Slide 1: Universally Implantable Regenerative Human Tissue
Universally Implantable Regenerative Human Tissue
Slide 2: Disclaimer
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 expe
Slide 3: V012 Interim Results – Study in Women Met Primary Endpoint
V012 Interim Results – Study in Women 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 Statistically Significant • ATEV patients incu
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 Prior Experience Kathleen Sebelius Chair of the Board Laura E. Niklason, MD, PhD Dale Sander Chief Financial Officer, John P. Bamforth, PhD Founder, President, Chief Corporate Chief Executive Officer Development Officer Emery N. Brown, M
Slide 6: Platform & Manufacturing
Platform & Manufacturing: Enable Broad Pipeline of Regenerative Medicine Products Bioengineering Platform Commercial-Scale Manufacturing 1 Cells transferred onto polymer Cell Working cell stock mesh seeding 2 Cells proliferate & Polymer mesh degrades, leaving Tissue build extracellular matrix vascul
Slide 7: Symvess Demonstrates Mechanical Strength and Remodeling with Patient's Own Cells
Symvess Demonstrates Mechanical Strength and Remodeling with Patient’s Own Cells 77
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 Approved by FDA Dialysis (AV Access) V007 Phase 3 Trial Met Co-Primary Endpoints ATEV Dialysis (AV Access) V012 Phase 3 Trial in Women – Met Primary Interim Endpoint PAD Phas
Slide 9: Symvess
Symvess acellular tissue engineered vessel-tyod FDA Approved in Extremity Vascular Trauma Vascular Trauma 9
Slide 10: Symvess is FDA Approved in Extremity Vascular Trauma
Symvess is FDA Approved in Extremity Vascular Trauma Repopulates with Low susceptibility No immune response Off-the-shelf, Low amputation the patient’s cells1-2,3 to infection4 observed1-3,5 ready to use1,3 results1 INDICATION SYMVESS is an acellular tissue engineered vessel indicated for use in adu
Slide 11: Vascular Trauma Injuries – Symvess Value Proposition
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: Amputation Symvess is immediately available, off-the-shel
Slide 12: Two Studies Were Used to Support FDA Approval
Two Studies Were Used to Support FDA Approval First Study: CLN-PRO-V005 Phase 2/3 Pivotal Trial In U.S. and Israel • Single-arm, open label study • 69 patients enrolled as of data cut off • Conducted at Level 1 trauma centers • As agreed upon with FDA, focus for BLA filing was 51 patients with extre
Slide 13: Ukraine Real World Experience in Vascular Repair
Ukraine Real World Experience in Vascular Repair Second Study: V017 Humanitarian Program in Ukraine • 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
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 Clinical Data Symvess represents a new definitive and durable repair option in patients with extremity arterial injury when a vascular graft is needed and no v
Slide 15: Durability of Symvess in Injury Repair
Durability of Symvess in Injury Repair Long-Term V005 Results1 Long-Term V017 Results2 After up to 36 months of follow-up, patients • Trauma patients with battlefield demonstrated: injuries in Ukraine were • High rates of limb salvage followed for up to 18 months. • Low rates of infection • No unpro
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 Target U.S. TAM for Symvess (All Injuries)1 Based on Hospital Claims Data2 79,000 26,000 Emergent Vascular Trauma – 56,000 Emergent Vascular Trauma – 18,667 Iatrogenic Vascular Trauma – 23,000 Iatrogeni
Slide 17: Drivers of U.S. Commercial Launch in Vascular Trauma
Drivers of U.S . C ommerc ial L aunc h in Vas c ular T rauma Concentrated Market Approximately 200 Level 1 Symvess Strong Clinical Results In the civilian and military clinical trauma centers in U.S. studies, Symvess was observed acellular tissue to have high rates of patency Approximately 3,000 vas
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 Additional hospital charges associated charges associated with each vascular wi
Slide 19: Symvess Budget Impact Model in Extremity Arterial Injury
Symvess Budget Impact Model (BIM) in Extremity Arterial Injury Published in J Med Econ, showed use of At its current price point of $17,000, Symvess was shown to be the second-most economical arterial Symvess in patients without feasible graft, after saphenous vein1 Healthcare Economics saphenous ve
Slide 20: Department of Defense Support
Department of Defense Support The Department of Defense (DoD) invested in Symvess in recognition of its benefit in battlefield injuries for warfighters DEPARTMENT OF DEFENSE SUPPORT Symvess (ATEV) for Vascular Trauma designated as a “Priority Product” by DoD • designation created by Public Law 115-9
Slide 21: Pipeline: AV Access for Dialysis
Pipeline: AV Access for Dialysis 21
Slide 22: Incident Patients With End-Stage Kidney Disease
Incident Patients With End-Stage Kidney Disease Every year, more than 100,000 people start hemodialysis. Most patients start hemodialysis on a catheter. 22 USRDS 2025: Chapter 1, Figures 1.1 and 1.3
Slide 23: AV Access for Hemodialysis Has Limitations
AV Access for Hemodialysis Has Limitations Estimate of Permanent Access Limitations of AV Fistulas Procedures Performed in U.S. (Current Standard of Care) ~60% AV fistulas Primary/AV Fistula (Autogenous) Market targeted by V007 and V012 Phase 3 Trials ~20% Catheters Venous / Temporary Catheter • ~40
Slide 24: 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. 24 USRDS 2025: Figure 4.8a, Chapter 4
Slide 25: Hospitalizations From Access Infections Each Year
Hospitalizations From Access Infections Each Year Annual Hospitalized Percentage for Each Access Type Though less than half of accesses one year after starting dialysis, Catheters and Synthetic Grafts together account for ≈90% of infections. 11,335 22,671 73,680 Patients Patients Patients hospitaliz
Slide 26: Over 100,000 Hospitalizations Per Year for Access Infections
> 100,000 Hospitalizations Per Year for Hemodialysis Access Infections: A Multi-Billion Dollar Problem for Insurers Hemodialysis Catheter Infections 1.3 Synthetic Graft Infections 2,3 Hospitalization rate ~ 60%/patient-year > 70,000 hospitalizations per year Hospitalization rate ~ 27%/patient-year A
Slide 27: 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. 27 USRDS
Slide 28: ATEV is Designed to Address Failures in AV Access
ATEV is Designed to Address Failures in AV Access ATEV provides potential for improved patient outcomes • ATEV usable for dialysis after only four weeks • ATEV reduces catheter contact time, thereby reducing risk of catheter infection Strategic collaboration with FMC, the largest provider of • > 80%
Slide 29: V007 Phase 3 Results in Dialysis Access
V007 Phase 3 Results in Dialysis Access 29
Slide 30: V007 Top-Line Results – ATEV Met Co-Primary Endpoints
V007 Top-Line Results – ATEV Met Co-Primary Endpoints • Subjects with end-stage renal disease in need ATEV of dialysis Single-stage AV • Enrollment completed April 2023, 242 total Fistula subjects ATEV was observed to have superior function and patency at six and 12 months (co-primary endpoints) com
Slide 31: V007 Superior Subgroup Results
V007 Superior Subgroup Results ATEV showed superior function and patency in subgroups with historically poor outcomes 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 Mo
Slide 32: V007 Safety Results in Key Subgroup
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 ATEV AVF Events 12-Month Safety Summary per Events per Subjects Patient Subjects Patient (%) n=54 Year (%) n=56 Year Treatment Emergent Advers
Slide 33: V007 Two-Year Results in Female Patients
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 33
Slide 34: V012 Top-Line Interim Results
V012 Top-Line Interim Results ATEV for Dialysis Access in Women 34
Slide 35: 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 PRE-SPECIFIED INTERIM ANALYSIS Follow-up Period Prospective · Multicenter · Open-Label · Randomized 0 6 12 18 24 Months n=80 patients enrolled 150 patient ATEV enrollment target Interim Analysis Trigger 1:1 Superior
Slide 36: V012 - Two Arms are Balanced in Baseline Characteristics
V012 - Two Arms are Balanced in Baseline Characteristics ATEV AVF Characteristic (N=40) (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-to-t
Slide 37: 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 TREATMENT DIFFERENCE 91 More Catheter-Free Days in Year 1 95% CI: 39.8 – 142.4 Statistically Significant p=0.00070 ATEV 220.4 A V F 129.3 Pre-specified superiority threshold met Interi
Slide 38: V012 – ATEV Superior Rate of Maturation
V012 – ATEV Superior Rate of Maturation The ATEV matured faster and a higher rate than AVF Earlier and more consistent ATEV (HAV) maturation AVF means less time on catheter 38
Slide 39: 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 ATEV 2 events [6 / 100 patient years] AVF 9 events [23 / 100 patient years] No hypothesis was pre-specified ATEV: 2 subjects (5.1%) AVF: 6 sub
Slide 40: V012 Secondary Efficacy Analyses
V012 Secondary Efficacy Analyses ATEV was observed to have consistent advantages over AVF 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
Slide 41: V012 Interim Safety Results
V012 Interim Safety Results Overall benefit-risk safety profile of ATEV is favorable with no new or unexpected safety concerns identified ATEV (n=39)(PYU1=26.6) AVF (n=40)(PYU=15.7) Events per Events per 12-Month Safety Summary Patient Year Patient Year % of of Use % of of Use Subjects Events (ETUY2
Slide 42: 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 43: Pipeline: Peripheral Arterial Disease (PAD)
Pipeline: Peripheral Arterial Disease (PAD) 43
Slide 44: Peripheral Artery Disease (PAD)
Peripheral Artery Disease (PAD) Critical Limb Threatening Treatment Requires Ischemia Restoration of Blood Flow • Tissue does not receive enough • Non-surgical, catheter-based Can progress to multiple leg blood flow to survive intervention arteries, further reducing • If untreated, leads to tissue l
Slide 45: Current Clinical Experience with ATEV in Peripheral Arterial Disease
Current Clinical Experience with ATEV in Peripheral Arterial Disease • Six-year results from V002 published Phase 2 • V002 – 20 patients (EU) in Journal of Vascular Surgery – Trials • V004 – 15 patients (US) Vascular Science1 Over 20 U.S. patients with critical limb • Publication of First Eight Expa
Slide 46: Pipeline: CTEV for Coronary Bypass Graft Surgery
Pipeline: CTEV for Coronary Bypass Graft Surgery 46
Slide 47: Coronary Artery Bypass Grafting (CABG)
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
Slide 48: Concerns with Saphenous Vein Grafts
Concerns with Saphenous Vein Grafts Vein Quality Issues Harvest-Related Morbidity • Varicosities (20-30% of patients) • Wound complications (5-10%) • Previous vein stripping or ablation • Leg edema and pain • Small diameter (<3mm) • Infection risk • Sclerotic or diseased veins • Nerve injury (saphen
Slide 49: Coronary Tissue Engineered Vessel (CTEV): Addressing an Unmet Need in Multivessel CABG
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 and
Slide 50: Non-Human Primate CABG Out To 6 Months
Non-Human Primate CABG Out To 6 Months 50 50
Slide 51: Remodeling of CABG Conduit in Non-Human Primates
Remodeling of CABG Conduit in Non-Human Primates 51
Slide 52: Pipeline: BioVascular Pancreas
Pipeline: BioVascular Pancreas 52
Slide 53: The BioVascular Pancreas (BVP)
The BioVascular Pancreas (BVP) Acellular Tissue Engineered Vessel (ATEV) is implanted in the arm 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
Slide 54: Milestones
Milestones 54
Slide 55: Commercial Manufacturing Scale – LUNA200 System
Commercial Manufacturing Scale – LUNA200 System Bioreactor bag Growth drawer LUNA200 System Each bioreactor 10 bioreactor bags Each LUNA200 can bag contains a per growth drawer; produce 200 ATEVs single polymer tubing connects to per batch (or mesh scaffold, shared nutritive ~1,000 ATEVs seeded with
Slide 56: Anticipated 2026 Milestones
Anticipated 2026 Milestones Completed in 2025 Planned for 2026 Vascular Trauma - Symvess: Vascular Trauma (Symvess): CABG (CTEV): • U.S. commercial launch • U.S. commercial launch growth • Commencement of first-in-human study • Long-term results showing • Expansion into international • First patient
Slide 57: Thank You
Universally Implantable Regenerative Human Tissue Thank You