Therapix Biosciences - TASE
Transcript of Therapix Biosciences - TASE
Therapix
Biosciences
(TASE: THXBY; OTCQB: THXBY)
7th Annual Biotech Showcase Conference Jan Turek, CEO
Therapix
Biosciences
Safe Harbor Statement This presentation has been prepared for informational purposes only and does not purport to be all-inclusive. 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.
Confidential
Therapix
Biosciences
LP-306:
unique synthetic inhaled THC
formulation for pain, MS and CINV
Robust “Entourage”* Pipeline:
Cannabinoid-analogs that enhance the effect of immunomodulators, including
cannabinoids
Novel oral combinations for pain:
PT-156, PEA / THC
PS-122, PEA / Prednisone
Confidential
Specialty pharmaceutical company developing and acquiring
unique synthetic cannabinoid-based therapies
with favorable risk/return profiles
* Subject to Board and shareholders approvals of Dekel Pharmaceuticals agreement and funding 3
Therapix
Biosciences
Company Highlights
4 Confidential
Strategy focused on development of differentiated synthetic cannabinoid assets with attractive risk / return profiles • Novel combination therapies, harnessing the “entourage” effect
• Unique formulations and drug delivery approaches
• Expedited approval pathways
• Known mechanisms of action with demonstrated efficacy/safety profiles
Target both prevalent and orphan indications
Experienced team of world-class senior executives
Therapix
Biosciences
LaraPharm - investment agreement • Private Israeli biotech company focused on cannabinoid therapies
• Lead program: LP-306
• Therapix has rights to acquire 49% of the company
Dekel Pharmaceuticals – Licensing “entourage” programs* • Focused on cannabinoid-analogs that enhance the effect of
immunomodulators, including cannabinoids (the “entourage effect”)
• Lead programs: PS-122, PT-156
Evaluating / seeking additional cannabinoid assets to expand pipeline
Building a Portfolio of Synthetic Cannabinoid Assets
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* Subject to Board and shareholders approvals of Dekel Pharmaceuticals agreement and funding
Therapix
Biosciences
Over 100 cannabinoids/cannabinoid-analogues identified • Best known agents: THC and CBD
• Sourced botanically (complex process) or synthetically (simple process)
• Effective as stand-alone therapies or combination agents (“entourage effect”)
Significant benefits shown in multiple indications: • Pain, Multiple Sclerosis, MS Spasticity, Epilepsy, Parkinson’s Disease
• Cancer pain, Cancer-Induced Nausea and Vomiting (CINV)
• Anti-inflammatory (e.g. Inflammatory bowel disease, arthritis)
• Dermatological indications (e.g. psoriasis)
• Psychiatric disorders
Cannabinoid Market Overview
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Therapix
Biosciences
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
Approved Drugs: • AbbVie: Marinol capsules for CINV
• GW Pharma: Sativex sublingual spray for MS spasticity
In Development: • GW Pharma: Sativex sublingual spray for cancer pain; Epidiolex sublingual spray
for Epilepsy
• Insys: THC oral solution for CINV, anorexia in AIDs patients; CBD oral solution for Epilepsy
Collaborations: Otsuka, Bayer, Almirall, Novartis and others
Cannabinoid Market: Landscape & Opportunity
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Therapix
Biosciences
Pipeline of Products Based on the “Entourage Effect”
Therapix
Biosciences
“Entourage” Effect • Certain cannabinoid-analogues enhance the effect of immunomodulators,
such as steroids and cannabinoids
• Enhance potency, allowing for dose reduction and avoidance of adverse events
• Supported by substantial scientific and clinical evidence
• Some of these analogues are already on the market
Therapix’ strategy: develop combination products offering significant advantages over the single agent alone • Potential to streamline and accelerate development path
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Pipeline of Products Based on the “Entourage Effect”
Subject to Board and shareholder approvals of Dekel agreement and funding, All information obtained from Dekel and subject to further DD by the Company
Therapix
Biosciences
Therapix’ Pipeline Focuses on High Value Indications
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Subject to Board and shareholders approvals of Dekel agreement and funding, All information obtained from Dekel and subject to further DD by the Company
Drug Candidate Composition Disease target
PS-122 (Oral) PEA, Prednisone Pain in RA patients
PT-156 (Oral) PEA, THC Chronic Pain, CINV
LP-306 (Inhaled) THC CINV, AIDS anorexia, pain, MS
PC-103 (Oral) PEA, CBD Epilepsy
PO-179 (Oral) PEA, Oxycodone Mod./severe pain
ST-622 (Topical) PEA Psoriasis
Confidential
Therapix
Biosciences
PS-122: Oral combination of PEA & prednisone for chronic pain in Rheumatoid Arthritis (RA) patients
• Prednisone: effective, but associated with significant side effects:
E.g., glaucoma, cataracts, increase blood pressure, psychiatric issues, weight gain, increased blood sugar, osteoporosis
Patients often instructed to reduce dose or have “drug-free” intervals
• PEA (palmitoylethanolamide): not considered a classic endocannabinoid because it lacks affinity for CB1 and CB2
Substantial clinical evidence suggests PEA exhibits analgesic characteristics
Company completed proof-of-concept trial in psoriasis
Since 2008, PEA has been marketed as a food supplement in Italy and Spain
Treatment for chronic pain and chronic inflammation
• The Company has IP and scientific data supporting the synergistic activity of PEA and steroids
Results in “steroid sparing effect”; potential for same efficacy with reduced side effects
Subject to Board and shareholders approvals of Dekel agreement and funding, All information obtained from Dekel and subject to further DD by the Company
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Lead “Entourage Effect” Product
Therapix
Biosciences
PT-156: Oral combination of PEA & THC for chronic pain and CINV
• THC: has mild to moderate analgesic effects, and used to treat pain
• Alleviate symptoms suffered both by AIDS and cancer patients by increasing appetite and decreasing nausea.
• Usage is limited by adverse events, including cognitive effects and psychosis.
• PEA: possesses analgesic and anti-craving effects
• Efficacious in the treatment of withdrawal symptoms
• Effective in the prevention of cannabis induced neurotoxicity and neuro-psychiatric disorders.
• PEA stabilizes mucosal mast cells
• Overcome the respiratory tract over-sensitization/irritation caused by THC
Combination of THC with PEA, could provide a safer and more effective treatment than THC alone
Subject to Board and shareholders approvals of Dekel agreement and funding, All information obtained from Dekel and subject to further DD by the Company
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Lead “Entourage Effect” Product
Therapix
Biosciences
Development Plan for PS-122 and PT 156: • Utilize existing safety data for all components
• Initiate formulation development of combinations
• In parallel, initiate POC Phase 1 trials with components dosed simultaneously
• PS-122: PEA/prednisone in RA patients
• PT-156: PEA/THC in chronic pain patients
• Start Phase 2/3 clinical trials for both drugs with the optimized formulations rapidly thereafter
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PS-122, PT-156 Can Move Rapidly into Clinical Development
Subject to Board and shareholders approvals of Dekel agreement and funding,
All information obtained from Dekel and subject to further DD by the Company
Targeting the $41 billion pain market
Therapix
Biosciences
1Clin Pharmacokinet. 2003;42(4):327-60. 2Pain Res Manag. 2005 Autumn;10 Suppl A:15A-22A. 3Clin Chem. 2011 January ; 57(1): 66–75. 14 Confidential
LP-306 represents a “Delivery” Opportunity
Parameter Oral Inhaled
Absorption variability High Low
Bioavailability Low High
Effect Slow Rapid
Pulmonary administration of THC superior to oral route
Studies suggest that oral administration could impact efficacy
Therapix
Biosciences
Unique synthetic THC formulation designed to be administered via a pharma-quality single use dry-powder inhaler
Key components: • Synthetic GMP Manufactured THC
• Unique powder formulation
• Off the shelf DPI inhaler
• Patents for the inhalation of certain cannabinoid formulations
Potential for significantly better efficacy over other cannabinoid based therapies (oral, mucosal): • Metered Dosing
• Enhanced Bioavailability (increased absorption)
• Rapid Onset
Potential to avoid psychotropic effects of THC due to the delivery of relatively low dose via dry-powder inhaler
LP-306
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Therapix
Biosciences
Accelerated development using 505(B)(2) regulatory path with the FDA; similar approach in EU • Utilize data from approved Marinol capsules with limited additional
pre-clinical requirements
• Phase 1 bioavailability study in healthy volunteers
Lead Indications: CINV; Chronic Pain; Anorexia in AIDS patients • Expansion potential into cancer pain, MS spasticity
• Chronic Pain represented a $41 billion in 2012 with double-digit annual growth
• MS Spasticity effects 80% of the 400,000 MS patients in the US
SeaChange Research 2011
J Support Oncol. 2007 May;5(5 Suppl 3):1-9
BMJ Case Rep. 2013 Jul 26;2013
Drugs. 2013 Oct;73(15):1711-22.
LP-306 Development Plan
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The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the LP-306 and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval (vis-a-vis 505(b)(2) - New Drug Application (NDA)) and similar approach in EU (i.e. – repositioning of a previously approved drug)) 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
Confidential
Therapix
Biosciences
Indications/comments MKT Cap
Price (USD)
Symbol Company
Pain, CINV, Epilepsy $1.57B $44.80 INSY Insys
Pain, MS, Epilepsy $1.52B $76.82 GWPH GW Pharma
* Updated January 8th , 2015
Comparables highlight the potential of cannabinoid companies
MJIC MARIJUANA INDEX is tracking performance of cannabis industry stocks, approximately 45 companies the average market cap is about $70M
Confidential 17
Therapix
Biosciences
Anticipated Milestones
Licensing: obtain necessary Board and shareholders approvals, and secure funding to complete the licensing of Dekel Pharmaceuticals assets
Entourage Pipeline: Finalize formulation of PS-122 & PT-156 and advance rapidly into clinical development
LP-306: complete the development of inhaled dry powder formulation and progress rapidly through 505(B)(2) process
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Therapix
Biosciences
Management Team &
Board of Directors
Therapix
Biosciences
Therapix Management Team
Dr. Elran Haber,
VP Business Strategy & Innovation • 10 years executive management positions
• Chairman & Board Director of Israel (public traded and privately held) companies & associations
• PhD in Pharmaceutical Science from The Hebrew University of Jerusalem
• MBA in Finance & Financial Engineering from The Hebrew University of Jerusalem
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Mr. Dov Weinberg
US Finance Dircetor • 30 years of experience as CFO in both startups and large multinational organizations
• 14 years of experience in the life science industry with private and public companies
• MBA in finance from Bar Ilan University
• B.A in economy and accountancy from the Tel Aviv University
Mr. Jan Turek CEO
• 30 years of global experience in general management, product and market development , M&A/licensing with large and small pharma and biotech companies
• Former CEO of Biolex Therapeutics
• Former Senior Vice President and General Manager of Bayer’s Biological Products Division
• Extensive expertise in building companies
• BSc in Biochemistry from McGill University
Therapix
Biosciences
Dr. Ascher Shmulewitz, Chairman
• Highly accomplished entrepreneur of early-stage medical companies as both an inventor and manager
• Successfully led 14 exits over the past decade
• Strong network of industry, financial and clinical contacts
• Vast VC experience.
• Founder of MGP, a private investment firm and incubator
• MD degree from Technion Medical School
• PhD in Engineering from Tel Aviv University
Therapix Board of Directors
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Mr. Avi Meizler, Director
• Experienced businessman and entrepreneur
• President of Meizler Biopharma S.A. 1990 to 2012 (acquired by UCB Pharma)
• Chairman & VP Business Development Meizler UCB Biopharma S.A.
• Co-founder and CEO of Advantech Bioscience Pharmaceutical Ltd.
Ms. Tamar Kfir, Director
• CEO at HBL (TASE)
• Managed BP&C consulting firm
• Venture Partner at Infinity IP Bank and Managing Director at Landes Biosciences Investments
• Former VP Licensing Healthcare at Yissum TTC of Hebrew University
• BA in Business & Economics , from Bar Ilan University
• MA in Economics & Finance, from Bar Ilan University
Therapix
Biosciences
Mr. Amit Berger, Independent Director
• CEO at Dolphin Investments Ltd
• Independent Director at N.R. Spuntech Industries Ltd. And Itay Financial AA Investments Ltd.
• Chairman at Enter Holdings Ltd.
• Chairman at Berger Holdings (DS Securities & Investments Ltd)
• BSc in Economics from Tel Aviv University
Confidential
Mr. Zohar Heiblum, Independent Director
• Co-founder of TeFen Ltd, a leading Israeli consulting firm
• Served in various companies as investor, consultant, board member and active chairman
• Led turnarounds at various companies
• BSc in Industrial Engineering from Tel Aviv University
• MBA from Tel Aviv University
Therapix Board of Directors
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Therapix
Biosciences
Therapix Summary
Specialty pharmaceutical company focused on synthetic cannabinoid therapies
• Assets with attractive risk/return profiles
• Large market potential
Significant near-term opportunities with PT-156, PS-122 and LP-306
Robust pipeline based on synergistic integration of proprietary technologies
• Novel formulation, “entourage” compounds
Experienced team of world-class senior executives & scientists
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