Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2024 | May 02, 2024 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-39532 | |
Entity Registrant Name | Humacyte, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 85-1763759 | |
Entity Address, Address Line One | 2525 East North Carolina Highway 54 | |
Entity Address, City or Town | Durham, | |
Entity Address, State or Province | NC | |
Entity Address, Postal Zip Code | 27713 | |
City Area Code | 919 | |
Local Phone Number | 313-9633 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 119,084,353 | |
Entity Central Index Key | 0001818382 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Common Stock | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | HUMA | |
Security Exchange Name | NASDAQ | |
Redeemable Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50 | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Redeemable Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50 | |
Trading Symbol | HUMAW | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets | ||
Cash and cash equivalents | $ 115,505 | $ 80,448 |
Prepaid expenses and other current assets | 2,421 | 2,830 |
Total current assets | 117,926 | 83,278 |
Property and equipment, net | 25,653 | 26,791 |
Finance lease right-of-use assets, net | 17,059 | 17,313 |
Other long-term assets | 828 | 841 |
Total assets | 161,466 | 128,223 |
Current liabilities | ||
Accounts payable | 3,452 | 6,490 |
Accrued expenses | 7,917 | 9,340 |
Finance lease obligation, current portion | 2,663 | 2,560 |
Operating lease obligation, current portion | 55 | 53 |
Total current liabilities | 14,087 | 18,443 |
Revenue interest liability | 57,959 | 38,600 |
Contingent Earnout Liability | 42,509 | 37,916 |
Finance lease obligation, net of current portion | 15,850 | 16,293 |
Contingent derivative liability | 4,079 | 2,636 |
Other long-term liabilities | 830 | 789 |
Total liabilities | 135,314 | 114,677 |
Commitments and contingencies (Note 11) | ||
Stockholders’ equity | ||
Preferred stock, $0.0001 par value; 20,000,000 shares designated as of March 31, 2024 and December 31, 2023; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023 | 0 | 0 |
Common stock, $0.0001 par value; 250,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 119,084,353 and 103,673,728 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 12 | 10 |
Additional paid-in capital | 595,350 | 550,850 |
Accumulated deficit | (569,210) | (537,314) |
Total stockholders’ equity | 26,152 | 13,546 |
Total liabilities and stockholders’ equity | $ 161,466 | $ 128,223 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares designated (in shares) | 20,000,000 | 20,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 |
Common stock, shares issued (in shares) | 119,084,353 | 103,673,728 |
Common stock, shares outstanding (in shares) | 119,084,353 | 103,673,728 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Statement of Comprehensive Income [Abstract] | ||
Revenue | $ 0 | $ 0 |
Operating expenses: | ||
Research and development | 21,264 | 17,278 |
General and administrative | 5,314 | 5,234 |
Total operating expenses | 26,578 | 22,512 |
Loss from operations | (26,578) | (22,512) |
Other income (expense), net: | ||
Interest income | 1,031 | 1,475 |
Change in fair value of Contingent Earnout Liability | (4,593) | (14,191) |
Interest expense | (1,816) | (1,699) |
Change in fair value of derivative liabilities | 60 | (42) |
Total other expense, net | (5,318) | (14,457) |
Net loss | (31,896) | (36,969) |
Comprehensive loss | $ (31,896) | $ (36,969) |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (0.29) | $ (0.36) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.29) | $ (0.36) |
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic (in shares) | 108,246,008 | 103,263,528 |
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, diluted (in shares) | 108,246,008 | 103,263,528 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2022 | 103,229,013 | |||
Beginning balance at Dec. 31, 2022 | $ 116,928 | $ 10 | $ 543,456 | $ (426,538) |
Equity | ||||
Proceeds from the exercise of stock options (in shares) | 100,158 | |||
Proceeds from the exercise of stock options | 119 | 119 | ||
Stock-based compensation | 1,809 | 1,809 | ||
Net loss | (36,969) | (36,969) | ||
Ending balance (in shares) at Mar. 31, 2023 | 103,329,171 | |||
Ending balance at Mar. 31, 2023 | $ 81,887 | $ 10 | 545,384 | (463,507) |
Beginning balance (in shares) at Dec. 31, 2023 | 103,673,728 | 103,673,728 | ||
Beginning balance at Dec. 31, 2023 | $ 13,546 | $ 10 | 550,850 | (537,314) |
Equity | ||||
Issuance of stock in public offering, net of issuance costs (in shares) | 15,410,000 | |||
Issuance of stock in public offering, net of issuance costs | $ 43,046 | $ 2 | 43,044 | |
Proceeds from the exercise of stock options (in shares) | 625 | 625 | ||
Proceeds from the exercise of stock options | $ 2 | 2 | ||
Stock-based compensation | 1,454 | 1,454 | ||
Net loss | $ (31,896) | (31,896) | ||
Ending balance (in shares) at Mar. 31, 2024 | 119,084,353 | 119,084,353 | ||
Ending balance at Mar. 31, 2024 | $ 26,152 | $ 12 | $ 595,350 | $ (569,210) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities | ||
Net loss | $ (31,896) | $ (36,969) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 1,274 | 1,558 |
Stock-based compensation expense | 1,454 | 1,809 |
Change in fair value of Contingent Earnout Liability | 4,593 | 14,191 |
Non-cash interest expense | 1,418 | 0 |
Change in fair value of derivative liabilities | (60) | 42 |
Amortization expense | 517 | 515 |
Non-cash operating lease costs | 13 | 12 |
Amortization of SVB debt discount | 0 | 360 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 0 | 31 |
Prepaid expenses and other current assets | 409 | 120 |
Accounts payable | (2,949) | 299 |
Accrued expenses | (2,107) | (597) |
Operating lease obligation | (13) | (12) |
Net cash used in operating activities | (27,347) | (18,641) |
Cash flows from investing activities | ||
Purchase of property and equipment | (391) | (1,152) |
Net cash used in investing activities | (391) | (1,152) |
Cash flows from financing activities | ||
Proceeds from issuance of stock in public offering, net of issuance costs | 43,396 | 0 |
Proceeds from revenue interest purchase agreement | 20,000 | 0 |
Proceeds from the exercise of stock options | 2 | 119 |
Payments of finance lease principal | (603) | (528) |
Net cash provided by (used in) financing activities | 62,795 | (409) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 35,057 | (20,202) |
Cash, cash equivalents and restricted cash at the beginning of the period | 80,801 | 149,772 |
Cash, cash equivalents and restricted cash at the end of the period | 115,858 | 129,570 |
Supplemental disclosure: | ||
Cash paid for interest on SVB loan | 0 | 881 |
Supplemental disclosure of noncash activities: | ||
Unpaid issuance costs in connection with public offering | 350 | 0 |
Unpaid transaction costs related to revenue interest purchase agreement | 500 | 0 |
Debt discount from embedded contingent derivative liability | $ 1,552 | $ 0 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Organization and Description of Business Organization Humacyte, Inc. and subsidiary (unless the context indicates otherwise, collectively, the “Company”) is pioneering the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues, advanced tissue constructs and organ systems with the goal of improving the lives of patients and transforming the practice of medicine. The Company is leveraging its regenerative medicine technology platform to develop proprietary product candidates for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. On August 26, 2021 (the “Closing Date”), Alpha Healthcare Acquisition Corp. (“AHAC”) consummated a merger pursuant to a Business Combination Agreement, dated as of February 17, 2021 (the “Merger Agreement”), by and among Humacyte, Inc. (“Legacy Humacyte”), AHAC and Hunter Merger Sub, Inc. (“Merger Sub”), a wholly owned subsidiary of AHAC. As contemplated by the Merger Agreement, Merger Sub merged with and into Legacy Humacyte, with Legacy Humacyte continuing as the surviving corporation and as a wholly-owned subsidiary of AHAC (such transactions, the “Merger,” and, collectively with the other transactions described in the Merger Agreement, the “Reverse Recapitalization”). On the Closing Date, AHAC changed its name to Humacyte, Inc. and Legacy Humacyte changed its name to Humacyte Global, Inc. (“Global”). The Merger was accounted for as a reverse recapitalization in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and under this method of accounting, AHAC was treated as the acquired company for financial reporting purposes and Legacy Humacyte was treated as the acquirer. Operations prior to the Merger are those of Legacy Humacyte. Liquidity and Going Concern Since its inception in 2004, the Company has generated no product revenue and has incurred operating losses and negative cash flows from operations in each year. To date, the Company has financed its operations primarily through the sale of equity securities and convertible debt, proceeds from the Reverse Recapitalization, borrowings under loan facilities, proceeds from a revenue interest purchase agreement and, to a lesser extent, through governmental and other grants. At March 31, 2024 and December 31, 2023, the Company had an accumulated deficit of $569.2 million and $537.3 million, respectively. The Company’s operating losses were $26.6 million and $22.5 million for the three months ended March 31, 2024 and 2023, respectively. Net cash flows used in operating activities were $27.3 million and $18.6 million during the three months ended March 31, 2024 and 2023, respectively. Substantially all of the Company’s operating losses resulted from costs incurred in connection with the Company’s research and development programs and from general and administrative costs associated with the Company’s operations. The Company expects to incur substantial operating losses and negative cash flows from operations for the foreseeable future as the Company advances its product candidates. As further disclosed in Note 6, on May 12, 2023, Humacyte, Inc. and Global entered into a Revenue Interest Purchase Agreement (the “Purchase Agreement”) with two purchasers, both affiliates of Oberland Capital Management LLC (the “Purchasers”), and another affiliate of Oberland Capital Management LLC, as agent for the Purchasers, to obtain financing with respect to the further development and commercialization of the Company’s HAV, to repay the Company’s then-existing credit facility with SVB, and for other general corporate purposes. As of March 31, 2024, $58.0 million was recorded as a revenue interest liability on the condensed consolidated balance sheet. The Purchase Agreement contains customary representations and warranties and affirmative covenants for transactions of this type, including, among others, the provision of financial and other information to the Purchaser, notice to the Purchaser upon the occurrence of certain material events, and compliance with applicable laws. The Purchase Agreement also contains customary negative covenants, including certain restrictions on the ability to incur indebtedness and grant liens or security interests on assets. On February 18, 2024, the Company agreed with the Purchasers and the Agent, to waive certain breaches related to, and extend the deadline for certain post-closing obligations under, the Purchase Agreement, including the requirement for a leasehold mortgage over the Company’s headquarters. Giving effect to the extension and waiver, the Company was obligated to deliver by no later than April 30, 2024 (or such later date as the Agent may agree in its sole discretion), an executed leasehold mortgage (or alternative documentation satisfactory to the Agent in its sole discretion) over the Company’s headquarters. On May 8, 2024, the Company agreed with the Purchasers and the Agent to waive such breaches, for so long as, among other requirements, the Company (i) delivers by no later than June 7, 2024 a landlord’s consent and waiver with respect to the Company’s headquarters and (ii) funds no later than August 17, 2024 an account in an amount of $54.0 million, over which the Agent will have certain consent and other rights. To the extent the Company is able to deliver a leasehold mortgage over its headquarters by June 7, 2024, the preceding requirements will not apply. If the Company is not successful in meeting the Agent’s deadlines in executing either a leasehold mortgage or a landlord consent and waiver or if the Company is unable to fund the required amount, the Purchasers have the right to terminate the Purchase Agreement and to require Global to repurchase the Revenue Interests. See Note 6 for further information. As of March 31, 2024, the Company had cash and cash equivalents of $115.5 million. The Company believes its cash and cash equivalents on hand will be sufficient to fund operations, including clinical trial expenses and capital expenditure requirements, for at least 12 months from the issuance date of these interim financial statements. As noted above, if the Company is not successful in executing a leasehold mortgage over its headquarters by June 7, 2024 and is required to fund a restricted account of $54.0 million or is required to repurchase the Revenue Interests, the Company’s available cash to fund operations going forward would be limited and, in such an event there could be substantial doubt about the Company’s ability to continue as a going concern as of the quarter ending June 30, 2024 unless the Company raises additional capital and/or obtains approval of the BLA, resulting in an assessment at that time that cash, additional funding commitments, and forecasted revenues are adequate to fund ongoing operations. Adequate capital may not be available to the Company when needed or on acceptable terms. If the Company is unable to raise capital, it could be forced to delay, reduce, suspend or cease its research and development programs or any future commercialization efforts, which would have a negative impact on its business, prospects, operating results and financial condition. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The Company has prepared the accompanying financial statements in conformity with U.S. GAAP. The Company ’ s condensed consolidated financial statements reflect the operations of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in the financial statements include stock-based compensation costs, right-of-use assets, accruals for research and development activities, contingent earnout liability, revenue interest liability, derivative liabilities, fair value of common stock warrants and income taxes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. 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, 2024 and its results of operations for the three months ended March 31, 2024 and 2023, and cash flows for the three months ended March 31, 2024 and 2023. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or any other period. The December 31, 2023 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, 2023 and the related notes included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 28, 2024 (the “Annual Report”), 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, 2023 and 2022 included in the Company ’ s Annual Report. Segments The Company operates and manages its business as one reportable and operating segment. 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 chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of evaluating financial performance and allocating resources. Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash balances exceeded insured balances by the Federal Deposit Insurance Corporation as of March 31, 2024 and December 31, 2023. As of both March 31, 2024 and December 31, 2023, the Company had cash equivalents held in highly rated money market funds that are invested only in obligations of the U.S. government and its agencies. 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 both March 31, 2024 and December 31, 2023, restricted cash consisted of $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 $0.1 million in cash balances held as collateral for the Company’s employee credit card program. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the total of the amounts shown in the condensed consolidated statements of cash flows as of March 31, 2024 and December 31, 2023. ($ in thousands) March 31, December 31, Cash and cash equivalents $ 115,505 $ 80,448 Restricted cash included in prepaid expenses and other current assets 144 144 Restricted cash included in other long-term assets 209 209 Total cash, cash equivalents and restricted cash $ 115,858 $ 80,801 Net Loss per Share Attributable to Common Stockholders Basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period without consideration of potentially dilutive shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”). Diluted net loss per share attributable to common stockholders reflects the potential dilution that could occur if securities or other contracts to issue Common Stock were exercised or converted into Common Stock or resulted in the issuance of Common Stock that then shared in the earnings of the Company unless inclusion of such shares would be anti-dilutive. As the Company has incurred losses for the three months ended March 31, 2024 and 2023, basic and diluted net loss per share is the same for each period. The following potential shares of Common Stock were excluded from the computation of diluted net loss per share for each period because including them would have had an antidilutive effect. Three Months Ended March 31, 2024 2023 Exercise of options under stock plan 11,882,290 7,174,560 Warrants to purchase Common Stock 5,588,506 5,588,506 The 15,000,000 Contingent Earnout Shares, as defined in Note 8, are excluded from the anti-dilutive table for all periods presented, as such shares are contingently issuable until the share price of the Company exceeds specified thresholds that have not yet been achieved, or upon the occurrence of a change in control. The Option Agreement, as defined in Note 6 — Revenue Interest Purchase Agreement, is excluded from the anti-dilutive table for the three months ended March 31, 2024 based on the Company’s assumption that the Option Agreement will not be exercised unless the Company’s stock price exceeds $7.50 per share, the minimum purchase price under the Option Agreement. Other Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, the success of clinical trials and other studies for its product candidates, including its ongoing V007 and V012 Phase 3 clinical trials, the regulatory approval and commercialization of its HAVs and other product candidates, the expected size of the target populations for the Company’s product candidates, the degree of market acceptance of the HAVs, if approved, the availability of third-party coverage and reimbursement, development by competitors of new technological innovations, the ability to manufacture HAVs and other product candidates in sufficient quantities, expectations regarding the Company’s strategic partnerships, dependence on third parties, key personnel and the ability to attract and retain qualified employees, protection of proprietary technology and confidentiality of trade secrets, compliance with governmental regulations, the Company’s implementation and maintenance of effective internal controls, and the ability to secure additional capital to fund operations and the commercial success of its product candidates. Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s commercialization efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales, and the Company may depend on certain strategic relationships to distribute its products, including the Company’s strategic partnership with Fresenius Medical Care, to sell, market and distribute its 6 millimeter HAV for certain specified indications outside the United States. Recent Accounting Pronouncements In November 2023, the FASB issued ASU No. 2023-07, “Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures” (“ASU 2023-07”). The FASB issued this update to improve the disclosures about an entity’s reportable segments, including providing more detailed information about a reportable segment’s expenses, enhancing interim disclosure requirements and providing new segment disclosure requirements for entities with a single reportable segment. This standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. Entities should apply the amendments retrospectively to all prior periods presented in the financial statements. This ASU is applicable to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2024, and subsequent interim periods. The Company is currently evaluating the impact of adopting ASU 2023-07 on its disclosures included in the notes to the consolidated financial statements. In December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740), Improvements to Income Tax Disclosures” (“ASU 2023-09”). The FASB issued this update to improve the transparency and comparability of income tax disclosures, including requiring consistent categories and greater disaggregation of information in the rate reconciliation and further disaggregation of income taxes paid by jurisdiction. This standard is effective for fiscal years beginning after December 15, 2024, with early adoption is permitted. Entities should apply the amendments prospectively, with retrospective application permitted. This ASU is applicable to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2025. The Company is currently evaluating the impact of adopting ASU 2023-09 on its disclosures included in the notes to the consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants at the measurement date. ASC 820, Fair Value Measurement and Disclosures , establishes a hierarchy whereby inputs to valuation techniques used in measuring fair value are prioritized, or the fair value hierarchy. There are three levels to the fair value hierarchy based on reliability of inputs, as follows: • Level 1 — Observable inputs that reflect unadjusted quoted prices for identical assets or liabilities in active markets. • Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3 — Unobservable inputs in which little or no market data exists, therefore requiring the Company to develop its own assumptions. The Company’s money market funds are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices. The carrying values of cash, prepaid expenses and other current assets, accounts payable and accrued expenses as of March 31, 2024 and December 31, 2023 approximated their fair values due to the short-term nature of these items. The Company evaluates assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them for each reporting period, utilizing valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The determination requires significant judgments to be made by the Company. The Company’s assets and liabilities that were measured at fair value on a recurring basis were as follows: ($ in thousands) Fair Value Measured as of March 31, 2024 Level 1 Level 2 Level 3 Total Assets: Cash equivalents (money market funds) $ 113,714 $ — $ — $ 113,714 Total financial assets $ 113,714 $ — $ — $ 113,714 Liabilities: Contingent Earnout Liability $ — $ — $ 42,509 $ 42,509 Contingent derivative liability — — 4,079 4,079 Private Placement Warrants liability — — 121 121 Option Agreement liability — — 41 41 JDRF Agreement derivative liability — — 28 28 Total financial liabilities $ — $ — $ 46,778 $ 46,778 ($ in thousands) Fair Value Measured as of December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash equivalents (money market funds) $ 78,995 $ — $ — $ 78,995 Total financial assets $ 78,995 $ — $ — $ 78,995 Liabilities: Contingent Earnout Liability $ — $ — $ 37,916 $ 37,916 Contingent derivative liability — — 2,636 2,636 Private Placement Warrants liability — — 78 78 Option Agreement liability — — 35 35 JDRF Agreement derivative liability — — 28 28 Total financial liabilities $ — $ — $ 40,693 $ 40,693 The fair value of the Contingent Earnout Liability, Private Placement Warrants liability (as defined in Note 8 — Stockholders’ Equity), contingent derivative liability related to the Put Option (as defined in Note 6 — Revenue Interest Purchase Agreement and discussed below), Option Agreement liability (as defined in Note 6 — Revenue Interest Purchase Agreement), and the derivative liability associated with the JDRF Agreement Disposition Payment are based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The fair values of the Private Placement Warrants liability, the Option Agreement liability and the derivative liability associated with the JDRF Agreement Disposition Payment, are included in other long-term liabilities on the condensed consolidated balance sheets. Contingent Earnout Liability The following table presents a summary of the changes in the fair value of the Contingent Earnout Liability: ($ in thousands) Contingent Earnout Liability Three Months Ended March 31, 2024 2023 Fair value as of beginning of period $ (37,916) $ (27,893) Change in fair value included in other income (expense), net (4,593) (14,191) Fair value as of end of period $ (42,509) $ (42,084) In determining the fair value of the Contingent Earnout Liability, the Company used the Monte Carlo simulation value 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 current Common Stock price, expected volatility, risk-free rate, expected term and expected dividend yield (see Note 8 — Stockholders’ Equity). Contingent earnout payments involve certain assumptions requiring significant judgment and actual results can differ from assumed and estimated amounts. Private Placement Warrants Liability The following table presents a summary of the changes in the fair value of the Private Placement Warrants liability: Private Placement Warrants Three Months Ended March 31, ($ in thousands) 2024 2023 Fair value as of beginning of period $ (78) $ (80) Change in fair value included in other income (expense), net (43) (42) Fair value as of end of period $ (121) $ (122) In determining the fair value of the Private Placement Warrants liability, the Company used the Monte Carlo simulation valuation model to estimate the fair value utilizing assumptions including the current Company stock price, expected volatility, risk-free rate, expected term and expected dividend yield (see Note 8 — Stockholders’ Equity). Derivative liabilities Contingent derivative liability The debt pursuant to the Purchase Agreement, as defined in Note 6, contains an embedded derivative related to the Put Option, as defined in Note 6, requiring bifurcation as a single compound derivative instrument. The Company estimated the fair value of the derivative liability using a “with-and-without” methodology. 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 derivative liability at issuance and each subsequent reporting period. In determining the fair value of the contingent derivative liability, the Company used the Monte Carlo simulation value model using a distribution of potential outcomes on a monthly basis over a 10-year period. The estimated probability and timing of underlying events triggering the exercisability of the Put Option contained within the Purchase Agreement, forecasted cash flows and the discount rates are significant unobservable inputs used to determine the estimated fair value of the entire instrument with the embedded derivative. As of March 31, 2024, the discount rates used to calculate the value of the contingent derivative liability were 13.9% to calculate the present-value of the revenue forecast and 17.5% to calculate the present-value of the payoff of the Put Option. As of December 31, 2023, the discount rates used to calculate the value of the contingent derivative liability were 14.5% to calculate the present-value of the revenue forecast and 17.1% to calculate the present-value of the payoff of the Put Option. Changes in fair value of the contingent derivative liability are recognized as other income (expense) in the condensed consolidated statements of operations and comprehensive loss, classified in change in fair value of derivative liabilities. The following table presents a summary of the changes in the fair value of the contingent derivative liability, which is classified as a Level 3 financial instrument. ($ in thousands) Three Months Ended Fair value as of beginning of period $ (2,636) Fair value of embedded derivative upon issuance of debt (1,552) (1) Change in fair value included in other income (expense), net 109 Fair value as of end of period $ (4,079) ___________________________ (1) Represents an increase in debt discount upon issuance of the second installment under the Purchase Agreement. See Note 6 for further information. |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net Property and equipment, net consist of the following: ($ in thousands) March 31, December 31, Scientific and manufacturing equipment $ 28,435 $ 28,400 Computer equipment 125 125 Software 768 682 Furniture and fixtures 1,066 1,066 Leasehold improvements 27,858 27,844 58,252 58,117 Accumulated depreciation (32,599) (31,326) Property and equipment, net $ 25,653 $ 26,791 Depreciation expense totaled $1.3 million and $1.6 million for the three months ended March 31, 2024 and 2023, respectively. All long-lived assets are maintained in the United States. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2024 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consisted of the following: ($ in thousands) March 31, December 31, Accrued external research, development and manufacturing costs $ 3,655 $ 3,845 Accrued employee compensation and benefits 3,381 5,238 Accrued professional fees 881 257 Total $ 7,917 $ 9,340 |
Revenue Interest Purchase Agree
Revenue Interest Purchase Agreement | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Revenue Interest Purchase Agreement | Revenue Interest Purchase Agreement Revenue Interest Purchase Agreement On May 12, 2023, Humacyte, Inc. and Global entered into the Purchase Agreement with the Purchasers, and another affiliate of Oberland Capital Management LLC, as agent for the Purchasers, to obtain financing with respect to the further development and commercialization of the Company’s HAV, to repay the Company’s then-existing credit facility with SVB, and for other general corporate purposes. Pursuant to the Purchase Agreement, on May 12, 2023, the Purchasers purchased certain revenue interests (the “Revenue Interests”) from Global in exchange for an aggregate investment amount of up to $150.0 million (the “Investment Amount”) to be paid in multiple tranches . On May 12, 2023, the Company received an initial payment of $40.0 million, less certain transaction expenses, which was used to repay in full the Company’s then-existing obligations under the Loan Agreement with SVB, as defined in Note 7 — Debt. In February 2024, the FDA accepted the Company’s BLA for an indication in vascular trauma, and in accordance with the Purchase Agreement, on March 11, 2024, the Company received a subsequent installment of $20.0 million. As of March 31, 2024, the Company is entitled to receive up to approximately $90.0 million in subsequent installments subject to the terms and conditions set forth in the Purchase Agreement, as follows: (i) $40.0 million, at the Company’s option, upon the Company receiving FDA approval of the HAV for the vascular trauma indication on or prior to December 31, 2024 and (ii) $50.0 million, at the Company’s option, upon reaching $35.0 million trailing worldwide three-month net sales any time prior to December 31, 2025. Each tranche is dependent on the satisfaction of the conditions and receipt of funds from the previous tranche. Pursuant to the Purchase Agreement, the Revenue Interests entitle the Purchasers to receive a royalty initially equal to 7.5% (the “Rate”) of global net sales of the Company’s products (subject to a lower rate for net sales by specified licensees outside the United States), to be paid on a calendar quarterly basis (the “Revenue Interest Payments”). If the Purchasers do not receive cumulative Revenue Interest Payments equal to 100% of the amount funded to date (the “Cumulative Purchaser Payments”) by the last business day of 2028 (the “Test Date”), the Rate will increase to a rate that, had such increased rate applied during the period from May 12, 2023 through the Test Date, would have provided the Purchasers with cumulative Revenue Interest Payments equal to the Cumulative Purchaser Payments as of the Test Date. Additionally, Global will be required to pay the Purchasers an amount equal to 100% of the Cumulative Purchaser Payments as of the Test Date less the total Revenue Interest Payments made by Global to the Purchasers under the Purchase Agreement as of the Test Date. Global’s obligation to make Revenue Interest Payments terminates on the date on which the Purchasers have received Revenue Interest Payments of 150% of the Cumulative Purchaser Payments unless the Purchase Agreement is terminated earlier due to the Purchaser’s exercise of a Put Option, the Company’s exercise of a call option, or by mutual consent. However, if the Purchasers have not received such Revenue Interest Payments as of such date, the Purchase Agreement will instead terminate on the date on which the Purchasers receive Revenue Interest Payments of 195% of the Cumulative Purchaser Payments. Under the Purchase Agreement, Global has an option (the “Call Option”) to repurchase the Revenue Interests and terminate the Purchase Agreement at any time upon advance written notice. Additionally, the Purchasers have an option (the “Put Option”) to terminate the Purchase Agreement and to require Global to repurchase the Revenue Interests upon enumerated events such as a bankruptcy event, an uncured material breach, a material adverse effect or a change of control. If the Put Option is exercised prior to August 12, 2024 by the Purchasers (except pursuant to a change of control), the required repurchase price will be 125% of the Cumulative Purchaser Payments (minus the aggregate Revenue Interest Payments Global has made to the Purchasers as of such date). If (i) the Put Option is exercised on or prior to August 12, 2024 by the Purchasers after the occurrence of a change of control, (ii) the Put Option is exercised after August 12, 2024 until May 12, 2026, or (iii) the Call Option is exercised on or prior to May 12, 2026, then in each case, the required repurchase price will be 175% of the Cumulative Purchaser Payments (minus the aggregate Revenue Interest Payments Global has made to the Purchasers as of such date). If a Put Option or Call Option is exercised after May 12, 2026, the required repurchase price will be 195% of the Cumulative Purchaser Payments (minus the aggregate Revenue Interest Payments Global has made to the Purchasers as of such date). The Purchase Agreement contains customary representations and warranties and affirmative covenants for transactions of this type, including, among others, the provision of financial and other information to the Purchaser, notice to the Purchaser upon the occurrence of certain material events, and compliance with applicable laws. The Purchase Agreement also contains customary negative covenants, including certain restrictions on the ability to incur indebtedness and grant liens or security interests on assets. On February 18, 2024, the Company agreed with the Purchasers and the Agent, to waive certain breaches related to, and extend the deadline for certain post-closing obligations under, the Purchase Agreement, including the requirement for a leasehold mortgage over the Company’s headquarters. Giving effect to the extension and waiver, the Company was obligated to deliver by no later than April 30, 2024 (or such later date as the Agent may agree in its sole discretion), an executed leasehold mortgage (or alternative documentation satisfactory to the Agent in its sole discretion) over the Company’s headquarters. On May 8, 2024, the Company agreed with the Purchasers and the Agent to waive such breaches, for so long as, among other requirements, the Company (i) delivers by no later than June 7, 2024 a landlord’s consent and waiver with respect to the Company’s headquarters and (ii) funds no later than August 17, 2024 an account in an amount of $54.0 million, over which the Agent will have certain consent and other rights. To the extent the Company is able to deliver a leasehold mortgage over its headquarters by June 7, 2024, the preceding requirements will not apply. If the Company is not successful in meeting the Agent’s deadlines in executing either a leasehold mortgage or a landlord consent and waiver or if the Company is unable to fund the required amount, the Purchasers have the right to terminate the Purchase Agreement and to require Global to repurchase the Revenue Interests. The Company has provided a parent company guaranty to guarantee the payment in full of the obligations under the Purchase Agreement. The Company’s obligations under the parent company guaranty and Global’s obligations under the Purchase Agreement and the Revenue Interests are secured by a perfected security interest on substantially all of the Company’s and Global’s assets. The Purchase Agreement is considered a sale of future revenues and accounted for as long-term debt recorded at amortized cost using the effective interest rate method. The Company recorded a revenue interest liability related to the Purchase Agreement on the accompanying condensed consolidated balance sheet on the date the Company entered into the Purchase Agreement, net of a debt discount comprised of $2.1 million issuance costs and transaction costs, $0.1 million fair value allocated to the Option Agreement, defined below, and the $2.4 million initial fair value of the bifurcated contingent derivative liability related to the Put Option. The revenue interest liability is based on the Company’s contractual repayment obligation to the Purchasers, based on the current estimates of future revenues, over the life of the Purchase Agreement. The Company imputes interest expense associated with this liability using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. The interest rate on this liability may vary during the term of the agreement depending on a number of factors, including the level and expected timing of forecasted net sales. The Company evaluates the interest rate quarterly based on its current net sales forecasts. If the level and timing of any forecasted net sales and related payments change, the Company prospectively adjusts the effective interest and the related amortization of the liability and related issuance costs on a quarterly basis. As of March 31, 2024 and December 31, 2023, $58.0 million and $38.6 million, respectively, was recorded as a revenue interest liability. The estimated effective annual interest rate as of March 31, 2024 and December 31, 2023 was 14.6% and 14.1%, respectively. The Company recorded $1.4 million in interest expense related to the Purchase Agreement for the three months ended March 31, 2024. The Put Option under the Purchase Agreement that is exercisable by the Purchasers upon certain contingent events was determined to be an embedded derivative requiring bifurcation and separately accounted for as a single compound derivative instrument. At May 12, 2023, the Company recorded the initial fair value of the derivative liability of $2.4 million as a debt discount. On March 11, 2024, upon the issuance of the second installment of the Purchase Agreement of $20.0 million, the Company estimated the fair value of the embedded derivative and recorded a $1.6 million increase in fair value as a debt discount. The debt discount is being amortized to interest expense over the expected term of the debt using the effective interest method. See Note 3 — Fair Value Measurements for a further discussion of the fair value of the contingent derivative liability associated with the Put Option. Revenue Interest Payments made as a result of the Company’s net product sales will reduce the revenue interest liability. During the three months ended March 31, 2024, the Company did not record any product sales revenue. The following table summarizes the revenue interest liability activity during the three months ended March 31, 2024: ($ in thousands) Revenue interest liability at December 31, 2023 $ 38,600 Proceeds from revenue interest purchase agreement 20,000 Debt discount from embedded contingent derivative liability (1,552) Interest expense recognized 1,411 Transaction costs accrued at March 31, 2024 (500) Revenue interest liability at March 31, 2024 $ 57,959 Option Agreement In connection with the Purchase Agreement, the Company also entered into an option agreement with TPC Investments III LP and TPC Investment Solutions LP (the “Option Agreement”), which gives TPC Investments III LP and TPC Investment Solutions LP (the “Holders”) the right to purchase, in the aggregate, up to $10.0 million worth of shares of common stock of the Company (the “Option”) at a purchase price per share equal to the greater of $7.50, or the 15 day volume-weighted average price as of the exercise date, exercisable in cash only at any time prior to the earlier of (i) December 31, 2026 and (ii) the closing date of a corporate reorganization. The Holders also received certain registration rights relating to the shares underlying the Option pursuant to the Option Agreement. The Option granted to the Holders represents a freestanding instrument separate from the purchaser commitments outlined in the Purchase Agreement. The Option Agreement does not qualify for the equity contract scope exception under ASC 815-40 and the Company recorded the Option as a liability (“Option Agreement liability”) on the condensed consolidated balance sheet at an initial fair value of $55 thousand, with subsequent changes in the fair value to be recognized in the condensed consolidated statements of operations and comprehensive loss at each reporting date. The fair value of the Option Agreement liability as of March 31, 2024 and December 31, 2023 was $41 thousand and $35 thousand, respectively. Pursuant to the Purchase Agreement, on May 12, 2023 , $40.0 million , less certain transaction expenses, was funded to the Company, which was used to repay in full the Company’s existing obligations under its term loan agreement with Silicon Valley Bank (“SVB”) and SVB Innovation Credit Fund VIII, L.P., entered into on March 30, 2021, as amended in June 2021 and September 2021 (the “Loan Agreement”). |
Debt
Debt | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
Debt | Revenue Interest Purchase Agreement Revenue Interest Purchase Agreement On May 12, 2023, Humacyte, Inc. and Global entered into the Purchase Agreement with the Purchasers, and another affiliate of Oberland Capital Management LLC, as agent for the Purchasers, to obtain financing with respect to the further development and commercialization of the Company’s HAV, to repay the Company’s then-existing credit facility with SVB, and for other general corporate purposes. Pursuant to the Purchase Agreement, on May 12, 2023, the Purchasers purchased certain revenue interests (the “Revenue Interests”) from Global in exchange for an aggregate investment amount of up to $150.0 million (the “Investment Amount”) to be paid in multiple tranches . On May 12, 2023, the Company received an initial payment of $40.0 million, less certain transaction expenses, which was used to repay in full the Company’s then-existing obligations under the Loan Agreement with SVB, as defined in Note 7 — Debt. In February 2024, the FDA accepted the Company’s BLA for an indication in vascular trauma, and in accordance with the Purchase Agreement, on March 11, 2024, the Company received a subsequent installment of $20.0 million. As of March 31, 2024, the Company is entitled to receive up to approximately $90.0 million in subsequent installments subject to the terms and conditions set forth in the Purchase Agreement, as follows: (i) $40.0 million, at the Company’s option, upon the Company receiving FDA approval of the HAV for the vascular trauma indication on or prior to December 31, 2024 and (ii) $50.0 million, at the Company’s option, upon reaching $35.0 million trailing worldwide three-month net sales any time prior to December 31, 2025. Each tranche is dependent on the satisfaction of the conditions and receipt of funds from the previous tranche. Pursuant to the Purchase Agreement, the Revenue Interests entitle the Purchasers to receive a royalty initially equal to 7.5% (the “Rate”) of global net sales of the Company’s products (subject to a lower rate for net sales by specified licensees outside the United States), to be paid on a calendar quarterly basis (the “Revenue Interest Payments”). If the Purchasers do not receive cumulative Revenue Interest Payments equal to 100% of the amount funded to date (the “Cumulative Purchaser Payments”) by the last business day of 2028 (the “Test Date”), the Rate will increase to a rate that, had such increased rate applied during the period from May 12, 2023 through the Test Date, would have provided the Purchasers with cumulative Revenue Interest Payments equal to the Cumulative Purchaser Payments as of the Test Date. Additionally, Global will be required to pay the Purchasers an amount equal to 100% of the Cumulative Purchaser Payments as of the Test Date less the total Revenue Interest Payments made by Global to the Purchasers under the Purchase Agreement as of the Test Date. Global’s obligation to make Revenue Interest Payments terminates on the date on which the Purchasers have received Revenue Interest Payments of 150% of the Cumulative Purchaser Payments unless the Purchase Agreement is terminated earlier due to the Purchaser’s exercise of a Put Option, the Company’s exercise of a call option, or by mutual consent. However, if the Purchasers have not received such Revenue Interest Payments as of such date, the Purchase Agreement will instead terminate on the date on which the Purchasers receive Revenue Interest Payments of 195% of the Cumulative Purchaser Payments. Under the Purchase Agreement, Global has an option (the “Call Option”) to repurchase the Revenue Interests and terminate the Purchase Agreement at any time upon advance written notice. Additionally, the Purchasers have an option (the “Put Option”) to terminate the Purchase Agreement and to require Global to repurchase the Revenue Interests upon enumerated events such as a bankruptcy event, an uncured material breach, a material adverse effect or a change of control. If the Put Option is exercised prior to August 12, 2024 by the Purchasers (except pursuant to a change of control), the required repurchase price will be 125% of the Cumulative Purchaser Payments (minus the aggregate Revenue Interest Payments Global has made to the Purchasers as of such date). If (i) the Put Option is exercised on or prior to August 12, 2024 by the Purchasers after the occurrence of a change of control, (ii) the Put Option is exercised after August 12, 2024 until May 12, 2026, or (iii) the Call Option is exercised on or prior to May 12, 2026, then in each case, the required repurchase price will be 175% of the Cumulative Purchaser Payments (minus the aggregate Revenue Interest Payments Global has made to the Purchasers as of such date). If a Put Option or Call Option is exercised after May 12, 2026, the required repurchase price will be 195% of the Cumulative Purchaser Payments (minus the aggregate Revenue Interest Payments Global has made to the Purchasers as of such date). The Purchase Agreement contains customary representations and warranties and affirmative covenants for transactions of this type, including, among others, the provision of financial and other information to the Purchaser, notice to the Purchaser upon the occurrence of certain material events, and compliance with applicable laws. The Purchase Agreement also contains customary negative covenants, including certain restrictions on the ability to incur indebtedness and grant liens or security interests on assets. On February 18, 2024, the Company agreed with the Purchasers and the Agent, to waive certain breaches related to, and extend the deadline for certain post-closing obligations under, the Purchase Agreement, including the requirement for a leasehold mortgage over the Company’s headquarters. Giving effect to the extension and waiver, the Company was obligated to deliver by no later than April 30, 2024 (or such later date as the Agent may agree in its sole discretion), an executed leasehold mortgage (or alternative documentation satisfactory to the Agent in its sole discretion) over the Company’s headquarters. On May 8, 2024, the Company agreed with the Purchasers and the Agent to waive such breaches, for so long as, among other requirements, the Company (i) delivers by no later than June 7, 2024 a landlord’s consent and waiver with respect to the Company’s headquarters and (ii) funds no later than August 17, 2024 an account in an amount of $54.0 million, over which the Agent will have certain consent and other rights. To the extent the Company is able to deliver a leasehold mortgage over its headquarters by June 7, 2024, the preceding requirements will not apply. If the Company is not successful in meeting the Agent’s deadlines in executing either a leasehold mortgage or a landlord consent and waiver or if the Company is unable to fund the required amount, the Purchasers have the right to terminate the Purchase Agreement and to require Global to repurchase the Revenue Interests. The Company has provided a parent company guaranty to guarantee the payment in full of the obligations under the Purchase Agreement. The Company’s obligations under the parent company guaranty and Global’s obligations under the Purchase Agreement and the Revenue Interests are secured by a perfected security interest on substantially all of the Company’s and Global’s assets. The Purchase Agreement is considered a sale of future revenues and accounted for as long-term debt recorded at amortized cost using the effective interest rate method. The Company recorded a revenue interest liability related to the Purchase Agreement on the accompanying condensed consolidated balance sheet on the date the Company entered into the Purchase Agreement, net of a debt discount comprised of $2.1 million issuance costs and transaction costs, $0.1 million fair value allocated to the Option Agreement, defined below, and the $2.4 million initial fair value of the bifurcated contingent derivative liability related to the Put Option. The revenue interest liability is based on the Company’s contractual repayment obligation to the Purchasers, based on the current estimates of future revenues, over the life of the Purchase Agreement. The Company imputes interest expense associated with this liability using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. The interest rate on this liability may vary during the term of the agreement depending on a number of factors, including the level and expected timing of forecasted net sales. The Company evaluates the interest rate quarterly based on its current net sales forecasts. If the level and timing of any forecasted net sales and related payments change, the Company prospectively adjusts the effective interest and the related amortization of the liability and related issuance costs on a quarterly basis. As of March 31, 2024 and December 31, 2023, $58.0 million and $38.6 million, respectively, was recorded as a revenue interest liability. The estimated effective annual interest rate as of March 31, 2024 and December 31, 2023 was 14.6% and 14.1%, respectively. The Company recorded $1.4 million in interest expense related to the Purchase Agreement for the three months ended March 31, 2024. The Put Option under the Purchase Agreement that is exercisable by the Purchasers upon certain contingent events was determined to be an embedded derivative requiring bifurcation and separately accounted for as a single compound derivative instrument. At May 12, 2023, the Company recorded the initial fair value of the derivative liability of $2.4 million as a debt discount. On March 11, 2024, upon the issuance of the second installment of the Purchase Agreement of $20.0 million, the Company estimated the fair value of the embedded derivative and recorded a $1.6 million increase in fair value as a debt discount. The debt discount is being amortized to interest expense over the expected term of the debt using the effective interest method. See Note 3 — Fair Value Measurements for a further discussion of the fair value of the contingent derivative liability associated with the Put Option. Revenue Interest Payments made as a result of the Company’s net product sales will reduce the revenue interest liability. During the three months ended March 31, 2024, the Company did not record any product sales revenue. The following table summarizes the revenue interest liability activity during the three months ended March 31, 2024: ($ in thousands) Revenue interest liability at December 31, 2023 $ 38,600 Proceeds from revenue interest purchase agreement 20,000 Debt discount from embedded contingent derivative liability (1,552) Interest expense recognized 1,411 Transaction costs accrued at March 31, 2024 (500) Revenue interest liability at March 31, 2024 $ 57,959 Option Agreement In connection with the Purchase Agreement, the Company also entered into an option agreement with TPC Investments III LP and TPC Investment Solutions LP (the “Option Agreement”), which gives TPC Investments III LP and TPC Investment Solutions LP (the “Holders”) the right to purchase, in the aggregate, up to $10.0 million worth of shares of common stock of the Company (the “Option”) at a purchase price per share equal to the greater of $7.50, or the 15 day volume-weighted average price as of the exercise date, exercisable in cash only at any time prior to the earlier of (i) December 31, 2026 and (ii) the closing date of a corporate reorganization. The Holders also received certain registration rights relating to the shares underlying the Option pursuant to the Option Agreement. The Option granted to the Holders represents a freestanding instrument separate from the purchaser commitments outlined in the Purchase Agreement. The Option Agreement does not qualify for the equity contract scope exception under ASC 815-40 and the Company recorded the Option as a liability (“Option Agreement liability”) on the condensed consolidated balance sheet at an initial fair value of $55 thousand, with subsequent changes in the fair value to be recognized in the condensed consolidated statements of operations and comprehensive loss at each reporting date. The fair value of the Option Agreement liability as of March 31, 2024 and December 31, 2023 was $41 thousand and $35 thousand, respectively. Pursuant to the Purchase Agreement, on May 12, 2023 , $40.0 million , less certain transaction expenses, was funded to the Company, which was used to repay in full the Company’s existing obligations under its term loan agreement with Silicon Valley Bank (“SVB”) and SVB Innovation Credit Fund VIII, L.P., entered into on March 30, 2021, as amended in June 2021 and September 2021 (the “Loan Agreement”). |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Common Stock On August 26, 2021, the Merger and a related private placement offering (the “PIPE Financing”) were consummated and the Company issued 27,346,449 shares of Common Stock for proceeds of $242.4 million, incurring $3.9 million of transaction costs, consisting of banking, legal, and other professional fees. Immediately following the Merger, there were 103,003,384 shares of Common Stock outstanding with a par value of $0.0001 per share. On February 29, 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Cowen and Company, LLC and Cantor Fitzgerald & Co., as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the issuance and sale in an underwritten offering (the “Offering”) of 15,410,000 shares of the Company’s Common Stock, which included a full exercise of the Underwriters’ option to purchase additional shares, at a price to the public of $3.00 per share. The net proceeds to the Company from the Offering were approximately $43.0 million after deducting underwriting discounts and commissions and Offering expenses. The Offering closed on March 5, 2024. As of March 31, 2024, there were $0.4 million of unpaid offering expenses included in accrued expenses on the condensed consolidated balance sheet. As of March 31, 2024, the Company’s Second Amended and Restated Certificate of Incorporation authorized the Company to issue 250,000,000 shares of Common Stock. The number of authorized shares of Common Stock may be increased or decreased (but not below the number of shares then outstanding or reserved for issuance) by the affirmative vote of the holders of a majority in interest of the Common Stock. The holders of Common Stock are entitled to receive dividends from time to time as may be declared by the Company’s board of directors. Through March 31, 2024, no dividends have been declared. The holders of Common Stock are entitled to one vote for each share held with respect to all matters voted on by the common stockholders of the Company. In the event of a reorganization of the Company, after payment to any preferred stockholders of their liquidation preferences, holders of Common Stock are entitled to share ratably in all remaining assets of the Company. As of March 31, 2024, the Company had reserved Common Stock for future issuances as follows: March 31, Common stock reserved for Contingent Earnout Shares 15,000,000 Common stock reserved for Option Agreement 1,333,334 (1) Exercise of options outstanding under stock plans 11,882,290 Options available for issuance under stock plans 6,712,249 Shares available for grant under ESPP 1,030,033 Warrants to purchase Common Stock 5,588,506 41,546,412 ___________________________ (1) Assumes the exercise of the entire Option as provided for in the Option Agreement at the minimum purchase price of $7.50 per share. Preferred Stock The Company’s Second Amended and Restated Certificate of Incorporation provides the Company’s board of directors with the authority to issue preferred stock, par value $0.0001 per share, in one more series and to establish from time to time the number of shares to be included in each such series, by adopting a resolution and filing a certification of designations. Voting powers, designations, powers, preferences and relative, participating, optional, special and other rights shall be stated and expressed in such resolutions. There were 20,000,000 shares designated as preferred stock and none were outstanding as of March 31, 2024 and December 31, 2023. Warrants The Company had the following Common Stock warrants outstanding as of March 31, 2024 and December 31, 2023: Common Stock Warrants Outstanding Legacy Humacyte Common Stock Warrants 411,006 Private Placement Warrants 177,500 Public Warrants 5,000,000 Total Common Stock Warrants 5,588,506 In connection with the Company’s Loan Agreement, in 2021 the Company granted warrants to the lenders to purchase 411,006 shares of Common Stock at an exercise price of $10.28 per share (such warrants, “Legacy Humacyte Common Stock Warrants”). The Company recognized the fair value of the warrants within stockholders’ equity using a Black-Scholes valuation model, as the settlement of the warrants is indexed to the Common Stock. There were no issuances, exercises or expirations of warrants during the three months ended March 31, 2024 or March 31, 2023. In connection with the Merger, the Company assumed 5,000,000 publicly-traded warrants ( “ Public Warrants ” ) and 177,500 private placement warrants issued to AHAC Sponsor LLC (the “ Sponsor ” ), Oppenheimer & Co. Inc. and Northland Securities, Inc., in connection with AHAC ’ s initial public offering ( “ Private Placement Warrants ” and, together with the Public Warrants, the “ Common Stock Warrants ” ). The Common Stock Warrants entitle the holder to purchase one share of Common Stock at an exercise price of $11.50 per share. The Company evaluated the Common Stock Warrants to determine the appropriate financial statement classification upon the consummation of the Merger. The Common Stock Warrants are not mandatorily redeemable and are considered to be freestanding instruments as they are separately exercisable into Common Stock. As such, the Common Stock Warrants were not classified as liabilities under FASB ASC Topic 480, Distinguishing Liabilities from Equity . The Company then evaluated the Common Stock Warrants under FASB ASC Topic 815, Derivatives and Hedging . Public Warrants The Public Warrants are publicly traded and are exercisable for cash unless certain conditions occur, such as the failure to have an effective registration statement related to the shares issuable upon exercise or redemption by the Company under certain conditions, at which time the Public Warrants may be eligible for a cashless exercise. The Public Warrants may only be exercised for a whole number of shares and will expire five years after the completion of the Merger. The Public Warrants became exercisable 30 days after the completion of the Merger. The Public Warrants are considered to be “indexed to the Company’s own stock.” The agreement provides that in the event of a tender or exchange offer made to and accepted by holders of more than 50% of the outstanding shares of the Company ’ s Common Stock, all holders of the Common Stock Warrants (both the Public Warrants and the Private Placement Warrants) would be entitled to receive cash for all of their Common Stock Warrants. As the Company has a single class of Common Stock, a qualifying cash tender offer of more than 50% of the Company ’ s 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, the Company concluded that the Public Warrants meet the criteria to be classified within stockholders ’ equity. The Public Warrants were initially recognized as equity on the Closing Date at a fair value of $2.80 per share. Private Placement Warrants The Private Placement Warrants are non-redeemable for cash so long as they are held by the initial purchasers or their permitted transferees. If the Private Placement Warrants are held by someone other than the initial purchasers or their permitted transferees, the Private Placement Warrants are redeemable by the Company and exercisable by such holders on the same basis as the Public Warrants. The agreement governing the Common Stock Warrants includes a provision, the application of which could result in a different settlement value for the Private Placement Warrants depending on their holder. Because the holder of an instrument is not an input into the pricing of a fixed-for-fixed option on the Common Stock, the Private Placement Warrants are not considered to be “ indexed to the Company ’ s own stock ” and therefore are not classified in stockholders ’ equity. As the Private Placement Warrants meet the definition of a derivative, the Company recorded these warrants as liabilities on the condensed consolidated balance sheet at fair value, with subsequent changes in their respective fair values recognized in the condensed consolidated statements of operations and comprehensive loss at each reporting date. The Private Placement Warrants were initially recognized as a liability on the Closing Date, at a fair value of $0.6 million. See Note 3 — Fair Value Measurements for a summary of the change in the fair value of the Private Placement Warrants during the three months ended March 31, 2024 and 2023. The remeasurement of the Private Placement Warrant liability is classified within Change in fair value of derivative liabilities in the condensed consolidated statements of operations and comprehensive loss. The Private Placement Warrants were valued using the following assumptions under the Monte Carlo simulation value model: March 31, December 31, Market price of public stock $ 3.11 $ 2.84 Exercise price $ 11.50 $ 11.50 Expected term (years) 2.41 2.65 Expected share price volatility 87.0 % 75.0 % Risk-free interest rate 4.51 % 4.09 % Estimated dividend yield 0 % 0 % Contingent Earnout Liability Following the closing of the Merger (the “Closing”), former holders of Legacy Humacyte common and preferred shares are eligible to receive up to 15,000,000 additional shares of Common Stock (the “Contingent Earnout Shares”) in the aggregate, in two equal tranches of 7,500,000 shares of Common Stock per tranche. The first and second tranches are issuable if the closing volume weighted average price (“VWAP”) per share of Common Stock quoted on The Nasdaq Stock Market LLC (“Nasdaq”) (or the exchange on which the shares of Common Stock are then listed), is greater or equal to $15.00 and $20.00, respectively, over any 20 trading days within any 30 consecutive trading day period. Upon the Closing, the contingent obligation to issue Contingent Earnout Shares was accounted for as a liability because the triggering events that determine the number of Contingent Earnout Shares required to be issued include events that are not solely indexed to the Common Stock. The Contingent Earnout Shares are subsequently remeasured at each reporting date with changes in fair value recorded as a component of other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. The estimated fair value of the total Contingent Earnout Shares at the Closing on August 26, 2021 was $159.4 million based on a Monte Carlo simulation valuation model using a distribution of potential outcomes on a monthly basis over a 10-year period using the most reliable information available. See Note 3 — Fair Value Measurements for a summary of the change in the fair value of the Contingent Earnout Liability during the three months ended March 31, 2024 and 2023. The remeasurement of the Contingent Earnout Liability to a fair value of $42.5 million as of March 31, 2024 from a fair value of $37.9 million as of December 31, 2023, resulted in a non-cash loss of $4.6 million for the three months ended March 31, 2024 compared to a non-cash loss of $14.2 million for the three months ended March 31, 2023 related to the remeasurement of the Contingent Earnout Liability. The remeasurement of the Contingent Earnout Liability is classified within Change in fair value of Contingent Earnout Liability in the condensed consolidated statements of operations and comprehensive loss. The assumptions utilized in the calculations of fair value were based on the achievement of certain stock price milestones, including the current Common Stock price, expected volatility, risk-free rate, expected term and expected dividend yield. Assumptions used in the valuations are described below: March 31, December 31, Current stock price $ 3.11 $ 2.84 Expected share price volatility 88.3 % 86.7 % Risk-free interest rate 4.20 % 3.88 % Estimated dividend yield 0 % 0 % Expected term (years) 10.00 10.00 |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based Compensation | Stock-based Compensation At Closing, the 2021 Long-Term Incentive Plan, (the “2021 Plan”), and the 2021 Employee Stock Purchase Plan, (the “ESPP”), became effective. Under the 2021 Plan, the Company can grant non-statutory stock options, incentive stock options, stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, performance awards and other forms of awards. Under the ESPP, when and if implemented, eligible employees will be permitted to purchase shares of the Company’s Common Stock at the lower of 85% of the closing trading price per share of the Company’s Common Stock on the first day of the offering or 85% of the closing trading price per share on the exercise date, which will occur on the last day of each offering. The 2021 Plan and ESPP provide that on January 1 of each year commencing January 1, 2022, the 2021 Plan and the ESPP reserve will automatically increase in an amount equal to the lesser of (a) 5% and 1%, respectively, of the number of shares of the Company’s Common Stock outstanding on December 31 of the preceding year and (b) a number of shares of Common Stock determined by the Company’s board of directors. The Company’s board of directors determined that there would be no automatic increase in the number of shares reserved under the 2021 Plan on either January 1, 2022 or January 1, 2023. The 2021 Plan share reserve automatically increased on January 1, 2024 by 5,183,686, which was equivalent to 5% of the number of shares of the Company’s Common Stock outstanding on December 31, 2023. Since the inception of the ESPP, the Company’s board of directors has determined that there would be no automatic increase in the number of shares reserved under the ESPP. As of March 31, 2024, 6,712,249 and 1,030,033 shares of Common Stock were available under the 2021 Plan and ESPP, respectively. Prior to the Closing, Legacy Humacyte had two equity incentive plans, the 2015 Omnibus Incentive Plan, as amended (the “2015 Plan”), and the 2005 Stock Option Plan (the “2005 Plan”). As a result of the Merger, no further awards will be granted under either the 2015 Plan or the 2005 Plan. All awards previously granted and outstanding as of the effective date of the Merger were adjusted to reflect the impact of the Merger as set forth in the Merger Agreement, but otherwise remain in effect pursuant to their original terms. The shares underlying any award granted under the 2021 Plan or the 2015 Plan that are forfeited, cancelled or reacquired by the Company prior to vesting, that expire or that are paid out in cash rather than shares will become available for grant and issuance under the 2021 Plan. As of March 31, 2024, 8,470,527, 3,393,700 and 18,063 shares of Common Stock remain reserved for outstanding options issued under the 2021 Plan, the 2015 Plan and the 2005 Plan, respectively. The Company has sufficient authorized and unissued shares to issue Common Stock in satisfaction of any outstanding awards and any awards available for grant under the 2021 Plan. The Company’s stock option plans allow for the grant of awards that the Company believes aid in aligning the interests of award recipients with those of its stockholders. The Company’s board of directors or compensation committee determines the specific terms of equity incentive grants, including the exercise price per share and vesting period for option awards. Option awards are granted with an exercise price equal to the fair market value of the Company’s Common Stock at the date of grant. The Company has granted options that include either a service-based or performance-based vesting condition, or both, and a 10-year contractual term. The service-based vesting condition for the plans is generally satisfied over 36 to 48 months from the date of grant. The performance-based vesting conditions are satisfied upon the attainment of certain product development milestones. The Company recognizes stock-based compensation expense based on the grant date fair value of the awards measured using the Black-Scholes option pricing model. Compensation expense related to awards with service-based vesting conditions is recognized on a straight-line basis over the requisite service period. 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. Compensation expense related to awards with performance-based vesting conditions 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. Option awards under the Company’s option plans generally provide for accelerated vesting of the unvested portions of any option award in the event of an involuntary termination, as such term is defined in the relevant stock option agreement, of a grantee’s employment during the period that commences 30 days prior to the effective date of a corporate transaction and that ends 12 months following the effective date of such transaction. Additionally, the Company’s board of directors may, in its sole discretion, accelerate the vesting of any unvested stock options in the event of a corporate transaction. The Company estimated the fair value of the stock options on the date of grant using the following assumptions in the Black-Scholes option-pricing model: Three Months Ended March 31, 2024 2023 Estimated dividend yield 0 % 0 % Expected share price volatility 90.8% 88.6% Risk-free interest rate 4.07% 3.58% Expected term of options (in years) 6.25 6.25 • Fair Value of Common Stock. The fair value of the 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. The Company 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 the Company’s Common Stock and that of several publicly traded peer companies over a period of time equal to the expected term of the options, as the Company has a limited trading history. For purposes of identifying these peer companies, the Company 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. The Company has not paid dividends on its Common Stock nor does it expect to pay dividends in the foreseeable future. Accordingly, the Company has estimated the dividend yield to be zero. The following table shows a summary of stock-based compensation expense included in the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023: Three Months Ended March 31, ($ in thousands) 2024 2023 Research and development $ 746 $ 421 General and administrative 708 1,388 Total $ 1,454 $ 1,809 As of March 31, 2024, unrecognized stock-based compensation cost for options was $16.5 million and is expected to be recognized over a weighted-average period of 3.0 years. A summary of option activity under the Company’s stock option plans during the three months ended March 31, 2024 is presented below: Number of Shares Weighted Weighted Aggregate Options outstanding at December 31, 2023 11,919,421 $ 4.64 8.3 $ 383 Granted 157,650 $ 3.37 Exercised (625) $ 3.07 Forfeited (194,156) $ 3.86 Options outstanding at March 31, 2024 11,882,290 $ 4.64 8.1 $ 1,968 Vested and exercisable, March 31, 2024 4,372,119 $ 7.09 5.9 $ 295 Vested and expected to vest, March 31, 2024 11,882,290 $ 4.64 8.1 $ 1,968 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company’s tax provision for interim periods is determined using an estimate of its annual effective tax rate, adjusted for discrete items, if any, that arise during the period. Each quarter, the Company updates its estimate of the annual effective tax rate and, if the estimated annual effective tax rate changes, the Company makes a cumulative adjustment in such period. No such adjustment was made as of March 31, 2024. The Company’s effective federal and state tax rate for the three months ended March 31, 2024 and 2023 was 0%, primarily as a result of estimated net operating losses for the fiscal year to date offset by the increase in the valuation allowance against its deferred tax asset. The Company did not record any income tax expense or benefit during the three months ended March 31, 2024 and 2023. The Company has a net operating loss and has provided a valuation allowance against net deferred tax assets due to uncertainties regarding the Company’s ability to realize these assets. All losses before income taxes arose in the United States. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Patent License Agreements Duke University In March 2006, the Company entered into a license agreement with Duke University (“Duke”), which was subsequently amended in 2011, 2014, 2015, 2018, 2019 and 2022. Under this license agreement, Duke granted the Company a worldwide, exclusive, sublicensable license to certain patents related to decellularized tissue engineering, referred to as the patent rights, as well as a non-exclusive license to use and practice certain know-how related to the patent rights. The relevant licensed patent on decellularization of tissue expired in 2021. The Company has agreed to use commercially reasonable efforts to develop, register, market and sell products utilizing the patent rights, referred to as the licensed products. Any services provided to a third party utilizing licensed products are referred to as licensed services. The Company has also agreed to meet certain benchmarks in its development efforts, including as to development events, clinical trials, regulatory submissions and marketing approval, within specified timeframes. Under the license agreement, Duke retains the right to use the patent rights for its own educational and research purposes, and to provide the patent rights to other non-profit, governmental or higher-learning institutions for non-commercial purposes without paying royalties or other fees. In connection with the Company’s entry into the license agreement, the Company granted equity consideration to Duke in the form of 52,693 shares of Common Stock. Under the license agreement, the Company also agreed to pay Duke: • a low single-digit percentage royalty on eligible sales of licensed products and licensed services, plus a low double-digit percentage of any sublicensing revenue; • an annual minimum royalty beginning in 2012, which increases in the calendar year immediately following the first commercial sale of licensed products or licensed services (whichever occurs first); and • an additional amount in license fees, as certain milestones are met. The license agreement remains effective until the later of (i) the last of the patent rights expires or (ii) four years after the Company’s first commercial sale, unless terminated earlier. Either party may terminate the agreement for fraud, willful misconduct or illegal conduct, or uncured material breach. Duke may terminate the agreement if the Company becomes insolvent. Duke may also terminate the license, convert the license into a non-exclusive license or seek assignment of any sublicense if the Company fails to reach diligence milestones within the applicable time period. If the Company abandons any claim, patent or patent application, its rights under the license with respect to such patent rights will be terminated in the territory in which the Company abandons such rights. The Company may terminate the license agreement unilaterally upon three months’ prior notice to Duke. The Company agrees to indemnify Duke against certain third-party claims. In December 2023, the Company filed a BLA with the FDA for urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. Based on the achievement of this milestone under the Duke license agreement, the Company recorded license expense payable of $0.5 million in accounts payable in the Company’s condensed consolidated balance sheets as of December 31, 2023. The Company paid the license fee payable to Duke during the three months ended March 31, 2024. Payments to Duke under the license agreement were immaterial during the three months ended March 31, 2023. Yale University In August 2019, the Company entered into a license agreement with Yale University (“Yale”) that granted the Company a worldwide license to the patents related to the biovascular pancreas (“BVP”) product candidate (the “BVP License Agreement”). The license granted under the BVP License Agreement is exclusive in the field of engineered vascular tissues that deliver pancreatic islet cells to patients, except that it is subject to Yale’s non-exclusive right, on behalf of itself and all other non-profit academic institutions, to use the licensed products for research, teaching, and other non-commercial purposes. The Company has agreed to pay to Yale an annual maintenance fee, increasing between the first and fourth anniversaries of the BVP License Agreement up to a maximum of less than $0.1 million per year for this license. In August 2019, the Company entered into a license agreement with Yale that granted the Company a worldwide license to the patents related to tubular prostheses (the “Tubular Prosthesis License Agreement”). The license granted under the Tubular Prosthesis License Agreement is exclusive in the field of engineered urinary conduits, engineered tracheas/airways, and engineered esophagi, except that it is subject to Yale’s non-exclusive right, on behalf of itself and all other non-profit academic institutions, to use the licensed products for research, teaching, and other non-commercial purposes. The Company has agreed to pay to Yale an annual maintenance fee, increasing between the first and fourth anniversaries of the Tubular Prosthesis License Agreement up to a maximum of less than $0.1 million per year for this license. The Company has agreed to use reasonable commercial efforts to develop and commercialize the licensed patents and any licensed products and methods, and to use reasonable efforts to make the licensed products available to patients in low and low-middle income countries. The Company is also obligated to provide Yale periodically an updated and revised copy of its plan for each license, which must indicate progress of its development and commercialization. The Company may also sublicense the Company’s rights without Yale’s prior written consent, but such sublicense is subject to certain conditions. In connection with its entry into the Tubular Prosthesis License Agreement, the Company paid Yale upfront cash fees. The Company has also agreed to pay Yale: • annual maintenance fees, increasing annually until the fifth anniversary for the BVP License Agreement and until the fourth anniversary for the Tubular Prostheses License Agreement up to a maximum of less than $0.1 million per year; • milestone payments upon achievement of certain regulatory and commercial milestones of $0.2 million and $0.6 million, respectively; • a low single-digit percentage royalty on worldwide net sales, subject to reductions for third-party license fees; and • a low double-digit percentage of sublicensing income. If the Company or any of its future sublicensees bring a patent challenge against Yale or assists another party in bringing a patent challenge against Yale, the license fees described above will be subject to certain increases and penalties. The BVP License Agreement and Tubular Prosthesis License Agreement expire on a country-by-country basis on the date on which the last of the patents in such country expires, lapses or is declared invalid. Yale may terminate the BVP License Agreement and Tubular Prosthesis License Agreement if the Company fails to (i) provide written diligence reports, (ii) provide commercially reasonable diligence plans, (iii) implement the plans in accordance with the obligations under the agreements, or (iv) reach certain research and development milestones within the scheduled timeframe set forth in the agreements; however, any such termination right would be limited in scope to the country to which such failure relates. Yale may also terminate for the Company’s non-payment, uncured material breach, failure to obtain adequate insurance, bringing or assisting in bringing of a patent challenge against Yale, abandonment of the research and development of the Company’s products or insolvency. The Company may terminate the BVP License Agreement and Tubular Prosthesis License Agreement (i) on 90 days’ prior written notice to Yale, provided the Company is not in breach of the license agreements and has made all required payments to Yale thereunder and (ii) on written notice to Yale following an uncured material breach. With respect to the BVP License Agreement, the Company’s rights under the agreement will also terminate automatically with respect to a patent application or patent within the licensed patents in a specified country if, upon receipt of written notice from Yale, the Company does not agree to pay the patent filing, prosecution and maintenance fees incurred by Yale for such patent applications or patents in the specified country. Under certain circumstances, Yale may, at its option, convert the exclusive licenses to non-exclusive licenses if the Company declines to initiate certain infringement or interference proceedings with respect to the licensed patents. The Company has agreed to indemnify Yale against certain third-party claims. Payments to Yale under the BVP License Agreement and Tubular Prosthesis License Agreement were immaterial during the periods presented. JDRF Agreement On April 1, 2023, the Company entered into an Industry Discovery and Development Partnership Agreement with JDRF International (“JDRF,” and such agreement, the “JDRF Agreement”) to further develop and perform preclinical testing of the BVP, a product candidate designed to deliver insulin-producing islets using the HAV as a means of treating patients with type 1 diabetes. According to the terms of the JDRF Agreement, JDRF will provide funding up to $0.8 million (“JDRF Award”) based on the achievement of certain research and development milestones related to the Company’s BVP. The JDRF Agreement refers to the total cumulative payments the Company has received from JDRF as of any point in time as the “Actual Award.” The Company received the first milestone payment of $80 thousand in April 2023 upon execution of the JDRF Agreement. The Company determined that the JDRF Actual Award payments are to be classified as long-term debt under ASC 470, Debt in the condensed consolidated balance sheets. The JDRF liability related to the Actual Award payments is reported at amortized cost and is included in other long-term liabilities in the condensed consolidated balance sheets. As of March 31, 2024 and December 31, 2023, the carrying value of the JDRF liability is $76 thousand and $69 thousand, respectively. In accordance with the JDRF Agreement, the Company has agreed to pay JDRF: • a one-time royalty in an amount equal to four times the Actual Award, to be paid in three equal installments following the first commercial sale of any product containing the Company’s technology identified in the JDRF Agreement; • an additional royalty equal to the Actual Award at a specified payment date after net sales exceed $250 million; and • in the event of a license, sale or transfer of the Company’s rights to the product’s technology identified in the JDRF Agreement or a change of control transaction, a payment equal to 10% of any license or purchase price payments received by the Company up to an amount equal to four times the Actual Award (the “Royalty Cap”), less any previous royalty payments paid towards the Royalty Cap (the “Disposition Payment”). The Disposition Payment was determined to meet the definition of an embedded derivative requiring bifurcation and is measured at fair value each reporting period with changes in fair value recognized as other income (expense) in the condensed consolidated statements of operations and comprehensive loss, classified in change in fair value of derivative liabilities. The JDRF Agreement expires on the date on which the Company has paid all of the royalty payments described above. Either party may terminate the JDRF Agreement for cause by providing the other party with written notice and allowing the other party 30 days to cure such breach. JDRF may terminate the JDRF Agreement without cause by providing 90 days’ notice to the Company at any time after April 1, 2024. Royalties on previously received milestone payments would remain due after a termination by JDRF without cause. Legal Matters The Company currently is not aware of any legal proceedings or claims that management believes will have, individually or in the aggregate, a material adverse effect on the Company’s business, financial condition, results of operations, or cash flows. Indemnification To the extent permitted under Delaware law, the Company has agreed to indemnify its directors and officers for certain events or occurrences while the director or officer is, or was serving, at the Company’s request in such capacity. The indemnification period covers all pertinent events and occurrences during the director’s or officer’s service. The maximum potential amount of future payments the Company could be required to make under these indemnification arrangements is not specified in such arrangements; however, the Company has director and officer insurance coverage that is intended to reduce its exposure and enable the Company to recover a portion of any potential future amounts the Company could be required to make. To date, the Company has not incurred any costs as a result of such obligations and has not accrued any liabilities related to such obligations in the condensed consolidated financial statements. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2024 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions Fresenius Medical Care investments and distribution agreement In June 2018, the Company completed a $150 million financing transaction pursuant to which Fresenius Medical Care purchased shares of series D redeemable convertible preferred stock that at the Closing converted into 15,812,735 shares of Common Stock. In August 2021, Fresenius Medical Care invested $25 million as part of the PIPE Financing and received an additional 2.5 million shares of Common Stock. In addition, the Company entered into a distribution agreement with Fresenius Medical Care in June 2018 which, as amended as of February 16, 2021, granted Fresenius Medical Care and its affiliates exclusive rights to develop outside the United States and European Union (the “EU”) and commercialize outside of the United States the Company’s 6 millimeter x 42 centimeter HAV and all improvements thereto, and modifications and derivatives thereof (including any changes to the length, diameter or configuration of the foregoing), for use in vascular creation, repair, replacement or construction, including renal replacement therapy for dialysis access, the treatment of peripheral artery disease, and the treatment of vascular trauma, but excluding coronary artery bypass graft, pediatric heart surgery, or adhering pancreatic islet cells onto the outer surface of the distribution product for use in diabetic patients. Within the United States, Fresenius Medical Care will collaborate with the Company in its commercialization of the product in the field, including adoption of the distribution product as a standard of care in patients for which such use is supported by clinical results and health economic analyses. The Company is responsible for developing and seeking regulatory approval for the distribution product in the field in the United States. For countries outside the United States, the parties agreed to use commercially reasonable efforts to satisfy certain agreed minimum market entry criteria for the distribution product in the field in such country. For the EU, once such criteria have been satisfied for the applicable country, or if the parties otherwise mutually agree to obtain regulatory approval for the distribution product in the field in the applicable country, the Company agreed to use commercially reasonable efforts to obtain such regulatory approval (other than pricing approval), and Fresenius Medical Care agreed to use commercially reasonable efforts to obtain the corresponding pricing approval. For the rest of the world (i.e., outside the United States and the EU), once such criteria have been satisfied for the applicable country, or if the parties otherwise mutually agree to obtain regulatory and pricing approval for the distribution product in the field in the applicable country, Fresenius Medical Care agreed to use commercially reasonable efforts to obtain such approvals, and the Company agreed to use commercially reasonable efforts to support Fresenius Medical Care in its efforts. Under the distribution agreement, the Company grants an exclusive, sublicensable license to Fresenius Medical Care under the patents, know-how and regulatory materials controlled by the Company during the term to commercialize the distribution product in the field outside the United States, subject to the Company’s retained rights to carry out its obligations under the distribution agreement. The Company also grants a non-exclusive, sublicensable license to Fresenius Medical Care under the patents, know-how and regulatory materials controlled by the Company during the term to develop the distribution product in accordance with the terms of the distribution agreement. In addition, the Company grants to Fresenius Medical Care, among other things, a perpetual, irrevocable, non-exclusive sublicensable license under the patents and know-how that primarily relate to the distribution product or its manufacture and that were created, conceived or developed solely or jointly by or on behalf of Fresenius Medical Care in the performance of its activities under the distribution agreement. The distribution agreement provides that the Company will own all know-how and patents that primarily relate to the distribution product or its manufacture that are created, conceived or developed by or on behalf of either party in the performance of activities under the distribution agreement. Ownership of all other know-how, patents, materials and other intellectual property created, conceived or developed during the performance of activities under the distribution agreement will be determined in accordance with U.S. patent laws for determining inventorship. The Company is obligated to make payments to Fresenius Medical Care based on a share of aggregate net sales by or on behalf of the Company of the distribution product in the United States in the field. Such revenue-share payments will be a percentage of net sales in the low double digits, without regard to the calendar year in which such net sales are attributable, until such time that the Company has paid to Fresenius Medical Care a certain total amount, at which time the revenue-share will decrease to a percentage of net sales in the mid-single digits. The amounts that Fresenius Medical Care will be obligated to pay the Company under the distribution agreement for sales of the distribution product in the field outside of the United States will vary. Fresenius Medical Care agreed to pay the Company initially, on a country-by-country basis for sales outside of the United States, the amount equal to the average cost of manufacturing the Company’s distribution product plus a fixed dollar amount per unit. Following a specified period, on a country-by-country basis outside of the United States, Fresenius Medical Care will pay the Company a fixed percentage of net sales for each unit sold in such country, such that the Company will receive more than half of such net sales. The distribution agreement will generally continue on a country-by-country basis until the later of (a) the tenth anniversary of the launch date of the distribution product in the relevant country or (b) the expiration of the last-to-expire valid claim of specified patents in such country. Each party is permitted to terminate the distribution agreement for insolvency of, or, under certain circumstances, including various cure periods, material breach by the other party. Subject to a cure period, Fresenius Medical Care may also terminate the distribution agreement in its entirety or on a country-by-country basis (i) for certain withdrawals of regulatory approval or (ii) for termination or expiration of any of our in-licenses that is necessary for the exercise of Fresenius Medical Care’s rights, or the satisfaction of its obligations, under the distribution agreement. In addition, Fresenius Medical Care may terminate the distribution agreement for convenience on a country-by-country basis upon not less than 12 months’ written notice to the Company, although Fresenius Medical Care is not permitted to give such notice prior to the end of the second year following launch of the distribution product in such country. Each party is required to indemnify one another for certain third-party claims. Agreement with Frenova Renal Research In May 2022 and June 2023, the Company entered into three services agreements with Frenova Renal Research (“Frenova”), a subsidiary of Fresenius Medical Care, to conduct a study to review the outcomes of 178,575 adult patients who received in-center dialysis at Fresenius Kidney Care dialysis centers. There were no amounts expensed under the agreements with Frenova during the three months ended March 31, 2024 and 2023. Arrangements with Yale University The Company’s President and Chief Executive Officer, Laura Niklason M.D., PhD., serves as an Adjunct Professor in Anesthesia at Yale University. As of March 31, 2024 and December 31, 2023, the Company was a party to license agreements with Yale University as described in Note 11 — Commitments and Contingencies above. Amounts expensed in relation to the license agreements with Yale University were insignificant during the three months ended March 31, 2024 and 2023. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net loss | $ (31,896) | $ (36,969) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Unaudited Interim Condensed Consolidated Financial Statements | Basis of Presentation The Company has prepared the accompanying financial statements in conformity with U.S. GAAP. The Company ’ s condensed consolidated financial statements reflect the operations of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. 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, 2024 and its results of operations for the three months ended March 31, 2024 and 2023, and cash flows for the three months ended March 31, 2024 and 2023. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or any other period. The December 31, 2023 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, 2023 and the related notes included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 28, 2024 (the “Annual Report”), 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, 2023 and 2022 included in the Company ’ s Annual Report. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in the financial statements include stock-based compensation costs, right-of-use assets, accruals for research and development activities, contingent earnout liability, revenue interest liability, derivative liabilities, fair value of common stock warrants and income taxes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. |
Segments | Segments The Company operates and manages its business as one reportable and operating segment. 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 chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of evaluating financial performance and allocating resources. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash balances exceeded insured balances by the Federal Deposit Insurance Corporation as of March 31, 2024 and December 31, 2023. As of both March 31, 2024 and December 31, 2023, the Company had cash equivalents held in highly rated money market funds that are invested only in obligations of the U.S. government and its agencies. |
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. |
Net Loss per Share Attributable to Common Stockholders | Net Loss per Share Attributable to Common Stockholders |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2023, the FASB issued ASU No. 2023-07, “Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures” (“ASU 2023-07”). The FASB issued this update to improve the disclosures about an entity’s reportable segments, including providing more detailed information about a reportable segment’s expenses, enhancing interim disclosure requirements and providing new segment disclosure requirements for entities with a single reportable segment. This standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. Entities should apply the amendments retrospectively to all prior periods presented in the financial statements. This ASU is applicable to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2024, and subsequent interim periods. The Company is currently evaluating the impact of adopting ASU 2023-07 on its disclosures included in the notes to the consolidated financial statements. In December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740), Improvements to Income Tax Disclosures” (“ASU 2023-09”). The FASB issued this update to improve the transparency and comparability of income tax disclosures, including requiring consistent categories and greater disaggregation of information in the rate reconciliation and further disaggregation of income taxes paid by jurisdiction. This standard is effective for fiscal years beginning after December 15, 2024, with early adoption is permitted. Entities should apply the amendments prospectively, with retrospective application permitted. This ASU is applicable to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2025. The Company is currently evaluating the impact of adopting ASU 2023-09 on its disclosures included in the notes to the consolidated financial statements. |
Fair Value of Financial Instruments | Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants at the measurement date. ASC 820, Fair Value Measurement and Disclosures , establishes a hierarchy whereby inputs to valuation techniques used in measuring fair value are prioritized, or the fair value hierarchy. There are three levels to the fair value hierarchy based on reliability of inputs, as follows: • Level 1 — Observable inputs that reflect unadjusted quoted prices for identical assets or liabilities in active markets. • Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3 — Unobservable inputs in which little or no market data exists, therefore requiring the Company to develop its own assumptions. The Company’s money market funds are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices. The carrying values of cash, prepaid expenses and other current assets, accounts payable and accrued expenses as of March 31, 2024 and December 31, 2023 approximated their fair values due to the short-term nature of these items. The Company evaluates assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them for each reporting period, utilizing valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The determination requires significant judgments to be made by the Company. |
Contingent Derivative Liability | The debt pursuant to the Purchase Agreement, as defined in Note 6, contains an embedded derivative related to the Put Option, as defined in Note 6, requiring bifurcation as a single compound derivative instrument. The Company estimated the fair value of the derivative liability using a “with-and-without” methodology. 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 derivative liability at issuance and each subsequent reporting period. In determining the fair value of the contingent derivative liability, the Company used the Monte Carlo simulation value model using a distribution of potential outcomes on a monthly basis over a 10-year period. The estimated probability and timing of underlying events triggering the exercisability of the Put Option contained within the Purchase Agreement, forecasted cash flows and the discount rates are significant unobservable inputs used to determine the estimated fair value of the entire instrument with the embedded derivative. |
Common Stock Warrants | In connection with the Merger, the Company assumed 5,000,000 publicly-traded warrants ( “ Public Warrants ” ) and 177,500 private placement warrants issued to AHAC Sponsor LLC (the “ Sponsor ” ), Oppenheimer & Co. Inc. and Northland Securities, Inc., in connection with AHAC ’ s initial public offering ( “ Private Placement Warrants ” and, together with the Public Warrants, the “ Common Stock Warrants ” ). The Common Stock Warrants entitle the holder to purchase one share of Common Stock at an exercise price of $11.50 per share. The Company evaluated the Common Stock Warrants to determine the appropriate financial statement classification upon the consummation of the Merger. The Common Stock Warrants are not mandatorily redeemable and are considered to be freestanding instruments as they are separately exercisable into Common Stock. As such, the Common Stock Warrants were not classified as liabilities under FASB ASC Topic 480, Distinguishing Liabilities from Equity . The Company then evaluated the Common Stock Warrants under FASB ASC Topic 815, Derivatives and Hedging . Public Warrants The Public Warrants are publicly traded and are exercisable for cash unless certain conditions occur, such as the failure to have an effective registration statement related to the shares issuable upon exercise or redemption by the Company under certain conditions, at which time the Public Warrants may be eligible for a cashless exercise. The Public Warrants may only be exercised for a whole number of shares and will expire five years after the completion of the Merger. The Public Warrants became exercisable 30 days after the completion of the Merger. The Public Warrants are considered to be “indexed to the Company’s own stock.” The agreement provides that in the event of a tender or exchange offer made to and accepted by holders of more than 50% of the outstanding shares of the Company ’ s Common Stock, all holders of the Common Stock Warrants (both the Public Warrants and the Private Placement Warrants) would be entitled to receive cash for all of their Common Stock Warrants. As the Company has a single class of Common Stock, a qualifying cash tender offer of more than 50% of the Company ’ s 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, the Company concluded that the Public Warrants meet the criteria to be classified within stockholders ’ equity. The Public Warrants were initially recognized as equity on the Closing Date at a fair value of $2.80 per share. Private Placement Warrants The Private Placement Warrants are non-redeemable for cash so long as they are held by the initial purchasers or their permitted transferees. If the Private Placement Warrants are held by someone other than the initial purchasers or their permitted transferees, the Private Placement Warrants are redeemable by the Company and exercisable by such holders on the same basis as the Public Warrants. The agreement governing the Common Stock Warrants includes a provision, the application of which could result in a different settlement value for the Private Placement Warrants depending on their holder. Because the holder of an instrument is not an input into the pricing of a fixed-for-fixed option on the Common Stock, the Private Placement Warrants are not considered to be “ indexed to the Company ’ s own stock ” and therefore are not classified in stockholders ’ |
Contingent Earnout Liability | Upon the Closing, the contingent obligation to issue Contingent Earnout Shares was accounted for as a liability because the triggering events that determine the number of Contingent Earnout Shares required to be issued include events that are not solely indexed to the Common Stock. The Contingent Earnout Shares are subsequently remeasured at each reporting date with changes in fair value recorded as a component of other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. |
Stock-Based Compensation | The Company recognizes stock-based compensation expense based on the grant date fair value of the awards measured using the Black-Scholes option pricing model. Compensation expense related to awards with service-based vesting conditions is recognized on a straight-line basis over the requisite service period. 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. Compensation expense related to awards with performance-based vesting conditions 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. Fair Value of Common Stock. The fair value of the 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. The Company 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 the Company’s Common Stock and that of several publicly traded peer companies over a period of time equal to the expected term of the options, as the Company has a limited trading history. For purposes of identifying these peer companies, the Company 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. The Company has not paid dividends on its Common Stock nor does it expect to pay dividends in the foreseeable future. Accordingly, the Company has estimated the dividend yield to be zero. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the total of the amounts shown in the condensed consolidated statements of cash flows as of March 31, 2024 and December 31, 2023. ($ in thousands) March 31, December 31, Cash and cash equivalents $ 115,505 $ 80,448 Restricted cash included in prepaid expenses and other current assets 144 144 Restricted cash included in other long-term assets 209 209 Total cash, cash equivalents and restricted cash $ 115,858 $ 80,801 |
Summary of Securities That Could Potentially Dilute Net Loss Per Share in the Future That Were Not Included in the Computation of Diluted Net Loss Per Share | The following potential shares of Common Stock were excluded from the computation of diluted net loss per share for each period because including them would have had an antidilutive effect. Three Months Ended March 31, 2024 2023 Exercise of options under stock plan 11,882,290 7,174,560 Warrants to purchase Common Stock 5,588,506 5,588,506 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis | The Company’s assets and liabilities that were measured at fair value on a recurring basis were as follows: ($ in thousands) Fair Value Measured as of March 31, 2024 Level 1 Level 2 Level 3 Total Assets: Cash equivalents (money market funds) $ 113,714 $ — $ — $ 113,714 Total financial assets $ 113,714 $ — $ — $ 113,714 Liabilities: Contingent Earnout Liability $ — $ — $ 42,509 $ 42,509 Contingent derivative liability — — 4,079 4,079 Private Placement Warrants liability — — 121 121 Option Agreement liability — — 41 41 JDRF Agreement derivative liability — — 28 28 Total financial liabilities $ — $ — $ 46,778 $ 46,778 ($ in thousands) Fair Value Measured as of December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash equivalents (money market funds) $ 78,995 $ — $ — $ 78,995 Total financial assets $ 78,995 $ — $ — $ 78,995 Liabilities: Contingent Earnout Liability $ — $ — $ 37,916 $ 37,916 Contingent derivative liability — — 2,636 2,636 Private Placement Warrants liability — — 78 78 Option Agreement liability — — 35 35 JDRF Agreement derivative liability — — 28 28 Total financial liabilities $ — $ — $ 40,693 $ 40,693 |
Summary of Changes in Fair Value of Level 3 Financial Instruments | The following table presents a summary of the changes in the fair value of the Contingent Earnout Liability: ($ in thousands) Contingent Earnout Liability Three Months Ended March 31, 2024 2023 Fair value as of beginning of period $ (37,916) $ (27,893) Change in fair value included in other income (expense), net (4,593) (14,191) Fair value as of end of period $ (42,509) $ (42,084) The following table presents a summary of the changes in the fair value of the Private Placement Warrants liability: Private Placement Warrants Three Months Ended March 31, ($ in thousands) 2024 2023 Fair value as of beginning of period $ (78) $ (80) Change in fair value included in other income (expense), net (43) (42) Fair value as of end of period $ (121) $ (122) The following table presents a summary of the changes in the fair value of the contingent derivative liability, which is classified as a Level 3 financial instrument. ($ in thousands) Three Months Ended Fair value as of beginning of period $ (2,636) Fair value of embedded derivative upon issuance of debt (1,552) (1) Change in fair value included in other income (expense), net 109 Fair value as of end of period $ (4,079) ___________________________ (1) Represents an increase in debt discount upon issuance of the second installment under the Purchase Agreement. See Note 6 for further information. |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, net consist of the following: ($ in thousands) March 31, December 31, Scientific and manufacturing equipment $ 28,435 $ 28,400 Computer equipment 125 125 Software 768 682 Furniture and fixtures 1,066 1,066 Leasehold improvements 27,858 27,844 58,252 58,117 Accumulated depreciation (32,599) (31,326) Property and equipment, net $ 25,653 $ 26,791 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: ($ in thousands) March 31, December 31, Accrued external research, development and manufacturing costs $ 3,655 $ 3,845 Accrued employee compensation and benefits 3,381 5,238 Accrued professional fees 881 257 Total $ 7,917 $ 9,340 |
Revenue Interest Purchase Agr_2
Revenue Interest Purchase Agreement (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Revenue Interest Liability Activity | The following table summarizes the revenue interest liability activity during the three months ended March 31, 2024: ($ in thousands) Revenue interest liability at December 31, 2023 $ 38,600 Proceeds from revenue interest purchase agreement 20,000 Debt discount from embedded contingent derivative liability (1,552) Interest expense recognized 1,411 Transaction costs accrued at March 31, 2024 (500) Revenue interest liability at March 31, 2024 $ 57,959 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' Equity Note [Abstract] | |
Summary of Common Stock Reserved for Future Issuances | As of March 31, 2024, the Company had reserved Common Stock for future issuances as follows: March 31, Common stock reserved for Contingent Earnout Shares 15,000,000 Common stock reserved for Option Agreement 1,333,334 (1) Exercise of options outstanding under stock plans 11,882,290 Options available for issuance under stock plans 6,712,249 Shares available for grant under ESPP 1,030,033 Warrants to purchase Common Stock 5,588,506 41,546,412 ___________________________ (1) Assumes the exercise of the entire Option as provided for in the Option Agreement at the minimum purchase price of $7.50 per share. |
Summary of Common Stock Warrants Outstanding | The Company had the following Common Stock warrants outstanding as of March 31, 2024 and December 31, 2023: Common Stock Warrants Outstanding Legacy Humacyte Common Stock Warrants 411,006 Private Placement Warrants 177,500 Public Warrants 5,000,000 Total Common Stock Warrants 5,588,506 |
Schedule of Assumptions Used in the Valuations | The Private Placement Warrants were valued using the following assumptions under the Monte Carlo simulation value model: March 31, December 31, Market price of public stock $ 3.11 $ 2.84 Exercise price $ 11.50 $ 11.50 Expected term (years) 2.41 2.65 Expected share price volatility 87.0 % 75.0 % Risk-free interest rate 4.51 % 4.09 % Estimated dividend yield 0 % 0 % Assumptions used in the valuations are described below: March 31, December 31, Current stock price $ 3.11 $ 2.84 Expected share price volatility 88.3 % 86.7 % Risk-free interest rate 4.20 % 3.88 % Estimated dividend yield 0 % 0 % Expected term (years) 10.00 10.00 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Assumptions Used to Estimate Fair Value of Stock Options | The Company estimated the fair value of the stock options on the date of grant using the following assumptions in the Black-Scholes option-pricing model: Three Months Ended March 31, 2024 2023 Estimated dividend yield 0 % 0 % Expected share price volatility 90.8% 88.6% Risk-free interest rate 4.07% 3.58% Expected term of options (in years) 6.25 6.25 |
Summary of Stock-Based Compensation Expense and Remaining Unrecognized Costs | The following table shows a summary of stock-based compensation expense included in the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023: Three Months Ended March 31, ($ in thousands) 2024 2023 Research and development $ 746 $ 421 General and administrative 708 1,388 Total $ 1,454 $ 1,809 |
Summary of Stock Option Activity | A summary of option activity under the Company’s stock option plans during the three months ended March 31, 2024 is presented below: Number of Shares Weighted Weighted Aggregate Options outstanding at December 31, 2023 11,919,421 $ 4.64 8.3 $ 383 Granted 157,650 $ 3.37 Exercised (625) $ 3.07 Forfeited (194,156) $ 3.86 Options outstanding at March 31, 2024 11,882,290 $ 4.64 8.1 $ 1,968 Vested and exercisable, March 31, 2024 4,372,119 $ 7.09 5.9 $ 295 Vested and expected to vest, March 31, 2024 11,882,290 $ 4.64 8.1 $ 1,968 |
Organization and Description _2
Organization and Description of Business (Details) $ in Thousands | 3 Months Ended | ||||
Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | May 08, 2024 USD ($) | Dec. 31, 2023 USD ($) | May 12, 2023 purchaser | |
Subsequent Event [Line Items] | |||||
Accumulated deficit | $ 569,210 | $ 537,314 | |||
Operating losses | 26,578 | $ 22,512 | |||
Net cash used in operating activities | 27,347 | $ 18,641 | |||
Revenue interest liability | 57,959 | 38,600 | |||
Cash and cash equivalents | 115,505 | 80,448 | |||
Revenue Interest Purchase Agreement | |||||
Subsequent Event [Line Items] | |||||
Number of purchasers | purchaser | 2 | ||||
Revenue interest liability | $ 58,000 | $ 38,600 | |||
Revenue Interest Purchase Agreement | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Contingent cash collateral to be funded | $ 54,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Segments (Details) | 3 Months Ended |
Mar. 31, 2024 segment | |
Accounting Policies [Abstract] | |
Number of reportable segments | 1 |
Number of operating segments | 1 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Restricted Cash and Cash Equivalents Items [Line Items] | ||||
Cash and cash equivalents | $ 115,505 | $ 80,448 | ||
Total cash, cash equivalents and restricted cash | 115,858 | 80,801 | $ 129,570 | $ 149,772 |
Prepaid Expenses and Other Current Assets | ||||
Restricted Cash and Cash Equivalents Items [Line Items] | ||||
Restricted cash | 144 | 144 | ||
Other Long-Term Assets | ||||
Restricted Cash and Cash Equivalents Items [Line Items] | ||||
Restricted cash | $ 209 | $ 209 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Net Loss per Share Attributable to Common Stockholders (Details) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 | Aug. 26, 2021 |
Accounting Policies [Abstract] | |||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Antidilutive Securities Excluded From Computation (Details) - $ / shares | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | May 12, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Maximum contingent earnout (in shares) | 15,000,000 | 15,000,000 | |
TPC Investments III LP and TPC Investment Solutions LP | Option Purchase Agreement | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Option agreement, minimum exercise price (in dollars per share) | $ 7.50 | ||
Exercise of options under stock plan | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Securities that were not included in the computation of diluted net loss per share (in shares) | 11,882,290 | 7,174,560 | |
Warrants to purchase Common Stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Securities that were not included in the computation of diluted net loss per share (in shares) | 5,588,506 | 5,588,506 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Recurring - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | May 12, 2023 |
Assets: | |||
Total financial assets | $ 113,714 | $ 78,995 | |
Liabilities: | |||
Contingent Earnout Liability | 42,509 | 37,916 | |
Private Placement Warrants liability | 121 | 78 | |
Total financial liabilities | 46,778 | 40,693 | |
Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | |||
Liabilities: | |||
Derivative liability | 4,079 | 2,636 | $ 2,400 |
Equity Option | |||
Liabilities: | |||
Derivative liability | 41 | 35 | $ 55 |
Embedded Derivative Financial Instruments, JDRF Agreement | |||
Liabilities: | |||
Derivative liability | 28 | 28 | |
Level 1 | |||
Assets: | |||
Total financial assets | 113,714 | 78,995 | |
Liabilities: | |||
Contingent Earnout Liability | 0 | 0 | |
Private Placement Warrants liability | 0 | 0 | |
Total financial liabilities | 0 | 0 | |
Level 1 | Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | |||
Liabilities: | |||
Derivative liability | 0 | 0 | |
Level 1 | Equity Option | |||
Liabilities: | |||
Derivative liability | 0 | 0 | |
Level 1 | Embedded Derivative Financial Instruments, JDRF Agreement | |||
Liabilities: | |||
Derivative liability | 0 | 0 | |
Level 2 | |||
Assets: | |||
Total financial assets | 0 | 0 | |
Liabilities: | |||
Contingent Earnout Liability | 0 | 0 | |
Private Placement Warrants liability | 0 | 0 | |
Total financial liabilities | 0 | 0 | |
Level 2 | Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | |||
Liabilities: | |||
Derivative liability | 0 | 0 | |
Level 2 | Equity Option | |||
Liabilities: | |||
Derivative liability | 0 | 0 | |
Level 2 | Embedded Derivative Financial Instruments, JDRF Agreement | |||
Liabilities: | |||
Derivative liability | 0 | 0 | |
Level 3 | |||
Assets: | |||
Total financial assets | 0 | 0 | |
Liabilities: | |||
Contingent Earnout Liability | 42,509 | 37,916 | |
Private Placement Warrants liability | 121 | 78 | |
Total financial liabilities | 46,778 | 40,693 | |
Level 3 | Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | |||
Liabilities: | |||
Derivative liability | 4,079 | 2,636 | |
Level 3 | Equity Option | |||
Liabilities: | |||
Derivative liability | 41 | 35 | |
Level 3 | Embedded Derivative Financial Instruments, JDRF Agreement | |||
Liabilities: | |||
Derivative liability | 28 | 28 | |
Cash equivalents (money market funds) | |||
Assets: | |||
Cash equivalents | 113,714 | 78,995 | |
Cash equivalents (money market funds) | Level 1 | |||
Assets: | |||
Cash equivalents | 113,714 | 78,995 | |
Cash equivalents (money market funds) | Level 2 | |||
Assets: | |||
Cash equivalents | 0 | 0 | |
Cash equivalents (money market funds) | Level 3 | |||
Assets: | |||
Cash equivalents | $ 0 | $ 0 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Fair Value of Level 3 Financial Instruments (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Contingent Earnout Liability | ||
Changes in the fair value of the Level 3 financial instruments | ||
Beginning balance | $ (37,916) | $ (27,893) |
Change in fair value included in other income (expense), net | (4,593) | (14,191) |
Ending balance | (42,509) | (42,084) |
Private Placement Warrants | ||
Changes in the fair value of the Level 3 financial instruments | ||
Beginning balance | (78) | (80) |
Change in fair value included in other income (expense), net | (43) | (42) |
Ending balance | $ (121) | $ (122) |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) | Mar. 31, 2024 year | Dec. 31, 2023 year |
Expected term (years) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Measurement input | 10 | 10 |
Expected term (years) | Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent derivative, measurement input | 10 | |
Measurement Input, Revenue Forecast, Discount Rate | Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent derivative, measurement input | 0.139 | 0.145 |
Measurement Input, Payoff of Instrument, Discount Rate | Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent derivative, measurement input | 0.175 | 0.171 |
Contingent Earnout Liability | Expected term (years) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Measurement input | 10 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Changes in Fair Value of Contingent Derivative Liability (Details) - Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Changes in the fair value of the Level 3 financial instruments | |
Fair value as of beginning of period | $ 2,636 |
Fair value of embedded derivative upon issuance of debt | (1,552) |
Change in fair value included in other income (expense), net | 109 |
Fair value as of end of period | $ 4,079 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 58,252 | $ 58,117 | |
Accumulated depreciation | (32,599) | (31,326) | |
Property and equipment, net | 25,653 | 26,791 | |
Depreciation expense | 1,274 | $ 1,558 | |
Scientific and manufacturing equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 28,435 | 28,400 | |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 125 | 125 | |
Software | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 768 | 682 | |
Furniture and fixtures | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 1,066 | 1,066 | |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 27,858 | $ 27,844 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Accrued Liabilities, Current [Abstract] | ||
Accrued external research, development and manufacturing costs | $ 3,655 | $ 3,845 |
Accrued employee compensation and benefits | 3,381 | 5,238 |
Accrued professional fees | 881 | 257 |
Total | $ 7,917 | $ 9,340 |
Revenue Interest Purchase Agr_3
Revenue Interest Purchase Agreement - Narrative (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | ||||
Mar. 11, 2024 USD ($) | May 12, 2023 USD ($) $ / shares | Mar. 31, 2024 USD ($) | May 08, 2024 USD ($) | Dec. 31, 2023 USD ($) | |
Revenue Interest Liability [Line Items] | |||||
Revenue interest liability | $ 57,959 | $ 38,600 | |||
Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | Recurring | |||||
Revenue Interest Liability [Line Items] | |||||
Derivative liability | $ 2,400 | 4,079 | 2,636 | ||
Increase in derivative liability | $ 1,600 | ||||
Equity Option | Recurring | |||||
Revenue Interest Liability [Line Items] | |||||
Derivative liability | 55 | 41 | 35 | ||
Revenue Interest Purchase Agreement | |||||
Revenue Interest Liability [Line Items] | |||||
Total investment amount | 150,000 | ||||
Upfront payment received | $ 40,000 | ||||
Aggregate milestone payments potentially receivable | 90,000 | ||||
Royalty percentage | 0.075 | ||||
Percentage of cumulative purchaser payments | 1 | ||||
Percentage of cumulative purchaser payments less total revenue interest payments due | 1 | ||||
Percentage threshold of cumulative purchaser payments required for discontinuance of revenue interest payments | 1.50 | ||||
Percentage threshold of cumulative purchaser payments required for termination of purchase agreement | 1.95 | ||||
Issuance and transaction costs incurred and paid in connection with the Purchase Agreement | $ 2,100 | ||||
Revenue interest liability | $ 58,000 | $ 38,600 | |||
Effective interest rate | 14.60% | 14.10% | |||
Interest expense | $ 1,411 | ||||
Revenue Interest Purchase Agreement | Subsequent Event | |||||
Revenue Interest Liability [Line Items] | |||||
Contingent cash collateral to be funded | $ 54,000 | ||||
Revenue Interest Purchase Agreement | Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | |||||
Revenue Interest Liability [Line Items] | |||||
Debt discount from embedded contingent derivative liability | 1,600 | 2,400 | |||
TPC Investments III LP and TPC Investment Solutions LP | Option Purchase Agreement | |||||
Revenue Interest Liability [Line Items] | |||||
Option agreement, value of shares authorized for issuance | $ 10,000 | ||||
Option agreement, minimum exercise price (in dollars per share) | $ / shares | $ 7.50 | ||||
Option agreement, number of days volume-weighted average price | 15 days | ||||
Period One | Revenue Interest Purchase Agreement | |||||
Revenue Interest Liability [Line Items] | |||||
Percentage of cumulative purchaser payments, repurchase price | 1.25 | ||||
Period Two | Revenue Interest Purchase Agreement | |||||
Revenue Interest Liability [Line Items] | |||||
Percentage of cumulative purchaser payments, repurchase price | 1.75 | ||||
Period Three | Revenue Interest Purchase Agreement | |||||
Revenue Interest Liability [Line Items] | |||||
Percentage of cumulative purchaser payments, repurchase price | 1.95 | ||||
Subsequent Installment One | Revenue Interest Purchase Agreement | |||||
Revenue Interest Liability [Line Items] | |||||
Milestone payment received | $ 20,000 | ||||
Subsequent Installment Two | Revenue Interest Purchase Agreement | |||||
Revenue Interest Liability [Line Items] | |||||
Milestone payment potentially receivable | $ 40,000 | ||||
Subsequent Installment Three | Revenue Interest Purchase Agreement | |||||
Revenue Interest Liability [Line Items] | |||||
Milestone payment potentially receivable | 50,000 | ||||
Trailing worldwide three-month net sales threshold | $ 35,000 |
Revenue Interest Purchase Agr_4
Revenue Interest Purchase Agreement - Summary of Revenue Interest Liability Activity (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
May 12, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | |
Revenue Interest Liability Activity [Roll Forward] | |||
Transaction costs accrued at March 31, 2024 | $ (500) | $ 0 | |
Revenue Interest Purchase Agreement | |||
Revenue Interest Liability Activity [Roll Forward] | |||
Revenue interest liability at December 31, 2023 | 38,600 | ||
Proceeds from revenue interest purchase agreement | $ 40,000 | 20,000 | |
Interest expense recognized | 1,411 | ||
Transaction costs accrued at March 31, 2024 | (500) | ||
Revenue interest liability at March 31, 2024 | 57,959 | ||
Revenue Interest Purchase Agreement | Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | |||
Revenue Interest Liability Activity [Roll Forward] | |||
Debt discount from embedded contingent derivative liability | $ (1,552) |
Debt - Term Loan (Details)
Debt - Term Loan (Details) - USD ($) $ in Thousands | 3 Months Ended | |
May 12, 2023 | Mar. 31, 2024 | |
Revenue Interest Purchase Agreement | ||
Line of Credit Facility [Line Items] | ||
Proceeds from revenue interest purchase agreement | $ 40,000 | $ 20,000 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock (Details) | 3 Months Ended | ||||||
Mar. 05, 2024 USD ($) shares | Aug. 26, 2021 USD ($) $ / shares shares | Mar. 31, 2024 USD ($) vote $ / shares shares | Mar. 31, 2023 USD ($) shares | Feb. 29, 2024 $ / shares | Dec. 31, 2023 $ / shares shares | Dec. 31, 2022 shares | |
Business Acquisition [Line Items] | |||||||
Proceeds from Merger and related PIPE Financing | $ | $ 242,400,000 | ||||||
Transaction costs | $ | $ 3,900,000 | ||||||
Common stock, shares outstanding (in shares) | shares | 103,003,384 | 119,084,353 | 103,673,728 | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||
Price per share (in dollars per share) | $ / shares | $ 3 | ||||||
Unpaid issuance costs in connection with public offering | $ | $ 350,000 | $ 0 | |||||
Common stock, authorized (in shares) | shares | 250,000,000 | 250,000,000 | |||||
Dividends, common stock | $ | $ 0 | ||||||
Number of vote per common share held | vote | 1 | ||||||
Public Stock Offering | |||||||
Business Acquisition [Line Items] | |||||||
Number of shares issued (in shares) | shares | 15,410,000 | ||||||
Net proceeds from public offering | $ | $ 43,000,000 | ||||||
Common Stock | |||||||
Business Acquisition [Line Items] | |||||||
Issuance of common stock upon reverse recapitalization and PIPE Financing (in shares) | shares | 27,346,449 | ||||||
Common stock, shares outstanding (in shares) | shares | 119,084,353 | 103,329,171 | 103,673,728 | 103,229,013 |
Stockholders' Equity - Common_2
Stockholders' Equity - Common Stock for Future Issuances (Details) - $ / shares | Mar. 31, 2024 | May 12, 2023 |
Class of Stock [Line Items] | ||
Reserved common stock for future issuances (in shares) | 41,546,412 | |
TPC Investments III LP and TPC Investment Solutions LP | Option Purchase Agreement | ||
Class of Stock [Line Items] | ||
Option agreement, minimum exercise price (in dollars per share) | $ 7.50 | |
Common stock reserved for Contingent Earnout Shares | ||
Class of Stock [Line Items] | ||
Reserved common stock for future issuances (in shares) | 15,000,000 | |
Common stock reserved for Option Agreement | ||
Class of Stock [Line Items] | ||
Reserved common stock for future issuances (in shares) | 1,333,334 | |
Exercise of options under stock plan | ||
Class of Stock [Line Items] | ||
Reserved common stock for future issuances (in shares) | 11,882,290 | |
Options available for issuance under stock plans | ||
Class of Stock [Line Items] | ||
Reserved common stock for future issuances (in shares) | 6,712,249 | |
Shares available for grant under ESPP | ||
Class of Stock [Line Items] | ||
Reserved common stock for future issuances (in shares) | 1,030,033 | |
Warrants to purchase Common Stock | ||
Class of Stock [Line Items] | ||
Reserved common stock for future issuances (in shares) | 5,588,506 |
Stockholders' Equity - Preferre
Stockholders' Equity - Preferred Stock (Details) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Stockholders' Equity Note [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants (Details) - shares | Mar. 31, 2024 | Dec. 31, 2023 |
Class of Warrant or Right [Line Items] | ||
Warrants (in shares) | 5,588,506 | 5,588,506 |
Legacy Humacyte Common Stock Warrants | ||
Class of Warrant or Right [Line Items] | ||
Warrants (in shares) | 411,006 | 411,006 |
Private Placement Warrants | ||
Class of Warrant or Right [Line Items] | ||
Warrants (in shares) | 177,500 | 177,500 |
Public Warrants | ||
Class of Warrant or Right [Line Items] | ||
Warrants (in shares) | 5,000,000 | 5,000,000 |
Stockholders' Equity - Warran_2
Stockholders' Equity - Warrants Narrative (Details) - $ / shares | Aug. 26, 2021 | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 30, 2021 |
Class of Warrant or Right [Line Items] | ||||
Warrants (in shares) | 5,588,506 | 5,588,506 | ||
Warrants, exercise price (in dollars per share) | $ 11.50 | |||
Number of shares of common stock called by each warrant (in shares) | 1 | |||
Legacy Humacyte Common Stock Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants (in shares) | 411,006 | 411,006 | ||
Public Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants (in shares) | 5,000,000 | 5,000,000 | ||
Private Placement Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants (in shares) | 177,500 | 177,500 | ||
Warrants to purchase Common Stock | Term Loan Agreement | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants (in shares) | 411,006 | |||
Warrants, exercise price (in dollars per share) | $ 10.28 | |||
Merger Agreement | Warrants to purchase Common Stock | Assumption of Publicly Traded Securities | Public Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Number of securities issued or issuable (in shares) | 5,000,000 | |||
Merger Agreement | Warrants to purchase Common Stock | Private Placement | Private Placement Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Number of securities issued or issuable (in shares) | 177,500 |
Stockholders' Equity - Public W
Stockholders' Equity - Public Warrants (Details) | Aug. 26, 2021 $ / shares |
Class of Warrant or Right [Line Items] | |
Share accepting a tender offer entitles warrants to receive cash (as a percent) | 50% |
Public Warrants | |
Class of Warrant or Right [Line Items] | |
Expected term (years) | 5 years |
Number of days warrants become exercisable after the completion of merger | 30 days |
Public Warrants | Current stock price | |
Class of Warrant or Right [Line Items] | |
Fair Value of Warrant per share (in dollars per share) | 2.80 |
Stockholders' Equity - Private
Stockholders' Equity - Private Placement Warrants (Details) - Private Placement Warrants $ in Millions | Mar. 31, 2024 $ / shares year | Dec. 31, 2023 $ / shares year | Aug. 26, 2021 USD ($) |
Class of Warrant or Right [Line Items] | |||
Common stock warrant liabilities | $ | $ 0.6 | ||
Market price of public stock | |||
Class of Warrant or Right [Line Items] | |||
Warrants, measurement input | 3.11 | 2.84 | |
Exercise price | |||
Class of Warrant or Right [Line Items] | |||
Warrants, measurement input | 11.50 | 11.50 | |
Expected term (years) | |||
Class of Warrant or Right [Line Items] | |||
Warrants, measurement input | year | 2.41 | 2.65 | |
Expected share price volatility | |||
Class of Warrant or Right [Line Items] | |||
Warrants, measurement input | 0.870 | 0.750 | |
Risk-free interest rate | |||
Class of Warrant or Right [Line Items] | |||
Warrants, measurement input | 0.0451 | 0.0409 | |
Estimated dividend yield | |||
Class of Warrant or Right [Line Items] | |||
Warrants, measurement input | 0 | 0 |
Stockholders' Equity - Continge
Stockholders' Equity - Contingent Earnout Liability (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | |||
Aug. 26, 2021 USD ($) year tranche $ / shares shares | Mar. 31, 2024 USD ($) $ / shares year shares | Mar. 31, 2023 USD ($) shares | Dec. 31, 2023 USD ($) year $ / shares | |
Business Acquisition, Contingent Consideration [Line Items] | ||||
Maximum contingent earnout (in shares) | shares | 15,000,000 | 15,000,000 | ||
Contingent Earnout Liability | $ 42,509 | $ 37,916 | ||
Non-cash loss on remeasurement of Contingent Earnout Liability | $ 4,593 | $ 14,191 | ||
Current stock price | ||||
Business Acquisition, Contingent Consideration [Line Items] | ||||
Measurement input | $ / shares | 3.11 | 2.84 | ||
Expected share price volatility | ||||
Business Acquisition, Contingent Consideration [Line Items] | ||||
Measurement input | 0.883 | 0.867 | ||
Risk-free interest rate | ||||
Business Acquisition, Contingent Consideration [Line Items] | ||||
Measurement input | 0.0420 | 0.0388 | ||
Estimated dividend yield | ||||
Business Acquisition, Contingent Consideration [Line Items] | ||||
Measurement input | 0 | 0 | ||
Expected term (years) | ||||
Business Acquisition, Contingent Consideration [Line Items] | ||||
Measurement input | year | 10 | 10 | ||
Earnout Shares | ||||
Business Acquisition, Contingent Consideration [Line Items] | ||||
Maximum contingent earnout (in shares) | shares | 15,000,000 | |||
Number of tranches of contingent earnout shares | tranche | 2 | |||
Number of contingent earnout shares per tranche (in shares) | shares | 7,500,000 | |||
Number of trading days | 20 days | |||
Number of consecutive trading days | 30 days | |||
Contingent Earnout Liability | $ 159,400 | $ 42,500 | $ 37,900 | |
Non-cash loss on remeasurement of Contingent Earnout Liability | $ 4,600 | $ 14,200 | ||
Earnout Shares | Expected term (years) | ||||
Business Acquisition, Contingent Consideration [Line Items] | ||||
Measurement input | year | 10 | |||
Tranche one | Earnout Shares | ||||
Business Acquisition, Contingent Consideration [Line Items] | ||||
Closing stock price to trigger contingent earnout shares (in dollars per share) | $ / shares | $ 15 | |||
Tranche two | Earnout Shares | ||||
Business Acquisition, Contingent Consideration [Line Items] | ||||
Closing stock price to trigger contingent earnout shares (in dollars per share) | $ / shares | $ 20 |
Stock-based Compensation - Narr
Stock-based Compensation - Narrative (Details) | 3 Months Ended | ||||
Jan. 01, 2024 shares | Aug. 25, 2021 plan | Mar. 31, 2024 shares | Mar. 31, 2023 | Dec. 31, 2023 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of equity incentive plans | plan | 2 | ||||
Outstanding awards (in shares) | 11,882,290 | 11,919,421 | |||
ESPP | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Purchase price of common stock, percent of closing trading price | 85% | ||||
Annual increase in available shares | 1% | ||||
Number of shares remaining available for grant (in shares) | 1,030,033 | ||||
Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Contractual term | 10 years | ||||
Accelerated vesting commencement period | 30 days | ||||
Accelerated vesting ending period | 12 months | ||||
Estimated dividend yield | 0% | 0% | |||
Options | Minimum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 36 months | ||||
Options | Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 48 months | ||||
Long-Term Incentive Plan, 2021 | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Annual increase in available shares | 5% | 5% | |||
Number of additional shares authorized (in shares) | 5,183,686 | ||||
Number of shares remaining available for grant (in shares) | 6,712,249 | ||||
Outstanding awards (in shares) | 8,470,527 | ||||
Omnibus Incentive Plan, 2015 | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Outstanding awards (in shares) | 3,393,700 | ||||
Stock Option Plan, 2005 | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Outstanding awards (in shares) | 18,063 |
Stock-based Compensation - Assu
Stock-based Compensation - Assumptions Used to Estimate Fair Value of Stock Options (Details) - Options | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Assumptions on the date of grant to estimate the fair value of the stock options | ||
Estimated dividend yield | 0% | 0% |
Weighted average expected share price volatility | 90.80% | 88.60% |
Risk-free interest rate | 4.07% | 3.58% |
Expected term of options (in years) | 6 years 3 months | 6 years 3 months |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 1,454 | $ 1,809 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 746 | 421 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 708 | $ 1,388 |
Stock-based Compensation - Rema
Stock-based Compensation - Remaining Unrecognized Costs (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Share-Based Payment Arrangement [Abstract] | |
Unrecognized stock-based compensation cost | $ 16.5 |
Unrecognized stock-based compensation cost, period for recognition | 3 years |
Stock-based Compensation - St_2
Stock-based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Number of Shares | ||
Options outstanding, beginning of period (in shares) | 11,919,421 | |
Granted (in shares) | 157,650 | |
Exercised (in shares) | (625) | |
Forfeited (in shares) | (194,156) | |
Options outstanding, end of period (in shares) | 11,882,290 | 11,919,421 |
Number of shares, vested and exercisable (in shares) | 4,372,119 | |
Number of shares, vested and expected to vest (in shares) | 11,882,290 | |
Weighted Average Exercise Price Per Share | ||
Options outstanding, beginning of period (in dollars per share) | $ 4.64 | |
Granted (in dollars per share) | 3.37 | |
Exercised (in dollars per share) | 3.07 | |
Forfeited (in dollars per share) | 3.86 | |
Options outstanding, end of period (in dollars per share) | 4.64 | $ 4.64 |
Weighted average exercise price, vested and exercisable (in dollars per share) | 7.09 | |
Weighted average exercise price, vested and expected to vest (in dollars per share) | $ 4.64 | |
Weighted Average Remaining Contractual Term and Aggregate Intrinsic Value | ||
Weighted average remaining contractual term, outstanding (in years) | 8 years 1 month 6 days | 8 years 3 months 18 days |
Weighted average remaining contractual term, vested and exercisable (in years) | 5 years 10 months 24 days | |
Weighted average remaining contractual term, vested and expected to vest (in years) | 8 years 1 month 6 days | |
Aggregate intrinsic value, outstanding | $ 1,968 | $ 383 |
Aggregate intrinsic value, vested and exercisable | 295 | |
Aggregate intrinsic value, vested and expected to vest | $ 1,968 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | ||
Effective tax rate | 0% | 0% |
Income tax expense or benefit | $ 0 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | |||
Aug. 31, 2019 USD ($) | Mar. 31, 2024 USD ($) shares | Dec. 31, 2023 USD ($) | Apr. 30, 2023 USD ($) | Apr. 01, 2023 USD ($) installment | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Other long-term liabilities | $ 830 | $ 789 | |||
Embedded Derivative Financial Instruments, JDRF Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Termination period | 90 days | ||||
Milestone payment potentially receivable | $ 800 | ||||
Upfront payment received | $ 80 | ||||
Other long-term liabilities | $ 76 | 69 | |||
Royalty cap, actual award multiplier | 4 | ||||
Number of installments | installment | 3 | ||||
Net sales minimum threshold for additional royalty | $ 250,000 | ||||
Disposition payment percentage | 0.10 | ||||
Cure period | 30 days | ||||
Duke University | License Agreement | Decellularized Tissue Engineering Patent Rights | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Shares issued under agreement (in shares) | shares | 52,693 | ||||
Expiration period of agreement | 4 years | ||||
Termination period | 3 months | ||||
License fee payable | $ 500 | ||||
Yale University | License Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Termination period | 90 days | ||||
Maximum annual maintenance fee, less than | $ 100 | ||||
Yale University | License Agreement | BVP Patent Rights | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Maximum annual maintenance fee, less than | $ 100 | ||||
Yale University | License Agreement | Tubular Prostheses Patent Rights | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Maximum annual maintenance fee, less than | $ 100 | ||||
Yale University | License Agreement | Regulatory Milestone | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Milestone payments | 200 | ||||
Yale University | License Agreement | Commercial Milestone | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Milestone payments | $ 600 |
Related Party Transactions - Na
Related Party Transactions - Narrative (Details) $ in Millions | 1 Months Ended | 3 Months Ended | ||||||
Aug. 26, 2021 shares | Feb. 16, 2021 | Aug. 31, 2021 USD ($) shares | Jun. 30, 2018 USD ($) | Mar. 31, 2024 USD ($) shares | Mar. 31, 2023 USD ($) | Dec. 31, 2023 shares | Jun. 30, 2023 patient agreement | |
Related Party Transaction [Line Items] | ||||||||
Common stock issued (in shares) | shares | 119,084,353 | 103,673,728 | ||||||
Fresenius Medical Care | Fresenius Medical Care | ||||||||
Related Party Transaction [Line Items] | ||||||||
Financing transaction | $ | $ 150 | |||||||
Conversion of stock (in shares) | shares | 15,812,735 | |||||||
Proceeds from PIPE Financing | $ | $ 25 | |||||||
Common stock issued (in shares) | shares | 2,500,000 | |||||||
Distribution agreement, termination period | 12 months | |||||||
Fresenius Medical Care | Frenova Renal Research | ||||||||
Related Party Transaction [Line Items] | ||||||||
Number of services agreements entered into | agreement | 3 | |||||||
Number of adult patients | patient | 178,575 | |||||||
Clinical research services expense | $ | $ 0 | $ 0 |