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Humacyte, Inc.

For the period ended Mar 31, 2026. Filed May 13, 2026.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2026 · Filed May 13, 2026

HUMA$0.46+1.6%Stored close · as of Nov 9, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

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Table of Contents

Page No.
PART I – FINANCIAL INFORMATION
Item 1.Financial Statements5
Condensed Consolidated Balance Sheets (unaudited)5
Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income (unaudited)6
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited)7
Condensed Consolidated Statements of Cash Flows (unaudited)8
Notes to Condensed Consolidated Financial Statements (unaudited)9
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations46
Item 3.Quantitative and Qualitative Disclosures About Market Risk59
Item 4.Controls and Procedures59
PART II – OTHER INFORMATION
Item 1.Legal Proceedings60
Item 1A.Risk Factors60
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds61
Item 3.Defaults Upon Senior Securities61
Item 4.Mine Safety Disclosures61
Item 5.Other Information61
Item 6.Exhibits62
SIGNATURES63

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (“Quarterly Report”) 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® (acellular tissue engineered vessel-tyod or “ATEV”) 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;

our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business;

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 and the public perception thereof;

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 and administrative proceedings, and the merits, potential outcomes and effects of both existing and potential claims and legal and administrative 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 timing and expected benefits of the commitment to purchase Symvess to facilitate a clinical evaluation and outreach program in the Kingdom of Saudi Arabia (the “KSA”);

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 Quarterly Report 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 by 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 titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in this Quarterly Report and our Annual Report on Form 10-K for the year ended December 31, 2025, which we filed with the SEC on March 27, 2026. 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.

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