Humacyte (HUMA) halts $60M ATM as Symvess gains early sales and KSA deal
Rhea-AI Filing 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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Insights
Humacyte pairs early Symvess revenue with new ex‑US initiatives while tightening equity issuance tools.
Humacyte is ending use of a $60 million at‑the‑market prospectus, signaling a pause on incremental open‑market equity sales under that program. At the same time, preliminary 2025 figures show modest commercialization traction, with $1.4 million in product revenue and 61 Symvess units sold.
Operational updates emphasize international expansion. A minimum Symvess purchase commitment of about $1.48 million in the Kingdom of Saudi Arabia, plus exclusive negotiations toward a joint venture and license, and a Marketing Authorization Application in Israel for vascular trauma, point to early geographic broadening of the platform.
Updated risk factors highlight substantial accumulated deficits, the need for additional capital, clinical and regulatory uncertainty, reimbursement and pricing pressure, and complex data‑privacy obligations. Overall, the disclosure blends incremental commercial progress with continued financing and execution risk, without a clear thesis‑changing data point.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 2.02. Results of Operations and Financial Condition.
The disclosure set forth under the caption "Operational Updates--Preliminary Financial Information for the Year Ended December 31, 2025" in Item 8.01, below, is incorporated herein by reference.
Item 8.01. Other Events.
Suspension and Termination of ATM Prospectus
On March 19, 2026, Humacyte, Inc. (the “Company”) delivered written notice to TD Securities (USA) LLC, as agent (“TD Cowen”), that it was suspending and terminating the prospectus, dated December 16, 2025 (the “ATM Prospectus”), relating to the sale of up to $60 million of the Company’s common stock, par value $0.0001 per share (“Common Stock”), that may be issued and sold pursuant to the Sales Agreement, dated as of December 16, 2025, by and between the Company and TD Cowen (the “Sales Agreement”). The Company will not make any further sales of its Common Stock pursuant to the Sales Agreement unless and until a new prospectus, prospectus supplement or registration statement is filed. Other than the suspension and termination of the ATM Prospectus, the Sales Agreement remains in full force and effect.
Investor Presentation
On March 19, 2026, the Company made available an investor presentation (the “Investor Presentation”), which the Company expects to use in connection with investor calls and/or conferences. A copy of the Investor Presentation is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Operational Updates
The Company wishes to provide certain operational updates, as described further below.
Preliminary Financial Information for the Year Ended December 31, 2025
The Company has not finalized its financial statements as of and for the year ended December 31, 2025. Based on its current estimates, the Company expects to report that it had approximately $50.9 million in cash, cash equivalents and restricted cash as of December 31, 2025. Based on its current estimates, the Company expects to further report that it received approximately $2.0 million in total revenue, including $1.4 million in product revenue, for the year ended December 31, 2025. Based on its current estimates, the Company expects to report 61 unit sales of Symvess® for the year ended December 31, 2025. The actual amounts that the Company reports will be subject to its financial closing procedures and any final adjustments that may be made prior to the time its financial results for the year ended December 31, 2025 are finalized and filed with the SEC. The preliminary financial information included in this Current Report on Form 8-K has been prepared by, and is the responsibility of, the Company’s management. PricewaterhouseCoopers LLP has not audited, reviewed, examined, compiled, or applied agreed-upon procedures with respect to the preliminary financial information and, accordingly, does not express an opinion or any other form of assurance with respect thereto. These estimates should not be viewed as a substitute for financial statements prepared in accordance with accounting principles generally accepted in the United States and they are not necessarily indicative of the results to be achieved in any future period. Accordingly, investors should not place undue reliance on these preliminary estimates. The Company assumes no duty to update these preliminary estimates except as required by law.
Commercial and Regulatory Updates
On March 4, 2026, the Company received a minimum purchase commitment of approximately $1.48 million of the Symvess acellular tissue engineered vessels (“ATEV”) to enable the education of surgeons, and the evaluation of Symvess by hospitals, in the Kingdom of Saudi Arabia (the “KSA”). The evaluation of Symvess is planned to be conducted in parallel with ongoing negotiations with a KSA-based entity for establishment of a joint venture and license to commercialize Symvess within the country. The Company has agreed to not engage in negotiation of commercialization rights within the KSA with any other party through July 2, 2026. Although the purchase commitment described above is binding, the establishment of a joint venture and license and the finalization of definitive terms are subject to further negotiation between the parties as well as the execution of definitive agreements between the KSA-based entity and the Company.
On March 16, 2026, the Company filed a Marketing Authorization Application (“MAA”) with the Ministry of Health of the State of Israel for approval of Symvess for the vascular trauma indication. In response to requests from surgeons, the Company is also pursuing methods of making Symvess available on a hospital-by-hospital basis in advance of any future MAA approval in Israel.
Risk Factor Updates
The Company has provided certain updates to its risk factors described under the heading “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, each filed by the Company with the U.S. Securities and Exchange Commission. A copy of these updated risk factors is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Forward-Looking Statements
This Current Report on Form 8-K 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 the Company believes that it has a reasonable basis for each forward-looking statement contained in this Current Report on Form 8-K, the Company cautions you that these statements are based on a combination of facts and factors currently known by the Company and the Company’s projections of the future, about which the Company cannot be certain. Forward-looking statements in this Current Report on Form 8-K include, but are not limited to, the Company’s plans and ability to commercialize Symvess and, if approved by regulatory authorities, the Company’s product candidates, successfully and on the Company’s 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, the Company’s product candidates; the Company’s ability to manufacture Symvess and, if approved by regulatory authorities, the Company’s product candidates in sufficient quantities to satisfy the Company’s clinical trial and commercial needs; the anticipated benefits of the Company’s ATEV relative to existing alternatives; the Company’s plans and ability to execute product development, process development and preclinical development efforts successfully and on the Company’s anticipated timelines; the Company’s ability to design, initiate and successfully complete clinical trials and other studies for the Company’s product candidates and the Company’s plans and expectations regarding the Company’s ongoing or planned clinical trials; the anticipated characteristics and performance of the Company’s ATEVs; the implementation of the Company’s business model and strategic plans for the Company’s business; the Company’s ability to execute and achieve the expected benefits of the Company’s cost-saving measures and whether these efforts will result in further actions or additional asset impairment charges that adversely affect the Company’s business; and the timing or likelihood of regulatory filings, acceptances and approvals. The Company cannot assure you that the forward-looking statements in this Current Report on Form 8-K 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 the Company 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 the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and Form 10-Q for the quarter ended September 30, 2025, each filed by the Company with the SEC, and in future SEC filings including this Current Report on Form 8-K. Most of these factors are outside of the Company’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 the Company or any other person that the Company will achieve its objectives and plans in any specified time frame, or at all. Except as required by law, the Company has no current intention of updating any of the forward-looking statements in this Current Report on Form 8-K. You should, therefore, not rely on these forward-looking statements as representing the Company’s views as of any date subsequent to the date of this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit Number |
Description | |
| 99.1 | Humacyte, Inc. Investor Presentation March 2026. | |
| 99.2 | Risk Factor Updates, dated March 19, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
1
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.
| HUMACYTE, INC. | |||
| Date: March 19, 2026 | By: | /s/ Dale A. Sander | |
| Name: | Dale A. Sander | ||
| Title: | Chief Financial Officer, Chief Corporate Development Officer and Treasurer | ||
2
| Universally Implantable Regenerative Human Tissue |
| 2 Disclaimer These slides and the accompanying oral presentation contain forward-looking statements. All statements, other than statements of historical fact, included in these slides and the accompanying oral presentation are forward-looking statements reflecting management’s current beliefs and expectations. In some cases, you can identify forward-looking statements by terminology such as “will,” “anticipate,” “expect,” “believe,” “intend” and “should” or the negative of these terms or other comparable terminology. Forward-looking statements in these slides and the accompanying oral presentation include, but are not limited to, statements about our plans and ability to commercialize our bioengineered acellular tissue engineered vessels (“ATEV s”) in the United States under the brand name Symvess in vascular trauma repair; the anticipated commercialization of our ATEVs and our ability to manufacture ATEVs and other product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our plans, anticipated timelines and ability to obtain marketing approval from the U.S. Food and Drug Administration (“FDA”) and other regulatory authorities, including the European Medicines Agency and Israel, for our ATEVs in other indications and other 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 preclinical and clinical trials; the outcome of our ongoing discussions with the FDA concerning the design of our clinical trials; our anticipated growth rate and market opportunities; the potential liquidity and trading of our securities; our ability to raise additional capital in the future; our ability to use our proprietary scientific technology platform to build a pipeline of additional product candidates; the anticipated characteristics and performance of our ATEVs; the expected size of the target populations and addressable markets for our product candidates; the anticipated benefits of our ATEVs relative to existing alternatives; our assessment of the competitive landscape; the degree of market acceptance of ATEVs and the availability of third-party coverage and reimbursement; the implementation of our business model and strategic plans for our business; our expectations regarding our strategic partnership with Fresenius Medical Care Holdings, Inc. to sell, market and distribute our 6 millimeter ATEV for certain specified indications and in specified markets; 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 ability to attract, retain and motivate qualified personnel and to manage our growth effectively; our future financial performance and capital requirements; our ability to implement and maintain effective internal controls; and the impact of the overall global economy and increasing interest rates and inflation on our business. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. The potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, those risks and uncertainties included under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K for the year ended December 31, 2024, our quarterly report on Form 10-Q for the quarter ended September 30, 2025, each filed by Humacyte with the Securities and Exchange Commission, and in future filings made with the Securities and Exchange Commission from time to time. Any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements, even if new information becomes available in the future. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of our securities, in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the reregistration or qualification under the securities laws of any such state or other jurisdiction. |
| Humacyte is a Leader the Field of Regenerative Medicine: Bioengineered Tissues & Organs Off-the-shelf, no special preparation required Universally implantable with no immuno-suppression Regenerate as the patient’s own tissue Category-Defining Innovation that Creates New Tissues 3 |
| Universally Implantable Regenerative Human Tissue U.S. FDA Approved FDA approved Symvess® (ATEV) BLA in December 2024 for treatment of extremity vascular trauma; U.S. market launch commenced 2025 First-in-Class Technology and Manufacturing Platform Large addressable markets trauma, dialysis, peripheral artery disease, diabetes, coronary bypass Commercial-Scale Manufacturing Commercial-scale manufacturing in place with annual capacity of up to 40,000 ATEVs in existing facility Validated through Multiple Partnerships 4 |
| Humacyte Leadership & Board Leadership Team Board of Directors Kathleen Sebelius Chair of the Board John P. Bamforth, PhD Emery N. Brown, MD, PhD Michael T. Constantino Brady W. Dougan Charles Bruce Green, MD Keith Anthony Jones, M.D., Laura E. Niklason, MD, PhD Todd M. Pope Diane Seimetz, PhD Max Wallace, JD Susan Windham-Bannister, PhD Laura E. Niklason, MD, PhD Founder, President, Chief Executive Officer Dale Sander Chief Financial Officer, Chief Corporate Development Officer Shamik Parikh, MD Chief Medical Officer Sabrina Osborne Chief People Officer Heather Connelly Chief Quality Officer Prior Experience 5 Rick McElheny SVP, Business Development Lisa Molyneux EVP, Enterprise Planning & Analysis |
| Platform & Manufacturing: Enable Broad Pipeline of Regenerative Medicine Products Vascular tissue constructs (ATEV) Advanced tissue constructs Advanced organ systems Bioengineering Platform Cell seeding Tissue formation Cell removal and packaging 1 2 3 Working cell stock Cells transferred onto polymer mesh Cells proliferate & build extracellular matrix Polymer mesh degrades, leaving vascular cells and extracellular matrix Decellularization solutions clean and remove vascular cells from vessel Commercial-Scale Manufacturing Strategically designed with modular capabilities to manufacture products at scale Enables creation of universally implantable tissues and organs Our platform technology enables development of a broad range of product candidates 6 |
| Symvess Demonstrates Mechanical Strength and Remodeling with Patient’s Own Cells 7 |
| Pipeline with Multiple Potential Commercial Launches Preclinical Phase 1/2 Phase 3 Approved Vascular Tissue Constructs Trauma Dialysis (AV Access) PAD CABG Pediatric Heart Disease Complex Tissue Constructs Urinary Conduit Tracheal Replacement Esophageal Replacement Complex Organ Systems BioVascular Pancreas (T1D) Lung Approved by FDA V007 Phase 3 Trial Met Co-Primary Endpoints Three Phase 2 Studies Completed 8 V012 Phase 3 Trial in Women – Interim Results 2Q26 Dialysis (AV Access) ATEV CTEV |
| 9 Vascular Trauma FDA Approved in Extremity Vascular Trauma Symvess acellular tissue engineered vessel-tyod |
| Symvess is FDA Approved in Extremity Vascular Trauma Repopulates with the patient’s cells1-2,3 Low susceptibility to infection4 No immune response observed1-3,5 Off-the-shelf, ready to use1,3 Low amputation results1 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. PLEASE SEE ACCOMPANYING FULL PRESCRIBING INFORMATION AT SYMVESS.COM, INCLUDING BOXED WARNING. REFERENCES: 1. Symvess U.S. Prescribing Information. Durham, NC. Humacyte Global, Inc. 2. Kirkton RD, et al. Bioengineered human acellular vessels recellularize and evolve into living blood vessels after human implantation. Sci Transl Med. 2019;11(485):eaau6934. 3. Dahl S, et al. Readily available tissue-engineered vascular grafts. Sci Transl Med. 2011 Feb 2;3(68):68ra9. 4. Wang J, et al. Biological mechanisms of infection resistance in tissue engineered blood vessels compared to synthetic expanded polytetrafluoroethylene grafts. JVS Vasc Sci. 2023;4:100120. 5. Moore EE, et al. Bioengineered Human Arteries for the Repair of Vascular Injuries. JAMA Surg. 2024 Nov 20:e244893. 10 |
| • Common causes of vascular injuries include workplace injuries, car accidents, gunshots and stabbings, and sports injuries • Symvess address major drawbacks of current treatment options: Vascular Trauma Injuries – Symvess Value Proposition Vein is the standard of care, but takes valuable time, delaying revascularization Prosthetic grafts are quick, but have infection risk and high rates of amputation Amputation 11 Symvess is immediately available, off-the-shelf, and does not require further injuring the patient |
| Two Studies Were Used to Support FDA Approval Gunshot Wound Industrial Accident Knee Dislocation 12 First Study: CLN-PRO-V005 Phase 2/3 Pivotal Trial In U.S. and Israel • Single-arm, open label study • Conducted at Level 1 trauma centers • Arteria injury repair • Extremity injuries at high risk of contamination / infection Statistical Analysis Plan • Historical Benchmark Comparator > Systematic literature review of synthetic grafts in vascular trauma • Primary Comparison > 30-day endpoint of patency • Secondary Comparisons > 30-day infection rate > 30-day amputation rate • 69 patients enrolled as of data cut off • As agreed upon with FDA, focus for BLA filing were 51 patients with extremity injuries Examples of Symvess Implants in V005 Study |
| • At request of Ukraine surgeons Humacyte supported humanitarian program for patients injured in conflict • 19 patients received Symvess • At suggestion of FDA, patients from humanitarian program were included in BLA filing • 17 consented for data collection and study participation • 16 patients had extremity trauma repair (one patient required Symvess for Iatrogenic trauma repair) Ukraine Real World Experience of Symvess Use in Vascular Repair Pre-op CT Scan Symvess repair of Femoral artery Ukraine Patient Blast Injury Walking once again (Day 113) 13 Second Study: V017 Humanitarian Program in Ukraine Case Study of Patient Treated in Ukraine Program |
| Clinical Improvement with Symvess over Synthetics Two studies demonstrate improved outcomes compared to synthetic graft benchmark Symvess represents a new definitive and permanent repair option in patients with extremity arterial injury when a vascular graft is needed and no vein is available. Symvess improves secondary patency and has lower amputation and infection rates compared to the synthetic graft benchmark used in the BLA filing.. Outcome Day 30 Combined Symvess V005 and V017 Studies (N=67) Synthetic Graft Benchmark Primary Patency 87.1% 78.9% Secondary Patency 91.5% 78.9% Conduit Infection rate 0.9% 8.4% Amputation rate 4.5% 24.3% Death rate (all cause) 3. 5% 3.4% Moore EE, et al. JAMA Surg. 2024 Nov 20:e244893. ; Humacyte BLA filed December 11, 2023. Clinical Data 14 |
| 15 After up to 36 months of follow-up, patients demonstrated: • High rates of limb salvage • low rates of infection • no unprovoked structural failures Durability of Symvess in Trauma Repair Long-Term V005 Results1 Long-Term V017 Results2 • Trauma patients with battlefield injuries in Ukraine were followed for up to 18 months. • Wartime patients treated with Symvess were observed to have: • High rate of patency (87.1%) • 100% limb salvage • Zero cases of conduit infection • Zero deaths Publications 1Curi MA, et al. J Vasc Surg Cases Innov Tech. 2025 Nov 2Parikh S, et al.. Mil Med. 2025 Sep |
| Symvess Limb Salvage and Infections are Similar to Vein • Symvess compared to Prospective Observational Vascular Injury Trial (PROOVIT) registry • Retrospective comparison to existing registry • Symvess patients (n=67) were propensity-matched 1:2 to PROOVIT patients (n=134) who were previously treated with vein. - Identical injured arteries - Similar injury severity scores (though SYMVESS patients were more severe) Day 30 Outcomes for Symvess (Average 16-day follow-up for vein) V005 + V017 (N=67) PROOVIT Autologous Vein (N=134) P-value Primary Patency 86.6% 91.8% 0.276 Secondary Patency 91.0% 97.7% 0.077 Amputation rate 7.5% 8.2% 0.852 Conduit Infection rate 1.5% 0.0% 0.333 Death rate (all cause) 4.5% 4.5% 0.991 Reintervention Thrombosis/Stenosis 6.0% 8.2% 0.550 Rajani RR, et al. Trauma Surg Acute Care Open 2025; 10:e001814 Clinical Data 16 |
| U.S. Vascular Trauma Market – Total Addressable Market for Symvess Total Vascular Trauma Patients (All Injuries)1 79,000 Emergent Vascular Trauma – 56,000 Iatrogenic Vascular Trauma – 23,000 Target U.S. TAM for Symvess Based on Hospital Claims Data2 26,000 Emergent Vascular Trauma – 18,667 Iatrogenic Vascular Trauma – 7,333 1Third-partymarket research based on procedural volumes (2019) and secondary literature search 2Based on analysis of Definitive Healthcare (DHC) Claims Database 2022, claims as of November 2023. Adjusted to reflect estimate the database captures approximately 60% of procedures: Diagnosis (Dx) Codes: Identify Injury type, location Procedure Codes: ICD-10 PCS or CPT 3Based on analysis of Prospective Observational Vascular Injury Trial (PROOVIT) registry Symvess-Eligible Patients Exclusions • Type of repair: Bypass,repair, replacement, supplement, destruction or restriction • Location: Extremity arteries of interest • Iatrogenic: Arterial injuries co-occurring with other surgeries • Vein injury / repair • Injuries to torso, head, neck, wrist, hand, ankle, foot • Primary repair: Ligation or endovascular repair 17 |
| Drivers of U.S. Commercial Launch in Vascular Trauma 18 The Right Team Sales team of 12 executives who are experienced in vascular and/or trauma surgery and regenerative therapies Sales team is complemented by Medical Affairs, market access, and marketing teams Health Economics Budget Impact Model projects that the per-patient cost of treating patients with Symvess is estimated to be less than the cost of treating with synthetic grafts and other conduits Concentrated Market Approximately 200 Level 1 trauma centers in U.S. Approximately 3,000 vascular surgeons across civilian and military market opportunities Strong Clinical Results In the civilian and military clinical studies, Symvess was observed to have high rates of patency and low rates of amputation and infection Symvess acellulartissue engineered vessel-tyod |
| Symvess in Extremity Injury: Savings in Hospital Charges Healthcare Economics Symvess is associated with meaningful reductions in hospital charges when used in patients lacking feasible saphenous vein Additional hospital charges associated with each vascular graft infection: $589,921 Additional hospital charges associated with each amputation: $492,986 1. Velez, F. F., Rajani, R. R., Malone, D. C., et al. Journal of Medical Economics, 28(1), 323–334. 2. Brouwer E, Velez FF, Tan J. Submitted manuscript undergoing peer review. 19 |
| Symvess Budget Impact Model (BIM) in Extremity Arterial Injury Healthcare Economics At its current price point of $17,000, Symvess was shown to be the second-most economical arterial graft, after saphenous vein1 Published in J Med Econ, showed use of Symvess in patients without feasible saphenous vein resulted in a net cost reduction1 1. Velez, F. F., Rajani, R. R., Malone, D. C., et al. Journal of Medical Economics, 28(1), 323–334. 2. Brouwer E, Velez FF, Tan J. Submitted manuscript undergoing peer review. 20 20 |
| Department of Defense Support DEPARTMENT OF DEFENSE SUPPORT Symvess (ATEV) for Vascular Trauma designated as a “Priority Product” by DoD • designation created by Public Law 115-92 to expedite the development and FDA review of DoD priority technologies V005 Phase 3 clinical trial was partially funded by the DoD Symvess successfully treated Ukrainian warfighters, resulting in 100% limb salvage FY 2026 DoD Appropriations Act includes funding for the evaluation and incorporation of biologic vascular repair technologies for warfighters The Department of Defense (DoD) invested in Symvess in recognition of its benefit in battlefield injuries for warfighters In civilian mass-casualty situations, having Symvess on the shelf can also help with response to terrorism/other threats, since surgeons can operate more quickly and treat more patients, not having to take time to harvest vein 21 |
| 22 AV Access for Dialysis |
| AV Access for Hemodialysis Has Limitations Estimate of Permanent Access Procedures Performed in U.S. ~20% Grafts ~20% Catheters ~60% AV fistulas Venous / Temporary Catheter Primary/AV Fistula (Autogenous) Secondary / Graft Market targeted by ongoing V007 Phase 3 Trial • ~40% of fistulas fail to mature • Even the fistulas that do mature take 3-6 months to become usable for dialysis • Catheter infection rates are up to 200% per patient-year Limitations of AV Fistulas (Current Standard of Care) 23 |
| ATEV is Designed to Address Failures in AV Access • ATEV usable for dialysis after only four weeks • ATEV reduces catheter contact time, thereby reducing risk of catheter infection • >80% of ATEVs functional for dialysis at 6 months • ATEV infection rate is comparable to AVF • Opportunity to reduce cost of access failures and other complications: • Access failures and complications • Dialysis complications • Infections RMAT RMAT designation granted by FDA 24 ATEV provides potential for improved patient outcomes Strategic collaboration with FMC, the largest provider of renal care services |
| Partnered with Fresenius / Frenova Renal Research to identify the hemodialysis subpopulations with highest unmet needs Analysis of 178,575 adults with in-center hemodialysis established that: • Women are more likely to use AVG ± CVC for access within 90 days of initiation • Women have up to 90% increased risk of AVG ± CVC use, as compared to men • AVG ± CVC access has much higher complication rates: ~2X higher than AVF • Nearly $3 billion spent by Medicare in 2013 for on access complications/maintenance • Top quintile of dialysis patients cost between $91,841 to >$155,632 annually to maintain access • Women are more likely to fail AVF maturation: Cost >$30,000 in first year • Women are 20% more likely to fail AVF maturation • Women are 20% more likely to have multiple access failures in the first 6 months • Women are 24% more likely to have multiple hospitalizations for access complications • Some female sub-groups are at especially high risk • Example: Obese, diabetic women have excess costs of ~$27,000 to $91,000 during the first year Current AV Access in Women Work Poorly and is Expensive 25 |
| • More adverse events were reported in patients on the ATEV treatment arm than those on the AV fistula treatment arm: • More thromboses in the ATEV group, but virtually all were resolved • A number of serious events occurred more frequently in the AVF arm: • Two ruptures of AVF (a potentially fatal event), none for ATEV • Substantially more “steal” (ischemia of the hand), surgical revisions, and balloon-assisted maturation in the AVF group compared to the ATEV group V007 Top-Line Results – ATEV Met Co-Primary Endpoints 26 ATEV demonstrated superior function and patency at six and 12 months (co-primary endpoints) compared to autogenous fistula, the current standard of care for hemodialysis Co-Primary Endpoints ATEV (N=123) AVF (N=119) p-value Functional Patency at Month 6 81.3% 66.4% 0.0071 Secondary Patency at Month 12 68.3% 62.2% • Subjects with end-stage renal disease in need ATEV of dialysis • Enrollment completed April 2023, 242 total subjects Single-stage AV Fistula |
| 27 V007 Superior Subgroup Results Females ATEV (N=37) AVF (N=33) p-value Functional Patency at Month 6 89.2% 54.5% <0.0001 Secondary Patency at Month 12 81.1% 48.5% Difference p-value Duration of Use Over First 12 Months 8.3 months 5.0 months 3.3 months 0.0011 ATEV showed superior function and patency in subgroups with historically poor outcomes Females, and males with BMI ≥ 30 and diabetes ATEV (N=56) AVF (N=54) p-value Functional Patency at Month 6 85.7% 51.9% <0.0001 Secondary Patency at Month 12 76.8% 46.3% Difference p-value Duration of Use Over First 12 Months 8.0 months 4.5 months 3.5 months 0.0002 |
| 28 V007 Safety Results in Key Subgroup ATEV has shown no increased safety events per year of usability in the expected target population (all females and males with BMI ≥ 30 kg/m2 and diabetes) 12-Month Safety Summary ATEV AVF Subjects (%) n=54 Events per Patient Year Subjects (%) n=56 Events per Patient Year Treatment Emergent Adverse Events 96.3% 14.8 98.2% 21.8 Serios Adverse Events 77.8% 4.2 67.9% 6.1 Adverse Events of Special Interest: CEC SA-related infections Thrombosis Stenosis Clinically significant Steal Syndrome Rupture of SA Leading to SA revision or ligation Leading to SA excision 7.4% 51.9% 64.8% 1.9% 0.0% 11.1% 5.6% 0.1 1.2 3.0 0.0 0.0 0.2 0.2 5.5% 12.5% 51.8% 3.6% 3.6% 28.6% 3.6% 0.1 0.3 2.9 0.1 0.1 1.2 0.1 |
| 29 V007 Two-Year Results in Female Patients ATEV has shown superior long-term patency at 24 months in females, and in all females and males with BMI ≥ 30 kg/m2 and diabetes |
| • Enrollment: • Target 150 total subjects (interim analysis after 80 patients) • 1:1 Prospective randomization ATEV vs. Autogenous fistula V012 (HUMAXX) Trial in Women Dialysis Patients To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis (HUMAXX) Female patients currently receiving hemodialysis via catheter and who are candidates for creation of an AVF or implantation of an ATEV. Objectives: • Primary Efficacy: Total days free from in-dwelling catheter (“catheter-free days”) until 365 days, or until access abandonment, whichever occurs first. • Primary Safety: Number and severity of infections related to all accesses (including catheters) from access creation until 365 days. Trial comparing Humacyte’s (ATEV ) to AVF in women 30 Expect to file supplemental BLA based after interim analysis of V012 study results: Planned supplemental BLA filling in 2nd half of 2026 Target subgroups in which the ATEV showed the best results in the V007 study: All females, and potentially males with one or more risk factors |
| 31 Peripheral Arterial Disease (PAD) |
| • Tissue does not receive enough blood flow to survive • If untreated, leads to tissue loss, gangrene, and ultimately amputation Critical Limb Threatening Ischemia • Non-surgical, catheter-based intervention • Surgical bypass Treatment Requires Restoration of Blood Flow 32 Can progress to multiple leg arteries, further reducing circulation For the 40% of PAD patients who do not have an ipsilateral saphenous vein for arterial bypass, ATEV may represent a promising means of revascularization and limb salvage Peripheral Artery Disease (PAD) 32 |
| Current Clinical Experience with ATEV in Peripheral Arterial Disease 1Piotr Gutowski, et al, 6-Year Outcomes of a Phase 2 Study of Human-Tissue Engineered Blood Vessels for Peripheral Arterial Bypass, JVS: Vascular Science (2023) 2Lauria A, Kersey A, Propper B, et al. Annals of Vascular Surgery. 2022 Apr 6:S0890-5096(22)00180-7 • V002 – 20 patients (EU) • V004 – 15 patients (US) Phase 2 Trials Over 20 U.S. patients with critical limb ischemia treated under FDA Expanded Access program Investigator-sponsored IND • 29 patients with severe PAD at risk of limb loss • Patients did no have saphenous vein available EA Mayo IND • Six-year results from V002 published in Journal of Vascular Surgery – Vascular Science1 • Publication of First Eight Expanded Access Cases in Annals of Vascular Surgery2 • Outcomes published in Midwestern Vascular Surgical Society showing 86% limb salvage rate 33 |
| Expanded Access: Restoring Mobility with ATEV • The ATEV was used under compassionate use program in 70-year-old patient with severe vascular disease • No vein was available to perform a bypass, as the vein was previously harvested for a CABG • A right distal superficial femoral artery-to-peroneal artery bypass was performed using an ATEV • The patient’s postoperative course was unremarkable • At 1-year follow-up the angiography showed a patent ATEV without significant stenosis at the distal anastomosis • Four years after ATEV implantation, the patient continues to do well and is walking. This case was included in ATEV results in critical limb ischemia presented at VESS meeting in January 2022 Knee joint Staples at incision ATEV Angiogram at 1 year Bypass performed using the ATEV in patient with severe vascular disease 34 |
| 35 Pipeline: CTEV for Coronary Bypass Graft Surgery |
| 36 Coronary Artery Bypass Grafting (CABG) Introduction • The most commonly performed cardiac surgical procedure in the U.S. (approx. 300,000 per year) • In the United States, 79 people per 100,000 have triple bypass surgery each year. • CABG is generally recommended when there are high-grade blockages in any of the major coronary arteries and/or percutaneous coronary intervention (PCI) has failed to clear the blockages Most commonly used autologous grafts • Left internal mammary artery (LIMA) • Most often used to bypass Left Anterior Descending (LAD) Artery • >90% patency at 10 years • Saphenous vein graft (SVG) • Often used to bypass Right Coronary Artery (RCA) or Left Circumflex Artery • SVGs used in 80-90% of CABG procedures • 10%-25% failure rate at 1 year, 40%-50% failure rate at 10 years • Radial artery and other arm veins |
| Concerns with Saphenous Vein Grafts Vein Quality Issues • Varicosities (20-30% of patients) • Previous vein stripping or ablation • Small diameter (<3mm) • Sclerotic or diseased veins • Peripheral vascular disease effects Medical Co-morbidities • Bilateral leg amputations • Need to preserve vein for future peripheral bypass • Prior vein harvest for CABG or peripheral surgery • Obesity (difficult harvest) • Patients with diabetes (higher failure rates) Harvest-Related Morbidity • Wound complications (5-10%) • Leg edema and pain • Infection risk • Nerve injury (saphenous nerve) • Prolonged recovery time Long-Term Clinical Impact • Need for repeat revascularization • Recurrent angina (20-30% at 5 years) • Risk of graft atherosclerosis • Reduced event-free survival • Higher healthcare costs • Zenati MA et al. N Engl J Med. 2019;380:2069-77 • Hess CN et al. Circulation. 2014;130:815-27 • Lopes RD et al. JAMA. 2012;307:265-74 |
| 38 Coronary Tissue Engineered Vessel (CTEV): Addressing an Unmet Need in Multivessel CABG • The CTEV is a first-of-its-kind, sterile, off-the-shelf human- derived vessel that requires no preparation, is non- immunogenic, and resists infection. • The CTEV has an inner diameter of 3.5 mm and is approximately 23 cm in length. • Designed to address unmet conduit needs in CABG patients lacking autologous options, potentially offering patency and durability comparable to or better than saphenous vein without the need for harvesting. • First human study of CTEV planned for 2nd Half 2026. |
| 39 Three primates were successfully bypassed with a 3.5 mm CTEV as aorta-Right Coronary Artery CABG conduits. CTA at 1, 3 and 6 months demonstrated patency of the CTEV with no significant stenosis or dilatation. There were no CTEV-related adverse events for the duration of the study. Histological staining of 6-month explanted tissues showed recellularization and remodeling of the CTEV. Positive Patency Results in Animal Models |
| Primate – CABG Angiography – Adaptive Remodeling 1 Month 3 Months 6 Months Jonas – Left Ventricular Function (%) Pre-Op 1-Month 3-Month 6-Month 70% 73% 74% 73% 40 |
| 41 Pipeline: BioVascular Pancreas |
| The BioVascular Pancreas (BVP) Acellular Tissue Engineered Vessel (ATEV) is implanted in the arm BioVascular Pancreas (BVP) The BVP is an innovative implantable device designed to deliver pancreatic islets, for treating Type 1 Diabetes (T1D) •Core Components: Combines Humacyte's FDA-approved Acellular Tissue-Engineered Vessel (ATEV) with a fibrin-based hydrogel "sleeve" populated with islets. •Mechanism: The ATEV hydrogel coating allows islets access to oxygen from arterial blood through the vessel wall without direct blood contact, reducing hypoxia and inflammation. •Implantation: Deployed as a vascular graft – i.e. as an arteriovenous graft in the arm. After implantation BVP promotes neovascularization and long-term islet survival and function. •Development Status: Non-human primate dose range finding studies planned 2026. First in human study planned 2027. Developed in collaboration with |
| 43 Drawbacks to Current Islet Transplantation Methods Intraportal Infusion: Injecting islets directly into the portal vein for liver engraftment ECTRA Commercial and developmental islet cell transplantation techniques have significant drawbacks impacting cell survival Islet Pouch Transplantation: create a protected, vascularized environment for transplanted insulin-producing islet cellsTRA Pouches become fibrotic, which reduces nutrient and oxygen availability impacting islet survival |
| 44 BioVascular Pancreas Solves the Islet Delivery Problem Precision Islet Delivery, while Protecting Islets from Bloodstream Damage Islet dosing Uniform and Controlled Immediate and continued Oxygen Delivery to Islets from bloodstream Angiogenesis supports Long-Term Islet engraftment O2 Avoids excessive first-pass insulin degradation in the liver |
| 45 BVP Proof of Concept in a Rat Model BVP stimulates small blood vessels that nourish islets after implantation Measure Blood Sugar Streptozotocin-Induced Diabetic Nude Rat BVP, rat islets Transplant BVP into Aorta, or adjacent to Aorta (negative control) Diabetic rats implanted with BVPs containing rat islets Equivalent human Islet dosage ~ 350,000 (fewer than portal vein) BVP implanted into the rat aorta, in line with blood flow Negative controls received BVP adjacent to the aorta, not in-line with blood flow. BVP stimulates angiogenesis/blood flow into islets on outer surface, as seen below: |
| 46 BVP Cures Diabetes in a Rat Model 0 50 100 0 200 400 600 Blood Glucose Levels Day Blood Glucose (mg/dL) BVP (n=5) No Flow (n=3) **** BVP not in circulation, so diabetes continues BVP in aorta corrects blood sugar All animals (n=5) who received BVP in the Aorta were cured of diabetes = 100% cure rate. BVP implanted just in the abdomen, but not in a blood vessel, failed to cure diabetes. Just transplanting islets, without the BVP, does not cure. BVP provides cure by supporting islet survival and ability to make insulin in response to glucose challenge. Diabetics and negative controls do not make insulin Islets survive in BVP, and can secrete insulin |
| 47 BVP NHP Preclinical Data • BVP Non-Human Primate (NHP) model: human 6mm ATEV combined with primate islets • Subjects: Cynomolgus macaques weighing 7-8 kg with streptozotocin-induced T1D • Treatment with allogeneic Biovascular Pancreas (BVP) delivering ~3840 islet equivalents/KG supported islet survival for up to 7 months post-implantation • Histology showed healthy and C-peptide-positive islets with few apoptotic cells • Greater than 80% islet retention observed at 2 months. • Significant neovascularization near islets by 7 months • Functional Outcomes Correlated with detectable plasma C-peptide levels starting at 4 months with reduced needs for exogenous insulin Greater than 80% |
| 48 • Cynomolgus monkeys, 7-8 kg weight • University of Miami Diabetes Research Center • Small size aortic implantation of 6mm human-sized ATEV • Animal islet dosing equivalent to 300,000 islets for a human • 2-month explant: >80% islet survival. • Superior to any known transplant method. BVP in non-human primates – Excellent Islet Survival |
| Islets 100 µm 100 µm 100 µm 100 µm BVP Supports Long-Term Islet Survival in Primates Islets Islets Pre-Op Islets at 2 Weeks Islets at 2 Months Islets Islets at 7 Months Islets C-Peptide (Insulin) DAPI - cells C-Peptide (Insulin) DAPI - cells C-Peptide (Insulin) DAPI - cells C-Peptide (Insulin) 49 DAPI - cells Implantation: BVP in aorta of small, non-human primate. I Primate BVP Pre-Implantation Islets show excellent survival and insulin production for at least 7 months in NHPs. |
| 50 Milestones |
| Our Technology Target Compelling Unmet Needs in Attractive Markets Pre-Clinical Trachea Pancreas Esophagus Urinary Conduit Lung Peripheral Arterial Disease (PAD) Dialysis AV Access Coronary Artery Bypass Graft (CABG) BT Shunt Clinical Programs Pre-Clinical Vascular Tissue Constructs Complex Tissue Constructs and Organ Systems 51 FDA Approved Vascular Trauma |
| Commercial Manufacturing Scale – LUNA200 System Commercial 83,000 sq ft Bioprocessing Facility • Currently operating 8 LUNA200 systems • Annual capacity expected to exceed 40,000 ATEVs • Functionally closed system with state-of-the-art process automation Bioreactor bag Each bioreactor bag contains a single polymer mesh scaffold, seeded with banked human cells 10 bioreactor bags per growth drawer; tubing connects to shared nutritive media Each LUNA200 can produce 200 ATEVs per batch (or ~1,000 ATEVs annually) Growth drawer LUNA200 System 52 |
| Anticipated 2026 Milestones Vascular Trauma (Symvess): • U.S. commercial launch growth • Expansion into international markets Dialysis (ATEV): • Publication of V007 Phase 3 results • Interim results from V012 Phase 3 trial in female patients • Supplemental BLA filing with FDA All milestone dates are only management estimates Vascular Trauma - Symvess: • U.S. commercial launch • Long-term results showing durability of Symvess V007 dialysis positive Phase 3 ATEV two-year results Cardiac Bypass Graft Surgery (CABG) CTEV preclinical results from large-animal studies Preclinical BVP results showing survival and function of islets in large animals Completed in 2025 Planned for 2026 CABG (CTEV): • Commencement of first-in-human study • First patient results BioVascular Pancreas (BVP) for type-1 diabetes: • Preparation for first human study Publications & Presentations (Multiple other clinical and preclinical publications and presentations expected for 2026) 53 |
| The Promise of Regenerative Medicine Broad platform of universally implantable off-the-shelf bioengineered human tissues and organs Bioengineering Platform Platform targets extensive markets across multiple indications Extensive Markets Existing facilities expected to support anticipated commercial launch with room for modular expansion Commercial Scale Manufacturing 54 |
| Universally Implantable Regenerative Human Tissue Thank You |
Exhibit 99.2
RISK FACTORS
Humacyte, Inc. (the “Company”) has provided the following updates to its risk factors set forth under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and Form 10-Q for the quarter ended September 30, 2025, each filed by the Company with the U.S. Securities and Exchange Commission (the “SEC”). If any of these risks actually occurs, the Company’s business, financial condition, results of operations or cash flow could be seriously harmed.
We have incurred significant losses to date and we expect to continue to incur losses for the foreseeable future and may never be profitable.
Since its inception in 2004, we have incurred operating losses and negative cash flows from operations in each year. Our operating losses were $77.3 million and $86.3 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025 and December 31, 2024, we had an accumulated deficit of $702.0 million and $686.0 million, respectively. Although we are a commercial-stage biotechnology platform company, we have a single product approved for commercial sale and a limited operating history as a commercial-stage company upon which you can evaluate our business and prospects. We have historically financed our operations primarily through the sale of equity securities and convertible debt, proceeds from our going public transaction, borrowings under loan facilities, including the loan and security agreement (the “Loan Agreement”), dated as of December 15, 2025, by and among the Company, Humacyte Global, Inc., and Avenue Venture Opportunities Fund II, L.P., as administrative agent and collateral agent for the lenders and as lender (the “Loan Agent”), the Common Stock Purchase Agreement, dated as of September 24, 2024, with Lincoln Park Capital Fund, LLC and, to a lesser extent, through grants from governmental agencies. We have devoted substantially all of our financial resources and efforts to sales, marketing, research and development, including preclinical studies and clinical trials and development of manufacturing technology, and we anticipate that our expenses will continue to increase over the next several years as we continue these activities.
To become and remain profitable, we must succeed in commercializing Symvess, obtaining marketing approval for Symvess outside of the United States, obtaining marketing approval for our product candidates, and in developing and commercializing additional product candidates that generate significant revenue. We may never succeed in these activities and, even if we do, may never generate revenue that is sufficient to achieve profitability.
Even if we do achieve profitability, we may not be able to sustain or increase profitability. Our failure to become and remain profitable would depress the value of our company and could impair our ability to maintain our research and development efforts, expand our business, diversify our product offerings or even continue our operations. A decline in our value could also cause you to lose all or part of your investment in our securities.
We may be subject to enforcement action, civil liability, regulatory investigation and penalties if we engage in the off-label promotion of Symvess.
Our promotional materials and training methods must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of off-label use. In a significant number of cases, physicians have used, and may in the future continue to use, Symvess off-label, as the U.S. Food and Drug Administration (“FDA”) does not restrict or regulate a physician’s choice of treatment within the practice of medicine. However, if the FDA determines that our promotional efforts constitute promotion of an off-label use, it could request that we modify our training or promotional efforts or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil penalties and criminal fines. It is also possible that other federal, state or foreign enforcement authorities, such as the Department of Justice or the Department of Health and Human Services, might take action if they consider our promotional or training materials to constitute promotion of an unapproved off-label use, which could result in significant criminal and/or civil sanctions under other statutory authorities, such as laws prohibiting false claims for reimbursement. In that event, our reputation could be damaged and adoption of Symvess would be impaired. Although our policy is to refrain from statements that could be considered off-label promotion of Symvess, the FDA or another regulatory agency could disagree and allege that we have engaged in off-label promotion. In addition, the off-label use of Symvess may increase the risk of injury to patients, and, in turn, the risk of product liability claims. Claims under federal false claims laws and product liability claims are expensive to defend and could divert our management’s attention, result in substantial damage awards against us and harm our reputation.
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.
Before obtaining marketing approval for any of our product candidates, and before gaining approval for additional indications for our approved Symvess product, we must conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive and time-consuming, and its outcomes are uncertain.
A number of factors may impact the timing of our preclinical and clinical programs and the development and commercialization of our product candidates. These include factors such as inability to recruit sufficient numbers of patients, delays in obtaining Institutional Review Board approval for planned trials, or disagreements with regulatory agencies on clinical trial design and/or imposition of clinical holds. For instance, our proposed coronary artery bypass grafting (“CABG”) clinical trial currently is on a clinical hold until we can provide batch testing data to the FDA for our smaller diameter acellular tissue engineered vessel (“ATEV”). We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all, or that they will be successful. Any inability to successfully complete development of our product candidates would likely result in significant additional costs to us, create delays in filing a Biologics License Application (“BLA”) for regulatory approval of our product candidates and impair our ability to generate revenue.
We believe the novelty of our research and development efforts, which are focused on the development of bioengineered human, acellular, tissue-based vessels for use across a wide spectrum of applications in vascular surgery, augments this uncertainty. The scientific discoveries that form the basis for our efforts to develop our product candidates are relatively new, and the scientific evidence to support the feasibility of developing product candidates based on these discoveries is limited. At this time, Symvess has been approved in the United States in an initial indication, and none of our other product candidates have been approved in the United States, Europe, Israel, or in any other jurisdiction. The clinical trial requirements of the FDA and other regulatory agencies and the criteria these regulators use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential product. In addition, because of the nature of the ATEVs, many of our clinical trials are “open label,” meaning that both the patient and the investigator know whether the patient is receiving the investigational product candidate. These studies often require the use of historical control arms consisting of patients previously treated with alternative therapies in the normal course of medical care. Use of open label study designs further complicates the clinical development process. Because of these and other factors, we may experience substantial difficulties in agreeing with FDA and other regulatory authorities on clinical trial design.
If our studies are not successful, we will be delayed in obtaining marketing approval or may not receive marketing approval at all. For example, our V006 Phase 3 clinical trial in arteriovenous (“AV”) access for hemodialysis did not meet its primary endpoint, which has delayed development of the ATEV for the hemodialysis access indication. If we fail to achieve the primary endpoint of our other ongoing or future clinical trials, or if safety issues arise, or the results from our clinical trials are otherwise inadequate to support regulatory approval of our product candidates, we may incur significant additional costs or experience significant delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
Even if our clinical trials achieve their primary endpoints, the FDA may still determine that such trials do not adequately establish the safety and effectiveness of our products. Data obtained from preclinical and clinical studies are subject to varying interpretations, which may delay, limit, or prevent marketing approval. In such a circumstance, the FDA may require that we design and conduct new, additional clinical trials to demonstrate safety and effectiveness, or may determine not to approve our products at all.
Additionally, even though we received FDA approval for Symvess in certain types of trauma, we may face a number of difficulties if the results of our clinical trials for additional Symvess indications or for our product candidates are unfavorable, inconclusive, or only modestly favorable or if there are safety concerns, such as adverse events or serious adverse events, which could include clotting, mechanical failure, immunological rejection or infection, that could outweigh potential benefits associated with such product candidates. This could result in:
| · | obtaining approval for indications or patient populations that are not as broad as intended or desired; |
| · | obtaining approval with, or later becoming subject to, labelling that includes significant use or distribution restrictions or significant safety warnings; |
| · | being subject to a Risk Evaluation and Mitigation Strategy or equivalent requirement from a comparable foreign regulatory agency, to ensure that the benefits of a biological product outweigh its risks or to change the way the product is used; |
| · | being required to perform additional clinical trials to support approval or comparability or being subject to additional post-marketing testing requirements; |
| · | having regulatory authorities withdraw their approval of the product; |
| · | being sued; or |
| · | suffering damage to our reputation. |
Any of these events could cause us to incur significant additional costs, significant delays and prevent us from achieving or maintaining market acceptance of or commercializing one or more of our product candidates.
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.
We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) continue to commercialize Symvess and seek marketing approval for Symvess in additional indications and for our product candidates in the United States and to obtain marketing approval for our 6 millimeter ATEV outside of the United States, (ii) continue clinical development of our 6 millimeter ATEV for use in hemodialysis AV access and submit a BLA for FDA approval of an indication in hemodialysis AV access, (iii) advance our pipeline in major markets, including peripheral artery disease Phase 3 trials and continue preclinical development and advance to planned clinical studies in CABG and pancreatic islet cell transplantation to treat Type 1 diabetes (our BioVascular PancreasTM), and (iv) scale out our manufacturing facility as required to satisfy market demand. We will need additional funding in connection with these activities.
Our future funding requirements, both short-term and long-term, will depend on many factors, including:
| · | the cost and timing of our sales and future commercialization activities, including product manufacturing, marketing and distribution for Symvess in the United States, and any other product candidate for which we receive marketing approval in the future; |
| · | the amount and timing of revenues that we receive from commercial sales of Symvess and any product candidates for which we receive marketing approval; |
| · | the progress and results of our clinical trials and interpretation of those results by the FDA and other regulatory authorities; |
| · | the cost, timing and outcome of regulatory review of our product candidates, particularly for marketing approval of Symvess outside of the United States and of our product candidates in the United States; |
| · | the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our additional product candidates; |
| · | the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and |
| · | the costs of operating as a public company, including hiring additional personnel as well as increased director and officer insurance premiums, audit and legal fees, and expenses for compliance with public company reporting requirements under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and rules implemented by the SEC and The Nasdaq Stock Market LLC. |
Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. As of September 30, 2025 and December 31, 2024, we had cash and cash equivalents of $19.5 million and $44.9 million, respectively.
Pursuant to the terms of the Loan Agreement, we may be limited in our ability to incur future debt.
Pursuant to the terms of the Loan Agreement, we are, among other things, limited in our ability to incur additional indebtedness without the prior written consent of the Loan Agent, which would constitute an event of default under the Loan Agreement. Upon the occurrence and continuation of such an event of default, the Loan Agent is entitled, without notice or demand, to declare all obligations under the Loan Agreement immediately due and payable. If an event of default under the Loan Agreement should occur, we could be required to immediately repay any outstanding indebtedness. If we are unable to repay such debt, the lenders would be able to foreclose on the secured collateral and take other remedies permitted under the Loan Agreement. Even if we are able to repay any indebtedness on an event of default, the repayment of these sums may significantly reduce our working capital and impair our ability to operate as planned.
We cannot assure you that our business will generate sufficient cash flow from operations, that we will be able to incur future debt on favorable terms or at all, or that future financing will be available to us in amounts sufficient to fund our operations.
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.
We have taken several cost reduction actions to reduce our workforce, cease recruitment of additional planned new hires, and reduce other operating expenses. We undertook these cost reductions to improve our cash runway and to better align our organizational structure with our top business objectives. From time to time, we also take actions intended to address the short-term health of our business as well as our long-term objectives based on our current estimates, assumptions and forecasts. These measures are subject to known and unknown risks and uncertainties, including whether we have targeted the appropriate areas for our cost-saving efforts and at the appropriate scale, and whether, if required in the future, we will be able to appropriately target any additional areas for our cost-saving efforts. As such, the actions we are taking in connection with our current cost saving measures and that we may decide to take in the future may not be successful in yielding our intended results and may not appropriately address either or both of the short-term and long-term strategy for our business. Implementation of our current and any other cost-saving initiatives may be costly and disruptive to our business, the expected costs and charges may be greater than we have forecasted, and the estimated cost savings may be lower than we have forecasted. Certain aspects of the cost saving measures, such as severance costs in connection with reducing our headcount, could negatively impact our cash flows. In addition, our initiatives could result in personnel attrition beyond our planned reduction in headcount or reduced employee morale, which could in turn adversely impact productivity, including through a loss of continuity, loss of accumulated knowledge or inefficiency during transitional periods, or our ability to attract highly skilled employees. Unfavorable publicity about us or any of our strategic initiatives could result in reputation harm and could diminish confidence in, and the use of, our ATEVs.
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.
The marketing approval process for novel product candidates such as ours may take longer to complete and be more expensive than the process for other, better known or extensively studied pharmaceutical or other product candidates. For example, on December 12, 2023, we submitted our BLA for the ATEV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated and autologous vein use is not feasible. We submitted our BLA using a “rolling review,” which means we may submit completed modules of a BLA rather than waiting until every module of the BLA is completed before submitting the full BLA for FDA review. Such “rolling review” is common for indications that are part of one of FDA’s expedited programs, such as our 6 millimeter ATEV, which has received Fast Track and Regenerative Medicine Advanced Therapy (“RMAT”) designations for AV access in hemodialysis, and RMAT designation for urgent arterial repair following extremity vascular trauma. In February 2024, the FDA accepted our BLA in the vascular trauma indication and granted priority review of that BLA. Under priority review, the FDA’s goal is to review an application within six months of the 60-day filing date, compared to ten months for a standard review. Even though we utilized a “rolling review” and we had received priority review for that BLA, we still did not receive approval of our initial Symvess BLA until December 2024. Thus, even if we are permitted to submit supplemental or additional BLAs under rolling review in the future, and even if those applications receive priority review, we cannot guarantee that those applications will be reviewed and approved on an expedited basis, if at all. The FDA could require us to submit major amendments to a BLA, which could lead to a longer review time. The FDA could also decide to consult an advisory committee as part of our BLA review process, which often leads to a longer review time. We are not permitted to commercialize our product candidates in the United States until they have been approved by the FDA, and if we experience a lengthier review period than expected, our ability to generate product revenues would be materially harmed.
Healthcare reform measures could hinder or prevent commercial success of Symvess or our product candidates.
Our industry is highly regulated, and changes in or revisions to laws, regulations, or other policies that make gaining coverage of and adequate reimbursement for Symvess or our product candidates more difficult or subject to different criteria and standards may adversely impact our business, prospects, operating results and financial condition. In the United States, there have been and we expect there will continue to be a number of legislative, regulatory and other changes to the healthcare system to contain or reduce healthcare costs that may adversely affect our ability to set a price we believe is fair for Symvess or our product candidates, our ability to generate revenues and achieve or maintain profitability, and the availability of capital.
Federal and state lawmakers regularly propose and, at times, enact legislation that would result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. At the federal level, the Inflation Reduction Act of 2022 (the “IRA”):
| · | Requires manufacturers to pay rebates for a Medicare Part B or Part D drug if the price increases for the drug exceed the rate of inflation. |
| · | Eliminates the “donut hole” under Medicare Part D beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and requiring manufacturers to subsidize 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket maximum and 20% once the out-of-pocket maximum has been reached. |
| · | Delays the rebate rule that would require pass through of pharmacy benefit manager rebates to beneficiaries. |
| · | Directs the Centers for Medicare & Medicaid Services (“CMS”) to engage in price-capped negotiation for certain Medicare Part B and Part D drugs and biologics. Specifically, the IRA’s Price Negotiation Program applies to high-expenditure single-source drugs and biologics that have been approved for at least 7 or 11 years, respectively, among other negotiation selection criteria, beginning with ten high-cost Part D drugs starting in 2026, to be followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond. The negotiated prices will be capped at a statutorily determined ceiling price. There are statutory exemptions from the IRA’s Price Negotiation Program, including for certain orphan products. The IRA’s Price Negotiation Program is currently the subject of legal challenges, but implementation and effectuation of the Program is ongoing. |
Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties or a potential excise tax. The IRA permits the Secretary of Health and Human Services to implement many of the IRA’s provisions through guidance, as opposed to regulation, for the initial years. The IRA is having significant effects on the pharmaceutical industry and may reduce the prices pharmaceutical manufacturers can charge and the reimbursement pharmaceutical manufacturers can receive for approved products, among other effects.
Lowering prescription drug prices was a stated priority of the Biden administration and resulted in additional drug pricing policies. For example, on October 14, 2022, President Biden signed an executive order to lower prescription drug costs for Americans. In response to this directive, the Center for Medicare and Medicaid Innovation developed new models intended to lower drug costs under federal health care programs. These models included establishing a new approach for administering outcomes-based agreements for cell and gene therapies.
Additionally, the American Rescue Plan Act of 2021 eliminated the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, as of January 1, 2024. This came as individual states have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
The FDA also released a final rule, which went into effect in 2020, providing guidance for states to build and submit plans for importation of drugs from Canada. FDA and states have moved forward with implementation efforts. For example, on January 5, 2024, the FDA authorized Florida to move forward with its importation program proposal, and other states have enacted state importation laws and submitted plans for approval to the FDA. Congressional action in this space has continued into the Trump Administration with the passage of the One Big Beautiful Bill Act, signed into law on July 4, 2025, which expanded the orphan exemption in the IRA and limited the availability of Medicaid and Medicare benefits, among other actions.
The Trump Administration has also continued the prioritization of reducing drug prices and effectuating broader industry reform. Most prominently, the Trump Administration has taken various actions to facilitate most-favored-nation (“MFN”) pricing for pharmaceuticals; this concept entails pharmaceutical manufacturers selling prescription drug products at the lowest price made available for the same or equivalent product in certain comparable countries abroad. For example, on May 12, 2025, President Trump issued an Executive Order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” which, among other things, ordered the Secretary of HHS to communicate MFN targets to pharmaceutical manufacturers, and advised of regulatory consequences if “significant progress towards most-favored-nation pricing” was not delivered. Since September 2025, the Administration has also announced its entrance into deals with pharmaceutical manufacturers to implement MFN pricing initiatives. Additionally, in November 2025, the CMS announced the GENErating cost Reductions for U.S. Medicaid (“GENEROUS”) Model, a voluntary model set to begin in 2026 to implement MFN pricing in Medicaid through states and pharmaceutical manufacturers’ entrance into supplemental rebate agreements. Under GENEROUS, participating manufacturers would provide supplemental rebates to state Medicaid agencies to approximate MFN pricing. In December 2025, CMS announced two proposed rules setting forth mandatory drug pricing models, the Global Benchmark for Efficient Drug Pricing (“GLOBE”) Model and the Guarding U.S. Medicare Against Rising Drug Costs (“GUARD”) Model, which would require the implementation of MFN pricing in Medicare Part B and Part D, respectively, through the replacement of inflation rebates under the IRA. As proposed, GLOBE and GUARD would apply to randomly selected geographic areas amounting to 25% of Medicare Part B and D beneficiaries. For these populations, pharmaceutical manufacturers would be responsible for rebates when the price at which a product is sold in the United States exceeds MFN, if the MFN rebate amount would be greater than the inflation rebate the pharmaceutical manufacturer would otherwise owe under the IRA.
We cannot predict how further developments of or changes to these laws and regulations will affect our business. The ultimate content, timing, or effect of any healthcare regulation, legislation, executive order, or other policy or the impact that the resulting changes may have on us is uncertain, but we expect there will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health care.
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.
We sell Symvess through our own sales force. In some situations, we store consigned inventory on site in freezers at hospitals or clinic facilities. Inventory management, revenue recognition, and inventory and receivables accounting are complicated by consignment arrangements. From the revenue recognition perspective, no revenue is recognized upon the placement of inventory into consignment, as we retain title and maintain the inventory on our balance sheet. For these products, revenue is recognized when we receive appropriate notification that the product has been used in a surgical procedure. If the FDA or any other regulatory authority determines that we are unable for any reason to distribute consigned inventory, either on account of the viability of that inventory or because of the withdrawal of necessary approvals or other qualifications allowing for the distribution and sale of that inventory, the value of that inventory may have to be written off and our balance sheet adjusted accordingly. If we are unable to track and maintain proper controls related to consigned inventory, we could experience difficulty in accurately managing and accounting for these consignment arrangements and any related tax implications, which may increase our operating expenses.
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 and any potential collaborators may be subject to federal, state and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state privacy and health information privacy laws and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements, including HIPAA. Depending on the facts and circumstances, we could be subject to civil or criminal penalties if we obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
International data protection laws, including Regulation 2016/679, known as the General Data Protection Regulation (“GDPR”), may also apply to health-related and other personal information obtained outside of the United States. The GDPR increased our responsibility and liability in relation to personal data that we process, and we may be required to put in place additional mechanisms to ensure compliance with the EU data protection rules (which also apply in the European Economic Area, or “EEA”) data protection rules. Likewise, after the United Kingdom’s (“UK”) separation from the EU, the UK retained the GDPR in UK law, which sits alongside the amended version of the Data Protection Act 2018, both of which have been recently modified by the Data (Use and Access) Act 2025. The EU adopted an adequacy decision so personal data can be transferred from the EU to the UK, which remains in force. Similarly, the UK deems transfers of personal data to the EU to be adequately protected. However, going forward, the EU and UK’s data protection rules could diverge, and data transfers may not be possible and/or new arrangements may need to be put in place. In particular, it is unclear when and to what extent the UK regime will begin diverging from the GDPR and how data transfers to and from the UK will be regulated in the future.
In addition, California enacted the California Consumer Privacy Act (“CCPA”), which creates individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households, and the CCPA was supplemented by the California Consumer Rights Act (“CPRA”). There are a number of other states that have considered similar privacy proposals, with states like Virginia and Colorado, among others, enacting their own privacy laws. Some states are also considering consumer health data privacy laws, with states like Washington and Nevada enacting such laws. In addition, the use of pixels and other website technologies increasingly are attracting attention from privacy regulators and private litigants, including under theories involving federal and state wiretap laws. These privacy laws may impact our business activities and exemplify the vulnerability of our business to the evolving regulatory environment related to personal data.
Further, the U.S. Department of Justice final rule implementing Executive Order 14117 (“Preventing Access to American’s Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern”) has taken effect, and it prohibits or restricts certain transactions involving access by “countries of concern” or “covered persons” to “government-related data” or “bulk U.S. sensitive personal data.” The final rule imposes certain diligence, security, and audit record-keeping obligations, among other requirements which could impact our business activities.
Compliance with U.S. and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions. Failure to comply with U.S. and international data protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation and adverse publicity and could negatively affect our operating results and business. Moreover, clinical trial subjects about whom we or our potential collaborators obtain information, as well as the providers who share this information with us, may contractually limit our ability to use and disclose the information. Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.
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.
We are a “smaller reporting company” as defined under the Exchange Act. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company for so long as (1) the market value of our common stock held by non-affiliates is less than $250 million as of the last business day of the second fiscal quarter, or (2) our annual revenues in our most recent fiscal year completed before the last business day of our second fiscal quarter are less than $100 million and the market value of our common stock held by non-affiliates is less than $700 million as of the last business day of the second fiscal quarter. To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible.
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