Bypassing the Blood-Brain Barrier Impel NeuroPharma 720 Broadway Seattle, WA Michael Hite, CEO (206)
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1 Bypassing the Blood-Brain Barrier 2012 Impel NeuroPharma 720 Broadway Seattle, WA Michael Hite, CEO (206)
2 A Seemingly Intractable Problem Blood Brain Barrier (BBB) Largest bottleneck in neurological drug development Affects >98% small molecules and ~100% biologics Limits >$75B Central Nervous System (CNS) market Current methods to address BBB have severe limitations Poor efficacy High systemic exposure, side effects Technologically complex, limited applicability
3 Cutting the Gordian Knot Bypassing the BBB Creates blockbuster drugs Improve existing drugs Avoids drug modification Non-invasive Biologic and small molecule drugs
4 Commercial Opportunities Enable New Drugs Alzheimer s Parkinson s Brain Cancer Pain Improve Existing Drugs Biodefense HIV/AIDS Epilepsy Neuroimaging Enable new types of biologic CNS drugs Expand number of potential clinical compounds Improve safety of existing drugs
5 Direct Nose-to-Brain Pathway Enabling BBB Bypass Only location where BBB is permeable ( leaky ) Passive absorption from nasal cavity Rapid distribution throughout brain
6 Pressurized Olfactory Delivery (POD) Platform Only POD targets upper nasal cavity
7 POD Device Hand-held Disposable Active delivery Single step actuation Unit-dose Liquid or powder dose Delivers 60-80% of dose to upper nasal cavity Novel propulsion & aerosol plume generation IP Animal and human devices
8 Upper Nasal Cavity Delivery Powder Dose Liquid Dose Deposition within upper nasal cavity achieved using human nasal cast CONFIDENTIAL
9 Superior CNS Bioavailability PAM concentration (ng/g tissue) IV POD liquid POD powder Higher brain drug concentrations within 5 minutes
10 Business Model Enabling Platform Technology Multiple technology licensees Revenue from development milestones, sales royalties Partners responsible for clinical, regulatory Non-dilutive R&D funding Economic Impact Goal of building leadership position for development of device-enabled CNS drug products R&D footprint US-based commercial manufacturing
11 Impel University of Washington Company Formation Original research by John Hoekman, PhD and Rodney Ho, PhD (Dept. Pharmaceutics, School of Pharmacy) Founding team met via MBA Business Plan Competition, (Foster School of Business) Center for Commercialization (C4C) licensed technology Mentored by Center for Innovation and Entrepreneurship (CIE) and C4C Entrepreneurs in Residence (EIR) Institute for Translational Health Sciences (ITHS) provided early funding
12 Impel SBIR grants Translating Research into Product Development $1.5M Small Business Investigational Research (SBIR) awards NIH/NIMH antiviral drugs for HIV/AIDS-related dementia NIH/NIDA safer, first-in-class pain drug DoD/Army nerve-agent antidote Platform validation POD technology applied to a wide range of drug molecules and indications Asset creation funded development of early stage licensable drug-device products
13 Impel Life Science Discovery Fund Accelerating Value Creation $150k LSDF Commercialization grant award Principal Investigator: Dr. Greg Terman MD, PhD (UW School of Medicine, Dept of Anesthesia) First-in-Human study Safety, efficacy evaluation of POD vs. IV pain drug Provides crucial human proof-of-concept University clinical site enables high-quality low-cost data
14 Enhancing Growth Impel WBBA Connects community of life science startups with established medical device firms, biotechnology companies and world class academic researchers Mentoring by experienced life science entrepreneurs Life Science Innovation Northwest annual conference WINGS angel investor network Industrial ecosystem reduces startup risk Networked community enables virtual business model Virtuous cycle of growth-exit-reinvestment
15 Bypassing the Blood-Brain Barrier 2012 Impel NeuroPharma 720 Broadway Seattle, WA Michael Hite, CEO (206)
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