Biotech Showcase 2013 Conference - Issuer...

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January 7, 2013 Health Sciences & Regenerative Medicine Investor Presentation The Power of Biology™ Biotech Showcase 2013 Conference

Transcript of Biotech Showcase 2013 Conference - Issuer...

Page 1: Biotech Showcase 2013 Conference - Issuer Directedg1.precisionir.com/companyspotlight/NA016283/...2013 Cardium Therapeutics, Inc. Forward Looking Statements This presentation may contain

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

4

2

regulatory matters & processengineering

3

marketing & finance

1

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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

20

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

1

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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

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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

 The

rape

utics, In

c.

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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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