include cost of goods sold, research and development and selling, general and administrative expenses, which are each separately presented on the Company’s condensed consolidated statements of operations and comprehensive (loss) income. Other segment items within net (loss) income include interest income, interest expense, changes in the fair value of the Company’s Contingent Earnout Liability (as defined in Note 7, Stockholders’ Equity (Deficit) and Warrants), and changes in the fair value of derivatives.

Additional disaggregated significant segment expenses that are not separately presented on the Company’s condensed consolidated statements of operations and comprehensive (loss) income are presented below:

Direct expenses for the Company’s vascular trauma, arteriovenous (“AV”) access for hemodialysis and peripheral artery disease (“PAD”) indications include costs related to the Company’s clinical trials, including fees paid to clinical research organizations (“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 cost prior to inventory capitalization, 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 development platform used across programs, process development, manufacturing analytics and preclinical research and development for prospective product candidates and new technologies.

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) income 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 $20.4 million of inventory as of March 31, 2026 and $22.5 million as of December 31, 2025. 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.

As of March 31, 2026 and December 31, 2025, the Company’s allowance for inventory obsolescence was $10.5 million and $8.9 million, respectively. Provision for inventory reserves and write-downs is recorded within cost of goods sold in the condensed consolidated statements of operations and comprehensive (loss) income. Cost of goods sold was $2.0 million for the three months ended March 31, 2026, which includes a $1.6 million provision to increase the allowance for inventory obsolescence, overhead related to unused production capacity, and royalty expense related to product sales. Cost of goods sold was $0.1 million for the three months ended March 31, 2025.

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 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 is derived 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 return, and replacements for damaged products are provided free of charge. Accounts receivable related to product sales were approximately $0.4 million as of both March 31, 2026, and December 31, 2025.

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) income. 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 as of both March 31, 2026, and December 31, 2025.

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 the Company’s net product revenue. Cost of goods sold may also include period costs related to excess, dated, or obsolete inventory adjustment charges, and unabsorbed manufacturing and other overhead costs. Inventory is expensed to costs of goods sold when revenue is recognized related to the product.

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 condensed consolidated statements of operations and comprehensive (loss) income.

Comprehensive (Loss) Income

Comprehensive (loss) income includes net (loss) income 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) income and comprehensive (loss) income for the periods ended March 31, 2026 and March 31, 2025.

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 March 31, 2026 and December 31, 2025. 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 March 31, 2026.

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 March 31, 2026 and December 31, 2025, 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 March 31, 2026 and December 31, 2025, $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.

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.

Net (Loss) Income per Share Attributable to Common Stockholders

Basic net (loss) income per share attributable to common stockholders is computed by dividing net (loss) income attributable to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period. Potentially dilutive securities are excluded from basic net (loss) income per share. Diluted net (loss) income 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 or otherwise resulted in the issuance of shares of Common Stock, except when the effect would be anti-dilutive. The calculation of net (loss) income per share also considers the effect of participating securities. The Common Stock warrants issued in the Company’s October 2024, November 2024, and October 2025 registered direct offerings are considered participating securities and are included in the computation of net (loss) income per share pursuant to the two-class method. In applying the two-class method, during periods of net income, earnings are allocated to both Common Stock shares and participating securities based on their respective weighted-average shares outstanding for the period. During periods of net loss, no allocation is made to participating securities because they do not share in the Company’s losses.

The 15,000,000 Contingent Earnout Shares (as defined in Note 7) were 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 shares subject to the Option Agreement, as defined in Note 5, Revenue Interest Purchase Agreement, were excluded from the anti-dilutive table in the prior period presented 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.

Recently Adopted Accounting Pronouncements

In July 2025, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2025-05, “Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets” (“ASU 2025-05”). ASU 2025-05 amends the guidance in ASC 326 to simplify the estimation of credit losses for current accounts receivable and current contract assets arising from transactions accounted for under ASC 606 by permitting entities to elect a practical expedient to assume that current conditions as of the balance sheet date will remain unchanged for the remaining life of the asset when developing reasonable and supportable forecasts for expected credit losses. ASU 2025-05 is effective for annual reporting periods beginning after December 15, 2025 and interim reporting periods within those annual reporting periods, with early adoption permitted. Companies that elect the practical expedient are required to apply the amendments prospectively. The Company adopted ASU 2025-05 in the first quarter of 2026 on a prospective basis and elected the practical expedient. The adoption of ASU 2025-05 did not have a material impact on the Company’s condensed consolidated financial statements.

Recently Issued Accounting Pronouncements

In November 2024, the FASB issued ASU No. 2024-03, “Income Statement: Reporting Comprehensive Income—Expense Disaggregation Disclosures” (Subtopic 220-40), “Disaggregation of Income Statement Expenses” (“ASU 2024-03”). In January 2025, the FASB issued ASU No. 2025-01, “Income Statement: Reporting Comprehensive Income—Expense Disaggregation Disclosures” (Subtopic 220-40), “Clarifying the Effective Date” (“ASU 2025-01”). ASU 2024-03 requires additional disclosure about the nature and amounts of expenses included in certain expense captions presented on the income statement to enhance the transparency of the relevant expense captions. ASU 2024-03, as clarified by ASU 2025-01, is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted. Entities may elect to apply the amendments either prospectively or retrospectively. The Company is currently evaluating the impact of adopting ASU 2024-03 on the Company’s consolidated financial statements and related disclosures.

In December 2025, the FASB issued ASU No. 2025-10, “Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities” (“ASU 2025-10”), to provide guidance on how business entities should recognize, measure, and present government grants received. ASU 2025-10 is effective for fiscal years beginning after December 15, 2028, including interim periods within those fiscal years. Early adoption is permitted, and the amendments may be applied using a modified prospective, modified retrospective, or full retrospective adoption. The Company is currently evaluating the impact of adopting ASU 2025-10 on the Company’s consolidated financial statements and related disclosures.

In December 2025, the FASB issued ASU No. 2025-11, “Interim Reporting (Topic 270): Narrow-Scope Improvements” (“ASU 2025-11”), which is intended to improve the navigability of the guidance in ASC 270, Interim Reporting, and clarify when it applies. Under the amendments, an entity is subject to ASC 270 if it provides interim financial statements and notes in accordance with U.S. GAAP. ASU 2025-11 also addresses the form and content of such financial statements, interim disclosures requirements, and establishes a principle under which an entity must disclose events since the end of the last annual reporting period that have a material impact on the entity. ASU 2025-11 is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted, and the amendments may be applied prospectively or retrospectively to all periods presented in the financial statements. The Company is currently evaluating the impact of adopting ASU 2025-11 on the Company’s consolidated financial statements and related disclosures.