Rapid Tests for Assessment of

TIA/Ischemic Stroke, Concussions

& Risk of Posttraumatic Epilepsy

Start testStart test

Problem

Currently, there is an urgent need for simple, rapid and on-field/on-site

assays assessing TIA, risk of ischemic stroke, severity of concussions &

risk of posttraumatic epilepsy

Potential users of assays:

Emergency providers

Trauma centers

Military and civilian hospitals

Neurologists, surgeons, and anesthesiologists

Sport clubs and schools

Medical offices at schools

Out-patient services

Insurance companies

Expert committes that determine return to work, duty, or play following a brain injury

Time is Brain

Solution

Rapid tests for assessment of TIA, risk of ischemic stroke,

severity of concussions & risk of posttraumatic epilepsy

Results within 5 minutes, with color detection via mobile

applications (IOS, Android, W8)

On-field or on-site detection (stadium,

emergency room, ambulance, combat)

User-friendly and affordable cost per

strip test

Laboratory devices unnecessary

Color detection software adjusts to existing

mobile platforms (IOS, Android, W8)

Safety of personal data storage in the

Cloud, with restricted access

Company background Developed proprietary cost-effective ELISA test kits for assessment of the risk

of ischemic stroke, post-traumatic epilepsy, and the severity of brain damage

after mild TBI

ELISA test kits for the risk of stroke and post-traumatic epilepsy have been

approved by the state Dept. for Control of Medications and Medical Devices of

Ministry of Health of the Russian Federation in 1998-2003

In 2005, stroke biomarkers were licensed to Bayer Diagnostics (Siemens

Medical Solution) for use in and automatic analyzer

Certificate Europa (CE Mark) clearance in the 27 EU countries since 2008. In

the US, the test kits are available for research use until FDA- approved

In 2000-2014, more than 29 peer-reviewed manuscripts published in

professional medical journals

Results of clinical trials of ELISA test-kits in Russia, Europe, and USA have

been presented at international conferences (2002-2014) and in textbooks

published in Russia (2003, 2013) and the UK (2012)

Market

Marketing strategy

Network of clinical and reference

laboratories

Private medical centers

Federal clinics and hospitals

Pharmacy/Drug store networks

Big Pharma (companion diagnostic)

Regions

Mild TBI Strokes

Number of new cases per year

Russia 1 million 499,000

China 13 million 8 million

USA 1.3 million 795,000

Europe 1.2 million 1.3 million

IVD, POC market

(market share, %)

Annual revenues, billion USD

2012 2017 2020

World wide (100%) 52,8 69,1 88

BRICS (13%-19%) 7,0 9,0 12,0

Russia (1%-2%) 0,5 1,25 2,0

0,5 1,25

Russia

7

9BRICS

0

5

10

15

[2012] [2017] [2020]

BLN

. U

SD

IVD market growth dynamics

Statistics of Strokes and mTBI by country: Target market:

CompetitorsAlternative Solutions

Product and

CompanyDisease Technology

Turnaround

Time

Test price

USD

Revenues

2013-14

USD

PLAC test

diaDexus, USA

Risk of stroke in

atherosclerosisELISA 5-7 days $185-$276

$23-24

milliion

Thrombx

Quest Diagnostics,

USA

Thrombotic

processesPCR 7-14 days $900 $1,9 billion

GFAP, UCH

Banyan Biomarkers,

USA

TBI ELISA 5-7 days —* —*

Cerebral Arrays I and II

Randox Labs, UK

Cerebrovascular

disease, Alzheimer

disease, and

multiple sclerosis

ELISA biochip 24 hours$7,253-

$8,222 ≥$120 million.

*In development; not commercially available

Advantages of the DRD Ltd.productRetail price <10 USD for each test

Differentiation of ischemic stroke from hemorrhagic stroke (NR2 peptide)

Severity of a concussion (AMPAR peptide)

Risk of ischemic stroke (NR2 antibody)

Risk of posttraumatic epilepsy (AMPAR antibody)

StagesAdvantages (Time)

Other Solutions DRD Ltd. Solutions

PhlebotomyVenous blood withdrawal and

centrifugation, 1 hourDigit blood sample

Blood sample preparation

and supplies

Sample dilution, dosing

(30-45 min, multi-channel pipette)Not needed

Reaction time2X incubation for 30 minutes

or 1 incubation for 1 hour

Seconds

(maximum 1 minute)

Additional reagentsBuffers, controls, conjugate,

substrate (preparation)Applied to test zone

Results processing

Reaction detection on the reader,

calibration curve, filing a report

(up to 2 hours)

Automatic image processing

using mobile application

(3-4 minutes)

Technology

Assays based on identifying glutamate neuroreceptor

peptide fragments and their antibodies in peripheral blood

Technical documentation for DRD Ltd. products

Blood sampling

from the digit

~20 µl sample,

19-second reaction timeResults in

<5 minutes

Photographing

the test strip

2,5 см

5 см

Scientific Basis

AMPA receptors located on

neuronal dendrites and axons

Concussions

NR2

peptides

GluR1

antibodies

AMPAR

peptidesStrokes

GluGlu

Glucose GlucoseMet

ATP

Htcy

B6

CysNMDA receptors are

located on the outer

wall of the brain’s

microvessels

The scheme of ionotropic glutamate

neuroreceptor localization

Epilepsy

Concussions Concussions

AMPAR

peptides

Road map

2018 Full scale

manufacturing

launch (GMP, ISO)

Enter Chinese

market

Initiate product

marketing in

India, South

Africa, Brazil

2017 Initiation of sales

in Russia

Partners search

in Custom Union

and BRICS

countries

Create marketing

materials, search

for distributors

Test prototype

(lateral flow)

Mobile

application

prototype

Patenting POC

rapid tests

Software

patenting

Clinical trials

in Russia

Pilot

manufacturing

of rapid tests

according to

GMP and ISO

Trademark(s)

registrations

in Russia and

abroad

2015 2016

TeamPotapov Alexander A.

MD, DSc, professor, Acad. RAS

Director Burdenko Neurosurgery Institute

Russian neurosurgeon and specialist in neurotraumatology

Published more than 250 manuscripts, monographs, manuals and textbooks

Dambinova Svetlana A.

PhD, DSc, professor

Outstanding Scientist of Buryatia and the Russian

Federation, a leader in brain biomarkers area

Authored over 300 scientific manuscripts, 36 international

patents with 16 patents transferred to industry

Skoromets Alexander A.

MD, DSc, professor, Acad. RAS

Chair of the Dept. Neurology and Neurosurgery with Clinic at

St. Petersburg Pavlov’ State Medical University

Authored over 850 scientific papers on neurology, including

textbooks for medical students, manuals and handbooks for

neurologists

Pokatsky Vyacheslav S.

CFO, DRD Ltd.

Member of the Parliament , Republic of Buryatia

Over 20 years’ investing experience in business

Owner of the holding "MV-Cinema-group" Republic of

Buryatia with a market capitalization of 1 billion rub

Zhimbiev Anzhey Ts.

CEO, DRD Ltd.

Economist and financier with 10-year experience in the

business

Development of mobile applications and services

«Young Master of Business» 2011 competition "Young

Entrepreneur of Russia"

Izykenova Galina A.

PhD, CTO, DRD Ltd.

Biotechnology

GRACE Labs

Author and co-author of over 60 research papers and five

international patents

Alexandrova Evgenya V.

MD, PhD, Medical director of DRD Ltd.

Clinical Trials, Burdenko Neurosurgery Institute

TBI clinic and cerebrovascular disease

Author of more than 15 scientific papers, coordinator of

Russian and international grants

Khunteev German A.

MD, PhD, Head of the Clinical Laboratory

Dept. Neurology and Neurosurgery with Clinic at

St. Petersburg Pavlov’ State Medical University

Clinic of cerebrovascular pathology

Authored more than 27 scientific papers

Danilenko Uliana I.

PhD, GRACE Labs

Preclinical trials

Reagents quality control: HPLC, mass spectrometry,

electron microscopy focal

Author and co-author of over 15 scientific papers

Burov Sergey V.

PhD, Institute of Macromolecular Compounds, RAS,

St. Petersburg

Head of Lab peptide synthesis and polymer microspheres

Author of over 170 scientific publications and 12 patents

Co-investigators

Scientific Project Leaders

DRD Biotech | DRD ltd.

Dambinova Svetlana

+1 (404) 661 4658

dambinova@aol.com

Zhimbiev Anzhey

+7 (914) 840 09 02

office@drdbiotech.ru

www.drdbiotech.ru