Taxus Cardium Pharmaceuticals Group Inc
Taxus Cardium Pharmaceuticals — Investor Presentation (January 2017)
37 slides from Taxus Cardium Pharmaceuticals's investor presentation, Jan 5, 2017
Slide 1: Developing New Therapeutics for a Global Market
Angionetics is a private, newly-formed, San Diego-based biotechnology company focused on the development of Generx® [alferminogene tadenovec], a phase 3 angiogenic gene therapy product candidate for the treatment of Myocardial Ischemia and Refractory Angina, and other patients with Cardiac Syndrome
Slide 2: Use of Information
USE OF INFORMATION This information is for the express use of the addressee. The document may not be reproduced in whole or part without written permission. This document provides information related to certain new product opportunities and does not constitute a an offer, license or authorization to
Slide 3: Medical Revascularization: Microvascular Gene Therapy
MEDICAL REVASCULARIZATION Microvascular Gene Therapy TODAY TOMORROW Myocardial Ischemia Refractory Angina Cerebral Ischemia Vascular Dementia
Slide 4: Recent Press Coverage: Scientific American
RECENT PRESS COVERAGE SCIENTIFIC AMERICAN January 2017
Slide 5: Strategic Positioning for a Large Unaddressed Segment of the Angina Market
Drug Therapy Mechanical Revascularization Medical Revascularization Strategic Positioning For a Large Unaddressed Segment of the Angina Market
Slide 6: Platform Building Blocks
Platform Building Blocks DNA FGF-4 Gene Adenovector & CAR Receptor Delivery System One-Time, Non- Surgical Delivery Localized Transfection Cardiac Angiogenic Response
Slide 7: Gene Therapy
GENE THERAPY Source: Mukherjee, Siddhartha, The Gene, An Intimate History
Slide 8: Leveraging Cardiac Plasticity
Leveraging Cardiac Plasticity OFF ON Natural Disease-Induced Collateral Network Formation
Slide 9: Catheter-Based Angiogenic Gene Therapy
Catheter-Based Angiogenic Gene Therapy Echocardiology
Slide 10: One-Time Treatment During Standard Angiographic Procedure
One-Time Treatment During Standard Angiographic Procedure SPECT Clinical Study (Agent-2) Efficacy Equivalent to Bypass Surgery or Percutaneous Coronary Intervention Cardiac Microvascular Gene Therapy
Slide 11: Cardiac SPECT Imaging
MEDICAL REVASCULARIZATION CARDIAC SPECT IMAGING Microvascular Gene Therapy fusic @ Reversible Perfusion Defect Before Treatment 4.Weeks Post Generx Treatment 8 weeks Post Generx Treatment Bice Gen sane ee cf
Slide 12: Generx: Arteriogenesis & Angiogenesis
Generx: arteriogenesis & Angiogenesis
Slide 13: Corporate Development Strategy: Value Unlock
CRXM 100% Corporate Development Strategy: “Value Unlock” FDA-Cleared Phase 3 FDA 510(K) Clearance Investor Preferred Stock Common Stock Preferred Stock Fully-Converted into Common Stock Stock ⃰⃰ Percent Huapont Life Sciences Affiliate 1,800,000 - 1,800,000 15.0% Taxus Cardium - 7,200,000 7,200,000 8
Slide 14: Investment Thesis
Investment Thesis Global Leader in Angiogenic Gene Therapy. With clinical success, Generx will be the first cardiovascular gene-base therapeutic in the world for a large addressable market as a treatment for otherwise healthy patients Current Management Team. Responsible for leading Generx from pre-
Slide 15: Product Candidate
Product Candidate ~ ANGIOGENIC GENE THERAPY 1969 1979 2002 Phase 3 Microvascular Gene Therapy — _ engionetics
Slide 16: Clinical & Medical Advancement: Why This? Why Now?
Clinical & Medical Advancement: Why This? Why Now? FDA Phase 3 clearance with expanded and newly demarcated patient population FDA Fast Track submission pending Initial strategic partnership completed New preclinical research on Ad5 receptor interaction with Generx supports new transient ischemia de
Slide 17: Licensing and Opportunity
Licensing and Opportunity Angionetics’ gene therapy technology is primarily based on discoveries at Bayer, Collateral and Cardium Therapeutics. Angionetics is a strategic partner of Huapont Life Sciences, the sublicensee of Generx in Mainland China. Generx is available world-wide for license and/or
Slide 18: Corporate Development Timetable
Event Target Initial Formation and Capital Investment 3Q/16 Private Capital Mezzanine Financing in Process 1Q/17 Planned Access to Public Capital Markets 2Q/3Q 2017 Corporate Development Timetable
Slide 19: Emerging Treatment Paradigms
Emerging Treatment Paradigms Recent Clinical Research Findings: COURAGE, BARI 2D, STICH, PROMISE Ongoing Clinical Research : International Study of Comparative Health Effectiveness with Medical and Invasive Approaches [ISCHEMIA: 8,000 Patients]] Optimal Medical Therapy Small Molecule Drugs Medical R
Slide 20: Initial Generx Targeted Medical Indications
Therapeutic Indication Description U.S. Patients Refractory Angina Coronary Artery Disease Myocardial ischemia and stable angina despite conventional forms of treatment. No longer responsive to maximally tolerated anti-angina medication. Low angiographic risk. Not candidates for PCI and CABG. 600,00
Slide 21: Global Summary of Refractory Angina Populations
Region Refractory Angina (12% of Angina) Access to Essential Medicine USA & Canada 1.8 M 0.6 M - 1.8 M(1) Europe 4.6 M 4.3 M Central Asia 4.1 M 2.0 M Middle East 1.5 M 1.0 M South Asia 6.8 M 2.3 M East Asia 4.1 M 2.9 M Pacific 1.2 M 0.8 M Latin America 1.3 M 0.9 M Sub-Saharan Africa 1.0 M 0.4 M Tota
Slide 22: Potential Baseline Generx Revenue Model
Unit Volume U.S. Market Capture World Market Capture Target Revenue per Dose Price Level Level I $2,000 / dose Level II $3,000 / dose Level III $5,000 / dose 50,000 doses 2.8% 0.3% $100 Million $150 Million $250 Million 100,000 doses 5.5% 0.6% $200 Million $300 Million $500 Million 150,000 doses 8.3
Slide 23: Cardiac Product Predicate
FACTOR Commercial Status FDA-Cleared Phase 3 FDA Approval: 2007 Medical Indication Refractory Angina Chronic Angina Class of Therapy Gene Therapy Small Molecule Mechanism of Action Angiogenesis & Arteriogenesis Metabolic Modulation Modality Regenerative Medicine: Increases Cardiac Blood Supply Sympt
Slide 24: Ranexa Clinical Success Predicate
3.3 attacks 2.1 attacks Placebo (N=258) Ranexa 1000 mg (N=261) Mean Number of Weekly Angina Attacks Weekly Angina Attacks 91.7 Seconds 115.8 Seconds Placebo (N=258) Ranexa 1000 mg (N=261) Change in Exercise Duration (Seconds) Change from Baseline at Week 12 24 second Difference p<0.001 { Ref: Chaitm
Slide 25: Therapeutic Objectives
Enhance Physical Exertion Improve Cardiac Perfusion Reduce Angina and Medication Usage Offer New Therapeutic Options Therapeutic Objectives Product Candidate Reduce Angina and Medication Usage Enhance Physical Exertion Improve Cardiac Perfusion Offer New Therapeutic Options
Slide 26: Clinical Studies
Study Country Phase Status Clinical Endpoint Patients AGENT-1 United States Phase 1 / 2 Dose Finding & Safety Refractory Class 2-3 Angina Exercise Treadmill Time 79 AGENT-2 North America Phase 2a Mechanism of Action Study >9% Reversible Perfusion Defect SPECT Imaging 52 AGENT-3 North America Phase 2
Slide 27: Clinical FDA Regulatory Dossier Findings
Study Clinical FDA Regulatory Dossier Findings AGENT-1 ETT Endpoint (N = 79) - Safe and well-tolerated (Treatment Response Correlates to Angina Severity) - Significant improvement in ETT vs. placebo when baseline ETT ≤ 10 min (p=0.01 at 4 wk; p= 0.05 at 12 wk) AGENT-2 SPECT Endpoint (N = 52) - Safe
Slide 28: Primary Efficacy: Exercise Tolerance
Primary Efficacy: Exercise Tolerance MICROVASCULAR GENE THERAPY alferminogene tadenovec [Ad5FGF-4] Phase 3 Product Candidate
Slide 29: Generx Phase Clinical Data
Generx Phase 2 Clinical Data Primary Endpoint: % Improvement in Reversible Profusion Defect Primary Endpoint: N=52 N=60 Physical Exertion (ETT) Cardiac Perfusion Measured by SPECT
Slide 30: Generx Phase Clinical Data
Generx Phase 2 Clinical Data No Angina Attacks No Nitroglycerin Use N=52 N=52 Secondary Endpoint: % Complete Remission of Angina Secondary Endpoint: % Zero Use of Nitroglycerin
Slide 31: New Patient Portal
New patient portal wwww.myrefractoryangina.com
Slide 32: U.S. FDA-Cleared Phase AFFIRM Clinical Study
U.S. FDA-Cleared Phase 3 AFFIRM Clinical Study Ad5FGF-4 In Patients with Refractory Angina due to Myocardial Ischemia Randomized, double-blind, placebo-controlled, multicenter study to evaluate the continued safety and definitive efficacy of Ad5FGF-4 in patients with stress-induced, myocardial ische
Slide 33: AFFIRM Primary Functional Study Endpoint
U.S. FDA-Cleared Phase 3 AFFIRM Clinical Study Ad5FGF-4 In Patients with Refractory Angina due to Myocardial Ischemia Primary Functional Study Endpoint Exercise Tolerance Testing Product Candidate
Slide 34: AFFIRM Study Efficacy Measures and Prior Study Validation
AFFIRM Study Efficacy Measure Prior Study Validation Clinical Data ETT Duration (Primary) AGENT-1 AGENT-3 & -4 Significant improvement in ETT duration at 12 weeks with Generx vs. Placebo for baseline ETT ≤10 min 1 Significant improvement in ETT duration at 12 weeks with Generx vs. Placebo for Age >
Slide 35: Angionetics Management Team
Christopher Reinhard Chief Executive Officer Gabor Rubanyi, M.D., Ph.D. Vice President-Medical Innovation Robert Engler, M.D. Medical Director Wei-Wei Zhang, M.D., Ph.D. Vice President-Scientific Research Lois Chandler, Ph.D. Vice President-Product Development Cardium Tissue Repair Co. Cardium Cardi
Slide 36: Generx: Corporate Development Historical Perspective
Generx®: corporate development Historical Perspective (NASDAQ) University of California San Diego Discovery, Licensing and Initial Preclinical Studies Phase 1/2 to Phase 2b/3 As Strategic Partner with Collateral Therapeutics Formed to Acquire Technology from Schering / Bayer Phase 2b/3 & Internation
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