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: 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 3
Slide 4: Universally Implantable Regenerative Human Tissue
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, periphe
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 Todd M. Pope Diane Seimetz, PhD Max W
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
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 address major drawbacks of current treatment options: Vascular Trauma Injuries – Symvess Value Proposition Vein is the standard of care, but takes valuable time, dela
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 of Symvess Use 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 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. Symve
Slide 15: Durability of Symvess in Trauma 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 Trauma Repair Long-Term V005 Results1 Long-Term V017 Results2 • Trauma patients with battlefield injuries in Ukraine were f
Slide 16: Symvess Limb Salvage and Infections are Similar to Vein
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 treat
Slide 17: 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 18: Drivers of U.S. Commercial Launch in Vascular Trauma
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 p
Slide 19: 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 20: 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 21: 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 22: AV Access for Dialysis
22 AV Access for Dialysis
Slide 23: 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 ongoing V007 Phase 3 Trial • ~40% of fistulas fail to matu
Slide 24: 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 25: Partnered with Fresenius / Frenova Renal Research
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% incr
Slide 26: 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 27: V007 Superior Subgroup Results
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 paten
Slide 28: V007 Safety Results in Key Subgroup
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 Pa
Slide 29: V007 Two-Year Results in Female Patients
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
Slide 30: V012 (HUMAXX) Trial in Women Dialysis Patients
• 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
Slide 31: Peripheral Arterial Disease (PAD)
31 Peripheral Arterial Disease (PAD)
Slide 32: 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 32 Can progress to multiple l
Slide 33: 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 34: Expanded Access: Restoring Mobility with ATEV
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 a
Slide 35: Pipeline: CTEV for Coronary Bypass Graft Surgery
35 Pipeline: CTEV for Coronary Bypass Graft Surgery
Slide 36: Coronary Artery Bypass Grafting (CABG) Introduction
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 blockag
Slide 37: 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 38: Coronary Tissue Engineered Vessel (CTEV): Addressing an Unmet Need in Multivessel CABG
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 approx
Slide 39: Positive Patency Results in Animal Models
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 st
Slide 40: Primate – CABG Angiography – Adaptive Remodeling
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
Slide 41: Pipeline: BioVascular Pancreas
41 Pipeline: BioVascular Pancreas
Slide 42: 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 43: Drawbacks to Current Islet Transplantation Methods
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: cr
Slide 44: BioVascular Pancreas Solves the Islet Delivery Problem
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 exces
Slide 45: BVP Proof of Concept in a Rat Model
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 containin
Slide 46: BVP Cures Diabetes in a Rat Model
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 r
Slide 47: BVP NHP Preclinical Data
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 su
Slide 48: BVP in non-human primates – Excellent Islet Survival
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-
Slide 49: BVP Supports Long-Term Islet Survival in Primates
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 DA
Slide 50: Milestones
50 Milestones
Slide 51: Our Technology Targets Compelling Unmet Needs in Attractive Markets
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 C
Slide 52: 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 53: 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 54: The Promise of Regenerative Medicine
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
Slide 55: Thank You
Universally Implantable Regenerative Human Tissue Thank You