powerpoint presentation · fibromyalgia and ptsd • established in 2014 in israel ... •phase i...

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Page 1: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

MARCH 2019

Page 2: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

January 2019 | 3

TRANSFORMING CANNABIS TO A SCIENTIFICALLY PROVEN AND APPROVED SOLUTIONS

Page 3: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

• This document details business information of OWC Pharmaceuticals Research Corp and/or our wholly-owned Israeli subsidiary, One World Cannabis Ltd. (collectively, “OWCP”, “OWC Pharmaceuticals Research Corp”, ”"One World Cannabis ", "OWC" or "the “Company")for the development of cannabinoid-based therapies targeting a variety of different medical conditions.

• The Company’s research division is focused on pursuing clinical trials, evaluating the effectiveness of cannabinoids in the treatment of various medical conditions.

• This presentation outlines the specific needs and the special opportunities that OWC believes exist in the medical cannabis market together with OWCP’s research and development activity to date and the potential target markets for OWC’s present and plannedproducts. This presentation also details the Company’s business strategy and financial information operation based on certainassumptions, market data, and OWC’s opinions.

• This presentation has been developed in a reasonable and rational manner to reflect OWC’s plan setting forth a defined time schedule based partly on known information, and partly on assumptions and forecasts of OWC. However, as with all business plans, its anticipated results are based on information available at the time of preparation, relying on that information’s accuracy and reliability, and also based on the specific assumptions made. Changes in the economic and regulatory factors, among others, as well as additional information or various other events, can change the assumptions as well as the results.

• This presentation itself does not guarantee the partial or full execution of the business plan. Therefore, it is possible that this business plan will not be fully implemented and executed as planned.

Confidential information

All information contained herein contains copyrighted © information that is proprietary, privileged or confidential. It is intended only for the purpose specified and directed to the recipients specifically identified by the company. Any unauthorized review, disclosure, reproduction, distribution, copying of, or reliance upon this document and any included exhibits is strictly prohibited.

4January 2019 |

DISCLAIMER

Page 4: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

5

• Conducting medical research and clinical trials through its wholly owned, Israel-based subsidiary, One World Cannabis Ltd. (OWC)

• Developing unique and effective delivery systems and dosage forms of medical cannabis for diverse medical conditions including multiple myeloma, psoriasis, fibromyalgia and PTSD

• Established in 2014 in Israel

• Licensed by the Medical Cannabis Unit of the Israeli Health Ministry

• Operates in full compliance with appropriate international regulatory standards for the development of cannabis-based medical products and treatments

OVERVIEW

January 2019 |

Page 5: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

CORPORATE & FINANCIAL DETAILS

• Issued and Outstanding shares: o Common Shares – ~170M

o Preferred Shares – 445

• Market Cap: ~$6M

• Total Capital raised since 2014: $9.1M

• Management stake: ~15% (Shares and options on a fully diluted basis)

January 2019 | 6

Page 6: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

To be a leader in creating new cannabis-related treatments and devices targeting a variety of diseases and medical conditions

VISION

January 2019 | 7

To improve patients’ quality of life through Israeli-based research and development of new solutions, products and devices derived from cannabis

MISSION

Page 7: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

WHAT IS MEDICAL CANNABIS?

Tetrahydrocannabinol (THC)

• Psychoactive component of cannabis

• Medically used for the treatment of pain and other conditions

• Isolated in 1964 by Israeli researchers at the Hebrew University of Jerusalem

Cannabidiol (CBD)• Non-psychoactive component of cannabis

• Medical uses as an anti-inflammatory agent with numerous beneficial qualities

January 2019 | 8

Page 8: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

ENDOCANNABINOID SYSTEM (ECS)

• Endogenous system of cannabinoid receptors and theirphysiological binding molecules

• ECS is involved in appetite, pain-sensation, mood, memory, voluntary exercise and immune system functionsas well as the psychoactive effects of cannabis

• Two key receptors: o CB1 – brain and central nervous systemo CB2 – peripheral organs and immune system cells

• Endocannabinoid Anandamide interacts with CB1

• Endocannabinoid 2-AG interacts with CB1 and CB2

• THC from cannabis is a natural mimetic for Anandamide

• CBD from cannabis is a natural mimetic for 2-AG

January 2019 | 9

Page 9: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

COMPETITIVE EDGE

Location:

• Based in Israel, an acknowledged leader in cannabis research (One of the few countries worldwide to approve clinical studies with cannabis)

• Research and clinical trials conducted at leading medical academic centers.

January 2019 | 10

Technology:

• Precise formulation

• Clinical validation

• Controlled dosage and delivery

• IP protection

Leadership:

• Dr. Oron Yacoby Zeevi: Chief Scientific Officer. Over 20 years of experience, served as Chief Scientific Officer of NeuroDermthat was sold to Mitsubishi Tanabe Pharma for US $1.1 billion in July 2017 and is named in top 10 most influential Israelis in international business, science and culture in 2017.

• Dr. Yehuda Baruch: Chief Medical Officer and Regulatory Affairs. A world renowned psychiatrist, founded, implemented and headed the Israeli Medical Cannabis Unit at the Israeli Ministry of Health for over 10 years

Management:

• Experienced professionals from the pharma, biotech, medical services and financial markets

Page 10: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

ROAD MAP

January 2019 | 11

Proof of Concept Studies

Medical Cannabis Product Development

Legal and Regulatory Framework Compliance

Marketing and Distribution in Specific Markets

Pharmaceutical Development

Full Regulatory Pathway

Marketing and Distribution in Specific Marketswith Approved Indication Label

Page 11: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

January 2019 | 12

PRODUCTS & PIPELINE

Page 12: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

January 2019 | 13

Topical Ointment: • Indicated for different skin diseases; initial indication - Psoriasis• ~8 Million Psoriasis patients in US & Canada (2.5% of population)

Sublingual Disintegrating Tablet: • Indicated for pain treatment, replacement to smoking medical cannabis • More than 10 million potential patients in approved MMJ states

Advantages:• Fixed and controlled dosage• Quality controlled• Safety and clinical efficacy testing ongoing• Proprietary IP covering innovative delivery systems

CANNABIS-BASED PRODUCTS IN DEVELOPMENT

Page 13: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

TOPICAL OINTMENT (FOR SKIN DISEASE)

• Preclinical studies showed significant reduction of Psoriasis biomarkers (IL-8 and IL-33) and reduction in keratinocytes proliferation

• Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

• Product fully developed without specific indication

• Phase II initiation planned for Q4/2019

• TLR Phase II estimated Q4/2020

• Phase II indication is Psoriasis

January 2019 | 14

Page 14: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

SUBLINGUAL DISINTEGRATING TABLET (FOR CHRONIC PAIN)

• First generation formulation fully developed

• Second generation formulation development completed

• Phase I safety and PK study completion expected in Q2/2019 at Tel Aviv Sourasky Medical Center

• May also function as a smoking/inhalation substitute

January 2019 | 15

Page 15: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

NASAL DELIVERY(FOR FIBROMYALGIA AND PTSD)

• First generation formulation fully developed: unique API carrier

• Six months stability

• Pre-clinical animal safety and MTD (Maximal Tolerated Dose) study completed successfully Q4/2018

January 2019 | 16

Page 16: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

OVERVIEW: UPCOMING KEY CLINICAL MILESTONES

January 2019 | 17

Q4 Q4Q3Q2Q1Q4Q3Q2Q1

2018 2019 2020

P1 Completion

P2 IRB Approval P2 IRB InitiationP2

CompletionTLR

P1 IRB & Initiation

P1 Completion

& P2 IRB Approval

P1 TLR P2 InitiationP2

CompletionTLR

Animal Safety &

MTDIMCA Approval Animal PK

IRB Approval

Safety Study in Human

Human Safety P1 Study

Animal Safety &

MTD

IMCA ApprovalAnimal PK

Pre-Clinical R&D on Orphan or Life Threatening Diseases

Topical Ointment

Sublingual Tablet

Nasal Delivery

Unique Delivery High Dose

Page 17: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

MULTIPLE MYELOMA (CANCER)

• Successfully tested a unique, innovative delivery formulation, OWC-1808, aimed at treating Multiple Myeloma

• Formulation administered in vivo in an animal model for the first time and found to be safe and tolerable

• Demonstrated combination of cannabidiol (CBD) and tetrahydrocannabinol (THC) decreased survival of cancerous cells, and had synergistic effect with known anti-MM drugs

• Subject to achieving research milestones, plan to submit an application to the FDA for an orphan drug designation

January 2019 | 18

Page 18: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

INTELLECTUAL PROPERTY

• 31 patent filings in selected domains at various stages from PCT filings, National Phase filings and Continuations in Part (CIPs)

• 2 patents granted in Australia and Czech Republic

• 9 patent families o2 of the patent families cover Multiple Myeloma

o7 patent families cover pharmaceutical emulsions, Fibromyalgia, Migraine, Sexual Function and Skin Disorders

January 2019 | 19

Page 19: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

STRATEGIC ALLIANCES & COMMERCIALIZATION

January 2019 | 20

Page 20: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

STRATEGIC ALLIANCES

January 2019 | 21

European Market• Joint Venture Company for European distribution: 75% OWCP; 25%

(MICHEPRO Ltd)

• Plan to establish a European entity to promote, manufacture and sell OWCP products in Europe

North American Market• Evaluating strategic alliances in North America to manufacture, promote and

sell OWCP products (USA and Canada)

Page 21: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

MANAGEMENT TEAM

January 2019 | 22

Highly experienced team of experts in various areas of the medical cannabis, clinical research, healthcare management, international business and financial markets

Mr. Mordechai Bignitz - CEO

35 years of capital markets experience and executive leadership in public corporations. Served as Chairman of the biggest investment fund in Israel for 9 Yrs.

Mr. Alon Sinai - Chief Operating Officer

Retired Lieutenant-Colonel in the IDF Medical Corps. Was responsible for supervising and developing emergency medical facilities

Group CEO of FuturaGene Limited and its predecessor company, FuturaGene Plc. since 2007. Chairman of the Board of Directors of Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) since 2016.

Dr. Yehuda Baruch – Chief Medical Officer and Director of Regulatory Affairs.

Former CEO of Abarbanel Mental Health Center in Bat-Yam. Founder of the Medical Cannabis program of the Israel Health Ministry and its director for 10 years

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Ms. Sigal Russo- CFO

Served in various financial roles at Rosetta Genomics (NASDAQ: ROSG), among them as Senior Director of Finance. Prior to her tenure at Rosetta Genomics, Ms. Russo was an audit manager at Ernst & Young, Israel, specializing in audits of companies from various fields, both publicly traded and privately owned.

Dr. Oron Yacoby-ZeeviChief Scientific Officer

20 years experience in leading research and development programs and GLP compliant pre-clinical development of numerous small molecule drugs and biologicals in various indications. Previously CSO at NeuroDerm (sold to Mitsubishi Tanabe) and Harlan Biotech, author of more than 15 patents

Dr. Stanley Hirsch - Chairman

Page 22: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

HIGHLIGHTS

• Innovative developer of Cannabis-based medical and pharmaceutical products

• Located in Israel- world leading center for Cannabis research and clinical trial capability

• Growing intellectual property portfolio

• Defined development pathways including medicinal and pharmaceutical products

• Multi-disciplinary management team with extensive experience in Medical Cannabis, pharma development, corporate management and capital markets

January 2019 | 23

Page 23: PowerPoint Presentation · fibromyalgia and PTSD • Established in 2014 in Israel ... •Phase I safety study completed at Sheba Hospital, Tel Hashomer. Plan to publish TLR in 1H/2019

THANK YOU!

January 2019 | 24