Humacyte, Inc. · NASDAQ:HUMA
Humacyte — SPAC Merger (February 2021)
38 slides from Humacyte's SPAC merger presentation, Feb 17, 2021
Slide 1: Alpha Healthcare Acquisition Corp Merger with Humacyte, Inc.
Alpha Healthcare Acquisition Corp Merger with Humacyte, Inc. Universally Implantable Regenerative Human Tissue
Slide 2: Disclaimer
DISCLAIMER This presentation (“Presentation”) is for informational purposes only to assist interested parties in making their own evaluation with respect to the proposed business combination (the “Business Combination”) between Alpha Healthcare Acquisition Corp . (“Alpha”) and Humacyte, Inc . (the “
Slide 3: Humacyte Overview
Humacyte Overview We are a clinical stage platform company capable of manufacturing universally implantable bioengineered human tissues at commercial scale
Slide 4: Our Leadership
OUR LEADERSHIP Rajiv Shukla: Chairman & CEO, Alpha Healthcare Acquisition Corp. • 3 - time public company CEO with extensive track record of healthcare M&A and investments • Previous SPAC acquired DMTK, cancer diagnostics company, one of the best performing healthcare SPAC deals • Served as Director
Slide 5: Investment Highlights
INVESTMENT HIGHLIGHTS ▪ Category - defining innovation allows the human body to grow its own living replacement parts ▪ Universally implantable/no immunosuppression required, regenerative/self - healing, off - the - shelf ▪ Deep product pipeline in massive markets estimated to exceed $150 billion: ▪
Slide 6: Humacyte Is Based on Breakthrough Science
HUMACYTE IS BASED ON BREAKTHROUGH SCIENCE 6 Science Validated By Extensive Top - tier Peer Reviewed Publications
Slide 7: The Era of Living Human Replacement Tissue Has Arrived
THE ERA OF LIVING HUMAN REPLACEMENT TISSUE HAS ARRIVED 7 Bioengineered Blood Vessel Bioengineered Human Coronary Artery Bioengineered Pancreas Bioengineered Human Lung
Slide 8: We Aim to Entirely Transform Medical Paradigms
WE AIM TO ENTIRELY TRANSFORM MEDICAL PARADIGMS No waiting for organ donors No life sentence of immunosuppression No amputations due to vascular blockages No plastic body parts that become infected No “cutting your left leg” to save “your right leg” No being hooked up to cumbersome machines 8
Slide 9: Addressing a Massive Market Opportunity
WE ARE ADDRESSING A MASSIVE MARKET OPPORTUNITY: MULTIPLE BLOCKBUSTER PRODUCTS IN DEVELOPMENT 9 Vascular Trauma Peripheral Arterial Disease (PAD) Dialysis AV Access Coronary Artery Bypass Graft (CABG) Lung Trachea Pancreas Urinary Conduit Vascular Products Non - Vascular Products Sources: 1. Coronary
Slide 10: Humacyte Is a Platform Company with Disruptive Medical Impact
HUMACYTE IS A PLATFORM COMPANY WITH DISRUPTIVE MEDICAL IMPACT Dialysis AV Access • ”Gold standard” fistula fails 40% of the time • Over 90% of HAVs can be used for dialysis at 6 months • 50% of US patients: 230,000 cases/year Expected US Launch: 2023 Peripheral Arterial Disease • Vein grafts not alw
Slide 11: Human Acellular Vessels (HAVs)
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 ves
Slide 12: Key Features of Humacyte Technology
KEY FEATURES OF HUMACYTE TECHNOLOGY Off - the - shelf ▪ Remove from packaging, cut and implant, current 18 - month shelf - life No Donor Site Harvesting ▪ Doesn’t require recovery from a second surgery No Evidence of Immunogenicity ▪ 430+ patients treated, 800+ patient - years of exposure: no clinic
Slide 13: Clinical Data Shows That HAV Becomes Living Blood Vessel
HAV repopulates with the patient’s own cells, angiogenesis enables self - maintenance, self - heals in response to injury CLINICAL DATA SHOWS THAT HAV BECOMES LIVING BLOOD VESSEL 1. Samples were assessed at 16, 18, 22, 27, 37, 44, 55, 97, 100, 121, and 200 weeks. 2. No evidence of chronic inflammati
Slide 14: Accelerated U.S. Regulatory Pathway
ACCELERATED U.S. REGULATORY PATHWAY 14 ▪ FDA Fast Track designation ▪ First product to receive FDA’s RMAT expedited review designation ▪ Benefits of Fast Track plus intensive FDA guidance on product development ▪ Priority designation for vascular trauma by Secretary of Defense ▪ Ongoing discussions
Slide 15: Humacyte's Clinical Programs
Humacyte’s Clinical Programs What sounded like science fiction earlier, is science reality today
Slide 16: Late-Stage Clinical Development: 800+ Patient Years of Data
LATE - STAGE CLINICAL DEVELOPMENT: 800+ PATIENT YEARS OF DATA 16 Peripheral Arterial Disease Vascular Trauma Dialysis AV Access 350+ Patients Treated > 92% Patency at 6 Months No Infections to Date 100% patency at 30 Days 1 No Infections to Date No Amputations to Date 1% Infection Rate Two Phase II
Slide 17: Dialysis: Addressing Recurrent Infections and Fistula Failure
DIALYSIS: ADDRESSING RECURRENT INFECTIONS AND FISTULA FAILURE 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. Source: Humacyte 17% 10 - 15% annual infection rate: sepsis, hospitalization, death Not durable: ~50% fail in
Slide 18: Excellent Hemodialysis Function Observed in 350+ Patients
EXCELLENT HEMODIALYSIS FUNCTION OBSERVED IN 350+ PATIENTS 1. Lok, et al; 2013 CJASN 2. Kakisis et al; 2017, JVS Source: Humacyte Phase II Dialysis Trial: In 5 - 10 year follow - up ▪ 40 patients ▪ Infection rate ~ 1% per patient year ▪ Outstanding Long - Term Patency in Hemodialysis Phase III Trial:
Slide 19: Vascular Trauma: Saving Lives and Limbs
VASCULAR TRAUMA: SAVING LIVES AND LIMBS 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, O., et al, Medicine 2018
Slide 20: Ongoing Phase II/III Trial in Vascular Trauma Repair
ONGOING Phase II/III TRIAL IN VASCULAR TRAUMA REPAIR DOD Priority Designation Iliac Artery Bypass with HAV (Pelvis and Leg) 20 ▪ Single - arm, open - label study in ± 75 patients ▪ Vascular injuries below the neck ▪ 37 patients enrolled to date ▪ 12 clinical sites, increasing to 28 in the U.S. and E
Slide 21: Peripheral Arterial Disease: Restoring Mobility
PERIPHERAL ARTERIAL DISEASE: RESTORING MOBILITY Knee joint staples at incision HAV Patient’s own arteries, smaller caliber 21 ▪ Case Study of using the HAV for Compassionate Use in patient with severe vascular disease. ▪ The patient was a 70 - year - old male with critical limb ischemia ▪ No vein wa
Slide 22: Transforming CABG Care: Greater Durability, Less Morbidity
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 women SVGs do not
Slide 23: BioVascular Pancreas for Type 1 Diabetes
BIOVASCULAR PANCREAS FOR TYPE 1 DIABETES 23 Restoring Glucose Control in Rats Islets Acellular Graft Hydrogel BioVascular Pancreas (BVP) Current Type 1 Diabetes Treatment Insulin injections, insulin pumps, finger sticks: $10k/year Constant vigilance for blood sugar control impairs quality of life. 1
Slide 24: Commercialization Strategy
Commercialization Strategy $150+ billion market opportunity
Slide 25: Humacyte Pipeline
25 Humacyte Pipeline 2021 2022 2023 2024 2025 2026 2027 Trauma AV Access PAD BioVascular Pancreas Pediatric Heart Disease CABG ESTIMATED 5 - YEAR PRODUCT LAUNCH TIMELINE Commercial launch of first product expected in 2023 Source: Humacyte Vascular Products Non - Vascular Products
Slide 26: Commercial Manufacturing Scale
COMMERCIAL MANUFACTURING SCALE 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 With 20 growt
Slide 27: Estimated Revenues from Near-Term Products
ESTIMATED REVENUES FROM NEAR - TERM PRODUCTS 27 Product Trauma AV Access PAD Pancreas CABG Total $1.3 $1.7 $4.3 $4.2 $12.1 $0.6 Projected Humacyte Annual Revenue From Late - Stage Pipeline Products 1 ( USD Billions ) Plus, additional revenue from future non - vascular applications: • lung • trachea
Slide 28: Commercialization Strategy
COMMERCIALIZATION STRATEGY Global collaboration for Dialysis AV Access and PAD 2,500 dialysis centers in the US: largest provider of dialysis services in the U.S. Leader in the management of outpatient surgical centers Over 60 outpatient centers for vascular procedures Department of Defense supply d
Slide 29: Anticipated Use of Proceeds
ANTICIPATED USE OF PROCEEDS BLA submissions in Dialysis AV Access and Vascular Repair • Completion of Phase III trials • BLA Submissions and FDA approval Commercial launch of HAV • U.S. market launches in dialysis AV access and vascular repair • Subsequent market launches in key international market
Slide 30: Transaction Overview
HUMACYTE Transaction Overview Health Coronavirus Artificial blood vessels keep in fridge until heart op ‘By James Gallagher Heath reporter BSC News ‘Pts J0e Klein onthe Bush book How to shrink a ety /The Sheconomy ‘Mark Twaie’s memoir / Mariage apps IME.
Slide 31: SPAC Sponsor Has Track Record of Backing Disruptive Growth Companies
SPAC SPONSOR HAS TRACK RECORD OF BACKING DISRUPTIVE GROWTH COMPANIES AHAC was founded by Rajiv Shukla, extensive track record in healthcare M&A and equity investments Previous SPAC acquired DermTech (NasdaqCM:DMTK): a disruptive innovator in skin cancer diagnostics DermTech vs standard of care biops
Slide 32: Transaction Summary
TRANSACTION SUMMARY Transaction Structure ▪ Existing Humacyte shareholders to receive the following consideration in AHAC common shares: ▪ Base valuation of $800 million ▪ Plus, stock performance linked incentive when the share price reaches or exceeds the following levels , for at least 20 days ove
Slide 33: Transaction Terms
1. Assumes no redemptions from the AHAC Trust, includes 2.5M Founder Shares and $3.55M pre - IPO investment. Based on $10.00 per share price for PIPE shares. Excludes 5.2M warrants issued at a strike price of $11.50. Sources, $M 1 Humacyte Equity Rollover $800 AHAC Trust $100 PIPE Proceeds $175 Tota
Slide 34: Humacyte Highlights
HUMACYTE HIGHLIGHTS 1. Clinical - stage platform company developing bioengineered universally implantable human tissues 2. $150+ billion in estimated commercial opportunities across multiple indications 3. $12+ billion in estimated annual peak sales from products expected to be launched in next 5 ye
Slide 35: Valuation Analysis
HUMACYTE CyUuMACYTE’ ‘Vascular Repair, Reconstruction and Replacement Valuation Analysis
Slide 36: Disruptive Medtech Companies
2.00 52.00 102.00 152.00 202.00 252.00 02/16 02/17 01/18 01/19 01/20 01/21 2.00 52.00 102.00 152.00 202.00 252.00 302.00 352.00 402.00 452.00 02/16 02/17 01/18 01/19 01/20 01/21 2.00 102.00 202.00 302.00 402.00 502.00 602.00 02/16 02/17 01/18 01/19 01/20 01/21 104.00 204.00 304.00 404.00 504.00 604.
Slide 37: Vascular Medtech Companies
20.00 30.00 40.00 50.00 60.00 70.00 80.00 04/19 08/19 01/20 06/20 10/20 20.00 40.00 60.00 80.00 100.00 120.00 140.00 03/19 07/19 12/19 05/20 09/20 2.00 12.00 22.00 32.00 42.00 52.00 62.00 72.00 82.00 92.00 11/11 11/12 11/13 11/14 11/15 11/16 12/17 12/18 12/19 12/20 VASCULAR MEDTECH COMPANIES Sapien
Slide 38: Valuation of Disruptive and Vascular Medtech Companies
VALUATION OF DISRUPTIVE AND VASCULAR MEDTECH COMPANIES 38 Equity Value Cash Debt TEV LTM 2021E 2022E 2023E 21E/20E 22E/21E 23E/22E LTM EBITDA TEV/LTM Rev TEV/2021E Rev TEV/2022E Rev TEV/2023E Rev $89,607 $6,361 - $83,245 $4,358 $4,954 $5,771 $6,492 14% 16% 13% $1,312 19x 17x 14x 13x $53,835 $1,894 $