humacyte inc 2025年季度报告

Humacyte, Inc.Quarterly Report on Form 10-QTable of Contents PART I – FINANCIAL INFORMATION Financial Statements •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 successfullyand 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 •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 byregulatory authorities; •the performance of other third parties on which we rely, including our third-party manufacturers, our licensors, our suppliersand 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 operateour business without infringing, misappropriating or otherwise violating the intellectual property rights of others; 3 •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 •our involvement in existing or potential claims and legal and administrative proceedings, and the merits, potential outcomesand effects of both existing and potential claims and legal and administrative proceedings, as well as regulatory •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 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 aremade. Any forward-looking statements are based on information current as of the date of this Quarterly Report and speak only as of 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 inour 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 December31, 2024, which we filed with PART I – FINANCIAL INFORMATIONItem 1. Financial StatementsHumacyte, Inc.Condensed Consolidated Balance Sheets(unaudited)(in thousands except for share and per share amounts) date, the Company has financed its operations primarily through the sale of equity securities and convertible debt, proceeds from thereverse recapitalization described below, borrowings under loan facilities, proceeds from a revenue interest purchase agreement and, to a lesser extent, through governmental and other grants. At March31, 2025 and December31, 2024, the Company had an accumulated administrative costs associated with the Company’s operations. The Company expects to incur substantial operating losses andnegative cash flows from operations for the foreseeable future as the Company advances its product candidates. As further disclosed in Note 7, on May 12, 2023, Humacyte, Inc. and Global entered into a Revenue Interest Purchase Agreement (the “Purchase Agreement”) withtwopurchasers, both affiliates of Oberland Capital Management LLC (the “Purchasers”), andanother affiliate of Oberland Capital Management LLC (“Oberland”), as agent for the Purchase