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Transforming fertility treatment with precision medicine 1
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Page 1: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

Transforming fertility treatment with precision medicine 1

Page 2: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

www.VivoPlex.com

A revolutionary digital health company in human fertility

With a novel approach to monitoring the uterine environment, VivoPlex can drastically change the dynamics of the fertility

treatment sector

2CONFIDENTIAL

Page 3: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

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Transforming fertility treatment with precision medicine

- Large global market with significant growth potential – currently 660,000 pts/yr in 6 initial markets

- Strong IP protection and first mover advantage

- First time clinicians can monitor the uterine environment for specialist fertility intervention, driven by clinical data

- Compelling preclinical data validates novel approach to monitoring of uterine variables

- Targeting improved patient outcomes and significant cost savings

- Novel digital health platform, applicable in other settings such as animal health

2013 20182015 2019 2020 2021

Early in vivo & proof of concept data

Human feasibility data & company

founded

Series A funding

Clinical study First commercial launch –product portfolio in

development

Preclinical data

CONFIDENTIAL

Page 4: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

IVF laboratories strive to match embryo culture conditions to the natural uterine environment

Evidence confirms pH, oxygen and temperature are critical factors in embryo development

50MFertility Issues

= =2MIVF Cycles

0.6MSuccessful

1.4MUnsuccessful

Clinical focus is shifting to understanding the endometrium (lining of the uterus)

*Literature search results from Medline, using key words ‘the role of endometrium in fertility’, years 2014-2018

Current standard of careThe opportunity

Addressing a global unmet clinical need

The number of publications in endometrium and fertility*

Number of publications

Lack of accurate data on the real conditions in the uterus – our device can have a major impact 4

Page 5: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

High impact - concentrated market, poor success rates

Patients & clinics are highly motivated to adopt

new technologies

~ £4bnWith success rates so low and costs so high,

global cost of failed IVF cycles

Private

NHS

59%

41%

UK IVF cycles

Global market for IVF treatments to

exceed $36bn by 202610% CAGR

~46% of global IVF cycles performed in our 6

primary target markets

UK, Spain, France, AUS/NZ, USA, Japan

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Growth drivers combine demographic and economic factors

Global growth of the middle class

Devices and consumables segment 16% CAGR

Unique opportunity to revolutionise the market with better data to drive outcomes

Page 6: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

Revolutionising IVF market with evidence-based approach

VivoPlex in IVF ecosystem Innovation &

research focused

Influencers

Key opinion

leader clinicians

Large network

& Scientific Advisory Board

Open to new

technology

Willing to self fund

Patients

Working with

patient groups

High volume

Research

experience

Clinics

Know all key clinics

Public healthcare

services

Private clinics

Payers

Building reimbursement

knowledge

High volume

Dominant groups

Permissive laws

Funding

6 key markets

Markets

Driving improved success rates

6

Working in partnership with all key stakeholders, leveraging our reach into the IVF market to develop a deep understanding of their needs and drive adoption of our technology

Page 7: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

The VivoPlex solution

Sensor head continuously monitors pH, oxygen and temperature

Microelectronic driving circuit controls the sensor head and data transfer

Antenna charges and transmits data

Wireless and battery-free device, inserted using the same outpatient procedure as a standard IUD

Garment provides wireless power and data transmission

Proprietary software platform integrates with existing clinical software to store, process & display data to fertility specialist

2

3

1

7CONFIDENTIAL

Page 8: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

A personalised approach to fertility treatment O

2/T

emp

erat

ure

/pH

Time

Abnormal

Normal

‘Normal’ ranges are defined

Cyclical variation is monitored

Individual patient data is collected

Subsequent fertility interventions monitored for effectiveness

Correlation with diseasesDiagnostic algorithms

1

2

3

4

4

Daytime Night time

VivoPlex technology provides unique insight into uterine health and fertility, enabling clinicians to optimize and personalize fertility treatments

Interventions could include change to IVF stimulation regime, embryo transfer timing, addition of probiotics to diet, personalized embryo culture conditions

8CONFIDENTIAL

Page 9: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

Proof of concept validated by new data

2013 study in 5 rabbits continuously for 14 days showed:

Successful proof of wireless power technology and data communication protocols

Good safety data: no inflammatory response and good biocompatibility

Strong in vivo study results Compelling new data validates our novel approach

Confirms earlier technical proof of concept & safety studies with temperature only

prototype

Data to be published

Tem

per

atu

re

Time

In vivo study at Northwick Park Institute for Medical Research (NPIMR) Daytime

Night time

Page 10: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

Moving towards human clinical application

Encouraging human feasibility data

2015 study in 15 women for up to 3 days showed:

• Safety and tolerability of a larger, temperature-only prototype

• Successful wireless power and data transmission

• Patterns of temperature variation within and between patients that gave early validation of our novel approach

Planning for first human study well advanced

Clinical feasibility study to confirm previous preclinical data

• Study in 2020

• Part funded by UK NIHR

• Continued interaction with KOLs, major clinics and insurers to run in parallel

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Results provide gateway to launch

Tem

per

atu

re

Time

Individual temperature data from 3 hours to 3 days

Daytime Night timeCONFIDENTIAL

Page 11: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

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Building data capability to capture full digital health opportunity

Animal health biosensor and digital health capabilities broaden our opportunity and validate our technology platform

Establishing architecture ready for data capture from device trials from 2020,

using state of the art technology to hold and analyze data in a secure

environment

Understanding & driving evolving regulatory landscapefor AI and machine learning, in step with regulatory framework

Unique and proprietary digital health platform with clean

data sets, making an impact on clinical decisions with novel data

Page 12: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

Delivering additional revenue by leveraging big data for true digital health

Fertility Clinic

Pharma Company

Diagnostic Company

Health Insurance

National Health System

Smoking

Medical Conditions

Pregnancy History Body composition

ExerciseNutrition

Family history

IVF Equipment Company

12CONFIDENTIAL

Page 13: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

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Launch strategy

Device monitors oxygen, pH and temperature continuously for a

multi-day period

First commercial launch

2021

Comparing individual patient data against normal values and known

causes of uterine dysfunction

Algorithms used to optimise IVF treatment, drug regimen and

demonstrate improved reproductive outcomes

(~100k patients’ data)

Second commercial launch

2023

Global expansion

2025

CONFIDENTIAL

Page 14: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

Clinical feasibility study

SAB and KOL network

Publications

CE Mark

Clinical trials

Big Data analytics

Improved outcomes

IP protection

Market launch

Clinical phase fundingenables CE mark to unlock future value

Realising market potential

Early market penetration

Commerciallaunch2021

Page 15: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

Results drive value creation

Preclinical studies

Shar

e P

rice

(G

BP

)*

2019 2020 2021

CE Mark & Launch

15

Series Afunding

*For illustrative purposes

Near term value inflection points for the company combine continuous risk reduction with a robust, long term growth strategy

MHRA approval for clinical feasibility

study

Page 16: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

Leveraging novel technology for additional growth in animal health

By leveraging closely related opportunities, we can use our animal health subsidiary to

build a business with strategic synergies but a different business model

Livestock monitoringProject MORPH

Small animal welfare monitoring

Project ARTEMIS

Partners and non-dilutive funding identified

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Page 17: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

Led by a world class team

Dr. Chris Dickson Chairman

Chris has had a long career in health information, holding senior positions at Bupa (Head for Healthcare Services), Ascribe PLC and EMIS Group (Director of International Strategy). He is a

qualified medical doctor

Prof. Hywel MorganCofounder

Hywel is Professor of Bioelectronics at the University of Southampton, specialising in bio-sensors and lab-on-a-chip technologies. He has been awarded a Royal Society- Leverhulme Senior Research

Fellowship at the University of Oxford and the Desty innovation Prize for separation science

Prof Ying Cheong Cofounder

Ying is Professor in Reproductive Medicine at the University of Southampton and a practicing consultant, treating thousands of patients with fertility problems. Her expertise centres on unravelling

the impact of reproductive disorders on implantation and reproductive health

Charles Dickson Executive DirectorAfter a career in corporate finance, Charles moved to lead family office, Tarncourt Group in 2008. He completed a leadership programme at Harvard Business School in 2009. and has been NXD of Apache Capital Partners since 2010

Joanna Smart CEOJo has over 20 years experience in the healthcare sector in Europe and the US. She studied Natural Sciences at Cambridge before joining Nomura Intl. Jo has held senior roles for Onyx Pharmaceuticals and Chiron Corporation and is Deputy Chair of the NIHR i4i Challenge Award Panel

David WilkinsonNon-Executive DirectorDavid is a non-executive Chairman and NED at a range of public and private businesses. He was previously a senior partner at Ernst & Young (EY), working for over 30 years with growth and entrepreneurial companies on corporate development, mergers and acquisitions, financing, IPOs and other exits. 17

CONFIDENTIAL

Page 18: Transforming fertility treatment with precision medicine 1 · Transforming fertility treatment with precision medicine - Large global market with significant growth potential –currently

For more information please contact us at E: [email protected] T: +44 (0)2380 111 555 www.VivoPlex.com

A revolutionary digital health company in human fertility

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