HUMA on Nasdaq

Humacyte, Inc.

American biological products company, incorporated in Delaware1

In its 2026 annual report the company says: “Humacyte, Inc. is a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, and in the first quarter of 2025 commenced the United States commercial launch of our first FDA-approved product. We are pioneering the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues, advanced tissue constructs and organ systems with the goal of improving the lives of patients and transforming the practice of medicine.”3 It is headquartered in Durham, North Carolina.1

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Last updated Oct 21, 2026.

Overview

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  • TickerHUMA on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersDurham, North Carolina1
  • Incorporated inDE2
  • Business address2525 East North Carolina Highway 54, Durham, Nc 277132
  • Filer categoryNon-accelerated filer, Smaller reporting company2

Humacyte, Inc. is a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, and in the first quarter of 2025 commenced the United States commercial launch of our first FDA-approved product. We are pioneering the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues, advanced tissue constructs and organ systems with the goal of improving the lives of patients and transforming the practice of medicine. We believe our regenerative medicine technology has the potential to overcome limitations in existing standards of care and address the lack of significant innovation in products that support tissue repair, reconstruction and replacement. We are leveraging our novel, scalable technology platform to develop proprietary, bioengineered, acellular human tissues for use in the…3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-5306.0%Operating margin4
-2003.6%Net margin4
-1313.4%Return on equity4
11.40×Debt to equity4
-$105.9MFree cash flow4

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Product brought in 68% of the revenue Humacyte, Inc. broke down this way in fiscal 2025.

  1. Product$1.4M468%
  2. Product and Service, Other$649.0K432%
Products and services by year
Products and services20242025
Product$0$1.4M
Product and Service, Other$0$649.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue12¢$9.7M
  • Research and development88¢$69.3M

Out of $2.0M in revenue.4 The company lost money this year.

Financial statements

Revenue4$2.0M in 2025
0$1.0M$2.0M$3.0M2024: $0$020242025: $2.0M$2.0M2025
Operating income56784-$108.1M in 2025+67% since 2020
-$150.0M-$100.0M-$50.0M02020: -$64.6M-$64.6M20202021: -$81.2M-$81.2M2021+26%2022: -$84.6M-$84.6M2022+4%2023: -$100.0M-$100.0M2023+18%2024: -$114.4M-$114.4M2024+14%2025: -$108.1M-$108.1M2025−5%
Net income56784-$40.8M in 2025−39% since 2020
-$150.0M-$100.0M-$50.0M02020: -$66.5M-$66.5M20202021: -$26.5M-$26.5M2021−60%2022: -$12.0M-$12.0M2022−55%2023: -$110.8M-$110.8M2023+826%2024: -$148.7M-$148.7M2024+34%2025: -$40.8M-$40.8M2025−73%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Revenue$2.0M$0
Cost of goods sold$9.7M$0
Research and development$69.3M$88.6M
General and administrative$31.2M$25.8M
Total operating expenses$110.2M$114.4M
Loss from operations-$108.1M-$114.4M
Interest income$2.6M$4.1M
Change in fair value of Contingent Earnout Liability$59.5M-$33.0M
Interest expense-$11.2M-$9.3M
Change in fair value of derivatives$38.8M$3.9M
Loss on extinguishment of debt-$22.3M$0
Total other expense, net$67.3M-$34.3M
Net loss and comprehensive loss-$40.8M-$148.7M
Net loss per share attributable to common stockholders, basic (in dollars per share)-$0.26-$1.26
Net loss per share attributable to common stockholders, diluted (in dollars per share)-$0.26-$1.26
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic (in shares)158.2M shares118.5M shares
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, diluted (in shares)158.2M shares118.5M shares

Compare Humacyte, Inc. with another company

Corporate structure

Humacyte, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Humacyte, Inc.

  • Humacyte, Inc. Durham, North Carolina

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Humacyte, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$59.9M4 Dec 31, 2025$59.1M4 Dec 31, 2024+1.2%
Accumulated depreciation$41.3M4 Dec 31, 2025$36.1M4 Dec 31, 2024+14.5%
Property and equipment, net$18.5M4 Dec 31, 2025$23.1M4 Dec 31, 2024−19.6%
Finance-lease assets$29.1M4 Dec 31, 2025$15.5M4 Dec 31, 2024+88.2%
Operating-lease assets (leased space)$04 Dec 31, 2025$600.0K4 Dec 31, 2024−100.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$50.5M4 Dec 31, 2025$44.9M4 Dec 31, 2024+12.4%

Inventory

ItemLatestA year beforeChange
Inventory, total$13.6M4 Dec 31, 2025$04 Dec 31, 2024
Work in process$6.5M4 Dec 31, 2025$04 Dec 31, 2024
Finished goods$10.1M4 Dec 31, 2025$04 Dec 31, 2024

Properties, in its own words

Our corporate headquarters, manufacturing, and research and development facilities are located in Durham, North Carolina where we lease approximately 83,000 square feet of space. This space includes approximately 55,000 square feet for production and distribution operations including manufacturing, bioprocessing, quality control, mechanical space and inventory. The remainder of the facility consists of offices, laboratories, and common spaces.

Item 2 of the 10-K filed Mar 27, 2026.3

Leadership

Who has led Humacyte, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (22)

Former names

  • Alpha Healthcare Acquisition Corp.Aug 4, 2020 to Aug 26, 20212

Timeline

  1. Sep 28, 20268-K Executive or director change; Regulation FD disclosure36
  2. Aug 12, 20268-K Results of operations37
  3. Jul 31, 20268-K Listing notice or transfer38
  4. Jun 11, 20268-K Entered a material agreement; Regulation FD disclosure39
  5. Jun 10, 20268-K Other events40
  6. Jun 9, 20268-K Bylaws or fiscal year changed; Shareholder vote41
  7. Jun 5, 20268-K Other events42
  8. May 8, 20268-K Listing notice or transfer43
  9. Apr 24, 20268-K Entered a material agreement; Regulation FD disclosure44
  10. Mar 19, 20268-K Results of operations; Other events45
  11. Mar 19, 20268-K Entered a material agreement; Regulation FD disclosure46
  12. Dec 16, 20258-K Entered a material agreement47
  13. Sep 17, 2020New chief executive Rajiv Shukla becomes CEO11

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.14) a share, on Nov 12, 2025.48

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results37
  2. Mar 19, 2026Reported quarterly or annual results45
  3. Nov 12, 2025Reported quarterly or annual results49
  4. Aug 11, 2025Reported quarterly or annual results50
  5. May 13, 2025Reported quarterly or annual results51
  6. Mar 28, 2025Reported quarterly or annual results52
  7. Nov 8, 2024Reported quarterly or annual results53
  8. Aug 13, 2024Reported quarterly or annual results54

Drug trials and FDA: coming up

  1. Jun 2027Phase 3 trial readout expected Phase 3 trial of Acellular Tissue Engineered Vessel (ATEV) in End Stage Renal Disease (ESRD): primary completion expected Jun 2027 (ClinicalTrials.gov NCT05908084).55

Drug trials and FDA: recently

  1. Sep 19, 2023Phase 2/3 trial completed Phase 2/3 trial of Acellular Tissue Engineered Vessel (ATEV) in Trauma: primary completion Sep 19, 2023, results posted Jul 29, 2026 (ClinicalTrials.gov NCT03005418).56

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

399 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 61 major events, 201 insider forms, 26 large holders, 91 other. The latest 20:

  1. Oct 7, 20264 EDGAR
  2. Oct 7, 20264 EDGAR
  3. Sep 28, 20263 EDGAR
  4. Sep 28, 20268-K EDGAR
  5. Sep 28, 20263 EDGAR
  6. Sep 15, 20264 EDGAR
  7. Aug 25, 202625-NSE EDGAR
  8. Aug 21, 20264 EDGAR
  9. Aug 19, 20264 EDGAR
  10. Aug 18, 2026SCHEDULE 13D/A EDGAR
  11. Aug 12, 202610-Q EDGAR
  12. Aug 12, 20268-K EDGAR
  13. Jul 31, 20268-K EDGAR
  14. Jul 28, 2026SCHEDULE 13G/A EDGAR
  15. Jul 13, 2026SCHEDULE 13D/A EDGAR
  16. Jun 22, 2026SCHEDULE 13G EDGAR
  17. Jun 15, 2026SCHEDULE 13D/A EDGAR
  18. Jun 12, 20264 OWNERSHIP DOCUMENT EDGAR
  19. Jun 12, 20264 OWNERSHIP DOCUMENT EDGAR
  20. Jun 12, 20264 OWNERSHIP DOCUMENT EDGAR

The 399 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

119 open-market trades by officers, directors and large owners since October 2021: 38 buys and 81 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 14, 2026Jones Keith AnthonyDirectorBuy10,000$0.56$5.6KForm 4
Aug 20, 2026Jones Keith AnthonyDirectorBuy10,000$0.69$6.9KForm 4
Aug 17, 2026Jones Keith AnthonyDirectorBuy30,000$0.59$17.7KForm 4
May 19, 2026Sebelius KathleenDirectorBuy56,818$0.88$50.0KForm 4
May 18, 2026Parikh Shamik JChief Medical OfficerSale45,887$0.90$41.3KForm 4
May 18, 2026Sander Dale A.CFO and Chief Corp. Dev. OffSale45,887$0.90$41.3KForm 4
May 18, 2026Constantino Michael T.DirectorBuy11,000$0.89$9.8KForm 4
Aug 20, 2025Dougan Brady WDirectorSale591,685$1.58$934.9KForm 4
Aug 20, 2025Niklason Laura EPresident, CEO and DirectorSale591,685$1.58$934.9KForm 4
Aug 19, 2025Dougan Brady WDirectorSale1,100,000$1.63$1.8MForm 4
Aug 19, 2025Niklason Laura EPresident, CEO and DirectorSale1,100,000$1.63$1.8MForm 4
Aug 18, 2025Dougan Brady WDirectorSale549,360$1.83$1.0MForm 4
Aug 18, 2025Niklason Laura EPresident, CEO and DirectorSale549,360$1.83$1.0MForm 4
Apr 14, 2025Scheessele William JohnChief Commercial OfficerBuy6,493$1.54$10.0KForm 4
Apr 10, 2025Sander Dale A.CFO and Chief Corp. Dev. OffBuy20,000$1.53$30.6KForm 4
Apr 10, 2025Parikh Shamik JChief Medical OfficerBuy7,500$1.55$11.6KForm 4
Apr 8, 2025Sebelius KathleenDirectorBuy50,000$1.32$66.0KForm 4
Apr 8, 2025Green Charles BruceDirectorBuy6,000$1.29$7.7KForm 4
Apr 7, 2025Constantino Michael T.DirectorBuy16,000$1.26$20.2KForm 4
Dec 4, 2024Constantino Michael T.DirectorBuy4,600$4.39$20.2KForm 4

All 119 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Laura E. Niklason63$633.6K$5.2M64
2025Dale A. Sander66$546.0K$2.1M64
2025Shamik J. Parikh53$519.5K$2.1M64
2024President and Chief Executive Officer$612.4K$905.4K64
2024Chief Financial OfficerChief Corporate Development Officer and Treasurer$505.8K$704.2K64

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
ANTIPODES PARTNERS Ltd10,103,647$7.9M0.1%+4,379,897
Vanguard Capital Management LLC10,107,679$7.9M0.0%+2,949,517
Alyeska Investment Group, L.P.6,022,925$4.7M0.0%New
Davidson Kempner Capital Management LP5,000,000$3.9M0.1%New
BlackRock, Inc.4,839,929$3.8M0.0%−7,477,026
Great Point Partners LLC3,750,000$2.9M0.7%No change
UBS Group AG2,843,493$2.2M0.0%+61,423
Aqr Capital Management LLC2,597,134$2.0M0.0%+672,443
Geode Capital Management, LLC2,185,225$1.7M0.0%−1,472,883
Millennium Management LLC1,909,049$1.5M0.0%+1,800,895
Susquehanna International Group, Llp1,699,243$1.3M0.0%+641,195
Citadel Advisors LLC1,443,376$1.1M0.0%New
Charles Schwab Investment Management Inc1,353,515$1.1M0.0%+62,170
Vanguard Fiduciary Trust Co1,181,276$921.4K0.0%+170,247
LPL Financial LLC1,025,535$800.3K0.0%+161,072
Private Advisor Group, LLC965,091$753.2K0.0%+132,292
State Street Corp842,537$657.5K0.0%−2,201,392
Hbk Investments L P790,000$616.5K0.0%New
Wealth Effects LLC693,920$541.5K0.1%+489,420
Lion Point Capital, LP650,000$507.3K2.4%No change
LuminArx Capital Management LP650,000$507.3K0.3%New
Goldman Sachs Group Inc586,524$457.7K0.0%−90,491
Bank Of America Corp /de/578,592$451.3K0.0%+182,479
Vanguard Portfolio Management LLC568,521$443.4K0.0%−849,304
Woodline Partners LP500,582$390.7K0.0%−1,502,000

13F reports cover disclosed long positions in U.S. stocks only.

Members of Congress who traded it

12 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
May 3, 2024Tommy TubervilleRepublican, SenateSale$1,001 - $15,000+141.0%Report
May 3, 2024Tommy TubervilleRepublican, SenatePartial sale$15,001 - $50,000+141.0%Report
Apr 30, 2024Tommy TubervilleRepublican, SenatePartial sale$50,001 - $100,000+142.5%Report
Mar 21, 2024Tommy TubervilleRepublican, SenateBuy$1,001 - $15,000−135.6%Report
Mar 21, 2024Tommy TubervilleRepublican, SenateBuy$1,001 - $15,000−135.6%Report
Mar 21, 2024Tommy TubervilleRepublican, SenateBuy$15,001 - $50,000−135.6%Report
Feb 12, 2024Tommy TubervilleRepublican, SenateBuy$15,001 - $50,000−142.7%Report
Jan 19, 2024Tommy TubervilleRepublican, SenatePartial sale$1,001 - $15,000+143.5%Report
Jul 25, 2023Tommy TubervilleRepublican, SenateBuy$1,001 - $15,000−154.1%Report
Jul 25, 2023Tommy TubervilleRepublican, SenateBuy$1,001 - $15,000−154.1%Report
Jul 25, 2023Tommy TubervilleRepublican, SenateBuy$1,001 - $15,000−154.1%Report
Mar 30, 2022Tommy TubervilleRepublican, SenateBuy$15,001 - $50,000−162.2%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

How Humacyte, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARHumacyte, Inc.1
  • CIK0001818382
  • Employer ID (EIN)85-17637593
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address2525 East North Carolina Highway 54, Durham, NC 277131
  • Phone919-313-96331
  • Shares outstanding277,798,105 as of Aug 10, 202610
  • Public float$280.3M as of Jun 30, 20253
  • AuditorPricewaterhouseCoopers LLP, Raleigh, North Carolina PCAOB ID 238; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceAug 4, 20201
  • Filings504 in all: 4 (204), 8-K (79), 3 (31), 144 (24), 10-Q (18), 424B3 (15), 425 (13), SC 13D/A (12)1
    All 37 form types

    CORRESP (11), UPLOAD (11), EFFECT (10), SCHEDULE 13D/A (8), 10-K (6), 424B5 (6), DEF 14A (5), SC 13G (5), DEFA14A (4), S-3 (4), S-4/A (4), S-8 (4), 424B7 (3), POS AM (3), S-1/A (3), SC 13D (3), 25-NSE (2), PRE 14A (2), S-1 (2), SC 13G/A (2), SEC STAFF LETTER (2), 10-K/A (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), S-4 (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 27, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Sep 28, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareHUMAThe Nasdaq Stock Market LLC
Redeemable Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50HUMAWThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 27, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Humacyte, Inc. names in Item 1A of its 10-K filed Mar 27, 2026: 73 risks under these headings, as written.3

  • Risks Related to the Development of Symvess and Commercialization of Our Product Candidates
  • Our near-term prospects are dependent on the success of Symvess, our sole FDA-approved product, and if we are unable to increase sales in the vascular trauma indication and obtain regulatory approval for Symvess in additional indications, our business, operating results and financial condition will be materially harmed.
  • Symvess and our product candidates, if approved, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • We may be subject to enforcement action, civil liability, regulatory investigation and penalties if we engage in the off-label promotion of Symvess.
  • If our clinical trials are delayed, do not produce favorable results, or otherwise fail to demonstrate safety and efficacy to the satisfaction of the FDA or similar regulatory authorities outside the United States, we may incur significant additional costs or experience significant delays in completing, or ultimately be unable to complete, the development, approval, and commercialization of our product candidates. If we experience significant delays or significant additional costs, our business will be materially harmed.
  • Our progress in early stage clinical trials may not guarantee success in late stage clinical trials, and our progress in trials for one product candidate or the FDA’s approval of Symvess may not be indicative of progress in trials for another product candidate.
  • Interim, “topline,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • If SAEs occur at an unacceptable rate or other unacceptable side effects are identified in our ATEVs we may need to delay, abandon or limit development and marketing of our product candidates.
  • We may experience delays or difficulties in the enrollment of patients in our clinical trials, which may delay or prevent additional clinical trials and our receipt of necessary marketing approvals.
  • Lack of experience by investigators and surgeons with our ATEVs can lead to incorrect implantation or follow-up procedures which could harm the results of our clinical trials and market acceptance of Symvess and our product candidates.
  • We may not be successful in our efforts to use our proprietary scientific technology platform to build a pipeline of additional product candidates.
  • The sizes of the market opportunities for Symvess or our product candidates have not been established with precision and are estimates that management believes to be reasonable. If these market opportunities are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the relevant patient population, our revenue and ability to achieve profitability might be materially and adversely affected.
The other 61 risks
  • We face and will continue to face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do, which may adversely affect our ability to successfully market or commercialize Symvess or our product candidates.
  • Our distribution agreement with Fresenius Medical Care imposes obligations on us that may restrict our ability to operate our business in ways we believe to be in our long-term best interest.
  • If we receive approval for a product candidate that is not subject to our distribution agreement with Fresenius Medical Care, and we are unable to establish our own marketing, sales and distribution capabilities or are unable to enter into agreements with third parties do so, we may not be able to generate product revenue and will have to alter our development and commercialization plans.
  • There is uncertainty with respect to third-party coverage and reimbursement of Symvess and our product candidates, if approved. They may also be subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, any of which could harm our business, prospects, operating results and financial condition.
  • Product liability lawsuits against us could cause us to incur substantial liabilities that may not be covered by our limited product liability insurance and may limit the development, approval and commercialization of Symvess and any product candidates that we develop in the future.
  • Risks Related to Manufacturing Symvess and Our Product Candidates
  • The manufacture of Symvess and our product candidates is complex, we have limited experience manufacturing commercial product, and we have in the past and may in the future encounter batch failures and difficulties in production. If we or any third-party supplier encounter such difficulties, our ability to supply Symvess for commercial sale or our product candidates for clinical trials could be delayed or halted entirely.
  • Manufacturing facilities are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply with the regulations or maintain the approvals.
  • Risks Related to Our Reliance on Third Parties
  • We rely on third parties to conduct and support our clinical trials, and those third parties may not perform satisfactorily, including by failing to adhere to regulatory requirements or our stated protocols or to meet deadlines for the completion of such trials.
  • We rely on third-party suppliers, including sole source suppliers, to provide certain components for Symvess and our product candidates. Any failure by a third-party supplier to supply these components for manufacture may delay or impair our ability to commercialize Symvess and to complete our clinical trials for our product candidates.
  • We intend to rely on our strategic, global relationship with Fresenius Medical Care to undertake, or assist with, the development and commercialization of certain of our product candidates if we receive marketing approval from relevant regulatory authorities. Disruption of this arrangement could materially adversely affect our business, prospects, operating results and financial condition.
  • Risks Related to Our Financial Position and Need for Additional Funding
  • We have concluded that substantial doubt is deemed to exist concerning our ability to continue as a going concern.
  • We have incurred significant losses to date and we expect to continue to incur losses for the foreseeable future and may never be profitable.
  • Our ability to use our net operating loss and tax credit carryforwards to offset future taxable income may be subject to certain limitations.
  • We expect to need to raise additional funding, which may not be available on acceptable terms, or at all, and any failure to obtain capital when needed may force us to delay, limit or terminate our product development or commercialization efforts.
  • Pursuant to the terms of the Loan Agreement, we may be limited in our ability to incur future debt.
  • We may not successfully execute or achieve the expected benefits of cost-saving measures that we have taken or may take in the future, and our efforts may result in further actions or additional asset impairment charges and adversely affect our business.
  • Risks Related to Government Regulation
  • Even though we received marketing approval for Symvess, we continue to be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to significant penalties if we fail to comply with applicable regulatory requirements.
  • We may not obtain marketing approval from the FDA for any of our product candidates even if we successfully complete our clinical trials, which failure would materially harm our business, prospects, operating results and financial condition.
  • Even though we obtained approval for Symvess from the FDA, we may never obtain approval for our ATEVs outside of the United States, where the regulatory process is also complex and subject to significant uncertainty. Failure to do so would limit our market opportunities and adversely affect our business.
  • Even if we seek “rolling review” or priority review, the review time for BLAs for our product candidates may be longer and more expensive than for other products because of the novelty and complexity of our product candidates, which would delay our ability to begin commercialization and earn product revenues.
  • We may in the future seek orphan drug designation for the use of our ATEVs to treat congenital pediatric heart defects. We may be unable to obtain such designation or to maintain the benefits associated with orphan drug designation, including market exclusivity, which may cause our revenue, if any, to be reduced.
  • Inadequate funding for the FDA and other government agencies, including from government shut downs, global health concerns or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Designation of our product candidates for expedited programs, such as Fast Track designation, Breakthrough Therapy Designation, or RMAT designation, or accelerated approval by the FDA, or priority designation by the Department of Defense, may not lead to a faster development or regulatory review or approval process, and even if granted, will not increase the likelihood that our product candidates will receive marketing approval.
  • Healthcare reform measures could hinder or prevent commercial success of Symvess or our product candidates.
  • If we fail to comply with healthcare regulations, we could face substantial penalties and our business, prospects, operating results and financial condition could be adversely affected.
  • We sell Symvess using arrangements that sometimes involve the consignment of inventory, which results in additional risk and uncertainty as to the viability of consigned inventory, inventory accounting, and tax consequences.
  • Our business and operations, including our development programs, could be materially disrupted in the event of system failures, security breaches, violations of data protection laws or data loss or damage by us or third parties on which we rely, including our CROs or other contractors or consultants.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines and penalties or incur costs that could harm our business.
  • Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation and adverse publicity and could negatively affect our operating results and business.
  • We or the third parties upon which we depend may be adversely affected by natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • We are subject to anti-corruption and a variety of other laws governing our international operations. If we fail to comply with these laws, we could be subject to, among other things, civil or criminal penalties, other sanctions and remedial measures, and reputational damage, which could adversely affect our business, prospects, operating results and financial condition.
  • Risks Related to Our Intellectual Property
  • Our ability to successfully commercialize Symvess or our product candidates, if approved, may be impaired if we are unable to obtain and maintain effective intellectual property rights for our proprietary scientific technology platform, Symvess and our product candidates.
  • The patent protection we obtain for Symvess or our product candidates may not be sufficient enough to provide us with any competitive advantage or our owned or licensed patents may be challenged.
  • We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming and unsuccessful.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could harm our business, prospects, operating results and financial condition.
  • If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.
  • We may not be successful in obtaining necessary intellectual property rights to product candidates for our development pipeline through acquisitions and in-licenses.
  • We may be unable to protect the confidentiality of our trade secrets, particularly in light of our reliance on third parties, which increases the possibility that such trade secrets will be disclosed or misappropriated, thus harming our business and competitive position.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • Patent terms may be inadequate to protect our competitive position on Symvess or our product candidates for an adequate amount of time.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Some of our internal intellectual property and most of our in-licensed intellectual property has been generated under U.S. Government grants and contracts that trigger certain obligations and U.S. Government rights and thus is subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats.
  • Risks Related to Business Matters and Our Ability to Manage Growth
  • Our future success depends on our ability to retain our key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
  • We expect to increase the size of our workforce in the future, and we may encounter difficulties in managing this growth, which could harm our operations.
  • Risks Related to Ownership of Our Securities
  • The price of our common stock may be volatile.
  • Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our common stock.
  • We may issue additional shares of common stock or other equity securities without stockholder approval, which would dilute your ownership interests and may depress the market price of our common stock.
  • Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment.
  • The Public Warrants may not be in the money in the future, and they may expire worthless, and the terms of the Public Warrants may be amended in a manner adverse to a holder if holders of at least 50% of the then outstanding Public Warrants approve of such amendment.
  • We may redeem your unexpired Public Warrants prior to their exercise at a time that is disadvantageous to you, thereby making your Public Warrants worth less than they would be if you held and exercised them at a later time.
  • We have derivative securities that are accounted for as assets and liabilities and the changes in value of such derivative securities could have a material effect on our financial results.
  • Our business could be adversely impacted by inflation.
  • We are and may continue to be subject to legal and other proceedings that could cause us to incur significant expenses, divert our management’s attention, and materially harm our business, financial condition, and operating results.
  • Changes in U.S. government policies under the Trump administration, including increased tariffs and reductions in federal research funding, could adversely affect our business.
  • We may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on our financial condition, results of operations and stock price, which could cause you to lose some or all of your investment.
  • The obligations associated with being a public company involve significant expenses and will require significant resources and management attention, which may divert from our business operations.
  • We are a “smaller reporting company” within the meaning of the rules adopted by the SEC, and if we take advantage of certain exemptions from disclosure requirements available to smaller reporting companies, this could make our securities less attractive to investors and may make it more difficult to compare our performance with other public companies.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
  • Anti-takeover provisions in our Second Amended and Restated Certificate of Incorporation and under Delaware law could make an acquisition of the Company, which may be beneficial to our stockholders, more difficult, and may prevent attempts by our stockholders to replace or remove our current management.

Legal proceedings

On November 18, 2024, James A. Cutshall filed a putative class action lawsuit, captioned Cutshall v. Humacyte, Inc., et al., No. 1:24-cv-00954 (the “Securities Litigation”), against the Company and certain of the Company’s officers in the United States District Court for the Middle District of North Carolina. The complaint in the Securities Litigation asserts claims under Sections 10(b) and 20(a) of the Exchange Act on behalf of a putative class of persons and entities that purchased or otherwise acquired securities of the Company between May 10, 2024 and October 17, 2024, based on allegations that the defendants made or were responsible for false or misleading statements and omissions related to the BLA for the vascular trauma indication and to alleged deficiencies at the Company’s Durham, North Carolina manufacturing facility. The Complaint seeks a variety of relief, including unspecified compensatory damages, attorneys fees and costs. On January 31, 2025, the court appointed co-lead plaintiffs. On May 22, 2025, the co-lead plaintiffs filed the amended complaint in the Securities Litigation. The amended complaint expands the putative class to include persons and entities that purchased or otherwise acquired securities of the Company between August 14, 2023 and March 25, 2025. It alleges that the defendants made or were responsible for false or misleading statements and omissions related to the safety of Symvess, alleged deficiencies at the Company’s Durham, North Carolina manufacturing facility, and the Company’s financial condition and liquidity. On July 25, 2025, defendants moved to dismiss the amended complaint in its entirety and with prejudice. The court has yet to rule on the motion, which remains pending.

The opening of Item 3, Legal Proceedings.3

Sources

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