THE ICA INTEGRATED COGNITIVE ASSESSMENT - TACKLINGDEMENTIAWHEN IT COUNTS - Cognetivity Neurosciences

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THE ICA INTEGRATED COGNITIVE ASSESSMENT - TACKLINGDEMENTIAWHEN IT COUNTS - Cognetivity Neurosciences
THE ICA
I N T E G R AT E D C O G N I T I V E A S S E S S M E N T

        TACKLING DEMENTIA WHEN IT COUNTS
THE ICA INTEGRATED COGNITIVE ASSESSMENT - TACKLINGDEMENTIAWHEN IT COUNTS - Cognetivity Neurosciences
CONTENTS

INTRODUCTION        03

THE PROBLEM         04

THE OPPORTUNITY     05

WHO WE ARE          06

THE ICA             07

BENEFITS            13

OPTIMIND            24

COMMERCIALIZATION   28

                         2
THE ICA INTEGRATED COGNITIVE ASSESSMENT - TACKLINGDEMENTIAWHEN IT COUNTS - Cognetivity Neurosciences
DEM E N T I                                            A
is the biggest healthcare challenge of the 21st century

Between 2000 and 2018, deaths in the US from heart disease fell by 7.8% while
deaths from Alzheimer’s increased by 146%.
Alzheimer’s on its own is the sixth-largest cause of death in the US, killing more than
breast, prostate & pancreatic cancer combined.

Dementias are the leading cause of death in the UK, accounting for 12.7% of deaths.
1 in 3 US seniors die with Alzheimer’s or another dementia…
… yet in high-income countries, around 1 in 2 people never receive a formal
diagnosis, increasing to 9 in 10 in poorer countries – on average, an estimated 75%
of the global dementia population.

                                         Sources: Alzheimer’s Association, 2020; UK Office for National Statistics, 2018;
                             Centers for Disease Control and Prevention, 2017; Alzheimer’s Disease International, 20153
THE ICA INTEGRATED COGNITIVE ASSESSMENT - TACKLINGDEMENTIAWHEN IT COUNTS - Cognetivity Neurosciences
T H E R E I S A P R O B L E M with diagnosing dementia
                                                  Existing assessment methods suffer from…

        PRECISION                           PRACTICAL                         LANGUAGE                           EDUCATION                           A LEARNING
       LIMITATIONS                           BURDENS                         DEPENDENCE                             BIAS                                EFFECT

 Current assessment methods          Traditional tests are pen-and-       Tests relying on any use of          Generally, the higher a           With existing methods, a
  are limited by imprecision,         paper-based, requiring face-          language can be greatly       patient’s level of education, the    patient can seem to be getting
 assessor bias and differences       to-face administration by an        affected if a patient is not a       better they will score in        better over time, when in fact
  in interpretation. They are        expert clinician. As the age of    native speaker; and tests taken      knowledge- and memory-           they are simply learning how to
 suited to late-stage diagnosis        telemedicine dawns, they        in different languages cannot be    based testing. The same goes                  do the test.
but display a lack of sensitivity    offer no capacity for remote          meaningfully compared.          for their cultural background.
   to early-stage disease for                   testing.
        timely diagnosis.

                                                                                                                                                                                4
THE ICA INTEGRATED COGNITIVE ASSESSMENT - TACKLINGDEMENTIAWHEN IT COUNTS - Cognetivity Neurosciences
Sources: Alzheimer’s Association, 2018; 2020

ENORMOUS OPPORTUNITY
for health economic savings

Investment in improved diagnostics could save the
healthcare system trillions

 “ … governments should ‘spend to save’ – in other words,
 invest now to save in the future … the costs associated
 with an earlier dementia diagnosis are more than offset
 by the cost savings from the benefits of anti-dementia
 drugs and caregiver interventions. These benefits include
 delayed institutionalisation and enhanced quality of life
 of people with dementia and their carers”
 Alzheimer’s Disease International, World Alzheimer Report 2011

                                                                                                                 5
THE ICA INTEGRATED COGNITIVE ASSESSMENT - TACKLINGDEMENTIAWHEN IT COUNTS - Cognetivity Neurosciences
OUR MANAGEMENT TEAM
 A Cambridge University spin-out, we are proud that our team has grown to include…

                                                                       DR SEYED RAZAVI Co-founder, CSO
DR SINA HABIBI Co-founder, CEO
                                                                       PhD (Computational Neuroscience), University of Cambridge;
PhD (Engineering, Nanobiotechnology), University of Cambridge;
                                                                       previously a postdoctoral researcher in Artificial Intelligence at the
formerly Chair of Cambridge University Entrepreneurs (CUE)
                                                                       Massachusetts Institute of Technology (MIT)

DR THOMAS SAWYER Chief Operating Officer
                                                                       DR CHRIS KALAFATIS Chief Medical Officer
PhD (Life Sciences), University of Glasgow; MBA, University of
                                                                       Consultant in Old Age Psychiatry at Maudsley Hospital, London;
Cambridge; over 15 years’ experience in entrepreneurship,
                                                                       Affiliate of King’s College London, running clinical trials in dementia at
consulting and private equity in biotechnology, pharmaceuticals,
                                                                       Institute of Psychiatry, Psychology & Neuroscience
logistics and information technology across the globe

DR MARK PHILLIPS Chief Compliance Officer
                                                                       ROB BROUGHAM Commercial Director
PhD (Management), University of Cambridge; 30 years’ experience
                                                                       Over 25 years’ experience in senior commercial roles, successfully
in the pharmaceutical and life science industries; previously Senior
                                                                       achieving sales up to £1 billion in value, including more than 6 years
Vice President in R&D and Head of Diagnostic Development and
                                                                       in digital health selling innovative solutions to the NHS
Supply at GlaxoSmithKline (GSK)

                                                                                                                                                    6
THE ICA INTEGRATED COGNITIVE ASSESSMENT - TACKLINGDEMENTIAWHEN IT COUNTS - Cognetivity Neurosciences
S O LV I N G T H E P R O B L E M
    with platform technology

                  Self-administered testing on a variety of
                  widely-available hardware solutions

                  Overcoming existing testing flaws
                  with an Integrated Cognitive
                  Assessment – the ICA

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THE ICA INTEGRATED COGNITIVE ASSESSMENT - TACKLINGDEMENTIAWHEN IT COUNTS - Cognetivity Neurosciences
T H E I N T E G R AT E D C O G N I T I V E A S S E S S M E N T ( I C A )
                       A rapid visual categorization task using natural images

    Images are displayed for a fraction of a second. Tap to classify each in turn as animal or non-animal.

STIMULUS                        INTERVAL                             MASK                               ANIMAL?

           Our Artificial Intelligence engine compares your speed and accuracy to test data from
                                  healthy and cognitively impaired individuals.

                                                                  The test takes advantage of millions of years of human evolution –
                                                                  the human brain’s strong reaction to animal stimuli

                                                                                                                                       8
THE ICA INTEGRATED COGNITIVE ASSESSMENT - TACKLINGDEMENTIAWHEN IT COUNTS - Cognetivity Neurosciences
I C A T H E O R Y AT T H E M I C R O L E V E L
          Information processing times give powerful insight into cognitive health for two reasons

                                             Healthy                                     Affected

1. SPEED OF INFORMATION
TRANSMISSION IS SLOWER IN
AFFECTED NEURONS

2. FEWER NEURONS MEAN
MORE PROCESSING TIME

                               Fast                                                                  Slow

                                                                                                            9
THE ICA INTEGRATED COGNITIVE ASSESSMENT - TACKLINGDEMENTIAWHEN IT COUNTS - Cognetivity Neurosciences
Engaging large volumes of neuronal pathways and
                                                     I C A T H E O R Y AT T H E
brain structures gives greater sensitivity to mild
                                                     MACRO LEVEL
impairment than memory-focused tests

                                                     “Detecting the first disruptions to brain
                                                     circuitry, and tracking the anatomical and
                                                     physiological damage underlying the steady
                                                     cognitive decline that is symptomatic of
                                                     Alzheimer's, will require tools that operate at
                                                     the 'mesoscopic' scale: techniques that probe
                                                     the activity of thousands or millions of
                                                     networked neurons.”

                                                     Kenneth S. Kosik,
                                                     Nature: 503, 31–32 (07 November 2013)

                                                                                                       10
UTILISING ARTIFICIAL INTELLIGENCE
          Reaction times and accuracy are used as predictive classifiers of disease status with a high degree of sensitivity

                                        Reaction   Accuracy
                                          (ms)       (%)

                                         2427        98

                                         2488        45

                                         1876        82

                                         1160        21        PATIENT
                                                                DATA
                                   SUMMARY FEATURE                             AI CLOUD PROCESSING             PREDICTION DELIVERED
             TEST DATA
                                      EXTRACTION                                                                      TO EHR

A patient takes an ICA test,       Summary features are             The AI engine computes their risk   EHR integration enables secure
   generating raw data         extracted and combined with          of cognitive impairment through     delivery of results and offers a
                               demographic data as inputs to             comparison to hundreds of       route to highly personalized
                                       the AI engine                                                             medical care
                                                                            previous test-takers

                                                                                                                                           11
D E V E LO P E D FO R U N I V E RS A L H A R D WA R E
                 Delivered on reliable, trusted hardware for security and scalability

      UBIQUITOUS PLATFORM                               SECURE & SAFE                                 CLOUD HOSTING

 By developing the ICA for commonplace         Data storage and processing conform to            Storage of user information and
hardware that is trusted by the market, we    international best practice standards and   processing and generation of test results are
remove the need for specialist equipment     the entire system is HIPAA-compliant with           carried out on our secure cloud-
   and carve ourselves a path for rapid          fully encrypted databases to ensure           based servers, so we can seamlessly
                 upscaling                               patient data security              integrate with and deliver analysis directly
                                                                                          into existing EHR systems, wherever they are

                                                                                                                                           12
SPEED
                                      A 5-minute test, self-administered under non-expert supervision,
                                      leading to increased patient throughput and cost-efficiency

                                      SENSITIVITY AND ACCURACY
                                      Potential to detect cognitive impairment significantly earlier
                                      than current methods

                                      AVOIDANCE OF BIAS
                                      Consistency across individuals from different cultural
                                      and educational backgrounds
BENEFITS FOR
H E A LT H C A R E                    REMOTE DELIVERY
                                      Potential to assess patients in the comfort of their homes
PROVIDERS…
                                      LONGITUDINAL MONITORING
Numerous competitive advantages in
clinical practice                     Long-term tracking of pre-dementia patients (MCI) or
                                      responses to treatment

             Ipad with stats screen
                                                                                                         13
CONTINUAL IMPROVEMENT
             Thanks to our AI engine, the ICA is always improving in sensitivity and scope

SENSITIVE
                                                                HEALTHY                           MCI                       MILD AD
Our AI engine uses multinomial logistic regression to
create accurate hyperplanes, enabling the ICA to be
extraordinarily sensitive to a new test-taker’s score
through comparison to learnt clusters

ADAPTABLE
Existing diagnostic tools remain static and never change.
Through machine learning, our AI engine can be
continually updated with clinical data from more patients
to improve its sensitivity and specificity over time.

USER-SPECIFIC                                                 • Patterns of ICA test responses from healthy, MCI and mild AD participants
Our AI-powered system can take into account an
unlimited number of patient attributes, including sex, age,   • Each cell in the matrix represents the relationship of accuracy and reaction
education level and much more, through EHR integration.         for a pair of images
Current testing methods ignore a wealth of relevant data
that is crucial to generate meaningful and accurate results   • These features are by the AI engine in making classifications
for diagnosis.

                                                                                                                                               14
…AND FURTHER AFIELD
Clear potential to add value in a range of
healthcare-related industries

         DRUG DISCOVERY
         Sensitivity to early-stage disease offers a solution to the difficulties of
         subject recruitment for clinical trials, while the lack of learning effect
         improves the capacity to detect therapeutic efficacy

         HEALTH INSURANCE
         A clinical-grade assessment tool for risk identification and stratification in
         determining premiums

         CORPORATE HEALTH
         Empower large companies to look after their employees’ health
         and wellbeing with objective measures of performance over time –
         scope for company-wide insights through data aggregation

         CONSUMER WELLNESS
         Availability on ubiquitous hardware, user-friendly set-up – track
         performance over time and make necessary lifestyle adjustments

                                                                                          15
P U B L I S H E D E X P E R I M E N TA L R E S U LT S
                                                                                                               Alzheimer’s and MCI

                Data collected from 10 NHS Trusts in England show a significant positive relationship between the ICA and established
                                                standard-of-care tests for the diagnosis of dementia

                       253 participants                                                               243 participants
                       r= 0.61                                                                        r= 0.58
                       p
P U B L I S H E D E X P E R I M E N TA L R E S U LT S
                                                                                             Multiple sclerosis (MS)

                                                                                                                                                                      True Positive Rate
                                           n= 174                                                n= 174                                               n= 174
                                           r= 0.82                                              r= 0.71                                                r= 0.6
                                                                                                                                                                                                          AUC = 0.95
                                         p
C O R E S C I E N T I F I C V A L I D AT I O N
                          EEG and fMRI have further substantiated the ICA’s underlying science

         Animal vs. non-animal image decoding                                Engagement of the critical brain areas affected in
                                                                                     pre-symptomatic Alzheimer’s

                                                                              8

                                                                              4

                                                                              0

     EEG results demonstrate the effectiveness of animacy stimuli.         In a task-based fMRI investigation, the ICA engages brain areas such as
Individuals with MCI show a significant reduction in speed and accuracy    the transentorhinal region, fusiform gyrus and the inferior and middle
      of processing ICA information compared to healthy controls.         temporal gyruses, which are anatomically identified as being among the
                                                                            earliest areas affected by tau-pathology and amyloid deposits in pre-
                                                                                                  symptomatic stages of AD.

                                                                                                                                                     18
C O R E S C I E N T I F I C V A L I D AT I O N
                   Clear differences in the level and areas of activation in the brain
                              among individuals of differing disease status

H E AT H Y C O N T R O L S                              MCI                                  MILD ALZHEIMER’S

                         In red: neural activation recorded by fMRI while the ICA is attempted
                                                                                                                19
A S E N S I T I V E B I O M A R K E R for physiological change
                                  The ICA is directly correlated with brain cell damage and can track changes in cognition
                  Strong correlation between ICA score and severity of neural damage          Sensitivity to differential changes in cognition

                          r= -0.79*                               r= -0.75*

                       • MS patients were divided into a control group and a group
                         receiving an 8-week physical and cognitive rehabilitation program
                                                                                                    i ne                           i ne
                                                                                               basel l)    fol l ow
                                                                                                                   -up        basel )          rehab
                                                                                                      ro                              b   post-
                       • In the rehab group, ICA scores rose while NfL levels fell             (cont                           (re a
                                                                                                                                  h

                                                                                                d= -0.4, p>0.05                d=0.8, p
C O M PA R I N G D I F F E R E N T D I A G N O S T I C M E T H O D O L O G I E S
                                    Across speed, cost, invasiveness, applicability…

                                                                    NON-                   EARLY-STAGE   DELIVERABLE
          METHOD                      QUICK        LOW-COST
                                                                  INVASIVE
                                                                               SENSITIVE
                                                                                            DETECTION     REMOTELY

The ICA                                 ✓             ✓             ✓            ✓             ✓            ✓
Traditional pen-and-paper tests        ✗              ✓             ✓            ✗            ✗             ✗
Computerized traditional tests         ✗              ✗             ✓            ✗            ✗             ✓
Biomarker analysis (CSF sampling)      ✗              ✗             ✗            ✓            ✗             ✗
Neuroimaging (MRI, CT)                 ✗              ✗             ✓            ✓             ✓            ✗

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P L AT F O R M T E C H N O L O G Y powering a wide range of solutions
                                    Multiple cognitive assessment products for multiple markets

                  Product               Market              Revenue Model         Development Plan        Competitive Advantage
                                                                                                       Speed
                             Screening                                       Expansion from
               ICATM
  HEALTHCARE

                                                      Charge per test                                  Accuracy
                             (Primary care)                                  secondary care market     Non-expert administration

                                                                                                       Speed
                             Specialist diagnostics                          UK sales
               ICATM         (Secondary care)
                                                      Charge per test
                                                                             FDA approval
                                                                                                       Sensitivity
                                                                                                       Cost-efficiency

                                                                                                       Sensitivity
CLINICAL

                                                                             FDA approval
 TRIAL

               ICA_CTTM      Drug development         Subscription
                                                                             International sales
                                                                                                       Lack of learning effect
                                                                                                       Remote deliverability

                                                                                                       Sensitivity
                             Monitoring of chronic                           Expansion from
               OptiMindTM                             Subscription (B2B2C)                             Lack of learning effect
CONSUMER-

                             health conditions                               secondary care market     Remote deliverability
  FACING

                                                                                                       Sensitivity
                                                                             UK sales
               OptiMindTM    Consumer wellness        Subscription (B2B2C)
                                                                             White-label development
                                                                                                       Lack of learning effect
                                                                                                       Cross-platform integration

                                                                                                                                    22
I C A _ C E : clinical cognitive assessment powered by the ICA
                                                          A case study in US primary care

 CRUDE MEMORY-BASED, PEN-AND-PAPER
 COGNITIVE TESTS ARE THE STATUS QUO

 FDA 510(k) substantial equivalent to Cognivue (DEN130033)
 Positive percent agreement of 56% with SLUMS compared to the ICA’s positive percent
 agreement of 85% with ACE and 82% with MoCA

 Existing CPT codes
 96132 – Neuropsychological testing evaluation services by physician or other
 qualified HCP – $133.71 per hour
 96116 – Neurobehavioral status exam – $97.31 per hour

 Enormous market
 c. 130,000,000 annual visits to primary healthcare by over-65s

Source: 2016 National Ambulatory Medical Survey (NAMCS)                                In-depth revenue forecast on page 28   23
Also introducing:

•   Consumer-facing personalized cognition tracking

•   Powered by the ICA, developed for iPhone

•   Able to generate revenue without the need
    for regulatory approval

•   Slick interface and personalized results,
    tuned to the individual

•   CPT code 96146 – Psychological and neuropsychological testing
    with automated administration – $2.16 per test

                                                                    24
OptiMind functions as an
                                                         individual data collection
                                                               tool, generating
                                                         personalised insights and
                                      r= 0.41              recommendations to                                                       r= 0.25
                                     p
Profile of a high-performing, highly cognitively stable individual

                                                                     Highly sensitive longitudinal monitoring enables
                                                                     OptiMind to spot individuals experiencing
                                                                     significant dips in cognitive performance that
                                                                     would otherwise go unnoticed.

                                                                     Simultaneous lifestyle tracking means that
                                VS.
                                                                     causes of these dips can be identified.
Someone with greater variation in scores with outlier performances

                                                                     Aggregating this data across all participating
                                                                     users offers the potential to identify trends and
                                                                     causes on a population-wide level.

                                                                                                                         26
A B2B2C case study
OptiMind is being deployed to hundreds of employees, first at AXA PPP healthcare and then at one of its corporate customers, Volkswagen
  Financial Services, as part of AXA’s Proactive Health offering, adding a much-needed cognitive component to an established wellbeing
                                                                  programme

        Enormous market reach through collaboration with one of the largest providers of private health insurance in the UK,
                                  owned by the world’s largest insurance group (AXA Group)

                                                                                                                                          27
MILESTONES
                                                    We’ve been busy, with a lot more to come…

2013-2019                                                  2020                                       2021

    ü Incorporation and IPO (listed on Canadian Stock        ü UK Commercial launch                    o US commercial launch
      Exchange, OTCQB & FSE)
                                                             ü Revenue generation                      o Completion of Android app
    ü Cloud-based AI and iOS apps developed
                                                                                                         development
    ü Proof of concept and validation completed              ü Collaboration with big pharma and
                                                               medical device manufacturers            o Completion of EHR integration
    ü Global IP covered (patents, trademarks and
      copyrights granted)                                    ü Partnership with health insurers        o Publication of independent health
    ü CE mark approval (December 2019)                                                                   economic validation study
                                                             ü Government grant extension
    ü Pre-submission to FDA                                                                            o VR and AR development
                                                             ü Publication of MS paper
    ü First commercial agreement signed
                                                                                                       o Adjunct tech research
                                                             o Deployment in UK clinical care
    ü Major government grant awarded

    ü Collaborative partnerships established with
                                                             o FDA filing and approval
      healthcare providers and leading research
                                                             o Independent health economic research
      organisations
                                                               commissioned
    ü Peer-reviewed scientific publications

                                                                                                                                             28
O N G O I N G D E V E L O P M E N T S T R AT E G I E S
 Our patented assessment technique and extensive AI capability offer multiple expansion routes

         EXPANDING OUR                           ENABLING NEW                         LOOKING BEYOND
         CLINICAL REACH                      HEALTHCARE PARADIGMS                       HEALTHCARE
Adapting to other classical neurological   Using big data and telemedicine to     Applying clinical-grade medical
  conditions and a broader array of        usher in a new era of clinical care    technology to a host of fertile
 conditions with cognitive symptoms
                                                 Personalized medicine                market opportunities
        Multiple sclerosis (MS)
                                                  Remote assessment                 Pharma | Health insurance
          Parkinson’s disease
                                                Longitudinal monitoring                    Recruitment
     Traumatic brain injury (TBI),
                                                     EHR integration             Individual and corporate wellness
        including concussion
                                               Population-wide screening          Performance/Risk monitoring
    Attention deficit hyperactivity
                                                                                        and optimization
           disorder (ADHD)                      Artificial Intelligence (AI)
                                                                                       VR and AR | Big data
     Depression | Diabetes | HIV

                                                                                                                     29
PA R T N E R S H I P S A N D C O L L A B O R AT I O N S

                                                          30
G L O B A L M E D I A are taking notice
                                                   It’s easy to see why we are being talked in…

BBC Business Live: Cognetivity CEO,   New Scientist Interview Cognetivity CEO:   Heroes in Health Tech: Dr Sina Habibi       Winners of the AXA ‘Health Tech + You’
Dr. Sina Habibi discusses dementia    Can an app tell if you have dementia       discusses the benefits of early detection   competition 2018
and testing for early diagnosis       years before your doctor?

                                      Forbes: five young companies making an
                                                                                 Biotech and Money: Cognetivity’s AI-         Winners of CambridgeElevator award
                                      impact on the world to watch in 2019
                                                                                 Driven congnitive test speaks to address
                                       Forbes: Cognetivity Neurosciences CEO     dementia diagnosis challenge
                                       Sina Habibi: Why Leaders Should Care
                                       About Dementia

                                                                                                                                                                      31
C O M PA N Y S U M M A R Y
                                    July 2020

Cognetivity Neurosciences Ltd.

                      CSE:CGN
                     FWB:1UB
                 OTCQB:CGNSF

              N America office:
  Suite 1980, 1075 W. Georgia St.
          Vancouver BC, V6E 3C9
                         Canada

               European office:
           3 Waterhouse Square
                   138 Holborn
              London EC1N 2SW
                           UK

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