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Precision Oncology

See it. Treat it.

Investor Presentation
JP Morgan Virtual Healthcare Conference, January 2022
Disclaimer

The information contained in this 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 may contain 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 directors, 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.

Telix’s lead product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been approved by the Australian Therapeutic Goods Administration (TGA), and the U.S.
Food and Drug Administration (FDA). Telix is also progressing marketing authorisation applications for Illuccix in the European Union and Canada. With the exception
of Illuccix in the US and Australia and Scintimun®, none of Telix’s products have received a marketing authorisation in any jurisdiction.

Full prescribing information for Illuccix can be found at http://illuccixhcp.com/s/illuccix-prescribing-information.pdf

Telix Pharmaceuticals Limited (ASX: TLX) 2


An established global leader in radiopharmaceuticals

Extensive portfolio of diagnostic and


therapeutic assets with compelling
clinical data

12,150 patient doses in past 12 months1

FDA approval for TLX591-CDx (Illuccix®)2

18 active clinical studies (8 indications)3

Leading supply chain and


distribution network
80 countries in the Telix distribution network

11 countries with a manufacturing footprint

1. Clinical trial doses and magisterial / compassionate use of TLX591-CDx. 12 months from Q4 2020 3. Includes partnered investigator-led studies.
2. United States Food and Drug Administration – ASX 20/12/21
Telix Pharmaceuticals Limited (ASX: TLX) 3
Our strategy: See It. Treat it.
Personalised, precision medicine

Targeted radiation delivery Systemically administered Imaging PET1 scanner TLX591-CDx2


(Prostate cancer)

Unique cancer cell


signature (target)
68Ga, 89Zr

(diagnostic isotopes)
Enables PET
images of cancer

TLX591
Therapy (Prostate cancer)

Radioactive
isotope
Targeting agent
(a small molecule or antibody) 177Lu, 131I, 225Ac
binds selectively to a (therapeutic isotopes)
cancer cell
Enables precise radiation
delivery to the cancer
1. Positron emission tomography
2. Courtesy of Ammar Chaudhry MD, City of Hope, Duarte CA, USA.
Telix Pharmaceuticals Limited (ASX: TLX) 4
Radiation has never been more important in cancer care
Underpinned by the shift from radiation “in a box” to radiation “in a shot”

The evolution from external-beam radiation to From a ‘box’ To a ‘shot’


systematically-delivered and targeted radiation is
transforming the role of radiation in cancer care

• Synergy between imaging and therapy


• Broad cancer utility
• Potential to enhance existing drug
classes (androgens, taxanes etc.)
• A vitally important “primer” for
immuno-oncology
• A future cornerstone modality for
gene/cell therapy conditioning

Telix is driving the integration of nuclear medicine and medical oncology with more
targeted and personalised therapy and patient-friendly dosing regimens

Telix Pharmaceuticals Limited (ASX: TLX) 5


Telix is pioneering a new cancer modality
Kidney Cancer
Glioblastoma
Ph Name Asset Dx/Tx
Ph Name Asset Dx/Tx
III TLX250-CDx Dx
I/II TLX101 Tx
I/II TLX250-CDx Dx
Breast Cancer II (IIT) TLX250 Tx
Ph Name Asset Dx/Tx II (IIT) TLX250 Tx
II OPALESCENCE (IIT) TLX250-CDx Dx

I Emory University (IIT) TLX591-CDx Dx Prostate Cancer

Lung and Ovarian Cancers Ph Name Asset Dx/Tx


Ph Name Asset Dx/Tx III University of Linz (IIT) TLX591-CDx Dx
I Royal Adelaide (IIT) APOMAB Dx/Tx
II Emory University (IIT) TLX591-CDx Dx

Bone Marrow Conditioning II (IIT) TLX591-CDx Dx

Ph Name Asset Dx/Tx II Mem. Sloan Kettering (IIT) TLX591-CDx Dx


I/IIa (IIT) TLX66 Tx
N/A* TLX599-CDx Dx

Bladder Cancer III TLX591 Tx

Ph Name Asset Dx/Tx I TLX592 Tx


I ZiP-UP (IIT) TLX250-CDx Dx *Registry study
I PERTINENCE (IIT) TLX250-CDx Dx
Telix Pharmaceuticals Limited (ASX: TLX) 6
Core pipeline: oncology & rare diseases

Shaded arrows indicate completion expectations in the next 12 months. *Registry Study

1. Prostate-specific membrane antigen. 3. Large amino acid transporter 1 5. Cluster of differentiation 66.
2. Carbonic anhydrase IX. 4. Bone marrow conditioning and rare disease.
Telix Pharmaceuticals Limited (ASX: TLX) 7
Strategic Priorities

Use Illuccix as a Create a high-value Deliver on commercial Expand the


commercial launchpad diagnostic portfolio value of therapeutics pipeline

Establish Telix’s Kidney cancer imaging Advance late-stage assets in Novel targets, clinical
leadership in urologic agent addresses major the core pipeline that benefit applications and
oncology unmet need, builds on from diagnostic market manufacturing
Illuccix engagement entrance technologies

Telix Pharmaceuticals Limited (ASX: TLX) 8


Focus for 2022
Unlocking the value in our pipeline

• US reimbursement
Illuccix global rollout • Additional global approvals including EU/UK, Canada
• Commercial launch from late Q1 (US and AU)

• Kidney cancer (TLX250-CDx) Phase III readout


Commercialise diagnostics • Prepare for US regulatory filing for TLX250-CDx
• US filing planned for brain cancer imaging product

• ProstACT studies active globally


Advance core therapeutics • Kidney cancer combination therapy Phase II studies
• Initiate Phase II studies in TLX101 and TLX66

• Seneffe manufacturing / R&D buildout to commence


Pipeline & manufacturing • Focus on strategic deals and in-licensing
• Advance early-stage alpha therapy programs

Telix Pharmaceuticals Limited (ASX: TLX) 9


Recent milestones and near-term catalysts

Recently completed milestones Upcoming milestones: Q1 2022


• Illuccix regulatory approvals granted in US • Illuccix commercial launch US and AU
and Australia • US reimbursement for Illuccix:
• HCPCS1 reimbursement submitted for Illuccix • Pass-through code submission (March 2022)
in the US • HCPCS code for US reimbursement
• ProstACT patient recruitment commenced expected 1 April 2022
• Distributors finalised for major EU markets • Illuccix EU marketing authorisation decision
(subject to regulatory approval) • ZIRCON Phase III study enrolment completed
• FDA Investigational New Drug (IND) granted • IPAX-2 Phase II study launched (glioblastoma)
for STARLITE 1 & 2 studies
• STARLITE Phase II kidney cancer therapy
studies progressed

1. Healthcare Common Procedure Coding System

Telix Pharmaceuticals Limited (ASX: TLX) 10


Illuccix® Imaging
Launching in Q1 2022

Telix Pharmaceuticals Limited (ASX: TLX) 11


Illuccix® is now approved in the United States
Indication and usage information

Illuccix is a kit for the preparation of gallium-68 (68Ga)


gozetotide (also known as PSMA-11) injection, a radioactive
diagnostic agent indicated for positron emission tomography
(PET) of prostate-specific membrane antigen (PSMA) positive
lesions in patients with prostate cancer with:

• Suspected metastasis who are candidates for


initial definitive therapy;
• Suspected recurrence based on elevated serum prostate-
specific antigen (PSA) level.

Important Safety Information:


https://www.illuccixhcp.com/important-safety-information

Please see full Prescribing Information at


http://illuccixhcp.com/s/illuccix-prescribinginformation.pdf

Telix Pharmaceuticals Limited (ASX: TLX) 12


Market opportunity for prostate imaging is expanding
Due to growing incidence rates and practice guidelines

Potential clinical utilisation:


US (REVISED)
1. Primary staging in newly diagnosed high-risk prostate 194,5101
cancer (NCCN) US (PRIOR)
146,000 57,000
2. Biochemical recurrence following prostatectomy or
radiation therapy (NCCN)
3. Monitoring of response to systemic therapy (Future) (1) 55,000

4. Patient selection for targeted radio-ligand therapy (Future) 74,000

(2) 52,000
35,000
(3) 22,000
(4) 17,000 28,000

US total addressable market (TAM) value USD $575M USD $725M

TAM value including EU2 USD $900M USD $1,08B

1. American Cancer Society. Cancer Facts & Figures 2021. Atlanta, GA: American Cancer Society; 2021.
2. EU countries included in MAA submission to Danish Medicines Authority on 30 April 2020.
Telix Pharmaceuticals Limited (ASX: TLX) 13
Commercial launch plans - US
Commercial ramp up during Q1 2022
Positioned to capture meaningful market share
• Access to ~90% of eligible PET sites
• Distribution network holds 60% market share of nuclear medicine
market in the US
• On-demand pharmacy-based production with a
high yield product
• Customer and patient scheduling flexibility

Market access strategy in place, commercial launch underway


• Q1 focus on early adopters – imaging centers and veteran affairs
• 400 imaging centres pre-qualified
• Telix + partners will have one of the largest commercial teams
(including sales, market access, MSL) to service the US prostate
imaging market

Telix / partner sites


On track for reimbursement in H1 2022
• HCPCS1 code expected 1st April 2022 Current competitor sites
(4 November 2021)
• Transitional Pass-Through (TPT) status expected 1st July 2022

1. Healthcare Common Procedure Coding System

Telix Pharmaceuticals Limited (ASX: TLX) 14


PSMA-PET imaging emerging as standard of care in prostate cancer
Inclusion in guidelines are driving clinical adoption and reimbursement

• National Comprehensive Cancer Network Guidelines® (NCCN Guidelines)


include Ga-68 PSMA-11 PET/CT to be considered as an alternative to
standard imaging of bone and soft tissue1

• Conventional imaging no longer a necessary prerequisite to PSMA-PET


• Aligns with indication for detection of unfavourable intermediate, high
and very high risk as well as recurrent prostate cancer

• Society of Nuclear Medicine and Molecular Imaging (SNMMI) updated


Appropriate Use Criteria (AUC) recognises higher accuracy in the initial
staging evaluation2

• Two of the four main Radiology Benefit Managers (RBMs) - AIM Specialty
Health3 and NIA Magellan4 – are now recommending PSMA-PET
representing a significant portion of commercial payor (health insurance)
reimbursement policies

1. NCCN® Prostate Cancer Guidelines Update, Version 1.2022 – 10/09/21


2. SNMMI AUC for PSMA-PET Imaging: https://www.snmmi.org/ClinicalPractice/content.aspx?ItemNumber=38657
3. AIM Clinical Appropriateness Guidelines, Advanced Imaging. AUC: Oncologic Imaging (Effective 7/11/21).
4. National Imaging Associates Magellan Clinical Guidelines For Medical Necessity Review, Advanced Imaging Guideline (Effective 01/01/22)

Telix Pharmaceuticals Limited (ASX: TLX) 15


The NOBLE Registry (TLX599-CDx): Nobody left behind
Improving access to PSMA imaging – beyond Illuccix

Chair
• Collaboration to investigate utility
of 99mTc-iPSMA SPECT1 imaging
in prostate cancer
• Global consortium of clinical sites
and investigators with experience
using 99mTc-iPSMA
• Geographic focus on developing
markets or remote regions where Dr. Ryan
Yudistiro
access to PET imaging is limited2 Dr. Akintunde
Orunmuyi
Indonesia

Nigeria

• Isotope (99mTc) supply chain well


established and inexpensive
• Rapid expansion planned
including APAC Peter Tually
Australia

Dr. Mike Sathekge


South Africa

1. Single photon emission computed tomography


2. Worldwide SPECT cameras outnumber PET by 4:1 (MEDraysintell 2021)
Telix Pharmaceuticals Limited (ASX: TLX) 16
1.
Renal cancer program
A clinical leadership opportunity
in diagnostics and therapy

Telix Pharmaceuticals Limited (ASX: TLX) 17


TLX250-CDx / TLX250 overview
An exciting target, with potential application beyond kidney cancer

• Target: Carbonic Anhydrase IX (CAIX / CA9)


Target: Dx Tx
• Indication: Kidney cancer (clear cell renal cell carcinoma, ccRCC) CAIX / CA9 (TLX250-CDx) (TLX250)
• Development status:
• TLX 250-CDx: Phase III ZIRCON diagnostic imaging study Targeting
Antibody Antibody
nearing completion molecule

• TLX250: Phase II STARLITE 1 & 2 therapeutic studies


(in combination with immunotherapy) initiated Targeting DFO- DOTA-
agent girentuximab girentuximab
• Rationale:
• CA9 is over-expressed in mutated ccRCC and many hypoxic solid Radionuclide 89Zr 177Lu
tumors, with low expression in most normal tissue.
• Tumour hypoxia correlates with progression and resistance
to therapy
• Potential for targeted radiation to enhance the effect of
existing ccRCC therapies such as immunotherapy
• Limited competition in imaging, optimises surgical management

Telix Pharmaceuticals Limited (ASX: TLX) 18


Building a high-value diagnostics portfolio
“Breakthrough Therapy” designation, clinical leadership opportunity
• Biologics License Application (BLA) consultation
process has commenced, Phase III study in final stages
of enrolment
• TLX250-CDx is an investigational product being developed
for the imaging of clear cell renal cell carcinoma (ccRCC)
with PET/CT
• Current options for patients are limited, potential for clinical
leadership with a non-invasive imaging modality for ccRCC
• Being studied as an imaging agent assessing ability to
determine if “indeterminate renal masses” are malignant
through improved, whole of body imaging
• May aid decision making and avoid unnecessary surgical
intervention An example of PET/CT imaging showing the uptake of
89Zr-girentuximab in a primary renal mass. The insert
• Opportunity to follow prostate cancer imaging, with a second
high-value product for the genitourinary (GU) oncology field shows the identification of a metastatic lesion of the
proximal radius, confirmed as ccRCC upon biopsy.1

1. Hekman et al, European Urology. 2018.

Telix Pharmaceuticals Limited (ASX: TLX) 19


TLX250-CDx: delivering an unmet need in kidney cancer imaging

• Total addressable
market value in US
and Europe estimated
Yearly estimated
at US$300-400M Yearly new cases,
number of deaths,
worldwide, both
• Potential for market worldwide, both
sexes, all ages
leadership, given sexes, all ages
limited patient options 431,288 179,368
• Addresses a major
unmet medical need
for more accurate
patient staging

Telix Pharmaceuticals Limited (ASX: TLX) 20


ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC
Study overview

Eligible Patients
• Single indeterminate renal mass ≤7cm Surgical removal
TLX250-CDx
diameter on CT or MRI suspicious for ccRCC & histology as
PET/CT scan
• Scheduled for surgical removal as part of standard of truth
management plan

• International, multi-centre, Phase III trial in ~252 patients with an indeterminate renal mass suspicious of ccRCC
• Primary endpoint: Sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect ccRCC
in patients with indeterminate renal masses, using histology as standard of truth (after surgical removal)
• 35 sites participating
• > 85% recruited, progressing well towards completion
• United States, Canada, Europe, Turkey, Australia
• ZIRDAC-JP Phase I/II bridging trial of TLX250-CDx in Japan
• Phase I objectives met, Phase II in planning, potential to include Chinese patients to expand Asian utility

Telix Pharmaceuticals Limited (ASX: TLX) 21


STARLITE 2 Phase II trial of TLX250 for Treatment of ccRCC
TLX250 in combination with immunotherapy
• STARLITE 2 now actively recruiting (screening patients)
• Phase II trial of TLX250 plus nivolumab in with ccRCC who have progressed
following prior immunotherapy
•NCT03849118
Evaluates TLX250-delivered radiation as an immune system “primer”
NCT03849118
• Targets carbonic anhydrase IX (CA9) – a protein highly expressed in
patients that are likely to demonstrate a more limited response to cancer
immunotherapy
• Primary endpoint
• To determine the safety and efficacy of combination therapy with 177Lu-
girentuximab (TLX250) FDA Investigational New Drug Application (IND)
accepted for STARLITE 2 study, being undertaken at Memorial Sloan
Kettering Cancer Centre

• Additional Phase II study – STARLITE 1 - (first-line combination study) to be


initiated at a second US site (awaiting ethics approval)

CA9 expression is correlated with


the presence of tumour-infiltrating
1. Giatromanolaki et al. British Journal of Cancer. 2020. lymphocytes, which may confer
resistance to immunotherapy.1 22
Telix Pharmaceuticals Limited (ASX: TLX)
CA9 indication expansion
New understanding leads to potential for applications beyond kidney cancer

• A transmembrane protein and a


tumor-associated carbonic anhydrase Potential Indication Status
isoenzyme
• Over-expressed in mutated ccRCC Bladder or Urothelial Cancer Commenced
and many hypoxic solid tumors, with
low expression in most normal tissue
Triple Negative Breast Cancer Commenced
• High expression in tumours including
bladder or urothelial, breast, brain,
cervix, colon, esophagus, head and Lung Cancer Planned
neck, lung, ovarian, pancreatic and
vulval cancers
Ovarian Cancer Planned
• Imaging is being used to “indication
scout” for future therapy applications,
highlight the value of a “theranostic” Colorectal Cancer Planned
approach
Head and Neck Cancer Planned

Pancreatic Cancer Planned

Telix Pharmaceuticals Limited (ASX: TLX) 23


Prostate cancer therapy
Our vision for prostate cancer

Telix Pharmaceuticals Limited (ASX: TLX) 24


Prostate cancer therapy assets overview
Next-generation therapy to follow TLX591

• Target: Prostate Specific Membrane Antigen (PSMA)


Target: PSMA TLX591 TLX592
• Indication: Prostate cancer
• Clinical status:
• TLX591: ProstACT GLOBAL Phase III + ancillary studies Targeting Engineered
recruiting Antibody
molecule Antibody
• TLX592: CUPID study enrolling patients for imaging initially –
next-generation PSMA-directed alpha therapy Targeting DOTA-
RADmAb®
• Rationale: agent rosopatamab

• Unmet need for treatment options for late-stage, metastatic


patients specifically target both soft tissue and bony lesions Radionuclide 177Lu 225Ac

• Antibody-based PSMA treatment may deliver superior


efficacy and side-effect profile compared to small molecule
• TLX592 a potential adjuvant for high-risk patients that may
have early metastatic disease. May also have utility in
patients progressing from conventional 177Lu-PSMA Tx

Telix Pharmaceuticals Limited (ASX: TLX) 25


ProstACT program overview
Multiple opportunities to deliver insights into TLX591

Radiogenomics study
• ~50 patients SELECT (Ph I) – radiogenomics
• 1st line metastatic study enhances patient selection
prostate cancer (mCRPC) and supports indication expansion
Treat the scan
• Rapid recruitment Correlation between imaging and therapy to optimise patient selection based on a “theranostic” approach

Combination with EBRT


in oligometastatic early
recurrence (Phase II) TARGET (Ph II) – in partnership
• ~50 patients with GenesisCare, evaluates
• Co-funded by TLX591
GenesisCare Early data in front line care in a front-line setting
Efficacy data in patients in their first recurrence

Pivotal Phase III study in


patients with mCRPC GLOBAL (Ph III) – Multiple data
progressing on 1st line read-outs throughout the ProstACT
novel androgen agents program duration
• 390 patients TLX591 + Standard of Care (SoC) vs. SoC alone
• 2nd line mCRPC

Telix Pharmaceuticals Limited (ASX: TLX) 26


ProstACT GLOBAL Phase III study
Pivotal trial

TLX591 + Standard of Care (SoC) vs. SoC alone​

Eligible Patients TLX591 + Standard of


care therapy
• PSMA avid (defined by TLX591-CDx)
• mCRPC1
Standard of care therapy
• Progressed despite prior therapy with NAAD2
alone

• International, multi-centre, Phase III RCT in ~390 patients with PSMA-expressing metastatic prostate cancer
(mCRPC), experiencing disease progression following prior treatment with an anti-androgen drug (NAAD)
• Primary endpoint: radiographic progression-free survival (rPFS)
• Secondary endpoints include: overall survival, quality of life, safety
• 2:1 randomisation and enrichment of study population, patient selection with TLX591-CDx
• Status: ProstACT GLOBAL has been initiated in Australia and will add EU, US and potentially Chinese sites
over the next six months, subject to satisfying the requisite regulator approvals

1. Metastatic castrate-resistant prostate cancer


2. Novel androgen axis drug
Telix Pharmaceuticals Limited (ASX: TLX) 27
ProstACT SELECT Phase 1 study
Enhances patient selection and supports indication expansion
Treat the scan
Correlation between imaging and therapy to optimise patient selection

Eligible Patients TLX591 + Standard of


care therapy
• PSMA avid (defined by TLX591-CDx)
Comparative imaging
• mCRPC
between 68Ga-PSMA and
• Progressed despite prior therapy with NAAD 177Lu -PSMA

• Ph I study of TLX591 for the treatment of mCRPC


• Multi-centre, multinational Phase I radiogenomics study in Australia and New Zealand in ~50 patients, comparing
68Ga-PSMA and 177Lu-PSMA, specifically confirming the similarity of small molecule and antibody-based targeting

• Radiogenomics study to enhance patient selection for ProstACT GLOBAL and support indication expansion for
Telix’s PSMA therapeutic portfolio, based on a “theranostic” approach
• Primary endpoints: biodistribution, safety and tolerability
• Secondary endpoints include: correlation between imaging and therapy molecules, radiographic
progression-free survival, PSA response
• Status: Actively recruiting (screening patients)
Telix Pharmaceuticals Limited (ASX: TLX) 28
ProstACT TARGET Phase II study
Expanding clinical data to include a front-line setting
Early data in front line care In partnership with:
Efficacy data in patients in their first recurrence

Eligible Patients
TLX591 + External Beam
• PSMA avid (defined by TLX591-CDx) Radiation Therapy
• Oligometastatic early recurrence (EBRT)

• Single arm Phase II study in Australia in 50 patients with PSMA-expressing biochemically recurrent oligometastatic
prostate cancer, in combination with external beam radiation therapy (EBRT)
• To determine the efficacy, biodistribution and combination dosimetry of TLX591 plus EBRT, including dose to tumour
• Primary endpoint: radiographic progression-free survival
• Secondary endpoints include: overall survival, quality of life, safety
Eligible Patients
• Status: Patient screening to commence early 2022 (subject to ethics approval)

Telix Pharmaceuticals Limited (ASX: TLX) 29


TLX591 differentiation
Potential advantages with PSMA antibody approach

Potential for improved overall survival (OS) in advanced metastatic disease, with
Efficacy
40+ months OS reported to date1

Reduced potential for off-target side-effects; dry eye, xerostomia (salivary gland
Patient comfort
ablation), back pain (ganglia irradiation)

Patient-centric Short treatment duration/significantly fewer hospital visits – two weeks total
regimen vs. 36 weeks, supports close supervision by medical oncology

Significantly lower 177Lu isotope requirements with commensurate reduction in


Cost effective
COGS, expected to also be available in “cold kit” format

1. Tagawa et al, Cancer 2019.

Telix Pharmaceuticals Limited (ASX: TLX) 30


TLX591 patient experience
Off-target irradiation – quality of life matters

TLX591 Lacrimal, Parotid, Small molecule


Submandibular
Antibodies are functionally (salivary) glands Small molecule
specific for tumour-expressed radioligands taken
PSMA and do not “hit” most up by endogenous
endogenous PSMA expression PSMA
Spleen, Liver
Additional off-target
Liver (preferred effects with small
Kidneys,
clearance organ) molecule radioligands
Small bowel
(not experienced with
Fecal excretion TLX591):
Bladder • Dry eye
(urinary excretion) • Xerostomia
• Back pain from
ganglia irradiation

Data courtesy of Prof. Neil Bander, WCMC.

Telix Pharmaceuticals Limited (ASX: TLX) 31


Our long-term vision for prostate cancer
Improving access, imaging and treatment options for patients

• Further development of the PSMA target underpins our lifecycle


management strategy for prostate cancer and vision to improve
patient outcomes

• PSMA pipeline includes imaging, therapy and surgical tools

• NOBLE Registry (PSMA-SPECT tracer): TLX599-CDx


(99mTc-iPSMA) – PSMA imaging access for patients in
developing and remote areas, where PET is not readily
available

• Next-generation alpha therapy: TLX592 (225Ac-


RADmAb®) – high potency, complementary to TLX591

• Image guided surgery: TLX591-Sx (68Ga-PSMA-IRDye) -


dual-labelled PET-optical tracer for image guided surgery,
enables real-time cancer detection1

1. Imaging and Robotics in Surgery Alliance with Mauna Kea Technologies.

Telix Pharmaceuticals Limited (ASX: TLX) 32


Our clinical mission: support the patient every step of the way

Localised disease Advancing clinical stages Metastatic castrate resistant


Radiation therapy +/- ADT Docetaxel, abiraterone (metastatic, First line:
Radical prostatectomy non-castrate), apalutamide, Docetaxel; Sipuleucel-T; Abiraterone
PSA Active surveillance enzalutamide, darolutamide Enzalutamide PSMA-617 failures
level (non-metastatic, castrate resistant)
68Ga / 99mTc

imaging
Rising PSA Radiogenomics and
ADT (non-castrate) tumour targeting of
Combination of EBRT TLX591
and TLX591 in early
biochemical recurrence Second line +
Clinical trial
Second line:
TLX592 (225Ac) Cabazitaxel; Abiraterone
Enzalutamide; Radium 223
Olaparib; Rucaparib

Pivotal Phase III study in patients with


mCRPC progressing on 1st line novel
androgen agents

Asymptomatic Symptomatic
Non-metastatic Metastatic
Castration-sensitive Castration-resistant
Time / disease progression

Telix Pharmaceuticals Limited (ASX: TLX) 33


CUPID trial
Next-generation alpha therapy, complements TLX591
Study with 64Cu-TLX592 to show biodistribution and tumour targeting
prior to targeted alpha therapy (TAT) with 225Ac-TLX592

Eligible Patients 225Ac-TLX592


64Cu-TLX592
• Prostate cancer patients with low-burden TAT
metastatic disease at ≤ 5 sites as detected PET/CT scan
using PSMA PET/CT scanning (TLX591-CDx) Subject to positive
outcomes with 64Cu

• TAT is becoming an important area of PSMA therapy research, particularly in men that are no longer responding to 177Lu

• TLX592 antibody re-engineered to clear ~10x faster from the body, while maintaining specificity for tumour-expressed
PSMA (liver cleared, no exocrine uptake)
• Designed for delivering TAT (225Ac) intended for:
i) Early-stage metastatic disease (e.g. biochemical recurrence (BCR)) and
ii) Late-stage disease when 177Lu-PSMA therapy is no longer providing treatment efficacy
• Single arm, open-label, first-in-human (FIH) study of 64Cu-TLX592 in men with metastatic prostate cancer using PET
• Primary endpoint: Determine the safety and tolerability, pharmacokinetics, whole body biodistribution and
radiation dosimetry of 64Cu-TLX592 using PET as a proxy for 225Ac-TLX592 TAT
• Status: Actively recruiting – multiple patients dosed in imaging phase
Telix Pharmaceuticals Limited (ASX: TLX) 34
Rare diseases program
High potential, high impact

Telix Pharmaceuticals Limited (ASX: TLX) 35


TLX101-CDx / TLX101 overview
Orphan designation status granted for imaging and therapy candidates

• Target: Large amino acid transporter 1 (LAT-1) Dx


Tx
• Indication: Glioblastoma multiforme (GBM) Target: LAT-1 (TLX101-
(TLX101)
CDx)
• Clinical status:
• TLX101-CDx: Progressing towards new drug application (NDA)
Targeting molecule Small molecule Small molecule
filing in 2022
• TLX101: IPAX-2 follow-on Phase I/II study in newly diagnosed
patients commencing in 2022 Fluoroethyl)-L- 4-L-[131I] Iodo-
Targeting agent
tyrosine (FET) Phenylalanine
• Rationale:
• TLX101-CDx: FET-PET demonstrated to provide greater
Radionuclide 18F 131I
diagnostic sensitivity compared to standard imaging procedures
• TLX101: Poor prognosis with few treatment options. Promising
overall survival data in IPAX-1 study warrants further
investigation in earlier stage patients

Telix Pharmaceuticals Limited (ASX: TLX) 36


IPAX-I Phase I/II trial of TLX101 for the treatment of GBM1
TLX101 in combination with EBRT2
• Multi-centre Phase I/II trial of TLX101 in combination with EBRT in patients with recurrent GBM
• Primary endpoint: Safety and tolerability
• Secondary endpoints include: MTD3, efficacy, dosimetry
NCT03849118
NCT03849118
• First-peer review data presented at Congress of Neurological Surgeons (CNS) Annual Meeting
in October 2021
• All patients evaluated received similar total activity dose of ~2GBq (2000 MBq) of TLX101,
either in a single administration or a triple-fractionated regime.
Baseline PET scan
• Treatment well tolerated, typically grade 1 – 2 adverse events
• Evidence of anti-tumour effect from both imaging and clinical assessment
• Overall survival (OS) on this interim analysis shows median 15.97 months to date
• 6/10 patients still alive and will be followed until 1 year after dosing for the final OS
calculation (May 2022)

. Day 45 PET scan post


TLX101 therapy
1. Glioblastoma Multiforme. 3. Maximum tolerated dose.
2. External beam radiation therapy
Telix Pharmaceuticals Limited (ASX: TLX) 37
Building on the IPAX-1 experience
IPAX-2 will evaluate TLX101 in newly-diagnosed patients
• Progression of TLX101 program into front-line setting, Phase I/II study
expected to commence in Q1 2022
• Initial dose finding study TLX101 plus standard of care (SOC) in patients with
newly diagnosed glioblastoma, after surgery
NCT03849118
NCT03849118
• Evaluates the potential for DNA damage from targeted radiation using TLX101 to
enhance SOC radio-chemotherapy for newly diagnosed glioma
• Study objectives expected to include:
• Maximum tolerated dose
• Safety and tolerability in combination with the Stupp regimen (SOC)
• 12 months overall survival rates
• Progression free survival at a range of treatment intervals
• Single-arm, multi-centre trial, expected to enrol 12-15 patients in Phase I
• Patients to be treated and monitored for up to 64 weeks

Telix Pharmaceuticals Limited (ASX: TLX) 38


TLX66 CD-X / TLX66 overview
Application across a range of conditions requiring bone marrow conditioning

• Target: CD66 (Cluster of differentiation 66) Dx


Tx
• Indication: Target: CD66 (TLX66-
(TLX66)
CDx)
• TLX66-CDx: Scintigraphic bone imaging
• TLX66: Bone marrow conditioning for systemic amyloid
Targeting molecule Antibody Antibody
light chain amyloidosis
• Development status:
• TLX66-CDx (Scintimun®): Approved in EU DOTA-
Targeting agent besilesomab
besilesomab
• TLX66: Phase I TRALA study completed in 2021, planning for
Phase II study in progress
Radionuclide 99mTc 90Y
• Rationale:
• TLX66-CDx: Lower cost, faster than white blood cell labelling
(current standard). Data from >100,000 patients in Europe to
support regulatory filing in US.
• TLX66: Significantly reduced toxicity and tolerability compared to
chemo-ablative approaches, potential to treat patients ineligible
for SoC (e.g., older patients, co-morbidities, children)
Telix Pharmaceuticals Limited (ASX: TLX) 39
New hope in a rare disease
Progressing development of TLX66 in bone marrow conditioning
• SALA1 is a rare disease with a poor prognosis (median survival ~11 months if untreated)
• Plasma cells in the bone marrow produce abnormal protein called ‘amyloid’ which accumulates
Faulty
in the organs and causes them to fail plasma cells
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•NCT03849118
Prevalence of ~30,000 to 45,000 (US + EU combined) patients, ~US$600M TAM2 in US and ‘EU5’
• Current standard of care comprises induction therapy (cyclophosphamide, bortezomib,
dexamethasone) plus high dose melphalan BMC3, followed by HSCT4, 5
Free antibody
• A novel monoclonal antibody, daratumumab has potential as an initial therapy for patients but is light chain
not curative or suitable for all patient populations

• TRALA study: Phase I trial of 90Y-besilesomab (TLX66) in SALA


• Primary endpoint: Safety and toxicity of 90Y-besilesomab as the sole BMC regimen for Amyloid
protein
autologous HSCT in patients with SALA accumulates
in organs
• Study complete, preliminary data (9 pts) demonstrated 100% engraftment and high PR/CR
rate (5/2) survival data. Regulator consultation in progress for next phase of development
Organ failure, death
1. Systemic amyloid light chain amyloidosis. 4. Hematopoietic stem cell transplant.
2. Total addressable market. 5. Venner C, et al. Blood. (2012) 119 (19): 4387–4390.
3. Bone marrow conditioning. 6. https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-002231-18/GB
Telix Pharmaceuticals Limited (ASX: TLX) 40
Future value creation
Focus on innovation and growth markets

Telix Pharmaceuticals Limited (ASX: TLX) 41


Near-term growth opportunities
Expansion into new geographic markets

• China Grand Pharma partnership


• NMPA consultations have
commenced (Mainland China)
• Regulatory filings for Illuccix Q1
2022 (Taiwan, Hong Kong)

• Largest Asia Pacific market


opportunity
• Key bridging clinical trials have
been successfully completed
(TLX591-CDx & TLX250-CDx)
• Launch Illuccix with distribution • DuChemBio partnership
partner (in progress) • NECA HTA1 completed
• NOBLE Registry expansion • Illuccix kit sales have
commenced, pursuing
1. National Evidence-based Healthcare Collaborating Agency. Health Technology Assessment. reimbursement
Telix Pharmaceuticals Limited (ASX: TLX) 42
Buildout of the Brussels (Seneffe) manufacturing facility
Vertical integration in Europe

• Seneffe will serve as the primary EU manufacturing site


for Telix’s products

• Will also be used manufacture 131I-based products for export


NCT03849118
(i.e. TLX101) using Belgian-sourced isotopes (Belgium is a
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major global supplier)

• Provides certainty / control over supply chain

• Seneffe will be an integral part of Telix’s EU R&D capability

• Enables the capture of intellectual property that is intrinsic in


manufacturing scale-up of this class of products
• First legacy cyclotron removed October 2021, second in
November 2021
• New buildout has commenced

Telix Pharmaceuticals Limited (ASX: TLX) 43


Future research and innovation focus

Targeted alpha MTR1 + Tumour Artificial Radio-guided


therapy immuno-oncology microenvironment intelligence (AI) surgery

"Next Generation" MTR sets the Combining MTR with Tools to Bringing molecular
therapeutics with “groundwork” for standard of care maximise clinical imaging into the
alpha-emitting cancer treatments for insights gained from operating room (OR)
radioisotopes immuno-therapy in improved efficacy with imaging, link to
combination biomarker-driven therapeutic outcomes
patient selection
1. Molecularly targeted radiation
Telix Pharmaceuticals Limited (ASX: TLX) 44
Precision Oncology
See it. Treat it.

www.telixpharma.com
IR contact: Kyahn Williamson
Email: [email protected]

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