Humacyte, Inc. · NASDAQ:HUMA
Humacyte — Investor Presentation (February 2024)
41 slides from Humacyte's investor presentation, Feb 29, 2024
Slide 1: Universally Implantable Regenerative Human Tissue
Universally Implantable Regenerative Human Tissue 1 Exhibit 99.1
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
3 Humacyte is a Leader the Field of Regenerative Medicine: Investigational 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
Slide 4: Universally Implantable Regenerative Human Tissue
4 Universally Implantable Regenerative Human Tissue Potential First-in-Class Technology & Manufacturing Platform Large addressable markets (trauma, dialysis, peripheral artery disease, diabetes, coronary bypass) Nearing Potential Market Launch BLA granted Priority Review by FDA in February 2024 for
Slide 5: Humacyte Leadership & Board
5 Humacyte Leadership & Board Leadership Team Board of Directors Kathleen Sebelius Chair of the Board Gordon M. Binder Emery N. Brown, MD, PhD Michael T. Constantino Brady W. Dougan Charles Bruce Green, MD Laura E. Niklason, MD, PhD Todd M. Pope Diane Seimetz, PhD Rajiv Shukla Max Wallace, JD Susan
Slide 6: Platform & Manufacturing: Enable Broad Pipeline of Regenerative Medicine Products
6 Platform & Manufacturing: Enable Broad Pipeline of Regenerative Medicine Products Vascular tissue constructs (HAV) 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 poly
Slide 7: Pipeline with Multiple Potential Commercial Launches
7 Pipeline with Multiple Potential Commercial Launches Preclinical Phase 1/2 Phase 3 Vascular Tissue Constructs (HAV) Trauma Dialysis (AV Access) PAD Pediatric Heart Disease CABG Complex Tissue Constructs Urinary Conduit Tracheal Replacement Esophageal Replacement Complex Organ Systems BioVascular P
Slide 8: HAV Observed to Repopulate with Patient's Own Cells
HAV Observed to Repopulate with Patient’s Own Cells Potentially Enabling Infection Resistance & Self-Healing More than 500 patients across multiple indications 250 µm αS MA DAP I L umen HAV wall Adventitial layer C apillaries S MC s Host cells observed to repopulate the HAV1 HAV may have the ability
Slide 9: Vascular Trauma
9 Vascular Trauma
Slide 10: Vascular Injuries – Value Proposition for the HAV
10 • Common causes of vascular injuries include workplace injuries, car accidents, gunshots and stabbings, and sports injuries • Currently available treatment options have significant drawbacks: Vascular Injuries – Value Proposition for the HAV 1. Vein is the standard of care, but causes injury from
Slide 11: Why HAV for Traumatic Vascular Injury?
11 • HAV is off the shelf and immediately available for implant • In contrast to harvesting vein from the patient which can take an hour 1 • HAV repopulates with the patient’s cells, becoming a living tissue 2 • HAV is resistant to infection, compared to synthetic grafts 3 Why HAV for Traumatic Vasc
Slide 12: HAV in Vascular Trauma: V005 Phase 2/3 Pivotal Trial
12 > Historical Benchmarks > Systematic literature review of synthetics in vascular trauma > Primary Comparison > 30-day endpoint of patency > Secondary Comparisons > Infection rate > Amputation rate Success Criteria > Comparable (or higher) Patency > Infection rate comparable or lower than Syntheti
Slide 13: Example Vascular Injuries Treated in CLN-PRO-V005 Trial
13 Example Vascular Injuries Treated in CLN-PRO-V005 Trial Industrial Accident Knee DislocationGunshot Wound
Slide 14: V005 Trial: HAV vs Synthetic Graft Benchmarks
14 Observations from V005 trial: Secondary Patency • HAV performed better than historic benchmark Conduit Infections • HAV point estimate lower than historic benchmark Amputations • HAV performed better than historic benchmark V005 Trial: HAV vs Synthetic Graft Benchmarks Endpoint HAV Extremit
Slide 15: Ukraine Real World Experience of HAV Use in Vascular Repair
15 • 19 patients received a HAV • 17 consented for data collection and study participation • 16 patients had extremity trauma repair; one patient required HAV for Iatrogenic Trauma Repair • Ukraine Humanitarian Experience presented at MHSRS1 2023 Annual meeting on August 14th 2023 Ukraine Real World
Slide 16: HAV Combined Results from V005 and V017 Trials
16 Observations from combined V005 and V017 trials: Secondary Patency • HAV performed better than historic benchmark Conduit Infections • HAV performed better than historic benchmark Amputations • HAV performed better than historic benchmark HAV Combined Results from V005 and V017 Trials End
Slide 17: Priority Review of BLA and Planned Market Launch
17 Priority Review of BLA and Planned Market Launch • BLA submitted to FDA in December 2023 • Priority Review granted by FDA in February 2024 • PDUFA date of August 10, 2024 • Factors supporting Priority Review: • In May 2023 the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation
Slide 18: AV Access for Dialysis
18 AV Access for Dialysis
Slide 19: AV Access for Hemodialysis Has Substantial Limitations
19 AV Access for Hemodialysis Has Substantial Limitations Estimates of Access (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 fi
Slide 20: HAV is Designed to Address Failures in AV Access
Reduce Costs from Infection HAV is Designed to Address Failures in AV Access Lawson, J.H, et al, The Lancet 2016; 387: 2026-2034. Halbert, R.J., et al, Kidney360 2020; doi: 10.34067/KID.003502020 • HAV usable for dialysis after only four weeks • HAV reduces catheter contact time, thereby reducing ri
Slide 21: Phase 3 Trial in Dialysis: HAV vs. Fistula
21 > 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. > Timelines > Top-line readout expected in 2024 (12-month follow- up from la
Slide 22: Supportive Data From Completed Phase 2 & 3 Studies of HAV
Supportive Data From Completed Phase 2 & Phase 3 Studies of HAV 1. Woods ide, K enneth J ., et. Al, American J ournal of K idney Dis eas es , Volume 71, Is s ue 6, 2018, P ages 793-801 2. Allon, M., et al. American J K idney Dis eas e 2018; 71: 677-689 3. Arhuides e, et al, 2018; J VS 4. L ok, et al
Slide 23: Peripheral Arterial Disease (PAD)
23 Peripheral Arterial Disease (PAD)
Slide 24: 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 24 Can progress to multiple l
Slide 25: Current Clinical Experience with HAV in Peripheral Arterial Disease
Current Clinical Experience with HAV in Peripheral Arterial Disease 25 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. 2
Slide 26: Expanded Access Case Study: Restoring Mobility with HAV
26 Expanded Access Case Study: Restoring Mobility with HAV • The HAV 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-t
Slide 27: Pipeline: Cardiac Bypass
27 Pipeline: Cardiac Bypass
Slide 28: 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 29: CABG Preclinical Results
CABG Preclinical Results 29 • Testing of HAV in baboon model has transitioned to right coronary artery (RCA) as distal target • Results showing HAV maintained patency and exhibited host-cell remodeling through six months Next Steps in CABG Development Proceeding to IND enabling non- clinical studies
Slide 30: Primate – CABG Angiography – Adaptive Remodeling
30 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%
Slide 31: Pipeline: BioVascular Pancreas
31 Pipeline: BioVascular Pancreas
Slide 32: Biovascular Pancreas May Deliver Curative Islets to Diabetics
32 Biovascular Pancreas May Deliver Curative Islets to Diabetics • Islets die after injection into the liver, due to lack of oxygen and nutrients • Humacyte’s HAV is being developed as a means to provide oxygen and nutrients to islets that are coated on the outside: “Biovascular Pancreas” (BVP) • On
Slide 33: 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 33 Transplant BVP into Vasculature 0 50 100 0 200 400 600 Blood Glucose Levels Day Bl oo d G
Slide 34: Primate BVP – Islets Survive, and Produce Insulin
Primate BVP – Islets Survive, and Produce Insulin 34 • In this model, the BVP is produced by harvesting islets from one animal, and creating a BVP comprising human HAV and primate islets • Animal receives the primate-islet BVP into the aorta • 25,600 islet equivalents • Corresponds to a potentially
Slide 35: Anticipated Path to Market
35 Anticipated Path to Market
Slide 36: Our Technology Addresses Compelling Unmet Needs in Attractive Markets
36 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 Const
Slide 37: Preparing for Strong Commercial Launch
37 Preparing for Strong Commercial Launch Majority of trauma vascular repair performed at Level 1 centers Approximately 200 level 1 trauma centers in U.S. Clear call point as majority of cases performed by vascular surgeons Humacyte expects DoD to stockpile for deployment to sites of conflicts Compe
Slide 38: Commercial Manufacturing Scale – LUNA200 System
38 Commercial Manufacturing Scale – LUNA200 System Commercial 83,000 sq ft Bioprocessing Facility • Currently operating 8 LUNA200 systems • Annual Capacity expected to exceed 40,000 HAVs • Functionally closed system with state-of-the-art process automation Bioreactor bag Each bioreactor bag contains
Slide 39: Anticipated 2024 Milestones
39 Anticipated 2024 Milestones Vascular Trauma (HAV): • BLA filing acceptance by FDA • FDA approval • U.S. commercial launch Top-line results V007 HAV dialysis (AV Access) Phase 3 trial Publication of Mayo Clinic HAV Phase 2 trial results in severe PAD All milestone dates are only management estimat
Slide 40: The Promise of Regenerative Medicine
40 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 commerci
Slide 41: Thank You
Universally Implantable Regenerative Human Tissue Thank You 41