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How to intervene early: Examples in depression, epilepsy and smoking cessation

Virtual reality and augmented reality technologies show promise for a wide range of medical applications from treating mental health conditions to assisting with physical rehabilitation. VR/AR interventions have been clinically validated for conditions such as PTSD, phobias, anxiety, depression, chronic pain, and addiction in over 3,000 studies. As the technology becomes more affordable, scalable and accessible due to developments from companies like Oculus, Samsung, Sony and Microsoft, its adoption is projected to grow significantly in healthcare over the next 5-6 years. Companies are now developing digital therapeutics using VR/AR and validating them through clinical trials to treat medical conditions via prescription.

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How to intervene early: Examples in depression, epilepsy and smoking cessation
How to intervene early: Examples in depression, epilepsy and smoking cessation
How to intervene early: Examples in depression,
epilepsy and smoking cessation
Chaired by: Avery
Bedows, Neurotechnology
Specialist at Loup
Ventures
David B. Klein, CEO of Click
Therapeutics
Ana Maiques, CEO
of Neuroelectrics
Dr. Walter Greenleaf,
Research Scientist
at Stanford University’s
Virtual Human Interaction
Lab
Walter Greenleaf PhD
VR & AR Technology
New Tools for Research and Clinical Care
Digital Health
Revolution
• Mobile Health / eHealth
• Wearable Sensors
• Patient Centered
• Leverages Internet:
social, quantitative, collaborative
Medical Applications
of Virtual Reality &
Augmented Reality
Technology
Digital Health Revolution

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How to intervene early: Examples in depression, epilepsy and smoking cessation

  • 3. How to intervene early: Examples in depression, epilepsy and smoking cessation Chaired by: Avery Bedows, Neurotechnology Specialist at Loup Ventures David B. Klein, CEO of Click Therapeutics Ana Maiques, CEO of Neuroelectrics Dr. Walter Greenleaf, Research Scientist at Stanford University’s Virtual Human Interaction Lab
  • 4. Walter Greenleaf PhD VR & AR Technology New Tools for Research and Clinical Care
  • 5. Digital Health Revolution • Mobile Health / eHealth • Wearable Sensors • Patient Centered • Leverages Internet: social, quantitative, collaborative
  • 6. Medical Applications of Virtual Reality & Augmented Reality Technology Digital Health Revolution
  • 7. Although entertainment, social connection and gaming will drive the initial adoption of VR technology, the deepest and most significant market for VR will be in clinical care and in improving health and wellness. Medical Applications of Virtual Reality Technology
  • 8. Now is the time for VR & AR VR technology is now affordable, scalable and accessible Facebook - Oculus Samsung - GearVR Sony – PlayStation VR Microsoft - HoloLens HTC - Vive Google - DayDream
  • 9. 11.3 16.9 27.3 41.5 56.2 68.0 Year 2 Year 3 Year 4 Year 5 Year 6Year 1 *Based on agent based modeling by Lieberman Research Worldwide Within 6 years, VR will likely be adopted by 70 million users The Medical VR / AR Market is projected to be $5.1 B in 2025
  • 10. AR MR XR Technology
  • 12. Virtual Humans For Training, Confidential Interaction, and Telemedicine Support
  • 13. Virtual Humans For Training, Confidential Interaction, and Telemedicine Support “Smart Avatar” with a virtual voice, image and mannerisms via AI
  • 14. Academic research has indicated that Virtual Reality can effectively treat a wide variety of clinical problems – ranging from addictions, to stroke, to PTSD
  • 15. Phobias / PTSD Stress Management / Relaxation Surgical Training / Planning Physical Rehabilitation Pain & Difficult Procedure Management Exercise Cognitive Rehabilitation Optical Rehabilitation Addictions Neuropsychological Assessments Cognitive Training Wellness Sports Training Disability Solutions Speech Therapy Autism Spectrum Disorder Mood Disorders Patient Education Preventive Health ADHD Senior Care 157 Emerging Medical VR/AR Companies 20 Clinical Sectors
  • 16. There are numerous companies applying VR & AR technology to behavioral medicine and mental health / wellness
  • 17. Over 30 years of academic research and over 3000 studies demonstrate that VR can improve behaviors, attitudes, and health Until now, the technology was expensive, bulky, and difficult to use. Today, we have the advancements to bring VR to scale in healthcare. Why Now?
  • 18. • Prevention and Wellness • Objective Assessments • Functional Training • Improved Interventions • Facilitate Adherence • Distributed Care Delivery VR and AR technology will significantly impact Medical Care
  • 19. New Approaches – Behavioral Health Mental Health / Wellness
  • 20. Standardized Environments for Neurocognitive Evaluation New Approaches for Cognitive Assessment Migrates traditional paper and subjective evaluations to a more sophisticated level. Provides robust assessments that can challenge cognitive skills in a more natural, standardized, objective and reproducible manner.
  • 22. Standardized Environments for Neurocognitive Evaluation New Approaches for Cognitive Assessment
  • 23. Standardized Environments for Neurocognitive Evaluation New Approaches for Cognitive Assessment
  • 24. We use brain circuit biotypes to connect brain imaging with VR Neuroimaging measures 1. Scan brain at rest 2. Emotion regulation task 3. Cognitive control task Virtual Reality: 1. Relaxing scene 2. Emotion regulation task 3. Cognitive control game
  • 25. We envision a precision health model using VR to elicit biotypes to help refine the intervention choices Cognitive training TMS Eliciting biotypes using normed environmentsHeterogeneous Disorder Quantify and refine biotypes Relaxation Negative Scene Positive Scene Cognitive Game 1st line Antidepressants Mindfulness-based. TMS Non-drug and new drug options Matching biotypes to the intervention “menu” Default Mode Negative Affect Positive Affect Cognitive Control
  • 26. Standardized platforms and norms Williams et al. invited revisions We are developing the first norms for VR to be used as assays correlated with brain circuits Lab-Based Virtual Reality Naturalistic fMRI Head Movement 288 Continuous Smart-Phone Sampling Variables Behavioral task Performance Screen Capture Self-Report Self-Report Self-Regulation Cognitive Emotional Self-Reflective
  • 27. PTSD, Phobias, and Anxiety Disorders • Exposure-based treatments can be conducted in the safety and comfort of an office setting • Effective tools for treating a variety of clinical problems, in particular anxiety and addictive disorders • Fully immersive environments, with include the use of a head mounted display, 3D sound, tactile stimulation via shaking platform, and olfactory stimulus are used for PTSD therapy
  • 28. • Post-Traumatic Stress Disorder • Generalized Anxiety Disorder • Social Anxiety Disorder • Depression • Mild Cognitive Impairment • Autism Spectrum Disorder • ADHD Virtual environments are used clinically to treat several important mental and behavioral health problems
  • 29.  Generalized Anxiety Disorder  Phobias  Obsessive Compulsive Disorder  Anger Management  Eating Disorders  Schizophrenia Virtual environments are used clinically to treat several important mental and behavioral health problems
  • 30. RISK AVOIDANCE TRAINING Refusal skill training, Situational Confidence
  • 31. VR for Pain Distraction Clinical Research and Validation Interactive virtual environments significantly reduce pain from as much as 44% during the most painful procedures (ex: burn wound treatment) Diverts patient attention away from perceiving and feeling pain; (selective attention theory) Decreases pain-related brain-activity Reduces need for anesthesia, opioid medication No pharmacological side effects
  • 32. Preparation and Training for Difficult Situations
  • 33. Virtual Hospital Tours Used To Relieve Pre-procedure Anxiety
  • 34. Digital Health Platforms deliver interventions to patients, and parse data for enhanced analysis and improved protocols
  • 35. VR & AR - A Key Part of a Combination Therapy Digital Health Platform Patient-facing software designed to enhance medication efficacy Medication with clinical benefit eFormulation- pharmaceutical product with enhanced efficacy =+
  • 36. A Fully Integrated, Closed Loop Solution for Mental Health and Wellness - Enabled on a Mobile, Digital Health Platform Miniaturized, programmable, low power electronic architecture w/extensive therapy delivery options
  • 37. The Neuroscience of How VR Promotes Behavior Change
  • 38. The Neuroscience of How VR Promotes Behavior Change VR can promote behavior change by taking advantage of the way our brain’s learning and reward systems function Activate neuroplastic change via reward systems Shorten the feedback loop –show progress Leverage mirror neuron systems VR systems can:
  • 39. Ability to change attitudes and behavior after “being” one’s future self. Leveraging Mirror Neurons
  • 40. Your Future Self Students interacted with 3-D avatars of future self. Participants who interacted with future self put more than twice as much money into retirement account.
  • 42. • Current technologies and concepts are founded on more than 30 years of research and development • Recent changes in cost and access make digital health technology affordable • Digital health technology is currently used for prevention, evaluation, treatment and chronic disease management • After years of validation and use by early adopters – validated systems are poised to move to the mainstream • On the horizon: enhanced, ubiquitous, informative and integrated Digital Health Technology For Medicine
  • 43. Walter Greenleaf PhD VR & AR Technology New Tools for Research and Clinical Care
  • 44. 2019 SharpBrains Virtual Summit David B. Klein, CEO of Click Therapeutics
  • 45. MISSION: TO BECOME THE LEADING DIGITAL THERAPEUTICS PROVIDER AND PLATFORM • We discover, validate and commercialize software as prescription medical treatments • These Digital Therapeutics™ are based on our clinically validated platform • They work independently or in conjunction with pharmacotherapies • Data collected are used to continuously improve & personalize interventions • Unique and robust intellectual property strategy and portfolio • Better outcomes through user engagement and neurobehavioral change 45
  • 46. SOFTWARE AS A MEDICAL DEVICE (SaMD) 46 We are a Software as a Medical Device (SaMD)-focused biotechnology company. We develop our applications in accordance with all relevant FDA, ISO and IEC standards. We seek FDA clearance for our apps as class II medical devices with independent therapeutic treatment claims or as drug-device combos (e.g.510(k), de novo or 505(b)(2) in the US; CE marking in the EEA, etc.) Physicians prescribe our apps and payers reimburse for them, while we generate and apply real world evidence to continuously improve the applications and expand labeling claims. We clinically validate these applications through rigorous randomized, controlled trials to demonstrate safety and efficacy. We develop prescription software applications as medical devices that work independently or in conjunction with pharmacotherapies to treat disease. What We Do DEVELOP VALIDATE REGISTER COMMERCIALIZE IEC 62304, IEC 82304, IEC 62366, ISO 13485, ISO 14971, CFR Title 21 Part 820, Part 11, Part 801, Part 803, Part 806, Part 822, Part 830, Part 210, Part 211 and EU MDR 2017/745
  • 47. DTx PRODUCT OPPORTUNITIES 47 Digital Therapeutics (DTx): clinically-validated software treatments that can deliver or enhance treatment outcomes. We are addressing 3 core product opportunities. Combination Rx-DTxComplementary Rx + DTxStand-Alone DTx Therapeutic Patients Treatment Outcomes • Single SaMD filing (510(k) or De Novo) • Clinically-validated safety and efficacy • Interactive patient experience • RWD collection and product learning • Separate SaMD and NDA filings • DTx complements Rx safety and efficacy • DTx enhances patient Rx experience • RWD collection may apply to Rx • Single NDA filing including 505(b)(2) • Combined safety and efficacy signal • RWE claims and superiority claims • Possibility for exclusivity + IP protection
  • 48. 48 SEASONED LEADERSHIP TEAM WITH EXPERIENCE BRINGING NEW TECHNOLOGY AND MEDICINES THROUGH DEVELOPMENT, REGULATORY APPROVAL AND TO MARKET DAVID BENSHOOF KLEIN CHAIRMAN & CEO Former Managing Director at Opus Point & Co.; 17+ years life science experience with key roles in founding, developing and financing 10+ life science companies; Co- founder and owner of Klein Sun Gallery, America's leading Chinese contemporary art gallery; Guest Lecturer, Columbia University Biotechnology Program, BA, Brandeis University CHRISTOPHER JORDAN CHIEF TECHNOLOGY OFFICER Former Engineering Manager at Bloomberg LP; Former Senior Research and Development Leader at Bloomberg LP; Former Software Developer at Bloomberg LP; BSE, Computer Engineering, University of Michigan Ann Arbor JOEL SANGERMAN CHIEF COMMERCIAL OFFICER Former VP of Sales, Managed Markets at Zillion Health; Former Area VP of Sales, Market Development at Walgreens Infusion Services/Option Care; Former Director of Payor Relations, Managed Markets, Reimbursement at Johnson & Johnson; Former Director of Reimbursement at Cell Therapeutics, Inc; Former National Account Manager, Managed Markets at Aventis Pharmaceuticals; BS, cum laude, Marketing, DePaul University RANDALL KAYE, MD CHIEF MEDICAL OFFICER Former Chief Scientific Officer at SSI Strategy; Former Chief Medical Officer at Axsome Therapeutics; Former Chief Medical Officer at Avanir Pharmaceuticals (acquired by Otsuka); Former VP, Medical Affairs at Scios Inc (acquired by Johnson and Johnson); Former VP, Medical Affairs, at InterMune (acquired by Roche); Former Senior Director at Pfizer; Former Research Fellow in Allergy and Immunology at Harvard Medical School; MD and MPH, George Washington University School of Medicine; BS, George Washington University TED SILVER CHIEF FINANCIAL OFFICER Former Senior Medical Technology Analyst at Visium Asset Management; Former Section Head, Medical Technology at Amaranth Advisors; Former Equity Research Associate, Medical Technology at Pequot Capital; MBA, Yale University; BA, Swarthmore College AUSTIN SPEIER CHIEF STRATEGY OFFICER Former Vice President, Emerging Technologies at Precision for Medicine; Former Chief Strategy Officer at American Genomics; Former Managing Director, Innovative Healthcare Products at Becker & Associates Consulting; Former Research Fellow at Brigham and Women’s Hospital; BA, cum laude, Neuroscience, Harvard University
  • 49. Total funding to date: $21 million $21 MILLION RAISED TO ADVANCE PROPRIETARY PLATFORM AND PIPELINE OF PRESCRIPTION DTx 2017 2018 After signing a groundbreaking strategic partnership for Clickotine in 2015, Magellan led a round of investment in 2017 to expand its collaboration with Click and to pursue FDA clearance for therapeutic apps. Prior to this, the company was funded by private investors. In 2018, Sanofi Ventures led a round of financing in Click to continue advancing our proprietary platform and pipeline of prescription digital therapeutics to treat a wide range of diseases. Sanofi Ventures is the corporate venture capital arm of Sanofi. Hikma Ventures participated in a financing round into Click, led by Sanofi Ventures in 2018. Hikma Ventures is the corporate venture capital arm of Hikma Pharmaceuticals.
  • 50. TWO-PRONGED PRODUCT DEVELOPMENT STRATEGY 50 Confidential – Not for Distribution CLICK NEUROBEHAVIORAL INTERVENTION PLATFORM FDA (Treatment claims) Major Depressive Disorder Insomnia Smoking Cessation OTC (No treatment claims) Acute Coronary Syndrome Overactive Bladder Migraine Chronic Pain CLICKOMETRICS®
  • 51. DEMONSTRATED SUCCESS DISCOVERING, VALIDATING, COMMERCIALIZING AND SCALING A DTx 51 Magellan provides care to 1 in 10 Americans as the largest behavioral health insurer in the U.S.: • Commercial, behavioral, specialty and government: 40 million lives • Pharmacy Benefit Manager: 53 health plans including Medicaid PBA for 27 US states • Click’s partnership with Magellan provides access to over 50 million covered lives Click working with Magellan to commercialize digital therapeutics: • Click products added to RFPs as part of disease management, EAP, and behavioral health programs • Magellan to drive and enable coverage, reimbursement and demand for Click’s prescription digital therapeutics through medical policy and formulary tiering • Full integration with Magellan’s medical, pharmacy benefit, and behavioral health solutions MAGELLAN HEALTH AS PARTNER Clickotine is in agreements to enter 181 employers and 14 payers with 11.1 million lives and counting. It is also included in 3 government RFPs covering 18 million beneficiaries A Digital Therapeutics™ Program for Smoking Cessation
  • 52. LAYING GROUNDWORK FOR WIDESPREAD COVERAGE AND ORGANIZING FOR IMMEDIATELY ENABLED PATIENT ACCESS 52 Click’s partnership with Magellan enables widespread reimbursement and system integrations across the nation: • Digital nature allows for direct integration with Electronic Medical Records • Physician sees specific therapeutic choices and coverage for each patient • Physician prescribes exactly the same as they would a drug Performance and efficacy can improve as more patients are treated with CT- 152 and data are used to optimize treatment
  • 54. FIRST FDA PRODUCT: MAJOR DEPRESSIVE DISORDER 54 EFMT targets the imbalance between hyperactive (ORANGE) emotion processing regions and hypoactive (GREEN) prefrontal regions underlying the cognitive control impairments observed in MDD patients Emotional Faces Memory Task (EFMT) helps patients with Major Depressive Disorder (MDD) enhance cognitive control over emotion by practicing emotion recognition and working memory together U.S. Patent No. 10,123,737
  • 55. COMPLETED 2 RCTs, AND 1 fMRI STUDY 55 Intervention Effective and functional connectivity between key neural nodes investigated pre-post EFMT training c) Expectation of benefit and ability to blind: participants in TAU and no contact controls would know immediately which trial arm they were in. With SMT, patients were made aware they were participating in a “study of 2 cognitive training exercises, and will be assigned to one or the other to complete over 6 weeks.” Thus, both conditions could plausibly deliver benefit, clinical equipoise would apply, and patients and investigators could remain blinded to hypothesis. Considered three control conditions for the studies: no-contact, treatment as usual (TAU), and Shapes Memory Task (SMT), an interactive task matched to EFMT with non-emotional stimuli, and concluded that SMT is the best control for EFMT for the following reasons: a) Time and effort: participants completed the same number of sessions in both conditions at the time selected by the participant. In TAU, time spent in therapy or using medication would be too variable to offer an accurate control. b) Clinician/staff attention: participants in both trial arms will received the same engagement with a clinician or staff member whereas patients in a no-contact or TAU control would receive variable attention from clinician and staff members. Sham Control fMRI Study vs. Acquisition Preprocessing Parcellation Regional Graph- Theory Metrics Functional Connectivity Matrix Time-series Extraction
  • 56. EFMT demonstrated a significant reduction of HAM-D scores from baseline to outcome (from 19.25 to 10.60) that was greater than CT (from 19.48 to 14.71); F(1,44)= 4.698, p= .036. Error bars indicate ± 1 standard error. * p < .05 between groups. Pilot study Completed Clinical Trial Publication: Iacoviello et al. (2018), Nature Digital Medicine Completed fMRI study 11 EFMT vs. 10 Control 1 28 EFMT vs. 23 Control 2 3 Publication: Iacoviello et al. (2014), Depression & Anxiety EFMT reduces MDD symptoms by modulating activity in key neural nodes POSITIVE RESULTS FROM THESE TRIALS AND NEXT STEPS ● ~45% reduction HAM-D vs ~ 25% in control group, in two peer-reviewed randomized, controlled trials ● Objective fMRI data support our hypothesis that EFMT has a neuroplastic effect EFMT demonstrated a significant reduction of HAM-D scores from baseline to outcome (from 21.55 to 10.91) that was greater than CT (from 19.80 to 14.10); F(1,19)= 5.605, p= .029. Error bars indicate ± 1 standard error. * p < .05 between groups. Objective fMRI data support our hypothesis that EFMT has a neuroplastic effect. EFMT was observed to modulate amygdala-DLPFC connectivity in two brain imaging modalities, with medium-sized effects (d > .3). The Mount Sinai brain imaging group, led by Dr. Sophia Frangou, is so encouraged by these results that they are submitting an NIH R01 grant to conduct a larger study to confirm these hypotheses. Publication: Abstract presented at Society of Biological Psychiatry convention (May 2018); Manuscript in preparation Download the CT-152 fact sheet Preparing a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial NEXT RESEARCH STEP: Effective and functional connectivity between key neural nodes investigated pre-post EFMT training Acquisition Preprocessing Parcellation Regional Graph- Theory Metrics Functional Connectivity Matrix Time-series Extraction 56
  • 57. + A GROUNDBREAKING COLLABORATION FOR PRESCRIPTION DTx FOR MDD 57 In January 2019, Click and Otsuka announced a groundbreaking collaboration for the development and commercialization of Click’s prescription digital therapeutic treatment for Major Depressive Disorder. This collaboration symbolizes the growing recognition of DTx as a new category of medicine. 1. World Health Organization (2018) DTx INDUSTRY MILESTONE In working to deliver clinically-validated digital interventions, we have the potential to bring safe, effective and convenient treatment options to a broader population of patients with depression. 300 million people affected worldwide1 Leading cause of disability worldwide < 50% receive treatment ADDRESSING GREAT UNMET MEDICAL NEED AND IMPROVING OUTCOMES 1 1 CO-DEVELOPMENT AND COMMERCIALIZATION $10MM Upfront and Regulatory Milestones Development Funding Commercial Milestone Payments Royalties $20MM $270MM Tiered, double-digit
  • 58. A GROUNDBREAKING PARTNERSHIP FOR PRESCRIPTION DTx FOR MDD 58 CLICK NEUROBEHAVIORAL INTERVENTION (CNI) PLATFORM ARCHITECTURE CLICK NEUROBEHAVIORAL INTERVENTION PLATFORM CLICKOMETRICS OPIATES / OPIOIDS Psychiatry SLEEP APNEA CORONARY ARTERY DISEASE Social Engagement Mindfulness Training Cognitive Restructuring Stimulus Control Acceptance and Commitment Therapy Medication Access and Adherence Personalized Messaging Cognitive-Emotional Training Outpatient Navigator Physical Activity Risk Factor Optimization Sleep Restriction Relaxation Techniques Environment Management Cognitive Behavioral Therapy Interpersonal Therapy Adaptive Engagement Messaging Contextual Momentary Assessments Controlled Breathing Financial Incentives Adaptive Program Engine RESTORE™ Exposure Therapy In-App Digital Communities Digital Diversions Telephonic Coaching Scheduling Engine Financial Institution Interfacing Contextual Momentary Interventions Multimedia Journaling Device Pairing and Interfacing Progress & Performance Feedback Reward & Badge Engine Content Library Health Recovered EngineAdaptive Mission System Morisky Medication Adherence Scale (MMAS-4) Patient Health Questionnaire (PHQ-9) Financial Savings Engine Medication Management System Neurobehavioral Challenge Engine ✓ Secure ✓ Compliant ✓ Scalable ✓ Clinically Validated Diet Optimization Just-in-Time InterventionsPersonalized Plan Formation Data-Driven Peer Group Formation Scheduling Engine Addiction TOBACCO ALCOHOL MAJOR DEPRESSIVE DISORDER GENERALIZE D ANXIETY DISORDER Sleep Cardio Chronic Pain Eating GI INSOMNIA Urology ACUTE CORONARY SYNDROME HEART FAILURE CHRONIC BACK PAIN CANCER PAIN RHEUMATOID ARTHRITIS MIGRAINE BINGE EATING DISORDE R OBESITY DIABETES OVERACTIV E BLADDER INTERSTITIA L CYSTITIS IRRITABLE BOWEL SYNDROME CROHN’S DISEASE APPLICATIONSDIGITAL MOA LIBRARY Provider Portal Caregiver Dashboard Medication Access & Adherence DashboardReal-Time Analytics Dashboard Fagerstrom Test Contingency Management Psychotherapeutic Messaging SCHIZOPHRENIA
  • 60. 60 Medication Adherence Digital Diversions Controlled Breathing Financial Incentives Personalized Messaging Social Engagement Professional Caregiving Partner Dashboard Providing a web-based portal for partners enables observation of population trends, as well as detailed user-by-user data streams Clickotine® is a clinically-validated digital program for smoking cessationA Digital Therapeutics™ Program for Smoking Cessation Individualized reminder system to optimize use of effective treatment Real-life support from friends, family and community. Quitting with a small quit team is proven to be a powerful tool for engagement Out-of-app incentives such as refunds & reimbursements provided by partners Adaptive text messages tailored to user profile, and provides contextualized, personalized support and guidance Controlled, mindfulbreathing experiences coupled with multi-sensory stimuli Timed and targeted strategies to cope with cravings, withdrawal symptoms & lapses Real-time access to qualified professional caregivers, quit coaches & counselors Partnered with Download the Clickotine fact sheet
  • 61. PROVEN SUPERIORITY OF PLATFORM FOR ENGAGEMENT AND OUTCOMES 61 AVERAGE PARTICIPANT PROFILE A Digital Therapeutics™ Program for Smoking Cessation In September 2016, Clickotine completed a 416- participant 8-week clinical trial in smoking cessation Participants opened the Clickotine application 100.6 times over an 8- week period, which is 3x to 6x better than the next best smoking cessation apps1 ASSOCIATION 45.2% of participants (n=188) had stopped smoking at the end of the study1 ; at the 6-month mark, 35.3% (n=147) of the 416 participants had achieved 30-day sustained abstinence3 Participants who remained engaged at the end of the 8-week study were 2.4 times more likely to achieve 30-day sustained abstinence than those who did not (p<0.0001)1 EFFICACY ENGAGEMENT 1. Iacoviello et al. (2017), JMIR mHealth and uHealth 2. Fagerstrom Test for Nicotine Dependence and scoring 3. Iacoviello et al. (2017), Society for Reseach on Nicotine and Tobacco Mean Age Years of Smoking Cigarettes Per Day Nicotine Dependence Score / Level 36 18.1 16. 7 6.1 / High 111 2
  • 62. 5. Zyban product label 6. Early and Recent NRT trials 7. Zbikowski et al., JMIR 8. QuitLogix reported 6 month outcomes 6-MONTH OUTCOMES COMPARED TO TOP SMOKING CESSATION OFFERINGS 62 1. Iacoviello et al., Society for Research on Nicotine and Tobacco 2. Nides et al., Archives of Internal Medicine 3. Hollis et al., Tobacco Control 4. Chantix product label 30-Day Abstinence at 6-Months Safety Concerns & Barriers to Use Nicotine Replacement Therapy3 Nicotine Patch + brief counseling 6 Advantages Over Other Cessation Strategies No treatment-related adverse event signal identified Accessible to any smoker with a smart device 4 Chantix + Counseling included 7 live counseling sessions 2 Bupropion + Counseling included 7 live counseling sessions 2 7Optum Quit for Life ® Telephone & web-based program 8 Coaching, website & messaging National Jewish Health’s QuitLogix Clickotine1 Common side effect: nausea, insomnia, headache. Indicated for use concurrently with counseling. Can be costly and requires prescription. 5 Heart palpitations / chest pains, nausea / vomiting, mouth / gastrointestinal problems, and insomnia . Replacing nicotine maintains the addiction. Can be costly. Common side effect: nausea, insomnia, headache. Indicated for use concurrently with counseling. Can be costly and requires prescription. Time intensive, costly and not accessible for most smokers. Time intensive, costly and not accessible for most smokers. 35.3% 15% 16.8% 28.8% 19.8% 20.5% 0 10 20 30 40 50
  • 63. INCREASED ACCESS / UTILIZATION OF AND ENHANCED ADHERENCE TO PHARMACOLOGIC QUIT AIDS 63 The distribution of the MMAS-4 scores at baseline: The distribution of the MMAS-4 scores at outcome: • Distributions of scores on the Morisky Medication Adherence Scale, 4-item version (MMAS-4). A score of 0 indicates “High Adherence,” 1-2 = “Medium Adherence,” and 3-4 = “Low Adherence.” • Mean MMAS-4 score at baseline was 2.35 (SD= 1.43) compared to 1.28 (SD= 1.31) at outcome (t(87)= 3.30, p= 0.001), indicating an increase in adherence to quit aids during the trial. • The distribution of MMAS-4 scores is significantly different between baseline and outcome (χ2(4)= 10.56, p= 0.032); there is a significant shift toward increased adherence during the Clickotine® trial. 0 2 4 6 8 0 High…1 Medium…2 Medium…3 Low… 4 Low… Count 0 10 20 30 0 High Adherence 2 Medium Adherence 4 Low Adherence Count Iacoviello et al. (2017), JMIR mHealth and uHealth Upon enrollment: 31 of 416 participants were using a pharmacologic smoking cessation aid. By study outcome: that number rose to 68 of 416. That is a 119% increase in pharmacologic cessation aid use during the study. PHARMACOLOGIC ADHERENCE PHARMACOLOGIC ACCESS AND UTILIZATION Baseline Outcome Change Chantix 3 10 +233% Zyban/Wellbutrin 3 7 +133% Any Meds 6 17 +183% Gum 9 28 +211% Inhaler 1 3 +200% Lozenge 3 9 +200% Patch 18 24 +33% Any NRT 28 54 +93% ANY QUIT AID 31 68 +119%
  • 65. A GROUNDBREAKING PARTNERSHIP FOR PRESCRIPTION DTx FOR MDDIN-HOUSE CLICK DISCOVERY LAB The Click Discovery Lab generates the insights and innovations that drive our products: from digitizing well-validated neurobehavioral MOAs to developing proprietary digital interventions, the Discovery Lab is where we invent the technology behind our digital therapeutics. CONCEPT GENERATION CONTENT DEVELOPMENT VALIDATION Click Scientists and KOLs conceptualize novel product features and digital MOAs Scientists and clinicians develop therapeutic content; Lab developers design testable prototypes Lab researchers execute small-scale usability and proof-of-concept studies ENGINEERING CLICK DIGITAL MOA LIBRARY CNI PLATFORM DISCOVERY PATIENT NEED PRODUCT APP-SPECIFIC FEATURES 65 INTELLECTUAL PROPERTY FILINGS
  • 66. A GROUNDBREAKING PARTNERSHIP FOR PRESCRIPTION DTx FOR MDDCLICK DIFFERENTIATORS Proprietary Click Engagement Platform Each Click app leverages multiple clinically validated MOAs from Click’s Digital MOA Library to maximize the chance of patient success 66 Multi-Modal Therapeutics In-House Tech Team In-House Discovery Lab We’ve Scaled DTx already Biotech Model and Capabilities Mobile-First Design No HCP Behavioral Change Payer Relationships All Click apps are built on our proprietary neurobehavioral platform that uses predictive, personalized approaches to drive engagement In-house team of PhD scientists conceptualizes, develops and tests novel product features, digital MOAs and custom content Tech team is fully in-house and co- located with our clinical, product and discovery groups to ensure constant cross-functional collaboration Magellan Health is both an investor and long-term partner committed to helping build the infrastructure for prescribing and reimbursing DTx Apps are designed by mobile experts with the latest UX and human factors considerations to drive sustained use Click takes a minimal disruption approach to product design, for all stakeholders. DTx prescribing for HCPs will be almost identical to for a drug Click has unique experience scaling DTx programs, from early discover yo active commercialization. Clickotine, our first commercial product, is in agreements to enter 167 employer and 14 payer offerings covering over 13 million lives SaMD-focused biotech company with clinical, regulatory, QMS (ISO, IEC< FDA CFR, etc) and commercial expertise in bringing new technology and medicines to market
  • 67. • 1 US issued patent • 4 US patents pending • 4 International patents pending • PATENT FILINGS INCLUDE: • Systems and Methods for Treating a Psychiatric Disorder. U.S. Patent Application No. 15/513490 (issued as U.S. Patent No. 10,123,737) • Claims directed to: Systems and computer products for conducting a therapy session by sequentially displaying subsets of images capable of inducing human amygdala activation and modifying a number of images between two images showing the same emotion based on responses to queries • Pending applications in US, AU, CA, EP and JP • Systems and Methods for Improving Efficiency of a Remote Computing Device. U.S. Patent Application No. 15/348777 • Claims directed to: Systems and methods for determining a time at which to send a subsequent message (just in time intervention) to a patient’s monitoring device based on a patient’s response to a previous message • Therapeutic System and Remote Patient Monitoring Device. U.S. Patent Application No. 15/563477 • Claims directed to: A medical treatment system and method configured to i) generate a treatment plan corresponding to the patient, the treatment plan including a plurality of events (missions/notifications) generated based on the patient profile and ii) modify the treatment plan in response to previous feedback to the events received from the patient UNIQUE & ROBUST IP STRATEGY & PORTFOLIO 67 CLICKARETTES® EMOTIONAL FACES MEMORY TASK CLICKOTINE®CLICKOMETRICS® CLICKMENTIATM CLICK THERAPEUTICS®
  • 68. DISCLOSURE NOTICE 68 This presentation contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not statements of historical facts may be deemed forward- looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “to,” “plan,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “would,” “estimate,” or “continue,” or the negative or other variations thereof or comparable terminology are intended to identify forward looking statements. Viewers are cautioned that all forward-looking statements involve risk and uncertainties which may cause results to differ materially from those set forth in the statements. Such risks and uncertainties include, but are not limited to the following: the success of research and development activities; competitive developments; the ability to obtain clinical trial insurance on reasonable terms, conditions and premiums; the Company’s ability to acquire and protect patents and other intellectual property both domestically and internationally; the absence of certainty regarding the requirement and receipt of required regulatory approval or the timing or terms of such approvals; any changes in business, political and economic conditions; business interruption due to hurricanes or other events outside of the Company’s control. Investors are cautioned not to place reliance on these forward-looking statements, which are valid only as of the date they were made. The Company undertakes no obligation to update or revise any forward-looking statements to reflect new information or the occurrence of unanticipated events or otherwise, except as expressly required by law.
  • 69. 69 NEUROELECTRICS personalized brain therapy Sharp Brains May 7th, 2019 ANA MAIQUES CEO V 2 0 1 9 0 4 0 4 - B I O E M E D
  • 70. One in five people worldwide will suffer from a brain disorder EPILEPSY 50M P A T I E N T S ALZHEIMER’S 90M P A T I E N T S DEPRESSION 240M P A T I E N T S PARKINSON’S 5M P A T I E N T S ADHD 120M P A T I E N T S
  • 71. Brain physiological data Behavioral data 01 Noninvasive, Portable Neuromodulation personalized treatment 02 Artificial Intelligence Machine Learning Biophysics Models 03 Neuroelectrics’ platform can treat brain diseases with a novel personalized approach
  • 72. Lead Indication: Epilepsy One in three of patients Do NOT have their seizures controlled with medication EPILEPSY 50M P A T I E N T S • One in three patients do NOT that have their seizures controlled by medication • Many who do have poor side effect profiles • Alternative therapies are surgery for resection, surgery for disconnection, or an expensive active implantable medical device – all alternatives require brain surgery • AND one in five patients are either not candidates for surgery, or have had surgery but do not see improvement • ONE IN FIVE OF ALL EPILEPSY PATIENTS – OVER 1M in the US an EU alone – are candidates for our solution
  • 73. 73 Some facts about epilepsy: from symptoms to targeting Large number of patients with an unmeet need
  • 74. Open Label Through July 2018 Pivotal Study 2019- approval 2021 20 patients ~110 patients Single site (BCH, referrals from BIDMC) Est. five sites, including BCH and BIDMC Co-Principal Investigator Mouhsin Shafi, MD, PhD Beth Israel Deaconess Medical Center Assistant Professor of Neurology, Harvard Medical School Co-Principal Investigator Alexander Rotenberg, MD, PhD Boston Children's Hospital Associate Professor of Neurology, Harvard Medical School approval expected by 2021 Neuroelectrics FDA Registration Study Open label study portion completed: • Uses our existing Starstim™ product • Inclusion criteria: refractory to at least two drugs, defined seizure foci • Patients continue on all prescribed medications • Treatment: 20 minute stimulation session, 10X over two weeks • Personalized set-up using Neuroelectrics’ proprietary Stimweaver™ • Eight weeks follow-up • Primary endpoint: seizure reduction from baseline, measured over two months
  • 75. Responder Rates and Mean Seizure Reduction 75
  • 76. Seizure Reduction at Eight Weeks Post Treatment 76
  • 77. “We and our patients are delighted to have a noninvasive and non-pharmacologic option for those whose seizures have not been controlled by drugs or by surgery… “Our patients and families have seen clear improvements in well-being and quality of life.” - Alexander Rotenberg, MD, PhD Co-Principal Investigator Alexander Rotenberg, MD, PhD Boston Children's Hospital Associate Professor of Neurology, Harvard Medical School
  • 79. Dr. Alvaro-Pascual Leone Chairman of Scientific Advisory Board Head of Translational Medicine Harvard Medical School Leadership Team Alan Walts Acting Executive Chairman, Former Head Genzyme Ventures, Advent Venture Partners Ana Maiques CEO and Co-Founder Henri Termeer Fellow Dr. Giuio Ruffini President and CTO, Co-Founder Yolanda Casas Managing Director Paul Pyzowski Corporate Development
  • 80. D r . A D A M G A Z Z A L E Y Integration with video games as a therapy for ADHD D r . A L V A R O P A S C U A L - L E O N E Treating patients with neurodegenerative diseases D r . E M E R Y B R O W N Change the way anesthesia is done in the OR D r . K E L V I N L I M Helping PTSD veteran patients D r . R O I C O H E N - K A D O S H Helping kids with learning disabilities D r . P A B L O C E L N I K Stroke recovery D r . N I E L S B I R B A U M E R Developing new brain computer interfaces for locked in and vegetative patients KOLs and Scientific Advisors
  • 81. Study Sponsor Indication Discover y Pilot Study FDA Study FDA Approval Academic Partner Patient Impact Estimated Annual Revenue Epilepsy 50M $$480M Dementia Symptomati 300M $1B+ Alzheimer’s Disease- Modifying 90M $1B+ Parkinson’s (Diagnostic) 5M $200M Depression 240M $600M ADHD Various 120M TBD Neuroelectrics’ Platform Verticals 81
  • 82. 82 Summary We have an unusually robust and fully developed technology platform already deployed and validated in the market We already on a path for FDA clinical approval in 2021 for Epilepsy. More indications to come. These technologies are going to change the way brain diseases are dealt with, affordable, scalable and personalized treatment
  • 83. 83 Thank you for your attention! ANA MAIQUES Co-Founder and CEO ana.maiques@neuroelectrics.com PAUL PYZOWSKI Corporate Development paul.pyzowski@neuroelectrics.com
  • 85. Access recorded talks, Q&A, and more at: SharpBrains.com