Humacyte, Inc.
For the period ended Dec 31, 2024. Filed Mar 31, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 31, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
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Table of Contents
| Page No. | ||
|---|---|---|
| PART I | ||
| Item 1. | Business | 5 |
| Item 1A. | Risk Factors | 59 |
| Item 1B. | Unresolved Staff Comments | 95 |
| Item 1C. | Cybersecurity | 96 |
| Item 2. | Properties | 97 |
| Item 3. | Legal Proceedings | 97 |
| Item 4. | Mine Safety Disclosures | 98 |
| PART II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 99 |
| Item 6. | [Reserved] | 99 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 99 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 113 |
| Item 8. | Financial Statements and Supplementary Data | 114 |
| Item 9. | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure | 156 |
| Item 9A. | Controls and Procedures | 156 |
| Item 9B. | Other Information | 157 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 157 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance | 158 |
| Item 11. | Executive Compensation | 158 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 158 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 158 |
| Item 14. | Principal Accountant Fees and Services | 158 |
| PART IV | ||
| Item 15. | Exhibits and Financial Statement Schedules | 159 |
| SIGNATURES | 163 | |
FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements that involve substantial risks and uncertainties.“Forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”) are statements that are not historical facts and involve a number of risks and uncertainties. These statements include, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used therein, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, our management.
Forward-looking statements may include, for example, statements about:
our plans and ability to commercialize Symvess TM (acellular tissue engineered vessel-tyod or “ATEVTM”) and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines;
the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates;
our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs;
the expected size of the target populations for Symvess and, if approved by regulatory authorities, our product candidates;
the anticipated benefits of our ATEVs relative to existing alternatives;
our assessment of the competitive landscape;
our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines;
our plans, anticipated timeline and ability to file applications for, and obtain marketing approvals from the United States (“U.S.”) Food and Drug Administration (“FDA”) and other regulatory authorities, including the European Medicines Agency (“EMA”), for our ATEVs and product candidates;
our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials, including for our V007 and V012 Phase 3 clinical trials;
the outcome of our ongoing discussions with the FDA concerning the design of our clinical trials;
our anticipated growth rate and market opportunities;
our ability to use our proprietary scientific technology platform to build a pipeline of additional product candidates;
the characteristics and performance of our ATEVs;
our expectations regarding our strategic partnership with Fresenius Medical Care Holdings, Inc. (“Fresenius Medical Care”) to sell, market and distribute our 6 millimeter ATEV for certain specified indications and in specified markets, if approved by regulatory authorities;
the performance of other third parties on which we rely, including our third-party manufacturers, our licensors, our suppliers and the organizations conducting our clinical trials;
our ability to obtain and maintain intellectual property protection for our product candidates as well as our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others;
our ability to maintain the confidentiality of our trade secrets, particularly with respect to our manufacturing process;
our compliance with applicable laws and regulatory requirements, including FDA regulations, healthcare laws and regulations, and anti-corruption laws;
our involvement in existing or potential claims and legal proceedings, and the merits, potential outcomes and effects of both existing and potential claims and legal proceedings, as well as regulatory determinations, on our business, prospects, financial condition and results of operations;
our ability to attract, retain and motivate qualified personnel and to manage our growth effectively;
our estimates regarding how long our existing cash and cash equivalents will be sufficient to fund our anticipated operating expenses, capital expenditures and debt service obligations;
our future financial performance and capital requirements, including our ability to raise additional capital in the future;
our ability to implement and maintain effective internal controls;
the potential liquidity and trading of our securities; and
the impact of the overall global economy and increasing interest rates and inflation on our business.
We caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Any forward-looking statements are based on information current as of the date of this Annual Report on Form 10-K and speak only as of the date on which such statements are made. Actual events or results may differ materially from the results, plans, intentions or expectations anticipated in these forward-looking statements as a result of a variety of factors, many of which are beyond our control. More information on factors that could cause actual results to differ materially from those anticipated is included from time to time in our reports filed with the Securities and Exchange Commission (the “SEC”), including, but not limited to, those described in the sections of this Annual Report on Form 10-K titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” We disclaim any obligation, except as specifically required by law, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.