Rev Corporate Presentation September 2014

Transcription

1 Rev Corporate Presentation September 2014

2 Forward Looking Statement This presentation contains forward-looking statements. Such forward-looking statements include but are not limited to that Cesca Therapeutics Inc. will provide unmatched world-class capability and service to its clients. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by our forward-looking statements is set forth under the caption "Risk Factors" in ThermoGenesis annual report on Form 10-K and other reports we file with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements. Contact: Cesca Therapeutics Inc. Website: Contact: Investor Relations , or ir@cescatherapeutics.com 2 Page

3 Cesca Therapeutics Corporate Snapshot NASDAQ Symbol Market Capitalization Shares Outstanding Options Outstanding Warrants Outstanding KOOL $56 Million 40.2 Million 1.2 Million 2.8 Million Stock Price $1.39 Average Trading Volume 169,000 Revenue (TTM) Assets Debt Corporate Headquarters India Operations Stock price and market cap as of September 3, 2014 Financials as of March 31, 2014 $16 Million $14 Million None Rancho Cordova, CA Gurgaon, India 3 Page

4 Cesca Therapeutics Regenerative Medicine Investor Checklist Safe? Clinically effective? Large markets? Regulatory hurdles? Cost effective/reimbursable? 4 Page

5 Cesca Therapeutics An integrated regenerative medicine company 5 Page Uniquely positioned to be a best in class Integrated Regenerative Medicine Company Clinical Research Organization (Fortis embedded) Proprietary cell formulations Devices; patented platform technology First commercially viable autologous cell therapy Safe & Effective; in the regulatory sweet spot Rapid; 60 minute bedside protocol Low cost delivery Opportunity to create substantial shareholder value Multiple therapies - 8 pilot & Phase 1b clinical trials Unlocks intrinsic value of multiples in regenerative medicine sector M&A/bolt on opportunities to help us further fill out our tools capabilities

6 Cesca Therapeutics Go-to-Market Success Formula Surgwerks TM CT Development Approach CT Product Attributes Autologous Cells, Minimally Manipulated + Bedside, Single Procedure 60 min Total Process Control, + Embedded CRO > 600 Trial Patients = = = Naturally Safest, Regulatory Fast track + Low COGS + Proven Curative Rapid CT Development & Commercialization = Multiple Shots on Goal Blockbuster CT Treatments 6 Page

7 Cesca Surgwerks TM Indication specific POC process control SurgWerks POC Advantages: Smart cell formulation & verification Autologous (safe and fast) Data validated Structured, protocol driven Highly consistent Dose controlled FDA approved & practice of medicine friendly 600 patients treated across eight clinical indications 7 Page

8 Fortis Partnership CRO embedded in New Delhi facility Cesca is exclusive regenerative medicine provider to Fortis 72 hospitals (6 countries) 10,000 inpatient beds 15,000 outpatients per day Experienced clinical research staff 2x as many sites as Kaiser Physician/patient access World class clinical facilities and equipment Lobby partner with government Embedded CRO Benefits Only global cell therapy CRO US FDA registered; FDA accepted foreign trial Over 600 patients treated Control over trial management Speed to completion 1/5 cost of US/ Europe patient related clinical trials Rx Clinical Trial Advantage ($M) Pilot P1/P1b Total Cesca Investment $2 $7 $9 US Equivalent Investment $17 $28 $45 Non-Dilutive Clinical Trial Funding Benefit $36 8 Page

9 Clinical Trial Pipeline Blockbuster therapy candidates $.7B 9 Page

10 Clinical Trial Pipeline Major Milestones Substantial clinical value drivers CLI Milestones Time Period FDA IDE/PMA Pivotal Trial Approval March Qtr Pivotal Phase Complete Late 2016 CLI PMA Approval/Commercialization Early 2017 BMT Milestones Time Period ABO Mismatch FDA 510(K) Approval March Qtr DCGI Haplo Phase I/II Trial Approval June Qtr Haplo Full Market launch/commercialization 2016 AMI Milestones Time Period DCGI Phase II Trial Approval June Qtr Phase II completed/data Reported Page

11 Critical Limb Ischemia Compelling clinical vascular results Trial Results Major Revascularization All patients no option and near term leg amputation recommended 12 Month F/U Data Major Amputation Free Rate post SurgWerks Therapy = 82.4% Reduction in VAS Pain Score from 7.8±0.97 to 0.2±0.58 Improvement in 6 minute walk test from 14.5m to 157m N=17 patients Completed Phase I/II IDE PMA Pivotal Begin March 2015 Day 0 Day Page

12 Acute Myocardial Infarction Compelling clinical cardiac results Trial Results Cardiac Tissue Repair LVEF improvement = from 36% to 60% Stroke volume improvement = from 39.7cc to 80cc Scar remains 11% of total heart mass Normal life resumed N=1 patient (24 Mo F/U) Pilot Completed Ph II Begin June Qtr (IDE PMA) 12 Page

13 Bone Marrow Transplant Automating clinical major mismatch & haploidentical transplant Major ABO Clinical Results 6,000 = new patients WW $1,500 = Price of treatment Improves Pediatric BMT (40% are mismatched) High - CD34 recoveries = 77.7% Low - hematocrit <12% Faster - Neutrophil engraftment = Day 18 $9 M = Addressable market 510(k) March Qtr Haploidentical Clinical Results Faster - Platelet engraftment = Day 35 6,000 = new patients India Enabling 6k annual patient market in India Plan to commercialize globally $25,000 = Price of treatment $150 M = Addressable market Reduces Expensive Reagent Usage Enables Cell Washing Faster, Lower Cost, Higher Cell Recovery 13 Page Phase I/II June Qtr. 2015

14 14 Page Cesca Therapeutics Commercialization Advantage

15 Cesca Regulatory Sweet Spot Lower risk = speed to market IND/BLA 3 Phase Trial Higher Trial Patient Pop IDE/PMA 2 Phase Trial Lower Trial Patient Pop 15 Page

16 Cesca Surgwerks TM Sustainable differentiation Significant commercial experience, proven technical reliability Over 20,000 patients POC with Cesca Cell Technologies Over 600,000 cord samples processed (laboratory) Near six-sigma disposable quality levels Clinically validated, proprietary protocols & method patents Proprietary, smart platforms Proprietary cell formulations addressing multiple disease indications Pioneering with regulatory strategy to be first cell therapy in a box IP Suite (device and algorithm patents) 43 Design and device patents Three protocol provisional patents (6 indications) 8 pilot & phase 1b clinical trials 7 clinical algorithms 16 Page

17 Cesca Therapeutics Market Cap Snapshot Cell Therapy Peer Company TCKR Market Capitalization (000 S) Aastrom Biosciences Inc. ASTM $27,000 Athersys ATHX $107,000 BioTime, Inc. BTX $220,000 Cytomedix, Inc. CMXI $47,000 Neuralstem, Inc. CUR $329,000 Cytori Therapeutics Inc. CYTX $104,000 Dendreon Corporation DNDN $216,000 NeoStem Inc. NBS $195,000 Osiris Therapeutics, Inc OSIR $474,000 Pluristem Therapeutics Inc. PSTI $195,000 StemCells Inc. STEM $102,000 Average Market Cap $183,000 Cesca Therapeutics KOOL $56, Page

18 Management Highlights Chief Executive Officer & Director Matthew T. Plavan - Leading Cesca since 2012, effected merger with TotipotentRX in 2014, served as COO and EVP Business Development, , CFO from Prior experience includes McKesson/Ernst & Young. President & Director Kenneth L. Harris - Joined Cesca in February 2014 pursuant to merger. Prior experience includes Chairman and CEO of TotipotentRX /MK Alliance, Inc, and Corporate Senior Vice President and Global President of Biosciences of Pall Corporation. Chief Financial Officer Dan T. Bessey - Joined Cesca in March Prior experience includes CFO of SureWest Communications and Vice President of Finance, Controller and Director of Corporate Finance. Chief Biologist Mitch Sivilotti Joined Cesca in February 2014 pursuant to merger. Prior experience includes President, Director and Chief Biologist of TotipotentRX/MK Alliance, Inc. and Pall Corporation. VP, Quality & Regulatory Affairs Raymond DeGrella Consulted for Cesca as VP of Quality and Management Representative since In March 2014 assumed current role. Former experience includes Vice President Advanced Supply Chain of Beckman Coulter, and Abbott Laboratories. VP, Operations Ken Pappa Joined Cesca in April 2006 as Director of Finance and has held several managerial roles until October 2012 when he took on his current role. Prior experience includes Manufacturing Controller and Senior Operations Manager for Hewlett Packard-Agilent Technologies. 18 Page

19 Cesca Therapeutics Regenerative Medicine Investor Checklist Safe - Autologous Clinically effective - Yes Large markets - Multiple Regulatory hurdles - Lower Cost effective - Very Reimbursable Well positioned 19 Page

20 Thank you