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8-K - FORM 8-K - RenovaCare, Inc.f8k_110220.htm
EX-99.1 - EXHIBIT 99.1 - RenovaCare, Inc.exh_991.htm

Exhibit 99.2

 

SkinGun Œ & CellMist Œ Next Generation Ultra - Gentle Cell Spray S y m b o l : RC A R RenovaCare Investor Forum 1 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved. October 29, 2020

 
 

This slide deck and the accompanying oral presentation contain forward - looking statements, including, but not limited to, statements related to RenovaCare Inc . ’s future financial and operating results, including 2019 financial guidance, 2020 goals and expectations for growth ; the company’s corporate development efforts ; the company’s growth strategy ; future product sales and volume ; planned sales and marketing and related efforts ; future inventory and supply challenges ; planned, ongoing and future clinical trials and other product development activities ; planned regulatory submissions ; ongoing and future product launches ; the timing of such events and activities ; and other statements that are not historical facts . These forward - looking statements are based on the company’s current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties . Actual results and the timing of events could differ materially from those anticipated in such forward - looking statements as a result of these risks and uncertainties, which including, without limitation, risks and uncertainties associated with : maintaining or increasing sales and revenue ; effectively commercializing the company’s products and product candidates ; the time - consuming and uncertain regulatory approval process, including the risk that the company’s current and planned regulatory submissions may not be submitted, accepted or approved by applicable regulatory authorities in a timely manner or at all ; the effectiveness of the license agreement ; costly and time - consuming product development and the uncertainty of clinical success, including risks related to failure or delays in initiating or completing clinical trials ; protecting and enhancing the company’s intellectual property rights ; delays or problems in the supply or manufacture of the company’s products or product candidates ; the company’s ability to maintain rights to its products and product candidates ; complying with applicable U . S . and non - U . S . regulatory requirements ; government investigations and other actions ; obtaining and maintaining adequate coverage and reimbursement for the company’s products ; identifying and acquiring, in - licensing or developing additional products or product candidates, financing these transactions and successfully integrating acquired businesses ; the company’s ability to realize the anticipated benefits of its collaborations with third parties for the development of product candidates ; the ability to achieve future financial performance and results and the uncertainty of future tax and other provisions and estimates ; and other risks and uncertainties affecting the company, including those described from time to time under the caption “Risk Factors” and elsewhere in RenovaCare Inc . ’s Securities and Exchange Commission filings and reports (Commission File No . 000 - 30156 , including the company’s Quarterly Report on Form 10 - Q for the quarter ended June 30 , 2020 and future filings and reports by the company . Other risks and uncertainties of which the company is not currently aware may also affect the company’s forward - looking statements and may cause actual results and the timing of events to differ materially from those anticipated . The forward - looking statements made in this slide deck and the accompanying oral presentations are made only as of the date hereof or as of the dates indicated in the forward - looking statements, even if they are subsequently made available by the company on its website or otherwise . The company undertakes no obligation to update or supplement any forward - looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward - looking statements were made . Forward - Looking Statements “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 2 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

Alan L. Rubino Chairman & CEO Robin A. Robinson, PhD Chief Scientific Officer Robert W. Cook Chief Financial Officer Today’s Presenters 3 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved. October 29, 2020

 
 

Development at StemCell Systems: SkinGun Œ Cell Spray Device CellMist Œ Cell Isolation Process Historical: Discovery Current: Clinical Future: Commercial Co m pa n y Focus T e c hn o l o g y Evolution Electronic SkinGun Œ Disposable SkinGun Œ CellMist Œ System Closed Cell Isolation Device Advanced Regeneration Therapies • Other Tissues (Adipose, etc.) • Skin Other Clinical Indications Burn, Wound & Other Therapies Strategic Partnerships Product Collaborations Early Research & Development Intellectual Property RenovaCare Launch 70+ Human Case Studies 4 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved. Advanced Research & Development Clinical Trial Program Intellectual Property Regulatory Submissions Corporate Development RenovaCare: Past, Present and Future

 
 

DIVERSE PRODUCT PORTFOLIO Burns, chronic wounds, acute wounds and scars ; regeneration of skin and other organs and tissues DISCIPLINED CAPITAL ALLOCATION Ba l a n c e d t o s u pp o r t p o r t f o li o g r o w t h opportunities, financings, corporate development and shareholder returns ROBUST, EXPANDING IP ESTATE Defensible, growing intellectual property and R&D portfolio in core areas focused on differentiated products for unmet needs EXECUTING GROWTH STRATEGY Portfolio growth in key therapeutic areas strategic partnerships , operational efficiency and world - class leadership Focused Strategies to Meet Long - Term Objectives SPRAYING SELF - DONATED STEM CELLS TO REGENERATE TISSUES & ORGANS 5 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

Next - Generation Biomedical Technologies Devices & Products 6 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

Patented technologies for isolating and spraying self - donated stem cells for the regeneration of skin and other organs and tissues. RenovaCare autologous cellular therapies are used to treat burns, scars, skin disorders, wounds, and cosmetic applications. An estimated $25 billion is spent annually on treating chronic wound patients in the U.S. alone. New Treatment for Wounds is Urgently Needed Regenerative Medicine is Common, Complex & Expensive EXPEDITED WOUND HEALING IS URGENTLY NEEDED Source: The Wall Street Journal The CellMist Œ System and SkinGun Œ 7 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved. *RenovaCare Inc. 2019 Form 10 - K, Market Opportunity

 
 

Grafting is Painful, Expensive and Leaves Scarring Skin Grafting is Current Standard - of - Care Painful & Lengthy Treatment Cycle › 200 - year old method with the last breakthrough 50 years ago › Large sheets of skin are surgically removed and re - stitched onto wound › Painful procedure that leaves extensive scarring › Grafted skin is not naturally pliable Expensive, Drug Dependent Psychologically Damaging › Creates new wounds from donor sites and requires multiple surgeries › Requires wound management for donor and target sites, while in hospital › Extensive pain management and physical and psychological therapy › Life - long physical and emotional scarring Sheets of meshed skin for surgical stitching Mesh scars in skin graft patient The current standard of care is expensive, lengthy and painful; resulting in multiple surgeries and extended hospital stays. 8 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved. INADEQUATE OPTIONS FOR BURN PATIENTS

 
 

RenovaCare SkinGun Œ Technology *Treated under special innovative practice approach at: Berlin - Brandenburg Center for Regenerative Therapies, Charité Berlin; and under innovative practice approach at UPMC Medical Center, Pittsburgh, Pennsylvania. **Raw patient data available. 70+ Patients Su c c e s s f ully Treated* SELF - HEALING. SCAR - FREE. SPRAY - ON WOUND CARE. 9 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

RenovaCare Breakthrough Technology CellMist Œ uses donor tissue sample. RenovaCare CellMist Œ Split Thickness Skin Graft 10cm 2 donor sample Donor Skin Sample 10cm 2 Typical › Small donor skin sample taken under local anesthetic › 90 minutes to harvest regenerative autologous stem cells › Water - based suspension of cells sprayed onto wound Natural Skin Growth › Treatment areas virtually indiscernible from untreated skin › No hypertrophic scars, contracture, or functional impairment › Complete re - epithelialization and full range of movement Quick Healing & Reduced Hospitalization/Follow - On Visits › 6 - 10 days for re - epithelialization and patient discharge › Versus weeks/months for skin graft patients Split Thickness Mesh Graft 1 : 100* 1:1* 1:3 – 1:9* Traditional skin grafts require large sheets of surgically removed skin. Donor Area Donor Area Burn Area Burn Area Burn Area THE CELLMIST Œ SYSTEM AND SKINGUN Œ 10 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

IDE/PMA 510(k) 510(k) 510(k) CellMist System Œ Electronic SkinGun Œ Autologous Skin Stem Cell Therapy for Burns POTENTIAL APPROVALS FROM 2020 - 2025 Disposable SkinGun Œ Cell Spray Deposition Device Electronic SkinGun Œ Cell Spray Deposition Device Cell Isolation Device Multi - Tissue Automated Closed System onsite, rapid cell isolation and spray | multiple cell types | tissues and organs, beyond skin Our Execution Will Lead To Four Major Submissions for Approval 11 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved. RENOVACARE PRODUCT PORTFOLIO: 3 SELECT MULTI - TISSUE CELL THERAPY PLATFORMS

 
 

Building A Pipeline For Sustainable Growth TARGETED APPROVALS WITHIN 5 YEARS: ONE BURN PMA + TWO SKINGUN Œ 510(k) 12 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

The RenovaCare Electronic SkinGun Œ OUR PATENTED CELL SPRAY TECHNOLOGIES SPRAY - ON STEM CELLS FOR RAPID HEALING Controlled Spray Large - Area Coverage Ultra - Gentle Deposition Ultra - Precise Even Distribution Even Droplets No Droplet Loss Non - Drip No Roll - Off Actual SkinGun Œ Spray 13 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

Research. D e v e l o p m e n t . Innovation. 14 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

Bioengineering & Cell Biology Regenerative Medicine Medical Device Engineering and Prototyping Regulatory - Centric IP Driven Engineering QMS Support Documentation RenovaCare R&D and Innovation Team 2 MD - PhDs 2 PhDs 1 MBA - Engineer 4 Engineers RenovaCare R&D Innovation Center SURGERY BIOENGINEERING MANUFACTURING CellMist Œ and SkinGun Œ Invented, Prototyped, Patented & Clinically Translated PRODUCT DESIGN 15 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved. Q U A L I T Y

 
 

RenovaCare IP Summary 16 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

2011 2013 2016 2018 2019 Cell spray device developed Di s p o s a b l e SkinGun Œ Encompass all types of cell tissues or organs Modular handheld spray device to spray cells Additional RenovaCare IP filings Electronic S k i n G un Œ IP tested and validated 2020 Cell isolation process developed Expanding Our Intellectual Property 17 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved. Closed Cell Isolation System PATENT PROTECTION HAS GROWN SIGNIFICANTLY TO INCLUDE SPRAYING ORGANS AND TISSUES

 
 

Disciplined Pathway & World Class Management 18 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

$1B ~ $ 60 0 - 700M ~ $ 200 - 300M ~$2B in - patient burns severe second degree operation theater RenovaCare Regenerative Cell Therapies POTENTIAL TWO BILLION DOLLAR MARKET OPPORTUNITY WITHIN THE U.S. Advanced Burn Care Current Market out - patient burns pediatric scalds clinical setting wounds trauma d e r m a t o l o g i c a l + gene therapy Future Expanded Markets SK I N EXPANDED INDICATIONS 19 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved. *According to Company Market Estimates. Commercial Market Potential

 
 

R&D / QMS Cl i n i c al Manufacturing Regulatory Partners Enabling Clinical Pathway DATA - DRIVEN PARTNERS WITH AN UNWAVERING FOCUS ON IMPACT 20 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

Regulatory Priorities Planned Clinical Trials Corporate Development Activities Five Sites Selected: Q1 2020 FDA IDE Submission: Q3 2020 FDA 510(k) Submission: 1H 2021 Hiring strategic talent to drive corporate activities, clinical trials, and FDA submissions Expand portfolio through multiple collaborative partnerships and strategic alliance activities Comprehensive financing plan 2020 Milestones / Goals 21 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved. KEY TRANSITION ACTIVITIES FOR DEVELOPMENT - STAGE GROWTH

 
 

COMMERCIALIZATION OPERATIONS REGULATORY R & D MANUFACTURING CLINICAL FU L L Y - I N T EG R A T ED CAPABILITIES Alan L. Rubino CEO / President / Chairman Robert Cook Chief Financial Officer Dr. Robin Robinson Chief Scientific Officer Dr. Jo Schweinle Chief Medical Officer Joseph Sierchio General Counsel Amit Singh Special Projects Dr. Roger Esteban - Vives VP R&D and Product Dev. Dr. Rodney Sparks VP Intellectual Property Jean Krebs Quality Affairs MCRA Regulatory Consulting StemCell Systems GmbH Strategic Alliance Partner Mike Lerner Business Counsel Experienced Leadership Team 22 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved. INTELLECTUAL PROPERTY REGENERATIVE MEDICINE | BIOMEDICAL DEVICES | BURNS & WOUNDS

 
 

Building For Success Focused On Results 23 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

~$320 Million Market Cap Closing price at 23 - Oct - 2020: $3.68 $10.2 Million Cash - on - Hand $14.3 Million Stockholders Equity Financials as of June 30, 2020 RenovaCare, Inc. Symbol: RCAR $1.9 Million Cash Used In Operations – 6 months ~87 Million Outstanding Shares ~18.1 Million Outstanding Warrants & Options Financial Highlights Q3 2020 Financial Results to Report Mid - November 24 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

Building Shareholder Value RenovaCare: Focused, Growing, Disciplined & Proven 1. Focused Portfolio: Cutting - Edge Stem - Cell Spray Therapies ▪ cell isolation and spray technologies ▪ stem cell therapies for acute and chronic wounds, including burns ▪ highly - innovative, proven R&D group (IP, regulatory, clinical) 2. Multiple Growth Drivers ▪ worldwide market demand for self - donated stem cell therapies ▪ diverse therapeutic opportunities for tissue and organ regeneration ▪ portfolio growth in key therapeutic areas and strategic partnerships 3. Robust, Expanding, Proven IP Estate ▪ sole ownership of all technology with no in - licensing ▪ key technology protections covering methods and devices ▪ core areas focused on differentiated products for unmet needs 4. Demonstrated Record: Strategic Commercial Partnerships ▪ clear and focused business development driven by experience ▪ established history of successful strategic longitudinal relationships ▪ well - positioned for government relationships with founding director, BARDA 5. Disciplined Capital Allocation with World - Class Management Team ▪ return on investment driven, time to market obsessive ▪ diversification and strengthening of immediate value - adds ▪ focused investment in strategic business drivers with operational efficiency 25 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

Questions & Answers 26 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved.

 
 

spray - on stem cells for rapid healing . 27 RenovaCare Investor Forum I October 2020 © 2020 RenovaCare Inc. All rights reserved. SkinGun Œ & CellMist Œ Next Generation Ultra - Gentle Cell Spray Symbol: RCAR Thank you for your participation. October 29, 2020 RenovaCare, Inc. contact@renovacareinc.com +1 888 398 0202