Humacyte, Inc. · NASDAQ:HUMA
Humacyte — Investor Presentation (January 2022)
37 slides from Humacyte's investor presentation, Jan 10, 2022
Slide 1: Humacyte, Inc. Universally Implantable Regenerative Human Tissue
1 Humacyte, Inc. 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: Leading Regenerative Medicine with Bioengineered Human Tissues and Organs
3 LEADING REGENERATIVE MEDICINE WITH THE DEVELOPMENT OF BIOENGINEERED HUMAN TISSUES AND ORGANS OFF-THE-SHELF REGENERATES AS THE PATIENTS’ OWN TISSUE UNIVERSALLY IMPLANTABLE WITH NO IMMUNO- SUPPRESSION CATEGORY-DEFINING INNOVATION DESIGNED TO TRANSFORM THE TREATMENT OF LIFE-THREATENING INJURIES AND D
Slide 4: Humacyte: The Promise of Regenerative Medicine
4 HUMACYTE: THE PROMISE OF REGENERATIVE MEDICINE ▪ Broad platform of universally implantable bioengineered human tissues ▪ Markets estimated to exceed $150 billion: ▪ Dialysis, peripheral artery disease, trauma, diabetes, coronary bypass ▪ First company to receive FDA RMAT designation. DOD priority
Slide 5: Platform and Manufacturing Enable Broad Pipeline of Regenerative Medicine Products
5 Vascular tissue constructs (HAV) Complex tissue constructs Complex organ systems PLATFORM AND MANUFACTURING ENABLE BROAD PIPELINE OF REGENERATIVE MEDICINE PRODUCTS OUR PLATFORM ENABLES DEVELOPMENT OF A BROAD RANGE OF PRODUCTS Bioengineering Platform Enables creation of universally implantable tiss
Slide 6: Our Pipeline Addresses Extensive Market Opportunities
6 OUR PIPELINE ADDRESSES EXTENSIVE MARKET OPPORTUNITIES Vascular Tissue Constructs Complex Tissue Constructs and Organ Systems PRE-CLINICAL CLINICAL PROGRAMS Vascular Trauma Peripheral Arterial Disease (PAD) Dialysis AV Access Coronary Artery Bypass Graft (CABG) Trachea Pancreas Esophagus Urinary Co
Slide 7: Pipeline with Multiple Potential Commercial Launches
7 PIPELINE WITH MULTIPLE POTENTIAL COMMERCIAL LAUNCHES All milestone dates are only management estimates based on currently available data Preclinical Phase 1/2 Phase 3 Vascular Tissue Constructs (HAV) Trauma AV Access PAD Pediatric Heart Disease CABG Complex Tissue Constructs Urinary Conduit Trache
Slide 8: Vascular Tissue Constructs: Human Acellular Vessel (HAV)
8 Vascular Tissue Constructs: HUMAN ACELLULAR VESSEL (HAV)
Slide 9: Potential Benefits of HAVs in Completed and Ongoing Clinical Trials
9 POTENTIAL BENEFITS OF HAVS IN COMPLETED AND ONGOING CLINICAL TRIALS IN MORE THAN 460 PATIENTS ACROSS MULTIPLE INDICATIONS Off-the-shelf, immediately available with 18-month shelf life No evidence of immunogenicity Long-term durability Multiple diameters and lengths
Slide 10: HAV Repopulates with the Patient's Own Cells
10 HAV REPOPULATES WITH THE PATIENT’S OWN CELLS, POTENTIALLY ENABLING INFECTION RESISTANCE AND SELF-HEALING HAV is highly resistant to infection Host cells repopulate the HAV 250 µm αSMA DAPI Lumen HAV wall Adventitial layer Capillaries SMCs HAV may have the ability to self-heal after host cell repo
Slide 11: HAV Repair of Vascular Trauma Phase 2/3 Trial Underway
11 HAV Repair of Vascular Trauma Phase 2/3 Trial Underway
Slide 12: Civilian and Wartime Vascular Trauma Injuries Threaten Life and Limb
12 CIVILIAN AND WARTIME VASCULAR TRAUMA INJURIES THREATEN LIFE AND LIMB 1) Alarhayem, A.Q., al, Journal of Vascular Surgery 2019; 69: 1519-1523. 2) Kauvar, D.S., et al, Journal of Vascular Surgery 2011; 53: 1598-603. 3) Siracuse, J.J. et al, Journal of Vascular Surgery 2013: 57: 700-705. 4) Andercou
Slide 13: The HAV in Vascular Trauma - Designed to Save Lives and Limbs
13 THE HAV IN VASCULAR TRAUMA - DESIGNED TO SAVE LIVES AND LIMBS HAV Trauma Case Study Iliac Artery Bypass withHAV (Pelvis and Leg) HAV Expected Improved Patient Outcomes in Trauma ▪ Off the shelf: Immediately available to the surgeon. Eliminates the time required to harvest a vein ▪ Outstanding pri
Slide 14: Ongoing V005 Phase 2/3 Trial in Trauma Shows Robust Results to Date
14 Low rates of amputation Low rates of HAV infection despite multiple implants into contaminated wound beds Zero instances of HAV rejection HAV performance to date in trial compares favorably to both saphenous vein and ePTFE historical reported literature ONGOING V005 PHASE 2/3 TRIAL IN TRAUMA SHOW
Slide 15: HAV in AV Access for Dialysis Phase 3 Trial Underway
15 HAV in AV Access for Dialysis Phase 3 Trial Underway
Slide 16: Traditional Methods of AV Access for Hemodialysis
16 TRADITIONAL METHODS OF AV ACCESS FOR HEMODIALYSIS 1) http://www.aakp.org/library/attachments/understandingyourhemodialysisaccessoptionseng.pdf Current Estimates of Access in the US Primary/AV Fistula (Autogenous) Secondary/Graft ~20% Grafts ~60% AV fistulas Venous/Temporary Catheter ~20% Catheter
Slide 17: HAV Is Designed to Address Fistula Failures, Infections
17 HAV IS DESIGNED TO ADDRESS FISTULA FAILURES, INFECTIONS 1 Lawson, J.H, et al, The Lancet 2016; 387: 2026-2034. 2 Halbert, R.J., et al, Kidney360 2020; doi: 10.34067/KID.003502020. Use of AV Fistula has Substantial Limitations ▪ ~40% of fistulas fail to mature ▪ Even the fistulas that do mature ta
Slide 18: Ongoing Phase 3 Trial in Dialysis Access Versus AV Fistula (V007)
18 ONGOING PHASE 3 TRIAL IN DIALYSIS ACCESS VERSUS AV FISTULA (V007) Enrollment: Target 240 total subjects 207 subjects enrolled as of December 31, 2021 NCT03183245: Compare the Efficacy and Safety of Humacyte’s Human Acellular Vessel with that of an Autologous Arteriovenous Fistula in Subjects with
Slide 19: Supportive Data from Completed Phase 2 and Phase 3 Studies of HAV
19 SUPPORTIVE DATA FROM COMPLETED PHASE 2 AND PHASE 3 STUDIES OF HAV 1) Woodside, Kenneth J., et. Al, American Journal of Kidney Diseases, Volume 71, Issue 6, 2018, Pages 793-801 2) Allon, M., et al. American J Kidney Disease 2018; 71: 677-689 3) Arhuidese, et al, 2018; JVS 4) Lok, et al; 2013 CJASN
Slide 20: HAV for Peripheral Arterial Disease Phase 2 Program
20 HAV for Peripheral Arterial Disease Phase 2 Program
Slide 21: Peripheral Arterial Disease (PAD)
21 PERIPHERAL ARTERIAL DISEASE (PAD) Treatment requires restoration of blood flow ▪ Non-surgical, catheter-based intervention ▪ Surgical bypass Critical Limb Threatening Ischemia ▪ Tissue does not receive enough blood flow to survive ▪ If untreated, leads to tissue loss, gangrene, and ultimately amp
Slide 22: Peripheral Arterial Disease: Restoring Mobility with HAV
22 PERIPHERAL ARTERIAL DISEASE: RESTORING MOBILITY WITH HAV Knee joint Staples at incision HAV Angiogram at 1 year ▪ Case Study of using the HAV for Compassionate Use in 70-year-old patient with severe vascular disease. ▪ No vein was available to perform a bypass, as the vein was previously used for
Slide 23: HAV for Cardiac Bypass Preclinical Program
23 HAV for Cardiac Bypass Preclinical Program
Slide 24: Potentially Transforming CABG Care: Greater Durability, Less Morbidity
24 POTENTIALLY TRANSFORMING CABG CARE: GREATER DURABILITY, LESS MORBIDITY SAPHENOUS VEIN GRAFT (SVG) ◼ Harvesting SVG from the patient is painful and complicated: ▪ 41% have persistent numbness ▪ 32% develop infection ▪ 23% have persistent swelling; worse in obese and diabetic patients; 2x worse in
Slide 25: BioVascular Pancreas for Type-1 Diabetes Preclinical Program
25 Humacyte Innovation in Complex Organ Systems: BioVascular Pancreas for Type-1 Diabetes Preclinical Program
Slide 26: BioVascular Pancreas May Deliver Curative Islets to Diabetics
26 BIOVASCULAR PANCREAS MAY DELIVER CURATIVE ISLETS TO DIABETICS Islets in hydrogel surrounding HAV ▪ Islets die after implantation under the skin, or after injection into the abdomen, due to lack of oxygen and nutrients. ▪ Without a blood supply, pancreatic islets cannot survive transplantation. ▪
Slide 27: BioVascular Pancreas Normalized Glucose in Diabetic Animals
27 0 50 100 0 200 400 600 Blood Glucose Levels Day B l o o d G l u c o s e ( m g / d L ) BVP (n=5) No Flow (n=3) **** Normal Blood Glucose Volume 12: 1-18 BIOVASCULAR PANCREAS NORMALIZED GLUCOSE IN DIABETIC ANIMALS Moving into large-animal preclinical studies ▪ Diabetic rodents implanted with BVPs c
Slide 28: Anticipated Path to Market
28 Anticipated Path to Market
Slide 29: Commercialization Strategy
29 ▪ Department of Defense supply depots ▪ Vascular Trauma is highly specialized market with 190 Level I Trauma centers ▪ Launch field sales force of up to 20 representatives ▪ Dual targeting of surgeons intended to create pull-through demand and hospital administrators to gain product placement in
Slide 30: Commercial Manufacturing Scale – LUNA200 System
30 COMMERCIAL MANUFACTURING SCALE – LUNA200 SYSTEM Commercial 83,000 sq ft Bioprocessing Facility Modular Manufacturing System ▪ Currently operating 8 LUNA200 systems ▪ Annual Capacity expected to exceed 40,000 HAVs ▪ Functionally closed system with state-of-the-art process automation LUNA200 system
Slide 31: Humacyte's Team
31 HUMACYTE’S TEAM Laura E. Niklason, MD, PhD Founder, President, Chief Executive Officer Dale Sander Chief Financial Officer, Chief Corporate Development Officer Heather Prichard, PhD Chief Operating Officer Juliana Blum, PhD Co-Founder, Executive Vice President, Corporate Development BJ Scheessele
Slide 32: Upcoming Milestones for Humacyte
32 UPCOMING MILESTONES FOR HUMACYTE All milestone dates are only management estimates HAV preclinical results in CABG to be presented at Advanced Therapies Week meeting (January 2022) HAV results in critical limb ischemia to be presented at VESS meeting (January 2022) Completion of enrollment of V00
Slide 33: The Promise of Regenerative Medicine
33 THE PROMISE OF REGENERATIVE MEDICINE ▪ Broad platform of universally implantable bioengineered human tissues ▪ Markets estimated to exceed $150 billion: ▪ Dialysis, peripheral artery disease, trauma, diabetes, coronary bypass ▪ First company to receive FDA RMAT designation. DOD priority product.
Slide 34: Humacyte, Inc. Universally Implantable Regenerative Human Tissue
34 Humacyte, Inc. Universally Implantable Regenerative Human Tissue
Slide 35: Appendix
HUMACYTE APPENDIX
Slide 36: Human Acellular Vessels (HAVs)
36 HUMAN ACELLULAR VESSELS (HAVs) Human donor aorta Working cell stock Flexible, single-use bioreactor bag Polymer mesh Seeded polymer mesh in bioreactor bag Vascular cells isolated from human aorta & cryopreserved Cells transferred onto polymer mesh in bioreactor bag Cell seeding 1 Bioengineered ve
Slide 37: Humacyte Is Based on Breakthrough Science
37 HUMACYTE IS BASED ON BREAKTHROUGH SCIENCE SCIENCE VALIDATED BY EXTENSIVE TOP-TIER PEER REVIEWED PUBLICATIONS