SlideShare a Scribd company logo
1 of 44
15-Jan-13




                                                                   Product &
                                                                  Technology
                                                                   Overview
 2013 Cardium Therapeutics, Inc.




                                         Generx      ®


                                    Angiogenic Therapy
                                    Regenerative Medicine for
                                    Interventional Cardiology       DNA-Based
                                                                   Non-Surgical
                                                         1      Angiogenic Therapy
Forward Looking Statements

                                    This presentation may contain forward-looking statements, including
                                    comments 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 other
                                    subjects. Actual results could differ materially from these forward-looking
                                    statements for many reasons, including the risks described under "Risk
                                    Factors" in the Company’s Annual Report on Form 10-K and Quarterly
                                    Reports on Form 10-Q as filed with the Securities and Exchange
                                    Commission. No guarantee about future results, performance or
                                    achievements can be made. Neither Cardium nor its agents intend to
 2013 Cardium Therapeutics, Inc.




                                    update any of the forward-looking statements after the date of this
                                    presentation to conform them to actual results or to changes in
                                    expectations.




                                                       2
Scientific Overview and Therapeutic Rationale
                                                     DNA-Based Cardiovascular Therapeutics

                                     New regenerative                                    Ischemia (coronary heart
                                      medicine biological                                  disease) is an important
                                      tools for interventional                             precursor for effective
                                      cardiology                                           growth factor DNA-based
                                                                                           therapy
                                     Leverages the
                                      healing power of                                    Designed to stimulate
                                      cardiac plasticity                                   microvascular cardiac
                                                                                           angiogenesis
                                     Proprietary, catheter-
                                      based intracoronary                                 Driven by upstream
                                      delivery approach                                    regulatory gene (FGF-4)
                                      during an angiographic                               that stimulates a cascade
                                      procedure                                            of other important growth
                                                                                           factors
                                     One-time non-surgical
 2013 Cardium Therapeutics, Inc.




                                      treatment                                           First DNA-based biologic
                                                                                           to advance to U.S. FDA
                                     DNA transgene                                        Phase 3 (with fast track
                                      delivery and CAR                                     status) and Registration /
                                      receptor-based                 Generx [Ad5FGF-4]     Phase 3 Study in Russia
                                      preferential cardiac
                                      uptake



                                                                 3
Generx® Highlights
                                       Generx [Ad5FGF-4] (CardioNovo® trade name in Russia) represents a new therapeutic class of
                                        regenerative medicine DNA-based biologics for interventional cardiology that is designed to
                                        stimulate the natural growth of microvascular circulation for a condition termed cardiac
                                        microvascular insufficiency (CMI) for patients with myocardial ischemia and symptomatic angina
                                        pectoris due to advanced coronary disease. Generx is administered one-time, using a standard
                                        balloon cardiac catheter.

                                       Generx is initially being currently developed, in markets outside the U.S., as treatment alternative
                                        for patients who may not have access to costly and invasive advanced mechanical
                                        revascularization procedures, including coronary artery bypass surgery and angioplasty/stents, or
                                        may no longer be optimal candidates for these procedures.

                                       Ad5FGF-4 has been evaluated in four clinical studies in North America and Western Europe at
                                        over 100 medical centers with over 650 patients participating in these studies. Data from the
                                        clinical studies have been published in leading peer reviewed medical journals.
                                          The product appears safe and capable of improving microvascular circulation
                                            in certain patients, as measured by SPECT imaging, and improvements using
                                            standard ETT assessments.
 2013 Cardium Therapeutics, Inc.




                                       An independent 10-year clinical study (n=845) by Swiss researchers, published in the American
                                        Heart Association’s journal Circulation, have reported that patients with high levels of collateral
                                        circulation in the heart have a statistically significant mortality advantage when compared to
                                        patients with low collateral flow.

                                       Generx was cleared by the FDA to initiate the AWARE Phase 3 clinical study (with Fast Track
                                        status) by the FDA, for certain refractory patients.           Ad5FGF-4 is the only DNA-based
                                        cardiovascular biologic to be cleared for Phase 3 clinical study by the FDA.


                                                                 4
Generx® Highlights
                                          The AWARE clinical trial was inactivated by Cardium based on economic
                                            considerations due to the patient recruitment challenges for a small targeted
                                            population group in the U.S. where by-pass surgery and angioplasty are
                                            commonly available to patients of all ages.

                                       Generx is now being evaluated in a Phase 3 / registration study (the Aspire Study) for 100 patients
                                        with advanced coronary artery disease at up to six major medical centers in the Russian
                                        Federation in connection with a commercialization plan covering the marketing and sale of Generx
                                        in Russia. Ad5FGF-4 will be marketed and sold in Russia under the trade name “Cardionovo.”

                                     Recent discoveries from Cardium-sponsored preclinical studies at Emory University showed that
                                        induced transient ischemia (i.e. balloon catheter-based occlusion/ reperfusion as in an ordinary
                                        angioplasty, but at lower pressure) substantially increases Generx’s DNA vector’s transfection
                                        efficiency to heart muscle cells. These new findings offer the opportunity to further enhance
                                        angiogenic response and lower response variability in patients.
                                          These findings have now been integrated into the Russian-based
                                            ASPIRE clinical study protocol.
                                       A senior group of current Cardium physicians and business executives have worked on the
 2013 Cardium Therapeutics, Inc.




                                        Generx research and development effort from the initial development (1996) to the present.
                                       During the Generx development cycle, over $250 million has been invested in the product
                                        formulation, manufacturing and clinical study by Collateral, Schering and Cardium.
                                       As a DNA-based bio-reactor manufactured product, Generx is projected to have favorable gross
                                        margins and offers the potential to generate substantial revenue in large markets with coronary
                                        artery disease.



                                                                  5
Generx®: Historical Perspective




                                     Collateral             Schering AG                Cardium               Commercial
                                    Therapeutics            As Strategic Partner
                                                                                     Therapeutics            International
                                        (NASDAQ)               with Collateral        Formed to              Development
                                                               Therapeutics            Acquire                 Activities
                                      University of                                Technology from
                                                            Schering Acquires
                                       California                                  Schering / Bayer
                                                            Collateral in 2002                                  Russia
                                       San Diego                                   FDA Phase 3 Clearance
                                                             for $160 Million
                                                                                    with Fast Track Status      Brazil
                                    Discovery, Licensing                            & Phase 3 Clearance          India
                                                              Phase 1/2 to
                                         and Initial                                for Registration Study
                                                              Phase 2b/3                  in Russia
                                     Preclinical Studies
 2013 Cardium Therapeutics, Inc.




                                         1996               1997 - 2005            2005 - Present            Current Status




                                                             6
Developing new and
                                         innovative, cost-effective
                                        advanced care for coronary
                                         heart disease patients in
                                           international markets
 2013 Cardium Therapeutics, Inc.




                                               Generx Cardio Chant




                                    7
Generx® [Ad5FGF-4]
                                                 Clinical & Commercial Development Activities

                                                                   Cardium Innovations
                                                                   • Expanded target coronary
                                                                     artery disease patient
                                                                     population
                                      AGENT 1–4                    • Established new quantitative           ASPIRE
                                                                     primary efficacy endpoint using
                                     Phases 1 & 2/3                  SPECT imaging                           Phase 3
                                      Clinical Studies                                                    Clinical Study
                                                                   • New balloon catheter-based
                                                                     delivery techniques to leverage
                                       Treatment: Stable             Cardium’s transient ischemia           Condition: Cardiac
                                                                     discoveries to boost cell         Microvascular Insufficiency
                                    Angina for Patients with
                                                                     transfection                      for Patients with Myocardial
                                     “Refractory” Coronary                                              Ischemia Due to Coronary
                                                                   • Developed new “bio-assay”
                                        Artery Disease               production batch release assay           Artery Disease
                                                                     that measures angiogenic
 2013 Cardium Therapeutics, Inc.




                                     Primary Endpoint:               response to Generx                  Primary Endpoint:
                                     ETT Improvement               • Five-year real-time product       RPDS Improvement as
                                                                     stability (at -70°C) confirmed     Measured by SPECT
                                       650 Patients at
                                                                   • Simplified and standardized
                                     100 Medical Centers             new cath lab product                    100 Patients
                                                                     preparation techniques




                                                               8
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 a condition termed Cardiac Microvascular
                                    Insufficiency (CMI) in patients with myocardial ischemia and symptomatic angina pectoris
                                    due to coronary artery disease, for such patients that have limited access to advanced
                                    medical care including coronary angioplasty and stents as well as coronary artery by-pass
                                    surgery, and 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

                                                                                             United          Russian
 2013 Cardium Therapeutics, Inc.




                                                      Demographic Metrics
                                                                                             States         Federation

                                              Average Life Expectancy - Males                   76               64


                                              Cardiovascular Death Rates per 100,000            80              297




                                                             9
CardioNovo®: Russian Federation
                                         Phase 3 Registration Study

                                                                     International Markets
                                              Elements          (Initially Russian Federation)
                                                                            (ASPIRE)

                                                                    CardioNovo [Ad5FGF-4]
                                    Product
                                                                   (alferminogene tadenovec)

                                                                    RHA Cleared Phase 3 /
                                    Clinical Status
                                                                      Registration Study

                                                                      100 Men & Women
                                                                   Multi-Center, Randomized,
                                    Clinical Study Population
                                                                   Controlled Parallel-Group
                                                                       Patient Population

                                                                   Myocardial Ischemia as a
                                                                 Treatment Option for Patients
                                    Medical Indication
                                                                   Considering Angioplasty /
 2013 Cardium Therapeutics, Inc.




                                                                   Stents & Bypass Surgery

                                                                   Improvement in Reversible
                                    Clinical Endpoint              Perfusion Deficit Based on
                                                                        SPECT Imaging

                                    Clinical Study Status                Initiated 2012




                                              10
Generx ®
                                         [Ad5FGF-4]
                                         DNA-Based Angiogenic Therapy

                                    Interventional cardiology-focused product candidate that is being developed for a medical
                                    condition termed Cardiac Microvascular Insufficiency (CMI) in patients with myocardial
                                    ischemia and symptomatic chronic stable angina pectoris due to coronary artery disease.
 2013 Cardium Therapeutics, Inc.




                                    Patients with CMI have had an insufficient angiogenic response to their current disease
                                    state and may benefit from a therapy to biologically enhance cardiac perfusion through the
                                    facilitation of collateral vessel formulation.
                                    This condition is diagnosed by SPECT imaging, and other catheter-based diagnostic
                                    techniques.




                                                             11
Generx® Pioneering
                                    DNA-Based Regenerative Medicine




                                                        DNA-based therapy is designed to
                                                        enable a patient’s own cells to
                                                        produce a therapeutic protein directly
                                                        where it is needed in the body. The
 2013 Cardium Therapeutics, Inc.




                                                        Generx product candidate is designed
                                                        to induce localized angiogenic growth
                                                        factor production following its one-
                                                        time delivery to stimulate the growth
                                                        of microvascular circulation.




                                       12
 2013 Cardium Therapeutics, Inc.




13
                                         Cardiovascular Angiogenesis
Coronary Artery Disease
                                    Natural Disease-Induced Angiogenic Vascularization
 2013 Cardium Therapeutics, Inc.




                                                OFF                         ON


                                                14
Beneficial Effects of a
                                             Disease-Induced
                                         Angiogenic Vascularization
                                            Summary Research
                                            “A well-functioning coronary
                                         collateral circulation saves lives in
                                             patients with chronic stable
                                              coronary artery disease.”
 2013 Cardium Therapeutics, Inc.




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




                                    15
Generx® Late-Stage Clinical Development
 2013 Cardium Therapeutics, Inc.




                                           16
Generx® Revolutionary Alternative
                                            Therapy for Heart Disease




                                    Coronary Artery              Non-Surgical
                                     Bypass Graft               Cardiovascular
                                       Surgery                  Gene Therapy
                                                                  Objective
 2013 Cardium Therapeutics, Inc.




                                             17
Generx® Leveraging the Power of Biology




                                                                               This illustration utilizes computer
                                                                               models     of   DNA-based    on    data
                                                                               generated by x-ray crystallography, a
                                                                               technique for determining the structure
 2013 Cardium Therapeutics, Inc.




                                                                               of a molecular sample, together with a
                                                                               portion of the DNA sequence of Generx
                                                                               (Ad5FGF-4), Cardium’s lead clinical
                                                                               product candidate.




                                    Digital illustration of DNA.




                                                                   18
Technology Platform:
                                    Non-Surgical DNA-Based Angiogenic Therapy

                                                      Methods of
                                                     Intracoronary
                                                      DNA-Based
                                                      Angiogenic
                                                       Therapy



                                                            X          Adenovirus
                                                                       DNA-Based
                                           Manufacturing              Delivery (Ad5)
                                            Know-How
                                            & Expertise                Angiogenic
                                                                      Growth Factor
                                                                        (FGF-4)
 2013 Cardium Therapeutics, Inc.




                                                  Generx® [Ad5FGF-4]
                                                  (alferminogene tadenovec)



                                             19
Generx®
                                    (alferminogene tadenovec)
                                                                                                        DNA-Based
                                                                                                    Adenovector Cassette
                                                                                                        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
                                                                Adenovector construct                    Host Genome
                                                                Carries the FGF-4 Gene
                                                                 for Cardiac Delivery                 Manufacturing in High Titer
 2013 Cardium Therapeutics, Inc.




                                                                                                      Easily Manipulated
                                              Research Studies:                      Coronary
                                        Intracoronary Administration              Extraction Rate
                                                                                                      Relatively Low Cytotoxity
                                    Pre-Clinical Porcine Study                                        Mutagenesis Improbable
                                                                                    98% (mean)
                                    Giordano et al. Nat Med 1996;2:(5):534
                                                                                                      Very Favorable
                                    Phase 1/2 Clinical Study – AGENT Trial                               Manufacturing Cost
                                                                                    87% (median)
                                    Grines et al. Circulation 2002;105:1291



                                                                 20
Generx® FGF-4 Gene


                                            Regulates angiogenesis



                                            Signal peptide – secreted FGF protein



                                            Binds to extracellular matrix proteins



                                            Abundant FGF-4 receptors found in cardiac tissue



                                            Upstream growth factor that can recruit and
                                             stimulate responses in downstream target cells
 2013 Cardium Therapeutics, Inc.




                                            Appears to require ischemia induced
                                             co-factors to augment the angiogenesis process




                                        21
Generx Dose Response Bioactivity Assay
                                                          Visualization of the Angiogenic Process
                                                              by Endothelial Tube Formation




                                            1ng/mL                              2ng/mL                             4ng/mL                             8ng/mL
                                    Representative Images (T=13.5 days) of rhFGF-4 stimulation of angiogenic networks in the Essen BioScience HUVEC Tube
                                    Formation Assay. E, 1ng/mL rhFGF-4 induced HUVEC clustering as well as a small amount of tube formation. F, 2ng/mL rhFGF-4 induced
                                    clusters and tube formation. G, 4ng/mL rhFGF-4 initiated HUVEC differentiation into longer tubes and more complex networks, as observed by
                                    the increase in branching. H, 8ng/mL rhFGF-4 stimulate significant tube and network formation.
 2013 Cardium Therapeutics, Inc.




                                                                          22
Generx® Understanding the
                                                                 Beauty of Cardiac Physiology




                                                                                              Microvascular
                                                                                                Pathways
                                                                                   When infused into the coronary arteries
                                                                                   using a non-surgical cardiac catheter, the
 2013 Cardium Therapeutics, Inc.




                                                                                   Generx product candidate travels through
                                                                                   the coronary microvascular circulation into
                                                                                   the small caliber capillaries where it is
                                                                                   believed to be taken up by the myocardium.
                                    Colored magnification: x3000 at 6x7cm size.




                                                                     23
Generx [Ad5FGF-4]
                                        Proprietary Intracoronary Administration of
                                    DNA-Based Cardiovascular Growth Factor Therapeutic




                                               Non-surgical delivery by intracoronary administration by
                                                interventional cardiologist during an angiogram procedure
 2013 Cardium Therapeutics, Inc.




                                               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 are
                                                designed to enhance DNA uptake and expression in the heart
                                               40% administered to right          coronary   circulation   and
                                                60% to left coronary circulation



                                                      24
Generx® [Ad5FGF-4]

                                        Catheter-Based                Enhanced Angiogenic
                                    Intracoronary Delivery           Microvascular Circulation
 2013 Cardium Therapeutics, Inc.




                                                25
The Therapeutic Process of
                                                       Cardiac Microvascular Angiogenesis
                                      Generx has been evaluated in studies of over 650 patients (including 450
                                      Generx-treated patients) in four multi-center, double-blind, placebo-controlled   SPECT Imaging
                                      clinical studies at 100 medical centers. Generx is the most clinically advanced
                                      DNA-based cardiovascular angiogenic growth factor therapeutic in the world.


                                     One-Time Treatment




                                                                                   DNA-Based Delivery
 2013 Cardium Therapeutics, Inc.




                                        Generx [Ad5FGF-4]
                                    (alferminogene tadenovec)
                                                                                   Angiogenic Response
                                                  AGENT-2 - Representative Generx-treated patient: 77%
                                                  improvement in cardiac perfusion at 8 weeks equivalent
                                                  to bypass surgery and PCI (angioplasty/stenting) at one year.



                                                                26
AGENT 2: Primary Endpoint SPECT Imaging Angiogenic
                                                 Mechanism of Action Study


                                                                      Change in Reversible Perfusion Defect
                                                                                   8 Weeks

                                             Mean Reduction in RPDS (%)
                                                                          6

                                                                          5

                                                                          4

                                                                          3

                                                                          2                                p=0.14

                                                                          1
                                                                                                          p<0.05*
 2013 Cardium Therapeutics, Inc.




                                                                          0
                                                                                       Placebo                      10e10 vp
                                                                                        n=17/16                        n=35

                                                                          * Excludes one extreme placebo outlier




                                                                              27
Generx® [Ad5FGF-4] Clinical Studies
                                                                          Clinical                                            Number
                                                          Region /                         Patient             Clinical
                                    Year   Study Name                      Study                                              Patients
                                                          County                           Status             Endpoint
                                                                          Phase                                              Recruited

                                                                         Phase 1/2
                                                                                         Class 2 – 3           Exercise
                                    1999    AGENT-1         U.S.        Dose finding                                            79
                                                                                           Angina           Treadmill Time
                                                                          & safety

                                                                         Phase 2a
                                                                                       9% Reversible
                                            AGENT-2                     Mechanism                                 SPECT
                                    2001                North America                   Reperfusion                             52
                                                                         of Action                                Imaging
                                                                                          Defect
                                                                          Study

                                            AGENT-3                                      Class 2 – 4           Exercise
                                    2004                North America   Phase 2b/3                                             300
                                                                                           Angina           Treadmill Time

                                                          Western
                                                                                         Class 2 – 4           Exercise
                                    2004    AGENT-4       Europe &      Phase 2b/3                                             252
                                                                                           Angina           Treadmill Time
                                                        South America
                                                                                                               Exercise
                                                                                         Class 3 – 4        Treadmill Time
 2013 Cardium Therapeutics, Inc.




                                                                                                                             U.S. Beta
                                    2008    AWARE           U.S.          Phase 3          Angina            (Time to ST
                                                                                                                              Tested
                                                                                                               Segment
                                                                                                             Depression)
                                                                         Phase 3
                                                          Russian                      9% Reversible             SPECT
                                    2011    ASPIRE                      Registration                                           100
                                                         Federation                    Perfusion Defect           Imaging
                                                                          Study

                                                                                                          TOTAL                783



                                                           28
Generx® Patient Pioneers




                                                    Marilyn L. was a trial participant in
                                                    the AGENT-3 clinical trial. She
                                                    received a one-time treatment of
 2013 Cardium Therapeutics, Inc.




                                                    Generx, our DNA-based angiogenic
                                                    product candidate for patients with
                                                    recurrent angina due to coronary
                                                    artery disease.




                                    29
Generx®
                                                       Key Peer-Reviewed
                                                   Scientific & Medical Journals
 2013 Cardium Therapeutics, Inc.




                                    Pre-Clinical               AGENT-1                  AGENT-2
                                      Nature                  Circulation          Journal of American
                                     Medicine               (American Heart        College of Cardiology
                                                          Association Journal)

                                                    30
Generx®
                                                AGENT 3 & 4
                                              Summary Research
                                           “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.”

                                              “The potential importance
                                           of the observed gender-specific
                                             angiogenic response on the
                                            clinical treatment of refractory
 2013 Cardium Therapeutics, Inc.




                                               angina is substantial and
                                           deserves further investigation.”


                                                     JACC
                                               September 11, 2007


                                    31
GENERX AGENT-2
                                                               PHASE 2A STUDY
                                                       CLINICAL EFFICACY USING SPECT




                                                                                                       77%
                                                                                                   Improvement


                                       AGENT-2
                                       Journal of
 2013 Cardium Therapeutics, Inc.




                                    American College
                                     of Cardiology

                                                            Generx-Treated Patient Demonstrating
                                                                Enhanced Cardiac Perfusion
                                                                     (n=52 / 88% men)




                                                       32
AGENT 2 - Comparison of SPECT Results to
                                                         Revascularization and Medical Therapy

                                                                        Coronary                   Generx AGENT-2
                                                                                      Medical
                                          Parameter                    Revascular-
                                                                                      Therapy
                                                                         ization                Placebo      1x1010 vp

                                    Number
                                                                                 83    206        17            35
                                    of Patients


                                    Age                                     66 11     68 10      57 9          59 8


                                    Stress defect
                                                                            18 11     16 10      20 8          20 9
                                    extent (%)
 2013 Cardium Therapeutics, Inc.




                                    Reduction of
                                    reversible                              -5 12     -0.8 7    -0.8 6         -4 6
                                    defect (%)


                                    From Berman DS, et al.
                                    J of Nuclear Cardiol, 2001; 4:428-437




                                                                            33
Generx AGENT 3 & 4 Clinical Studies
                                                             Clinical Efficacy Using ETT
                                               Pooled-Analysis: Protocol-Specified Gender-Based Subgroup

                                                                      12 weeks                       6 months
                                           Women
                                            n=76
                                                          Placebo      109 vp    1010 vp   Placebo    109 vp    1010 vp


                                           Exercise         -4          60*        69*        7        75*        83*
                                           Duration
                                          (seconds
                                        percentage )      (-1%)       (16%)     (23%)      (2%)      (20%)     (28%)


                                                            50          111        86        55        157*       94
                                       Angina Onset
                                          (seconds
                                        percentage )
 2013 Cardium Therapeutics, Inc.




                                                           (26%)       (52%)     (46%)      (28%)     (73%)     (48%)


                                     Time to 1mm ST         13           50        63*       14        59*        86*
                                       Segment 
                                           (seconds
                                         percentage )     (4%)        (16%)     (27%)      (5%)      (19%)     (36%)

                                    * < 0.05



                                                                 34
AGENT 3/4 Clinical Studies:
                                               Concordance of Results from Prespecified Pooled
                                                    Analysis of Gender-Based Subgroup

                                                                                    Generx Ad5FGF-4
                                              Women
                                                                 Time Point
                                               n=76
                                                                              1x109 vp          1x1010 vp

                                                                 12 Weeks      p=0.032           p=0.002
                                    ETT Duration
                                                                 6 Months      p=0.042           p=0.009

                                                                 12 Weeks     NS (0.216)         p=0.031
                                    Time to ECG Ischemia
                                                                 6 Months      p=0.036           p=0.011

                                                                 12 Weeks     NS (0.146)        NS (0.125)
                                    Time to Angina
                                                                 6 Months      p=0.003          NS (0.094)
 2013 Cardium Therapeutics, Inc.




                                                                 12 Weeks     NS (0.222)         p=0.014
                                    CCS Class Improvement        6 Months     NS (0.341)         p=0.042
                                                                 12 Months     p=0.038           p=0.006

                                     NS=Not Significant




                                                            35
Effect of Chronic Angina Treatment with Ranexa
                                                                         and Single Intracoronary Administration of
                                                                      Generx (Ad5FGF-4) on ETT Duration at 12 Weeks
                                                                                            (Difference from Placebo)
                                                                      100
                                                                                        *                                       ETT
                                                                                              * P > 0.05 vs. placebo
                                    Mean change from Baseline (sec)




                                                                       75


                                                                                    Generx
                                                                       50           One Time
                                                                                  Non-Surgical
                                                                                   Angiogenic
                                                                                    Therapy                                       *
 2013 Cardium Therapeutics, Inc.




                                                                       25
                                                                                                                             Ranexa
                                                                                                                               Chronic
                                                                                                                          Anti-Anginal Drug
                                                                                                                           1000 mg Daily
                                                                        0
                                                                             Baseline ETT (sec): 300                   Baseline ETT (sec): 470
                                                                             % increase         + 25%                  % increase         + 5%
                                                                                    (n = 30)                                   (n = 255)




                                                                                   36
Beneficial Effects of Natural Disease-Induced Collateral Vessels
                                      10-Year Follow-up in Patients with Coronary Heart Disease



                                                                       %
                                                                                                                        CARDIAC DEATHS:
                                           Cumulative Survival Rate




                                                                                                                        10 year follow-up
                                                                                                                            (n = 845)

                                                                                                                           High Flow:
                                                                                                                          5 (2%) Deaths

                                                                                                                           Low Flow:
                                                                                                                         37 (6%) Deaths
                                                                                                (low collateral flow)
 2013 Cardium Therapeutics, Inc.




                                                                                                                             67% ↓
                                                                                               (high collateral flow)    Cardiac Deaths




                                                                                       Time of Follow-up (months)

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




                                                                                      37
Generx®: Current Global Clinical Study Status
                                                                                                            International Markets
                                                                              U.S. Market
                                                Elements                                               (Initially Russian Federation)
                                                                               (AWARE)
                                                                                                                   (ASPIRE)

                                                                           Generx® [Ad5FGF-4]              CardioNovo [Ad5FGF-4]
                                    Product                             (alferminogene tadenovec)         (alferminogene tadenovec)

                                                                         FDA Clearance Phase 3             RHA Cleared Phase 3 /
                                    Clinical Status                      (with Fast Track Status)            Registration Study

                                                                                                             100 Men & Women
                                                                        300 Women Multi-Center,
                                                                                                          Multi-Center, Randomized,
                                    Clinical Study Population            Randomized, Placebo-
                                                                                                          Controlled Parallel-Group
                                                                       Controlled Patient Population
                                                                                                              Patient Population

                                                                        Anti-Angina for Refractory        Myocardial Ischemia as a
                                                                       Patients who are not Optimal     Treatment Option for Patients
                                    Proposed Medical Indication        Candidates for Angioplasty /       Considering Angioplasty /
                                                                        Stents & Bypass Surgery           Stents & Bypass Surgery
 2013 Cardium Therapeutics, Inc.




                                                                                                          Improvement in Reversible
                                                                         Improvement in Exercise
                                    Clinical Endpoint                    Time Based on Treadmill
                                                                                                          Perfusion Deficit Based on
                                                                                                               SPECT Imaging

                                                                          Pending Completion
                                    Clinical Study Status                                                       Initiated 2012
                                                                         of International Studies




                                                                  38
Clinical Efficacy Measures


                                    ETT                                                              SPECT
 2013 Cardium Therapeutics, Inc.




                                            Exercise Treadmill               Single Photon Emission Computed
                                               Stress Test                        Tomography Stress Test
                                      [United States Efficacy Measure]        [Russian Federation Efficacy Measure]




                                                            39
 2013 Cardium Therapeutics, Inc.




40
                                         Therapeutic Comparison
Potential Therapeutic Positioning:
                                           Generx® / Cardionovo®


                                                                    (PTCA)
                                                                 Percutaneous
                                     Traditional                 Transluminal
                                        Drug                       Coronary
                                      Therapy                     Angioplasty
                                                                   & Stents


                                                    Coronary
                                                     Artery
                                                    Disease


                                                                   Generx®
                                       (CABG)
                                                                 Non-Surgical
 2013 Cardium Therapeutics, Inc.




                                      Coronary                    DNA-Based
                                    Artery Bypass                 Angiogenic
                                       Surgery                     Therapy




                                           41
Potential Generx® [Ad5FGF-4] Medical Indications
                                                      Based on Clinical Study Design
                                       Patients with Cardiac Microvascular            Patients who have recurrent ischemic
                                        Insufficiency (CMI) with myocardial             episodes under observation during or
                                        ischemia and stable angina pectoris             after an acute myocardial infarction
                                        due to coronary artery disease
                                                                                       Patients with ischemic heart disease
                                       Patients with stable angina pectoris who        who desire or need revascularization
                                        have already had coronary bypass surgery        but do not have access to coronary
                                        but have persistent angina                      bypass surgery or angioplasty
                                       Patients who have had angioplasty              Patients who would benefit from
                                        or stenting but who continue to have            revascularization (as above) but who
                                        symptoms of myocardial ischemia                 are at high risk for invasive procedures
                                       Patients who are undergoing angioplasty         or who do not want invasive procedures
                                        in whom revascularization is judged to be
                                        incomplete                                     Patients undergoing cardiac
                                                                                        catheterization at a facility that does
                                       Patients who are undergoing angioplasty         not perform angioplasty who need
                                        with at risk myocardium downstream              revascularization
 2013 Cardium Therapeutics, Inc.




                                        from a coronary stenosis that can not
                                        be adequately dilated                          Patients undergoing routine diagnostic
                                                                                        cardiac catheterization for coronary artery
                                       Patients who have evidence of silent            disease who have any of the indications
                                        ischemia, as indicated by intermittent          above. Generx may obviate the need for
                                        electrocardiographic changes during             subsequent referral for bypass surgery or
                                        ambulatory monitoring, or ventricular           for angioplasty
                                        contraction abnormalities during stress.
                                        Silent ischemia is a risk factor for
                                        subsequent major cardiac events

                                                                 42
Generx® Potential Economic Opportunity

                                                                            Target Revenue per Dose
                                      Unit Volume
                                     Opportunity per           Level I              Level II             Level III
                                    Economic Region         $2,000 / dose        $3,000 / dose        $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
 2013 Cardium Therapeutics, Inc.




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




                                                       43
 2013 Cardium Therapeutics, Inc.
              2013 Cardium Therapeutics, Inc.




 44

More Related Content

What's hot

ESC 2012 research highlights: A slideshow presentation
ESC 2012 research highlights: A slideshow presentationESC 2012 research highlights: A slideshow presentation
ESC 2012 research highlights: A slideshow presentationtheheart.org
 
Edoxaban monograph
Edoxaban monographEdoxaban monograph
Edoxaban monographTerri Newman
 
THE ENGAGE AF TIMI 48 trial
THE ENGAGE AF TIMI 48 trialTHE ENGAGE AF TIMI 48 trial
THE ENGAGE AF TIMI 48 trialPraveen Nagula
 
Edoxaban versus warfarin in patients with atrial fibrallation
Edoxaban versus warfarin in patients with atrial fibrallationEdoxaban versus warfarin in patients with atrial fibrallation
Edoxaban versus warfarin in patients with atrial fibrallationDrJawad Butt
 
07 stemi treatment in areas remote from primary pci centres
07 stemi treatment in areas remote from primary pci centres07 stemi treatment in areas remote from primary pci centres
07 stemi treatment in areas remote from primary pci centresNPSAIC
 
Engage af timi 48 - lawrie
Engage af timi 48 - lawrieEngage af timi 48 - lawrie
Engage af timi 48 - lawrieFaraz Lawrie
 
Q3, 2016 earnings slides 9 nov 16
Q3, 2016 earnings slides   9 nov 16 Q3, 2016 earnings slides   9 nov 16
Q3, 2016 earnings slides 9 nov 16 Galenabio
 

What's hot (9)

ESC 2012 research highlights: A slideshow presentation
ESC 2012 research highlights: A slideshow presentationESC 2012 research highlights: A slideshow presentation
ESC 2012 research highlights: A slideshow presentation
 
!Dawson.cardium presentation oct 2011
!Dawson.cardium presentation oct 2011!Dawson.cardium presentation oct 2011
!Dawson.cardium presentation oct 2011
 
Edoxaban monograph
Edoxaban monographEdoxaban monograph
Edoxaban monograph
 
THE ENGAGE AF TIMI 48 trial
THE ENGAGE AF TIMI 48 trialTHE ENGAGE AF TIMI 48 trial
THE ENGAGE AF TIMI 48 trial
 
Edoxaban versus warfarin in patients with atrial fibrallation
Edoxaban versus warfarin in patients with atrial fibrallationEdoxaban versus warfarin in patients with atrial fibrallation
Edoxaban versus warfarin in patients with atrial fibrallation
 
07 stemi treatment in areas remote from primary pci centres
07 stemi treatment in areas remote from primary pci centres07 stemi treatment in areas remote from primary pci centres
07 stemi treatment in areas remote from primary pci centres
 
Alpheus trial ppt
Alpheus trial pptAlpheus trial ppt
Alpheus trial ppt
 
Engage af timi 48 - lawrie
Engage af timi 48 - lawrieEngage af timi 48 - lawrie
Engage af timi 48 - lawrie
 
Q3, 2016 earnings slides 9 nov 16
Q3, 2016 earnings slides   9 nov 16 Q3, 2016 earnings slides   9 nov 16
Q3, 2016 earnings slides 9 nov 16
 

Similar to Cardium Therapeutics Generx Presentation January 2013

Cardium Therapeutics Biotech Showcase January 2013 Investor Presentation
Cardium Therapeutics Biotech Showcase January 2013 Investor PresentationCardium Therapeutics Biotech Showcase January 2013 Investor Presentation
Cardium Therapeutics Biotech Showcase January 2013 Investor PresentationCardium Therapeutics Inc.
 
SSI PR Partnership 0816 - final
SSI PR Partnership 0816 - finalSSI PR Partnership 0816 - final
SSI PR Partnership 0816 - finalDan Kasprzyk
 
Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics D...
Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics D...Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics D...
Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics D...MaRS Discovery District
 
Ascendis Pharma Investment Presentation
Ascendis Pharma Investment PresentationAscendis Pharma Investment Presentation
Ascendis Pharma Investment PresentationZacharyHensley4
 
Regulatory Landscape for Gene Therapies Current Status and Future Prospects
Regulatory Landscape for Gene Therapies Current Status and Future ProspectsRegulatory Landscape for Gene Therapies Current Status and Future Prospects
Regulatory Landscape for Gene Therapies Current Status and Future Prospectsijtsrd
 
guidelines-150703103126-lva1-app6891.pdf
guidelines-150703103126-lva1-app6891.pdfguidelines-150703103126-lva1-app6891.pdf
guidelines-150703103126-lva1-app6891.pdfdabloosaha
 
Pharmacovigilance and ICH guidlines
Pharmacovigilance and ICH guidlinesPharmacovigilance and ICH guidlines
Pharmacovigilance and ICH guidlineschandroo80
 
Galena presentation 22 sept 16
Galena presentation   22 sept 16Galena presentation   22 sept 16
Galena presentation 22 sept 16Galenabio
 
Protalix analyst day presentation
Protalix analyst day presentationProtalix analyst day presentation
Protalix analyst day presentationJames Hilbert
 
Sales Management Term Project: Marketing Plan for Johnson and Johnson 2015
Sales Management Term Project: Marketing Plan for Johnson and Johnson 2015Sales Management Term Project: Marketing Plan for Johnson and Johnson 2015
Sales Management Term Project: Marketing Plan for Johnson and Johnson 2015Hannah Joy Stacy
 
Metastatic breast cancer ver 3.0
Metastatic breast cancer ver 3.0Metastatic breast cancer ver 3.0
Metastatic breast cancer ver 3.0Vivek Verma
 
Emerging Trends in Clinical Data Management
Emerging Trends in Clinical Data ManagementEmerging Trends in Clinical Data Management
Emerging Trends in Clinical Data ManagementArshad Mohammed
 

Similar to Cardium Therapeutics Generx Presentation January 2013 (20)

Cardium Therapeutics Biotech Showcase January 2013 Investor Presentation
Cardium Therapeutics Biotech Showcase January 2013 Investor PresentationCardium Therapeutics Biotech Showcase January 2013 Investor Presentation
Cardium Therapeutics Biotech Showcase January 2013 Investor Presentation
 
SSI PR Partnership 0816 - final
SSI PR Partnership 0816 - finalSSI PR Partnership 0816 - final
SSI PR Partnership 0816 - final
 
Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics D...
Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics D...Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics D...
Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics D...
 
Ascendis Pharma Investment Presentation
Ascendis Pharma Investment PresentationAscendis Pharma Investment Presentation
Ascendis Pharma Investment Presentation
 
Regulatory Landscape for Gene Therapies Current Status and Future Prospects
Regulatory Landscape for Gene Therapies Current Status and Future ProspectsRegulatory Landscape for Gene Therapies Current Status and Future Prospects
Regulatory Landscape for Gene Therapies Current Status and Future Prospects
 
From biomarkers to diagnostics –the road to success
From biomarkers to diagnostics –the road to successFrom biomarkers to diagnostics –the road to success
From biomarkers to diagnostics –the road to success
 
guidelines-150703103126-lva1-app6891.pdf
guidelines-150703103126-lva1-app6891.pdfguidelines-150703103126-lva1-app6891.pdf
guidelines-150703103126-lva1-app6891.pdf
 
Pharmacovigilance and ICH guidlines
Pharmacovigilance and ICH guidlinesPharmacovigilance and ICH guidlines
Pharmacovigilance and ICH guidlines
 
Galena presentation 22 sept 16
Galena presentation   22 sept 16Galena presentation   22 sept 16
Galena presentation 22 sept 16
 
Protalix analyst day presentation
Protalix analyst day presentationProtalix analyst day presentation
Protalix analyst day presentation
 
Sales Management Term Project: Marketing Plan for Johnson and Johnson 2015
Sales Management Term Project: Marketing Plan for Johnson and Johnson 2015Sales Management Term Project: Marketing Plan for Johnson and Johnson 2015
Sales Management Term Project: Marketing Plan for Johnson and Johnson 2015
 
TERMPROJECT1
TERMPROJECT1TERMPROJECT1
TERMPROJECT1
 
Metastatic breast cancer ver 3.0
Metastatic breast cancer ver 3.0Metastatic breast cancer ver 3.0
Metastatic breast cancer ver 3.0
 
Emerging Trends in Clinical Data Management
Emerging Trends in Clinical Data ManagementEmerging Trends in Clinical Data Management
Emerging Trends in Clinical Data Management
 
Physician Initiated Research
Physician Initiated ResearchPhysician Initiated Research
Physician Initiated Research
 
1 1 Innovation Wild
1 1 Innovation Wild1 1 Innovation Wild
1 1 Innovation Wild
 
04 cgix
04 cgix04 cgix
04 cgix
 
Veloxis -Neurosearch - Kapitalmarkedsdag marts 2012
Veloxis -Neurosearch - Kapitalmarkedsdag marts 2012Veloxis -Neurosearch - Kapitalmarkedsdag marts 2012
Veloxis -Neurosearch - Kapitalmarkedsdag marts 2012
 
Cgix december investor-presentation
Cgix december investor-presentationCgix december investor-presentation
Cgix december investor-presentation
 
Not me drugs
Not me drugsNot me drugs
Not me drugs
 

Recently uploaded

Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service AvailableCall Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service AvailableSheetaleventcompany
 
Corporate Presentation Probe Canaccord Conference 2024.pdf
Corporate Presentation Probe Canaccord Conference 2024.pdfCorporate Presentation Probe Canaccord Conference 2024.pdf
Corporate Presentation Probe Canaccord Conference 2024.pdfProbe Gold
 
Western Copper and Gold - May 2024 Presentation
Western Copper and Gold - May 2024 PresentationWestern Copper and Gold - May 2024 Presentation
Western Copper and Gold - May 2024 PresentationPaul West-Sells
 
Corporate Presentation Probe May 2024.pdf
Corporate Presentation Probe May 2024.pdfCorporate Presentation Probe May 2024.pdf
Corporate Presentation Probe May 2024.pdfProbe Gold
 
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts PodanurTop Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanurdharasingh5698
 
Teck Supplemental Information, May 2, 2024
Teck Supplemental Information, May 2, 2024Teck Supplemental Information, May 2, 2024
Teck Supplemental Information, May 2, 2024TeckResourcesLtd
 
Pakistani Call girls in Ajman +971563133746 Ajman Call girls
Pakistani Call girls in Ajman +971563133746 Ajman Call girlsPakistani Call girls in Ajman +971563133746 Ajman Call girls
Pakistani Call girls in Ajman +971563133746 Ajman Call girlsgwenoracqe6
 
B2 Interpret the brief.docxccccccccccccccc
B2 Interpret the brief.docxcccccccccccccccB2 Interpret the brief.docxccccccccccccccc
B2 Interpret the brief.docxcccccccccccccccMollyBrown86
 
Enjoy Night⚡Call Girls Udyog Vihar Gurgaon >༒8448380779 Escort Service
Enjoy Night⚡Call Girls Udyog Vihar Gurgaon >༒8448380779 Escort ServiceEnjoy Night⚡Call Girls Udyog Vihar Gurgaon >༒8448380779 Escort Service
Enjoy Night⚡Call Girls Udyog Vihar Gurgaon >༒8448380779 Escort ServiceDelhi Call girls
 
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)kojalkojal131
 
The Leonardo 1Q 2024 Results Presentation
The Leonardo 1Q 2024 Results PresentationThe Leonardo 1Q 2024 Results Presentation
The Leonardo 1Q 2024 Results PresentationLeonardo
 
countries with the highest gold reserves in 2024
countries with the highest gold reserves in 2024countries with the highest gold reserves in 2024
countries with the highest gold reserves in 2024Kweku Zurek
 
Dattawadi ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready Fo...
Dattawadi ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready Fo...Dattawadi ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready Fo...
Dattawadi ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready Fo...tanu pandey
 
VIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 BookingVIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 Bookingdharasingh5698
 
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...mriyagarg453
 
Deutsche EuroShop | Annual Report 2023 (EN)
Deutsche EuroShop | Annual Report 2023 (EN)Deutsche EuroShop | Annual Report 2023 (EN)
Deutsche EuroShop | Annual Report 2023 (EN)Deutsche EuroShop AG
 
Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024nicola_mining
 

Recently uploaded (20)

Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service AvailableCall Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
 
Corporate Presentation Probe Canaccord Conference 2024.pdf
Corporate Presentation Probe Canaccord Conference 2024.pdfCorporate Presentation Probe Canaccord Conference 2024.pdf
Corporate Presentation Probe Canaccord Conference 2024.pdf
 
Western Copper and Gold - May 2024 Presentation
Western Copper and Gold - May 2024 PresentationWestern Copper and Gold - May 2024 Presentation
Western Copper and Gold - May 2024 Presentation
 
Corporate Presentation Probe May 2024.pdf
Corporate Presentation Probe May 2024.pdfCorporate Presentation Probe May 2024.pdf
Corporate Presentation Probe May 2024.pdf
 
(👉゚9999965857 ゚)👉 VIP Call Girls Friends Colony 👉 Delhi 👈 : 9999 Cash Payment...
(👉゚9999965857 ゚)👉 VIP Call Girls Friends Colony 👉 Delhi 👈 : 9999 Cash Payment...(👉゚9999965857 ゚)👉 VIP Call Girls Friends Colony 👉 Delhi 👈 : 9999 Cash Payment...
(👉゚9999965857 ゚)👉 VIP Call Girls Friends Colony 👉 Delhi 👈 : 9999 Cash Payment...
 
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts PodanurTop Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
 
Teck Supplemental Information, May 2, 2024
Teck Supplemental Information, May 2, 2024Teck Supplemental Information, May 2, 2024
Teck Supplemental Information, May 2, 2024
 
Pakistani Call girls in Ajman +971563133746 Ajman Call girls
Pakistani Call girls in Ajman +971563133746 Ajman Call girlsPakistani Call girls in Ajman +971563133746 Ajman Call girls
Pakistani Call girls in Ajman +971563133746 Ajman Call girls
 
B2 Interpret the brief.docxccccccccccccccc
B2 Interpret the brief.docxcccccccccccccccB2 Interpret the brief.docxccccccccccccccc
B2 Interpret the brief.docxccccccccccccccc
 
Enjoy Night⚡Call Girls Udyog Vihar Gurgaon >༒8448380779 Escort Service
Enjoy Night⚡Call Girls Udyog Vihar Gurgaon >༒8448380779 Escort ServiceEnjoy Night⚡Call Girls Udyog Vihar Gurgaon >༒8448380779 Escort Service
Enjoy Night⚡Call Girls Udyog Vihar Gurgaon >༒8448380779 Escort Service
 
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
Dubai Call Girls O525547&19 Calls Girls In Dubai (L0w+Charger)
 
The Leonardo 1Q 2024 Results Presentation
The Leonardo 1Q 2024 Results PresentationThe Leonardo 1Q 2024 Results Presentation
The Leonardo 1Q 2024 Results Presentation
 
countries with the highest gold reserves in 2024
countries with the highest gold reserves in 2024countries with the highest gold reserves in 2024
countries with the highest gold reserves in 2024
 
Call Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort Service
Call Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort ServiceCall Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort Service
Call Girls in Panjabi Bagh, Delhi 💯 Call Us 🔝9953056974 🔝 Escort Service
 
Dattawadi ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready Fo...
Dattawadi ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready Fo...Dattawadi ( Call Girls ) Pune  6297143586  Hot Model With Sexy Bhabi Ready Fo...
Dattawadi ( Call Girls ) Pune 6297143586 Hot Model With Sexy Bhabi Ready Fo...
 
SME IPO Opportunity and Trends of May 2024
SME IPO Opportunity and Trends of May 2024SME IPO Opportunity and Trends of May 2024
SME IPO Opportunity and Trends of May 2024
 
VIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 BookingVIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 Booking
VIP Call Girls Kheda 7001035870 Whatsapp Number, 24/07 Booking
 
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
 
Deutsche EuroShop | Annual Report 2023 (EN)
Deutsche EuroShop | Annual Report 2023 (EN)Deutsche EuroShop | Annual Report 2023 (EN)
Deutsche EuroShop | Annual Report 2023 (EN)
 
Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024
 

Cardium Therapeutics Generx Presentation January 2013

  • 1. 15-Jan-13 Product & Technology Overview  2013 Cardium Therapeutics, Inc. Generx ® Angiogenic Therapy Regenerative Medicine for Interventional Cardiology DNA-Based Non-Surgical 1 Angiogenic Therapy
  • 2. Forward Looking Statements This presentation may contain forward-looking statements, including comments 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 other subjects. Actual results could differ materially from these forward-looking statements for many reasons, including the risks described under "Risk Factors" in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q as filed with the Securities and Exchange Commission. No guarantee about future results, performance or achievements can be made. Neither Cardium nor its agents intend to  2013 Cardium Therapeutics, Inc. update any of the forward-looking statements after the date of this presentation to conform them to actual results or to changes in expectations. 2
  • 3. Scientific Overview and Therapeutic Rationale DNA-Based Cardiovascular Therapeutics  New regenerative  Ischemia (coronary heart medicine biological disease) is an important tools for interventional precursor for effective cardiology growth factor DNA-based therapy  Leverages the healing power of  Designed to stimulate cardiac plasticity microvascular cardiac angiogenesis  Proprietary, catheter- based intracoronary  Driven by upstream delivery approach regulatory gene (FGF-4) during an angiographic that stimulates a cascade procedure of other important growth factors  One-time non-surgical  2013 Cardium Therapeutics, Inc. treatment  First DNA-based biologic to advance to U.S. FDA  DNA transgene Phase 3 (with fast track delivery and CAR status) and Registration / receptor-based Generx [Ad5FGF-4] Phase 3 Study in Russia preferential cardiac uptake 3
  • 4. Generx® Highlights  Generx [Ad5FGF-4] (CardioNovo® trade name in Russia) represents a new therapeutic class of regenerative medicine DNA-based biologics for interventional cardiology that is designed to stimulate the natural growth of microvascular circulation for a condition termed cardiac microvascular insufficiency (CMI) for patients with myocardial ischemia and symptomatic angina pectoris due to advanced coronary disease. Generx is administered one-time, using a standard balloon cardiac catheter.  Generx is initially being currently developed, in markets outside the U.S., as treatment alternative for patients who may not have access to costly and invasive advanced mechanical revascularization procedures, including coronary artery bypass surgery and angioplasty/stents, or may no longer be optimal candidates for these procedures.  Ad5FGF-4 has been evaluated in four clinical studies in North America and Western Europe at over 100 medical centers with over 650 patients participating in these studies. Data from the clinical studies have been published in leading peer reviewed medical journals.  The product appears safe and capable of improving microvascular circulation in certain patients, as measured by SPECT imaging, and improvements using standard ETT assessments.  2013 Cardium Therapeutics, Inc.  An independent 10-year clinical study (n=845) by Swiss researchers, published in the American Heart Association’s journal Circulation, have reported that patients with high levels of collateral circulation in the heart have a statistically significant mortality advantage when compared to patients with low collateral flow.  Generx was cleared by the FDA to initiate the AWARE Phase 3 clinical study (with Fast Track status) by the FDA, for certain refractory patients. Ad5FGF-4 is the only DNA-based cardiovascular biologic to be cleared for Phase 3 clinical study by the FDA. 4
  • 5. Generx® Highlights  The AWARE clinical trial was inactivated by Cardium based on economic considerations due to the patient recruitment challenges for a small targeted population group in the U.S. where by-pass surgery and angioplasty are commonly available to patients of all ages.  Generx is now being evaluated in a Phase 3 / registration study (the Aspire Study) for 100 patients with advanced coronary artery disease at up to six major medical centers in the Russian Federation in connection with a commercialization plan covering the marketing and sale of Generx in Russia. Ad5FGF-4 will be marketed and sold in Russia under the trade name “Cardionovo.”  Recent discoveries from Cardium-sponsored preclinical studies at Emory University showed that induced transient ischemia (i.e. balloon catheter-based occlusion/ reperfusion as in an ordinary angioplasty, but at lower pressure) substantially increases Generx’s DNA vector’s transfection efficiency to heart muscle cells. These new findings offer the opportunity to further enhance angiogenic response and lower response variability in patients.  These findings have now been integrated into the Russian-based ASPIRE clinical study protocol.  A senior group of current Cardium physicians and business executives have worked on the  2013 Cardium Therapeutics, Inc. Generx research and development effort from the initial development (1996) to the present.  During the Generx development cycle, over $250 million has been invested in the product formulation, manufacturing and clinical study by Collateral, Schering and Cardium.  As a DNA-based bio-reactor manufactured product, Generx is projected to have favorable gross margins and offers the potential to generate substantial revenue in large markets with coronary artery disease. 5
  • 6. Generx®: Historical Perspective Collateral Schering AG Cardium Commercial Therapeutics As Strategic Partner Therapeutics International (NASDAQ) with Collateral Formed to Development Therapeutics Acquire Activities University of Technology from Schering Acquires California Schering / Bayer Collateral in 2002 Russia San Diego FDA Phase 3 Clearance for $160 Million with Fast Track Status Brazil Discovery, Licensing & Phase 3 Clearance India Phase 1/2 to and Initial for Registration Study Phase 2b/3 in Russia Preclinical Studies  2013 Cardium Therapeutics, Inc. 1996 1997 - 2005 2005 - Present Current Status 6
  • 7. Developing new and innovative, cost-effective advanced care for coronary heart disease patients in international markets  2013 Cardium Therapeutics, Inc. Generx Cardio Chant 7
  • 8. Generx® [Ad5FGF-4] Clinical & Commercial Development Activities Cardium Innovations • Expanded target coronary artery disease patient population AGENT 1–4 • Established new quantitative ASPIRE primary efficacy endpoint using Phases 1 & 2/3 SPECT imaging Phase 3 Clinical Studies Clinical Study • New balloon catheter-based delivery techniques to leverage Treatment: Stable Cardium’s transient ischemia Condition: Cardiac discoveries to boost cell Microvascular Insufficiency Angina for Patients with transfection for Patients with Myocardial “Refractory” Coronary Ischemia Due to Coronary • Developed new “bio-assay” Artery Disease production batch release assay Artery Disease that measures angiogenic  2013 Cardium Therapeutics, Inc. Primary Endpoint: response to Generx Primary Endpoint: ETT Improvement • Five-year real-time product RPDS Improvement as stability (at -70°C) confirmed Measured by SPECT 650 Patients at • Simplified and standardized 100 Medical Centers new cath lab product 100 Patients preparation techniques 8
  • 9. 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 a condition termed Cardiac Microvascular Insufficiency (CMI) in patients with myocardial ischemia and symptomatic angina pectoris due to coronary artery disease, for such patients that have limited access to advanced medical care including coronary angioplasty and stents as well as coronary artery by-pass surgery, and 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 United Russian  2013 Cardium Therapeutics, Inc. Demographic Metrics States Federation Average Life Expectancy - Males 76 64 Cardiovascular Death Rates per 100,000 80 297 9
  • 10. CardioNovo®: Russian Federation Phase 3 Registration Study International Markets Elements (Initially Russian Federation) (ASPIRE) CardioNovo [Ad5FGF-4] Product (alferminogene tadenovec) RHA Cleared Phase 3 / Clinical Status Registration Study 100 Men & Women Multi-Center, Randomized, Clinical Study Population Controlled Parallel-Group Patient Population Myocardial Ischemia as a Treatment Option for Patients Medical Indication Considering Angioplasty /  2013 Cardium Therapeutics, Inc. Stents & Bypass Surgery Improvement in Reversible Clinical Endpoint Perfusion Deficit Based on SPECT Imaging Clinical Study Status Initiated 2012 10
  • 11. Generx ® [Ad5FGF-4] DNA-Based Angiogenic Therapy Interventional cardiology-focused product candidate that is being developed for a medical condition termed Cardiac Microvascular Insufficiency (CMI) in patients with myocardial ischemia and symptomatic chronic stable angina pectoris due to coronary artery disease.  2013 Cardium Therapeutics, Inc. Patients with CMI have had an insufficient angiogenic response to their current disease state and may benefit from a therapy to biologically enhance cardiac perfusion through the facilitation of collateral vessel formulation. This condition is diagnosed by SPECT imaging, and other catheter-based diagnostic techniques. 11
  • 12. Generx® Pioneering DNA-Based Regenerative Medicine DNA-based therapy is designed to enable a patient’s own cells to produce a therapeutic protein directly where it is needed in the body. The  2013 Cardium Therapeutics, Inc. Generx product candidate is designed to induce localized angiogenic growth factor production following its one- time delivery to stimulate the growth of microvascular circulation. 12
  • 13.  2013 Cardium Therapeutics, Inc. 13 Cardiovascular Angiogenesis
  • 14. Coronary Artery Disease Natural Disease-Induced Angiogenic Vascularization  2013 Cardium Therapeutics, Inc. OFF ON 14
  • 15. Beneficial Effects of a Disease-Induced Angiogenic Vascularization Summary Research “A well-functioning coronary collateral circulation saves lives in patients with chronic stable coronary artery disease.”  2013 Cardium Therapeutics, Inc. From Meier et al. Circulation 2007; 116:975-83. 15
  • 16. Generx® Late-Stage Clinical Development  2013 Cardium Therapeutics, Inc. 16
  • 17. Generx® Revolutionary Alternative Therapy for Heart Disease Coronary Artery Non-Surgical Bypass Graft Cardiovascular Surgery Gene Therapy Objective  2013 Cardium Therapeutics, Inc. 17
  • 18. Generx® Leveraging the Power of Biology This illustration utilizes computer models of DNA-based on data generated by x-ray crystallography, a technique for determining the structure  2013 Cardium Therapeutics, Inc. of a molecular sample, together with a portion of the DNA sequence of Generx (Ad5FGF-4), Cardium’s lead clinical product candidate. Digital illustration of DNA. 18
  • 19. Technology Platform: Non-Surgical DNA-Based Angiogenic Therapy Methods of Intracoronary DNA-Based Angiogenic Therapy X Adenovirus DNA-Based Manufacturing Delivery (Ad5) Know-How & Expertise Angiogenic Growth Factor (FGF-4)  2013 Cardium Therapeutics, Inc. Generx® [Ad5FGF-4] (alferminogene tadenovec) 19
  • 20. Generx® (alferminogene tadenovec) DNA-Based Adenovector Cassette  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 Adenovector construct Host Genome Carries the FGF-4 Gene for Cardiac Delivery  Manufacturing in High Titer  2013 Cardium Therapeutics, Inc.  Easily Manipulated Research Studies: Coronary Intracoronary Administration Extraction Rate  Relatively Low Cytotoxity Pre-Clinical Porcine Study  Mutagenesis Improbable 98% (mean) Giordano et al. Nat Med 1996;2:(5):534  Very Favorable Phase 1/2 Clinical Study – AGENT Trial Manufacturing Cost 87% (median) Grines et al. Circulation 2002;105:1291 20
  • 21. Generx® FGF-4 Gene  Regulates angiogenesis  Signal peptide – secreted FGF protein  Binds to extracellular matrix proteins  Abundant FGF-4 receptors found in cardiac tissue  Upstream growth factor that can recruit and stimulate responses in downstream target cells  2013 Cardium Therapeutics, Inc.  Appears to require ischemia induced co-factors to augment the angiogenesis process 21
  • 22. Generx Dose Response Bioactivity Assay Visualization of the Angiogenic Process by Endothelial Tube Formation 1ng/mL 2ng/mL 4ng/mL 8ng/mL Representative Images (T=13.5 days) of rhFGF-4 stimulation of angiogenic networks in the Essen BioScience HUVEC Tube Formation Assay. E, 1ng/mL rhFGF-4 induced HUVEC clustering as well as a small amount of tube formation. F, 2ng/mL rhFGF-4 induced clusters and tube formation. G, 4ng/mL rhFGF-4 initiated HUVEC differentiation into longer tubes and more complex networks, as observed by the increase in branching. H, 8ng/mL rhFGF-4 stimulate significant tube and network formation.  2013 Cardium Therapeutics, Inc. 22
  • 23. Generx® Understanding the Beauty of Cardiac Physiology Microvascular Pathways When infused into the coronary arteries using a non-surgical cardiac catheter, the  2013 Cardium Therapeutics, Inc. Generx product candidate travels through the coronary microvascular circulation into the small caliber capillaries where it is believed to be taken up by the myocardium. Colored magnification: x3000 at 6x7cm size. 23
  • 24. Generx [Ad5FGF-4] Proprietary Intracoronary Administration of DNA-Based Cardiovascular Growth Factor Therapeutic  Non-surgical delivery by intracoronary administration by interventional cardiologist during an angiogram procedure  2013 Cardium Therapeutics, Inc.  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 are designed to enhance DNA uptake and expression in the heart  40% administered to right coronary circulation and 60% to left coronary circulation 24
  • 25. Generx® [Ad5FGF-4] Catheter-Based Enhanced Angiogenic Intracoronary Delivery Microvascular Circulation  2013 Cardium Therapeutics, Inc. 25
  • 26. The Therapeutic Process of Cardiac Microvascular Angiogenesis Generx has been evaluated in studies of over 650 patients (including 450 Generx-treated patients) in four multi-center, double-blind, placebo-controlled SPECT Imaging clinical studies at 100 medical centers. Generx is the most clinically advanced DNA-based cardiovascular angiogenic growth factor therapeutic in the world. One-Time Treatment DNA-Based Delivery  2013 Cardium Therapeutics, Inc. Generx [Ad5FGF-4] (alferminogene tadenovec) Angiogenic Response AGENT-2 - Representative Generx-treated patient: 77% improvement in cardiac perfusion at 8 weeks equivalent to bypass surgery and PCI (angioplasty/stenting) at one year. 26
  • 27. AGENT 2: Primary Endpoint SPECT Imaging Angiogenic Mechanism of Action Study Change in Reversible Perfusion Defect 8 Weeks Mean Reduction in RPDS (%) 6 5 4 3 2 p=0.14 1 p<0.05*  2013 Cardium Therapeutics, Inc. 0 Placebo 10e10 vp n=17/16 n=35 * Excludes one extreme placebo outlier 27
  • 28. Generx® [Ad5FGF-4] Clinical Studies Clinical Number Region / Patient Clinical Year Study Name Study Patients County Status Endpoint Phase Recruited Phase 1/2 Class 2 – 3 Exercise 1999 AGENT-1 U.S. Dose finding 79 Angina Treadmill Time & safety Phase 2a 9% Reversible AGENT-2 Mechanism SPECT 2001 North America Reperfusion 52 of Action Imaging Defect Study AGENT-3 Class 2 – 4 Exercise 2004 North America Phase 2b/3 300 Angina Treadmill Time Western Class 2 – 4 Exercise 2004 AGENT-4 Europe & Phase 2b/3 252 Angina Treadmill Time South America Exercise Class 3 – 4 Treadmill Time  2013 Cardium Therapeutics, Inc. U.S. Beta 2008 AWARE U.S. Phase 3 Angina (Time to ST Tested Segment Depression) Phase 3 Russian 9% Reversible SPECT 2011 ASPIRE Registration 100 Federation Perfusion Defect Imaging Study TOTAL 783 28
  • 29. Generx® Patient Pioneers Marilyn L. was a trial participant in the AGENT-3 clinical trial. She received a one-time treatment of  2013 Cardium Therapeutics, Inc. Generx, our DNA-based angiogenic product candidate for patients with recurrent angina due to coronary artery disease. 29
  • 30. Generx® Key Peer-Reviewed Scientific & Medical Journals  2013 Cardium Therapeutics, Inc. Pre-Clinical AGENT-1 AGENT-2 Nature Circulation Journal of American Medicine (American Heart College of Cardiology Association Journal) 30
  • 31. Generx® AGENT 3 & 4 Summary Research “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.” “The potential importance of the observed gender-specific angiogenic response on the clinical treatment of refractory  2013 Cardium Therapeutics, Inc. angina is substantial and deserves further investigation.” JACC September 11, 2007 31
  • 32. GENERX AGENT-2 PHASE 2A STUDY CLINICAL EFFICACY USING SPECT 77% Improvement AGENT-2 Journal of  2013 Cardium Therapeutics, Inc. American College of Cardiology Generx-Treated Patient Demonstrating Enhanced Cardiac Perfusion (n=52 / 88% men) 32
  • 33. AGENT 2 - Comparison of SPECT Results to Revascularization and Medical Therapy Coronary Generx AGENT-2 Medical Parameter Revascular- Therapy ization Placebo 1x1010 vp Number 83 206 17 35 of Patients Age 66 11 68 10 57 9 59 8 Stress defect 18 11 16 10 20 8 20 9 extent (%)  2013 Cardium Therapeutics, Inc. Reduction of reversible -5 12 -0.8 7 -0.8 6 -4 6 defect (%) From Berman DS, et al. J of Nuclear Cardiol, 2001; 4:428-437 33
  • 34. Generx AGENT 3 & 4 Clinical Studies Clinical Efficacy Using ETT Pooled-Analysis: Protocol-Specified Gender-Based Subgroup 12 weeks 6 months Women n=76 Placebo 109 vp 1010 vp Placebo 109 vp 1010 vp Exercise -4 60* 69* 7 75* 83* Duration (seconds percentage ) (-1%) (16%) (23%) (2%) (20%) (28%) 50 111 86 55 157* 94 Angina Onset (seconds percentage )  2013 Cardium Therapeutics, Inc. (26%) (52%) (46%) (28%) (73%) (48%) Time to 1mm ST 13 50 63* 14 59* 86* Segment  (seconds percentage ) (4%) (16%) (27%) (5%) (19%) (36%) * < 0.05 34
  • 35. AGENT 3/4 Clinical Studies: Concordance of Results from Prespecified Pooled Analysis of Gender-Based Subgroup Generx Ad5FGF-4 Women Time Point n=76 1x109 vp 1x1010 vp 12 Weeks p=0.032 p=0.002 ETT Duration 6 Months p=0.042 p=0.009 12 Weeks NS (0.216) p=0.031 Time to ECG Ischemia 6 Months p=0.036 p=0.011 12 Weeks NS (0.146) NS (0.125) Time to Angina 6 Months p=0.003 NS (0.094)  2013 Cardium Therapeutics, Inc. 12 Weeks NS (0.222) p=0.014 CCS Class Improvement 6 Months NS (0.341) p=0.042 12 Months p=0.038 p=0.006 NS=Not Significant 35
  • 36. Effect of Chronic Angina Treatment with Ranexa and Single Intracoronary Administration of Generx (Ad5FGF-4) on ETT Duration at 12 Weeks (Difference from Placebo) 100 * ETT * P > 0.05 vs. placebo Mean change from Baseline (sec) 75 Generx 50 One Time Non-Surgical Angiogenic Therapy *  2013 Cardium Therapeutics, Inc. 25 Ranexa Chronic Anti-Anginal Drug 1000 mg Daily 0 Baseline ETT (sec): 300 Baseline ETT (sec): 470 % increase + 25% % increase + 5% (n = 30) (n = 255) 36
  • 37. Beneficial Effects of Natural Disease-Induced Collateral Vessels 10-Year Follow-up in Patients with Coronary Heart Disease % CARDIAC DEATHS: Cumulative Survival Rate 10 year follow-up (n = 845) High Flow: 5 (2%) Deaths Low Flow: 37 (6%) Deaths (low collateral flow)  2013 Cardium Therapeutics, Inc. 67% ↓ (high collateral flow) Cardiac Deaths Time of Follow-up (months) From Meier et al. Circulation 2007; 116:975-83. 37
  • 38. Generx®: Current Global Clinical Study Status International Markets U.S. Market Elements (Initially Russian Federation) (AWARE) (ASPIRE) Generx® [Ad5FGF-4] CardioNovo [Ad5FGF-4] Product (alferminogene tadenovec) (alferminogene tadenovec) FDA Clearance Phase 3 RHA Cleared Phase 3 / Clinical Status (with Fast Track Status) Registration Study 100 Men & Women 300 Women Multi-Center, Multi-Center, Randomized, Clinical Study Population Randomized, Placebo- Controlled Parallel-Group Controlled Patient Population Patient Population Anti-Angina for Refractory Myocardial Ischemia as a Patients who are not Optimal Treatment Option for Patients Proposed Medical Indication Candidates for Angioplasty / Considering Angioplasty / Stents & Bypass Surgery Stents & Bypass Surgery  2013 Cardium Therapeutics, Inc. Improvement in Reversible Improvement in Exercise Clinical Endpoint Time Based on Treadmill Perfusion Deficit Based on SPECT Imaging Pending Completion Clinical Study Status Initiated 2012 of International Studies 38
  • 39. Clinical Efficacy Measures ETT SPECT  2013 Cardium Therapeutics, Inc. Exercise Treadmill Single Photon Emission Computed Stress Test Tomography Stress Test [United States Efficacy Measure] [Russian Federation Efficacy Measure] 39
  • 40.  2013 Cardium Therapeutics, Inc. 40 Therapeutic Comparison
  • 41. Potential Therapeutic Positioning: Generx® / Cardionovo® (PTCA) Percutaneous Traditional Transluminal Drug Coronary Therapy Angioplasty & Stents Coronary Artery Disease Generx® (CABG) Non-Surgical  2013 Cardium Therapeutics, Inc. Coronary DNA-Based Artery Bypass Angiogenic Surgery Therapy 41
  • 42. Potential Generx® [Ad5FGF-4] Medical Indications Based on Clinical Study Design  Patients with Cardiac Microvascular  Patients who have recurrent ischemic Insufficiency (CMI) with myocardial episodes under observation during or ischemia and stable angina pectoris after an acute myocardial infarction due to coronary artery disease  Patients with ischemic heart disease  Patients with stable angina pectoris who who desire or need revascularization have already had coronary bypass surgery but do not have access to coronary but have persistent angina bypass surgery or angioplasty  Patients who have had angioplasty  Patients who would benefit from or stenting but who continue to have revascularization (as above) but who symptoms of myocardial ischemia are at high risk for invasive procedures  Patients who are undergoing angioplasty or who do not want invasive procedures in whom revascularization is judged to be incomplete  Patients undergoing cardiac catheterization at a facility that does  Patients who are undergoing angioplasty not perform angioplasty who need with at risk myocardium downstream revascularization  2013 Cardium Therapeutics, Inc. from a coronary stenosis that can not be adequately dilated  Patients undergoing routine diagnostic cardiac catheterization for coronary artery  Patients who have evidence of silent disease who have any of the indications ischemia, as indicated by intermittent above. Generx may obviate the need for electrocardiographic changes during subsequent referral for bypass surgery or ambulatory monitoring, or ventricular for angioplasty contraction abnormalities during stress. Silent ischemia is a risk factor for subsequent major cardiac events 42
  • 43. Generx® Potential Economic Opportunity Target Revenue per Dose Unit Volume Opportunity per Level I Level II Level III Economic Region $2,000 / dose $3,000 / dose $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  2013 Cardium Therapeutics, Inc. 200,000 doses $400 Million $600 Million $800 Million 43
  • 44.  2013 Cardium Therapeutics, Inc.  2013 Cardium Therapeutics, Inc. 44