OWC PHARMACEUTICAL RESEARCH OTCQB:OWCP

Transcription

1 OWC PHARMACEUTICAL RESEARCH OTCQB:OWCP

2 Disclaimer 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 planned products. This presentation also details the Company s business strategy and financial information operation based on certain assumptions, 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.

3 Who we are OWC Pharmaceutical Research Corporation (OTCQB:OWCP) a Delaware corporation, conducts medical research and clinical trials through its wholly owned, Israel-based subsidiary, One World Cannabis Ltd. (OWC). OWC was established in 2014 in Israel. OWC is licensed by the Medical Cannabis Unit of the Israeli Health Ministry OWC operates in full compliance with appropriate international regulatory standards for the development of cannabis-based medical products and treatments.

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

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

6 What is Medical Cannabis? Cell level

7 What is Medical Cannabis? Human level The Endocanabinoid System (ECS) Endogenous system of cannabinoid receptors and their physiological binding molecules The ECS is involved in appetite, pain-sensation, mood, memory, voluntary exercise and immune system functions as well as the psychoactive effects of cannabis Two key receptors: CB1 brain and central nervous system CB2 peripheral organs and immune system cells The endocannabinoid Anandamide interacts with CB1 The 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

8 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

9 OWCP 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. Technology: Precise formulation Clinical validation Controlled dosage and delivery IP protection Leadership: Dr. Yehuda Baruch: Chief Scientific Officer and Head of 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

10 Roadmap Proof of Concept Studies Medical Cannabis Product Development Pharmaceutical Development Legal and Regulatory Framework Compliance Full Regulatory Pathway Marketing and Distribution in Specific Markets Marketing and Distribution in Specific Markets with Approved Indication Label

11 OWCP Products & Pipeline

12 Developed Cannabis-Based Products Sublingual disintegrating tablet: Indicated for pain treatment, replacement to smoking medical marijuana More than 10 million potential patients in approved MMJ states Topical cream: Indicated for different skin diseases; initial indication - psoriasis Potential income: $2-4 million/month in 3 year time-frame from launch (at current market prices) Advantages: Fixed and controlled dosage Quality controlled Safety and clinical efficacy testing ongoing Proprietary IP covering innovative delivery systems

13 Clinical Development

14 Psoriasis (Skin Disease) Preclinical Dead Sea Study showed up to 70% decline of inflammatory skin disease markers and decline in proliferation of Keratocytes Phase I safety study will be completed at Sheba Hospital, Tel Hashomer in Q1/ patients Phase II initiation planned for Q3/2018 TLR Phase II expected Q2/2019 Product fully developed without indication label

15 Cannabis Cream (CanaPsor014) Development Plan Timeline Completion human safety and PK/PD study (Phase 1) IRB approval 6 week efficacy study (Phase 2) 6 week human efficacy study single or multicenter trial (Phase 2) Final results and analysis (Phase 2) Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pre-IND meeting request TLR (Phase 2)

16 Oral Disintegrating Tablet (Fibromyalgia and chronic pain syndromes ) First generation formulation is fully developed Second generation formulation is in development Phase I safety study initiation expected Q1/2018 at Tel Aviv Sourasky Medical Center May also function as a smoking/inhalation substitute

17 Oral Disintegrating Tablet (ODP012) Development Plan Timeline IRB human safety and PK/PD study (single dose) Completion of safety study (Phase 1)) 12 week efficacy study: chronic neuropathic pain (Phase 2A) Initiation of a multicenter 12 weeks efficacy study (Phase 2B) Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Completion of 3 month stability study Pre-IND meeting

18 Multiple Myeloma (Cancer) Designed to be an Orphan Disease study approved by the FDA In-vitro study completed 06/2015 Cannabis kills the MM cancer cells Initial pre-clinical study on mice completed 12/2015 calibration phase for dosage, optimization of ratio of active cannabinoids THC:CBD In-vitro study for a combination of cannabis with 4 approved drugs completed 05/2016 promising results Pre-clinical study for the most effective combination on mice with new cannabis extracts. On-going testing. SUBJECT TO ACHIEVING RESEARCH MILESTONES, THE COMPANY WILL SUBMIT AN APPLICATION TO THE FDA FOR AN ORPHAN DISEASE DESIGNATION

19 Development Program Overview 2017 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Total Psoriasis Ph 1 TLR IRB approval Ph 2 initiation )CanaPsor Cream( PK/PD Ph 2 Fibromyalgia/Pain Ph 1 initiation Ph 2A initiation )tablet( PK/PD (12 weeks) Pre-clinical Fibromyalgia/PTSD safety (animals) )Nasal spray( PK/PD Multiple Myeloma Pre-clinical studies R&D Budget ($000) Ph 1 initiation (single- or multi-center) Ph 1 (6 weeks) Ph 2A TLR Ph 2 TLR Ph 2B initiation (12 weeks, multi-center) Ph 1 TLR Ph 2 Final results Ph 2 Initiation (12 weeks) ,085 Multiple Myeloma: additional budget depends on additional funding

20 Strategic Alliances & Commercialization

21 MICHEPRO Michepro JV Joint Venture Company for European distribution: 75% OWCP; 25% (MICHEPRO Ltd) Will establish a European entity to promote, manufacture and sell OWCP products in Europe. Additional MOUs in Canada in negotiation

22 Corporate & Financial Details Debt free and fully funded for 2017 operations and development plan Authorized Capital :500,000,000 Issued and Outstanding shares: 146,416,300 (October 2017) 2017 cash opening balance: $472K Capital raised in 2017: $1.74M Average quarterly cash burn: ~$300K Projected ending balance at 2017 YE: $750K

23 Management Team OWCP management is composed of a highly experienced team of experts in various areas of the medical cannabis, clinical research, healthcare management, international business and financial markets. Dr. Stanley Hirsch Chairman Served as Group CEO of FuturaGene Limited and its predecessor company, FuturaGene Plc., since Served as Chairman of the Board of Directors of Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX), since 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. Dr. Med. Yehuda Baruch - CSO, Director of Research and Regulatory Affairs. Former CEO of Abarbanel Mental Health Center in Bat-Yam. The founder of the Israeli Medical Cannabis program of the Israel Health Ministry and its director for 10 years Mr. Alon Sinai - Chief Operating Officer Retired Lieutenant-Colonel in the IDF Medical Corps. Was responsible for supervising and developing emergency medical facilities Mr. Yossi CPA - CFO Extensive experience with Nasdaq-listed companies in various industries and provides financial, capital markets, accounting and regulatory expertise. Mr. Jeffrey Friedland Advisory Board Member. The author of "Marijuana: The World's Most Misunderstood Plant." He is a regular speaker on the cannabis industry and has been featured or quoted in numerous publications. Mr. Friedland has investments and business involvements in the cannabis industry globally. 23

24 Mr. Mordechai Bignitz, CEO Mordechai.bignitz@OWCpharma.com