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Humacyte Inc SEC Filings

HUMA NASDAQ

Welcome to our dedicated page for Humacyte SEC filings (Ticker: HUMA), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.

The Humacyte, Inc. (HUMA) SEC filings page on Stock Titan provides direct access to the company’s U.S. Securities and Exchange Commission disclosures, alongside AI-generated summaries to help interpret complex documents. As a commercial-stage biotechnology platform company listed on Nasdaq, Humacyte files current and periodic reports that describe its bioengineered tissue programs, regulatory status, and capital structure.

Investors researching HUMA SEC filings can review Form 8-K current reports detailing material events such as credit facilities, revenue interest purchase agreements and their amendments or termination, registered direct offerings of common stock and warrants, at-the-market sales agreements, and senior secured term loan arrangements. These filings often explain how proceeds are intended to support commercialization of Symvess in the vascular trauma indication, development of acellular tissue engineered vessel (ATEV™) product candidates, and general corporate purposes.

Humacyte’s filings also identify it as an emerging growth company and disclose the listing of its common stock under ticker HUMA and redeemable warrants under HUMAW on The Nasdaq Stock Market. Over time, investors can expect Forms 10-K and 10-Q to provide detailed information on the company’s biotechnology platform, the approved ATEV for extremity vascular trauma, late-stage clinical trials in hemodialysis access and peripheral artery disease, preclinical programs, risk factors, and financial results.

On Stock Titan, AI-powered tools highlight key elements within lengthy filings, helping users quickly locate sections on financing terms, covenants, regulatory designations such as RMAT and Fast Track, and disclosures related to Symvess and other ATEV programs. The platform also surfaces Form 4 insider transaction reports and other ownership-related filings when available, giving a fuller view of executive and major holder activity. Use this page to monitor Humacyte’s regulatory reporting history, understand the obligations underlying its debt and equity financings, and follow how the company describes its bioengineered tissue platform to regulators and shareholders.

Rhea-AI Summary

Humacyte, Inc. and Fresenius Medical Care have amended their 2018 distribution agreement for Symvess, an acellular tissue engineered vessel. Humacyte now has exclusive rights to distribute Symvess outside the U.S., while Fresenius Medical Care Holdings, Inc. will receive low-single-digit royalties on ex-U.S. net sales.

Existing terms for U.S. distribution remain unchanged. Fresenius Medical Care Holdings, Inc. and its parent, Fresenius Medical Care, report beneficial ownership of 18,312,735 shares of Humacyte common stock, representing 8.4% of the class, all with shared voting and dispositive power.

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Rhea-AI Summary

Humacyte, Inc. entered a Third Amendment to its distribution agreement with Fresenius Medical Care, giving Humacyte the sole right to develop, manage regulatory matters for, and commercialize its 6 millimeter acellular tissue engineered vessel, branded Symvess, on a worldwide basis.

In return, Humacyte will pay Fresenius low-single-digit royalties on net sales of Symvess outside the U.S., after a two-year royalty-free period following launch in each country, while existing U.S. royalty rates from mid-single digits to low double digits remain in place and Fresenius stays obligated to adopt Symvess as a standard of care where supported. Humacyte highlights that this realignment supports its planned international expansion and potential indication-specific partnerships, while Symvess currently holds FDA approval only for extremity vascular trauma and remains investigational for other uses.

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Rhea-AI Summary

Humacyte, Inc. is soliciting proxies for its 2026 Annual Meeting of Stockholders to be held virtually on June 9, 2026 at 8:00 a.m. Eastern Time. The meeting will vote on director elections, advisory votes on executive compensation and frequency, ratification of PwC as auditor, and a proposal to amend the Certificate of Incorporation to increase authorized common shares from 350,000,000 to 550,000,000 shares. Only holders of record as of April 23, 2026 may vote. Proxy materials and the Annual Report are available at www.proxyvote.com, and the company will hold the meeting virtually at www.virtualshareholdermeeting.com/HUMA2026.

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Rhea-AI Summary

Humacyte, Inc. (HUMA) is now a commercial-stage biotech company after the FDA granted full approval on December 19, 2024 for Symvess, an acellular tissue engineered vessel (ATEV), for adult extremity arterial injury when urgent revascularization is needed and autologous vein is not feasible. U.S. commercial launch began in the first quarter of 2025.

The company’s platform grows bioengineered, decellularized human vessels at scale in its 83,000 sq. ft. facility using modular LUNA200 systems, with capacity to produce thousands of ATEVs annually in multiple diameters and lengths. As of December 31, 2025, ATEVs had been implanted in about 636 patients across vascular trauma, hemodialysis access and peripheral artery disease, plus expanded access and humanitarian use, with low infection rates, no clinical rejection and evidence of remodeling into living tissue.

Humacyte is pursuing additional indications, including AV access for hemodialysis (positive Phase 3 V007 results and an ongoing women-focused Phase 3 V012 with a planned supplemental BLA in the second half of 2026), PAD, CABG, pediatric heart surgery and a BioVascular Pancreas concept for Type 1 diabetes. Multiple RMAT designations and Department of Defense support underscore its regulatory and strategic positioning.

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Rhea-AI Summary

Fresenius Medical Care Holdings, Inc. and Fresenius Medical Care AG report their updated ownership in Humacyte, Inc. common stock. As of this amendment, Fresenius Medical Care Holdings, Inc. beneficially owns 18,312,735 shares, representing 8.4% of Humacyte’s outstanding voting shares.

The ownership percentage is calculated against 218,453,511 shares outstanding as of March 20, 2026, which include shares previously outstanding plus 5,725,190 shares issued on December 15, 2025 and 25,000,000 shares issued on March 20, 2026. The decrease from 9.5% to 8.4% results solely from these new issuances; Fresenius states it has neither acquired nor disposed of Humacyte shares since its initial 2021 report.

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Humacyte, Inc. is raising $20 million through a registered direct offering of 25,000,000 shares of common stock at $0.80 per share. After placement fees and expenses, net proceeds are expected to be about $18.4 million.

The cash will support commercialization of Symvess in the vascular trauma indication, a planned Biologics License Application supplement for a hemodialysis use, related Phase 3 activities, broader pipeline development, and general corporate purposes. The offering, led by institutional investors, is expected to close on or about March 20, 2026, subject to customary conditions.

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Rhea-AI Summary

Humacyte, Inc. is raising $20 million through a registered direct offering of 25,000,000 shares of common stock at $0.80 per share. After placement fees and expenses, net proceeds are expected to be about $18.4 million.

The cash will support commercialization of Symvess in the vascular trauma indication, a planned Biologics License Application supplement for a hemodialysis use, related Phase 3 activities, broader pipeline development, and general corporate purposes. The offering, led by institutional investors, is expected to close on or about March 20, 2026, subject to customary conditions.

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Rhea-AI Summary

Humacyte, Inc. is offering 25,000,000 shares of common stock at $0.80 per share pursuant to this prospectus supplement, representing a gross offering size of $20,000,000. Delivery is expected on or about March 20, 2026.

The placement agent fee reduces estimated net proceeds to approximately $18,400,000, which the company intends to use to fund commercialization of Symvess in the vascular trauma indication, support a planned BLA supplement and Phase 3 readout activities, advance pipeline programs, and for working capital and general corporate purposes. The company discloses substantial doubt about its ability to continue as a going concern and estimates cash runway into the first quarter of 2027 absent additional financing.

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Rhea-AI Summary

Humacyte, Inc. is offering 25,000,000 shares of common stock at $0.80 per share pursuant to this prospectus supplement, representing a gross offering size of $20,000,000. Delivery is expected on or about March 20, 2026.

The placement agent fee reduces estimated net proceeds to approximately $18,400,000, which the company intends to use to fund commercialization of Symvess in the vascular trauma indication, support a planned BLA supplement and Phase 3 readout activities, advance pipeline programs, and for working capital and general corporate purposes. The company discloses substantial doubt about its ability to continue as a going concern and estimates cash runway into the first quarter of 2027 absent additional financing.

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Humacyte, Inc. is suspending and terminating its at-the-market equity program prospectus that had allowed sales of up to $60 million in common stock under a sales agreement with TD Cowen, while leaving the underlying agreement in place for potential future use with a new prospectus.

Based on preliminary estimates for the year ended December 31, 2025, the company expects about $50.9 million in cash, cash equivalents and restricted cash, total revenue of roughly $2.0 million including $1.4 million in product revenue, and 61 Symvess unit sales. Operationally, Humacyte obtained a minimum Symvess purchase commitment of approximately $1.48 million in the Kingdom of Saudi Arabia tied to a potential joint venture and license, and filed a Marketing Authorization Application in Israel for Symvess in vascular trauma. The company also released an investor presentation and updated its risk factors to reflect ongoing losses, funding needs, regulatory and clinical trial uncertainties, pricing pressures and data-privacy compliance risks.

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Rhea-AI Summary

Humacyte, Inc. is suspending and terminating its at-the-market equity program prospectus that had allowed sales of up to $60 million in common stock under a sales agreement with TD Cowen, while leaving the underlying agreement in place for potential future use with a new prospectus.

Based on preliminary estimates for the year ended December 31, 2025, the company expects about $50.9 million in cash, cash equivalents and restricted cash, total revenue of roughly $2.0 million including $1.4 million in product revenue, and 61 Symvess unit sales. Operationally, Humacyte obtained a minimum Symvess purchase commitment of approximately $1.48 million in the Kingdom of Saudi Arabia tied to a potential joint venture and license, and filed a Marketing Authorization Application in Israel for Symvess in vascular trauma. The company also released an investor presentation and updated its risk factors to reflect ongoing losses, funding needs, regulatory and clinical trial uncertainties, pricing pressures and data-privacy compliance risks.

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Humacyte, Inc. received an updated Schedule 13D/A showing that Fresenius Medical Care Holdings, Inc. (FMCH) beneficially owns 18,312,735 shares of Humacyte common stock, representing about 9.5% of the outstanding voting shares. This percentage is based on 192,996,511 shares outstanding as of December 15, 2025. The filing explains that the stake declined from 9.9% to 9.5% solely because Humacyte’s total shares outstanding increased; FMCH and its parent Fresenius Medical Care AG (FME AG) have neither bought nor sold Humacyte shares since their initial Schedule 13D in 2021. All 18,312,735 shares are issued, outstanding, and owned directly by FMCH, while FME AG may be deemed an indirect beneficial owner through its ownership of FMCH. The amendment also notes board and management changes at FME AG and FMCH, including new roles for Dr. Charles Hugh-Jones and Joseph E. Turk following the retirement of two prior executives.

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Humacyte, Inc. entered into a Sales Agreement with TD Securities (USA) LLC, as agent, that permits it to offer and sell, from time to time, its common stock with an aggregate offering price of up to $60,000,000 in an at the market offering under a previously filed and effective registration statement.

TD Securities (USA) LLC, referred to as TD Cowen, will use commercially reasonable efforts to execute sales on the Nasdaq Global Select Market or other permitted markets, and may also sell shares in negotiated transactions if expressly authorized. TD Cowen will receive a commission of up to 3.0% of the gross proceeds from any share sales. Humacyte plans to use any net proceeds to fund commercialization of Symvess® in the vascular trauma indication, advance its product candidates, and for working capital and general corporate purposes. The agreement can end once all shares are sold or be terminated by either party on ten days’ notice, with additional termination rights for TD Cowen in certain circumstances.

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FAQ

How many Humacyte (HUMA) SEC filings are available on StockTitan?

StockTitan tracks 29 SEC filings for Humacyte (HUMA), including 10-K annual reports, 10-Q quarterly reports, 8-K current reports, and Form 4 insider trading disclosures. Each filing includes AI-generated summaries, impact scoring, and sentiment analysis.

When was the most recent SEC filing for Humacyte (HUMA)?

The most recent SEC filing for Humacyte (HUMA) was filed on April 27, 2026.