precision urologic oncology

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Precision Urologic Oncology

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Page 1: Precision Urologic Oncology

Precision Urologic

Oncology

Page 2: Precision Urologic Oncology

Notices

The information contained in the presentation is not intended to be an offer for subscription, invitation or recommendation with respect to

shares of Telix Pharmaceuticals Limited (“Telix”) in any jurisdiction, including the United States. No representation or warranty, express or

implied, is made in relation to the accuracy or completeness of the information contained in this document or opinions expressed in the

course of this presentation. The information contained in this presentation is subject to change without notification.

This presentation contains forward-looking statements which can be identified by the use of words such as “may”, “should”, “will”, “expect”,

“anticipate”, “believe”, “estimate”, “intend”, “scheduled” or “continue” or similar expressions. Any forward-looking statements contained in

this presentation are subject to significant risks, uncertainties, assumptions, contingencies and other factors (many of which are outside the

control of, and unknown to Telix, and its officers, employees, agents or associates), which may cause the actual results or performance to

be materially different from any future result so performed, expressed or implied by such forward-looking statements.

There can be no assurance or guarantee that actual outcomes will not differ materially from these statements. The data and results

pertaining to clinical subjects used in this presentation are illustrative of medical conditions and outcomes associated with potential

applications of Telix’s product pipeline. Actual results from clinical trials may vary from those shown. None of the products or potential

products described in this presentation have received a marketing authorization in any jurisdiction.

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Page 3: Precision Urologic Oncology

Company Snapshot

• Telix is a late-stage biotech developing an advanced pipeline of molecularly-targeted

radiation (MTR) products. Founded in 2015

• Clear unmet medical needs in high-value oncology segments, multi $Bn market opportunity

• Board : Kevin McCann (ex-Chairman, Macquarie Bank), Mark Nelson (Caledonia), Jann

Skinner (ex-PwC Partner), Oliver Buck (ITM Group), Andreas Kluge (ABX CRO)

• Melbourne (Australia) HQ with operations in USA, Europe and Japan – 50 headcount

• January 2017 : $8.5m in “seed” funding at 18c (equivalent)

• November 2017 : ASX IPO – raised $50m at 65c

• July 2019 : $45m financing (placement + SPP) at $1.30

Indication Diagnostic Therapeutic

Metastatic prostate cancer Pre-NDA Phase III

Renal (kidney) cell cancer Phase III Phase II

Brain cancer (glioblastoma) Phase I/II

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Page 4: Precision Urologic Oncology

• Management / Board ~30% of the company

• Predominantly institutional shareholder base: Fidelity, Portland, Acorn Capital, UV Cap

• Early revenue generation from prostate cancer imaging product

• Financed through to commercialisation of the first two products (prostate/renal imaging)

$1.52(25 July 2019)

Mkt. Cap: ~A$380m

Disease Focus Oncology

Clinical Stage Phase I - III

Shares on Issue ~250m

Options on Issue 17.7m

Cash on Hand ~AUD $60m

ASX Ticker TLX

Financial Snapshot

IPO Price: $0.65

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Page 5: Precision Urologic Oncology

Our Approach : Molecularly-Targeted Radiation (MTR)

MTR works by chemically

“linking” radioactive isotopes

to targeting molecules that

are very specific for cancer

cells. At low doses, this

enables the location of the

cancer cells to be pinpointed

using PET imaging. At high

doses the patient is very

effectively treated

We distinguish the term MTR

because there are many

“radiopharmaceuticals” that

are not targeted. Telix is

targeting agent agnostic – we

use both antibody and small-

molecule approaches

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Page 6: Precision Urologic Oncology

• Telix develops drugs that deliver targeted radiation directly to cancer. At low radiation dose (or using diagnostic nuclides), the patient can be imaged

At higher radiation doses (with therapeutic nuclides) the patient is treated

See it then Treat it…

TLX591-CDx (Prostate)1 TLX250-CDx (Kidney)2 TLX101 (Brain)3

Positron Emission

Tomography – “PET”

The use of

molecular imaging

with PET enables a

precision medicine

approach to

treatment through

better patient

selection and

personalized dose

optimization

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1 Courtesy of Dubai Nuclear Medicine & Molecular Imaging Center, UAE 2 Courtesy of Radboud University Medical Centre, Netherlands3 Courtesy of ZentralKlinik Bad Berka, Germany

Page 7: Precision Urologic Oncology

Nuclear Medicine’s Biggest Problem – Investment (or Lack Thereof)

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Page 8: Precision Urologic Oncology

What’s Changed?

• New isotopes (177Lu, 225Ac) that are user-friendly, “drug-like”

• Global supply chain evolved

• Out of the basement and into the outpatient setting

• “Next gen” oncologists love their PET scans

• Data sets grew in size, significance

• Bigger data demonstrated affirmed the astonishingdiagnostic and therapeutic benefit

• Pharma has realized that targeted radiation is a matchmade in heaven for immuno-oncology

• Decent transactions (Algeta, Endocyte, AAA, Sirtex, Blue Earth)

• The rest is history …

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Page 9: Precision Urologic Oncology

The “Awakening”

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177Lu-DOTATATE

SoC (Octreotide)

• NETTER trial (AAA)

was considered

ground-breaking in a

very challenging type

of cancer

• Impressive survival

benefit in NETs

• Difference between

comparator arms was

essentially just the 177Lu

Page 10: Precision Urologic Oncology

Telix’s Clinical PipelineR

enal

Pro

sta

teG

BM

Phase I Phase II Phase III Commercial

TLX250 (Girentuximab)

TLX591

TLX591-Cdx (PSMA-11)

TLX101-Cdx – Research Use Only

TLX250-Cdx (Girentuximab)

177Lu CA-IX Antibody

Isotope Target Agent

89Zr CA-IX Antibody

177Lu PSMA Antibody

68Ga PSMASmall

Molecule

131I LAT-1Small

Molecule

124I LAT-1Small

Molecule

Therapy

Imaging

Therapy

Imaging

Therapy

Imaging

Shaded arrows indicate the company’s development objectives over the next 18 months

CDx denotes “Companion Diagnostic”

TLX591

TLX591-Cdx (PSMA-11)

TLX101

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Page 11: Precision Urologic Oncology

Backup

Global Supply Chain and Distribution Network

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✓ Multiple commercial partnerships withleading global healthcare companies

✓ For clinical trials andearly commercialproduct roll-out

Page 12: Precision Urologic Oncology

Competitive Landscape

▪ Very few companies in the radiopharmaceutical / MTR space with a late-stage product pipeline. Telix is a unique company

▪ Moderate competition in prostate and GBM, zero meaningful competition in renal cancer for our drug class

▪ Novartis (Endocyte / AAA) : have a Phase III prostate cancer program. “Co-opetition” – Telix provides PSMA imaging for VISION trial

▪ Progenics : has both prostate imaging and therapy programs. Product profile for prostate therapy program is difficult due to use of 131I. Currently suing Novartis for IP infringement

▪ Bayer : antibody-based PSMA thorium conjugates. Nice data but clinically challenging to use and recent Xofigo® counter-indication for combo ADT may be a significant problem because 223Ra is a daughter decay product of 227Th

▪ Janssen : active, early stage (Phase I) prostate program with 225Ac

▪ Theragnostics : early-stage company, has tried to develop a “room temperature” prostate kit for 68Ga-PSMA. Clinical data is difficult to interpret

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Page 13: Precision Urologic Oncology

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TLX591 : Significant benefit … 40+ months of survival in mCRPC

TLX591

2x 45mCiPSMA-617*

(Novartis)

*Data from the German multi-center trial for PSMA-617 :

Rahbar et al. (JNM 2017)

Retrospective cross-

trial comparison

between PSMA-617

(Novartis) and TLX591

(Telix)

Median overall

survival (OS) is >40

months (Telix) vs 15

months (Novartis)

Survival data now

published in Cancer

(March ’19)

Overall Survival

(P=0.011)

Page 14: Precision Urologic Oncology

What has Telix Done Differently?

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Commercial

▪ Commitment to “theranostics”

▪ Disruptive pipeline with extensive clinical data – de-risk

▪ Properly fund the development

▪ Rapidly built a global supply chain / production network

Technical

▪ Developed scalable processes, automation

▪ Invested in linker technologies that give better product profiles, COGS

▪ Focus on chemistry that allows rapid room-temperature processes => enables production to be turned into consumables

Page 15: Precision Urologic Oncology

Our Secret Weapon : Australia

• Outstanding nuclear medicine, people

• Capable university labs / pre-clinicalfirepower

• World-class infrastructure

• Therapeutic Goods Administration (TGA) isfairly pragmatic

• A variety of manufacturing options fromclinical trial scale to scale-up

• Gov’t incentives

ANM Project

OPAL

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Page 16: Precision Urologic Oncology

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Page 17: Precision Urologic Oncology

Front-Intervention in Prostate Cancer : Surgery

~165,000

new cases

annually

(US)

~90,000

prostatectomies~40,000

recurrences

~30,000

deaths

Most common cancer in men (after skin cancer) and second

leading cause of death (after cardiovascular disease).

One in seven Australian (and Kiwi) men will get prostate cancer

(robotic surgery)

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Page 18: Precision Urologic Oncology

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Local DiseaseLocally

Advanced

Lymph Node

MetsDistant Mets

Low Risk Medium Risk High Risk

Active

Surveillance

Radical

Prostatectomy

Radical

Prostatectomy

Radical

ProstatectomyEBRT

EBRT +

Endocrine Tx

EBRTEBRT + LDR

Brachytherapy

EBRT + HDR

+ Endocrine Tx

LDR

Brachytherapy

EBRT +

Endocrine Tx Watchful

Waiting

Radical

P’tectomy ++

P’tectomy +

Endocrine TxEndocrine Tx

EBRT +

Endocrine Tx

EBRT +

Endocrine Tx

Bone Seeking

Agents

EBRT + HDR

+ Endocrine TxEndocrine Tx

Symptom

Oriented Tx

Watchful

Waiting

Active

Surveillance

Watchful

Waiting

Watchful

Waiting

Watchful

Waiting

Why is imaging important to PCa management?

A lot of watching and waiting…

EBRT = External Beam Radiation Therapy

“Typical” PCa treatment strategies (darker illustrate trend

toward systemic therapy).

Page 19: Precision Urologic Oncology

The Big Challenge : High Risk Men

Drugs(Chemo/Hormone

Therapy)

Years …

19

Bone scan

Page 20: Precision Urologic Oncology

Telix’s Solution? Superior imaging…

EVERYWHERE

Tumour Load Low Medium High

PSA Level 4.8ng/ml 454ng/ml 2860ng/ml

Before it

becomes

this:

If we can

find this:

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We give

prostate

cancer

patients

new

options.

Page 21: Precision Urologic Oncology

Two Ways to Product PET Tracers for Prostate Cancer Imaging

Cyclotrons. 18F is the most commercially used

isotope (2 hour half-life). Very high-scale

production but also high infrastructure /

operating cost, ageing install base. Scheduled

production means less patient flexibility and

challenging to deliver product to the “last mile”

Generators. For PET imaging we use 68Ge/68Ga

(gallium) generators. This is a portable radiation

source that “lives” in the hospital radiopharmacy

and is replenished every 6 months or so.

Convenient, dose-on-demand, easy to use. Lower

throughput but can be used anywhere. 68Ga has a

short half-life of 68 minutes which means that a

dose needs to be prepared very quickly

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Page 22: Precision Urologic Oncology

68Ga Generator-based complete kit

• Proprietary formulation of PSMA-11

• High quality (cGMP) production

• Use results in highly reproducible image quality

• Elution accessories included. Generator + kit = dose

Fast. Cost-Effective. Convenient. Accessible

• Patient-ready dose - 5 min. room temp incubation

• PET agent “on-demand” - minimises “no show” losses

• No synthesizer - equipment, process and time savings

• Superior use of 68Ga elution / activity

• Nuc pharmacy sufficient, no cyclotron required

Making PSMA Imaging Accessible

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Page 23: Precision Urologic Oncology

Adoption is Growing Fast …

8

1

38 1

5

3

7

1

5

5

12

Australia: 1

UAE: 1

3

49

✓ >100 sites around the world

use Telix’s product routinely

or in clinical trials

✓ Mostly large cancer centres

that are capable of doing

10-15 pts a week (upon

product approval)

✓ On track to deliver between

10,000 and 15,000 doses in

2019 (globally)

EU and US product approval

expected 1H 2020

*68Ga-PSMA-11 is an investigational product and

has not received marketing authorization in any jurisdiction 23

Page 24: Precision Urologic Oncology

TLX250-CDx (Renal Ca Imaging)

▪ 252 patient global phase III study, recruiting

▪ Imaging of ccRCC in pre-surgical patients

▪ 25 sites US/Europe/Australia/Canada

▪ Trial approved and recruiting in AU/FR/NL

▪ FDA IND submission planned Sept 2019

▪ Primary end-point : sensitivity/specificity for clear

cell RCC vs histology (from surgical resection)

89Zr-DFO-

girentuximab

Carbonic

Anhydrase IX

(CAIX)

>300 patients

imaged with124I, 89Zr

Phase III

(Confirmatory)

Benign

Malignant

ccRCC

▪ Prior Ph III trial

with 124I

▪ ZIRDOSE 124I

to 89Zr bridging

study complete

▪89Zr = superior

image quality,

clinical utility,

economics

NCT03849118

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Page 25: Precision Urologic Oncology

TLX250-CDx (Renal Imaging) Clinical Proposition

CT Scan TX250 PET

TX250 PET

Courtesy – Radboud Univ.

TX250PET Scan

Bone lesion

• TLX250-CDx re-stages about 30% of kidney cancer patients

• Optimise surgery / systemic therapy• No meaningful product competition• Selling synergies with IllumetTM

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Page 26: Precision Urologic Oncology

Near-Term Inflection Points

✓ End-July : report outcome on FDA pre-NDA meeting (24th of July) with

FDA for illumetTM (prostate imaging) – to discuss product approval

✓ End-July : Commercial / collaboration update for renal cancer therapy

program, including finalization of STARLITE Phase II protocols (combo

immuno-oncology programs)

✓ End-Aug/Early-Sept : FDA guidance on Phase III PROSTACT prostate

cancer therapy trial design, commencement in Australia (subject to

TGA approval)

✓ End-Sept/Early-Oct : Initial stage of IPAX-1 (glioblastoma therapy)

study expected to complete

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Page 27: Precision Urologic Oncology

www.telixpharma.com