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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 Cesca Therapeutics 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 $34 Million
Shares Outstanding 40.4 Million
Options Outstanding 2.4 Million
Warrants Outstanding 5.1 Million
Stock Price $0.83
Average Trading Volume 94 Thousand
Revenue (TTM) $16 Million
Total Assets $56 Million
Debt None
Corporate Headquarters Rancho Cordova, CA
Clinical Research (GLP Labs) Emeryville, CA
India Operations (CRO & GMP Labs) Gurgaon, India
Stock price and market cap as of March 20, 2015
Financials, including options and warrants outstanding as of December 31, 2014
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• Multiple Therapies – 8 Pilot & Phase
1b Clinical Trials
• M&A/Bold on Opportunities to Help
us Further Fill Out our Tools
Capabilities
• Late Stage (Pivotal) Clinical Trials for
CLI
• Safe & Effective; in the Regulatory
“Sweet Spot”
• Rapid; 90 Minute Bedside Protocol
• Low Cost Delivery (No External GMP
Manufacturing or Cold Supply Chain)
• Existing Manufacturing & Selling
Experience
• Devices; Patented Platform
Technology (>40 Issued
Patents)
• Methods; 3 Patents Pending
Methods for CLI, AMI & General
Ischemia
• Biologics Development
• Device Engineering
Development
• Clinical Development
⁻ Clinical Research
Organization (CRO)
Cesca TherapeuticsAn Integrated Regenerative Medicine Company in Late Stage Clinical Trial
Research &
Development
Strong Intellectual
Property
Commercialization
Stockholder
Value
Concept to Commercialization
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Fortis PartnershipCRO Embedded in New Delhi State-of-the-Art Tertiary Care Hospital
Cesca is exclusive regenerative medicine
provider to Fortis
• 72 hospitals (6 countries)
• 10,000 inpatient beds
• 15,000 outpatients per day
• Experienced clinical research staff
• 2x as many sites as Kaiser
Physician/patient access
World class clinical facilities and equipment
Lobby partner with government
Embedded CRO Benefits
• Only cell therapy specialty CRO worldwide
• US FDA registered; FDA accepted foreign trials
• Over 600 patients treated
• Better Control over trial management
• Speed to completion
• 1/5 cost of US/ Europe patient related clinical
trials
Rx Clinical Trial Advantage ($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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Cesca Regulatory AdvantageLower Risk = Speed to Market
HIGH LOWRegulatory Risk
• 3 Phase Trial • 2 Phase Trial
• Higher Trial Patient Population • Lower Trial Patent Population
• Higher FDA Marketing Approval Threshold
• Lower FDA Market Approval Threshold
• Allogeneic Cells • Autologous Cells
• Manipulated Cells • Minimally Manipulated Cells
• Homologous or Non-Homologous
• Homologous or Non-Homologous
IND/NDA or BLA IDE/PMA
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Cesca SurgWerksTM
Indication Specific POC Process Control
SurgWerks POC Advantages:
• Integrated Optimized Devices
• “Smart” cell VXP Cell Processing
System
• Integrated QC System
• Software Driven
• Vision Based
• Autologous (Safe and Fast)
• Data Validated
• Highly Consistent
• Removes Autologous Dose Variability
• 600 Patients Treated Across Eight
Clinical Indications
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Ischemic Cardiovascular
Disease• Critical Limb Ischemia
• Myocardial Infarction
Hematopoietic Stem Cell
Therapy (BMT)• ABO Mismatch
• Haplo-identical
Cell Therapy Priorities
SurgWerks™
CellWerks™
IDE/PMAIntra-operative therapies
510(k)Intra-laboratory devices
Clinical Targets Regulatory Pathway
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Primary Mechanism of Actions• Paracrine Effect and EPCs
⁻ 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
Vascular Cell TherapiesUnderlying Science for Ischemic Diseases - Revascularization
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Vascular Cell TherapiesConfirming Our MOA for Ischemic Diseases with Human Data
IM Delivery of BMMNCs : > 21 Day Life but < 28 Days BMMNC (with EPCs) Initiate Tube Formation
Odaka et al (2011) PLoS One. 6(10):e25487
Verified In Human Trials Ph I/II
Sanghi et al 2013, AMIRST IAMIRST cell product – Cook catheter study, 2014
Kang et al CMAJ, 2004
Bukhari et al, 2013, CLIRST IIn vitro bioactivity data, CLIRST III
Critical Limb Ischemia (CLIRST)
Acute Myocardial Infarction (AMIRST)
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Critical Limb IschemiaCompelling Clinical Vascular Results (CLIRST I)
All patients “no option”, near term leg amputation recommended
12 Month F/U Data
• Major Amputation Free Rate post SurgWerks™ Therapy PP = 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
Day 0 Day 365
CompletedPhase I/II
IDE PMA Path
Pivotal
Submit IDE Amendment Q2 2015
CLIRST I CLIRST III
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Critical Limb IschemiaIDE U.S. Pivotal Clinical Study Application (CLIRST III)
• Double Blinded Randomized Controlled Trial
• 12 Month Follow Up
• Subjects = 224
80% Power, delta of 20pp, dropout of 7%
• Up to 60 Clinical Trial Sites
• Blinded Independent Review Committee
Study Principal Investigator:
• Dr. Richard Powell, M.D.Chief, Vascular Surgery Dartmouth
EndpointsTrial Design
• Primary: Major Amputation Free
Survival
• Secondary:
- Time to Treatment
Failure
- Wound Healing
- Skin Perfusion Pressure (SPP)
- Quality of Life (QoL)
- Ankle Brachial Index (ABI)
- Pain
- Adverse Events (AEs)
- Major Adverse Cardiac Event (MACE)
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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 (AMIRST I)
PilotCompleted
Phase II
Submit Q2 2015Begin Q4 2015
(India DCGI)
AMIRST I AMIRST II
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Faster,Lower Cost,Higher Cell Recovery
CellWerksTM Bone Marrow TransplantAutomating Clinical Major Mismatch & Haplo-identical HSCT Transplant
• Higher - CD34 recoveries = 77.7%
• Lower - hematocrit <12%
• Faster - Neutrophil engraftment = Day 18
• Faster - Platelet engraftment = Day 35
Haplo-identical Clinical Results
Major ABO Clinical Results
510(k) Q4 2015
6,000 = new patients WW
$1,500 = Price of treatment
$9 M = Addressable market
• HLA half match from parent or children
• Fortis-TotipotentRX Center World Class
Transplant Center
• Reduces Expensive Reagent Usage
• Cell Washing without high stem cell loss
6,000 = new patients in India
$25,000 = Price of treatment
$150 M = Addressable market
Enabling 6,000 new
Transplants/Year in India
Phase I/II Q1 2016
Improves Access for Pediatric
BMT (40% are mismatched)
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Clinical Trial Pipeline Major MilestonesSubstantial Clinical Value Drivers
CLI Milestones Calendar Quarter
FDA IDE/PMA Pivotal Trial Resubmission Q2 2015
FDA Approval of Trial Design Q2 2015
First Patient Enrolled Q3 2015
Pivotal Phase Completed Early 2017
CLI PMA Submission (commercialization dependent on US FDA) 2017
BMT Milestones Calendar Quarter
MXP Intra-Operative Device Approval - India Completed February 2015
ABO Mismatch FDA 510(K) Submission Q4 2015
Haplo Pilot Phase Trial Data Published Q1 2016
Haplo India DCGI Submission for Marketing H2 2016
AMI Milestones Calendar Quarter
DCGI Phase II Trial Submission Q2 2015
Phase II First Patient Treated Q4 2015
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Cesca TherapeuticsMarket Cap Snapshot
Cell Therapy Peer Company TCKR Market Capitalization (000's)
Vericel Corporation (Aastrom) VCEL $86,000
Athersys Inc. ATHX $270,000
BioTime, Inc. BTX $416,000
Nuo Therapeutics Inc. (Cytomedix) NUOT $29,000
Neuralstem, Inc. CUR $215,000
Cytori Therapeutics Inc. CYTX $128,000
NeoStem Inc. NBS $126,000
Osiris Therapeutics, Inc. OSIR $613,000
Pluristem Therapeutics Inc. PSTI $200,000
StemCells Inc. STEM $71,000
Average Market Cap $215,000
Cesca Therapeutics KOOL $34,000
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Cesca’s SurgWerksTM & CellWerksTM
Industry Leader in Vascular & Hemotology
Significant commercial experience, proven technical reliability
• Over 20,000 patients treated @ the POC with Cesca Cell Technologies
• Over 2,500 pediatric patients treated with AXP processed cord blood stem cells
• Over 600,000 cord samples processed (laboratory processing & storage)
• Near six-sigma disposable quality levels
Clinically validated, proprietary protocols & method patents
• Proprietary, smart platforms
• Proprietary cell formulations addressing multiple disease indications
• Advantage with IDE regulatory strategy to be first device cell therapy “in a box”
IP Suite (device and algorithm patents)
• 43 Design and device patents
• Three treatment patents (pending) for AMI, CLI and Ischemia diseases (U.S. national phase)
• 8 pilot & phase 1b clinical trials
• 7 clinical algorithms
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Cesca TherapeuticsRegenerative Medicine Investor Checklist
Safe – Autologous; Understood safety
Clinically effective – Yes; Bone Marrow Cells
Large markets – Multiple; Ischemia & BMT Key
Regulatory hurdles – Lower; US IDE Path
Cost effective – Yes; Significantly Lower then Autologous GMP
Reimbursable – Well positioned
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Management HighlightsChief Executive Officer & Director
Robin C. Stracey - Interim CEO having served on Cesca Board of Directors for the past three years. Prior experience
includes President and Chief Executive Officer at both publicly-traded and privately held companies in the life sciences sector,
including Integrated Fluidics, Inc., Cantimer Incorporated, and Applied Imaging Corporation. He has also held senior leadership
roles at Thermo Electron (now Thermo Fisher Scientific) and Dade Behring (now Siemens Healthcare).
President & DirectorKenneth 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.