Digital Mental Health: the Hurt, the Hype, the Hope + Brainnovations Session 1

3. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. Digital Mental Health: the Hurt, the Hype, the Hope (with an introductory editorial on the changing ecosystem) Tom Insel,MD Co-founder and President, Mindstrong Health December 6, 2017

4. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. Political Economic Scientific Cultural Populism/Nationali sm Conflict/Chaos Income Disparities Bull Market Health Care Reform Tax Reform Mergers and Acquisition Opioid Epidemic Social Media Disintermediaries Precision Medicine BRAIN Initiatives Big Data/AI Open Science December, 2017

5. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. The Changing Ecosystem of Biomedical Research 2000 - 2010 Public Sector NIH, NSF, DARPA Pharma Biotech/Med Devices Other (Philanthropy) Public Sector NIH, NSF, DARPA Pharma Biotech Other Tech 2015 - 2020

6. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. The Changing Ecosystem of Biomedical Research Start-ups: $15B invested in Health Tech since 2012 > 1,000 new companies (Rock Health, 2017) Insel, Nature, 2017 Tech Giants with health/biomedical initiatives: Alibaba, Alphabet, Apple, Facebook, Fitbit, GE, IBM, Intel, Microsoft Philanthropy spawned by tech or AI: Allen Brain Institute Chan Zuckerberg Initiative Flatiron Institute/SFARI Gates Foundation (+ personal funds)

7. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. The Changing Ecosystem of Health Tech AI comes of age Google and Baidu become “AI companies” Diagnostics incorporate “neural nets” (Gulshan et al, JAMA, 2016) Treatments via chatbot (Lark, Woebot, Triggr, Koko, et al) China will be the innovation hub Alibaba purchases 50 hospitals Tencent lead investor in both US and China health tech iCarbonX – remains in stealth FDA begins to adapt; CMS fails to adopt Pre-cert pilot (9/17) Approval of Proteus and Pear CMS rejects MDPP (11/17) but remote monitoring on deck

10. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. U.S. Burden of Diseases: 291 diseases and injuries Leading Categories of DALYs 2010 US Burden of Disease Collaborators, JAMA, 2013. DALY = disability adjusted life year

12. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. U.S. suicide rate unchanged in 2 decades Homicides have dropped from 9.8/100,000 in 1992 to 4.8/100,000 in 2010 (<15,000/yr) RatePer100,000 SOURCES: Bureau of Justice Statistics (homicide); Centers for Disease Control (suicide) 2014 Suicides: 42,773 2014 Homicides: 14,249

16. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. Why have we failed to bend the curve? Lack of measurement – We can’t manage what we can’t measure Peter Drucker • 60% not receiving careLack of Rx Delay Quality • DUP 74 weeks • Fragmented, episodic, reactive More counterfactuals: Treatments work Clinicians help Individuals recover

19. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. Digital Phenotyping Mobile Interventions Care Management CBT, DBT, IPT Coaching Peer Support Crisis Intervention Sensors HCI Voice Socialit y Coordination Data capture Quality metrics Feedback Learning Engine The Digital Mental Health Landscape

21. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. MEASURING MOOD, COGNITION, AND BEHAVIOR Mood 24/7 Measure 14 day Average Negative Peak End Peak-End Mood Retrospective PHQ 2wk Depression Score 0.48 0.57 0.56 0.61 Peak – End Rule Kahneman and Tversky Srijan Sen unpublished

22. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. WHAT WE DO TODAY • Subjective • Episodic • Clinic-based • Reactive MEASURING MOOD, COGNITION, AND BEHAVIOR WHAT WE NEED • Objective • Continuous • Ubiquitous • Proactive

23. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. 23 Smartphones A medical tool for global health – improving diagnosis and connecting care Over 3 billion globally and 6 billion by 2020 Over 70 daily checks Over 2600 daily “touches” More ubiquitous than clean water, indoor plumbing, and stable electricity Smartphone subscriptions per region 2014-2020

25. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. 24 SENSORS Activity Location Sociality VOICE/SPEECH Prosody Sentiment Coherence HCI - KEYBOARD Reaction Time Attention Memory Executive Function DIGITAL PHENOTYPING A New Kind of Biomarker Digital PhenotypeRaw Features Digital Biomarkers MACHINE LEARNING Pattern Identification Feature Extraction

26. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. 26 HCI STRATEGY Digital Phenotyping with Machine Learning ‣Begin with 45 keyboard and scroll patterns (e.g., latency between space and character, scrolling patterns) ‣Create a time-series of performance measures from each of the 45 patterns ‣Apply 23 signal processing transforms to each time-series to derive 1,035 potential digital biomarkers ‣Test highest performing biomarkers with 2-fold cross validation and with replication studies to avoid overfitting errors ‣Validate in clinical trials along three dimensions: (1) psychometric properties; (2) neural correlates; (3) clinical constructs

28. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. 28 THE BEST DIGITAL BIOMARKERS CREATE SIGNATURES THAT REPRODUCE GOLD STANDARD TESTS COGNITIVE METRIC MEAN (SD) RANGE R(predicted) WORKING MEMORY Digits Forward 10.9 (2.9) 7 — 15 0.82* Digits Backward 8.3 (2.9) 4 — 14 0.84* EXECUTIVE FUNCTION Trails A 22.6 (7.6) 12 — 39 0.81* Trails B 57.4 (14.5) 42 — 88 0.80* LANGUAGE Animal Fluency 21.9 (3.5) 15 — 29 0.78* FAS Phonemic Fluency 41 (7.2) 27 — 52 0.60* DEXTERITY Grooved Pegboard Test (dominant hand) 61.2 (7.3) 46 — 75 0.85* EPISODIC MEMORY California Verbal Learning Test (delayed free recall) 13.6 (2.1) 9 — 16 0.85* WMS-III Logical Memory (delayed free recall) 28 (5.3) 19 — 40 0.50** Brief Visuospatial Memory Test (delayed free recall) 10.0 (2.0) 5 — 12 0.71* *p < 10-5 **p<0.01 ‣Highest correlating biomarkers are selected for each cognitive metric ‣Cross-validated kernel PCA ensemble is used to make predictions ‣Predictions are as good as the test-retest variability of the tests themselves Will digital biomarkers become a new clinical ground truth for cognition?

29. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. WHAT WE DO TODAY • Subjective • Episodic • Clinic-based • Reactive MEASURING MOOD, COGNITION, AND BEHAVIOR WHAT WE NEED ✓ Objective ✓ Continuous ✓ Ubiquitous ✓ Proactive Passive

31. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. Digital Phenotyping Mobile Interventions Care Management CBT, DBT, IPT Coaching Peer Support Crisis Intervention Sensors HCI Voice Socialit y Coordination Data capture Quality metrics Feedback Learning Engine The Digital Mental Health Landscape

32. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. >53M messages since 2013, >2M/month 1/3 of messages -- depression and suicide 19% from 10% lowest income zipcodes 9% Native American; 14% Hispanic > 3K active rescues Text 741741 Immediate access Support for free 24/7

33. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. 7 Cups – an online global peer support system 1.5M monthly users -- 220K listeners 189 countries providing support in 140 languages. 7 Cups approach: Anonymous – no stigma Community-focused On demand 24/7 Convenience – smartphone/laptop Task shifting/stepped care Data driven

34. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. The Efferent Limb – From Decision Support to Optimal Care Consumer Self Care Crisis Intervention Psychotherapy Coaching Peer Support Education Provider Collaborative Care Digital Alerts Dashboards Digital triage Digital Assistants Enterprise Integrated Care Coordination EHRs Primary-Specialty Quality Metrics Digital Interventions Technologies: AI, Apps, Conversational Bots, Virtual Reality Value: On demand, Scalable, Data-driven, Efficient

35. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. Technologies to Reduce Suicide Predictive signals HCI data Speech/text signals Online classifiers Crisis intervention Upskilling tools for volunteers On demand support Social networks Postvention Care management Peer support AI nurse Goal: 20% reduction in 5 years.

36. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. Technologies to Reduce Relapse Predictive signals Digital phenotype Adherence tools ”Smoke alarms” Connected Care Dashboards AI nurse Integrated care Building community Online peer support Online education Goal: 50% reduction in 5 years.

37. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. Technologies to Prevent Psychosis Predictive signals Digital phenotyping Semantic signals Sleep monitoring Cognitive Training Cognitive games Supportive employ/educ Coordinated spec care Psychoeducation Online education Family-to-family Goal: 20% reduction in 5 years.

38. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. Value Trust Transparency Agency Responsibility Empowering Patients and Families With Information The Digital Mental Health Challenge Efficacy Engagement Efficiency

39. ©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. “We always overestimate the change that will occur in the next two years and underestimate the change that will occur in the next ten.” --Bill Gates Jr. Finally

43. Top Brainnovations to measure Brain Health & Performance Savonix — pitch by Greg Wong, VP Product Management HealthTech Connex — pitch by Dr. Ryan D’Arcy, President & Chief Scientific Officer NeuraMetrix — pitch by Jan Samzelius, Co-Founder & CEO

44. Judges Dr. Adam Haim, Chief of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs at the National Institute of Mental Health (NIMH) Dr. Edward Kliphuis, Investment Director at Merck Ventures Dr. David Barash, Chief Medical Officer and ED of Global Health at GE Foundation Dr. Karen Postal, President of the American Academy of Clinical Neuropsychology (AACN)

45. Digital Cognitive Assessment Platform

46. PROBLEM 1,002 Neuropsychologists are licensed to administer cognitive testing 43K+ patients per qualified clinician That’s 43.4 million people in the U.S. have been diagnosed with cognitive disorders

47. SAVONIX as a SOLUTION Designed for Research and Clinical Applications Range of cognition Virtual clinician Test behavior flags Normed percentile reports Mobile platform Psychomotor control sensitive Real time compliance monitoring HIPAA, Part 11 compliant

48. Daily Digit Span The Virtual Clinician ensures consistent, valid administration through written and spoken instructions ABOUT SAVONIX

49. Practice Mode ensures standard clinical administration with adaptive feedback ABOUT SAVONIX

50. Detailed test data delivered to the Savonix Dashboard for clinical review ABOUT SAVONIX

51. CUSTOM ANALYTICS SCALABLE & FLEXIBLE PERSONALIZED MEDICINE OPTIMIZED CLINICAL TRIAL DESIGN ENABLES DATA- DRIVEN R&D SaaS Licenses Generate immediate revenue and enable data collection for Savonix Cognitive Database HEALTHCARE SYSTEMS INSURANCE COMPANIES ACTUARIAL COMPANIES PHARMA & BIOTECH SAVONIX COGNITIVE DATABASE PATIENT DATA COLLECTION DaaS Licenses Deliver Value to 4 customer segments • $10.00-$40.00/test range • Enterprise business buys blocks of test licenses • Recurring revenue HOW SAVONIX WORKS

52. CUSTOM ANALYTICS SCALABLE & FLEXIBLE PERSONALIZED MEDICINE OPTIMIZED CLINICAL TRIAL DESIGN ENABLES DATA- DRIVEN R&D SaaS Licenses Generate immediate revenue and enable data collection for Savonix Cognitive Database HEALTHCARE SYSTEMS INSURANCE COMPANIES ACTUARIAL COMPANIES PHARMA & BIOTECH SAVONIX COGNITIVE DATABASE PATIENT DATA COLLECTION DaaS Licenses Deliver Value to 4 customer segments • $10.00-$40.00/test range • Enterprise business buys blocks of test licenses • Recurring revenue HOW SAVONIX WORKS

53. ADRESSABLE MARKET $15.2B TAM $23.4B MARKET OPPORTUNITY

54. MYLEA CHARVAT, PHD CEO & Founder MANAGEMENT TEAM DAN KOGAN VP Engineering DAVID COOPER COO GREG WONG VP Product

55. BRAIN HEALTH = OVERALL HEALTH Monitor cognition relative to baseline assessment Detect cognitive impairment early Define optimal treatment & management plan Assess cognition at multiple time points HEALTHIER PEOPLE LIVE LONGER LIVES

56. Thank You

57. ENDING NEUROLOGICAL ILLNESS Combining technology and clinical innovation healthtechconnex.com l @brainvitalsigns

58. WHAT ARE YOUR BRAIN VITAL SIGNS? 120/80 60 bpm ? 45 mL*kg /min

59. Brain Vital Signs Framework (2012)* + Portable EEG technology increasingly affordable #1 Most Cited Article in Frontiers of Neuroscience More than 200 Published Works; 44 Trademarks, Patents and Technical Reports 20+ years of clinical R&D 70+ years of research evidence

60. NeuroCatch Platform™ ✓ ✓ ✓Rapid Automated User-friendly

61. Tones Words n = 60 5 mins 5 secs Auditory sensation (N100): 1-5 Basic attention (P300): 1-5 Cognitive processing (N400): 1-5 Includes N100 + P300 + N400✓ Objective and Physiological

62. 0.00 20.00 40.00 60.00 80.00 100.00 Auditory Sensati… Auditory Sensati… Basic Attenti… Basic Attenti… Cognitive Processi… Cognitive Processi… Baseline 0.00 20.00 40.00 60.00 80.00 100.00 Auditory Sensati… Auditory Sensati… Basic Attenti… Basic Attenti… Cognitive Processi… Cognitive Processi… Concussio n 0.00 20.00 40.00 60.00 80.00 100.00 Auditory Sensati… Auditory Sensati… Basic Attenti… Basic Attenti… Cognitive Processi… Cognitive Processi… Return to Play Concussion Profile using Brain Vital Signs™ and NeuroRadar™

63. IMPACT HEALTH INSTITUTIONS Accuracy & Efficiency Risk Mitigation SOCIETY Reduced Tax Burden Global Health INDIVIDUALS Evaluation Prevention 1 in 3 people will experience a neurological condition in their lifetime

64. Upfront Charge: NeuroCatch Platform™ Recurring Revenue: Reports Generated Pay-Per-Scan Subscription Model Lease Purchase Future: Big Data Analytics SALES PROJECTION Baseline Evaluation Prognostics $750M BVS 10% $75M by 2020 Total addressable market: Comparison (US alone)

65. GLOBAL MARKET Neuro Healthcare Market: Over $30 billion within 5 years (Grand View Research: Neuroscience Market Analysis 2015)

66. WE CAN HAVE A VITAL SIGN FOR BRAIN FUNCTION healthtechconnex.com l @brainvitalsigns TRANSLATING ADVANCED NEUROSCIENCE R&D INTO PRACTICAL SOLUTIONS

67. ConfidentialDecember 6, 2017 SharpBrains Virtual Summit Jan Samzelius, CEO

68. 68 • Rid the world of passwords Novelty

69. 69 • Rid the world of passwords • Discovered that typing cadence is the strongest habit Novelty

70. 70 • Rid the world of passwords • Discovered that typing cadence is the strongest habit • “I bet you that can also be used to detect Alzheimer’s” Novelty

71. 71 • Rid the world of passwords • Discovered that typing cadence is the strongest habit • “I bet you that can also be used to detect Alzheimer’s” • “You realize we have been looking for this for 30 years.” - Bob Mahley, Founder, Gladstone Novelty

72. 72 Digital Bio-marker •Install and forget •Passive •No tests •No sensors •Cadence NOT content •Runs in background •Fully automated •Cloud-based •Big data analytics •Proprietary algorithms •HIPAA compliant •Sub-clinical (ms) •Binary •Continuous •Predictive •Personalized All software and internet – infinite scalability and great economics + =

73. 73 Drug Development Clinical Management Consumer Use Cases • New therapies • Early detection/ applications • Monitor • Manage • Differentiate • Monitor • Self-manage

74. 74 PD Patient - Unstable PD Patient – Unstable/Getting Worse Control - Diagnosed/Treated? PD Patient - Stable Research

75. 75 Early Diagnosis Tool? Fox Trial Finders – Control

76. 76 Academic institutions Research Programs Diseases/ Disorders Countries 10 14 10 5 Ongoing Research

77. 77 IP Approach • Patents • Trade Secrets • Reverse engineering not possible • Size of database • 100M data points > 1B by end of Q1 • Disease fingerprints

78. 78 Impact • Millions of patients enjoying a better life • Early detection enabling pharma to develop drugs leading to people enjoying life without suffering from the disease or outright cures

79. 79 • Large unmet need • Huge market • Lots of well protected IP • Very simple solution • Internet and software = great financials Summary

80. ConfidentialDecember 6, 2017 SharpBrains Virtual Summit Jan Samzelius, CEO

82. Thank you, Speakers & Participants!

83. Thank you, Summit Sponsors!

84. Thank you, Summit Partners!

85. To learn more, visit sharpbrains.com

Digital Mental Health: the Hurt, the Hype, the Hope + Brainnovations Session 1

Digital Mental Health: the Hurt, the Hype, the Hope + Brainnovations Session 1

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