Humacyte, Inc. · NASDAQ:HUMA
Humacyte — Investor Presentation (June 2026)
55 slides from Humacyte's investor presentation, Jun 10, 2026
Slide 1: Universally Implantable Regenerative Human Tissue
Universally Implantable Regenerative Human Tissue
Slide 2: Disclaimer
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 ex
Slide 3: V012 Interim Results – Study Met Primary Endpoint
V012 Interim Results – Study Met Primary Endpoint • The ATEV met V012’s primary endpoint by demonstrating superior catheter-free days compared to arteriovenous fistula (AVF), the standard of care • 91 more catheter-free days for ATEV versus AVF • ATEV patients incurred 17 fewer dialysis access infec
Slide 4: Humacyte is a Leader in the Field of Regenerative Medicine
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 4
Slide 5: Humacyte Leadership & Board
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 Diane Seimetz, PhD Max Wallace, JD Su
Slide 6: Platform & Manufacturing: Enable Broad Pipeline of Regenerative Medicine Products
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 polym
Slide 7: Symvess Demonstrates Mechanical Strength and Remodeling with Patient’s Own Cells
Symvess Demonstrates Mechanical Strength and Remodeling with Patient’s Own Cells 7
Slide 8: Pipeline with Multiple Potential Commercial Launches
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
Slide 9: Vascular Trauma FDA Approved in Extremity Vascular Trauma
9 Vascular Trauma FDA Approved in Extremity Vascular Trauma Symvess acellular tissue engineered vessel-tyod
Slide 10: Symvess is FDA Approved in Extremity Vascular Trauma
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 adu
Slide 11: Vascular Trauma Injuries – Symvess Value Proposition
• Common causes of vascular injuries include workplace injuries, car accidents, gunshots and stabbings, and sports injuries • Symvess addresses major drawbacks of current treatment options: Vascular Trauma Injuries – Symvess Value Proposition Vein is the standard of care, but takes valuable time, de
Slide 12: Two Studies Were Used to Support FDA Approval
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 c
Slide 13: Ukraine Real World Experience in Vascular Repair
• 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
Slide 14: Clinical Improvement with Symvess over Synthetics
Clinical Improvement with Symvess over Synthetics Improved outcomes of Symvess compared to synthetic graft benchmark observed in two studies Symvess represents a new definitive and durable repair option in patients with extremity arterial injury when a vascular graft is needed and no vein is availab
Slide 15: Durability of Symvess in Injury Repair
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 Injury Repair Long-Term V005 Results1 Long-Term V017 Results2 • Trauma patients with battlefield injuries in Ukraine were f
Slide 16: U.S. Vascular Trauma Market – Total Addressable Market for Symvess
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 Iatrogeni
Slide 17: Drivers of U.S. Commercial Launch in Vascular Trauma
Drivers of U.S . C ommercial L aunch in Vas cular Trauma 17 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 Mod
Slide 18: Symvess in Extremity Injury: Savings in Hospital Charges
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 hosp
Slide 19: Symvess Budget Impact Model in Extremity Arterial Injury
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 ve
Slide 20: Department of Defense Support
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
Slide 21: Pipeline: AV Access for Dialysis
21 Pipeline: AV Access for Dialysis
Slide 22: AV Access for Hemodialysis Has Limitations
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 V007 and V012 Phase 3 Trials • ~40% of fistulas fail to ma
Slide 23: Access During the First Year: Too Many Catheters
Access During the First Year: Too Many Catheters! More than 80% of patients begin dialysis with a catheter. After 12 Months, many patients are still on a catheter – Fistulas and Synthetic Grafts Are Not Working for These Patients. USRDS 2025: Figure 4.8a, Chapter 4
Slide 24: Hospitalizations From Access Infections Each Year
Hospitalizations From Access Infections Each Year Annual Hospitalized Percentage for Each Access Type USRDS 2025: Figures 4.5a and 4.6, Chapter 4 Prevalent patients from Figure 1.12, Chapter 1 Assumes no more than 1 hospitalization per month per patient. 11,335 Patients hospitalized per year 22,671
Slide 25: Over 100,000 Hospitalizations Per Year for Hemodialysis Access Infections
> 100,000 Hospitalizations Per Year for Hemodialysis Access Infections: A Multi-Billion Dollar Problem for Insurers 1: Farrington, C.A. et al, Am J Nephrol 2019; 50: 126-132. 2: Cheng, T.W. et al, J Vasc Surg 2019; 70: 193-198. 3: Mohapatra, A., et al, J Vasc Surg 2021; 73: 581-587 Hemodialysis Cath
Slide 26: Women are Burdened with Infection-Prone Accesses
Women are Burdened with Infection-Prone Accesses 49.9% of women use an infection-prone access – half of all women on dialysis. Catheters cause more bloodstream infections; episodes of sepsis; metastatic infections; and hospitalizations. Catheters and infections substantially increase costs. USRDS 20
Slide 27: ATEV is Designed to Address Failures in AV Access
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
Slide 28: V007 Phase 3 Results in Dialysis Access
28 V007 Phase 3 Results in Dialysis Access
Slide 29: V007 Top-Line Results – ATEV Met Co-Primary Endpoints
• 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
Slide 30: V007 Superior Subgroup Results
30 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 paten
Slide 31: V007 Safety Results in Key Subgroup
31 V007 Safety Results in Key Subgroup ATEV has shown no increased safety events per year of usability in 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 Adv
Slide 32: V007 Two-Year Results in Female Patients
32 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
Slide 33: V012 Top-Line Interim Results
33 V012 Top-Line Interim Results ATEV for Dialysis Access in Women
Slide 34: CLN-PRO-V012: Phase 3 Study Designed to Address the Unmet Need in Women
CLN-PRO-V012: Phase 3 Study Designed to Address the Unmet Need in Women STUDY DESIGN Prospective · Multicenter · Open-Label · Randomized NCT05908084 | ClinicalTrials.gov | CLN-PRO-V012 PRE-SPECIFIED INTERIM ANALYSIS Follow-up Period 0 24 Months 6 12 18 n=80 patients enrolled Interim Analysis Trigger
Slide 35: V012 - Two Arms are Balanced in Baseline Characteristics
35 V012 - Two Arms are Balanced in Baseline Characteristics Characteristic ATEV (N=40) AVF (N=40) Age (Y), Mean (SD) 53.9 (16.6) 52.6 (16.9) Age > 65 years, N (%) 10 (25.0%) 11 (27.5%) Obese (BMI ≥ 30), N (%) 20 (50.0%) 19 (47.5%) Diabetes, N (%) 21 (52.5%) 20 (50.0%) Subject counts (N) are intent-t
Slide 36: V012 Met Primary Endpoint: 12-Month Catheter-Free Days
V012 Met Primary Endpoint: 12-Month Catheter-Free Days PRE - SPECIFIED PRIMARY ENDPOINT • 12 - MONTH CATHETER - FREE DAYS Statistically Significant p=0.00070 Pre-specified superiority threshold met Interim analysis: ATEV (N=40) vs AVF (N=40) TREATMENT DIFFERENCE 91 More catheter-Free Days in Year 1
Slide 37: V012 Primary Safety – Fewer Access Infections
V012 Primary Safety – Fewer Access Infections ATEV Observed to Have Reduced Dialysis Infection Rates 17 Less Dialysis Access Infections per 100 Patient-Years No hypothesis was pre-specified ATEV 2 events [6 / 100 patient years] AVF 9 events [23 / 100 patient years] ATEV: 2 subjects (5.1%) AVF: 6 sub
Slide 38: V012 Secondary Efficacy Analyses
38 V012 Secondary Efficacy Analyses Secondary Analyses ATEV (N=40) AVF (N=40) p-value 1. Six-Month Catheter-Free Days 88.4 days 32.3 days 0.00009 2. 12-Month Functional Patency 250.1 days 151.7 days 0.00057 3. Six-Month Secondary Patency 87.5% 65.0% 0.0013 4. 12-Month Secondary Patency 77.5% 62.5% 0
Slide 39: V012 Interim Safety Results
39 V012 Interim Safety Results Overall benefit-risk safety profile of ATEV is favorable with no new or unexpected safety concerns identified 12-Month Safety Summary ATEV (n=39) AVF (n=40) % of Subjects Events Events per Patient Year of Use % 0f Subjects Events Events per Patient Year of Use Treatmen
Slide 40: V012 Interim Results Summary
V012 Interim Results Summary • The ATEV met V012’s primary endpoint by demonstrating superior catheter-free days compared to AVF, the current standard of care • 91 more catheter-free days than AVF (p=0.0007) • ATEV patients incurred 17 fewer dialysis access infections than AVF per 100 patient years,
Slide 41: Pipeline: Peripheral Arterial Disease (PAD)
41 Pipeline: Peripheral Arterial Disease (PAD)
Slide 42: Peripheral Artery 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 42 Can progress to multiple l
Slide 43: Current Clinical Experience with ATEV in Peripheral Arterial Disease
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. 202
Slide 44: Pipeline: CTEV for Coronary Bypass Graft Surgery
44 Pipeline: CTEV for Coronary Bypass Graft Surgery
Slide 45: Coronary Artery Bypass Grafting (CABG) Introduction
45 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 blockag
Slide 46: Concerns with Saphenous Vein Grafts
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
Slide 47: Coronary Tissue Engineered Vessel (CTEV): Addressing an Unmet Need in Multivessel CABG
47 Coronary Tissue Engineered Vessel (CTEV): Addressing an Unmet Need in Multivessel CABG • The CTEV is designed to be a first-of-its-kind, sterile, off-the- shelf human-derived vessel that requires no preparation, is non-immunogenic, and resist infection. • The CTEV has an inner diameter of 3.5 mm
Slide 48: Non-Human Primate CABG Out To Months
48 Non-Human Primate CABG Out To 6 Months
Slide 49: Remodeling of CABG Conduit in Non-Human Primates
Remodeling of CABG Conduit in Non-Human Primates
Slide 50: Pipeline: BioVascular Pancreas
50 Pipeline: BioVascular Pancreas
Slide 51: The BioVascular Pancreas (BVP)
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 Acellul
Slide 52: Milestones
52 Milestones
Slide 53: Commercial Manufacturing Scale – LUNA200 System
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
Slide 54: Anticipated 2026 Milestones
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
Slide 55: Thank You
Universally Implantable Regenerative Human Tissue Thank You