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Transcript
Intec Pharma Unfolding drug delivery solutions Investor Presentation Nasdaq: NTEC September 2016 Forward Looking Statements This presentation by Intec Pharma Ltd. (referred to as “we” or “our”) contains forward-looking statements about our expectations, beliefs and intentions regarding, among other things, our product development efforts, business, financial condition, results of operations, strategies, plans and prospects. In addition, from time to time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan“, “may“, “should“, “could“, “might“, “seek“, “target“, “will”, “project“, “forecast“, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forwardlooking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including those described in the sections entitled “risk factors” in the documents that we file with the Securities and Exchange Commission. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date of this presentation and are expressly qualified in their entirety by the cautionary statements included in this presentation. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except as required by applicable law. In evaluating forward-looking statements, you should consider these risks and uncertainties. The presentation contains information about investigation-stage drug products under development, which have not yet been approved by the FDA for commercial distribution in the United States. All representations in this Presentation are based upon investigations in certain clinical and other research, but which accordingly should not be construed as general claims for the safety or efficacy of the products when used by patients. 2 Investment Highlights • Late clinical stage biopharmaceutical company focused on developing drugs based on our proprietary oral drug delivery system – the Accordion PillTM (AP) The Accordion Pill is designed to provide a significant improvement in the pharmacokinetics (PK) profile of various drugs and a corresponding improvement in efficacy and safety • Future potential value drivers: AP Carbidopa/Levodopa (AP-CDLD) for the treatment of Parkinson’s disease (PD) symptoms: Currently in pivotal Phase III clinical trial (US, EU, ISR) AP Cannabinoids (AP-CBD/THC) for various indications including pain management – planned initiation Phase I clinical study in 1Q 2017 AP Zaleplon (AP-ZP) for the treatment of insomnia: Phase II clinical trial completed • Utilizing 505(b)(2) regulatory pathway – faster and less expensive pathway to market • Strong and long-term IP protection • Experienced management team with proven abilities to execute 3 Accordion Pill Platform Technology • Combines drugs and inactive ingredients into polymeric films that are welded into a planar structure, folded into the shape of an accordion and placed inside a capsule • Retained in the stomach for 8 to 12 hours compared to as little as 2 to 3 hours for other solid dosage forms • Releases the drug in a pre-defined profile • Prolongs the absorption phase of drug in the upper part of the gastrointestinal (GI) tract • All inactive ingredients are included in the FDA’s list of approved inactive ingredients • We have conducted more than 30 clinical trials with over 3,000 administrations 4 Drug Candidates for the Accordion Pill Technology Poorly soluble drugs Absorbed mainly in the upper GI tract (Narrow Absorption Window) Act locally in the upper GI tract 5 Product Pipeline Product Candidate Research Phase I Phase II Phase III AP-CDLD* Parkinson's disease symptoms in advanced Parkinson’s disease patients AP-ZP* Insomnia AP-Undisclosed Drug Prevention and treatment of gastroduodenal and small bowel nonsteroidal anti-inflammatory drug (NSAID) induced ulcers AP-CBD/THC** Cannabinoid treatments for various indications, including pain management AP-Undisclosed Drug Under collaboration with Biogen * Under 505(b)(2)Disease ** Planned initiation of Phase I clinical trial - 1Q17 6 AP-CDLD Parkinson’s disease Symptoms in Advanced Parkinson’s Disease Patients 7 Parkinson’s Disease • Progressive, degenerative disease characterized by movement symptoms such as involuntary tremor, muscle rigidity, slowness of and a decline in movement and impaired balance and coordination • The second most common neurodegenerative disorder in elderly, affecting 1%–2% of individuals ages ≥65 years worldwide1 • Disease progression and motor complications have a considerable impact on quality of life • Approximately 6.3 million people worldwide have Parkinson's disease2 • Drug market in the Seven Major Markets plus Brazil: $3.6 billion annually in 2012, forecasted $4.67 billion annually by 20221,3 1 Source: Global Data European Parkinson’s Association, 2007 3 The Seven Major Markets include the United States, Japan, France, Germany, Italy, Spain and the United Kingdom 2 Source: 8 Levodopa is the Most Common Parkinson's Disease Treatment • • • Levodopa (LD) remains the most effective and most prescribed therapy for Parkinson’s disease throughout early and late-stage Parkinson's disease However, frequent LD plasma level fluctuations are correlated with: Off episodes (debilitating periods of decreased motor functions) Troublesome dyskinesia (vigorous involuntary movements) These PK fluctuations are due to: A very short half-life of about 90 minutes LD is absorbed only in the upper part of the GI tract (Narrow Absorption Window) In advanced Parkinson's patients, stabilizing LD plasma levels becomes the major factor for improving anti-parkinsonian control1 Dyskinesia Levodopa Plasma Levels Day Desired levodopa profile Current typical levodopa oral medications Good On Off Episodes 1 PK/PD Crossover Comparison of Two LD Extension Strategies, Peter LeWitt et all, Movement Disorders, Vol 24, No.9, 2009 Night 9 AP-CDLD: New Horizon for Levodopa Treatment Phase 2 clinical trial has shown that AP-CDLD: Provided more stable LD plasma levels Significantly reduced motor complications Significantly reduced number of LD administrations per day In comparison to patients’ current LD treatment BID or TID administration of AP-CDLD is designed to provide basal, therapeutic, stable LD plasma levels for PD patients in various stages of the disease, for the purpose of significantly improved LD therapy Accordion films contain Levodopa and Carbidopa Accordion is folded into a capsule 10 AP-CDLD Phase II Structure Trial Purpose Population Group Number Trial Design Group 1 Open-label, multi-dose, 2-way crossover comparative multi-center, randomized PK trial Group 2 This trial was orignially planned in early non-fluctuators with a dose of 50/375 mg b.i.d. In light of the satisfactory PK results with the 50/250 mg b.i.d in this population, the higher dose was considered unneccessary and therefore the trial was not performed Group 3 Open-label, multi-dose, 2-way crossover comparative multi-center, randomized PK and PHDS trial Advanced PD patients 10a AP-CDLD 50/375 mg b.i.d for 7 days Group 4** Open-label, multi-dose, 2-way crossover comparative multi-center, randomized PHDS trial Advanced PD patients 16 AP-CDLD 50/375 mg b.i.d for 21 days Group 5b** Open-label, multi-dose, 2-way crossover comparative multi-center, randomized PHDS trial Advanced PD patients 4 AP-CDLD 50/500 mg b.i.d for 21 days Group 6** Open-label, multi-dose, 2-way crossover comparative multi-center, randomized PHDS trial Advanced PD patients 18 AP-CDLD 50/500 mg b.i.d for 21 days Early-stage PD patients N (PP) Test Treatment Treatment and Duration* 12 AP-CDLD 50/250 mg b.i.d for 7 days a Eight patients completed the PK trial 5 was terminated early due to low enrollment d = days; PP = per protocol; N = number of subjects; PD = Parkinson’s disease; PHDS = pharmacodynamics * Not including add-on dosing of immediate release Carbidopa/Levodopa, if needed ** Compared vs. each patient’s optimized current Levodopa treatment b Group 11 Phase II, Advanced Patients - Study Design Phase II Group 3 PK Day 7 6 days Randomization AP-CDLD 50/375 mg bid Day 7 6 days PK Phase II Groups 4 & 6 test 17 days optimization 4 days Current CD/LD Tx Screening Randomization (4) AP-CDLD 50/375 mg bid* (6) AP-CDLD 50/500 mg bid* 17 days conversion 6 days Day 14 Current CD/LD Tx Current CD/LD Tx Screening PK 4 days test AP-CDLD 50/375 mg bid Day 14 6 days PK test 17 days optimization 4 days Current CD/LD Tx (4) AP-CDLD 50/375 mg bid* (6) AP-CDLD 50/500 mg bid* 4 days 17 days conversion test * If needed, additional IR CD/LD were allowed 12 AP-CDLD Phase II Results Advanced Parkinson Patients More Stable PK Observed Significantly Reduced TSD Significantly Reduced Off Time Reduced Pill Burden 13 AP-CDLD Status Regulatory and Clinical: Phase III clinical study ongoing Patient recruitment initiated in April 2016 Eligibility for 505(b)(2) regulatory route confirmed Only one pivotal study needed for NDA submission IP: Specific AP-CDLD IP is granted in the US and Europe, with expiration in April 2029 14 AP-CDLD Phase III Design • Design: a multi-center, global, randomized, double-blind, double-dummy, active-controlled, parallel-group study in adult patients with fluctuating PD • Primary endpoint: Total Off Time (% of waking hours) • Secondary endpoints: Daily Off time (hours), On time with and w/o troublesome dyskinesia (hours), Number of daily LD doses, Questionnaires: CGI-I ,Parkinson’s Disease Questionnaire, Parkinson’s Disease Sleep Scale, UPDRS • 460 patients will be enrolled, 130 sites in US, Europe and Israel • Active control: Sinemet® 15 AP-CDLD Phase III Design Double Blind 13 Weeks Open label Treatment Period Open label Sinemet + AP CDLD dummy Screening Stabilization on Sinemet® AP- CDLD Conversion 2 Weeks 12 Months AP CDLD + Sinemet dummy N=~460 4 Weeks Follow Up Open Label Ext. w/APCDLD 6 Weeks Treatment Period 6 Weeks 50/400, 50/500 BID, TID With reference drug = Sinemet 13 Weeks Randomization 16 AP-CBD/THC Cannabinoid Therapies 17 AP-CBD/THC • Cannabinoids could represent ~10% of overall specialty pharmaceutical market over the next five years – a market size of at least $20 billion1 • AP-CBD/THC is an Accordion Pill that contains the primary cannabinoids contained in Cannabis sativa: Cannabidiol (CBD) and 9-Tetrahydrocannabinol (THC) • Intec plans to develop AP- CBD/THC for various indications, including pain management Market Opportunity Drawbacks to current methods of treatment with cannabis and cannabinoids are: short duration of effect delayed onset variability of exposure dose variability, narrow therapeutic window adverse events that correlate with peak levels Intec’s Solution Under Development Accordion Pill’s gastric retention and specific release mechanism is planned to extend the absorption phase for CBD and THC, in order to provide a prolonged and more consistent therapeutic effect Phase I PK study to evaluate AP-CBD/THC is planned to initiate in 1Q 2017 1 Source: Viridian Capital Advisors. (2015, December 2). REPORT: The Cannabis biotech/Pharma market could surpass $20 Billion by 2020. Retrieved September 1, 2016, from Equities, https://www.equities.com/news/report-the-cannabis-biotech-pharma-market-could-surpass-20-billion-by-2020 18 AP- Zaleplon (ZP) for the Treatment of Insomnia 19 Insomnia Market Overview • In 2013, there were approximately 140 million prevalent cases of chronic insomnia in the Seven Major Markets1,2,3 • The sleep disorder drug market in these markets is forecasted to reach ~$1.8 billion in 20231,3 • Available insomnia drugs, prescribed for both sleep induction and sleep maintenance, do not provide a comprehensive solution that: rapidly induces the onset of sleep within a short time maintains continuous sleep throughout the night has no or minimal “next-day” residual side effects, such as drowsiness or “hangover” • In 2011, the Centers for Disease Control and Prevention estimated that drowsy driving contributes to ~100,000 car accidents and ~1,500 deaths each year in the United States4 1 Source: Global Data Seven Major Markets include the United States, Japan, France, Germany, Italy, Spain and the United Kingdom 3 Includes cases both fulfilling the definition of chronic insomnia in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), and not fulfilling the DSM-IV criteria 4 Source: Medscape from WebMD 2 The 20 Next Day Safety Concerns of Existing Insomnia Drugs May :2013 The FDA announced that patients who take CR formulations of Zolpidem should refrain, for the day after using the drug, from driving or engaging in any activity that requires full alertness, even if the patient has slept for the required eight-hour period after taking the drug. January 2014: The FDA ordered a reduction of the recommended dosages of drugs that contained Zolpidem by 50% due to the decline in next day functionality and alertness. May 2014: The FDA ordered a reduction of the recommended starting dose of Lunesta, to the minimum approved dose because the drug levels in some patients may be high enough the next morning to impair activities that require alertness, including driving. 21 AP-ZP • AP-ZP contains Zaleplon (generic Sonata) in both immediate and controlled release forms • Zaleplon is approved for sleep induction. Its short half life (~1 hour) results in limited or no next-day effects • Positive data from a Phase II clinical trial (N=83) with AP-ZP 25mg met the primary endpoint of a statistically significant increase in Total Sleep Time Met secondary endpoint of statistically significant improvement of latency to persistent sleep Residual next-day effects were not observed in comparison to placebo • Additional Phase I clinical trial with AP-ZP 30mg and 35mg revealed no difference in next-day cognitive side-effects between the two doses of AP-ZP and placebo • 505(b)(2) regulatory pathway confirmed • Seeking strategic partner for further clinical development and commercialization 22 Collaboration with Biogen 23 Collaboration with Biogen • April 2015, entered into an agreement with Biogen to develop a designated Accordion Pill with one of Biogen’s marketed, proprietary drugs • Intec to receive up to $920k to develop and execute the research plan, $8mm upon exercise of the option, and up to $139mm in milestone and royalty payments • Upon exercise of the option, Biogen will be responsible for all costs associated with pre-clinical and clinical activities required for obtaining regulatory approval, as well as for the manufacturing and commercialization thereof $250k up front to fund research plan Up to $670k for research milestones $8mm upon exercise of option Up to $39mm for milestones Up to $100mm in aggregate royalties 24 Accordion Pill Platform for Poorly Soluble Drugs 25 Prolonging Absorption to Provide an Increased Bioavailability • The AP platform technology is also designed for drugs with low solubility, namely Biopharmaceutics Classification System, or BCS, Class II (low solubility, high permeability) and Class IV (low solubility, low permeability) drugs • Of the top 200 oral drugs in the United States, UK, Spain and Japan in 2006, around 40% were BCS Class II or Class IV drugs* • Further, Approximately 90% of New Chemical Entities, in development in 2006, were either BCS Class II or Class IV drugs** • Poorly soluble drugs are sometimes characterized by: Low bioavailability Non-linear pharmacokinetics • An Accordion Pill has clinically demonstrated an increased bioavailability of a commercially available BCS Class II/IV drug *AAPS Journal published by the American Association of Pharmaceutical Scientists ** Drug Development & Delivery 26 The Accordion Pill with Poorly Soluble Drugs: PK Clinical Study Drug concentration ng/ml Example: Low Solubility Marketed Drug AP Xmg 2 AP Xmg Commercial formulation Xmg 0 12 24 36 Hour 48 60 72 N=12 • PK issues of drug X include only 30% absorption and lack of dose proportionality above an approved marketed dose (Xmg) • AP significantly extended the absorption phase of the drug • Approximately a 100% increase in bioavailability in 12 healthy volunteers, with the AP at Xmg • Dose proportionality obtained with AP at 2x dose vs. 1x dose 27 Strong Rationale for the Accordion Pill Technology for Poorly Soluble Drugs For poorly soluble drugs, we believe that our technology acts through the following mechanism of action: • The gradual delivery of a drug from the AP in the stomach, is proposed to enable complete dissolution of the drug dose during gastric retention and over the delivery period. This gradual passage enables an increase in the amount of the drug that can be dissolved, and thus absorbed, in the upper small bowel • Bile secretion in the upper part of the GI tract facilitates the intestinal environment for in vivo drug solubility and therefore better absorption • The significant dilution of the drug solution in the small bowel caused by prolonged delivery is posited to increase the opportunity for complete drug absorption of these poorly soluble actives 28 Intellectual Property 29 Three Layers of IP Protection • Platform IP Various Accordion Pill dosage forms Latest US patent expires in 2029 • Manufacturing IP Methods for making/folding gastroretentive drug delivery system US patent expires in 2028 • IP related to integration of specific drugs into designated Accordion Pill products For example, US patent of AP-CDLD expires in 2029 30 Corporate Overview 31 Experienced Management Team Zeev Weiss, BSc, CPA Nadav Navon, PhD, MBA Nir Sassi, CPA, BA Pnina Strauss-Levy, BSc, MBA Chief Executive Officer EVP R&D and Operations Chief Financial Officer VP of Clinical and Regulatory Affairs • Former Head of Life Sciences Strategic Consulting, PwC Israel • Former Head Analytical and QA operations, Sharon Laboratories • 15 years of experience in healthcare corporate development, strategic planning and corporate finance • Former Manager R&D Programs, Negev’s Nuclear Research Center • Former Senior Manager at PwC Israel • Former VP of Clinical Development & IP, Kamada (NASDAQ: KMDA) 32 Scientific Advisory Board Parkinson's disease Dr. Peter LeWitt • Professor of Neurology at Wayne State University School of Medicine in Detroit Dr. Werner Poewe • Professor of Neurology and Director of the Department of Neurology at Innsbruck Medical University in Innsbruck, Austria Prof. Nir Giladi • Associate professor at the Sackler Faculty of Medicine at Tel Aviv University and chairman of the Department of Neurology at the Tel Aviv Sourasky Medical Center Insomnia Prof. Thomas Roth • Professor of Neurology and Director of the Department of Neurology at Innsbruck Medical University in Innsbruck, Austria Dr. James Walsh • Executive director and senior scientist of the Sleep Medicine and Research Center at St. Luke’s Hospital in St. Louis, a visiting professor in the Department of Psychiatry at Stanford University and an adjunct professor of psychology at Saint Louis University 33 Recent Milestones Enrolled First Patient In pivotal Phase III with our AP-CDLD in advanced Parkinson's disease patients, in April 2016 Completed a Phase I clinical trial with our product for the prevention and treatment of gastrointestinal disorders, in 1Q 2016 Initiated Cannabinoid development project with the Accordion Pill platform technology Nominated Dr. John W. Kozarich, Chairman of Ligand Pharmaceuticals (LGND), as Chairman of the Board of Directors, in May 2016 Received approval for $5.2 Million grant for the 2016 R&D program from the Israeli National Authority for Technological Innovation, in May 2016 Granted European Patent for AP-CDLD, in September 2016 34 Goals for 2016/2017 • Continue advancing pivotal Phase III clinical trial for APCDLD in advanced Parkinson’s disease patients • Launch AP Cannabinoids program with the planned initiation of Phase I study of AP-CBD/THC in 1Q 2017 • Pursuing discussions with various pharmaceutical companies for potential collaborations and/or licensing agreements • Build and expand intellectual property portfolio 35 INSTITUTIONAL HODLERS CASH CAPITAL STRUCTURE Capital Structure and Cash Position 11.4 $6.00 MILLION Ordinary Shares Outstanding IPO Stock Price (08/04/2015) $21.4M in cash and short term bank deposits and financial assets as of June 30, 2016 $ 30.61% % of Institutional Holders • • • • • • • $70.3M Market Cap (09/01/2016) $5.2M Approved grant from the Israeli National Authority for Technological Innovation (NATI) Cormorant Asset Management, LLC Sabby Management, LLC Opaleye Management, Inc. DAFNA Capital Management Phoenix Holdings Migdal Insurance and Financial Holdings Meitav Dash 36 Investment Highlights • Late clinical stage biopharmaceutical company focused on developing drugs based on our proprietary oral drug delivery system – the Accordion PillTM (AP) The Accordion Pill is designed to provide a significant improvement in the pharmacokinetics (PK) profile of various drugs and a corresponding improvement in efficacy and safety • Future potential value drivers: AP Carbidopa/Levodopa (AP-CDLD) for the treatment of Parkinson’s disease (PD) symptoms: Currently in pivotal Phase III clinical trial (US, EU, ISR) AP Cannabinoids (AP-CBD/THC) for various indications including pain management – planned initiation Phase I clinical study in 1Q 2017 AP Zaleplon (AP-ZP) for the treatment of insomnia: Phase II clinical trial completed • Utilizing 505(b)(2) regulatory pathway – faster and less expensive pathway to market • Strong and long-term IP protection • Experienced management team with proven abilities to execute 37 INTEC PHARMA LTD. 12 Hartom st. (RMPE building) P.O. Box 45219, Jerusalem 9777512 Israel Tel: +972-2-5864657 Fax: +972-2-5869176 [email protected] 38