Humacyte, Inc. · NASDAQ:HUMA
Humacyte — Investor Presentation (March 2025)
52 slides from Humacyte's investor presentation, Mar 25, 2025
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 Universally implantable with no immuno-suppression Observed to regenerate as the patient’s own tissue Category-Defining Innovation that Creates New Tissues 3
Slide 4: U.S. Market Launch Q1 2025
Universally Implantable Regenerative Human Tissue U.S. Market Launch Q1 2025 FDA approved Symvess (ATEV ) BLA in December 2024 for treatment of extremity vascular trauma; U.S. market launch commenced Q1 2025 First-in-Class Technology and Manufacturing Platform Large addressable markets trauma, dialy
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: Pipeline with Multiple Potential Commercial Launches
Pipeline with Multiple Potential Commercial Launches Preclinical Phase 1/2 Phase 3 Approved Vascular Tissue Constructs (ATEV) Trauma Dialysis (AV Access) PAD Pediatric Heart Disease CABG Complex Tissue Constructs Urinary Conduit Tracheal Replacement Esophageal Replacement Complex Organ Systems BioVa
Slide 8: ATEV Observed to Repopulate with Patient's Own Cells
ATEV Observed to Repopulate with Patient’s Own Cells Potentially Enabling Infection Resistance & Self-Healing Over 600 patients across multiple indications 250 µm αS MA DAPI Lumen AT E V wall Adventitial layer C apillaries S MC s Host cells observed to repopulate the ATEV1 ATEV may have the ability
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: Symvess Value Proposition in Vascular Trauma Injuries
• 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: 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 included in BLA filing • 17 consented for data collection and study participation • 16 patients had
Slide 14: Symvess Performed Better than Synthetic Graft Benchmark
14 • Benchmark for Symvess efficacy was the published performance of prosthetic grafts1 • Data from V005 and V017 and the benchmark were included in the BLA file, supporting Symvess approval Symvess Performed Better than Synthetic Graft Benchmark Outcome Day 30 Symvess V005 (n=51)1 Symvess V017 (n=1
Slide 15: Symvess was Durable in Trauma Repair in V005 and V017 Studies
15 • Function of Symvess is durable over 36 months of observation in trauma repair • Zero reports of late infection, aneurysm, or mechanical failure Symvess was Durable in Trauma Repair in V005 and V017 Studies1 1Moore EE, et al. Bioengineered Human Arteries for the Repair of Vascular Injuries. JAMA
Slide 16: Symvess Compares Well to Autologous Vein
16 • Symvess was compared to Prospective Observational Vascular Injury Trial (PROOVIT) registry • NOT a head-to-head study. 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
Slide 17: Vascular Trauma: Commercial Launch in Extremity Vascular Trauma
17 Vascular Trauma Commercial Launch in Extremity Vascular Trauma Symvess acellular tissue engineered vessel-tyod
Slide 18: 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 19: Drivers of U.S. Commercial Launch in Vascular Trauma
Drivers of U.S. Commercial Launch in Vascular Trauma 19 The Right Team Sales team of ten 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
Slide 20: Symvess Pricing Supported by Budget Impact Model
• A Budget Impact Model supporting Symvess economic benefit was based on: • Symvess clinical results • Estimated reduction in clinical complications • Medical costs incurred by hospitals derived from real-world hospital and claims databases • The per-patient cost of treating patients with Symvess is
Slide 21: NTAP Reimbursement and CMS Progress
21 NTAP Reimbursement And CMS Progress NTAP Implications • Enables additional payment to hospitals, specifically for ATEV usage in Medicare beneficiaries • Also provides a benchmark payment for Medicaid and private payers to imitate • Covers up to 65% of the cost of ATEV and is active for 2 to 3 yea
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 on Unmet Needs
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 Phase 3 Trial: ATEV vs. Fistula
> Endpoints > Efficacy: Useability for dialysis and patency during the first year > Safety: interventions, infections, etc. > Duration > Subjects followed for 24 months after implantation > Sites > 30 centers in the U.S. V007 Phase 3 Trial: ATEV vs. Fistula V007 Phase 3 Trial Design: Compare the Eff
Slide 27: 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 serious events occurred more frequently in the AVF arm: • Two ruptures of AVF (a potentially fatal eve
Slide 28: V007 Superior Subgroup Results
28 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 29: V007 Superior Subgroup Results (continued)
29 V007 Superior Subgroup Results (continued) Diabetic ATEV (N=82) AVF (N=83) p-value Functional Patency at Month 6 81.7% 61.4% 0.0024 Secondary Patency at Month 12 68.3% 59.0% Difference p-value Duration of Use Over First 12 Months 7.4 months 5.5 months 1.9 months 0.0155 Females, and males with BMI
Slide 30: V007 Long-Term Results in Key Subgroup
30 V007 Long-Term Results in Key Subgroup ATEV has shown superior long-term patency to date in the expected target population (all females and males with BMI ≥ 30 kg/m2 and diabetes) The 24-month results reflect data from the 70% of patients who had reached their 24-month visit as of 12-month data c
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 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 32: V012 (HUMAXX) Trial in Women Dialysis Patients
• Enrollment: • Target 150 total subjects (interim analysis after 80 patients) • 60 patients enrolled as of December 31, 2024 • 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
Slide 33: Strategic Value of V012 Study
Women are 43% of the US dialysis population and many struggle with access V012 was designed in consultation with nephrologists and FDA to quantify value of ATEV vs. AVF for women • V012 is focused on catheter exposure in women: • Captures failures of AVFs • Catheters are the most expensive access fo
Slide 34: Planned Supplemental BLA Strategy
Our current thinking, subject to modification based on FDA discussions… • 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, an
Slide 35: Peripheral Arterial Disease (PAD)
35 Peripheral Arterial Disease (PAD)
Slide 36: 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 36 Can progress to multiple l
Slide 37: 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 38: 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 39: Pipeline: Cardiac Bypass
39 Pipeline: Cardiac Bypass
Slide 40: Potentially Transforming CABG Care: Greater Durability, Less Morbidity
• Does not require tissue harvest from the patient • Immediately available and avoids morbidity of vein harvest • Particularly important to avoid vein harvest in diabetics, women, and the overweight • Durable and highly uniform in diameter and quality Potentially Transforming CABG Care: Greater Dura
Slide 41: CABG Preclinical Results
CABG Preclinical Results 41 • Testing of ATEV in baboon model has transitioned to right coronary artery (RCA) as distal target • Results showing ATEV maintained patency and exhibited host-cell remodeling through six months Next Steps in CABG Development Proceeding to IND enabling non-clinical studie
Slide 42: 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% 42
Slide 43: Pipeline: BioVascular Pancreas
43 Pipeline: BioVascular Pancreas
Slide 44: Biovascular Pancreas May Deliver Curative Islets to Diabetics
Biovascular Pancreas May Deliver Curative Islets to Diabetics • Islets die after injection into the liver, due to lack of oxygen and nutrients • Humacyte’s ATEV is being developed as a means to provide oxygen and nutrients to islets that are coated on the outside: “Biovascular Pancreas” (BVP) • Once
Slide 45: Biovascular Pancreas Normalized Glucose in Diabetic Animals
Biovascular Pancreas Normalized Glucose in Diabetic Animals • Diabetic rodents implanted with BVPs • All treated animals normalized glucose over time. All sham-treated animals (“No Flow”) remained diabetic 45 Transplant BVP into Vasculature 0 50 100 0 200 400 600 Blood Glucose Levels Day Blood Gluco
Slide 46: Primate BVP – Islets Survive, and Produce Insulin
Primate BVP – Islets Survive, and Produce Insulin • In this model, the BVP is produced by harvesting islets from one animal, and creating a BVP comprising human ATEV and primate islets • Animal receives the primate-islet BVP into the aorta • 25,600 islet equivalents • Corresponds to a potentially cu
Slide 47: Milestones
47 Milestones
Slide 48: Our Technology Addresses Compelling Unmet Needs in Attractive Markets
Our Technology Addresses Compelling Unmet Needs in Attractive Markets Pre-Clinical Trachea Pancreas Esophagus Urinary Conduit Lung Peripheral Arterial Disease (PAD) Vascular Trauma Dialysis AV Access Coronary Artery Bypass Graft (CABG) BT Shunt Clinical Programs Pre-Clinical Vascular Tissue Construc
Slide 49: 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 50: Anticipated 2025 Milestones
Anticipated 2025 Milestones Vascular Trauma (Symvess): • U.S. commercial launch • Multiple publications including Budget impact model • NTAP reimbursement ATEV dialysis (AV Access): • Completion of enrollment in V012 Phase 3 trial in women • Publication of V007 Phase 3 results All milestone dates ar
Slide 51: 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 52: Thank You
Universally Implantable Regenerative Human Tissue Thank You