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
1.
2.
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
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
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
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
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.
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
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
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
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
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
53.
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
59.
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%
64.
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.
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
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
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