21
2015 Opportunities and Outlook for Growth Human & Animal Health

Zivo

Embed Size (px)

Citation preview

Page 1: Zivo

2015 Opportunities and Outlook for Growth

Human & Animal Health

Page 2: Zivo

OTC:ZIVO.QBNotice to Investors & AnalystsThis Business Summary, Investment Summary and any Exhibits to itcontain forward-looking statements that involve risks and uncertainties.These statements reflect the Company’s future plans, objectives,expectations and intentions, and the assumptions underlying or relatingto any of these statements. These statements may be identified by theuse of the words “anticipate,” “expect,” “estimate,” “intend,” “believe,”and similar expressions. The Company’s actual results could differmaterially from those discussed in these statements. Factors that couldcontribute to these differences include, but are not limited to, thosediscussed in this document.

Screen #2

Page 3: Zivo

Overview ZIVO Bioscience (formerly Health Enhancement Products, Inc.) holds valuable intellectual property in the form of bioactive compounds that promise to:

Support a healthy immune response in animals and humans

Promote healthy cholesterol balance in humans

Support joint health in animals and humans

Applications in food ingredients, dietary supplements, pharma

Screen#3

Page 4: Zivo

Speed to Revenue The company intends to drive near-term revenue by monetizing animalnutrition and health market verticals while we continue to developlonger-range products that represent larger opportunities, such ashuman therapeutic agents

After efficacy/safety testing and registration, the Company’s natural animal products may be monetized in a matter of months by licensing to larger, well-established brand names as healthy feed and pet treat ingredients

Company is validating and intends to license its bioactive compounds to animal health companies for future therapeutic use

Human product development/compliance as a dietary supplement starts once revenue streams from animal licenses are realized

Company spreads development risk and capital across feed, food, dietary supplement, medicinal and pharma market verticals, while sprinting toward positive cash flow

Monetizing Multiple Verticals

Screen #4

Page 5: Zivo

Market Potential Animal HealthThe Company’s proprietary, algae-derived bioactive compounds are found to be effective in early studies when applied to dairy cattle and dog models – our highest near-term priorities

Accelerate recovery from bovine mastitis – potentially saving US dairy farmers $2.8+ billion in lost milk production annually. The world’s 244 million dairy cows represent an untapped market

Have been shown to slow the degenerative effects of canineosteoarthritis – a proven $300 million market in the US alone

Company has already executed a Collaboration/Optionagreement with world’s largest animal health company for bovine mastitis research

Near-Term Opportunities

Screen #5

Page 6: Zivo

Research Animal HealthThe Company’s proprietary algal culture, its extracts and isolates, are found to be effective in pre-NDI studies as applied to dairy cattle and dog models

In-vitro testing of primary bovine mammary epithelial cells in 3D culture at University of Wisconsin-Madison Dept. of Dairy Science indicated enhanced immune response when cells were exposed to infective pathogens responsible for bovine mastitis, 2013-2014

Explant testing of canine joint tissues at University of Missouri Comparative Orthopaedic Laboratory has indicated the Company’s bioactive compounds may slow the degenerative effects of canine osteoarthritis in early 2014

Dairy cow mastitis in vivo pilot study at UC-Davis yielded very impressive results in combatting mycoplasma bovis. Company is currently negotiating option with Zoetis, formerly Pfizer Animal Health – world’s largest animal pharma company

Recent Developments

Screen #6

Page 7: Zivo

Research Bovine Mastitis Study

Recent News

0

1

2

3

4

5

6

7

8

9

10

IMM NO TX SQ ORAL

Nu

mb

er o

f A

nim

als

Abnormal milk

Normal milk

Milk Appearance Scoring

Screen #7

Page 8: Zivo

IMM Mycoplasma (cfu/ml) NO TX Mycoplasma (cfu/ml) SQ Mycoplasma (cfu/ml) ORAL Mycoplasma (cfu/ml)

356

572

153 4 181 8 212 2 248 1 283 3 299 2 33

69

253

1143

1842

1888

2568

2581

3880

3975 42 139

568

1088

1456

1656

2298

2929

3664 68 533

1036

1384

1570

2153

2919

3539

TREA

TMEN

T1 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 0 0 >300 >300 >300 0 >300 >300 >300 >300 0 >300 0 0 >300 >300 >300 0 >300 0

2 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 0 0 >300 >300 >300 0 0 >300 13 >300 >300 >300 CT 0 >300

3 >300 >300 >300 >300 300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 2 300 >300 >300 >300 >300 >300 0 >300 >300 >300 >300 0 >300 >300 >300 >300 >300 >300

4 0 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 16 0 >300 >300 >300 >300 0 >300 >300 >300 >300 0 >300 >300 >300 30 >300 >300

5 >300 >300 0 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 0 >300 >300 >300 >300 >300 0 >300 >300 >300 >300 >300 0 >300 >300 >300 >300 >300 >300

6 >300 >300 >300 0 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 300 >300 >300 >300 >300 0 0 >300 >300 >300 >300 0 >300 >300 >300 >300 >300 >300

7 >300 >300 >300 >300 >300 >300 >300 300 120 >300 >300 CT 100 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 0 >300 >300 >300 NS >300 >300

8 >300 >300 >300 >300 >300 >300 20 200 50 >300 >300 >300 200 >300 100 300 75 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 0 >300 >300 >300 >300 >300 300

POST

-TRE

ATM

ENT

9 >300 50 >300 >300 >300 >300 170 >300 200 >300 >300 >300 300 >300 >300 >300 300 >300 >300 >300 >300 300 >300 >300 >300 >300 >300 0 >300 >300 >300 NS >300 >300

10 >300 45 >300 >301 >300 >300 >300 50 >300 300 >300 0 >300 >300 NS >300 55 >300 >300 >300 300 >300 >300 >300 >300 >300 >300 0 200 >300 300 >300 >300 200

11 15 42 0 0 300 >300 150 100 >300 >300 >300 300 >300 >300 100 >300 16 4 >300 >300 200 0 >300 >300 >300 >300 300 0 >300 >300 >300 >300 >300 >300

12 >300 0 0 0 >300 >300 >300 >300 >300 >300 >300 300 >300 NS >300 >300 1 >300 >300 >300 >300 >300 >300 >300 >300 >300 >300 0 >300 >300 100 300 >300 >300

13 300 0 >300 300 250 300 300 >300 NS 300 300 >300 >300 >300 >300 >300 0 270 >300 300 100 >300 100 300 >300 >300 >300 0 >300 >300 300 >300 300 2

14 0 0 >300 >300 200 >300 >300 >300 NS >300 >300 >300 >300 >300 >300 >300 7 >300 >300 >300 0 >300 200 >300 >300 >300 >300 0 300 >300 250 >300 >300

15 >300 0 >300 200 0 200 39 >300 NS 200 300 200 >300 NS 300 75 0 >300 >300 >301 5 >300 >300 200 >300 >300 0 0 200 >300 >300 >300 >300 NS

16 170 0 >300 >300 0 0 >300 >300 NS 250 >300 200 >300 >300 300 300 6 100 0 100 3 0 300 0 >300 >300 300 0 >300 >300 300 300 >300 NS

17 200 0 >300 >300 0 65 >300 >300 NS >300 >300 190 >300 >300 0 200 0 0 >300 300 0 0 0 120 >300 >300 300 0 >300 >300 170 >300 >300 >300

18 0 0 >300 300 300 14 >300 >300 NS 200 >300 >300 >300 >300 >300 >300 0 300 >300 170 0 0 0 >300 >300 >300 >300 0 300 >300 250 >300 >300 >300

19 60 0 >300 0 300 25 >300 >300 NS >300 >300 200 >300 >300 35 >300 0 150 >300 300 0 4 200 >300 >300 >301 200 0 >300 >300 200 >300 >300 >300

20 17 0 300 200 >300 0 >300 150 NS NS >300 >300 >300 NS 0 >300 0 43 300 300 0 300 90 >300 >300 >300 >300 0 >300 >300 75 >300 250 >300

21 150 0 >300 0 0 0 >300 150 NS 300 >300 >300 >300 >300 0 >300 0 300 0 300 0 >300 >300 >300 >300 >300 >300 0 >300 >300 13 >300 >300 >300

22 15 0 >300 90 45 2 >300 >300 NS NS >300 80 >300 >300 NS >300 0 81 >300 300 0 >300 300 >300 >300 >300 300 0 150 >300 5 >300 >300 >300

Mycoplasma Presence in CultureScreen #8

Page 9: Zivo

Research Bovine Mastitis Study

Notable Findings

o Trend for improved milk appearance (color and consistency) in the intra-mammary (IMM) treatment group

o By study end, 7 out of 9 IMM-treated animals (78%) had normal milk appearance vs. the non-treated group, which had 1 out of 8 animals with normal milk production

o There is a trend for IMM group to have considerably fewer cows infected with mycoplasma pathogen at the end of the study period compared to non-treated group

Screen #9

Page 10: Zivo

Licenses/Joint-VenturesAnimal Feed & Health Ingredients

NATURAL PRODUCTSSYNTHETIC COMPOUNDS

Bovine Feed

Bovine Mastitis pharma

The Company expects to execute licenses as shown. Timeline “0” is close of funding

0 6 months 12 months 18 months

Canine Supplement

Canine Food

MORE REGULATED MORE REGULATED

Canine OA pharma

NATURAL PRODUCTS

Bovine Supplement (Non-US)

Canine CollaborationOption AgreementPartner TBD

HIGHLYREGULATED

LESSREGULATED

Bovine CollaborationOption AgreementSigned Dec. 20, 2013

Screen #10

Page 11: Zivo

Market Potential Human HealthThe Company’s algal biomass, secondary metabolites and extractsmay be developed into ingredients for these market verticals

• Dietary Supplement/Nutraceutical – a $28 billion USand worldwide market that includes spirulina, algae-derivedOmega-3s, algae-derived astaxanthin, dried kelp, etc.

• Functional Food Ingredient – over 400 good-for-you foodand beverage categories need powerful ingredients to supporttheir product claims – dozens of licenses can be created

Refined isolates and bioactive molecules for therapeutic applications

• Medical Food – a specialized but stable and profitable marketniche for ingredients in prescribed foods and beverages

• Pharmaceuticals – as potential lead compounds for drugdevelopment

Natural Products/Future Therapeutics

Screen #11

Page 12: Zivo

Research Human HealthThe Company’s proprietary algal culture extracts were found to be beneficial in pre-NDI/pre-IND studies as applied to human and hamster models

In-vivo testing of hypercholesterolemia at Wayne State University Dept. of Nutrition and Food Science found test subjects treated with culture extracts dropped total cholesterol by 32% and increased HDL cholesterol counts by 5% in studies conducted 2009-2012

In-vitro testing of human HEP-G2 and PBMC cell lines revealed early promise in addressing inflammatory cascades resulting from lipid peroxidation in repeated studies at Wayne State University School of Medicine conducted 2010-2012

Company conducted isolation and characterization efforts of bioactive components in 2014 as funding permitted

Natural Products/Future Therapeutics

Screen #12

Page 13: Zivo

Licenses/Joint-VenturesHuman Nutrition & Health Products

BIOPHARMACOLOGICAL ORSYNTHETIC COMPOUNDS

Cholesterol Balance

Autoimmune Modulation

The Company expects to execute licenses as shown. Timeline “0” is close of funding

0 12 months 18 months 24 months

Cholesterol Balance

Joint Health

Immune Response

NATURAL PRODUCTS

Joint Health

Human NutritionIngredient JV or License

PHARMAREGULATIONS

FOOD SAFETYREGULATIONS

Human TherapeuticLead Compound Option Agreement

Screen #13

Page 14: Zivo

Business ModelCompany builds the value of intellectual property by:

Validating a specific application, i.e., bovine mastitis feed ingredient, through safety/tox testing, in vitro and in vivo studies and then patenting uses, production methods, administration modes

Creating a valuable dataset for such a specific application, to shrink risk and development time for a potential licensee, such as an animal feed manufacturer, dietary supplement marketer, animal health co.

Executing royalty agreements, joint ventures and licenses to boost market value and earning power of the intellectual property

Core Business: Monetizing Early Results

Screen #14

Page 15: Zivo

Prioritized ObjectivesPotential Revenue Streams

Near-Term < 24 months

Bovine Feed Ingredient Canine Diet Supplement

Porcine Feed Ingredient Human Diet Supplement

Longer-Term > 24 months and beyond

Bovine Medicinal App Canine Medicinal App

Pharmaceutical Lead Compound

Screen #15

Page 16: Zivo

Company SnapshotPublicly traded, fully-reporting since 2003

New management and $5.25 million new capital infusion over 3 years beginning January, 2012

New business model adopted in January 2012 – Company primarily engaged in R&D and subsequent licensing/JV of Intellectual Property

Actively acquiring intellectual property Acquired assets of metabolic testing company August 2013 – WellMetris

subsidiary currently in FDA pre-submission, preparing for market launch and active partnering, pending capital funding

Optioned libido-enhancement drug candidate August 2014 – newly formed Derivlan Bioscience subsidiary to test compounds in Brazil

Company initiates $4.5M capital funding initiative Q4 2014

Trading symbol: OTC:ZIVO.QB

Screen #16

Page 17: Zivo

Company SnapshotWellMetris Profile: Pre-clinical screening tool for insurers, employers and accountable care organizations

Subsidiary Product Pipeline

Point-of-Care Reporting Software

Analyzer Device

Test Cartridge

Cloud-Based Records Management

WellMetrisScreen #17

Page 18: Zivo

Exit StrategyZIVO Bioscience, Inc. is a publicly-traded Nevada corporation. Once revenue is optimized, the options to consider are:

Sell the entire Company to a larger, well established JV or licensee for a healthy multiple

Spin out the revenue-generating licenses or subsidiaries into another public entity and conduct an IPO, distribute proceeds to Company shareholders pro-rata

Continue to operate the Company in its current form and develop new applications from the Company’s proprietary IP

Realizing the Potential

Screen #18

0

1000

2000

3000

4000

5000

6000

7000

8000

Quarterly Revenues in (000)

Page 19: Zivo

ManagementSince taking over in late December of 2011, the new management team has focused on reorganizing and revitalizing the enterprise:

• Andrew A. Dahl – President & CEO, former Fortune 500 marketing executive and consultant with 20+ year track record, previously in private consulting practice

• Philip M. Rice II – Chief Financial Officer, former DeLoitte CPA, former CFO Stahl’s, 20+ years management consulting, corporate finance and turnaround

• Scott M. Freeman, MD – Chief Science Officer, former COO/Clinical Studies Director, Onyx Pharmaceuticals with 20+ years in drug development, clinical trials management, compliance and regulatory affairs

• Amy E. Steffek, Ph.D.,-- Director, Research & Development, with 14+ yearsin scientific research experience spanning neurology, cardiology, oncology,psychiatry, and endocrinology

• Scott Forsberg – Director, Product Development, former Director of R&D for Solaray and Director of Marketing for Nature’s Way with 20+ year history in nutrition and supplement industry

Core Team

Screen #19

Page 20: Zivo

SummaryThe Company holds valuable intellectual property that can be exploited across several market verticals and potentially dozens of licenses within:

• Functional food/feed ingredients• Medicinal products and drug development lead compounds• Health and Wellness products

These distinctly different market verticals substantially increase the odds that any one market vertical or application may be successful. Acquiring related IP provides opportunities that may help mitigate risk and amortize internal resources

Realizing the Potential

Screen #20

Page 21: Zivo

Healthy OutcomesZIVO Bioscience, Inc. is dedicated to the discovery, re-purposing and development of products and processes that positively impact health and wellness in humans and animals

Corporate Mission

Screen #21