Biotech Showcase 2013 Conference - Issuer...
Transcript of Biotech Showcase 2013 Conference - Issuer...
January 7, 2013
Health Sciences & Regenerative
Medicine
Investor Presentation
The Power of Biology™
Biotech Showcase 2013 Conference
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Forward Looking Statements
This presentation may contain forward-looking statements, includingcomments concerning clinical trials and product development programs,evaluation of potential opportunities, the level of corporate expenditures,the assessment of Cardium’s technology by potential corporate partners,capital market conditions, timing of events, cash consumption and othersubjects. Actual results could differ materially from these forward-lookingstatements for many reasons, including the risks described under "RiskFactors" in the Company’s Annual Report on Form 10-K and QuarterlyReports on Form 10-Q as filed with the Securities and ExchangeCommission. No guarantee about future results, performance orachievements can be made. Neither Cardium nor its agents intend toupdate any of the forward-looking statements after the date of thispresentation to conform them to actual results or to changes inexpectations.
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Cardium: Focus & Key Skill Set
science & medicine
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regulatory matters & processengineering
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marketing & finance
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Focus Technology Platforms Summary
Tissue Engineering:Formulated Collagen and DNA-Activated Matrices for Wound & Orthopedic Repair
Excellagen®
Wound CareFDA 510(k) Clearance
Initial Product IntroductionUnderway
Portfolio ofCardiovascular Growth
Factor Biologics Acquired from Schering AG
Generx®
[Ad5FGF-4] “ASPIRE” Phase 3
Registration Study for International Markets
MedPodium Health SciencesBrand Platform: Organic Mixes, Nutraceuticals
& Dietary Supplements
®
®
Portfolio Status
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Focus Technology Platforms Summary
Tissue engineering and regenerative medicine platform
and DNA-Activated matrices for wound repair & orthopedic
repair and restoration
Planning small, cost-effective Phase 2b/3 study to confirm accelerated DNA-based wound healing. Next generation product
candidate represents first product extension from the FDA-cleared Excellagen technology. Plug-n-Play Phase 3 biologic
product candidates offer considerable economic value opportunity
Medical analytics and e-commerce platform of
algorithms and medical-based social media focused programs
to support specialized survivable risk life insurance underwriting
for cancer patients, cancer survivors and patients with chronic medical diseases
Millions of cancer survivors remain uninsurable by traditional life insurance
underwriting standards. Cardium is developing new scalable methodologies designed to assess relative survival risks for life insurance companies to address
this significant under-appreciated economic opportunity
MedPodium Health Sciences in-house brand platform:
organic mixes, nutraceuticals and dietary supplements
Leverage TO GO BRANDS® established infrastructure, distribution capabilities and retail network to support external product
acquisitions and strategic partnerings
Strategic Partner-Enabled Opportunities
Distribution & Logistics Platform
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Capital-efficient, asset-based, business strategy focused on finding “diamonds in the rough” and leveragingresearch and development investments by big pharma, venture and institutional investors │ Strategy intended toprovide a diversified and more balanced portfolio of risk/return opportunities
Excellagen® Advanced Wound Care Management Platform: FDA 510(k) clearance for U.S. marketing and sales │International CE mark registration targeted for 1Q/2013 │ Initial focus on diabetic foot ulcers │ Consistent withbusiness strategy, support initial market introduction, seed the market, then monetize through strategicpartnerships and distribution deals in U.S. and international markets │ Strategic partnering process underway │CPT® code reimbursement in place (for surgical debridement using Excellagen) │ CMS and private payorreimbursement plan progressing │ Recently announced marketing and sales agreement with Academy Medical forU.S. Government installations including Veterans Administration and military hospitals
Generx® Global Cardiovascular Platform: International cost-efficient “ASPIRE” Phase 3 / Registration Studyunderway │ Study Design: 100 patients with SPECT imaging efficacy endpoint │ Initial medical condition: CardiacMicrovascular Insufficiency (CMI) for patients with myocardial ischemia with symptomatic chronic stable anginadue to coronary artery disease
MedPodium® In-House Brand Platform: Portfolio of premium, science-based, easy-to-use nutraceuticals designed topromote personal health and well being for today's active, informed and professional lifestyles │ Recentlyannounced the acquisition of To Go Brands® to support logistical infrastructure to accelerate revenue
Cardium Werks™: Portfolio of strategic partner-enabled product and platform opportunities that have beeninternally developed based on Cardium’s unique skill set, capabilities and technology │ Genedexa™: a Phase 2b/3DNA-based wound healing product candidate representing the first product extension from the FDA clearedExcellagen technology │ LifeAgain™: a medical analytics and e-commerce platform of algorithms and medical-based social media focused programs │ To Go Brands®: leverage established logistics and retail platform tomarket, distribute and sell new products based on internal development and external acquisitions │ Alternativeindependent financing strategies may be utilized to support these opportunities
Key Investor Metrics: No outstanding debt, substantial trading liquidity, continuing news flow expected fromproduct platforms and other opportunities under consideration │ Current capital structure provides for significanteconomic upside potential as CXM executes its asset-based business strategy │ Capital-efficient ATM ShelfRegistration in place
Investment Highlights
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Excellagen is an FDA-cleared syringe-based flowable topical gel that promotes theactivation of the healing process for the treatment of dermal wounds. It is designed toaccelerate granulation tissue growth in non-healing wounds and activates platelets,triggering the localized release of endogenous growth factors including Platelet-DerivedGrowth Factor (PDGF), a key biologic mediator of wound healing.
It is indicated for the treatment of a broad array of wounds including partial and full thicknesswounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers,tunneled/undermined wounds, surgical wounds (donor sites/ grafts, post-Mohs surgery,post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations,second-degree burns, and skin tears) and draining wounds.
Excellagen®Pharmaceutically-Formulated Collagen (2.6%)
Acellular Biological Modulator
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Excellagen® Summary & Commercialization Status
Excellagen is the best-in-class acellular biological modulator designed to accelerate the growth of granulation tissue for wound healing
FDA 510(k) clearance for treatment of a broad array of dermal wounds
Initial medical focus: Diabetic Foot Ulcers
Competitively positioned via aseptically manufactured, pharmaceutically-formulated collagen, flowable syringe-based format, ease and simplicity of use
Matrix multi-center clinical study shows significant tissue growth and positive wound closure versus control at 12 weeks based on average of 1.6 treatments
Matrix Excellagen clinical study data published in peer-reviewed journal
®
Post-marketing in vitro study supports platelet activation triggering the release of endogenous PDGF, an important wound healing mediator
Market introduction underway to KOLphysicians
Unified packaging, web site and DTCpositioning complete
Selected as 2012 Top 10 Innovation in Podiatry by Podiatry Today magazine
Uses controlled temperature storage (2-8°C) to maintain bio-activity
Outsourced supply chain fully operational including U.S. cold chain distributor: Smith Medical Partners
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Excellagen® Summary & Commercialization Status
Medical Advisory Board established; sampling and case studies advancing
International CE mark registration in progress, (expected 1Q/2013)
New product CMS reimbursement submissions completed
Current CPT® procedure codes cover use with debridement for DFUs
Fully validated cGMP and ISO-certified collagen manufacturing process and facilities
Aseptic manufacturing process utilizes cost-effective, single-use, disposable bio-process components and avoids potentially inactivating terminal sterilization
®
Enabling product extensions for new and innovative regenerative medicine product formulations
Initial broad labeling allows for conduct of cost-efficient, post-marketing studies for specifically narrowed and higher economic value product labeling claims
Excellagen uses subject of patent applications
In discussions with potential strategic partners to support marketing and sales into four vertical markets: (1) podiatry; (2) dermatology; (3) wound care centers and hospitals; and (4) government healthcare system markets
Recently announced marketing and sales agreement with Academy Medical for U.S. government medical providers
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Excellagen: Integration into the Practice of Medicine
Stage I
Debridement & Dressing
Stage II Stage III
NormalHealing Response
Excellagen is an acellular biological modulator. It is comprised of flowablefibrillar Type I bovine collagen gel that is configured into a staggeredquaternary array of three-dimensional triple helical, telopeptide-deletedtropocollagen molecules. This configuration provides a structural scaffoldfor cell adhesion, migration and proliferation, and a bioactive substrate forplatelet activation and release of essential growth factors including platelet-derived growth factor (PDGF).
Diabetic Foot Ulcers
Diabetic Foot Ulcers
Diabetic Foot Ulcers
Debridement, Excellagen®
& Dressing
DermaGraft®
Apligraf®
NPWT
StalledHealing Response
ChronicNon-Healing (> 6 weeks)
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Simple | Flowable | Ready to UseOnce Weekly Treatment
Excellagen®: Technology & Formulation®
FDA-Cleared, Specialized
Aseptic Process & Clinical Study Data Published in Peer Review Journal
Functional Pharmaceutical
Excipients
High Molecular Weight Fibrillar Type I
Bovine Collagen
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Excellagen®: Advanced Wound Care Management Platform
Refined custom formulated fibrillar Type I bovine collagen
High molecular weight
Biocompatible, physiologic pH
Pre-filled, ready to use syringes
Simple and easy: no thawing or mixing
Flowable: no staples or sutures
Viscosity optimized for complete, dripless wound coverage
Treatment at only one week intervals
Excellagen has been shown to activate human platelets, triggering the release of Platelet-Derived Growth Factor (PDGF)
Formulated collagen (2.6%) accelerates growth of granulation tissue immediately following treatment compared to standard of care control arm (n=45 / P=0.018) based on Matrix Clinical Study. Blume et al., Wound Rep. Reg. 19: 302-308 (2011).
Refrigerated storage required: Cold Chain logistics partner: Smith Medical
For professional use only; established standard CPT® procedure codes may apply when used with debridement
Each kit contains four single-use syringes containing 0.5cc of Excellagen topical gel and four sterile flexible applicators
®
engineered for debridement procedures
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Excellagen: Next Generation Product Format
®
0.5cc/syringeSyringe Format
0.5cc/ampuleAmpule Format
First Generation Next Generation
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Excellagen® Treatment:Diabetic Foot Ulcers
Debride Treat Bandage Offload1 2 3 4
www.excellagen.com
®
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In Vitro Research Study DataExcellagen Activates the Healing Process
Activated Platelet Release of PDGF
The Power of Biology™
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Excellagen: Post-Marketing Case Studies®
Excellagen® Pharmaceutically-Formulated Collagen Topical Gel Accelerates Healing Rate Immediately After Application in Patients with Diabetic Neuropathic Foot Ulcers1
Acellular Biological Modulator
42 Days Stalled: 4 Excellagen® Applications49 Days to Closure
1 2
3 4
1 2
3 4
240 Days Stalled: 5 Excellagen® Treatments63 Days to Closure
1 Blume et al., Wound Rep. Reg. 19: 302-308 (2011).
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0
20
40
60
80
100
0 1 2 3 4 5 6 7 8 9 10 11 12
% Area Re
duction
Weeks
% Area ReductionCase 2
Zimny Pfohl
Excellagen: Tissue Regeneration Case Studies®
Acellular Biological Modulator
Excellagen® Pharmaceutically-Formulated Collagen Topical Gel Accelerates Healing Rate Immediately After Application in Patients with Diabetic Neuropathic Foot Ulcers2
42 Days Stalled: 4 Excellagen® Applications49 Days to Closure
240 Days Stalled: 5 Excellagen® Treatments63 Days to Closure
Healing Prediction Study Baseline1
Healing Prediction Study Baseline1
1Healing Times and Prediction of Wound Healing. Zimny S. and Pfohl M. Exp. Clin. Endocrinol Diabetes 113:90-93 (2005).
2Blume et al., Wound Rep. Reg. 19: 302-308 (2011).
0
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40
60
80
100
0 1 2 3 4 5 6 7 8 9 10 11 12
% Area Re
duction
Weeks
% Area ReductionCase 1
Zimny Pfohl
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MATRIX Multi-Center Controlled & Randomized Metrics of Tissue Growth Wound Study
Bio-Metric
Pre-Specified MatrixProtocol Assessment:
Wound Size Reduction (n = 47)
Pharmaceutically-Formulated Collagen
2.6%Standard of Care ∆ Percent
Improvement(n = 31) (n = 16)
Average Wound Size 3.0 cm2 3.0 cm2 X
Wound Size (Area) Reduction @ Week 1
37% 12%1 ∆ + 208%(p = 0.018)
Cumulative Wound Size (Area) Reduction @ Week 2 49% 24%1 ∆ + 104%
(p = 0.032)
Wound Size (Area) Reduction @ Week 1
37% 8%2 ∆ + 362%
Cumulative Wound Size (Area) Reduction @ Week 2 49% 15%2 ∆ + 227%
Matrix: Tissue Regeneration®
1Blume et al., Wound Rep. Reg. 19: 302-308 (2011).2Healing Times and Prediction of Wound Healing. Zimny S. and Pfohl M.
Exp. Clin. Endocrinol Diabetes 113:90-93 (2005).
Matrix Non-Healing Ulcers: Excellagen vs. Control1
Excellagen vs. Healing Prediction Study2
One Excellagen Treatment
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Commercial Business: Vertical Marketing & Sales Opportunities
Hospital, Wound Healing
Centers & Long-Term Facilities
Podiatry Focus
U.S. Government including Veterans
Administration & military hospitals
Dermatology Focus
International Markets
®
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Excellagen: Strategic Fit with CurrentAdvanced Wound Healing Products
Advanced Wound Care
Bioresorable Scaffold with Metabolically Active Living Cells Higher Priced
Professional Use
Dermal Engraftment
Specific Therapeutic Use Claims for Treatment of Diabetic Foot Ulcers Only
Cold Chain Distribution
Lower Priced
Professional Use
Adjunct to Surgical Debridement Standard of Care
Broad Product Use Applications
Cold Chain Distribution
Dermagraft® is a Registered Trademark of Advanced BioHealing, a subsidiary of Shire PLC.
®
Acellular Biological Modulator
Advanced Wound Healing
Tissue Regeneration
Treatments for Diabetic Foot Ulcers
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Excellagen: Strategic Fit with CurrentAdvanced Wound Healing Products
®
Regenerative Medicine
Advanced Wound Care
FDA-Cleared
Professional Use
Adjunct to Platelet-Rich Plasma Therapy
Broad Product Use Applications
Platelet Growth Factor Activation
Autologous Platelet-Rich Therapy
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Medical Condition Wound Type Incidence
Illness
Venous Ulcers 1,625,000
Arterial ulcers 1,725,000
Diabetic foot ulcers 1,260,0001
Immobility Pressure Ulcers 2,500,000
Surgical
Surgical Wounds: Major 36,000,000
Surgical Wounds: Moderate/Minor 31,000,000
Mohs Surgery 850,000
Trauma
Burn injuries 1,285,000
Amputations 150,000
Traumatic Wounds/Lacerations2 16,250,000
TOTAL 92,645,000
Excellagen U.S. Market Opportunities: Beyond Diabetic Foot Ulcers
Source: Medtech Insight1Source: American Diabetes Association2Traumatic wounds/lacerations consist of open wounds (approx. 8.7 million), superficial wounds
(approx. 1.7 million), and contusions (approx. 5.8 million) seen in emergency rooms.
®
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Excellagen® Medical Opportunity
Chronic Diabetic
Foot Ulcers
Other Wounds: Including Surgical & Burns
Pressure Ulcers
Venous Ulcers
®
Activate the Healing Process
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Patient Demographic Data
Age 62
Sex Male
General Health Status Venous Insufficiency
Wound Duration Prior to Treatment 13 Months
Prior Therapies Anticoagulants, Four-layer compression dressing
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Excellagen® Case Study: Venous Leg Ulcer®
Arthur Tallis, DPM, FACFASPhoenix, AZ
Day 1: Pretreatment Day 56: After 4 applications of Excellagen (Unna boot worn from Day 27-56)
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Patient Demographic Data
Age 75
Sex Male
General Health StatusNursing home resident with dementia. Mohs surgery performed on
recurrent squamous cell carcinoma. Repair with skin grafting not feasible due to expectation that patient would disturb surgical dressings.
Mohs Surgical Site Left-Posterior Ear/Mastoid
Excellagen Treatment Days 4, 14, and 22 post-surgery
Day 14: After One Excellagen Treatment
Day 22: After Two Excellagen Treatments
Day 49: After Three Excellagen Treatments. Full Re-Epithelization
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Excellagen® Case Study: Mohs Surgery®
“Excellagen gel proved to be an outstanding healing agent for an extensive Mohs surgery wound. It is an economical alternative to costly skilled nursing care.”
Steven Smith, MD, Wellesley, MA
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Patient Demographic Data
Age 68
Sex Male
General Health Status Obese, Wheelchair-Dependent, Type II Diabetes
Wound Location Left Plantar Heel- formed at pressure point (foot rest of wheelchair)
Wound Duration Prior to Treatment 16 Weeks
Prior Therapies Debridement, Hydrophilic Wound Dressing, Pressure-Relieving Padding
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Excellagen® Case Study: Pressure Ulcer“Noticed healing accelerated after first week-I was pleasantly surprised. I’m very pleased”
Curtis Long, DPM, Walla Walla, WA
5/21/2012: Wound Area 3.5 cm2.Sharp Debridement Followed
by Excellagen Application
7/16/2012: Complete WoundClosure at 8 weeks After Single
Application of Excellagen
®
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Advanced Modality Cost Comparison for Wound Therapies
1Excellagen® assumes 4 treatments.2Assumes 2 treatments.3Based on 16 weeks of DFU treatment of NPWT in accordance with RCT.4Based on an average of 4 surgical applications (per Policy up to 5 surgical applications are allowed).5Based on an average of 6 surgical applications (per Policy up to 8 applications are allowed).
$0
$5,000
$10,000
$15,000
$20,000
Estimated costs associated with full 12 weeks of DFU treatment including physician and nursing time, facility charges,
treatment costs and associated standard of care.
$600
$3,590
$13,900
$8,100
$11,600
Excellagen®
Topical Gel1KCI
GraftJacketXpress Gel®2
Negative Pressure Wound
Therapy3
Apligraf4 Dermagraft5
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Peptides
DNA-Based Biologics
Excellagen: Enabling Delivery Platform
®
Anti-microbials
Small Molecule
Drugs
PluripotentStem Cells
Conditioned Cell Media
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CardiumWerks™: GenedexaNext Generation DNA-Based Wound Healing Therapeutic
Excellagen Technology
Platform
Phase 1 & 2Clinical Studies Manufacturing
Know-How & Expertise
Adenovector DNA-Based
Delivery (Ad5)
PDGF-BBGrowth Factor
Gene• Planning CXM-Supported Small
(10-20 Patient) Confirmatory Phase 2b/3 Clinical Study
• Strategic Partnered-Enabled Phase 3 Product Opportunity
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Interventional cardiology-focused product candidate that is being developed for a medicalcondition termed Cardiac Microvascular Insufficiency (CMI) in patients with myocardialischemia and symptomatic chronic stable angina pectoris due to coronary artery disease.
Patients with CMI have had an insufficient angiogenic response to their current diseasestate and may benefit from a therapy to biologically enhance cardiac perfusion through thefacilitation of collateral vessel formulation.
This condition is diagnosed by SPECT imaging, and other catheter-based diagnostictechniques.
Generx®[Ad5FGF-4]DNA-Based Angiogenic Therapy
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Coronary Artery DiseaseDisease-Induced Angiogenic Response
ONOFF
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“A well-functioning coronary collateral circulation saves lives in
patients with chronic stable coronary artery disease.”
Beneficial Effects of a Disease-Induced
Angiogenic Vascularization Summary Research
From Meier et al. Circulation 2007; 116:975-83.
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Generx®: Historical Perspective
Collateral Therapeutics
(NASDAQ)
University of California San Diego
1996
Discovery, Licensing and Initial
Preclinical Studies
1997 - 2005 2005 - Present Current Status
Schering AG
Phase 1/2 to Phase 2b/3
As Strategic Partner with Collateral Therapeutics
CardiumTherapeutics
Formed to Acquire
Technology from Schering / Bayer
FDA Phase 3 Clearance with Fast Track Status & Phase 3 Clearance for Registration Study
in Russia
Commercial International Development
Activities
RussiaBrazilIndia
Schering Acquires Collateral in 2002 for $160 Million
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Generx® [Ad5FGF-4] Clinical & Commercial Development Activities
AGENT 1–4 Phases 1 & 2/3 Clinical Studies
Treatment: Stable Angina for Patients with “Refractory” Coronary
Artery Disease
Primary Endpoint: ETT Improvement
650 Patients at 100 Medical Centers
ASPIREPhase 3
Clinical Study
Treatment: Patients with Myocardial Ischemia Due to
Coronary Artery Disease
Primary Endpoint: RPDS Improvement as Measured by SPECT
100 Patients
Cardium Innovations
• Expanded target coronary artery disease patient population
• Established new quantitative primary efficacy endpoint using SPECT imaging
• New balloon catheter-based delivery techniques to leverage Cardium’s transient ischemia discoveries to boost cell transfection
• Developed new “bio-assay” production batch release assay that measures angiogenic response to Generx
• Five-year real-time product stability (at -70°C) confirmed
• Simplified and standardized new cath lab product preparation techniques
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Generx®: Current Global Clinical Study Status
Elements U.S. Market(AWARE)
International Markets (Initially Russian Federation)
(ASPIRE)
Product Generx® [Ad5FGF-4](alferminogene tadenovec)
CardioNovo [Ad5FGF-4](alferminogene tadenovec)
Clinical Status FDA Clearance Phase 3 (with Fast Track Status)
RHA Cleared Phase 3 /Registration Study
Clinical Study Population300 Women Multi-Center,
Randomized, Placebo-Controlled Patient Population
100 Men & WomenMulti-Center, Randomized, Controlled Parallel-Group
Patient Population
Proposed Medical IndicationAnti-Angina for Refractory
Patients who are not Optimal Candidates for Angioplasty /
Stents & Bypass Surgery
Myocardial Ischemia as a Treatment Option for Patients
Considering Angioplasty / Stents & Bypass Surgery
Clinical Endpoint Improvement in Exercise Time Based on Treadmill
Improvement in Reversible Perfusion Deficit Based on
SPECT Imaging
Clinical Study Status Pending Completion of International Studies Initiated 2012
®
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Traditional Drug
Therapy
(CABG) Coronary
Artery Bypass Surgery
(PTCA) Percutaneous Transluminal
CoronaryAngioplasty
& Stents
Generx®
Non-Surgical DNA-Based Angiogenic
Therapy
Coronary Artery
Disease
Potential Therapeutic Positioning: Generx® / Cardionovo®
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Non-surgical delivery by intracoronary administration byinterventional cardiologist during an angiogram procedure
Utilizes standard balloon catheter which can be easilyintegrated into diagnostic angiogram procedures or with otherpercutaneous coronary interventions
New induced transient ischemia / reperfusion techniques aredesigned to enhance DNA uptake and expression in the heart
40% administered to right coronary circulation and60% to left coronary circulation
Generx® [Ad5FGF-4]Proprietary Intracoronary Administration of
DNA-Based Cardiovascular Growth Factor Therapeutic
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Generx® [Ad5FGF-4]
Catheter-Based Intracoronary Delivery
Angiogenic Microvascular Circulation
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DNA-Based Delivery
Angiogenic Response
Generx [Ad5FGF-4](alferminogene tadenovec)
Generx has been evaluated in studies of over 650 patients (including 450Generx-treated patients) in four multi-center, double-blind, placebo-controlledclinical studies at 100 medical centers. Generx is the most clinically advancedDNA-based cardiovascular angiogenic growth factor therapeutic in the world.
AGENT-2 - Representative Generx-treated patient: 77%improvement in cardiac perfusion at 8 weeks equivalentto bypass surgery and PCI (angioplasty/stenting) at one year.
One-Time Treatment
The Therapeutic Process of Cardiac Microvascular Angiogenesis
SPECT Imaging
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Effect of Chronic Angina Treatment with Ranexaand Single Intracoronary Administration of
Generx (Ad5FGF-4) on ETT Duration at 12 Weeks (Difference from Placebo)
0
25
50
75
100
*
* P > 0.05 vs. placebo
Chronic Anti-Anginal Drug
1000 mg Daily
Ranexa
Baseline ETT (sec): 470% increase + 5%
Mea
n ch
ange
from
Bas
elin
e (s
ec)
*
Baseline ETT (sec): 300% increase + 25%
GenerxOne Time
Non-Surgical Angiogenic
Therapy
(n = 30) (n = 255)
ETT
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Technology Platform: Non-Surgical DNA-Based Angiogenic Therapy
Methods of Intracoronary DNA-Based Angiogenic
Therapy
Manufacturing Know-How & Expertise
Adenovirus DNA-Based
Delivery (Ad5)
Angiogenic Growth Factor
(FGF-4)
X
Generx® [Ad5FGF-4](alferminogene tadenovec)
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Generx®
Demonstrated CV Safety Database with FDA
Established FDA Manufacturing Standards
High Cardiac Transfection Levels due to a Binding Affinity with CAR Receptors and Enhanced by Ischemia
Transient Expression -Does Not Integrate into Host Genome
Manufacturing in High Titer
Easily Manipulated
Relatively Low Cytotoxity
Mutagenesis Improbable
Very Favorable Manufacturing Cost
DNA-Based Adenovector Cassette
Research Studies:Intracoronary Administration
CoronaryExtraction Rate
Pre-Clinical Porcine StudyGiordano et al. Nat Med 1996;2:(5):534 98% (mean)
Phase 1/2 Clinical Study – AGENT TrialGrines et al. Circulation 2002;105:1291 87% (median)
(alferminogene tadenovec)
Adenovector constructCarries the FGF-4 Gene
for Cardiac Delivery
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Generx Dose Response Bioactivity AssayVisualization of the Angiogenic Process
by Endothelial Tube Formation
Representative Images (T=13.5 days) of rhFGF-4 stimulation of angiogenic networks in the Essen BioScience HUVEC TubeFormation Assay. E, 1ng/mL rhFGF-4 induced HUVEC clustering as well as a small amount of tube formation. F, 2ng/mL rhFGF-4 inducedclusters and tube formation. G, 4ng/mL rhFGF-4 initiated HUVEC differentiation into longer tubes and more complex networks, as observed bythe increase in branching. H, 8ng/mL rhFGF-4 stimulate significant tube and network formation.
1ng/mL 2ng/mL 4ng/mL 8ng/mL
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Science-Based Lifestyle Solutions
Cardium (CXM) announces acquisition of To Go Brands®
MEDPODIUM Health Sciences
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To Go Brands® develops markets and sells a portfolio of über healthy,science-based, great tasting, anti-oxidant rich, super-charged phytonutrientsand nutraceuticals supplements in an array of easy use formats, includingdrink mixes, chews, powders and capsules, to empower busy lifestyles intoday’s fast-paced, teach driven world. These products are sold through thecompany’s web-based store and food, drug and mass channels at retailers.
Go Active! | Go Healthy! | Go Trim!
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Cardium: Expanded Health Sciences Platform
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Cardium Acquisition: To Go Brands®
Founded in 2007, To Go Brands is a privately-held San Diego-based company that develops, markets and sells a portfolio of over 25 products, including nutraceutical powder mixes, supplements and chews to support healthy lifestyles.
Acquisition is focused on accelerating the growth and development of Cardium’s in-house MedPodium brand platform. This transaction provides:
portfolio of marketed products
established logistics and distribution capabilities
a website e-commerce platform
experienced management team with key contacts and a track record of developing and placing new and innovative health and nutraceutical products into the mass, food and drug retail channels
revenue platform with growth potential.
To Go Brands will coordinate Cardium’s health sciences brand platform including MedPodium Nutra-Apps® product line, as well as the strategic investment in SourceOne Global Partners.
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To Go Brands®: Current Retail Platform
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To Go Brands®: Energy & Weight Management
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To Go Brands®: Product Portfolio
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To Go Brands®: Product Formats
Stick Packs
Chews
Scoop
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To Go Brands®: Spotlight on Product Portfolio
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To Go Brands®: Portfolio Intersection
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Focus Technology Platforms Summary
Tissue engineering and regenerative medicine platform
and DNA-Activated matrices for wound repair & orthopedic
repair and restoration
Planning small, cost-effective Phase 2b/3 study to confirm accelerated DNA-based wound healing. Next generation product
candidate represents first product extension from the FDA-cleared Excellagen technology. Plug-n-Play Phase 3 biologic
product candidates offer considerable economic value opportunity
Medical analytics and e-commerce platform of
algorithms and medical-based social media focused programs
to support specialized survivable risk life insurance underwriting
for cancer patients, cancer survivors and patients with chronic medical diseases
Millions of cancer survivors remain uninsurable by traditional life insurance
underwriting standards. Cardium is developing new scalable methodologies designed to assess relative survival risks for life insurance companies to address
this significant under-appreciated economic opportunity
MedPodium Health Sciences in-house brand platform:
organic mixes, nutraceuticals and dietary supplements
Leverage TO GO BRANDS® established infrastructure, distribution capabilities and retail network to support external product
acquisitions and strategic partnerings
Strategic Partner-Enabled Opportunities
Distribution & Logistics Platform
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Cardium: Focus & Key Skill Set
science & medicine
4
2
regulatory matters & processengineering
3
marketing & finance
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CardiumWerks™: GenedexaNext Generation DNA-Based Wound Healing Therapeutic
Excellagen Technology
Platform
Phase 1 & 2Clinical Studies Manufacturing
Know-How & Expertise
Adenovector DNA-Based
Delivery (Ad5)
PDGF-BBGrowth Factor
Gene• Planning CXM-Supported Small
(10-20 Patient) Confirmatory Phase 2b/3 Clinical Study
• Strategic Partnered-Enabled Phase 3 Product Opportunity
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Demonstrated Phase 1/2 Safety Data with FDA
No Cytotoxicity Observed
Established FDA Manufacturing Standards
Manufacturing in High Titer
Favorable Manufacturing Costs
High Dermal Transfection Levels
Transient Expression
Mutagenesis Improbable
DNA-Based Adenovector Cassette
Research Studies:Topical Administration
Preclinical Efficacy StudiesDoukas et al; Human Gene Therapy 2001 12:783-798 Gu et al; Wounds 2004 16:34-41
Toxicology and BiolocalizationGu et al; Molecular Therapy 2004 9:699-711
Genedexa
Adenovector constructCarries the PDGF-B Gene
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Genedexa: Stimulates Increased Granulation Tissue
Collagen without Platelet Activation
Cartilage removed Day 7, 20x, Ad5PDGF-B 2.3x109 vp, Ad5Luc 6x109 vp
Ad5Luc/Collagen
Genedexa™Ad5PDGF-BB (saline)
Synergistic Effect of
Collagen and Ad5PDGF-B
Granulation Tissue Growth
Doukas et al. Hum Gene Therapy, 2001 Vol 12(7)
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Genedexa [Ad5PDGF-B] Induces Increased Granulation Tissue and Re-Epithelialization
4E + 9 PN AdPDGF-B2.6% Collagen gelN = 6Day 8
0
5
10G
ranu
latio
n Ti
ssue
Are
a (m
m2 )
±SD
0.0
0.5
1.0
Epith
eliu
m A
rea
(mm
2 ) ±
SD
** P = 0.001
Collagenw/o Platelet Activation
*
* P = 0.009
AdPDGF-B Collagenw/o Platelet Activation
AdPDGF-B
Pre-Clinical Studies
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Estimated Number of US Cancer Survivors
61
Sources: Data Modeling Branch, Division of Cancer Control and Population Sciences, National Cancer Institute; American Cancer Association.
Form of Disease Current 2012 Projected 2022
Prostate 2,778,630 3,922,600
Breast 2,971,610 3,786,610
Thyroid 436,590 609,690
Testis 230,910 295,590
Melanoma 977,250 1,324,260
Hodgkin's Lymphoma 534,950 713,810
Other 5,670,060 7,347,440
Total 13.6 Million 18.0 Million
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Percentage of U.S. Households Owning Individual Life Insurance
62
Source data: LIMRA’s 2010 Life Ownership study.
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Despite all time low priced web-based life insurance premiums, policy ownership is at a 26-year low
Percentage of Adults Admitting “I Need More Life Insurance”
63
= 117 million adults
Source data: U.S. Census – 2010; LIMRA’s 2010 Life Ownership study.
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LifeAgain Case Study:Advances in Prostate Cancer Survival
1Source data: National Cancer Institute from Surveillance, Epidemiology and EndResult Program (SEER) Survival Monograph. Chapter 22.
Prostate CancerRelative Survivor
Rate
Relative Survival Rates as of 19841
Five Year Ten Year
72%58%
Current Relative Survival Rates1
Five Year Ten Year
100%100%
Median Age of Death for Cancer of the Prostate in the U.S.1 80 years
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New Prostate Cancer Drug Pipeline
Drug Mechanism of Action Status
Jevtana®
Sanofi Microtubule Inhibitor Approved in 2010
Provenge®
Dendreon Therapeutic Vaccine Approved in 2010
Zytiga®
Johnson & JohnsonAndrogen
Biosynthesis Inhibitor Approved in 2011
MDV3100®
Astellas/MedivationAndrogen Receptor Signaling Inhibitor
Successfully completed Phase 3
Alpharadin®
Algeta/BayerRadiopharmaceutical Successfully
completed Phase 3
Tasquinimod®
Ipsen/Active BiotechAnti-angiogenic Currently in Phase 3
Continued improvement in medical care and therapeutic drugs are expected over the next decade!
2013
Cardium
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The Power of Simply Being There When Others Are Not!
“We just got married and
we need some life insurance”
“Now that we’re parents, we should
increase our life insurance coverage”
“As new homeowners, we need more life insurance”
“My father just passed away.
I need to rethink my life insurance”
“I’ve just been diagnosed with cancer and
I don’t have enough
life insurance”
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