Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 02, 2023 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
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 | 103,575,256 | |
Entity Central Index Key | 0001818382 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
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 | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 99,986 | $ 149,772 |
Prepaid expenses and other current assets | 2,865 | 2,298 |
Short-term investments | 0 | 2,107 |
Accounts receivable | 0 | 31 |
Total current assets | 102,851 | 154,208 |
Finance lease right-of-use assets, net | 17,828 | 19,373 |
Property and equipment, net | 27,851 | 30,039 |
Other long-term assets | 855 | 682 |
Total assets | 149,385 | 204,302 |
Current liabilities | ||
Accounts payable | 3,018 | 1,595 |
Accrued expenses | 9,586 | 7,108 |
Finance lease obligation, current portion | 2,481 | 2,256 |
Operating lease obligation, current portion | 52 | 50 |
SVB loan payable, current portion | 0 | 8,571 |
Total current liabilities | 15,137 | 19,580 |
Contingent Earnout Liability | 39,601 | 27,893 |
Revenue interest liability | 37,286 | 0 |
Finance lease obligation, net of current portion | 16,960 | 18,853 |
Contingent derivative liability | 2,536 | 0 |
Other long-term liabilities | 872 | 712 |
SVB loan payable, net of current portion | 0 | 20,336 |
Total liabilities | 112,392 | 87,374 |
Commitments and contingencies (Note 11) | ||
Stockholders’ equity | ||
Preferred stock, $0.0001 par value; 20,000,000 shares designated as of September 30, 2023 and December 31, 2022; 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.0001 par value; 250,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 103,460,836 and 103,229,013 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 10 | 10 |
Additional paid-in capital | 549,191 | 543,456 |
Accumulated deficit | (512,208) | (426,538) |
Total stockholders’ equity | 36,993 | 116,928 |
Total liabilities and stockholders’ equity | $ 149,385 | $ 204,302 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
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) | 103,460,836 | 103,229,013 |
Common stock, shares outstanding (in shares) | 103,460,836 | 103,229,013 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Grant revenue | $ 0 | $ 31 | $ 0 | $ 1,565 |
Operating expenses: | ||||
Research and development | 18,552 | 17,337 | 56,370 | 48,303 |
General and administrative | 6,070 | 6,188 | 17,495 | 17,050 |
Total operating expenses | 24,622 | 23,525 | 73,865 | 65,353 |
Loss from operations | (24,622) | (23,494) | (73,865) | (63,788) |
Other income (expense), net: | ||||
Interest income | 1,369 | 883 | 4,323 | 1,215 |
Change in fair value of Contingent Earnout Liability | (1,144) | (962) | (11,708) | 58,649 |
Employee retention credit | 0 | 0 | 3,107 | 0 |
Loss on extinguishment of debt | 0 | 0 | (2,421) | 0 |
Interest expense | (1,463) | (1,641) | (4,872) | (4,561) |
Change in fair value of derivative liabilities | (135) | (67) | (234) | 240 |
Total other income (expense), net | (1,373) | (1,787) | (11,805) | 55,543 |
Net loss | (25,995) | (25,281) | (85,670) | (8,245) |
Comprehensive loss | $ (25,995) | $ (25,281) | $ (85,670) | $ (8,245) |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (0.25) | $ (0.25) | $ (0.83) | $ (0.08) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.25) | $ (0.25) | $ (0.83) | $ (0.08) |
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic (in shares) | 103,444,246 | 103,031,980 | 103,357,087 | 103,014,009 |
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, diluted (in shares) | 103,444,246 | 103,031,980 | 103,357,087 | 103,014,009 |
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, 2021 | 103,003,646 | |||
Beginning balance at Dec. 31, 2021 | $ 122,174 | $ 10 | $ 536,737 | $ (414,573) |
Equity | ||||
Proceeds from the exercise of stock options (in shares) | 926 | |||
Proceeds from the exercise of stock options | 1 | 1 | ||
Stock-based compensation | 1,547 | 1,547 | ||
Net income (loss) | (19,832) | (19,832) | ||
Ending balance (in shares) at Mar. 31, 2022 | 103,004,572 | |||
Ending balance at Mar. 31, 2022 | 103,890 | $ 10 | 538,285 | (434,405) |
Beginning balance (in shares) at Dec. 31, 2021 | 103,003,646 | |||
Beginning balance at Dec. 31, 2021 | 122,174 | $ 10 | 536,737 | (414,573) |
Equity | ||||
Net income (loss) | (8,245) | |||
Ending balance (in shares) at Sep. 30, 2022 | 103,098,768 | |||
Ending balance at Sep. 30, 2022 | 118,672 | $ 10 | 541,480 | (422,818) |
Beginning balance (in shares) at Mar. 31, 2022 | 103,004,572 | |||
Beginning balance at Mar. 31, 2022 | 103,890 | $ 10 | 538,285 | (434,405) |
Equity | ||||
Proceeds from the exercise of stock options (in shares) | 2,231 | |||
Proceeds from the exercise of stock options | 11 | 11 | ||
Stock-based compensation | 1,491 | 1,491 | ||
Net income (loss) | 36,868 | 36,868 | ||
Ending balance (in shares) at Jun. 30, 2022 | 103,006,803 | |||
Ending balance at Jun. 30, 2022 | 142,260 | $ 10 | 539,787 | (397,537) |
Equity | ||||
Proceeds from the exercise of stock options (in shares) | 91,965 | |||
Proceeds from the exercise of stock options | 217 | 217 | ||
Stock-based compensation | 1,476 | 1,476 | ||
Net income (loss) | (25,281) | (25,281) | ||
Ending balance (in shares) at Sep. 30, 2022 | 103,098,768 | |||
Ending balance at Sep. 30, 2022 | $ 118,672 | $ 10 | 541,480 | (422,818) |
Beginning balance (in shares) at Dec. 31, 2022 | 103,229,013 | 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 income (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, 2022 | 103,229,013 | 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) | 231,823 | |||
Net income (loss) | $ (85,670) | |||
Ending balance (in shares) at Sep. 30, 2023 | 103,460,836 | 103,460,836 | ||
Ending balance at Sep. 30, 2023 | $ 36,993 | $ 10 | 549,191 | (512,208) |
Beginning balance (in shares) at Mar. 31, 2023 | 103,329,171 | |||
Beginning balance at Mar. 31, 2023 | 81,887 | $ 10 | 545,384 | (463,507) |
Equity | ||||
Proceeds from the exercise of stock options (in shares) | 79,077 | |||
Proceeds from the exercise of stock options | 95 | 95 | ||
Stock-based compensation | 1,841 | 1,841 | ||
Net income (loss) | (22,706) | (22,706) | ||
Ending balance (in shares) at Jun. 30, 2023 | 103,408,248 | |||
Ending balance at Jun. 30, 2023 | 61,117 | $ 10 | 547,320 | (486,213) |
Equity | ||||
Proceeds from the exercise of stock options (in shares) | 52,588 | |||
Proceeds from the exercise of stock options | 99 | 99 | ||
Stock-based compensation | 1,772 | 1,772 | ||
Net income (loss) | $ (25,995) | (25,995) | ||
Ending balance (in shares) at Sep. 30, 2023 | 103,460,836 | 103,460,836 | ||
Ending balance at Sep. 30, 2023 | $ 36,993 | $ 10 | $ 549,191 | $ (512,208) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (85,670) | $ (8,245) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 4,341 | 4,552 |
Stock-based compensation expense | 5,422 | 4,514 |
Change in fair value of Contingent Earnout Liability | 11,708 | (58,649) |
Loss on extinguishment of debt | 2,421 | 0 |
Non-cash interest expense | 1,780 | 0 |
Change in fair value of derivative liabilities | 234 | (240) |
Loss on disposal of property and equipment | 9 | 0 |
Amortization expense | 1,545 | 1,544 |
Non-cash operating lease costs | 37 | 34 |
Amortization of SVB debt discount | 482 | 1,211 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 31 | 145 |
Prepaid expenses and other current assets | (423) | 812 |
Accounts payable | 1,292 | 984 |
Accrued expenses | 2,577 | 1,202 |
Operating lease obligation | (37) | (34) |
Net cash used in operating activities | (54,251) | (52,170) |
Cash flows from investing activities | ||
Proceeds from maturity of short-term investments (certificates of deposit) | 2,107 | 8,000 |
Purchase of property and equipment | (2,130) | (367) |
Purchase of short-term investments (certificates of deposit) | 0 | (8,000) |
Net cash used in investing activities | (23) | (367) |
Cash flows from financing activities | ||
Proceeds from revenue interest purchase agreement, net of issuance costs | 39,377 | 0 |
Payments of transaction costs related to revenue interest purchase agreement | (1,450) | 0 |
Principal payments on SVB loan | (31,500) | 0 |
Payments for debt prepayment and extinguishment costs | (310) | 0 |
Proceeds from the exercise of stock options | 313 | 229 |
Proceeds from JDRF Agreement | 80 | 0 |
Payments of finance lease principal | (1,668) | (1,463) |
Net cash provided by (used in) financing activities | 4,842 | (1,234) |
Net decrease in cash, cash equivalents and restricted cash | (49,432) | (53,771) |
Cash, cash equivalents and restricted cash at the beginning of the period | 149,772 | 217,502 |
Cash, cash equivalents and restricted cash at the end of the period | 100,340 | 163,731 |
Supplemental disclosure: | ||
Cash paid for interest on SVB loan | 1,613 | 1,867 |
Supplemental disclosure of noncash activities: | ||
Purchase of property and equipment in accounts payable and accrued expenses | 167 | 198 |
Initial fair value of contingent derivative liability related to revenue interest liability | $ 2,354 | $ 0 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Sep. 30, 2023 | |
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 designed to improve the lives of patients and transform 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. (“New Humacyte”) 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. Concurrently with the execution of the Merger Agreement, certain investors (the “PIPE Investors”) purchased an aggregate of 17,500,000 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock” and such shares purchased by the PIPE Investors, the “PIPE Shares”), in a private placement for an aggregate purchase price of $175 million (the “PIPE Financing”). The Company received $242.4 million in proceeds from the Merger and related PIPE Financing, and incurred $3.9 million of transaction costs, consisting of banking, legal, and other professional fees. 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 September 30, 2023 and December 31, 2022, the Company had an accumulated deficit of $512.2 million and $426.5 million, respectively. The Company’s operating losses were $73.9 million and $63.8 million for the nine months ended September 30, 2023 and 2022, respectively. Net cash flows used in operating activities were $54.3 million and $52.2 million during the nine months ended September 30, 2023 and 2022, respectively. Substantially all of the Company ’ s operating losses resulted from costs incurred in connection with the Company’s research and development programs and from general and administrative costs associated with the Company’s operations. The Company expects to incur substantial operating losses and negative cash flows from operations for the foreseeable future as the Company advances its product candidates. As of September 30, 2023, the Company had cash and cash equivalents of $100.0 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. 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 | 9 Months Ended |
Sep. 30, 2023 | |
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 subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in the financial statements include stock-based compensation costs, right-of-use assets, accruals for research and development activities, contingent earnout liability, revenue interest liability, 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 September 30, 2023 and its results of operations for the three and nine months ended September 30, 2023 and 2022, and cash flows for the nine months ended September 30, 2023 and 2022. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ended December 31, 2023 or any other period. The December 31, 2022 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, 2022 and the related notes included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 24, 2023 (the “Annual Report”), which provides a more complete discussion of the Company’s accounting policies and certain other information. Other than the policies noted below, 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, 2022 and 2021 included in the Company ’ s Annual Report. Reclassifications Certain amounts from prior periods have been reclassified to conform to the current period’s presentation. None of these reclassifications had a material impact on the Company’s condensed consolidated financial statements. 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 and short-term investments consisting of certificates of deposit (“CDs”). As of September 30, 2023 and December 31, 2022, there were no material cash balances in excess of balances insured by the Federal Deposit Insurance Corporation (“FDIC”). As of both September 30, 2023 and December 31, 2022, the Company had cash equivalents in highly rated money market funds that are invested only in obligations of the U.S. government and its agencies. As of December 31, 2022 , the Company had approximately $10.1 million in CDs. These cash deposits were deposited at a bank that is a member of the Certificate of Deposit Account Registry Service (“CDARS”), in which large deposits are divided into smaller amounts and placed with other FDIC insured banks which are also members of the CDARS network. Those members issue CDs in amounts under $250,000, so that the entire deposit balance is eligible for FDIC insurance. As of December 31, 2022, t he Company classified $8.0 million of its CDs as cash and cash equivalents and $2.1 million of its CDs as short-term investments on its condensed consolidated balance sheet. The Company did not have any CDs as of September 30, 2023 . 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 September 30, 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 $0.1 million in cash balances held as collateral for the Company’s employee credit card program. There was no restricted cash as of December 31, 2022. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the total of the amounts shown in the condensed consolidated statements of cash flows as of September 30, 2023 and December 31, 2022. ($ in thousands) September 30, December 31, Cash and cash equivalents $ 99,986 $ 149,772 Restricted cash included in prepaid expenses and other current assets 144 — Restricted cash included in other long-term assets 210 — Total cash, cash equivalents and restricted cash $ 100,340 $ 149,772 Employee Retention Credit The Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) provided refundable employee retention credits, which could be used to offset payroll tax liabilities. Under the provisions of the extension of the CARES Act, the Company qualified for the employee retention credit for the first three quarters of 2021, and the Company applied for the credit in February 2023. As there is no authoritative guidance under U.S. GAAP for accounting for grants to for-profit business entities, the Company accounted for the grant by applying Accounting Standards Codification (“ASC”) 450, Contingencies . The Company received an employee retention credit of $3.1 million in July 2023, and recognized the credit as income during the second quarter of 2023 after the Company received notices from the Internal Revenue Service specifying the amount of the credit receivable, and all uncertainties were resolved regarding receipt of the credit. The Company recognized the credit as a component of other income (expense), net on the condensed consolidated statement of operations and comprehensive loss during the nine months ended September 30, 2023. Revenue Interest Liability 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. The revenue interest liability associated with the Purchase Agreement is presented net of a debt discount comprised of issuance costs, transaction costs, the fair value of a freestanding option agreement related to the Purchase Agreement, and the fair value of embedded derivatives requiring bifurcation on the condensed consolidated balance sheets. 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 the 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. If the level and timing of any forecasted net sales and related payments change, the Company will prospectively adjust the effective interest and the related amortization of the liability and related issuance costs on a quarterly basis. Contingent Derivative Liability The Purchase Agreement contains certain features that meet the definition of embedded derivatives requiring bifurcation as a separate compound financial instrument apart from the Revenue Interest Liability. The contingent derivative liability related to the Put Option, as defined in Note 6 — Revenue Interest Purchase Agreement, was initially measured at fair value upon issuance and is subject to remeasurement at 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. JDRF Award 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 Biovascular Pancreas (“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 our 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 as of September 30, 2023 the carrying value is $64 thousand and is included in other long-term liabilities in the condensed consolidated balance sheet. The derivative liability related to the Disposition Payment, as defined in Note 3, was initially measured at fair value upon issuance and is subject to remeasurement at 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. See Note 3 — Fair Value Measurements for further information. Net Loss per Share Attributable to Common Stockholders Basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period without consideration of potentially dilutive 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 and nine months ended September 30, 2023 and 2022, 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 and Nine Months Ended September 30, 2023 2022 Exercise of options under stock plan 7,170,891 6,722,422 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 and nine months ended September 30, 2023, 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 for its ongoing V005 Phase 2/3 clinical trial and V007 Phase 3 clinical trial, 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. Recently Adopted Accounting Pronouncements The Company did not adopt any new standards or updates issued by the Financial Accounting Standards Board (the “FASB”) during the nine months ended September 30, 2023 that had a material impact on the Company’s condensed consolidated financial statements and related disclosures. Recently Issued Accounting Pronouncements The Company reviewed all recently issued accounting pronouncements through September 30, 2023 and concluded that they were not applicable or not expected to have a material impact on the Company’s condensed consolidated financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
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. Certificates of deposit were carried at amortized cost in the Company’s condensed consolidated balance sheets, which approximates their fair value based on Level 2 inputs. The carrying values of other receivables, accounts payable and accrued expenses as of September 30, 2023 and December 31, 2022 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 September 30, 2023 Level 1 Level 2 Level 3 Total Assets: Cash equivalents (money market funds) $ 98,539 $ — $ — $ 98,539 Total financial assets $ 98,539 $ — $ — $ 98,539 Liabilities: Contingent Earnout Liability $ — $ — $ 39,601 $ 39,601 Contingent derivative liability — — 2,536 2,536 Private Placement Warrants liability — — 149 149 Option Agreement liability — — 38 38 JDRF Agreement derivative liability — — 28 28 Total financial liabilities $ — $ — $ 42,352 $ 42,352 ($ in thousands) Fair Value Measured as of December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Cash equivalents (money market funds) $ 141,159 $ — $ — $ 141,159 Cash equivalents (certificates of deposit) — 8,000 — 8,000 Short-term investments (certificates of deposit) — 2,107 — 2,107 Total financial assets $ 141,159 $ 10,107 $ — $ 151,266 Liabilities: Contingent Earnout Liability $ — $ — $ 27,893 $ 27,893 Private Placement Warrants liability — — 80 80 Total financial liabilities $ — $ — $ 27,973 $ 27,973 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 September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Fair value as of beginning of period $ (38,457) $ (44,049) $ (27,893) $ (103,660) Change in fair value included in other income (expense), net (1,144) (962) (11,708) 58,649 Fair value as of end of period $ (39,601) $ (45,011) $ (39,601) $ (45,011) 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 September 30, Nine Months Ended September 30, ($ in thousands) 2023 2022 2023 2022 Fair value as of beginning of period $ (158) $ (190) $ (80) $ (497) Change in fair value included in other income (expense), net 9 (67) (69) 240 Fair value as of end of period $ (149) $ (257) $ (149) $ (257) 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 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 May 12, 2023 and September 30, 2023. 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 May 12, 2023, the discount rates used to calculate the value of the contingent derivative liability were 12.7% to calculate the present-value of the revenue forecast and 12.1% to calculate the present-value of the payoff of the Put Option. As of September 30, 2023, the discount rates used to calculate the value of the contingent derivative liability were 15.4% to calculate the present-value of the revenue forecast and 17.4% to calculate the present-value of the payoff of the Put Option. 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 Nine Months Fair value as of beginning of period $ (2,392) $ — Initial fair value of contingent derivative liability — (2,354) Change in fair value included in other income (expense), net (144) (182) Fair value as of end of period $ (2,536) $ (2,536) JDRF derivative liability 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, the Company is obligated to pay JDRF 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. The Company estimated the fair value of the Disposition Payment by performing an analysis of the Disposition Payment under different scenarios, based on the Actual Award of $80 thousand as of September 30, 2023 and a Royalty Cap of $320 thousand. The estimated probability and timing of a change in control event triggering the Disposition Payment and the discount rates are significant unobservable inputs used to determine the estimated fair value of the Disposition Payment. As of September 30, 2023, the discount rate used to calculate the value of the Disposition Payment was 19.4%. The estimated fair value of the Disposition Payment was $28 thousand as of September 30, 2023, which is classified as a component of other long-term liabilities on the condensed consolidated balance sheet. |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net Property and equipment, net consist of the following: ($ in thousands) September 30, December 31, Scientific and manufacturing equipment $ 28,505 $ 27,821 Computer equipment 125 167 Software 673 209 Furniture and fixtures 1,066 988 Leasehold improvements 27,672 26,355 Construction in progress 58 680 58,099 56,220 Accumulated depreciation (30,248) (26,181) Property and equipment, net $ 27,851 $ 30,039 Depreciation expense totaled $1.3 million and $4.3 million for the three and nine months ended September 30, 2023, respectively, and $1.5 million and $4.6 million for the three and nine months ended September 30, 2022, respectively. All long-lived assets are maintained in the United States. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consisted of the following: ($ in thousands) September 30, December 31, Accrued external research, development and manufacturing costs $ 4,002 $ 2,437 Accrued employee compensation and benefits 5,342 4,227 Accrued professional fees 242 444 Total $ 9,586 $ 7,108 |
Revenue Interest Purchase Agree
Revenue Interest Purchase Agreement | 9 Months Ended |
Sep. 30, 2023 | |
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 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”). 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 existing obligations under the Loan Agreement with SVB . The Company will also be entitled to receive up to approximately $110.0 million in subsequent installments subject to the terms and conditions set forth in the Purchase Agreement, as follows: (i) $20.0 million upon the Company’s biologics license application (“BLA”) for an indication in vascular trauma being accepted on or prior to March 31, 2024, (ii) $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 (iii) $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. As of September 30, 2023, the Company was in compliance with all covenants. 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. As of September 30, 2023, $37.3 million was recorded as a revenue interest liability on the accompanying condensed consolidated balance sheets (net of transaction costs, the fair value allocated to the Option Agreement and the fair value of the bifurcated contingent derivative liability). 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 estimated effective annual interest rate as of September 30, 2023 was 11.5%. The Company will evaluate 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 will prospectively adjust the effective interest and the related amortization of the liability and related issuance costs. The Company recorded $1.0 million and $1.8 million in interest expense related to the Purchase Agreement for the three and nine months ended September 30, 2023, respectively. 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. The Company recorded the initial fair value of the derivative liability of $2.4 million as a debt discount, which will be 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. For the three and nine months ended September 30, 2023, the Company incurred zero and $2.1 million of issuance and transaction costs, respectively, in connection with the Purchase Agreement. The issuance and transaction costs were capitalized to debt discount and are being amortized to interest expense over the estimated term of the debt. The Company paid $1.8 million of the issuance and transaction costs during the second quarter of 2023 and paid $0.3 million during the third quarter of 2023. Revenue Interest Payments made as a result of the Company’s net product sales will reduce the revenue interest liability. During the three and nine months ended September 30, 2023, the Company did not record any product sales revenue. The following table summarizes the revenue interest liability activity during the nine months ended September 30, 2023: ($ in thousands) Revenue interest liability at inception $ — Proceeds from revenue interest purchase agreement, gross 40,000 Less issuance costs (623) Proceeds from revenue interest purchase agreement, net 39,377 Transaction costs paid (1,450) Debt discount from embedded contingent derivative liability (2,354) Debt discount from fair value of Option Agreement (55) Interest expense recognized 1,768 Revenue interest liability at September 30, 2023 $ 37,286 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. 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”). The Loan Agreement provided a term loan facility of up to $50.0 million with a maturity date of March 1, 2025. On March 10, 2023, SVB was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation (the “FDIC”) was appointed as receiver. On March 13, 2023, the FDIC announced that all of SVB’s deposits and substantially all of its assets had been transferred to a newly created, full-service, FDIC-operated bridge bank, Silicon Valley Bridge Bank, N.A. (“SVBB”). SVBB assumed all loans that were previously held by SVB. On March 27, 2023, First-Citizens Bank & Trust Company assumed all of SVBB’s customer deposits and certain other liabilities and acquired substantially all of SVBB’s loans and certain other assets from the FDIC, including the Loan Agreement. In connection with the Loan Agreement, the Company granted warrants to the lenders to purchase shares of Common Stock at an exercise price of $10.28 per share, of which 287,704 warrants were immediately exercisable. The warrants are classified within stockholders’ equity, as the settlement of the warrants is indexed to the Common Stock. The Company recognized the fair value of the warrants immediately exercisable within stockholders’ equity using a Black-Scholes valuation model at issuance. At issuance, the Company initially determined that the funding of an additional tranche was not probable, and therefore no value was ascribed to the remaining 123,302 warrants that were only exercisable upon the funding of the first additional tranche. As a result of the Company’s additional $10.0 million borrowings under the Loan Agreement on October 13, 2021, the warrants to purchase the additional 123,302 shares of Common Stock became exercisable at an exercise price of $10.28 per share and the value of the warrants was recorded as of that date. The additional warrants are classified within stockholders’ equity using a Black-Scholes valuation model, as the settlement of the warrants is indexed to the Common Stock. The fair value of warrants ($3.3 million), a 5% final payment fee ($1.5 million) and debt issuance costs ($0.3 million) were being accreted to interest expense over the term of the loan using the effective interest method. In connection with the termination of the Loan Agreement, the Company paid a prepayment premium of $0.3 million and recorded a loss on extinguishment of debt of $2.4 million during the nine months ended September 30, 2023 in other income (expense) in the condensed consolidated statements of operations and comprehensive loss. The loss on extinguishment of debt consists of the prepayment premium, the unamortized debt discount and issuance costs and the unaccreted final payment fee. |
Debt
Debt | 9 Months Ended |
Sep. 30, 2023 | |
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 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”). 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 existing obligations under the Loan Agreement with SVB . The Company will also be entitled to receive up to approximately $110.0 million in subsequent installments subject to the terms and conditions set forth in the Purchase Agreement, as follows: (i) $20.0 million upon the Company’s biologics license application (“BLA”) for an indication in vascular trauma being accepted on or prior to March 31, 2024, (ii) $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 (iii) $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. As of September 30, 2023, the Company was in compliance with all covenants. 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. As of September 30, 2023, $37.3 million was recorded as a revenue interest liability on the accompanying condensed consolidated balance sheets (net of transaction costs, the fair value allocated to the Option Agreement and the fair value of the bifurcated contingent derivative liability). 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 estimated effective annual interest rate as of September 30, 2023 was 11.5%. The Company will evaluate 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 will prospectively adjust the effective interest and the related amortization of the liability and related issuance costs. The Company recorded $1.0 million and $1.8 million in interest expense related to the Purchase Agreement for the three and nine months ended September 30, 2023, respectively. 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. The Company recorded the initial fair value of the derivative liability of $2.4 million as a debt discount, which will be 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. For the three and nine months ended September 30, 2023, the Company incurred zero and $2.1 million of issuance and transaction costs, respectively, in connection with the Purchase Agreement. The issuance and transaction costs were capitalized to debt discount and are being amortized to interest expense over the estimated term of the debt. The Company paid $1.8 million of the issuance and transaction costs during the second quarter of 2023 and paid $0.3 million during the third quarter of 2023. Revenue Interest Payments made as a result of the Company’s net product sales will reduce the revenue interest liability. During the three and nine months ended September 30, 2023, the Company did not record any product sales revenue. The following table summarizes the revenue interest liability activity during the nine months ended September 30, 2023: ($ in thousands) Revenue interest liability at inception $ — Proceeds from revenue interest purchase agreement, gross 40,000 Less issuance costs (623) Proceeds from revenue interest purchase agreement, net 39,377 Transaction costs paid (1,450) Debt discount from embedded contingent derivative liability (2,354) Debt discount from fair value of Option Agreement (55) Interest expense recognized 1,768 Revenue interest liability at September 30, 2023 $ 37,286 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. 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”). The Loan Agreement provided a term loan facility of up to $50.0 million with a maturity date of March 1, 2025. On March 10, 2023, SVB was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation (the “FDIC”) was appointed as receiver. On March 13, 2023, the FDIC announced that all of SVB’s deposits and substantially all of its assets had been transferred to a newly created, full-service, FDIC-operated bridge bank, Silicon Valley Bridge Bank, N.A. (“SVBB”). SVBB assumed all loans that were previously held by SVB. On March 27, 2023, First-Citizens Bank & Trust Company assumed all of SVBB’s customer deposits and certain other liabilities and acquired substantially all of SVBB’s loans and certain other assets from the FDIC, including the Loan Agreement. In connection with the Loan Agreement, the Company granted warrants to the lenders to purchase shares of Common Stock at an exercise price of $10.28 per share, of which 287,704 warrants were immediately exercisable. The warrants are classified within stockholders’ equity, as the settlement of the warrants is indexed to the Common Stock. The Company recognized the fair value of the warrants immediately exercisable within stockholders’ equity using a Black-Scholes valuation model at issuance. At issuance, the Company initially determined that the funding of an additional tranche was not probable, and therefore no value was ascribed to the remaining 123,302 warrants that were only exercisable upon the funding of the first additional tranche. As a result of the Company’s additional $10.0 million borrowings under the Loan Agreement on October 13, 2021, the warrants to purchase the additional 123,302 shares of Common Stock became exercisable at an exercise price of $10.28 per share and the value of the warrants was recorded as of that date. The additional warrants are classified within stockholders’ equity using a Black-Scholes valuation model, as the settlement of the warrants is indexed to the Common Stock. The fair value of warrants ($3.3 million), a 5% final payment fee ($1.5 million) and debt issuance costs ($0.3 million) were being accreted to interest expense over the term of the loan using the effective interest method. In connection with the termination of the Loan Agreement, the Company paid a prepayment premium of $0.3 million and recorded a loss on extinguishment of debt of $2.4 million during the nine months ended September 30, 2023 in other income (expense) in the condensed consolidated statements of operations and comprehensive loss. The loss on extinguishment of debt consists of the prepayment premium, the unamortized debt discount and issuance costs and the unaccreted final payment fee. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Stockholders ’ Equity Common Stock On August 26, 2021, the Merger and related PIPE Financing was consummated and the Company issued 27,346,449 shares of Common Stock for proceeds of $242.4 million. The Company incurred $3.9 million of transaction costs, consisting of banking, legal, and other professional fees. Legacy Humacyte assumed $15.2 million of liabilities, including PIPE Financing fees and legal fees, and $0.1 million of assets from AHAC. Immediately following the Merger, there were 103,003,384 shares of Common Stock outstanding with a par value of $0.0001 per share. As of September 30, 2023, 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 September 30, 2023, 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 September 30, 2023, the Company had reserved Common Stock for future issuances as follows: September 30, 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 7,170,891 Options available for issuance under stock plans 6,501,655 Shares available for grant under ESPP 1,030,033 Warrants to purchase Common Stock 5,588,506 36,624,419 ___________________________ (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 September 30, 2023 and December 31, 2022. Warrants The Company had the following Common Stock warrants outstanding as of September 30, 2023 and December 31, 2022: 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 See Note 7 — Debt for a discussion of Common Stock warrants issued in conjunction with the Company ’ s Loan Agreement in 2021 (such warrants, “Legacy Humacyte Common Stock Warrants”). There were no issuances, exercises or expirations of warrants during the nine months ended September 30, 2023 or September 30, 2022. 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 (“ASC 480”). 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 and the estimated fair value of the Private Placement Warrants at December 31, 2022 was $0.1 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 and nine months ended September 30, 2023 and 2022. The remeasurement of the Private Placement Warrant liability to a fair value of $0.1 million as of September 30, 2023 resulted in an insignificant non-cash gain and a non-cash loss of $0.1 million for the three and nine months ended September 30, 2023, respectively, compared to a non-cash loss of $0.1 million and a non-cash gain of $0.2 million for the three and nine months ended September 30, 2022. 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: September 30, December 31, Market price of public stock $ 2.93 $ 2.11 Exercise price $ 11.50 $ 11.50 Expected term (years) 2.91 3.65 Expected share price volatility 90.0 % 78.3 % Risk-free interest rate 4.82 % 4.14 % 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. The estimated fair value of the total Contingent Earnout Shares at December 31, 2022 was $27.9 million. See Note 3 — Fair Value Measurements for a summary of the change in the fair value of the Contingent Earnout Liability during the three and nine months ended September 30, 2023 and 2022. The remeasurement of the Contingent Earnout Liability to a fair value of $39.6 million as of September 30, 2023 resulted in non-cash losses of $1.1 million and $11.7 million for the three and nine months ended September 30, 2023, respectively, compared to a non-cash loss of $1.0 million and a non-cash gain of $58.6 million for the three and nine months ended September 30, 2022, respectively. 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: September 30, December 31, Current stock price $ 2.93 $ 2.11 Expected share price volatility 87.1 % 89.0 % Risk-free interest rate 4.59 % 3.88 % Estimated dividend yield 0 % 0 % Expected term (years) 10.00 10.00 |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
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. As of September 30, 2023, 6,501,655 and 1,030,033 shares of Common Stock were available under the 2021 Plan and ESPP, respectively. 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. In both December 2021 and 2022, the Company’s board of directors determined that there would be no automatic increase in the number of shares reserved under the 2021 Plan or the ESPP on either January 1, 2022 or January 1, 2023. 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. 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 may 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 September 30, 2023, 3,405,878, 3,485,882 and 279,131 shares of Common Stock remain reserved for outstanding options issued under the 2021 Plan, the 2015 Plan and the 2005 Plan, respectively. 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 September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Estimated dividend yield 0 % 0 % 0 % 0 % Expected share price volatility (weighted average and range, if applicable) 89.8% 89.3% (89.2% to 89.4%) 89.0% (88.6% to 89.8%) 93.3% (89.0% to 100.0%) Risk-free interest rate (weighted average and range, if applicable) 4.39% 3.58% (3.46% to 3.65%) 3.91% (3.58% to 4.39%) 2.96% (1.89% to 3.65%) Expected term of options (in years) 6.25 6.25 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. At September 30, 2023, there were 6,501,655 options remaining available for grant under the 2021 Plan. The Company has sufficient authorized and unissued shares to issue Common Stock in satisfaction of any awards available for grant under the 2021 Plan. 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 and nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, ($ in thousands) 2023 2022 2023 2022 Research and development $ 361 $ 216 $ 1,262 $ 682 General and administrative 1,411 1,260 4,160 3,832 Total $ 1,772 $ 1,476 $ 5,422 $ 4,514 As of September 30, 2023, unrecognized stock-based compensation cost for options was $8.5 million and is expected to be recognized over a weighted-average period of 2.4 years. A summary of option activity under the Company ’ s stock option plans during the nine months ended September 30, 2023 is presented below: Number of Shares Weighted Weighted Aggregate Options outstanding at December 31, 2022 7,203,874 $ 5.90 7.5 $ 429 Granted 564,150 $ 3.52 Exercised (231,823) $ 1.35 Forfeited (365,310) $ 5.03 Options outstanding at September 30, 2023 7,170,891 $ 5.90 7.0 $ 639 Vested and exercisable, September 30, 2023 3,463,584 $ 6.93 5.1 $ 632 Vested and expected to vest, September 30, 2023 7,170,891 $ 5.90 7.0 $ 639 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
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 September 30, 2023. The Company ’ s effective federal and state tax rate for the three and nine months ended September 30, 2023 and 2022 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 and nine months ended September 30, 2023 and 2022. 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 | 9 Months Ended |
Sep. 30, 2023 | |
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. Payments to Duke under the license agreement were immaterial during the periods presented. Yale University In February 2014, the Company entered into a license agreement with Yale University (“Yale”) that granted the Company a worldwide license to the patents related to coatings for small-diameter vessels to inhibit clotting (the “Small Diameter Vessel License Agreement”). The license granted under the Small Diameter Vessel License Agreement is exclusive in the field of engineered vascular tissues and extracellular matrix-based implants used for vascular repair, reconstruction and replacement (provided that all uses are vascular tissues within the range of 1 – 12mm in diameter), except that it was 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 agreed to pay to Yale an annual maintenance fee, increasing between the first and fourth anniversaries of the Small Diameter Vessel License Agreement up to a maximum of less than $0.1 million per year for this license. In December 2022, in accordance with the terms of the Small Diameter Vessel License Agreement, the Company provided Yale with 90 days written notice of termination, effective March 21, 2023. In August 2019, the Company entered into a license agreement with Yale that granted the Company a worldwide license to the patents related to the BVP (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 between the first anniversary of the Tubular Prosthesis License Agreement until the fifth anniversary for the Small Diameter Vessel License Agreement (through the termination of the agreement on March 21, 2023) and 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 Small Diameter Vessel License Agreement, BVP License Agreement and Tubular Prosthesis License Agreement were immaterial during the periods presented. JDRF Agreement On April 1, 2023, the Company entered into the JDRF Agreement to further develop and perform preclinical testing of the BVP, as discussed in Note 2 — Summary of Significant Accounting Policies. According to the terms of the JDRF Agreement, JDRF will provide funding up to $0.8 million based on the achievement of certain research and development milestones. The Company received the first milestone payment of $80 thousand in April 2023 upon execution of the agreement. 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 the Royalty Cap, less any previous royalty payments paid towards the Royalty Cap. 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 | 9 Months Ended |
Sep. 30, 2023 | |
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. The Company expensed less than $0.1 million and approximately $0.2 million during the three and nine months ended September 30, 2023, respectively, for clinical research services performed by Frenova Renal Research, a subsidiary of Fresenius Medical Care. The Company expensed approximately $0.2 million for such services during each of the three and nine months ended September 30, 2022. As of September 30, 2023, less than $0.1 million payable to Frenova Renal Research was included in accounts payable on the Company’s consolidated balance sheet. Arrangements with Yale University The Company’s President and Chief Executive Officer, Laura Niklason M.D., PhD., serves as an Adjunct Professor in Anesthesia at Yale University. As of September 30, 2023 and December 31, 2022, the Company was a party to license agreements with Yale University as described in Note 11 — Commitments and Contingencies, above. The following table shows a summary of related party expenses pertaining to Yale University included in the statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, ($ in thousands) 2023 2022 2023 2022 License expenses $ — $ — $ 55 $ 50 Other 18 8 22 16 Total 18 8 77 66 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
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 subsidiaries. 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 September 30, 2023 and its results of operations for the three and nine months ended September 30, 2023 and 2022, and cash flows for the nine months ended September 30, 2023 and 2022. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ended December 31, 2023 or any other period. The December 31, 2022 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, 2022 and the related notes included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 24, 2023 (the “Annual Report”), which provides a more complete discussion of the Company’s accounting policies and certain other information. Other than the policies noted below, 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, 2022 and 2021 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. |
Reclassifications | Reclassifications Certain amounts from prior periods have been reclassified to conform to the current period’s presentation. None of these reclassifications had a material impact on the Company’s condensed consolidated financial statements. |
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 and short-term investments consisting of certificates of deposit (“CDs”). As of September 30, 2023 and December 31, 2022, there were no material cash balances in excess of balances insured by the Federal Deposit Insurance Corporation (“FDIC”). As of both September 30, 2023 and December 31, 2022, the Company had cash equivalents 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. |
Employee Retention Credit | The Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) provided refundable employee retention credits, which could be used to offset payroll tax liabilities. Under the provisions of the extension of the CARES Act, the Company qualified for the employee retention credit for the first three quarters of 2021, and the Company applied for the credit in February 2023. As there is no authoritative guidance under U.S. GAAP for accounting for grants to for-profit business entities, the Company accounted for the grant by applying Accounting Standards Codification (“ASC”) 450, Contingencies . The Company received an employee retention credit of $3.1 million in July 2023, and recognized the credit as income during the second quarter of 2023 after the Company received notices from the Internal Revenue Service specifying the amount of the credit receivable, and all uncertainties were resolved regarding receipt of the credit. The Company recognized the credit as a component of other income (expense), net on the condensed consolidated statement of operations and comprehensive loss during the nine months ended September 30, 2023. |
Revenue Interest Liability, JDRF Award | The revenue interest liability associated with the Purchase Agreement is presented net of a debt discount comprised of issuance costs, transaction costs, the fair value of a freestanding option agreement related to the Purchase Agreement, and the fair value of embedded derivatives requiring bifurcation on the condensed consolidated balance sheets. 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 the 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. If the level and timing of any forecasted net sales and related payments change, the Company will prospectively adjust the effective interest and the related amortization of the liability and related issuance costs on a quarterly basis.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 as of September 30, 2023 the carrying value is $64 thousand and is included in other long-term liabilities in the condensed consolidated balance sheet. |
Contingent Derivative Liability and JDRF Award | The Purchase Agreement contains certain features that meet the definition of embedded derivatives requiring bifurcation as a separate compound financial instrument apart from the Revenue Interest Liability. The contingent derivative liability related to the Put Option, as defined in Note 6 — Revenue Interest Purchase Agreement, was initially measured at fair value upon issuance and is subject to remeasurement at 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 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 as of September 30, 2023 the carrying value is $64 thousand and is included in other long-term liabilities in the condensed consolidated balance sheet. |
Net Loss per Share Attributable to Common Stockholders | Net Loss per Share Attributable to Common StockholdersBasic 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 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. |
Recently Adopted Accounting Pronouncements and Recently Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements The Company did not adopt any new standards or updates issued by the Financial Accounting Standards Board (the “FASB”) during the nine months ended September 30, 2023 that had a material impact on the Company’s condensed consolidated financial statements and related disclosures. Recently Issued Accounting Pronouncements The Company reviewed all recently issued accounting pronouncements through September 30, 2023 and concluded that they were not applicable or not expected to have a material impact on the Company’s condensed consolidated financial statements and related disclosures. |
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. Certificates of deposit were carried at amortized cost in the Company’s condensed consolidated balance sheets, which approximates their fair value based on Level 2 inputs. The carrying values of other receivables, accounts payable and accrued expenses as of September 30, 2023 and December 31, 2022 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. |
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 (“ASC 480”). 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) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Securities That Could Potentially Dilute Net Loss Per Share in the Future That Were Not Included in the Computation of Diluted Net Income (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 and Nine Months Ended September 30, 2023 2022 Exercise of options under stock plan 7,170,891 6,722,422 Warrants to purchase Common Stock 5,588,506 5,588,506 |
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 September 30, 2023 and December 31, 2022. ($ in thousands) September 30, December 31, Cash and cash equivalents $ 99,986 $ 149,772 Restricted cash included in prepaid expenses and other current assets 144 — Restricted cash included in other long-term assets 210 — Total cash, cash equivalents and restricted cash $ 100,340 $ 149,772 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 September 30, 2023 Level 1 Level 2 Level 3 Total Assets: Cash equivalents (money market funds) $ 98,539 $ — $ — $ 98,539 Total financial assets $ 98,539 $ — $ — $ 98,539 Liabilities: Contingent Earnout Liability $ — $ — $ 39,601 $ 39,601 Contingent derivative liability — — 2,536 2,536 Private Placement Warrants liability — — 149 149 Option Agreement liability — — 38 38 JDRF Agreement derivative liability — — 28 28 Total financial liabilities $ — $ — $ 42,352 $ 42,352 ($ in thousands) Fair Value Measured as of December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Cash equivalents (money market funds) $ 141,159 $ — $ — $ 141,159 Cash equivalents (certificates of deposit) — 8,000 — 8,000 Short-term investments (certificates of deposit) — 2,107 — 2,107 Total financial assets $ 141,159 $ 10,107 $ — $ 151,266 Liabilities: Contingent Earnout Liability $ — $ — $ 27,893 $ 27,893 Private Placement Warrants liability — — 80 80 Total financial liabilities $ — $ — $ 27,973 $ 27,973 |
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 September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Fair value as of beginning of period $ (38,457) $ (44,049) $ (27,893) $ (103,660) Change in fair value included in other income (expense), net (1,144) (962) (11,708) 58,649 Fair value as of end of period $ (39,601) $ (45,011) $ (39,601) $ (45,011) 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 September 30, Nine Months Ended September 30, ($ in thousands) 2023 2022 2023 2022 Fair value as of beginning of period $ (158) $ (190) $ (80) $ (497) Change in fair value included in other income (expense), net 9 (67) (69) 240 Fair value as of end of period $ (149) $ (257) $ (149) $ (257) 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 Nine Months Fair value as of beginning of period $ (2,392) $ — Initial fair value of contingent derivative liability — (2,354) Change in fair value included in other income (expense), net (144) (182) Fair value as of end of period $ (2,536) $ (2,536) |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, net consist of the following: ($ in thousands) September 30, December 31, Scientific and manufacturing equipment $ 28,505 $ 27,821 Computer equipment 125 167 Software 673 209 Furniture and fixtures 1,066 988 Leasehold improvements 27,672 26,355 Construction in progress 58 680 58,099 56,220 Accumulated depreciation (30,248) (26,181) Property and equipment, net $ 27,851 $ 30,039 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: ($ in thousands) September 30, December 31, Accrued external research, development and manufacturing costs $ 4,002 $ 2,437 Accrued employee compensation and benefits 5,342 4,227 Accrued professional fees 242 444 Total $ 9,586 $ 7,108 |
Revenue Interest Purchase Agr_2
Revenue Interest Purchase Agreement (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 nine months ended September 30, 2023: ($ in thousands) Revenue interest liability at inception $ — Proceeds from revenue interest purchase agreement, gross 40,000 Less issuance costs (623) Proceeds from revenue interest purchase agreement, net 39,377 Transaction costs paid (1,450) Debt discount from embedded contingent derivative liability (2,354) Debt discount from fair value of Option Agreement (55) Interest expense recognized 1,768 Revenue interest liability at September 30, 2023 $ 37,286 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Summary of Common Stock Reserved for Future Issuances | As of September 30, 2023, the Company had reserved Common Stock for future issuances as follows: September 30, 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 7,170,891 Options available for issuance under stock plans 6,501,655 Shares available for grant under ESPP 1,030,033 Warrants to purchase Common Stock 5,588,506 36,624,419 ___________________________ (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 September 30, 2023 and December 31, 2022: 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: September 30, December 31, Market price of public stock $ 2.93 $ 2.11 Exercise price $ 11.50 $ 11.50 Expected term (years) 2.91 3.65 Expected share price volatility 90.0 % 78.3 % Risk-free interest rate 4.82 % 4.14 % Estimated dividend yield 0 % 0 % Assumptions used in the valuations are described below: September 30, December 31, Current stock price $ 2.93 $ 2.11 Expected share price volatility 87.1 % 89.0 % Risk-free interest rate 4.59 % 3.88 % Estimated dividend yield 0 % 0 % Expected term (years) 10.00 10.00 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Estimated dividend yield 0 % 0 % 0 % 0 % Expected share price volatility (weighted average and range, if applicable) 89.8% 89.3% (89.2% to 89.4%) 89.0% (88.6% to 89.8%) 93.3% (89.0% to 100.0%) Risk-free interest rate (weighted average and range, if applicable) 4.39% 3.58% (3.46% to 3.65%) 3.91% (3.58% to 4.39%) 2.96% (1.89% to 3.65%) Expected term of options (in years) 6.25 6.25 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 and nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, ($ in thousands) 2023 2022 2023 2022 Research and development $ 361 $ 216 $ 1,262 $ 682 General and administrative 1,411 1,260 4,160 3,832 Total $ 1,772 $ 1,476 $ 5,422 $ 4,514 |
Summary of Stock Option Activity | A summary of option activity under the Company ’ s stock option plans during the nine months ended September 30, 2023 is presented below: Number of Shares Weighted Weighted Aggregate Options outstanding at December 31, 2022 7,203,874 $ 5.90 7.5 $ 429 Granted 564,150 $ 3.52 Exercised (231,823) $ 1.35 Forfeited (365,310) $ 5.03 Options outstanding at September 30, 2023 7,170,891 $ 5.90 7.0 $ 639 Vested and exercisable, September 30, 2023 3,463,584 $ 6.93 5.1 $ 632 Vested and expected to vest, September 30, 2023 7,170,891 $ 5.90 7.0 $ 639 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Summary of Related Party Expenses | The following table shows a summary of related party expenses pertaining to Yale University included in the statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, ($ in thousands) 2023 2022 2023 2022 License expenses $ — $ — $ 55 $ 50 Other 18 8 22 16 Total 18 8 77 66 |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Aug. 26, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Asset Acquisition [Line Items] | ||||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Proceeds from Merger and related PIPE Financing | $ 242,400 | |||||
Transaction costs | $ 3,900 | |||||
Accumulated deficit | $ 512,208 | $ 512,208 | $ 426,538 | |||
Operating losses | 24,622 | $ 23,494 | 73,865 | $ 63,788 | ||
Net cash used in operating activities | 54,251 | $ 52,170 | ||||
Cash and cash equivalents | $ 99,986 | $ 99,986 | $ 149,772 | |||
Private Placement | ||||||
Asset Acquisition [Line Items] | ||||||
Number of shares issued (in shares) | 17,500,000 | |||||
Aggregate purchase price | $ 175,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Segments (Details) | 9 Months Ended |
Sep. 30, 2023 segment | |
Accounting Policies [Abstract] | |
Number of reportable segments | 1 |
Number of operating segments | 1 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Concentration of Credit Risk (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Concentration Risk [Line Items] | ||
Certificates of deposit | $ 0 | $ 10.1 |
Cash and Cash Equivalents | ||
Concentration Risk [Line Items] | ||
Certificates of deposit | 8 | |
Short-term Investments | ||
Concentration Risk [Line Items] | ||
Certificates of deposit | $ 2.1 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Restricted Cash and Cash Equivalents Items [Line Items] | ||||
Cash and cash equivalents | $ 99,986 | $ 149,772 | ||
Restricted cash | 0 | |||
Total cash, cash equivalents and restricted cash | 100,340 | 149,772 | $ 163,731 | $ 217,502 |
Prepaid Expenses and Other Current Assets | ||||
Restricted Cash and Cash Equivalents Items [Line Items] | ||||
Restricted cash | 144 | 0 | ||
Other Long-Term Assets | ||||
Restricted Cash and Cash Equivalents Items [Line Items] | ||||
Restricted cash | $ 210 | $ 0 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Employee Retention Credit (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jul. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Employee retention credit | $ 3,100 | $ 0 | $ 0 | $ 3,107 | $ 0 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - JDRF Liability (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Apr. 30, 2023 | Apr. 01, 2023 | Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Other long-term liabilities | $ 872 | $ 712 | ||
Embedded Derivative Financial Instruments, JDRF Agreement | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Milestone payment potentially receivable | $ 800 | |||
Upfront payment received | $ 80 | |||
Other long-term liabilities | $ 64 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Antidilutive Securities Excluded From Computation (Details) - $ / shares | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | 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 | 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) | 7,170,891 | 6,722,422 | 7,170,891 | 6,722,422 | |
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 | 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 | Sep. 30, 2023 | May 12, 2023 | Dec. 31, 2022 |
Assets: | |||
Short-term investments (certificates of deposit) | $ 2,107 | ||
Total financial assets | $ 98,539 | 151,266 | |
Liabilities: | |||
Contingent Earnout Liability | 39,601 | 27,893 | |
Private Placement Warrants liability | 149 | 80 | |
Total financial liabilities | 42,352 | 27,973 | |
Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | |||
Liabilities: | |||
Derivative liability | 2,536 | $ 2,400 | |
Equity Option | |||
Liabilities: | |||
Derivative liability | 38 | $ 55 | |
Embedded Derivative Financial Instruments, JDRF Agreement | |||
Liabilities: | |||
Derivative liability | 28 | ||
Level 1 | |||
Assets: | |||
Short-term investments (certificates of deposit) | 0 | ||
Total financial assets | 98,539 | 141,159 | |
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 | ||
Level 1 | Equity Option | |||
Liabilities: | |||
Derivative liability | 0 | ||
Level 1 | Embedded Derivative Financial Instruments, JDRF Agreement | |||
Liabilities: | |||
Derivative liability | 0 | ||
Level 2 | |||
Assets: | |||
Short-term investments (certificates of deposit) | 2,107 | ||
Total financial assets | 0 | 10,107 | |
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 | ||
Level 2 | Equity Option | |||
Liabilities: | |||
Derivative liability | 0 | ||
Level 2 | Embedded Derivative Financial Instruments, JDRF Agreement | |||
Liabilities: | |||
Derivative liability | 0 | ||
Level 3 | |||
Assets: | |||
Short-term investments (certificates of deposit) | 0 | ||
Total financial assets | 0 | 0 | |
Liabilities: | |||
Contingent Earnout Liability | 39,601 | 27,893 | |
Private Placement Warrants liability | 149 | 80 | |
Total financial liabilities | 42,352 | 27,973 | |
Level 3 | Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | |||
Liabilities: | |||
Derivative liability | 2,536 | ||
Level 3 | Equity Option | |||
Liabilities: | |||
Derivative liability | 38 | ||
Level 3 | Embedded Derivative Financial Instruments, JDRF Agreement | |||
Liabilities: | |||
Derivative liability | 28 | ||
Cash equivalents (money market funds) | |||
Assets: | |||
Cash equivalents | 98,539 | 141,159 | |
Cash equivalents (money market funds) | Level 1 | |||
Assets: | |||
Cash equivalents | 98,539 | 141,159 | |
Cash equivalents (money market funds) | Level 2 | |||
Assets: | |||
Cash equivalents | 0 | 0 | |
Cash equivalents (money market funds) | Level 3 | |||
Assets: | |||
Cash equivalents | $ 0 | 0 | |
Cash equivalents (certificates of deposit) | |||
Assets: | |||
Cash equivalents | 8,000 | ||
Cash equivalents (certificates of deposit) | Level 1 | |||
Assets: | |||
Cash equivalents | 0 | ||
Cash equivalents (certificates of deposit) | Level 2 | |||
Assets: | |||
Cash equivalents | 8,000 | ||
Cash equivalents (certificates of deposit) | Level 3 | |||
Assets: | |||
Cash equivalents | $ 0 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Fair Value of Level 3 Financial Instruments (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Contingent Earnout Liability | ||||
Changes in the fair value of the Level 3 financial instruments | ||||
Beginning balance | $ (38,457) | $ (44,049) | $ (27,893) | $ (103,660) |
Change in fair value included in other income (expense), net | (1,144) | (962) | (11,708) | 58,649 |
Ending balance | (39,601) | (45,011) | (39,601) | (45,011) |
Private Placement Warrants | ||||
Changes in the fair value of the Level 3 financial instruments | ||||
Beginning balance | (158) | (190) | (80) | (497) |
Change in fair value included in other income (expense), net | 9 | (67) | (69) | 240 |
Ending balance | $ (149) | $ (257) | $ (149) | $ (257) |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) $ in Thousands | 9 Months Ended | ||||
Sep. 30, 2023 USD ($) year yr | Sep. 30, 2022 USD ($) | May 12, 2023 | Apr. 01, 2023 | Dec. 31, 2022 yr | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Proceeds from JDRF Agreement | $ 80 | $ 0 | |||
Embedded Derivative Financial Instruments, JDRF Agreement | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Disposition payment percentage | 0.10 | ||||
Royalty cap, actual award multiplier | 400% | ||||
Proceeds from JDRF Agreement | 80 | ||||
Royalty cap | 320 | ||||
Embedded Derivative Financial Instruments, JDRF Agreement | Recurring | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Derivative liability | $ 28 | ||||
Expected term (years) | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Measurement input | yr | 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 | year | 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 | 0.154 | 0.127 | |||
Measurement Input, Payoff Off 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 | 0.174 | 0.121 | |||
Measurement Input, Discount Rate | Embedded Derivative Financial Instruments, JDRF Agreement | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Contingent derivative, measurement input | 0.194 | ||||
Contingent Earnout Liability | Expected term (years) | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Measurement input | yr | 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 - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Changes in the fair value of the Level 3 financial instruments | ||
Fair value as of beginning of period | $ 2,392 | $ 0 |
Initial fair value of contingent derivative liability | 0 | (2,354) |
Change in fair value included in other income (expense), net | (144) | (182) |
Fair value as of end of period | $ 2,536 | $ 2,536 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | $ 58,099 | $ 58,099 | $ 56,220 | ||
Accumulated depreciation | (30,248) | (30,248) | (26,181) | ||
Property and equipment, net | 27,851 | 27,851 | 30,039 | ||
Depreciation expense | 1,300 | $ 1,500 | 4,341 | $ 4,552 | |
Scientific and manufacturing equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 28,505 | 28,505 | 27,821 | ||
Computer equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 125 | 125 | 167 | ||
Software | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 673 | 673 | 209 | ||
Furniture and fixtures | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 1,066 | 1,066 | 988 | ||
Leasehold improvements | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 27,672 | 27,672 | 26,355 | ||
Construction in progress | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | $ 58 | $ 58 | $ 680 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] | ||
Accrued external research, development and manufacturing costs | $ 4,002 | $ 2,437 |
Accrued employee compensation and benefits | 5,342 | 4,227 |
Accrued professional fees | 242 | 444 |
Total | $ 9,586 | $ 7,108 |
Revenue Interest Purchase Agr_3
Revenue Interest Purchase Agreement - Narrative (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 USD ($) | Jun. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | May 12, 2023 USD ($) $ / shares | Dec. 31, 2022 USD ($) | |
Revenue Interest Liability [Line Items] | |||||
Revenue interest liability | $ 37,286 | $ 37,286 | $ 0 | ||
Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | Recurring | |||||
Revenue Interest Liability [Line Items] | |||||
Derivative liability | 2,536 | 2,536 | $ 2,400 | ||
Equity Option | Recurring | |||||
Revenue Interest Liability [Line Items] | |||||
Derivative liability | 38 | 38 | 55 | ||
Revenue Interest Purchase Agreement | |||||
Revenue Interest Liability [Line Items] | |||||
Total investment amount | 150,000 | ||||
Upfront payment received | 40,000 | ||||
Aggregate milestone payments potentially receivable | $ 110,000 | ||||
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 | ||||
Revenue interest liability | $ 37,300 | $ 37,300 | |||
Effective interest rate | 11.50% | 11.50% | |||
Interest expense | $ 1,000 | $ 1,768 | |||
Issuance and transaction costs incurred in connection with the Purchase Agreement | 0 | $ 2,100 | |||
Payments of debt issuance and transaction costs | $ 300 | $ 1,800 | |||
Revenue Interest Purchase Agreement | Embedded Derivative Financial Instruments, Revenue Interest Purchase Agreement | |||||
Revenue Interest Liability [Line Items] | |||||
Debt discount | $ 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 potentially receivable | $ 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 | 9 Months Ended | ||
May 12, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue Interest Liability Activity [Roll Forward] | ||||
Proceeds from revenue interest purchase agreement, net | $ 39,377 | $ 0 | ||
Payments of transaction costs related to revenue interest purchase agreement | (1,450) | $ 0 | ||
Revenue Interest Purchase Agreement | ||||
Revenue Interest Liability Activity [Roll Forward] | ||||
Revenue interest liability at inception | 0 | |||
Proceeds from revenue interest purchase agreement, gross | $ 40,000 | 40,000 | ||
Less issuance costs | (623) | |||
Proceeds from revenue interest purchase agreement, net | 39,377 | |||
Payments of transaction costs related to revenue interest purchase agreement | (1,450) | |||
Interest expense recognized | $ 1,000 | 1,768 | ||
Revenue interest liability at September 30, 2023 | $ 37,286 | 37,286 | ||
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 | (2,354) | |||
Option Purchase Agreement | ||||
Revenue Interest Liability Activity [Roll Forward] | ||||
Debt discount from embedded contingent derivative liability | $ (55) |
Debt - Term Loan (Details)
Debt - Term Loan (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
May 12, 2023 | Oct. 13, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Aug. 26, 2021 | Mar. 30, 2021 | |
Line of Credit Facility [Line Items] | ||||||||
Warrants, exercise price (in dollars per share) | $ 11.50 | |||||||
Prepayment premium | $ 310,000 | $ 0 | ||||||
Loss on extinguishment of debt | $ 0 | $ 0 | 2,421,000 | $ 0 | ||||
Term Loan Agreement | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Proceeds from Loan Agreement | $ 10,000,000 | |||||||
Common stock warrant liabilities | 3,300,000 | $ 3,300,000 | ||||||
Final payment fee percentage | 5% | |||||||
Final payment fee | $ 1,500,000 | $ 1,500,000 | ||||||
Debt issuance costs | 300,000 | |||||||
Term Loan Agreement | Warrants to purchase Common Stock | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Warrants, exercise price (in dollars per share) | $ 10.28 | $ 10.28 | ||||||
Warrants immediately exercisable (in shares) | 287,704 | |||||||
Exercisable warrants upon funding of additional tranche (in shares) | 123,302 | 123,302 | ||||||
Term Loan Agreement | Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P. | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Maximum loan facility amount | $ 50,000,000 | |||||||
Revenue Interest Purchase Agreement | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Proceeds from revenue interest purchase agreement, gross | $ 40,000,000 | $ 40,000,000 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock (Details) | 9 Months Ended | ||||||||
Aug. 26, 2021 USD ($) $ / shares shares | Sep. 30, 2023 USD ($) vote $ / shares shares | Jun. 30, 2023 shares | Mar. 31, 2023 shares | Dec. 31, 2022 $ / shares shares | Sep. 30, 2022 shares | Jun. 30, 2022 shares | Mar. 31, 2022 shares | Dec. 31, 2021 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 | 103,460,836 | 103,229,013 | ||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||
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 | ||||||||
AHAC | |||||||||
Business Acquisition [Line Items] | |||||||||
Liabilities assumed | $ 15,200,000 | ||||||||
Assets assumed | $ 100,000 | ||||||||
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 | 103,460,836 | 103,408,248 | 103,329,171 | 103,229,013 | 103,098,768 | 103,006,803 | 103,004,572 | 103,003,646 |
Stockholders' Equity - Common_2
Stockholders' Equity - Common Stock for Future Issuances (Details) - $ / shares | Sep. 30, 2023 | May 12, 2023 |
Class of Stock [Line Items] | ||
Reserved common stock for future issuances (in shares) | 36,624,419 | |
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) | 7,170,891 | |
Options available for issuance under stock plans | ||
Class of Stock [Line Items] | ||
Reserved common stock for future issuances (in shares) | 6,501,655 | |
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 | Sep. 30, 2023 | Dec. 31, 2022 |
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 | Sep. 30, 2023 | Dec. 31, 2022 |
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) | Aug. 26, 2021 $ / shares shares |
Class of Warrant or Right [Line Items] | |
Number of shares of common stock called by each warrant (in shares) | 1 |
Warrants, exercise price (in dollars per share) | $ / shares | $ 11.50 |
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 | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) $ / shares yr | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) $ / shares yr | Aug. 26, 2021 USD ($) | |
Class of Warrant or Right [Line Items] | |||||
Common stock warrant liabilities | $ | $ 0.1 | $ 0.1 | $ 0.6 | ||
Change in fair value of derivative liabilities | $ | $ (0.1) | $ (0.1) | $ 0.2 | ||
Market price of public stock | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants, measurement input | $ / shares | 2.93 | 2.11 | |||
Exercise price | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants, measurement input | $ / shares | 11.50 | 11.50 | |||
Expected term (years) | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants, measurement input | yr | 2.91 | 3.65 | |||
Expected share price volatility | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants, measurement input | 0.900 | 0.783 | |||
Risk-free interest rate | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants, measurement input | 0.0482 | 0.0414 | |||
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 | 9 Months Ended | ||||
Aug. 26, 2021 USD ($) yr tranche $ / shares shares | Sep. 30, 2023 USD ($) yr $ / shares shares | Sep. 30, 2022 USD ($) shares | Sep. 30, 2023 USD ($) yr $ / shares shares | Sep. 30, 2022 USD ($) shares | Dec. 31, 2022 USD ($) yr $ / shares | |
Business Acquisition, Contingent Consideration [Line Items] | ||||||
Maximum contingent earnout (in shares) | shares | 15,000,000 | 15,000,000 | 15,000,000 | 15,000,000 | ||
Contingent Earnout Liability | $ | $ 39,601 | $ 39,601 | $ 27,893 | |||
Change in fair value of Contingent Earnout Liability | $ | $ (1,144) | $ (962) | $ (11,708) | $ 58,649 | ||
Current stock price | ||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||
Measurement input | $ / shares | 2.93 | 2.93 | 2.11 | |||
Expected share price volatility | ||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||
Measurement input | 0.871 | 0.871 | 0.890 | |||
Risk-free interest rate | ||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||
Measurement input | 0.0459 | 0.0459 | 0.0388 | |||
Estimated dividend yield | ||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||
Measurement input | 0 | 0 | 0 | |||
Expected term (years) | ||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||
Measurement input | yr | 10 | 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 | |||||
Estimated fair value of total Contingent Earnout Shares | $ | $ 159,400 | |||||
Earnout Shares | Expected term (years) | ||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||
Measurement input | yr | 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 | 9 Months Ended | ||||
Aug. 25, 2021 plan | Sep. 30, 2023 shares | Sep. 30, 2022 | Sep. 30, 2023 shares | Sep. 30, 2022 | Dec. 31, 2022 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of equity incentive plans | plan | 2 | |||||
Outstanding awards (in shares) | 7,170,891 | 7,170,891 | 7,203,874 | |||
ESPP | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares remaining available for grant (in shares) | 1,030,033 | 1,030,033 | ||||
Annual increase in available shares | 1% | |||||
Purchase price of common stock, percent of closing trading price | 85% | |||||
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% | 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] | ||||||
Number of shares remaining available for grant (in shares) | 6,501,655 | 6,501,655 | ||||
Annual increase in available shares | 5% | |||||
Outstanding awards (in shares) | 3,405,878 | 3,405,878 | ||||
Long-Term Incentive Plan, 2021 | Options | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares remaining available for grant (in shares) | 6,501,655 | 6,501,655 | ||||
Omnibus Incentive Plan, 2015 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Outstanding awards (in shares) | 3,485,882 | 3,485,882 | ||||
Stock Option Plan, 2005 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Outstanding awards (in shares) | 279,131 | 279,131 |
Stock-based Compensation - Assu
Stock-based Compensation - Assumptions Used to Estimate Fair Value of Stock Options (Details) - Options | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Assumptions on the date of grant to estimate the fair value of the stock options | ||||
Estimated dividend yield | 0% | 0% | 0% | 0% |
Weighted average expected share price volatility | 89.80% | 89.30% | 89% | 93.30% |
Weighted average expected share price volatility, minimum | 89.20% | 88.60% | 89% | |
Weighted average expected share price volatility, maximum | 89.40% | 89.80% | 100% | |
Risk-free interest rate | 4.39% | 3.58% | 3.91% | 2.96% |
Risk-free interest rate, minimum | 3.46% | 3.58% | 1.89% | |
Risk-free interest rate, maximum | 3.65% | 4.39% | 3.65% | |
Expected term of options (in years) | 6 years 3 months | 6 years 3 months | 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 | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | $ 1,772 | $ 1,476 | $ 5,422 | $ 4,514 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | 361 | 216 | 1,262 | 682 |
General and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | $ 1,411 | $ 1,260 | $ 4,160 | $ 3,832 |
Stock-based Compensation - Rema
Stock-based Compensation - Remaining Unrecognized Costs (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Share-Based Payment Arrangement [Abstract] | |
Unrecognized stock-based compensation cost | $ 8.5 |
Unrecognized stock-based compensation cost, period for recognition | 2 years 4 months 24 days |
Stock-based Compensation - St_2
Stock-based Compensation - Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | |
Number of Shares | ||
Options outstanding, beginning of period (in shares) | shares | 7,203,874 | |
Granted (in shares) | shares | 564,150 | |
Exercised (in shares) | shares | (231,823) | |
Forfeited (in shares) | shares | (365,310) | |
Options outstanding, end of period (in shares) | shares | 7,170,891 | 7,203,874 |
Number of shares, vested and exercisable (in shares) | shares | 3,463,584 | |
Number of shares, vested and expected to vest (in shares) | shares | 7,170,891 | |
Weighted Average Exercise Price Per Share | ||
Options outstanding, beginning of period (in dollars per share) | $ / shares | $ 5.90 | |
Granted (in dollars per share) | $ / shares | 3.52 | |
Exercised (in dollars per share) | $ / shares | 1.35 | |
Forfeited (in dollars per share) | $ / shares | 5.03 | |
Options outstanding, end of period (in dollars per share) | $ / shares | 5.90 | $ 5.90 |
Weighted average exercise price, vested and exercisable (in dollars per share) | $ / shares | 6.93 | |
Weighted average exercise price, vested and expected to vest (in dollars per share) | $ / shares | $ 5.90 | |
Weighted Average Remaining Contractual Term and Aggregate Intrinsic Value | ||
Weighted average remaining contractual term, outstanding (in years) | 7 years | 7 years 6 months |
Weighted average remaining contractual term, vested and exercisable (in years) | 5 years 1 month 6 days | |
Weighted average remaining contractual term, vested and expected to vest (in years) | 7 years | |
Aggregate intrinsic value, outstanding | $ | $ 639 | $ 429 |
Aggregate intrinsic value, vested and exercisable | $ | 632 | |
Aggregate intrinsic value, vested and expected to vest | $ | $ 639 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Effective tax rate | 0% | 0% | 0% | 0% |
Income tax expense or benefit | $ 0 | $ 0 | $ 0 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Thousands | 1 Months Ended | 9 Months Ended | ||||
Aug. 31, 2019 USD ($) | Feb. 28, 2014 USD ($) | Sep. 30, 2023 USD ($) shares | Apr. 30, 2023 USD ($) | Apr. 01, 2023 USD ($) installment | Dec. 31, 2022 | |
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 | |||||
Royalty cap, actual award multiplier | 400% | |||||
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 | |||||
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 | 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 | |||||
Yale University | Small Diameter Vessel License Agreement | Coatings for Small-Diameter Vessels Patent Rights | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Termination period | 90 days | |||||
Maximum annual maintenance fee, less than | $ 100 | |||||
Yale University | BVP License Agreement | BVP Patent Rights | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Maximum annual maintenance fee, less than | $ 100 | |||||
Yale University | Tubular Prosthesis License Agreement | Tubular Prostheses Patent Rights | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Maximum annual maintenance fee, less than | $ 100 |
Related Party Transactions - Na
Related Party Transactions - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Aug. 26, 2021 | Feb. 16, 2021 | Aug. 31, 2021 | Jun. 30, 2018 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | |||||||||
Common stock issued (in shares) | 103,460,836 | 103,460,836 | 103,229,013 | ||||||
Accounts payable (less than) | $ 3,018 | $ 3,018 | $ 1,595 | ||||||
Fresenius Medical Care | Fresenius Medical Care | |||||||||
Related Party Transaction [Line Items] | |||||||||
Financing transaction | $ 150,000 | ||||||||
Conversion of stock (in shares) | 15,812,735 | ||||||||
Proceeds from PIPE Financing | $ 25,000 | ||||||||
Common stock issued (in shares) | 2,500,000 | ||||||||
Distribution agreement, termination period | 12 months | ||||||||
Fresenius Medical Care | Frenova Renal Research | |||||||||
Related Party Transaction [Line Items] | |||||||||
Clinical research services expense (less than for the three months ended September 30, 2023) | 100 | $ 200 | 200 | $ 200 | |||||
Accounts payable (less than) | $ 100 | $ 100 |
Related Party Transactions - Re
Related Party Transactions - Related Party Expenses (Details) - Yale University - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Related Party Transaction [Line Items] | ||||
Related party expenses | $ 18 | $ 8 | $ 77 | $ 66 |
License expenses | ||||
Related Party Transaction [Line Items] | ||||
Related party expenses | 0 | 0 | 55 | 50 |
Other | ||||
Related Party Transaction [Line Items] | ||||
Related party expenses | $ 18 | $ 8 | $ 22 | $ 16 |