Renalytix AI : JP Morgan Conference Call Presentation

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RenalytixAI

Company Overview

JP Morgan Conference

January 2021

Disclaimer

This Presentation is confidential and is being supplied to you solely for your information and may not be reproduced, further distributed to any other person or published, in whole or in part, for any purpose. Subject to certain exceptions, this Presentation is not for distribution in the United States, Australia, Canada or Japan or any other jurisdiction where its distribution may constitute a violation of the laws of such jurisdiction.

The information contained in this confidential document ("Presentation") has been prepared by Renalytix AI plc (the "Company") solely for your information and use at a presentation for the purposes of providing background information on the Company, its business and the industry in which it operates and neither this Presentation, nor the information contained in it should be considered a recommendation by the Company or any of its shareholders, directors, officers, agents, employees or advisers in relation to any purchase of the Company's securities, including any purchase of or subscription for any shares (or securities convertible into shares) in the capital of the Company. This Presentation has not been fully verified and is subject to material updating, revision and further amendment. Any person who receives this Presentation should not rely or act upon it. This Presentation should not be re-distributed,re-published, reproduced or disclosed by recipients, in whole or in part.

While the information contained herein has been prepared in good faith, neither the Company nor any of its shareholders, directors, officers, agents, employees or advisers give, have given or have authority to give, any representations or warranties (express or implied) as to, or in relation to, the accuracy, reliability or completeness of the information in this Presentation, or any revision thereof, or of any other written or oral information made or to be made available to any interested party or its advisers (all such information being referred to as "Information") and liability therefor is expressly disclaimed. Accordingly, neither the Company nor any of its shareholders, directors, officers, agents, employees or advisers take any responsibility for, or will accept any liability whether direct or indirect, express or implied, contractual, tortious, statutory or otherwise, in respect of, the accuracy or completeness of the Information or for any of the opinions contained herein or for any errors, omissions or misstatements or for any loss, howsoever arising, from the use of this Presentation.

This Presentation may contain forward-looking statements that involve substantial risks and uncertainties, including those described in the Company's filings with the Securities and Exchange Commission and actual results and developments may differ materially from those expressed or implied by these statements and past performance is no guarantee of future performance. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the Company's results of operations, financial condition, prospects, revenue generation, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. These forward-looking statements speak only as of the date of this Presentation and the Company does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date of this Presentation. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential" "predict," "project," "should," "target," or "will" or the negative of these terms or other similar expressions.

The Presentation also contains estimates, projections and other information concerning our industry, our business and the markets for KidneyIntelX and any other products we may develop in the future. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in the information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from our own internal estimates and research as well as from reports, research, surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. While we are not aware of any misstatements regarding any third-party information presented in this Presentation, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties and are subject to change based on various factors. Market data and industry information used throughout this Presentation are based on management's knowledge of the industry and the good faith estimates of management. We also relied, to the extent available, upon management's review of independent industry surveys and publications and other publicly available information prepared by a number of third-party sources. All of the market data and industry information used in this Presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Although we believe these sources are reliable, we cannot guarantee the accuracy or completeness of this information, and we have not independently verified this information. While we believe that the estimated market position, market opportunity and market size information included in this Presentation are generally reliable, such information, which is derived in part from management's estimates and beliefs, are inherently uncertain and imprecise.

This Presentation is only addressed to and directed at (i) persons who are outside the United Kingdom, (ii) persons who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), (iii) persons who are high net worth entities falling within Article 49(2)(a) to (d) of the Order, and/or (iv) any other persons to whom this presentation may otherwise lawfully be communicated without contravention of section 21 of the Financial Services and Markets Act 2000 or to whom it may otherwise lawfully be distributed (all such persons together being referred to as "relevant persons"). This presentation may not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this presentation relates is available only (i) in the United Kingdom, to relevant persons who are qualified investors within the meaning of Article 2(e) of the Prospectus Regulation (Regulation (EU) 2017/1129) ("Qualified Investors") and (ii) in any member state of the European Economic Area ("EEA"), to Qualified Investors, and will be engaged in only with such persons. This presentation must not be acted on or relied on (i) in the United Kingdom, by persons who are not relevant persons and Qualified Investors, and (ii) in any member state of the EEA, by persons who are not Qualified Investors.

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JPM 2021

1

Investment Highlights

FIRST in	Growth Model with Core	Anticipated Near-Term
AI in vitro Diagnostics	Partnerships	Major Events
• KidneyIntelX is first-in-class, clinical	• System population health	• FDA clearance and national roll-out
grade, artificial intelligence-enabledin
vitro Dx
		• National Medicare coverage under
• First advanced prognostic in early-stage		MCIT
kidney disease (Stage 1, 2, 3), if	• Integrated care models
approved by the FDA		• Expanding use to broader disease
		populations to achieve TAM ~40M
• Granted FDA Breakthrough Device		patients
designation	• Payor driven
	• International markets regulatory review
• New York State Department of Health
approved for commercial testing
• Commercial capable in 50 states	• Precision therapeutic care pathways
• Unique configuration real-time biology +
EHR features + machine learning
enabled algorithm
		JPM 2021		2

Key Events Timeline

Q4 18

Q1 19

Q2 19

Q3 19

Q4 19

Q1 20

Q2 20

London Stock

First Payor

Received

New York State

Exchange IPO

Coverage

$950 Medicare

Commercial

(LON:RENX)

Pricing

Testing Approval

FDA Grants		CLIA Authorized		Begin Expanded
Breakthrough		Testing Facility		Payor Coverage
Device Designation		Opens In Utah

CPT Code Granted		Nasdaq
for KidneyIntelX		Listing:
		$85M Raise

*Quarters based on calendar year

Q3 20

Begin Live

EHR

Integration

Partnership with

Final FDA Submission

Q4 20		Q1 21
Roll out		Partnership
testing		with

Partnership		Medicare MCIT
with		Rule finalized

JPM 2021

3

Unprecedented Size and Cost Drivers in Kidney Disease Market

The Numbers

The

Healthcare

Challenge

The Cost

37 million

Americans currently estimated with CKD

~60 million

adults in the U.S. expected to be diagnosed with diabetes by 2060

>$120 billion

or 20% of Medicare budget spent per year for treatment of CKD (incl. ESKD)

850 million

people estimated with CKD worldwide

100,000

Americans waiting for kidney transplant; 13 die every day

$36 billion

or 6.7% of Medicare budget spent per year for treatment for kidney failure to care for <1% of the covered population

>100,000

Americans begin hemodialysis from kidney failure / year

63%

of patients initiate dialysis in an unplanned fashion ("crash")

$1.3 billion1

can be saved over 5 years per 100,000 patients with

DKD

KidneyIntelX

estimated TAM*

(Initial Indicated Use)

~$12 billion

*Based on one test per patient assuming Medicare national price of $950 per reportable test. Source: McCullough, KP, et al. J Am Soc Nephrol. 2019;30:127-135

JPM 2021

4

Urgent and Immediate Need to Clarify Who Has Progressive Kidney Disease

1 in 5

will rapidly progress

to kidney failure

Each of these patients has an UACR between 30-299mg/g

Who Is It?

and a GFR of 45-59 ml/min/1.73m2

JPM 2021

5

KidneyIntelX Enables Precision Prognosis Anchored in Real-time Biology in Early-Stage Kidney Disease

Step 1		Step 2	Step 3	Step 4		Step 5
Blood draw		Data extraction	Algorithms	Reportable result		Care navigation
Precision		Patient records	Risk score	Clinicians and		Optimized referrals
Biomarkers		historic + current	analysis	patients		& treatment

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Clear, Easily Understood Prognosis with Actionable Steps

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7

Real-World Reactions

Low Risk

"	OMG, this is the best news ever. I am so motivated to bring my number down lower than 40%. I plan to change my eating habits,
when can I re-test to make sure that my number is heading in the right direction?
I'm freaking happy. Thank you, Thank you. I work in a lab, so I know how important it is for me to diet and exercise to maintain or
""	improve my numbers. I would love to be a spokesperson for your program. You people are amazing.
My sister and mother died from diabetes and kidney problems. I am so happy! Please tell me what I can do to maintain?

Intermediate Risk

" I am willing to do anything to prevent dialysis, so please tell me what I can do to fix this? How often can I get this test?

High Risk

• This is not good news, but this information can be very helpful. When can I get the test done next. I want to see a nutritionist"
• This is disappointing. What do I have to do to prevent dialysis? Can the doctor up my medications. When can I be tested again?

JPM 2021

8

KidneyIntelX Could Drive ROI in 12-24 Months

Slowed Progression through CKD Stages

Better risk assessment & patient awareness allows intervention to modify DKD progression

Positive Returns and Cost

Savings for Health Insurers

KidneyIntelX could deliver cost savings of up to $1.3 billion over five years per 100,000 patients with DKD1

Fewer ER Events &

Dialysis Crashes

Advanced warning of acute events allows for planned dialysis

Delayed or Prevented Dialysis & Transplants

Early intervention can delay or prevent dialysis and kidney transplant events

1 Based on the Medicare price of $950 per reportable test

JPM 2021

9

Potential Near Term Major Value Drivers

• FDA Clearance and National Commercial Roll-Out
• National Medicare Coverage Determination Under MCIT
• Expanded indicated uses into broader disease categories, growing TAM
• Growing body of real-world health economics and utility data

JPM 2021 10

An End-to-End Solution for Kidney Disease

early risk assessment of kidney decline		comprehensive care management

Help slow kidney disease progression,

improve care coordination and reduce costs

• Anticipated launches in three major markets in 2021
• Expected outcome of the collaboration will also be used to expand indicated use claims for KidneyIntelX

JPM 2021 11

Accretive Innovation to Renalytix Shareholders

• May '20 spin-out from Renalytix; shares	•	Renalytix / Mount Sinai Joint Venture
distributed to Renalytix shareholders	•	Quantitative COVID antibody testing
• Kidney transplant Dx portfolio
•	Partnerships
• Oct '20 London Stock Exchange IPO (VRCI)
	─ Biotechne (NASDAQ TECH)
• Jan 11th market capitalization ~$120M		─ EKF Diagnostics (LSE EKF)
	•	Nov '20 CE Mark
	• Dec '20 FDA EUA

JPM 2021 12

Leadership Team

James McCullough

Co-Founder, CEO

Fergus Fleming

Chief Technology Officer

Dr. Barbara Murphy, M.D.

Non-Executive Director

Tom Mclain

President & CCO

O. James Sterling

Chief Financial Officer

Dr. Steven Coca, DO

Co-Founder

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JPM 2021