Unique Pharmaceutical Cannabinoid Technologies Developed in Israel

Transcription

1 Unique Pharmaceutical Cannabinoid Technologies Developed in Israel (TASE: THXBY; OTCQB: THXBY) July 2016

2 Safe Harbor Statement presentation has been prepared for informational purposes only and does not purport to be allinclusive. The following presentation contains forward-looking statements that include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from those expressed or implied by such forward-looking statements due to factors that include, but are not limited to: (1) local and areal political and economic conditions, (2) changes in local and international economy and capital markets, (3) technological developments which may surrogate Company's future products, (4) future technological changes, (5) competitive environment, (6) future changes in legislation, international standards and regulation, (7) changes in local economic and budgetary policy, (8) uncontrolled variables with respect to time to market and achieving significant R&D milestones, (9) uncertainty about products future pricing, (10) expectation of low or the lack of revenue and earnings in the coming years, (11) investment in high risk life science areas, (12) failure in raising sufficient funds for the completion of products R&D,(13) failure to receive required permits or other prior market approvals for marketing products, (14) delay in product development schedules, (15) failure to receive approvals for patent registration applications, (16) infringement of third party s patents protected rights, (17) failure to contract with strategic partners and/or investors, and (18) dependence on key personnel. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this presentation We have based the forward-looking statements on our current expectations and projections about future events. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about us and our affiliate companies. There can be no assurance that such results will be realized and actual results in each case could differ materially from those currently anticipated in such statements as a result of various factors. Therapix Biosciences is not under any obligation to update or correct any future forecasts and/or forecasting statements to reflect events or circumstances after the date of this presentation. Therapix Biosciences makes no express or implied representation or warranty as to the achievement of the forecasts or the accuracy or completeness of the information contained herein. Therapix Biosciences expressly disclaims any and all liability which may be based on such information, errors therein or omissions therefrom. In order to have a comprehensive understanding and information over the Company, including the risks its activity is subject to, you must review the Company's Immediate and Periodical reports (in Hebrew) with the Israeli Security Authority and the Tel Aviv Stock Exchange and with the OTCQX and Company's web site (in English). The Company undertakes no obligation to update any forward-looking statements, to report events or to report the occurrence of unanticipated events that may lead to the actual events, results, performance, circumstances, or achievements of the Company being different from as envisaged by such forwardlooking statements. This presentation does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or sell securities of Therapix Biosciences. 2

3 Investment Highlights Unique formulations, dosage and delivery of FDA approved synthetic THC Reorganized under new experienced management and scientific team Focused on high-reward CNS indications Near-term: combination drug therapy for Tourette Syndrome THC & PEA: increased efficiency, lower dosage and side effects Filed for orphan drug designation POC (Phase II) trials in Q Longer term: Ultra Low-Dose THC for high value indication of Mild Cognitive Impairment Developing sublingual and nasal delivery of novel THC formulations 3

4 Cannabis and Cannabinoid Overview Proven medicinal use of Cannabis and derivatives. Best known agents: THC and CBD Sourced botanically (complex) or synthetically (simpler) Therapix utilizes FDA approved compound: Dronabinol (synthetic THC) Effective as stand-alone therapies or combination agents ( Entourage Effect ) Significant benefits shown in multiple indications: CNS, pain, cancer, anti-inflammatory, dermatology, psychiatric disorders 4 The therapeutic potential of cannabis and cannabinoids, Dtsch Arztebl Int Jul;109(29-30): Epub 2012 Jul 23. Kogan NM, Mechoulam R. Cannabinoids in health and disease. Dialogues Clin Neurosci. 2007;9(4):413-30

5 The Therapix Difference Repurposing approved Cannabinoids for new indications Joint Pharma BrainBright Tourette Syndrome, based upon the Entourage Effect using PEA Orphan Drug Designation request was submitted Cognitive deterioration/ Pre-Alzheimer s Ultra Low-Dose A synthetic cannabinoid-based therapy for brain related conditions targeting the multi-billion CNS drug market 5 The Company s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company s activity in the field of life sciences, which are not in Company s control and which actual results may be substantially different than assessed and estimated previously

6 Joint Pharma the Entourage Effect The "Entourage Effect", first described by Prof. Raphael Mechoulam in 1998 Effect of the Endocannabinoid system constituents working together, synergistically Entourage technology licensed by Therapix Joint Pharma 6 European Journal of Pharmacology Expert Opin Pharmacother Oct;4(10): Behav Neurol. 2013;27(1):

7 Targeting Tourette Syndrome - an Orphan Disease Primary indication for Therapix: Tourette Syndrome - involuntary movements, vocalizations and tics Unmet medical need: No new drugs for symptoms in 30 years THC demonstrated to reduce symptoms Filed an Orphan Drug Designation request FDA approval for Tourette can be broadened to many more indications Joint Pharma 7 Note: The Company s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company s activity in the field of life sciences, which are not in Company s control and which actual results may be substantially different than assessed and estimated previously

8 Entourage Effect - THC and PEA THC Tetrahydrocannabinol Used in FDA approved drugs to alleviate disease symptoms PEA Palmitoylethanolamide Endocannabinoid-like compound, approved for sale in Europe as Medical Food" THC and PEA, a Proprietary Combination: safer and more effective than THC alone Joint Pharma 8

9 Joint Pharma Solution THX-TS01 Several studies show beneficial effects of THC in treatment of tics in Tourette patients Combination of PEA and THC in Therapix IP portfolio through 2015 licensing agreement with Dekel Pharmaceuticals Ltd. THX-TS01 combines a synthetic cannabinoid analog of PEA with THC Entourage effect: THC & PEA increase efficiency and decrease dosage and side effects Initiating POC (Phase IIa) clinical studies in Q Joint Pharma 9

10 Joint Pharma Development Plan Joint Pharma Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Formulation Development Pre-Clinical studies ODD Submission POC (Phase IIa) Clinical Study TS Phase IIb Clinical Study Joint Pharma 10 Note: The Company s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company s activity in the field of life sciences, which are not in Company s control and which actual results may be substantially different than assessed and estimated previously

11 BrainBright Ultra-Low Doses of THC BrainBright 11

12 Alzheimer s and Mild Cognitive Impairment (MCI) Global market for Alzheimer s disease expected to reach $9.5 billion in 2017 Alzheimer s expected to more than double, from 21 million cases in 2010 to 53 million in 2050 More than 30 million people in major markets (10-20% of 65+ population) suffer from MCI Substantial unmet medical need - limited therapeutic options (no drug approved for MCI by the FDA since 2003) BrainBright 12 Mild Cognitive Impairment: An Off-Label Market with Significant Unmet Need and High Prevalence Carries Substantial Opportunity, DecisionBase 2008 report, by Decision Resources P.-J. Lin and P.J. Neumann / Alzheimer s & Dementia 9 (2013) The Global Market For Alzheimer s Disease Expected To Reach $9.5 Billion In 2017, BCC Research

13 Cannabis and Cognition Cannabis, considered a mild, soft drug without long-lasting negative effects Shown to cause long-term cognitive deficits in chronic users manifested as impairment in attention, memory or executive functions However, demonstrated by Prof. Sarne at the Tel Aviv University that Ultra- Low Doses of THC prevent and reverse cognitive decline in preclinical trials BrainBright 13 Journal of Neuroscience Research 92: (201

14 Unique & Proprietary Drug Development Platform The Ultra Low-Dose THX-ULD01 Targets large, high value and under-served market of Pre-Alzheimer's and Mild Cognitive Impairment (MCI) Recent research demonstrates Ultra-Low Doses of THC can prevent cognitive impairment (severe cases might lead to Alzheimer's disease) THX-ULD01 - Therapix is developing a unique FDA approved synthetic cannabinoid-based prescribed drug is for delaying memory loss and potential progression to early stages of Alzheimer s Regulatory path to be streamlined using 505(b)(2) strategy based on Marinol (dronabinol) Phase I-type study with healthy volunteers to demonstrate safety and bioavailability to be initiated in Q POC (Phase II) study to demonstrate efficacy to be initiated in H BrainBright 14 Note: The Company s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company s activity in the field of life sciences, which are not in Company s control and which actual results may be substantially different than assessed and estimated previously

15 BrainBright Development Plan BrainBright Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Formulation Development Pre-Clinical studies Phase I - PK & Bioavailability POC (Phase IIa) Clinical Study - MCI BrainBright 15 Note: The Company s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company s activity in the field of life sciences, which are not in Company s control and which actual results may be substantially different than assessed and estimated previously

16 Unique Drug Development Platforms Formulations Therapix developing formulation methods to optimize delivery of active cannabinoid compounds Studies suggest that oral administration could negatively impact efficacy Research indicates nasal and sub-lingual administration of THC is superior to oral route Clin Pharmacokinet. 2003;42(4): Pain Res Manag Autumn;10 Suppl A:15A-22A. Clin Chem January ; 57(1):

17 Strengthened Leadership Team Dr. Ascher Shmulewitz, Dr. Elran Haber, Mr. Doron Ben Ami, Dr. Adi Zuloff-Shani, Mr. Guy Goldin, Chairman CEO Served over than 10 years as Chairman and Board Director of several publicly traded, privately held companies & various associations. Elran held key roles at various life science start-ups & private investment firm. Prior to his current role Elran served as VP Business Strategy & Innovation of Therapix. Holds a PhD in Pharmaceutical Science and MBA in Finance & Financial Engineering from The Hebrew University of Jerusalem Chief Strategy Officer A seasoned executive with more than 20 years of management experience holding various leadership roles in the multinational pharmaceutical industry. Among Doron s roles were Associate Vice President of the Eastern Europe and Israel region at Merck and the General Manager of Lundbeck, Israel. Holds a Master of Health Systems Administration (M.H.A.) from Tel Aviv University CTO Has more than a 15 years of vast experience as an Executive R&D. Prior to joining Therapix Biosciences she served as a Vice President Development at Macrocure Ltd (NASDAQ). Holds a PhD in human biology and immunology from the Bar- Ilan University CFO Has over 20 years of experience in a wide variety of managerial, financial, tax and accounting related positions. Guy s most recent position are as CFO at Petro- Group Ltd. and at BSP Ltd. He holds a B.A in Accounting and Economics and a MBA from Tel- Aviv University A prolific inventor and serial entrepreneur in biomedical technologies. He has originated over two dozen life science companies and has led 14 of these compvanies to successful exits, mostly through M&A transactions. Ascher is the founder of Medgenesis Partners, a private investment firm and incubator based in Israel. Holds an MD from Technion Medical School and PhD in Engineering from Tel Aviv University 17

18 Strengthened Scientific Team Prof. Raphael Mechoulam A Professor Emeritus of the School of Pharmacy at the Faculty of Medicine of the Hebrew University in Jerusalem. He is a recipient of the Israel Prize, known for his work in identifying the main active compound in the cannabis plant, the THC, and is considered a world-renowned expert Prof. James Leckman A child Psychiatrist, psychiatrist and physician at Yale University, served as Director of the Child Study Center at Yale for over two decades and is a prominent international expert in the field of research and treatment of Tourette Syndrome Prof. Kirsten Müller-Vahl, Professor of Psychiatry the Hannover Medical School, Germany, recognized as the leading researcher in the field of cannabinoid use in treatment of Tourette Syndrome and since 1994 has served as a member of the scientific advisory board of the German Tourette Syndrome Association Prof. Michael Davidson, Professor of Psychiatry, served as Chief Psychiatrist at the Department of Psychiatry of the Sheba Medical Centre Tel- Hashomer, and currently serves as Chairman of the Stuckinski Centre for Alzheimer's Disease Research in Ramat Gan, Israel Dr. Michael Bloch Chief Resident at Yale's Clinical Neuroscience Research Unit, noted researcher on the study of Tourette Syndrome, obsessivecompulsive disorder and trichotillomania Prof. Daniele Piomelli The Editor-in-Chief of Cannabis and Cannabinoid Research. Prof. Piomelli serves as Louise Turner Arnold Chair in Neurosciences and Professor of Anatomy and Neurobiology, Pharmacology, and Biological Chemistry at University of California, Irvine Prof. Howard L. Weiner A Robert L. Kroc Professor of Neurology at Harvard Medical School, Director of the Multiple Sclerosis Center at the Brigham & Women s Hospital and Massachusetts General Hospital, and Co-director of the Center for Neurologic Diseases at BWH in Boston, USA Prof. Avi Weizman, Professor of Psychiatry at the Sackler School of Medicine Tel Aviv University, Head of the Laboratory of Biological Psychiatry at the Felsentein Medical Research Center and Director and Head of Geha Mental Health Center's Research Unit 18

19 Board of Directors Dr. Ascher Shmulewitz, Chairman Dr. Yafit Stark, Independent Director VP & Global Clinical Advisor, Global Clinical Development at Teva Pharmaceuticals Ltd. Dr. Stark established the Innovative R&D Division of Teva USA and was responsible for the clinical development of Copaxone. Dr. Stark serves as a Director in several life science companies. Holds a PhD degree in Pathology from the Tel Aviv University Mr. Avi Meizler, Director An experienced businessman and entrepreneur in Brazil since 1979 in the fields of pharmaceuticals, engineering and construction. He was founder and President of Meizler Biopharma S.A. Mr. Meizler is also co-founder and CEO of Advantech Bioscience Pharmaceutical Ltd Mr. Amit Berger, Independent Director Mr. Berger serves as the Chairman of Prisma Capital Markets Ltd. He served as Chairman and Director of Enter Holdings 1 Ltd., CEO of Delphine 1 Investment Ltd. and serves as a Director of various companies. Holds BA in Economics from Tel Aviv University Mr. Zohar Heiblum, Independent Director Co-founder of TeFen Ltd, a leading consulting firm in Israel. Has been involved in various companies as investor, consultant, board member and active chairman. Has a BSc in Industrial Engineering and MBA, both from Tel Aviv University Mr. Micha Jesselson, Director Mr. Jesselson is part of the Jesselson Family Office that operates from Tel Aviv & New York. He manages Jesselson Investments Ltd. which is involved in a variety of sectors including venture capital investments, private equity transactions and real estate development in NYC. Holds BA of Business degree from the Interdisciplinary Center (IDC), Herzliya 19

20 Cannabinoid Market: Landscape and Opportunities FDA-regulated drugs vs. medical marijuana Medical marijuana: variable dosing; therapeutic and psychoactive effects; poor compliance; abuse potential; political issues FDA-regulated drugs: Rigorous GMP manufacturing; clinical efficacy/safety studies; controlled dosing FDA- option for 505(B)(2) regulatory route- abbreviated development and shorter time to market Approved Drugs: AbbVie: Marinol capsules (synthetic THC) for CINV (Schedule 3 drug) GW Pharma: Sativex sublingual spray (botanical THC and CBD) for MS spasticity In Development: GW Pharma (GWPH, Market Cap ~1.6B USD): Sativex sublingual spray for cancer pain; Epidiolex sublingual spray (botanical CBD) for Epilepsy Insys (INSY, Market Cap ~1.0B USD): Synthetic THC oral solution for CINV, anorexia in AIDs patients; Synthetic CBD oral solution for Epilepsy Zynerba pre-clinical Pharmaceuticals (NASDAQ: ZYNE): Developing transdermal synthetic cannabinoid treatments, raised $42m on 4th August 2015, market cap $214m post IPO 20

21 Recent Developments Binding MOU with Yissum (Hebrew University) for license to formulation of nasal administration of cannabinoid substances MOU with Swiss company for exclusive worldwide license to formulation for sublingual administration of Ultra Low- Dosages of THC Filed for Orphan Drug Indication for Tourette Syndrome Medical Advisory Board joined by five international experts in the fields of psychiatry including Alzheimer's & Tourette Syndrome Licensing agreement with Ramot (Tel Aviv University) for Ultra Low Dose cannabinoid technology Dekel agreement approved by shareholders rights to IP based on "Entourage Effect" Strengthened management and scientific teams 21

22 Therapix Biosciences Unique Pharmaceutical Cannabinoid Technologies Developed in Israel New management team focused on high value CNS indications with unique combinations, formulations and delivery methods Two indications with shorter regulatory paths due to Orphan Indication & repurposing of approved active ingredients 505(b)(2) POC (Phase IIa) clinical trials for Tourette to start in Q Phase I-type trials for Mild Cognitive Disorder to start in Q with POC (Phase II) trial in 2017 Note: The Company s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company s activity in the field of life sciences, which are not in Company s control and which actual results may be substantially different than assessed and estimated previously 22

23 Therapix Biosciences Ltd. 5 Azrieli Center (Square Tower) 27 Fl. Tel-Aviv , Israel Tel: