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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: http://www.cescatherapeutics.com Contact: Investor Relations +1-916-858-5107, or [email protected]
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Cesca Therapeutics Corporate Snapshot
NASDAQ Symbol KOOL
Market Capitalization $56 Million
Shares Outstanding 40.2 Million
Options Outstanding 1.2 Million
Warrants Outstanding 2.8 Million
Stock Price $1.39
Average Trading Volume 169,000
Revenue (TTM) $16 Million
Assets $14 Million
Debt None
Corporate Headquarters Rancho Cordova, CA
India Operations Gurgaon, India Stock price and market cap as of September 3, 2014 Financials as of March 31, 2014
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Cesca Therapeutics Regenerative Medicine Investor Checklist
• Safe? • Clinically effective? • Large markets? • Regulatory hurdles? • Cost effective/reimbursable?
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Cesca Therapeutics An integrated regenerative medicine company
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
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Cesca Therapeutics Go-to-Market Success Formula
Autologous Cells, Minimally Manipulated
Naturally Safest, Regulatory Fast track
=
Bedside, Single Procedure 60 min
Total Process Control, +
CT Development Approach CT Product Attributes
Embedded CRO > 600 Trial Patients
+ =
+ Low COGS
= +
Proven Curative
Rapid CT Development & Commercialization
Multiple Shots on Goal
Blockbuster CT Treatments =
SurgwerksTM
1
2
3
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Cesca SurgwerksTM
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
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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
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Clinical Trial Pipeline Major Milestones Substantial clinical value drivers
CLI Milestones Time Period
FDA IDE/PMA Pivotal Trial Approval March Qtr. 2015
Pivotal Phase Complete Late 2016
CLI PMA Approval/Commercialization Early 2017
BMT Milestones Time Period
ABO Mismatch FDA 510(K) Approval March Qtr. 2015
DCGI Haplo Phase I/II Trial Approval June Qtr. 2015
Haplo Full Market launch/Commercialization 2016
AMI Milestones Time Period
DCGI Phase II Trial Approval June Qtr. 2015
Phase II completed/Data Reported 2016
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Critical Limb Ischemia Compelling clinical vascular results
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
Major Revascularization Trial Results
Completed Phase I/II
IDE PMA
Pivotal
Begin March 2015 Day 0 Day 365
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• 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)
Cardiac Tissue Repair Trial Results
Acute Myocardial Infarction Compelling clinical cardiac results
Pilot Completed
Ph II
Begin June Qtr. 2015 (IDE PMA)
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Bone Marrow Transplant Automating clinical major mismatch & haploidentical transplant
Improves Pediatric BMT (40% are mismatched)
• High - CD34 recoveries = 77.7%
• Low - hematocrit <12%
• Faster - Neutrophil engraftment = Day 18
• Faster - Platelet engraftment = Day 35
Haploidentical Clinical Results
Major ABO Clinical Results
Faster, Lower Cost,
Higher Cell Recovery
510(k) March Qtr. 2015
6,000 = new patients WW
$1,500 = Price of treatment
$9 M = Addressable market
• Reduces Expensive Reagent Usage
• Enables Cell Washing
6,000 = new patients India
$25,000 = Price of treatment
$150 M = Addressable market
Enabling 6k annual patient market in India
Plan to commercialize globally
Phase I/II June Qtr. 2015
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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
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Cesca SurgwerksTM
Sustainable differentiation
Significant commercial experience, proven technical reliability • Over 20,000 patients treated @ 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
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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 $56,000
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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, 2008-2010, CFO from 2005. 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 2013. 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 2012. 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.
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Cesca Therapeutics Regenerative Medicine Investor Checklist
Safe - Autologous Clinically effective - Yes Large markets - Multiple Regulatory hurdles - Lower Cost effective - Very Reimbursable – Well positioned