Developing cannabinoid based pharmaceuticals (TASE: THXBY; OTCQB: THXBY) Corporate Presentation September 2015

Transcription

1 Developing cannabinoid based pharmaceuticals (TASE: THXBY; OTCQB: THXBY) Corporate Presentation September 2015

2 Safe Harbor Statement This 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. 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.

3 Therapix CompanyHighlights Developing cannabinoid based pharmaceuticals The company owns, licenses and develops its Intellectual Property (IP) portfolio of prescribed cannabinoid drugs and novel delivery systems Focus on central nervous system (CNS) disorders with two leading indications: prevention of cognitive deterioration, such as Alzheimer's disease and movement disorders, such as Tourette (orphan indication) Based on extensive research, collaboration and discoveries from leading Universities

4 The Therapix story Therapix Specialty Pharmaceutical Company focused on repurposing approved Cannabinoids for new indications. Two drug development programs: BrainBright Joint Pharma Cognitive deterioration/dementias and Alzheimer- ultra low-dose BrainBright is a unique synthetic cannabinoid-based therapy for brain related conditions targeting the multibillion CNS drug market. Tourette Syndrome Therapy based upon the entourage effect phenomenon Joint Pharma develops combination product for TS, which is designated as an Orphan disease by FDA. The company develops targeted cannabinoid drug delivery methods 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

5 Cannabis and Cannabinoid Overview Cannabis and its derivatives have great therapeutic potential and have been used for centuries for medicinal purposes. Over 100 cannabinoids/cannabinoidanalogues identified: Best known active ingredients: THC and CBD. Sourced botanically (complex process) or synthetically (simple process( Effective as stand-alone therapies or combination agents (by utilizing the entourage effect ) Significant benefits shown in multiple indications: Pain, Multiple Sclerosis, MS Spasticity, Epilepsy, Parkinson s Disease. Cancer treatment, Cancer pain, Cancer- Induced Nausea and Vomiting (CINV). Anti-inflammatory (e.g. Inflammatory bowel disease, arthritis). Dermatological indications (e.g. psoriasis). Psychiatric disorders. 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

6 BrainBright BrainBright

7 Alzheimer s and Mild Cognitive Impairment (MCI) The Global Market For Alzheimer s Disease Expected To Reach $9.5 Billion in 2017 Alzheimer s disease is expected to more than double, jumping from 21 million cases in 2010 to 53 million in 2050 More than 30 million patients suffer from MCI in the major markets (10-20% of 65 yrs) Substantial unmet medical need - limited therapeutic options BrainBright 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) 58 62

8 Cannabis and Cognition Standard doses of THC and its chronic use have been implicated to cause long-term cognitive deficits manifested as impairment in attention, memory or executive functions However, it has been demonstrated in preclinical trials that ultra-low doses of THC act as opposed to standard doses of THC, prevent and reverse cognitive decline BrainBright Journal of Neuroscience Research 92: (201

9 Unique drug development platform The Ultra low-dose BrainBright targets a large, high value and under-served market of Alzheimer and Mild Cognitive Impairment (MCI) Recent research discovered that Ultra-low doses of THC can be used for the prevention of cognitive impairment (MCI) Therapix is developing a unique FDA approved synthetic cannabinoid based prescribed drug for delaying memory loss and early stages of Alzheimer s The company believes the development will be streamlined due to shorter regulatory pathusing public domain data available from FDA Rapidly initiate POC Clinical studies 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 BrainBright

10 JOINT PHARMA The Entourage Effect The "Entourage Effect", first described by Prof. Raphael Mechoulam in 1998 Effects of the Endocannabinoid system can be explained by its overall constituents working together, synergistically, rather to any single component. The Entourage technology is the basis of the therapeutic drugs we are targeting for Tourette (Orphan Indication). European Journal of Pharmacology Expert Opin Pharmacother Oct;4(10): Behav Neurol. 2013;27(1): BrainBright

11 Targeting Tourette Syndrome- an Orphan Drug designation Tourette syndrome (TS), a neurological disorder characterized by repetitive, stereotyped, involuntary movements, vocalizations and tics Tics are often accompanied by neurobehavioral disorders such as attention-deficit hyperactivity disorder and obsessive-compulsive disorder The early symptoms of TS are typically manifest themselves first in childhood (3-9 yrs.) There have been no new treatments introduced for tics associated with Tourette syndrome in more than 30 years The company believes Tourette syndrome prevalence is within the FDA s criteria for Orphan Drug program, as it is estimated that less than 200,000 Americans have the most severe form of TS Joint Pharma

12 Joint Pharma s solution Combination of THC with PEA for Tourette Therapix' IP, part of the licensing agreement signed in 2015 with Dekel, enables adding a synthetic cannabinoid mimetic of PEA (palmitoylethanolamide) to THC in order to increase the efficiency and reduce required dosage and associated adverse events Data obtained from several studies consistently provide evidence for beneficial effects of cannabinoids in the treatment of tics in patients with TS Joint Pharma

13 Entourage Effect - THC and PEA THC An active ingredient of cannabis, has mild to moderate analgesic effects and is also used to treat pain. THC is already used in FDA approved drugs to alleviate symptoms suffered both by AIDS and cancer patients by increasing appetite and decreasing nausea. PEA (palmitoylethanolamide) An endocannabinoid-like compound, that is not considered a classic endocannabinoid because it lacks affinity for CB1 and CB2 receptors. PEA is approved for sale in Europe as Medical Food". Combination of THC with PEA, could provide a safer and more effective treatment than THC alone. Joint Pharma

14 Unique drug development platforms Formulations Therapix has formulation methods to optimize the delivery of active cannabinoid compounds and bioavailability to the human body Researches indicates that pulmonary, nasal and sublingual 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):

15 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 routeabbreviated 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 ~2.1B USD): Sativex sublingual spray for cancer pain; Epidiolex sublingual spray (botanical CBD) for Epilepsy Insys (INSY, Market Cap ~2.4B USD): Synthetic THC oral solution for CINV, anorexia in AIDs patients; Synthetic CBD oral solution for Epilepsy Zynerba Pharmaceuticals (NASDAQ : ZYNE): Developing transdermal synthetic cannabinoid treatments, pre-clinical stage, raised $42m on 4th August 2015, market cap $214m post IPO

16 Therapix Management Team Dr. Ascher Shmulewitz, Chairman entrepreneur of medical companies, both as the inventor and leader, 14 exits over the past decade, MD and PhD in Engineering. Dr. Elran Haber, VP Business Strategyand Innovation PhD in Pharmaceutical Science, MBA in Finance & Financial Engineering, chairman and director of public companies. Board of Directors Mr. Avi Meizler, Director Experienced businessman and entrepreneur. President and Chairman of Meizler Biopharma S.A.. Co-founder and CEO of Advantech Bioscience Pharmaceutical Ltd. Ms. Tamar Kfir, Director CEO at HBL (TASE) Managed BP&C Consulting. Infinity IP Bank, Landes Biosciences, Yissum. Mr. Zohar Heiblum, Indepen den t Director Co-founder TeFen Ltd, Investor, consultant, board member and active chairman. Mr. Amit Berger, Indepen den t Director CEO at Dolphin Chairman at Enter Holdings and Berger Holdings (DS Securities & Investments). Dr. Yafit Stark, Indepen den t Director Vice President Global Clinical Advisor, Global Clinical Development at Teva Pharmaceuticals Ltd. Mr. Ahmed Alimi, Director Chairman at Vaxil Bioscience (TASE) Businessman and entrepreneur Mr. Micha Jesselson, Director Jesselson Investments Family Office- US and Israel

17 Therapix Biosciences - a summary Unique technologies in the cannabis market- currently one of the fasted growing markets Focus on cannabinoid family products with unique combinations, methods of administrations and formulations The company is focused on two indications Shorter regulatory paths- orphan indication, repurposing of approved active ingredients Clinical trials to start within a year Strong and supportive shareholders who are committed to the company s success 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

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