corporate presentation october 2014 - cesca...
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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.
http://www.cescatherapeutics.com
Investor Contact: Kirin Smith, ProActive Capital Group
+ 1-646-863-6519, or ir@cescatherapeutics.com
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Cesca TherapeuticsCorporate Snapshot
NASDAQ Symbol KOOL
Market Capitalization $51 Million
Shares Outstanding 40.2 Million
Options Outstanding 1.3 Million
Warrants Outstanding 5.1 Million
Stock Price $1.28
Average Trading Volume 80,725
Revenue (TTM) $16 Million
Total Assets $63 Million
Debt None
Corporate Headquarters Rancho Cordova, CA
Clinical Research (GLP Labs) Emeryville, CA
India Operations (CRO & GMP Labs) Gurgaon, India
Stock price and market cap as of October 3, 2014
Financials as of June 30, 2014
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Cesca TherapeuticsAn 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; 60-90 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 TherapeuticsRegenerative Medicine Investor Checklist
• Safe?
• Clinically effective?
• Large markets?
• Regulatory hurdles?
• Cost effective/reimbursable?
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Cesca TherapeuticsGo-to-Market Success Formula
Autologous Cells,
Minimally Manipulated
Naturally Safest,
Regulatory Fast track=
Bedside,
Single Procedure 60-90 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 Regulatory “Sweet Spot”Lower risk = speed to market
• IND/BLA• Trial: Three phases• Higher Trial Patient Pop
• IDE/PMA (US)• Trial: only two phases• Lower Trial Patient Pop
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Cesca SurgWerksTM
Indication specific POC process control
SurgWerks POC Advantages:
• Integrated Optimized Devices
• “Smart” cell VXP System
• Autologous (safe and fast)
• Data validated
• Highly consistent
• Removes autologous dose variability
• 600 patients treated across eight
clinical indications
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Cesca SurgWerksTM
Kit Individualization
• Engineering development collaboration with Cook Medical
• Unique design, pressure regulated
• Licensed device IP and internal method IP
• Proprietary OEM cell harvest technology
• Increases cell recovery
• Maximizes cell viability
• Smart cell vision system – programmable by indication, minimal manipulation
• Infrared optical sensors enable indication specific cell formulations
• Capital purchase & recurring disposable sales
• Strong IP protection (device; method)
• On-board cell diagnostics ensure therapeutic dose
• Proprietary OEM technology (under 2 mins)
• Capital purchase & recurring disposable sales
Harvest
Process
DX
Administer
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Fortis PartnershipCRO 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 MilestonesSubstantial clinical value drivers
CLI Milestones Calendar Quarter
FDA IDE/PMA Pivotal Trial Submission Q4 2014
Pivotal Phase Completed Late 2016
CLI PMA Approval/Commercialization Early 2017
BMT Milestones Time Period
ABO Mismatch FDA 510(K) Submission Q1 2015
Haplo Pilot Phase Trial Data Published Q3 2015
Haplo Full Market launch/Commercialization 2016
AMI Milestones Time Period
DCGI Phase II Trial Submission Q1 2015
Phase II First Patient Treated Q3 2015
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• Primary Mechanism : Paracrine Effect and EPCs– Drives Revascularization
(Collaterals)
• Implanted cells migrate to ischemic regions
• Implanted cells secrete cytokines for mobilization of local tissue stem cells
• Implanted cells secrete cytokines for mobilization of bone marrow stem cells
– Revascularization drives regeneration
Clinical Trial Pipeline Underlying Science (Mechanism of Actions)
Sen et al, Clinical Science (2011) 120; 263-283
Asahara T et al. Science. 1997: 275:964-7Takahashi T et al. Nature Med. 1990:5:434-8
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Clinical Trial Pipeline Confirming Our MOA with Human Data
Critical Limb IschemiaIM Delivery of BMMNCs : > 21 Day Life but < 28 Days BMMNC (with EPCs) Initiate Tube Formation
Odaka et al (2011) PLoS One. 6(10):e25487
Acute Myocardial Infarction
Gnecchi et al (2008). Circ Res. 103: 1204-1219
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Critical Limb IschemiaCompelling 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 RevascularizationTrial Results
CompletedPhase I/II
IDE PMA
Pivotal
Submit Q4 2014 /
First Subject 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 RepairTrial Results
Acute Myocardial InfarctionCompelling clinical cardiac results
PilotCompleted
Ph II
Submit Q1 2015Begin June Qtr. 2015 (DCGI)
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Bone Marrow TransplantAutomating 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 September Qtr. 2015
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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 TherapeuticsMarket Cap Snapshot
Cell Therapy Peer Company TCKR Market Capitalization (000’S)
Aastrom Biosciences Inc. ASTM $66,000
Athersys ATHX $102,000
BioTime, Inc. BTX $239,000
Cytomedix, Inc. CMXI $45,000
Neuralstem, Inc. CUR $284,000
Cytori Therapeutics Inc. CYTX $52,000
Dendreon Corporation DNDN $212,000
NeoStem Inc. NBS $184,000
Osiris Therapeutics, Inc. OSIR $426,000
Pluristem Therapeutics Inc. PSTI $208,000
StemCells Inc. STEM $87,000
Average Market Cap $173,000
Cesca Therapeutics KOOL $52,000As of October 6, 2014
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Cesca TherapeuticsRegenerative Medicine Investor Checklist
Safe - Autologous
Clinically effective - Yes
Large markets - Multiple
Regulatory hurdles - Lower
Cost effective – Yes
Reimbursable – Well positioned
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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, OperationsKen 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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