Cardax Inc · OTC:CDXI
Cardax — Investor Presentation (December 2019)
56 slides from Cardax's investor presentation, December 2019
Slide 1: Corporate Presentation December 2019
CORPORATE PRESENTATION December 2019 1
Slide 2: Certain Disclaimers
CERTAIN DISCLAIMERS There are statements in this presentation that are not historical facts. These “forward-looking statements” can be identified by use of terminology such as “anticipate,” “believe,” “estimate,” “expect,” “hope,” “intend,” “may,” “plan,” “positioned,” “project,” “propose,” “should,”
Slide 3: Cardax Overview
● Cardax is a development stage biopharmaceutical company founded in 2006 (OTCQB:CDXI) ● Focused on development of pharmaceuticals to safely address one of the major underlying causes of many chronic diseases – inflammation ● Innovative product platform based on xanthophyll carotenoids (astaxanthin a
Slide 4: Management Team
● David G Watumull – Chief Executive Officer Co-founder of Cardax and co-inventor of technology. Experienced biotech executive, former biotech analyst and investment banker. ● David M Watumull – Chief Operating Officer Two decades of experience in astaxanthin product development, commercialization, an
Slide 5: Board of Directors
● George W Bickerstaff – Chairman Former Chief Financial Officer of Novartis Pharma. ● David G Watumull – Director Chief Executive Officer of Cardax. ● Terence A Kelly, PhD – Director BOARD OF Former research executive with Boehringer Ingelheim. DIRECTORS ● Michele Galen – Director Former communicatio
Slide 6: Scientific Advisory Board
● Deepak Bhatt, MD, MPH – SAB Chairman Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital. Professor of Medicine at Harvard Medical School. Chair of REDUCE-IT clinical trial. SCIENTIFIC ● Paresh Soni, MD, PhD – SAB Member ADVISORY Cardax Chief Clinical and R
Slide 7: Key Opinion Leaders Agree: Inflammation = Major Unmet Need in CVD
KEY OPINION LEADERS AGREE Inflammation = Major Unmet Medical Need in Cardiovascular Disease (CVD) 7
Slide 8: Important Example: CANTOS (Novartis)
IMPORTANT EXAMPLE CANTOS (Novartis) ⬇ ⬇ 8
Slide 9: CANTOS Trial
CANTOS Trial Canakinumab ANti-inflammatory Thrombosis Outcome Study Randomized, double-blind, placebo controlled VALIDATING THE ● ● Subjects: INFLAMMATORY ○ 10,061 cardiovascular patients, 39 countries HYPOTHESIS ○ ○ Standard of care (including statins) Elevated inflammation (CRP > 2 mg/L) ● Agent: Ca
Slide 10: Response to the CANTOS Trial
Response to The CANTOS Trial: “It (this study) opens up an entirely new vista for the treatment of heart disease, because now everybody on the planet—in the pharmaceutical industry and in research institutions like ours and at the National Institutes of Health—are going to be looking to find anti-infl
Slide 11: Ibuprofen Aspirin Celecoxib Acetaminophen Corticosteroids
IBUPROFEN ASPIRIN CELECOXIB ACETAMINOPHEN CORTICOSTEROIDS 11
Slide 12: Side Effects
Because of the risk of dangerous SIDE EFFECTS associated with chronic use
Slide 13: Key Opinion Leaders Agree: Pleiotropic Effects on CVD Markers
KEY OPINION LEADERS AGREE Pleiotropic Effects on CVD Markers = Major CVD Benefit 13
Slide 14: Important Example: REDUCE-IT (Amarin)
IMPORTANT EXAMPLE REDUCE-IT (Amarin) ⬇ ⬇ 14
Slide 15: REDUCE-IT Trial
REDUCE-IT Trial Reduction of Cardiovascular Events–Intervention Trial ● Randomized, double-blind, placebo controlled ● Subjects: PLEIOTROPIC ○ 8,179 statin treated patients with elevated CV risk BENEFITS REDUCE ○ Elevated triglycerides (median baseline 216 mg/dL) Agent: Vascepa (fish oil derived drug
Slide 16: Why not manage chronic inflammation with prescription fish oils?
Why not manage chronic inflammation and dyslipidemia with prescription fish oils? a - NDC 0093-5401-89 a ag aunts Vascepa Capsules USP (icosapent ethyl) 7 1gram* Capsules a PAAR ISPENSE Wi INACIST PLEASE DISPENSE WITH a ATTACHED PATIENT INFORMATION LEAFLET i Benly 1 gram
Slide 17: Disadvantages of Fish Oil Drugs
DISADVANTAGES OF FISH OIL DRUGS *Safety risks of prescription fish oils: Lovaza and other DHA, EPA combination fish oil drugs have risks of side effects including back pain, eructation, dysgeusia, and increases in LDL cholesterol; Vascepa has risks of side effects including arthralgia, atrial fibrillat
Slide 18: The Solution Requires a Unique Combination of Benefits
THE SOLUTION REQUIRES A UNIQUE COMBINATION OF BENEFITS
Slide 19: Cardax Product Platform
UNIQUE COMBINATION OF BENEFITS: CARDAX ✓ Excellent safety profile that supports chronic use PRODUCT ✓ Broad anti-inflammatory activity & pleiotropic effects PLATFORM ✓ Oral dosing convenience & ease of administration COMPETITIVE ✓ Scalable manufacturing ADVANTAGES ✓ Economical pricing 19
Slide 20: Cardax Product Platform
CARDAX PRODUCT PLATFORM PHARMACEUTICAL CANDIDATES DISCOVERY PRECLINICAL CLINICAL CDX-101 (ASTAXANTHIN RX CANDIDATE) XXXXXXXXXXXXXXXXXXXXXXXXXXXX for SEVERE HYPERTRIGLYCERIDEMIA CDX-301 (ZEAXANTHIN RX CANDIDATE) XXXXXXXXXXXXXXXXXXXXXX for STARGARDT DISEASE DIETARY SUPPLEMENTS DEVELOPMENT LAUNCH MARKE
Slide 21: Cardax Product Platform
CARDAX PRODUCT PLATFORM PHARMACEUTICAL CANDIDATES DISCOVERY PRECLINICAL CLINICAL CDX-101 (ASTAXANTHIN RX CANDIDATE) XXXXXXXXXXXXXXXXXXXXXXXXXXXX for SEVERE HYPERTRIGLYCERIDEMIA CDX-301 (ZEAXANTHIN RX CANDIDATE) XXXXXXXXXXXXXXXXXXXXXX for STARGARDT DISEASE DIETARY SUPPLEMENTS DEVELOPMENT LAUNCH MARKE
Slide 22: CDX-101
● CDX-101: Proprietary prodrug of astaxanthin with broad anti-inflammatory activity, pleiotropic effects, excellent safety ● Primary Therapeutic Area: Cardiovascular disease CDX-101 (cardiovascular inflammation and mixed dyslipidemia) ● Proof of Concept: Human & animal studies with astaxanthin,* which
Slide 23: What Is Astaxanthin?
WHAT IS ASTAXANTHIN? Astaxanthin is a naturally occurring marine carotenoid found in salmon, microalgae, krill, lobster, and crab. Carotenoids are natural pigments that impart coloration and support animal health and vitality. Astaxanthin is responsible for turning salmon and shellfish pink. 23
Slide 24: Without Astaxanthin, Salmon Are:
WITHOUT ASTAXANTHIN, SALMON ARE: ● ● ● ● ● 24
Slide 25: Astaxanthin Safety
ASTAXANTHIN SAFETY No significant side effects reported in published human studies (over 1,800 subjects) ● Long history of use in humans and animals ● Extensive safety testing (see table on next slide) Source: ncbi.nlm.nih.gov 25
Slide 26: Astaxanthin Safety
ASTAXANTHIN SAFETY No clinically meaningful safety issues found even at extremely high doses: TYPE OF STUDY MAXIMUM DOSING (mg/kg) Acute Toxicity >8,000 (mouse, rat), 2,000 (non-human primates) Sub-Chronic Toxicity 1,240 (rat), 160 (dog) 1 Year Chronic Toxicity/Carcinogenicity 1,000 (rat), 1,400 (mo
Slide 27: Astaxanthin Mechanism of Action
ASTAXANTHIN CELLULAR AND MITOCHONDRIAL MECHANISM LOCALIZATION AND FUNCTIONALITY OF ACTION ● Astaxanthin spans and stabilizes cellular and mitochondrial membrane (see figures on this slide and next slide) ● Reduces pathological activation of inflammatory pathways by modulating oxidative stress in cells
Slide 28: Astaxanthin Mechanism of Action
ASTAXANTHIN MECHANISM OF ACTION SPANS & STABILIZES BIOLOGICAL LIPID BILAYER (MEMBRANE) 28
Slide 29: Astaxanthin Mechanism of Action
ASTAXANTHIN MECHANISM REDUCTION OF INFLAMMATION OF ACTION HUMAN STUDIES Astaxanthin demonstrates positive and ● TNF-α decreased (-30%, p=0.0022) quantifiable pleiotropic effects on many ● CRP decreased (-20%, p<0.05, two studies) inflammatory cytokines and drug targets: ● Oxidative stress decreased (M
Slide 30: Astaxanthin Reduced TNF-α in Inflammatory Animal Model
ASTAXANTHIN MECHANISM OF ACTION ASTAXANTHIN REDUCED TNF-α TNF-α Concentration (pg/ml) CONTROL IN INFLAMMATORY ANIMAL MODEL = PREDNISOLONE Effect of astaxanthin on TNF-α concentrations in aqueous humor. The aqueous humor was collected 24 ASTAXANTHIN STEROID hours after lipopolysaccharide (LPS) treatm
Slide 31: Astaxanthin Research
ASTAXANTHIN RESEARCH 2,000+ peer reviewed papers More than 50 peer reviewed papers published by Cardax team members 50+ pilot human clinical trials 20+ randomized, double-blind, placebo-controlled human proof-of-concept studies 31
Slide 32: Astaxanthin Therapeutic Areas
ASTAXANTHIN THERAPEUTIC AREAS* Cardiovascular Metabolic Liver Disease Disease Disease COMMONALITIES ● Inflammation ● Oxidative Stress Arthritis Aging *Potential therapeutic areas for CDX-101 pharmaceutical development 32
Slide 33: Astaxanthin & Cardiovascular Disease
Human Studies* ● CRP decreased (-20%, p<0.05, two studies) ● Triglycerides decreased (-25.8%, p<0.05) INITIAL FOCUS ● LDL-C decreased (-10.4%, p<0.05) ASTAXANTHIN & ● HDL-C increased (+14.5%, p<0.01) Apolipoprotein B decreased (-7.5%, p<0.01) CARDIOVASCULAR ● ● Adiponectin increased DISEASE ○ Three
Slide 34: Astaxanthin & Cardiovascular Disease: CHASE Interim Results
● Cardax CHASE Clinical Trial Interim Results (9/23/19) Interim Results High Dose Low Dose Placebo (40 subjects, 12 weeks) (96 mg/day) (24 mg/day) (0 mg/day) ASTAXANTHIN & CRP ⬇ 28% ⬇ 32% ⬇ 5% CARDIOVASCULAR LDL-C ⬇ 12% ** ⬇ 7% ⬆ 5% DISEASE Total cholesterol ⬇ 8% * ⬇ 5% ⬆ 4% Triglycerides ⬇ 16% ⬇ 13
Slide 35: Astaxanthin & Cardiovascular Disease Key Points
● Reduces inflammation ASTAXANTHIN & CARDIOVASCULAR ● Improves lipid profiles DISEASE ● Lowers blood pressure KEY POINTS ● Decreases artery plaque formation in animals 35
Slide 36: Astaxanthin & Metabolic Disease
Human Studies ASTAXANTHIN & ● Adiponectin increased METABOLIC ○ Three studies: +26% (p<0.01), +14% (p=0.0053), +30% (p=0.01) ● TNF-α decreased (-30%, p=0.0022) DISEASE ● Oxidative stress decreased (MDA, IsoP, SOD, TAC increased) Animal Studies In human proof-of-concept “pilot” studies conducted by t
Slide 37: Astaxanthin & Metabolic Disease Key Points
● Reduces inflammation ASTAXANTHIN & METABOLIC ● Increases adiponectin levels DISEASE ● Improves blood glucose & insulin levels in animals KEY POINTS ● Increases insulin signaling/response in animals 37
Slide 38: Astaxanthin & Liver Disease
Human Studies ASTAXANTHIN & ● NASH disease markers decreased in patients LIVER DISEASE ○ ○ Steatosis: p<0.05 NAFLD Activity Score (NAS): p<0.08 ○ Lobular inflammation decreased: trend In human proof-of-concept “pilot” studies ● TNF-α decreased (-30%, p=0.0022) conducted by third parties, astaxanthin
Slide 39: Astaxanthin & Liver Disease Key Points
● Decreases liver fat (steatosis) ASTAXANTHIN & ● Reduces inflammation and oxidative stress LIVER DISEASE ● Decreases elevated liver enzyme levels in animals KEY POINTS ● Improves fibrosis and insulin response in animals 39
Slide 40: Astaxanthin & Arthritis
Human Studies ASTAXANTHIN & ● TNF-α decreased (-30%, p=0.0022) ARTHRITIS ● ● CRP decreased (-20%, p<0.05, two studies) Adiponectin increased ○ Three studies: +26% (p<0.01), +14% (p=0.0053), +30% (p=0.01) In human proof-of-concept “pilot” ● Oxidative stress decreased (MDA, IsoP, SOD, TAC increased) n
Slide 41: Astaxanthin & Arthritis Key Points
● Reduces inflammation ASTAXANTHIN & ● Lowers oxidative stress ARTHRITIS ● Decreases joint degeneration in animal OA model KEY POINTS ● Reduces major inflammatory markers in animals 41
Slide 42: Astaxanthin & Aging
Background ● Activation of anti-inflammatory, anti-aging gene ASTAXANTHIN & FOXO3 promotes longevity in humans AGING ○ Replicated in >20 independent studies ○ Confers CVD protective benefit (p=0.001) In human studies conducted by third ○ Decreases inflammation (CRP, trend; parties, activation of the FO
Slide 43: CDX-101 In Summary
● CDX-101: Proprietary prodrug of astaxanthin with broad anti-inflammatory activity, pleiotropic effects, excellent safety ● Primary Therapeutic Area: Cardiovascular disease (cardiovascular inflammation and mixed dyslipidemia) CDX-101 ● Proof of Concept: Human & animal studies with astaxanthin,* which
Slide 44: Cardax Product Platform
CARDAX PRODUCT PLATFORM PHARMACEUTICAL CANDIDATES DISCOVERY PRECLINICAL CLINICAL CDX-101 (ASTAXANTHIN RX CANDIDATE) XXXXXXXXXXXXXXXXXXXXXXXXXXXX for SEVERE HYPERTRIGLYCERIDEMIA CDX-301 (ZEAXANTHIN RX CANDIDATE) XXXXXXXXXXXXXXXXXXXXXX for STARGARDT DISEASE DIETARY SUPPLEMENTS DEVELOPMENT LAUNCH MARKE
Slide 45: CDX-301
● CDX-301: Zeaxanthin pharmaceutical candidate ● Mechanism of Action: Zeaxanthin accumulates in human eye via retinal receptor and provides protection against blue light, oxidative CDX-301 damage, and inflammation that occurs in macular degeneration ● Therapeutic Area: Macular degeneration ZEAXANTHIN
Slide 46: Cardax Product Platform
CARDAX PRODUCT PLATFORM PHARMACEUTICAL CANDIDATES DISCOVERY PRECLINICAL CLINICAL CDX-101 (ASTAXANTHIN RX CANDIDATE) XXXXXXXXXXXXXXXXXXXXXXXXXXXX for SEVERE HYPERTRIGLYCERIDEMIA CDX-301 (ZEAXANTHIN RX CANDIDATE) XXXXXXXXXXXXXXXXXXXXXX for STARGARDT DISEASE DIETARY SUPPLEMENTS DEVELOPMENT LAUNCH MARKE
Slide 47: ZanthoSyn Overview
ZANTHOSYN® ZanthoSyn® is a physician recommended astaxanthin OVERVIEW dietary supplement for inflammatory health* ● 2.85x better absorption vs. ordinary astaxanthin ● Precision & purity (cGMP) ● No aftertaste or smell ● Generally Recognized as Safe according to FDA regulations Health applications inc
Slide 48: ZanthoSyn Astaxanthin Absorption
ZANTHOSYN® ASTAXANTHIN ABSORPTION ● ○ p=0.013 ● ○ p=0.013 ● ○ ZanthoSyn = 27% ○ Ordinary asta = 62% ● ● 48
Slide 49: ZanthoSyn Clinical Trial (CHASE)
CHASE Clinical Trial Cardiovascular Health Astaxanthin Supplement Evaluation ZANTHOSYN® ● Randomized, double-blind, placebo controlled, IRB approved CLINICAL TRIAL ● Subjects: Up to 120 subjects with CV risk factors and CRP > 2 mg/L ● Primary Endpoint: Cardiovascular health as measured by CRP (ongoi
Slide 50: ZanthoSyn Marketing
ZANTHOSYN® MULTI-PRONGED APPROACH MARKETING ZanthoSyn® provides a combination of safety, purity, manufacturing rigor, bioavailability, and scientific support not often present in other supplements. ZanthoSyn® is well-accepted at medical conferences where crowds of physicians and other healthcare prof
Slide 51: ZanthoSyn
ZanthoSyn® is a physician recommended astaxanthin dietary supplement for inflammatory health* ZANTHOSYN® ✓ ✓ ✓ ✓ ✓ ✓ * These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. 51
Slide 52: CDX-101 vs. ZanthoSyn
CDX-101 ZANTHOSYN® Synthetic Astaxanthin Synthetic Astaxanthin COMPOSITION Prodrug (NCE) Formulation CDX-101 vs. INTELLECTUAL Composition of Matter Use (pending) ZANTHOSYN® PROPERTY and Use (issued & pending) PRODUCT Rx Candidate Dietary Supplement While both deliver astaxanthin to the TYPE bloodstr
Slide 53: Intellectual Property
● Cardax IP consists of 29 issued patents and 5 patent applications: ○ 14 patents issued in the United States ○ 15 patents issued in Europe, Canada, China, India, Japan, Hong Kong, and Brazil ○ 4 patent applications pending in United States, INTELLECTUAL Europe, and PCT countries PROPERTY ● Cardax I
Slide 54: Upcoming Milestones
● CDX-101 (astaxanthin Rx candidate) IND filing: Q4 2020 / Q1 2021 UPCOMING ○ MILESTONES ● CHASE Clinical Trial (astaxanthin supplement study) ○ Final results: 2020 The milestones presented above are our best estimates and subject to adjustment. There is no assurance such milestones will be achieved
Slide 55: In Summary
● Cardax is focused on development of pharmaceuticals to safely address one of the major underlying causes of many chronic diseases – inflammation ● Innovative product platform based on xanthophyll carotenoids (astaxanthin and zeaxanthin) – powerful anti-inflammatory agents with pleiotropic effects, e
Slide 56: Thank You
THANK YOU 56