The document is an investor presentation for Cardium Therapeutics, focusing on their portfolio of regenerative medicine and biotherapeutic products. It summarizes the status of their lead product Excellagen, an FDA-cleared collagen gel for wound care that activates platelet release of growth factors. Clinical studies demonstrate Excellagen significantly increases tissue growth and wound closure rates compared to standard of care. Cardium is working to expand Excellagen's commercialization through partnerships and new product formats.
Osisko Gold Royalties Ltd - Corporate Presentation, April 10, 2024
Health Sciences & Regenerative Medicine Investor Presentation
1. Health Sciences
& Regenerative
Medicine
Investor
Presentation
January 7, 2013
Biotech Showcase 2013
Conference
The Power of Biology™
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
update any of the forward-looking statements after the date of this
presentation to conform them to actual results or to changes in
2013 Cardium Therapeutics, Inc.
expectations.
2
3. Cardium: Focus & Key Skill Set
science &
medicine
1 4
2 3
regulatory
matters
2013 Cardium Therapeutics, Inc.
& process marketing
engineering & finance
3
4. Portfolio Status
Technology
Focus Summary
Platforms
Excellagen®
®
Tissue Engineering: Wound Care
Formulated Collagen FDA 510(k)
and DNA-Activated Clearance
Matrices for Wound Initial Product
& Orthopedic Repair Introduction
Underway
Portfolio of Generx®
®
Cardiovascular Growth [Ad5FGF-4]
Factor Biologics “ASPIRE” Phase 3
Acquired from Registration Study for
Schering AG International Markets
MedPodium
2013 Cardium Therapeutics, Inc.
Health Sciences
Brand Platform:
Organic Mixes,
Nutraceuticals
& Dietary
Supplements
4
5. Strategic Partner-Enabled Opportunities
Technology
Focus Summary
Platforms
Planning small, cost-effective Phase 2b/3
study to confirm accelerated DNA-based
Tissue engineering and
wound healing. Next generation product
regenerative medicine platform
candidate represents first product
and DNA-Activated matrices
extension from the FDA-cleared Excellagen
for wound repair & orthopedic
technology. Plug-n-Play Phase 3 biologic
repair and restoration
product candidates offer considerable
economic value opportunity
Medical analytics and
Millions of cancer survivors remain
e-commerce platform of
uninsurable by traditional life insurance
algorithms and medical-based
underwriting standards. Cardium is
social media focused programs
developing new scalable methodologies
to support specialized survivable
designed to assess relative survival risks
risk life insurance underwriting
for life insurance companies to address
for cancer patients, cancer
this significant under-appreciated
survivors and patients with
economic opportunity
chronic medical diseases
2013 Cardium Therapeutics, Inc.
MedPodium Health Sciences Leverage TO GO BRANDS® established
in-house brand platform: infrastructure, distribution capabilities and
organic mixes, nutraceuticals retail network to support external product
and dietary supplements acquisitions and strategic partnerings
Distribution &
Logistics Platform
5
6. Investment Highlights
Capital-efficient, asset-based, business strategy focused on finding “diamonds in the rough” and leveraging
research and development investments by big pharma, venture and institutional investors Strategy intended to
provide a diversified and more balanced portfolio of risk/return opportunities
Excellagen® Advanced Wound Care Management Platform: FDA 510(k) clearance for U.S. marketing and sales
International CE mark registration targeted for 1Q/2013 Initial focus on diabetic foot ulcers Consistent with
business strategy, support initial market introduction, seed the market, then monetize through strategic
partnerships and distribution deals in U.S. and international markets Strategic partnering process underway
CPT® code reimbursement in place (for surgical debridement using Excellagen) CMS and private payor
reimbursement plan progressing Recently announced marketing and sales agreement with Academy Medical for
U.S. Government installations including Veterans Administration and military hospitals
Generx® Global Cardiovascular Platform: International cost-efficient “ASPIRE” Phase 3 / Registration Study
underway Study Design: 100 patients with SPECT imaging efficacy endpoint Initial medical condition: Cardiac
Microvascular Insufficiency (CMI) for patients with myocardial ischemia with symptomatic chronic stable angina
due to coronary artery disease
MedPodium® In-House Brand Platform: Portfolio of premium, science-based, easy-to-use nutraceuticals designed to
promote personal health and well being for today's active, informed and professional lifestyles Recently
announced the acquisition of To Go Brands® to support logistical infrastructure to accelerate revenue
Cardium Werks™: Portfolio of strategic partner-enabled product and platform opportunities that have been
internally developed based on Cardium’s unique skill set, capabilities and technology Genedexa™: a Phase 2b/3
DNA-based wound healing product candidate representing the first product extension from the FDA cleared
Excellagen technology LifeAgain™: a medical analytics and e-commerce platform of algorithms and medical-
2013 Cardium Therapeutics, Inc.
based social media focused programs To Go Brands®: leverage established logistics and retail platform to
market, distribute and sell new products based on internal development and external acquisitions Alternative
independent financing strategies may be utilized to support these opportunities
Key Investor Metrics: No outstanding debt, substantial trading liquidity, continuing news flow expected from
product platforms and other opportunities under consideration Current capital structure provides for significant
economic upside potential as CXM executes its asset-based business strategy Capital-efficient ATM Shelf
Registration in place
6
7. Excellagen ®
Pharmaceutically-
Formulated Collagen (2.6%)
Acellular Biological Modulator
Excellagen is an FDA-cleared syringe-based flowable topical gel that promotes the
activation of the healing process for the treatment of dermal wounds. It is designed to
accelerate granulation tissue growth in non-healing wounds and activates platelets,
triggering the localized release of endogenous growth factors including Platelet-Derived
Growth Factor (PDGF), a key biologic mediator of wound healing.
2013 Cardium Therapeutics, Inc.
It is indicated for the treatment of a broad array of wounds including partial and full thickness
wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers,
tunneled/undermined wounds, surgical wounds (donor sites/ grafts, post-Mohs surgery,
post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations,
second-degree burns, and skin tears) and draining wounds.
7
8. ®
Excellagen® Summary & Commercialization Status
Excellagen is the best-in-class acellular Post-marketing in vitro study supports
biological modulator designed to platelet activation triggering the release
accelerate the growth of granulation of endogenous PDGF, an important
tissue for wound healing wound healing mediator
FDA 510(k) clearance for treatment of a Market introduction underway to KOL
broad array of dermal wounds physicians
Initial medical focus: Diabetic Foot Ulcers Unified packaging, web site and DTC
positioning complete
Competitively positioned via aseptically
manufactured, pharmaceutically-
Selected as 2012 Top 10 Innovation in
formulated collagen, flowable syringe-
Podiatry by Podiatry Today magazine
based format, ease and simplicity of use
Matrix multi-center clinical study shows Uses controlled temperature storage
significant tissue growth and positive (2-8 C) to maintain bio-activity
2013 Cardium Therapeutics, Inc.
wound closure versus control at 12 weeks
based on average of 1.6 treatments Outsourced supply chain fully
operational including U.S. cold chain
Matrix Excellagen clinical study data distributor: Smith Medical Partners
published in peer-reviewed journal
8
9. ®
Excellagen® Summary & Commercialization Status
Medical Advisory Board established; Enabling product extensions for new and
sampling and case studies advancing innovative regenerative medicine product
formulations
International CE mark registration in
progress, (expected 1Q/2013) Initial broad labeling allows for conduct
of cost-efficient, post-marketing studies
New product CMS reimbursement for specifically narrowed and higher
submissions completed economic value product labeling claims
Excellagen uses subject of patent
Current CPT® procedure codes cover use
applications
with debridement for DFUs
In discussions with potential strategic
Fully validated cGMP and ISO-certified partners to support marketing and sales
collagen manufacturing process and into four vertical markets: (1) podiatry; (2)
facilities dermatology; (3) wound care centers and
hospitals; and (4) government healthcare
2013 Cardium Therapeutics, Inc.
Aseptic manufacturing process utilizes system markets
cost-effective, single-use, disposable bio-
process components and avoids Recently announced marketing and sales
potentially inactivating terminal agreement with Academy Medical for U.S.
sterilization government medical providers
9
10. Excellagen: Integration into the Practice of Medicine
Stage I Stage II Stage III
Normal Stalled Chronic
Healing Response Healing Response Non-Healing
(> 6 weeks)
Debridement,
Debridement DermaGraft®
Excellagen®
& Dressing Apligraf®
& Dressing
NPWT
Diabetic Diabetic Diabetic
Foot Ulcers Foot Ulcers Foot Ulcers
Excellagen is an acellular biological modulator. It is comprised of flowable
fibrillar Type I bovine collagen gel that is configured into a staggered
2013 Cardium Therapeutics, Inc.
quaternary array of three-dimensional triple helical, telopeptide-deleted
tropocollagen molecules. This configuration provides a structural scaffold
for cell adhesion, migration and proliferation, and a bioactive substrate for
platelet activation and release of essential growth factors including platelet-
derived growth factor (PDGF).
10
11. ®
Excellagen®: Technology & Formulation
High Molecular Weight
Fibrillar Type I
Bovine Collagen
FDA-Cleared,
Specialized Functional
Aseptic Process & Pharmaceutical
Clinical Study Data Excipients
Published in Peer
Review Journal
2013 Cardium Therapeutics, Inc.
Simple | Flowable | Ready to Use
Once Weekly Treatment
11
12. ®
Excellagen®: Advanced Wound Care Management Platform
Refined custom formulated engineered for debridement procedures
fibrillar Type I bovine collagen
High molecular weight
Biocompatible, physiologic pH
Pre-filled, ready to use syringes
Simple and easy: no thawing or mixing
Flowable: no staples or sutures
Viscosity optimized for complete,
dripless wound coverage
Treatment at only one week intervals
Excellagen has been shown to activate
Refrigerated storage required:
human platelets, triggering the release of
Cold Chain logistics partner: Smith Medical
Platelet-Derived Growth Factor (PDGF)
For professional use only; established
Formulated collagen (2.6%) accelerates
2013 Cardium Therapeutics, Inc.
standard CPT® procedure codes may
growth of granulation tissue immediately
apply when used with debridement
following treatment compared to standard
of care control arm (n=45 / P=0.018) Each kit contains four single-use syringes
based on Matrix Clinical Study. Blume et containing 0.5cc of Excellagen topical gel
al., Wound Rep. Reg. 19: 302-308 (2011). and four sterile flexible applicators
12
13. ®
Excellagen: Next Generation
Product Format
First Generation Next Generation
2013 Cardium Therapeutics, Inc.
0.5cc/syringe 0.5cc/ampule
Syringe Format Ampule Format
13
15. In Vitro Research Study Data
Excellagen Activates the Healing Process
Activated Platelet Release of PDGF
2013 Cardium Therapeutics, Inc.
The Power of Biology™
15
16. ®
Excellagen: Post-Marketing Case Studies
Acellular Biological Modulator
1 2 1 2
3 4 3 4
42 Days Stalled: 4 Excellagen® Applications 240 Days Stalled: 5 Excellagen® Treatments
2013 Cardium Therapeutics, Inc.
49 Days to Closure 63 Days to Closure
Excellagen® Pharmaceutically-Formulated Collagen Topical Gel Accelerates Healing
Rate Immediately After Application in Patients with Diabetic Neuropathic Foot Ulcers1
1 Blume et al., Wound Rep. Reg. 19: 302-308 (2011).
16
17. ®
Excellagen: Tissue Regeneration Case Studies
Acellular Biological Modulator
% Area Reduction % Area Reduction
100 100 Case 2
Case 1
Zimny Pfohl
Zimny Pfohl
80 80
% Area Reduction
% Area Reduction
60 60
40 40
Healing Prediction Healing Prediction
Study Baseline1 Study Baseline1
20 20
0 0
0 1 2 3 4 5 6 7 8 9 10 11 12 0 1 2 3 4 5 6 7 8 9 10 11 12
Weeks Weeks
42 Days Stalled: 4 Excellagen® Applications 240 Days Stalled: 5 Excellagen® Treatments
2013 Cardium Therapeutics, Inc.
49 Days to Closure 63 Days to Closure
Excellagen® Pharmaceutically-Formulated Collagen Topical Gel Accelerates Healing
Rate Immediately After Application in Patients with Diabetic Neuropathic Foot Ulcers2
1Healing Times and Prediction of Wound Healing. Zimny S. and Pfohl M.
Exp. Clin. Endocrinol Diabetes 113:90-93 (2005).
2Blume et al., Wound Rep. Reg. 19: 302-308 (2011).
17
18. ®
Matrix: Tissue Regeneration
MATRIX Multi-Center Controlled & Randomized
Metrics of Tissue Growth Wound Study
Wound Size Reduction (n = 47)
Bio-Metric
Pharmaceutically-
Standard
Pre-Specified Matrix Formulated Collagen
of Care Percent
Protocol Assessment: 2.6%
Improvement
One Excellagen Treatment
(n = 31) (n = 16)
Average Wound Size 3.0 cm2 3.0 cm2 X
Matrix Non-Healing Ulcers: Excellagen vs. Control1
+ 208%
Wound Size (Area) 37% 12%1
(p = 0.018)
Reduction @ Week 1
Cumulative Wound Size (Area) + 104%
49% 24%1
Reduction @ Week 2 (p = 0.032)
2013 Cardium Therapeutics, Inc.
Excellagen vs. Healing Prediction Study2
Wound Size (Area) 37% 8%2 + 362%
Reduction @ Week 1
Cumulative Wound Size (Area)
49% 15%2 + 227%
Reduction @ Week 2
1Blume et al., Wound Rep. Reg. 19: 302-308 (2011).
2Healing Times and Prediction of Wound Healing. Zimny S. and Pfohl M.
Exp. Clin. Endocrinol Diabetes 113:90-93 (2005).
18
19. Commercial Business:
Vertical Marketing & Sales Opportunities
®
U.S. Government
Hospital,
including
Wound Healing
Veterans Podiatry Dermatology
Centers &
Administration Focus Focus
Long-Term
& military
Facilities
hospitals
2013 Cardium Therapeutics, Inc.
International Markets
19
20. ®
Excellagen: Strategic Fit with Current
Advanced Wound Healing Products
Treatments for Diabetic Foot Ulcers
Advanced Wound Care Advanced Wound Healing
Bioresorable Scaffold with
Acellular Biological Modulator
Metabolically Active Living Cells
Lower Priced Higher Priced
Professional Use Professional Use
Adjunct to Surgical Dermal Engraftment
Debridement
Standard of Care Specific Therapeutic Use
Claims for Treatment of
Broad Product
2013 Cardium Therapeutics, Inc.
Diabetic Foot Ulcers Only
Use Applications
Cold Chain Distribution
Cold Chain Distribution
Tissue Regeneration
Dermagraft® is a Registered Trademark of
Advanced BioHealing, a subsidiary of Shire PLC.
20
21. ®
Excellagen: Strategic Fit with Current
Advanced Wound Healing Products
Regenerative Medicine
Advanced Wound Care
Platelet Growth
Factor Activation
FDA-Cleared
Professional Use
Adjunct to Platelet-
2013 Cardium Therapeutics, Inc.
Rich Plasma Therapy
Broad Product
Autologous Platelet-Rich Therapy Use Applications
21
22. ®
Excellagen U.S. Market Opportunities:
Beyond Diabetic Foot Ulcers
Medical Condition Wound Type Incidence
Venous Ulcers 1,625,000
Illness Arterial ulcers 1,725,000
Diabetic foot ulcers 1,260,0001
Immobility Pressure Ulcers 2,500,000
Surgical Wounds: Major 36,000,000
Surgical Surgical Wounds: Moderate/Minor 31,000,000
Mohs Surgery 850,000
Burn injuries 1,285,000
Trauma Amputations 150,000
2013 Cardium Therapeutics, Inc.
Traumatic Wounds/Lacerations2 16,250,000
TOTAL 92,645,000
Source: Medtech Insight
1Source: American Diabetes Association
2Traumatic wounds/lacerations consist of open wounds (approx. 8.7 million), superficial wounds
(approx. 1.7 million), and contusions (approx. 5.8 million) seen in emergency rooms.
22
23. Excellagen® Medical Opportunity
Chronic
Diabetic Pressure
Foot Ulcers Ulcers
®
Other
Wounds:
Including Venous
Surgical Ulcers
& Burns
2013 Cardium Therapeutics, Inc.
Activate the Healing Process
23
24. ®
Excellagen® Case Study: Venous Leg Ulcer
Arthur Tallis, DPM, FACFAS
Phoenix, AZ
Day 56: After 4 applications of Excellagen
Day 1: Pretreatment
(Unna boot worn from Day 27-56)
Patient Demographic Data
2013 Cardium 2013 Cardium Therapeutics, Inc.
Age 62
Sex Male
Therapeutics, Inc.
General Health Status Venous Insufficiency
Wound Duration 13 Months
Prior to Treatment
Prior Therapies Anticoagulants, Four-layer compression dressing
24
25. ®
Excellagen® Case Study: Mohs Surgery
“Excellagen gel proved to be an outstanding healing agent for an extensive
Mohs surgery wound. It is an economical alternative to costly skilled nursing care.”
Steven Smith, MD, Wellesley, MA
Day 14: After One Day 22: After Two Day 49: After Three
Excellagen Treatment Excellagen Treatments Excellagen Treatments.
Full Re-Epithelization
Patient Demographic Data
2013 Cardium Therapeutics, Inc.
Age 75
Sex Male
2013 Cardium Therapeutics, Inc.
Nursing home resident with dementia. Mohs surgery performed on
General Health Status recurrent squamous cell carcinoma. Repair with skin grafting not feasible
due to expectation that patient would disturb surgical dressings.
Mohs Surgical Site Left-Posterior Ear/Mastoid
Excellagen Treatment 25 Days 4, 14, and 22 post-surgery
26. ®
Excellagen® Case Study: Pressure Ulcer
“Noticed healing accelerated after first week-
I was pleasantly surprised. I’m very pleased”
Curtis Long, DPM, Walla Walla, WA
5/21/2012: Wound Area 3.5 cm2. 7/16/2012: Complete Wound
Sharp Debridement Followed Closure at 8 weeks After Single
by Excellagen Application Application of Excellagen
Patient Demographic Data
Age 68
2013 Cardium 2013 Cardium Therapeutics, Inc.
Sex Male
Therapeutics, Inc.
General Health Status Obese, Wheelchair-Dependent, Type II Diabetes
Wound Location Left Plantar Heel- formed at pressure point (foot rest of wheelchair)
Wound Duration 16 Weeks
Prior to Treatment
Prior Therapies 26 Debridement, Hydrophilic Wound Dressing, Pressure-Relieving Padding
27. Advanced Modality Cost Comparison for Wound Therapies
$20,000
Estimated costs associated with full 12 weeks of DFU treatment
including physician and nursing time, facility charges,
treatment costs and associated standard of care.
$15,000
$13,900
$11,600
$10,000
$8,100
$5,000
$3,590
$600
$0
2013 Cardium Therapeutics, Inc.
Excellagen® KCI Negative Apligraf4 Dermagraft5
Topical Gel1 GraftJacket Pressure
Xpress Gel®2 Wound
Therapy3
1Excellagen® assumes 4 treatments.
2Assumes 2 treatments.
3Based on 16 weeks of DFU treatment of NPWT in accordance with RCT.
4Based on an average of 4 surgical applications (per Policy up to 5 surgical applications are allowed).
5Based on an average of 6 surgical applications (per Policy up to 8 applications are allowed).
27
28. Excellagen: Enabling Delivery Platform
Small
Peptides Molecule
Drugs
®
Anti- Conditioned
microbials Cell Media
2013 Cardium Therapeutics, Inc.
DNA-Based Pluripotent
Biologics Stem Cells
28
30. 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.
Patients with CMI have had an insufficient angiogenic response to their current disease
2013 Cardium Therapeutics, Inc.
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.
30
31. Coronary Artery Disease
Disease-Induced Angiogenic Response
2013 Cardium Therapeutics, Inc.
OFF ON
31
32. 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.
32
33. 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
1996 1997 - 2005 2005 - Present Current Status
2013 Cardium Therapeutics, Inc.
33
34. 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 Treatment: Patients
discoveries to boost cell
Angina for Patients with with Myocardial
transfection
“Refractory” Coronary Ischemia Due to
• Developed new “bio-assay”
Artery Disease production batch release assay Coronary Artery Disease
that measures angiogenic
Primary Endpoint: response to Generx Primary Endpoint:
ETT Improvement • Five-year real-time product RPDS Improvement as
2013 Cardium Therapeutics, Inc.
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
34
35. ®
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
Improvement in Reversible
2013 Cardium Therapeutics, Inc.
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
35
36. Potential Therapeutic Positioning:
Generx® / Cardionovo®
(PTCA)
Percutaneous
Traditional Transluminal
Drug Coronary
Therapy Angioplasty
& Stents
Coronary
Artery
Disease
Generx®
(CABG)
Non-Surgical
Coronary DNA-Based
Artery Bypass Angiogenic
2013 Cardium Therapeutics, Inc.
Surgery Therapy
36
37. 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
Utilizes standard balloon catheter which can be easily
integrated into diagnostic angiogram procedures or with other
2013 Cardium Therapeutics, Inc.
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
37
39. 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
Generx [Ad5FGF-4]
2013 Cardium Therapeutics, Inc.
(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.
39
40. 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 *
25
Ranexa
2013 Cardium Therapeutics, Inc.
Chronic
Anti-Anginal Drug
1000 mg Daily
0
Baseline ETT (sec): 300 Baseline ETT (sec): 470
% increase + 25% % increase + 5%
(n = 30) (n = 255)
40
42. 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
Easily Manipulated
Research Studies: Coronary
Relatively Low Cytotoxity
2013 Cardium Therapeutics, Inc.
Intracoronary Administration Extraction Rate
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
42
43. 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.
43
44. MEDPODIUM Health Sciences
Science-Based Lifestyle Solutions
2013 Cardium Therapeutics, Inc.
Cardium (CXM)
announces acquisition
of To Go Brands®
44
45. To Go Brands® develops markets and sells a portfolio of über healthy,
science-based, great tasting, anti-oxidant rich, super-charged phytonutrients
and nutraceuticals supplements in an array of easy use formats, including
drink mixes, chews, powders and capsules, to empower busy lifestyles in
today’s fast-paced, teach driven world. These products are sold through the
company’s web-based store and food, drug and mass channels at retailers.
2013 Cardium Therapeutics, Inc.
Go Active! | Go Healthy! | Go Trim!
45
47. Cardium Acquisition: To Go Brands®
Founded in 2007, To Go Brands is a privately-held San Diego-based company that
develops, markets and sells a portfolio of over 25 products, including nutraceutical
powder mixes, supplements and chews to support healthy lifestyles.
Acquisition is focused on accelerating the growth and development of
Cardium’s in-house MedPodium brand platform. This transaction provides:
portfolio of marketed products
established logistics and distribution capabilities
a website e-commerce platform
experienced management team with key contacts and a track
record of developing and placing new and innovative health and
nutraceutical products into the mass, food and drug retail channels
revenue platform with growth potential.
2013 Cardium Therapeutics, Inc.
To Go Brands will coordinate Cardium’s health sciences brand platform
including MedPodium Nutra-Apps® product line, as well as the strategic
investment in SourceOne Global Partners.
47
48. To Go Brands®: Current Retail Platform
2013 Cardium Therapeutics, Inc.
48
49. To Go Brands®: Energy & Weight Management
2013 Cardium Therapeutics, Inc.
49
50. To Go Brands®: Product Portfolio
2013 Cardium Therapeutics, Inc.
50
51. To Go Brands®: Product Formats
Stick Packs Scoop
2013 Cardium Therapeutics, Inc.
Chews
51
52. To Go Brands®: Spotlight on Product Portfolio
2013 Cardium Therapeutics, Inc.
52
53. To Go Brands®: Portfolio Intersection
2013 Cardium Therapeutics, Inc.
53
54. Strategic Partner-Enabled Opportunities
Technology
Focus Summary
Platforms
Planning small, cost-effective Phase 2b/3
study to confirm accelerated DNA-based
Tissue engineering and
wound healing. Next generation product
regenerative medicine platform
candidate represents first product
and DNA-Activated matrices
extension from the FDA-cleared Excellagen
for wound repair & orthopedic
technology. Plug-n-Play Phase 3 biologic
repair and restoration
product candidates offer considerable
economic value opportunity
Medical analytics and
Millions of cancer survivors remain
e-commerce platform of
uninsurable by traditional life insurance
algorithms and medical-based
underwriting standards. Cardium is
social media focused programs
developing new scalable methodologies
to support specialized survivable
designed to assess relative survival risks
risk life insurance underwriting
for life insurance companies to address
for cancer patients, cancer
this significant under-appreciated
survivors and patients with
economic opportunity
chronic medical diseases
2013 Cardium Therapeutics, Inc.
MedPodium Health Sciences Leverage TO GO BRANDS® established
in-house brand platform: infrastructure, distribution capabilities and
organic mixes, nutraceuticals retail network to support external product
and dietary supplements acquisitions and strategic partnerings
Distribution &
Logistics Platform
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55. Cardium: Focus & Key Skill Set
science &
medicine
1 4
2 3
regulatory
matters
2013 Cardium Therapeutics, Inc.
& process marketing
engineering & finance
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57. Genedexa DNA-Based
Adenovector Cassette
Demonstrated Phase 1/2
Safety Data with FDA
No Cytotoxicity Observed
Established FDA
Manufacturing Standards
Manufacturing in
High Titer
Adenovector construct Favorable Manufacturing
Carries the PDGF-B Gene Costs
Research Studies: High Dermal Transfection
Topical Administration Levels
2013 Cardium Therapeutics, Inc.
Preclinical Efficacy Studies
Transient Expression
Doukas et al; Human Gene Therapy 2001 12:783-798
Gu et al; Wounds 2004 16:34-41
Mutagenesis Improbable
Toxicology and Biolocalization
Gu et al; Molecular Therapy 2004 9:699-711
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58. Genedexa: Stimulates Increased Granulation Tissue
Collagen without Ad5Luc/Collagen
Platelet Activation
Granulation Tissue Growth
Synergistic
2013 Cardium Therapeutics, Inc.
Effect of
Collagen and
Ad5PDGF-BB (saline) Genedexa™
Ad5PDGF-B
Cartilage removed Day 7, 20x,
Ad5PDGF-B 2.3x109 vp, Ad5Luc 6x109 vp
Doukas et al. Hum Gene Therapy, 2001 Vol 12(7)
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59. Genedexa [Ad5PDGF-B] Induces Increased
Granulation Tissue and Re-Epithelialization
Pre-Clinical Studies
10 1.0
* P = 0.009
*
* P = 0.001
SD
*
SD
Granulation Tissue Area (mm2)
Epithelium Area (mm2)
5 0.5
2013 Cardium Therapeutics, Inc.
0 0.0
Collagen AdPDGF-B Collagen AdPDGF-B
w/o Platelet w/o Platelet
4E + 9 PN AdPDGF-B
2.6% Collagen gel Activation Activation
N=6
Day 8
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61. Estimated Number of US Cancer Survivors
Form of Disease Current 2012 Projected 2022
Prostate 2,778,630 3,922,600
Breast 2,971,610 3,786,610
Thyroid 436,590 609,690
Testis 230,910 295,590
Melanoma 977,250 1,324,260
Hodgkin's Lymphoma 534,950 713,810
Other 5,670,060 7,347,440
2013 Cardium Therapeutics, Inc.
Total 13.6 Million 18.0 Million
Sources: Data Modeling Branch, Division of Cancer Control and Population Sciences, National Cancer Institute;
American Cancer Association.
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62. Percentage of U.S. Households
Owning Individual Life Insurance
Despite all time low priced web-based life insurance
premiums, policy ownership is at a 26-year low
2013 Cardium Therapeutics, Inc.
Source data: LIMRA’s 2010 Life Ownership study.
62
63. Percentage of Adults Admitting
“I Need More Life Insurance”
= 117 million adults
2013 Cardium Therapeutics, Inc.
Source data: U.S. Census – 2010; LIMRA’s 2010 Life Ownership study.
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65. LifeAgain Case Study:
Advances in Prostate Cancer Survival
Relative
Prostate Cancer Survivor
Rate
Relative Survival Rates as of 19841
Five Year 72%
Ten Year 58%
Current Relative Survival Rates1
Five Year 100%
Ten Year 100%
Median Age of Death for Cancer
80 years
2013 Cardium Therapeutics, Inc.
of the Prostate in the U.S.1
1Source data: National Cancer Institute from Surveillance, Epidemiology and End
Result Program (SEER) Survival Monograph. Chapter 22.
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