Longevity Health Holdings, Inc. · OTC:XAGE
Longevity Health — Alpha Healthcare Acquisition Corp III — SPAC Merger (January 2023)
29 slides from Longevity Health's SPAC merger presentation, Jan 4, 2023
Slide 1: Carmell Therapeutics Merger With Alpha Healthcare Acquisition Corp III
Carmell Therapeutics Merger With Alpha Healthcare Acquisition Corp III (Nasdaq: ALPA) January 3, 2023 Exhibit 99.2
Slide 2: Disclaimer and Forward-Looking Statements
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. III (“ALPA”) and Carmell Therapeutics (the “Comp
Slide 3: Investment Highlights
INVESTMENT HIGHLIGHTS 1. Platform product with multiple therapeutic applications 2. Clinical proof of concept from Phase II trial 3. Fast Track review granted by the US FDA 4. 21 issued patents provide protection until 2031 5. Deeply experienced team with shared experience at Johnson & Johnson 6. At
Slide 4: Carmell's Technology Platform
CARMELL’S TECHNOLOGY PLATFORM Medical application: Local application at the site requiring regeneration Controlled degradation over weeks/months Assured quantum of platelets that release regenerative growth factors Benefits to Care Provider: Ready to use No mixing No need for prep at clinical settin
Slide 5: Platform Technology Used in Phase II Trial
PLATFORM TECHNOLOGY USED IN PHASE II TRIAL Mechanism of Action via Cytokines, Chemokines and Adhesive Proteins Biological Pathways for Regenerative Healing Source: Platelets and Infection – An Emerging Role of Platelets in Viral Infection, December 2014, Frontiers in Immunology 5(Suppl 1):649 Biolog
Slide 6: Allogeneic vs Autologous PRP
ALLOGENEIC VS AUTOLOGOUS PRP Extracting Platelets is a Complex, Multi-step Process Resulting in Variable Outcomes Driven by Donor Biology and Process Control Autologous PRP: Individualized Treatment Allogeneic PRP: Universal Treatment What is it? Platelets (via PRP) drawn from individual patient for
Slide 7: Regenerative Healing with Platelet-Rich Plasma (PRP)
REGENERATIVE HEALING WITH PLATELET-RICH PLASMA (PRP) CARMELL IS FOCUSED ON MULTIPLE THERAPEUTIC AREAS Orthopedic Dental TISSUE APPLICATIONS Hair Loss/Skin Rejuvenation Surgical/Wound Healing BONE APPLICATIONS
Slide 8: R&D Pipeline with Multiple Shots on Goal
R&D PIPELINE WITH MULTIPLE SHOTS ON GOAL R&D Candidates Indications preclinical Phase 1 Phase 2 Anticipated Milestones Bone Healing Accelerant (BHA) Tibia Fracture Healing (FDA Fast Track granted) First Patient In HEAL II Q3 2023 Foot/Ankle Fusion Phase 2 study: First Patient in Q3 2023 Spinal Fusio
Slide 9: Rigorous Manufacturing Process & In-House Expertise
RIGOROUS MANUFACTURING PROCESS & IN-HOUSE EXPERTISE Multiple full-scale batches successfully produced (stability 9 month to-date, 24 month expected) Eleven release tests developed and validated to support lot-to-lot consistency ISO 13485 Certified Estimated ~90% Gross Profit Margin Process – maintai
Slide 10: Intellectual Property & Marketing Exclusivity
INTELLECTUAL PROPERTY & MARKETING EXCLUSIVITY Proprietary Products and Processes: 21 Issued Patents 1 12-year BLA Marketing Exclusivity (42 USC 262: Regulation of biological products) 2 Practical Barriers-to-Entry Company know-how and trade secrets related to processing plasma and maintaining bioact
Slide 11: Deeply Experienced Management Team
DEEPLY EXPERIENCED MANAGEMENT TEAM Extensive Experience at Johnson & Johnson Randy Hubbell President & CEO Former Chief Commercial Officer at Cardiva Medical (acquired by Haemonetics) Worldwide Vice President J&J Biosurgery Worldwide Vice President Global Strategic Marketing, Pain Therapeutics and C
Slide 12: Medical & Scientific Advisory Board
MEDICAL & SCIENTIFIC ADVISORY BOARD Aesthetics Medical Advisors Dr. Grant Stevens is the founder and medical director of Marina Plastic Surgery and the Marina Med Spa in Marina Del Rey, California. Dr. Amelia Hausauer is the Director of Dermatology and Minimally Invasive Aesthetics for Aesthetx, a h
Slide 13: Bone Applications
BONE APPLICATIONS
Slide 14: Carmell Versus Standard of Care: Orthopedics
CARMELL VERSUS STANDARD OF CARE: ORTHOPEDICS Product Standard of Care Current products used Carmell™ benefits Long bone fracture Metal fixation No adjunctive product used to accelerate healing in long bone fractures Human data vs. SOC to support design of Phase 2 study Spine fusion DBM enhancer or D
Slide 15: Carmell vs Marketed Alternatives (Tibia Fractures)
CARMELL VS MARKETED ALTERNATIVES (TIBIA FRACTURES) Carmell® Bone Healing Accelerant Medtronic INFUSE® Bone Graft Platelet Rich Plasma (PRP) Bioventus EXOGEN® Bone Healing System Composition/ Configuration Pooled allogeneic plasma proteins (crosslinked) with β-TCP/glycerol carrier Recombinant BMP-2 o
Slide 16: Phase II Clinical Trial (HEAL I) Summary: Tibia Fractures
PHASE II CLINICAL TRIAL (HEAL I) SUMMARY: TIBIA FRACTURES Study Design Double arm (20 treatment/10 control) Prospective, randomized, multi-center Patient Population Open tibia fractures Highly co-morbid population (e.g., 70% smokers) 70% most severe injuries* with significant soft tissue compromise
Slide 17: Phase II Study (HEAL II): FDA Agreed Upon Primary Endpoints
PHASE II STUDY (HEAL II): FDA Agreed Upon Primary Endpoints Target Open Tibia Fractures with IM Rodding Study Rationale SOC + application of Bone Healing Accelerant vs. SOC alone Key Results and Design Elements Primary endpoints: Same composite endpoint as HEAL I (180-day x-ray + clinical) One-year
Slide 18: Foot & Ankle Fusion Program
FOOT & ANKLE FUSION PROGRAM Clinical Need: Deterioration of cartilage between the bones in the foot and ankle due to age, injury or disease Standard of Care: Fusion surgery – remove the cartilage and fuse the two ends of the bone together utilizing hardware such as pins, screws and/or plates. Depend
Slide 19: Phase II Clinical Trial Summary: Foot & Ankle Fusion
PHASE II CLINICAL TRIAL SUMMARY: FOOT & ANKLE FUSION Study Design (FDA feedback on synopsis Nov 2022) Full protocol under development Prospective, randomized, multi-center Double arm, approx. 60 pts, 2:1 randomization ~10 sites Patient Population (to be finalized) Ankle and/or foot fusion procedures
Slide 20: US/EU Regulatory Pathway
US/EU REGULATORY PATHWAY US (BLA/CBER) – Combination Product Current Status: FDA clearance of HEAL II trial CMC plan agreement with FDA Clinical protocol approved EU Class III Medical Device Current Status: Clinical Trial Applications underway MDR application for CE mark in development ISO 13485 aud
Slide 21: Soft Tissue Applications
SOFT TISSUE APPLICATIONS
Slide 22: Carmell Versus Standard of Care: Soft Tissue
CARMELL VERSUS STANDARD OF CARE: SOFT TISSUE Need Standard of Care (SOC) Current products used Potential Carmell™ benefits Androgenetic Alopecia Topical Minoxidil Autologous Platelet Rich Plasma is growing in usage with some encouraging, but mixed results due to significant variability in the final
Slide 23: Hair Growth Observed in Androgenetic Alopecia Placebo Controlled Trial
HAIR GROWTH OBSERVED IN ANDROGENETIC ALOPECIA PLACEBO CONTROLLED TRIAL The Effect of Platelet-Rich Plasma in Hair Regrowth: A Randomized Placebo-Controlled Trial. Stem Cells Transl Med. 2015 Nov; 4(11): 1317–1323. Dr. Pietro Gentile 20 patients: 10 received placebo 10 received autologous PRP once a
Slide 24: Tissue Healing Observed in Mouse Radiation Burn Model
TISSUE HEALING OBSERVED IN MOUSE RADIATION BURN MODEL Study Purpose Investigate efficacy of THA using a mouse radiation burn model Study conducted in Laboratory of Dr. Naduparambil Jacob, Ph.D. at Ohio State University Miller, E., et.al., (2019). "Plasma-based biomaterials for the treatment of cutan
Slide 25: Anti-Infective Effect Observed in Rat Pacemaker Model
ANTI-INFECTIVE EFFECT OBSERVED IN RAT PACEMAKER MODEL Study Purpose Demonstrate the ability of THA with and without antibiotics to reduce infection in rabbit pacemaker model Design Pacemakers and THA paste with and without rifampicin/minocycline hydrochloride were implanted into a subcutaneous pocke
Slide 26: Increased Vascularization Observed in Rat Skin Flap Model
INCREASED VASCULARIZATION OBSERVED IN RAT SKIN FLAP MODEL Study conducted by Stephen Badylak, D.V.M., Ph.D., M.D. at Univ. of Pittsburgh Point of Attachment Proximal Distal Head Control Distal Vascular regeneration THA Proximal THA-G Control THA THA-G * ** * *Significance to Control *p<0.05 *p<0.001
Slide 27: Transaction Overview
TRANSACTION OVERVIEW
Slide 28: Transaction Summary
TRANSACTION SUMMARY Transaction Structure Carmell pre-money valuation of $150M ALPA founder linking 50% of Class B Founder Shares to achievement of $11.50 price target for at least 20 days out of any 30 days over next 5 years Capitalization & Use of Proceeds Market capitalization of ~$328M Proceeds
Slide 29: Transaction Terms
TRANSACTION TERMS Sources1, $M Sources, $M Carmell Equity Rollover $150 ALPA Trust $154 Total Sources $304 Uses1, $M Sources, $M Carmell Equity Rollover $150 Cash to Balance Sheet $144 Transaction Expenses $10 Total Sources $304 Enterprise Value1, $M Sources, $M Shares 32.839 Share price $10 Equity
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