CXM Investor Presentation

download CXM Investor Presentation

of 46

Transcript of CXM Investor Presentation

  • 8/3/2019 CXM Investor Presentation

    1/46

    October 25, 2011

    Health Sciences& Regenerative

    Medicine

    InvestorPresentation

  • 8/3/2019 CXM Investor Presentation

    2/46

    2

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    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 Cardiums technology by potential corporate partners,capital market conditions, timing of events, cash consumption and other subjects. Actual results could differ materially from these forward-lookingstatements for many reasons, including the risks described under "RiskFactors" in the Companys 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 or achievements 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.

  • 8/3/2019 CXM Investor Presentation

    3/46

    3

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Capital-efficient business strategy focused on finding diamonds in the rough and leveraging

    research and development investments by big pharma, venture and institutional investors Strategyintended to provide a diversified and more balanced portfolio of risk/return opportunities.

    Excellagen Wound Care Management Platform: Initial product has now received FDA 510(k)clearance for U.S. marketing and sales Initial focus on diabetic foot ulcers Other product lineextensions currently under consideration Consistent with business strategy, support initial launch,seed the market, then monetize Now preparing for launch.

    Generx Global Cardiovascular Platform: International cost-efficient Phase 3 / Registration Studynow cleared for initiation Study Design: 100 patients with SPECT imaging efficacy endpoint Initialmedical focus: Patients in Russia with advanced coronary artery disease who have limited access tocostly and rationalized bypass surgery and angioplasty / stent procedures (Russian CVD death rates5X greater than U.S.; average life expectancy for males 57 years) Preparing to initiate.

    MedPodium In-House Brand Platform: Portfolio of premium, science-based, easy-to-use condition-specific nutraceuticals designed to promote personal health and well being for today's active,informed and professional lifestyles Seeking revenue-based strategic acquisitions in thenutraceutical space Preparing for initial retail launch of Nutra-Apps products in selectedgeographic areas.

    Acquisition Search: Challenging economic environment continues to generate a steady stream ofdeal flow CXM remains highly selective focused primarily on late-stage clinical developmentopportunities and revenue-based businesses.

    Key Investor Metrics: No outstanding debt, substantial trading liquidity, continuing news flowexpected Current capital structure provides for significant economic upside potential as CXMexecutes business strategy Capital-efficient ATM Shelf Registration in place.

    Investment Highlights

  • 8/3/2019 CXM Investor Presentation

    4/46

    4

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Company Acquisition CurrentKey Product

    Portfolio ofCardiovascular Growth

    Factor Biologicsfrom Schering AG

    Generx [Ad5FGF-4]

    Phase 3

    Registration Study forInternational Markets

    Endovascular

    TherapeuticHypothermia System

    Strategic

    Sale to

    DNA-ActivatedMatrices for Wound& Orthopedic Repair

    Excellagen Wound CareFDA 510(k)Clearance

    Preparing for InitialMarket Launch

    Portfolio Status

    CollateralTherapeutics

    InnerCoolTherapies

    Tissue RepairCompany

  • 8/3/2019 CXM Investor Presentation

    5/46

    5

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Excellagen

  • 8/3/2019 CXM Investor Presentation

    6/46

    6

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Excellagen: Medical Focus

    ChronicDiabetic

    Foot Ulcers

    OtherWounds:IncludingSurgical& Burns

    Pressure

    Ulcers

    Venous

    Ulcers

    FormulatedCollagen

  • 8/3/2019 CXM Investor Presentation

    7/46

    7

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Wound Care Management PlatformFormulated Collagen Topical Gel

    Highly-Refined Fibrillar Type I Bovine Collagen

    Specialized Formulation

    Kit Provides for up to Four Applications over 12 WeeksImmediately Following SurgicalDebridement Procedure

    Pre-Formulated Ready-to-Use.One 0.5 cc Excellagen Syringe willTreat Wounds up to 5cm 2 in Size

    Pre-Filled Single Use Sterile Syringes

    Refrigerated Storage

    For Professional Use Only

  • 8/3/2019 CXM Investor Presentation

    8/46

    8

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Excellagen: Initial Medical Focus

    Wound Care Management for Diabetic Foot Ulcers

  • 8/3/2019 CXM Investor Presentation

    9/46

    9

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Excellagen Treatment:Diabetic Foot Ulcers

    Debride Treat Bandage Offload1 2 3 4

    www.excellagen.com

  • 8/3/2019 CXM Investor Presentation

    10/46

    10

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Excellagen: Competitive Landscape

    HomeTreatmentby Patient:

    Regranex Topical Gel &OTC Products

    MedicalDevices:

    NegativePressure Wound

    Therapy

    Dermal / TissueEngraftment:

    ProfessionalUse Standard of

    Care Enhancement:Excellagen

    Intregra Flowable Oasis

    Dermagraft

    Apligraf Graftjacket

  • 8/3/2019 CXM Investor Presentation

    11/46

    11

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Excellagen: Strategic Fit with CurrentAdvanced Wound Healing Products

    Advanced Wound Care

    Treatments for Diabetic Foot Ulcers

    Tissue Regeneration

    Advanced Wound Healing

    Professional Use

    Dermal EngraftmentSpecific Therapeutic UseClaims for DFUs OnlyPrep: 24 Step Process(Requiring Documentation)Storage: Frozen (-75 C)

    Higher Cost

    Professional Use

    Adjunct to Standard of CareSurgical DebridementBroad Product Use

    ApplicationsPrep: Ready UseStorage:

    Refrigeration (2

    - 8

    C)Lower Cost

    Dermagraft is a Registered Trademark of Advanced BioHealing, a subsidiary of Shire PLC.

  • 8/3/2019 CXM Investor Presentation

    12/46

    12

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Excellagen: Potential for Diabetic Foot Ulcer Market

    Diabetic Foot Ulcers AnnualU.S. Patients with Diabetic Foot Ulcers 1

    Average Number of PhysicianVisits per Year 2

    Projected Patient Visits InvolvingSurgical Debridement (est. 50%)

    1.3 Million

    14 per patient

    7 per patient

    Potential Number of U.S. SurgicalDebridement Procedures for DFUs 9.1 Million

    Potential Revenue Opportunity at VaryingExcellagen Market Penetration Levels 3

    0.5%1.0%2.0%4.0%6.0%

    8.0%10.0%

    $5 Million$10 Million$20 Million$35 Million$50 Million

    $70 Million$80 Million

    1 American Diabetes Association.2 U.S. Department of Health and Human Services: Agency for Healthcare Research and Quality.

    3 Assumes $95.00 per Excellagen Treatment.

  • 8/3/2019 CXM Investor Presentation

    13/46

    13

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    MATRIX Clinical Study DataThe Science of Formulated Collagen Gel

    Blume P, et al. Wound Repair Regen . 2011 May-Jun;19(3):302-8.

    PeerReviewedMedicalJournalArticle

    Formulated collagen gel causes a large and rapid time-dependent effect on tissue growth rates. A single application increases the healing rate of neuropathic DFUs..., and more frequent applications hold promise to significantly improve overall incidence of complete wound closure.

  • 8/3/2019 CXM Investor Presentation

    14/46

    14

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    In Vitro Research Study DataThe Science of Formulated Collagen Topical Gel

    Activated Platelet Release of PDGF

  • 8/3/2019 CXM Investor Presentation

    15/46

    15

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Diabetic Foot Ulcers: Continuing Unmet Medical Need

    Looking for a New Wound Care Pathway

    Diabetic patients with non-healing footulcers are frustrated and disappointed withtreatment outcomes. Even with access toquality medical care and advanced woundtreatment modalities, patients in Cardiums

    Matrix clinical study had unhealed footulcers averaging 69 weeks (1.3 years).

  • 8/3/2019 CXM Investor Presentation

    16/46

    16

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Excellagen: Web-Based Banner Ad

  • 8/3/2019 CXM Investor Presentation

    17/46

    17

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Excellagen: Web-BasedDirect-to-Consumer Positioning

    Non-healing foot ulcers are serious.If you have received treatment withoutsuccess, become part of the solution,try something new! Find a new woundcare pathway with Excellagen

    Find a New Wound Care Pathway

  • 8/3/2019 CXM Investor Presentation

    18/46

    18

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Generx Late-Stage Clinical Development

  • 8/3/2019 CXM Investor Presentation

    19/46

  • 8/3/2019 CXM Investor Presentation

    20/46

    20

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Cardiovascular Angiogenesis

  • 8/3/2019 CXM Investor Presentation

    21/46

    21

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Generx Potential Economic Opportunity

    Unit VolumeOpportunity per

    Economic Region

    Target Revenue per Dose

    Level I

    $2,000 / dose

    Level II

    $3,000 / dose

    Level III

    $4,000 / dose

    50,000 doses $100 Million $150 Million $200 Million

    100,000 doses $200 Million $300 Million $400 Million

    150,000 doses $300 Million $450 Million $600 Million

    200,000 doses $400 Million $600 Million $800 Million

  • 8/3/2019 CXM Investor Presentation

    22/46

    22

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Generx : Historical Perspective

    CollateralTherapeutics

    (NASDAQ)

    University of CaliforniaSan Diego

    1996

    Discovery, Licensingand Initial

    Preclinical Studies

    1997 - 2005 2005 - Present Current Status

    Schering AG

    Phase 1/2 toPhase 2b/3

    As Strategic Partner with CollateralTherapeutics

    CardiumTherapeutics

    Formed toAcquire

    Technology fromSchering / Bayer

    FDA Phase 3 Clearancewith Fast Track Status& Phase 3 Clearancefor Registration Study

    in Russia

    CommercialInternationalDevelopment

    Activities

    RussiaBrazilIndia

    Schering AcquiresCollateral in 2002

    for $160 Million

  • 8/3/2019 CXM Investor Presentation

    23/46

    23 2011 Cardium Therapeutics, Inc.

    GENERX [Ad5FGF-4]

    Generx [Ad5FGF-4] represents a new regenerativemedicine therapeutic class of DNA-based biologics that

    is being developed for interventional cardiology that isdesigned to promote a disease-modifying physiologicalresponse which stimulates the growth of microvascular circulation based on the one-time administration, using astandard cardiac catheter, as a treatment for patientswith advanced coronary artery disease.

    Generx is currently being developed for internationalmarkets outside the United States as a treatmentalternative for patients who may not have access tocostly and invasive advanced care revascularizationprocedures, including coronary artery bypass surgeryand angioplasty/stents, or may not be optimalcandidates for these procedures.

  • 8/3/2019 CXM Investor Presentation

    24/46

    24

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Non-surgical delivery by intracoronary administration byinterventional cardiologist during an angiogram procedure

    Utilizes standard balloon catheter which can be easily

    integrated into diagnostic angiogram procedures or with other percutaneous 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

  • 8/3/2019 CXM Investor Presentation

    25/46

  • 8/3/2019 CXM Investor Presentation

    26/46

    26

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    DNA-Based Delivery

    Angiogenic ResponseGenerx [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 ofCardiac Microvascular Angiogenesis

    SPECT Imaging

  • 8/3/2019 CXM Investor Presentation

    27/46

    27

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    AGENT 2: Primary Endpoint SPECT Imaging AngiogenicMechanism of Action Study

    p=0.14

    p

  • 8/3/2019 CXM Investor Presentation

    28/46

  • 8/3/2019 CXM Investor Presentation

    29/46

  • 8/3/2019 CXM Investor Presentation

    30/46

    30

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Developing new andinnovative, cost-effective

    advanced care for coronaryheart disease patients ininternational markets

    Generx Cardio Chant

  • 8/3/2019 CXM Investor Presentation

    31/46

    31 2011 Cardium Therapeutics, Inc.

    Generx [Ad5FGF-4]Product Focus for Russian Federation

    Generx is being developed to promote the growth of microvascular circulation in the heart. It is administered by a cardiologist through a cardiac catheter during an outpatient procedure.

    The product is a new treatment option for patients with myocardial ischemia due to advanced coronary artery disease that have limited access to advanced medical care including coronary angioplasty and stents as well as coronary artery by-pass surgery or patients who are

    not optimal candidates for those procedures.A long-term study (n = 845) has shown that patients with a higher collateral blood flow index may have an improved mortality benefit when compared to patients with a relatively lower collateral blood flow index.

    Selected Health Statistics Benchmarks

    Demographic Metrics UnitedStatesRussian

    Federation Variance

    Average Life Expectancy - Males 75 57 1 - 24%

    Cardiovascular Death Rates per 100,000 (Ages 35-74) Males 2 283 1,555 5.5X

    Cardiovascular Death Rates per 100,000 (Ages 35-74) Females 2 145 659 4.5X

    1R I A Novosti, Feb. 2, 2010.2 American Heart Association 2009.

    CONFIDENTIAL

  • 8/3/2019 CXM Investor Presentation

    32/46

    32

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Why Generx for India?64.0 Million Indians are Projected to have

    Coronary Artery Disease by 2015

    Generx [Ad5FGF-4]Coronary Anatomy andCardiovascular Disease

    Issues in India 1

    Simpler administration and cost effective treatmentcompared to bypass and stents

    First non-surgical revascularization therapy

    Stimulates the growth of microvascular circulationin patients with coronary artery disease

    Women and patients with more advanceddisease demonstrated significant treatmenteffect based on distal disease

    New induced transient ischemiatechniques may reduce treatmentvariability in earlier stage patients

    Involvement at younger age

    Smaller coronary arteries

    Diffuse distal disease

    Multi-vessel disease

    Higher incidence in women

    1Source: Cardiovascular Disease Trends in India Naresh Terhan, Escorts Heart Institute and Research Centre

  • 8/3/2019 CXM Investor Presentation

    33/46

  • 8/3/2019 CXM Investor Presentation

    34/46

    34

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c

    .

    We found a significant, gender- specific beneficial effect of

    Ad5FGF-4 on total ETT time, time to

    1 mm ST-segment depression, time to angina and CCS Class in women.This is the first clinical report of a gender difference in response to

    cardiac angiogenic therapy.

    JACCSeptember 11, 2007

    The potential importance of the observed gender-specific

    angiogenic response on the clinical treatment of refractory

    angina is substantial and

    deserves further investigation.

    Generx AGENT 3 & 4

    Summary Research

  • 8/3/2019 CXM Investor Presentation

    35/46

    35

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    A well-functioning coronary collateral circulation saves lives in

    patients with chronic stable coronary artery disease.

    Beneficial Effects of aDisease-Induced

    Angiogenic VascularizationSummary Research

    From Meier et al . Circulation 2007; 116:975-83.

  • 8/3/2019 CXM Investor Presentation

    36/46

    36

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Coronary Artery DiseaseNatural Disease-Induced Angiogenic Vascularization

    ONOFF

  • 8/3/2019 CXM Investor Presentation

    37/46

    37

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    MedPodium Initial ProductsWeb-Based Boutique

    MedPodium is a portfolio of premium, science-based, easy-to-use condition-specific nutraceuticals, metabolics,aesthetics, and other products designed to promote personal health and well being based on natural formulationsfor today's active, informed and professional lifestyles. MedPodium's products address healthy lifestyle intereststhat are increasingly important in our technology-based society, including millennials (young adults aged 20 to 35)who are leading the information revolution. The MedPodiums products will feature sealed capsules, quality, easyto use pills, and will also include, fast-acting drops and sprays, and transdermal delivery system.

    www.medpodium.com

  • 8/3/2019 CXM Investor Presentation

    38/46

    38

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    MedPodium: Product Strategy

    NutraceuticalFormulation

    PharmaceuticalPhilosophy

    X

    MillennialTarget Market

  • 8/3/2019 CXM Investor Presentation

    39/46

    39

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    MedPodium: Product Differentiation

  • 8/3/2019 CXM Investor Presentation

    40/46

    40

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    MedPodium: Conceptual Product Focus

    PositiveBrain

    ChemistryModulators

    MillennialTargetMarket

    (Age 20 35)

    Nutra Apps

  • 8/3/2019 CXM Investor Presentation

    41/46

    41

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    Level I Level II

    Sugar

    Caffeine

    iPod

    Nutraceuticals

    Nicotine

    Alcohol

    Medicinal Marijuana

    ADHD (Ritalin )

    Anxiety ( Xanax )

    Depression ( Prozac, Zoloft )

    Sleep ( Lunesta )

    Relax ( Valium )

    Pain ( Vicoden, Oxycontin )

    MedPodium: Millennial Brain Chemistry Modulators

  • 8/3/2019 CXM Investor Presentation

    42/46

    42

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    MedPodium Nutra-AppsConvenience & Retail Stores

  • 8/3/2019 CXM Investor Presentation

    43/46

    43

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    MedPodium: Nutra AppsCommercial C-Store Positioning

    Conceptual Product Inspiration

  • 8/3/2019 CXM Investor Presentation

    44/46

    44

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    MedPodium: Nutra AppsCommercial C-Store Promotion

  • 8/3/2019 CXM Investor Presentation

    45/46

    45

    2 0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .

    MedPodium: Nutra AppsCommercial Strategy

    Stage I

    2011 2013

    InitialConvenience

    StoreDistribution

    Program

    Stage II

    Broader,Product

    Distribution toFood, Drug

    & Mass Market

  • 8/3/2019 CXM Investor Presentation

    46/46

    0 1 1 C a r d

    i u m

    T h e r a p e u

    t i c s ,

    I n c .