Humacyte Q3 Symvess sales rise 151% to $1M
October sales reached $0.8 million, and Humacyte anticipates at least doubling third-quarter sales in Q4 2026.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Humacyte, Inc. reported third-quarter 2026 product revenue of $1.023 million, compared with $703,000 a year earlier, and total revenue of $1.028 million versus $753,000. Symvess sales were $1.0 million, up from $0.4 million in Q2; October sales were $0.8 million. The company anticipates at least doubling Q3 sales in Q4 2026. Hospitals ordering Symvess rose from 34 at the end of Q2 to 49 as of September 30, 2026.
Third-quarter net loss was $15.538 million, versus $17.510 million a year earlier; nine-month net loss was $69.959 million, compared with $16.029 million, primarily due to non-cash remeasurement of the contingent earnout liability. Research and development expense was $14.104 million for the quarter, down from $17.273 million in 2025. Cash, cash equivalents and restricted cash totaled $64.9 million as of September 30, 2026, and operating cash use was $15.0 million in Q3. Humacyte plans to submit an ATEV dialysis-access supplemental BLA to FDA in November 2026 and initiated a Phase 2a CTEV study for CABG in November.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointSymvess Q3 sales rose 151% versus Q2, reaching $1.0 million.
- Moderate pointThird-quarter net loss narrowed to $15.538 million from $17.510 million.
- Moderate pointOperating cash use was $15.0 million, versus $23.9 million in Q3 2025.
Negative
- Major pointNine-month net loss reached $69.959 million, versus $16.029 million in 2025.
Filing Explained
Humacyte’s
8-K Event Classification
Key Figures
Key Terms
supplemental Biologics License Application regulatory
acellular tissue engineered vessel (ATEV) technical
contingent earnout liability financial
anastomotic failure medical
antiplatelet therapy medical
Earnings Snapshot
Humacyte anticipates at least doubling third-quarter sales revenue in Q4 2026.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much revenue did HUMA report in Q3 2026?
What was HUMA's net loss in Q3 2026?
When does Humacyte plan to file its ATEV dialysis-access application?
What did the V012 trial report about ATEV for hemodialysis access?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
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Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Name of each exchange on which registered |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 2.02. Results of Operations and Financial Condition
On November 10, 2026, Humacyte, Inc. issued a press release regarding its financial results for its fiscal third quarter ended September 30, 2026. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
The information contained herein, including the exhibit attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
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Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number |
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Description |
99.1 |
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Press release, dated November 10, 2026. |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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HUMACYTE, INC. |
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Date: November 10, 2026 |
By: |
/s/ Dale A. Sander |
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Name: |
Dale A. Sander |
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Title: |
Chief Financial Officer, Chief Corporate Development Officer and Treasurer |
3
Exhibit 99.1
Humacyte Reports Third Quarter 2026 Results, Highlighted by More Than Doubling Symvess Revenue and Expanding Commercial Adoption
– Commercial adoption of Symvess® accelerated during the third quarter with sales totaling $1.0 million, a 151% increase over the 2nd quarter.
– Symvess commercial momentum continued into the fourth quarter, with October 2026 sales totaling $0.8 million.
– Supplemental Biologics License Application (sBLA) for the ATEV in dialysis access on track for filing with the Food and Drug Administration (FDA) in November 2026.
– Company initiates first-in-human clinical Phase 2a study of CTEV for CABG.
– Conference call today at 8:00 am ET.
DURHAM, N.C., November 10, 2026 – Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced financial results for the third quarter ended September 30, 2026, and provided a business update.
“During our third quarter, we continued the transformation of our Symvess commercial program in vascular injury repair, doubling revenue over our second quarter and significantly increasing the number of hospitals ordering Symvess,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “In our future targeted market in dialysis access, our plan is to file a supplemental BLA for the ATEV in November 2026, supported by results from three Phase 3 studies. Publication of our V007 Phase 3 results in The Lancet Digital Health and presentation of our V012 Phase 3 results in a late-breaking session at ASN Kidney Week gave the vascular surgery and nephrology communities an overview of the data that will form the basis of our sBLA filing. These results also support our belief that the ATEV has the potential to address significant unmet needs for dialysis patients seeking improved hemodialysis access options. Elsewhere in our pipeline, we have initiated our Phase 2a study in coronary artery bypass grafting (CABG) and look forward to enrollment of the first patients.”
“Execution of our revamped commercial program for Symvess generated significant momentum during the third quarter,” said Jim Mercadante, Chief Commercial Officer of Humacyte. “Symvess sales revenue for the third quarter was $1.0 million, more than double our results for the second quarter, and achieved the goal we set for the period. Momentum has continued into the fourth quarter and based on expanded hospital adoptions and physician engagement, we anticipate at least doubling our third quarter sales revenue in Q4 2026. We believe the strategy we’ve established is working and that we have positioned Symvess for sustainable growth throughout the remainder of 2026 and beyond.”
Third Quarter 2026 and Recent Corporate Highlights
Symvess Commercialization
Breakthrough Phase 3 Results of ATEV in Dialysis Support Planned BLA Filing
First Human Study in CABG
Corporate Update
For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. The CTEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
Third Quarter 2026 Financial Highlights
Conference Call and Webcast Details
Title: |
Humacyte Third Quarter 2026 Financial Results and Corporate Update |
Date: |
November 10, 2026 |
Time: |
8:00 AM Eastern Time |
Conference Call Details: |
1-877-704-4453 (U.S. Investors Dial) 1-201-389-0920 (International Investors Dial) 13763173 (Conference ID) |
Call meTM Feature: |
Click Here |
Webcast: |
Click Here |
A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days.
INDICATION
Symvess is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: GRAFT FAILURE
Loss of Symvess integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage.
CONTRAINDICATIONS
DO NOT use Symvess in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries.
WARNINGS AND PRECAUTIONS
Vascular graft rupture has occurred in patients treated with Symvess. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia.
Anastomotic failure has occurred in patients treated with Symvess. In clinical studies of Symvess, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin.
Thrombosis has occurred in patients treated with Symvess. In clinical trials of Symvess, patients received antiplatelet therapy following implantation of Symvess to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with Symvess.
Symvess is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of Symvess are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum). The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing.
ADVERSE REACTIONS
The most common adverse reactions (occurring at ≥ 10%), were vascular graft thrombosis, pyrexia (fever) and pain.
Please see full Prescribing Information at www.symvess.com, including Boxed Warning, for Symvess.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
Forward-Looking Statements
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; our expectations regarding future sales and sales growth of Symvess; 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 anticipated benefits of our ATEVs and CTEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; 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; the anticipated characteristics and performance of our ATEVs or CTEVs; our plans and expectations regarding the potential commercialization of the ATEV for dialysis access, if approved, including our expectations regarding market access, reimbursement and commercialization preparations; the implementation of our business model and strategic plans for our business; 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; our ability to realize the benefits of the DoD’s funding in the DoD Appropriations Act; and the timing or likelihood of regulatory filings and submissions, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and Form 10-Q for the quarter ended June 30, 2026, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
Humacyte, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands except for share and per share amounts)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenue: |
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Product revenue, net |
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$ |
1,023 |
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$ |
703 |
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$ |
1,922 |
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$ |
950 |
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Contract revenue |
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5 |
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50 |
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7 |
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621 |
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Total revenue |
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1,028 |
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753 |
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1,929 |
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1,571 |
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Operating expenses: |
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Cost of goods sold |
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1,429 |
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260 |
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4,698 |
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620 |
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Research and development |
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14,104 |
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17,273 |
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51,710 |
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54,697 |
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General and administrative |
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9,014 |
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7,610 |
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24,971 |
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23,555 |
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Total operating expenses |
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24,547 |
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25,143 |
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81,379 |
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78,872 |
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Loss from operations |
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(23,519 |
) |
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(24,390 |
) |
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(79,450 |
) |
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(77,301 |
) |
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Other income, net: |
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Change in fair value of contingent earnout liability |
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3,387 |
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4,893 |
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5,401 |
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49,154 |
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Other income, net |
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4,594 |
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1,987 |
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4,090 |
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12,118 |
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Total other income, net |
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7,981 |
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6,880 |
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9,491 |
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61,272 |
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Net loss and comprehensive loss |
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$ |
(15,538 |
) |
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$ |
(17,510 |
) |
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$ |
(69,959 |
) |
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$ |
(16,029 |
) |
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Net loss per share, basic and diluted |
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$ |
(0.06 |
) |
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$ |
(0.11 |
) |
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$ |
(0.30 |
) |
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$ |
(0.11 |
) |
Weighted-average shares outstanding, basic and diluted |
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277,798,105 |
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158,313,290 |
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236,901,920 |
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148,514,044 |
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Humacyte, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
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September 30, |
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December 31, |
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2026 |
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2025 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
64,523 |
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$ |
50,497 |
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Inventory, net |
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5,611 |
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13,589 |
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Insurance recovery asset |
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9,119 |
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- |
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Prepaid expenses and other current assets |
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3,426 |
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3,709 |
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Total current assets |
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82,679 |
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67,795 |
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Restricted cash |
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209 |
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209 |
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Property and equipment, net |
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14,883 |
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18,544 |
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Finance lease right-of-use assets, net |
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27,801 |
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29,146 |
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Other long-term assets |
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- |
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|
672 |
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Total assets |
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$ |
125,572 |
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$ |
116,366 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ |
2,820 |
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$ |
5,404 |
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Accrued expenses |
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11,582 |
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|
|
10,540 |
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Litigation settlement liability |
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9,750 |
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|
- |
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Other current liabilities |
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|
609 |
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|
|
2,428 |
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Total current liabilities |
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24,761 |
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18,372 |
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Long-term debt |
|
|
36,803 |
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|
35,444 |
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Contingent Earnout Liability |
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6,091 |
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|
|
11,492 |
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Common stock warrant liabilities |
|
|
9,115 |
|
|
|
19,392 |
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Finance lease obligation, net of current portion |
|
|
29,070 |
|
|
|
26,974 |
|
Other long-term liabilities |
|
|
1,668 |
|
|
|
1,583 |
|
Total liabilities |
|
|
107,508 |
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|
|
113,257 |
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Stockholders' equity: |
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|
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Common stock and additional paid-in capital |
|
|
814,871 |
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|
|
729,957 |
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Accumulated deficit |
|
|
(796,807 |
) |
|
|
(726,848 |
) |
Total stockholders' equity |
|
|
18,064 |
|
|
|
3,109 |
|
Total liabilities and stockholders' equity |
|
$ |
125,572 |
|
|
$ |
116,366 |
|