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Telix Pharmaceuticals Ltd Investor Presentation 2021

Nov 15, 2021

31324_rns_2021-11-15_7007c7de-6d00-4b49-98e1-67bf5fb754d0.pdf

Investor Presentation

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Precision Oncology See it. Treat it.

Investor Presentation

November 2021

Disclaimer

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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 accepted for filing by 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 Australia and Scintimun®, none of Telix’s products have received a marketing authorisation in any jurisdiction.

Telix Pharmaceuticals Limited (ASX: TLX)

An established global leader in radiopharmaceuticals

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Extensive portfolio of diagnostic and therapeutic assets with compelling clinical data

12 150 patient doses in past 12 months[1] , 1st marketing authorisation approval for TLX591-CDx (Illuccix[®] ) received[2]

17 active clinical trials (7 indications)[3]

Leading supply chain and distribution network

80[countries in the Telix distribution network] 11[countries with a manufacturing footprint]

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  1. Clinical trial doses and magisterial / compassionate use of TLX591-CDx. 12 months from Q4 2020

  2. Therapeutic Goods Administration (TGA) Australia – ASX 2/11/21 3. Includes partnered investigator-led studies.

Telix Pharmaceuticals Limited (ASX: TLX)

Our strategy: See It. Treat it. Personalised, precision medicine

Targeted radiation delivery Systemically administered

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Unique cancer cell signature (target)

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Radioactive isotope Targeting agent (a small molecule or antibody) binds selectively to a cancer cell

  1. Courtesy of Ammar Chaudhry MD, City of Hope, Duarte CA, USA.

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Imaging

TLX591-CDx[1] (Prostate cancer)

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PET scanner
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68Ga, 89Zr (diagnostic isotopes) Enables PET images of cancer

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TLX591 (Prostate cancer)

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Therapy
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177Lu, 131I, 225Ac (therapeutic isotopes)

Enables precise radiation delivery to the cancer

Telix Pharmaceuticals Limited (ASX: TLX)

Radiation has never been more important in cancer care Underpinned by the shift from radiation “in a box” to radiation “in a shot”

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The evolution from external-beam radiation to systematically-delivered and targeted radiation is transforming the role of radiation in cancer care

From a ‘box’

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  • 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

To a ‘shot’

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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)

Telix is pioneering a new cancer modality

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Kidney Cancer

Ph
Name
Asset
Dx/Tx
Ph
Name
Asset
Dx/Tx
Ph
Name
Asset
Dx/Tx
Ph
Name
Asset
Dx/Tx
III TLX250-CDx Dx
I/II TLX250-CDx Dx
II (IIT) TLX250 Tx
II (IIT) TLX250 Tx
Ph
Name
Asset
Dx/Tx
I/II
TLX101
Tx
Glioblastoma
Ph
Name
Asset
Dx/Tx
I/II
TLX101
Tx
Glioblastoma
Ph
Name
Asset
Dx/Tx
I/II
TLX101
Tx
Glioblastoma
Ph
Name
Asset
Dx/Tx
I/II
TLX101
Tx
Glioblastoma
I/II TLX101 Tx

Breast Cancer

Ph
Name
Asset
Dx/Tx
II
OPALESCENCE (IIT)
TLX250-CDx
Dx
I
Emory University (IIT)
TLX591-CDx
Dx
Ph
Name
Asset
Dx/Tx
II
OPALESCENCE (IIT)
TLX250-CDx
Dx
I
Emory University (IIT)
TLX591-CDx
Dx
Ph
Name
Asset
Dx/Tx
II
OPALESCENCE (IIT)
TLX250-CDx
Dx
I
Emory University (IIT)
TLX591-CDx
Dx
Ph
Name
Asset
Dx/Tx
II
OPALESCENCE (IIT)
TLX250-CDx
Dx
I
Emory University (IIT)
TLX591-CDx
Dx
II OPALESCENCE (IIT) TLX250-CDx Dx
I Emory University (IIT) TLX591-CDx Dx

Prostate Cancer

Prostate Cancer Prostate Cancer Prostate Cancer Prostate Cancer
Ph
Name
Asset
Dx/Tx
III University of Linz (IIT) TLX591-CDx Dx
II Emory University (IIT) TLX591-CDx Dx
II (IIT) TLX591-CDx Dx
II Mem. Sloan Kettering (IIT) TLX591-CDx Dx
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

Lung Cancer

Ph
Name
Asset
Dx/Tx
I Royal Adelaide (IIT) APOMAB Dx/Tx
Bone Marrow Conditioning
Ph
Name
Asset
Dx/Tx
I/IIa (IIT) TLX66 Tx
Ph
Name
Asset
Dx/Tx
I Royal Adelaide (IIT) APOMAB Dx/Tx
Bone Marrow Conditioning
Ph
Name
Asset
Dx/Tx
I/IIa (IIT) TLX66 Tx
Bladder Cancer Bladder Cancer
Ph Name Asset Dx/Tx
I ZiP-UP (IIT) TLX250-CDx Dx

*Registry study

Telix Pharmaceuticals Limited (ASX: TLX)

Core pipeline: Oncology & rare diseases

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Shaded arrows indicate completion expectations in the next 12 months.

*Registry study

  1. Prostate-specific membrane antigen.

  2. Carbonic anhydrase IX.

  3. Bone marrow conditioning and rare disease. 5. Cluster of differentiation 66.

  4. Large amino acid transporter 1.

Telix Pharmaceuticals Limited (ASX: TLX)

Strategic Priorities

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Use Illuccix as a commercial launchpad

Establish Telix’s leadership in the urologic oncology domain

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Create a high-value diagnostic portfolio

Kidney cancer imaging agent addresses major unmet need, builds on Illuccix engagement

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Deliver on commercial value of therapeutics

Advance late-stage assets in the core pipeline that benefit from diagnostic market entrance

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Expand the pipeline

Novel targets, clinical applications and manufacturing technologies

8

Telix Pharmaceuticals Limited (ASX: TLX)

Near-term objectives Unlocking the value in our pipeline

2021

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Launch Illuccix Complete ZIRCON

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Commence ProstACT

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2022

Illuccix commercial rollout Establish a leading presence in the urologic oncology domain

Regulatory filing for kidney cancer imaging product to follow-on Illuccix

Advance late-stage therapeutic portfolio to address significant unmet medical needs

Telix Pharmaceuticals Limited (ASX: TLX)

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Telix Pharmaceuticals Limited (ASX: TLX)

Illuccix[® ] approval and rollout milestones US FDA PDUFA[1] goal date 23 December 2021

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  1. United States Food and Drug Administration (FDA) Prescription Drug User Fee Act, Goal Date

  2. Healthcare Common Procedure Coding System

Telix Pharmaceuticals Limited (ASX: TLX)

Illuccix (TLX591-CDx) PSMA-PET[1] imaging A differentiated offering in the PSMA-PET market

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  • Access to ~90% of eligible PET sites

  • On-demand

pharmacy-based production with a high yield product

  • Customer and patient scheduling flexibility

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Telix / partner sites
Current competitor sites
(4 November 2021)
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Illuccix[®] (Kit for the preparation of[68] Ga-PSMA-11) has received marketing authorisation approval in Australia. In all other jurisdictions, including the United States, it is an investigational product and has not attained a marketing authorisation. Product launch in the United States is subject to FDA approval of a New Drug Application (NDA)

  1. Prostate-specific membrane antigen (PSMA) Positron emission tomography (PET)

Telix Pharmaceuticals Limited (ASX: TLX)

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

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  • Updated National Comprehensive Cancer Network Guidelines® include Ga-68 PSMA-11 PET/CT to be considered as an alternative to standard imaging of bone and soft tissue[1]

  • ✓ Conventional imaging no longer a necessary prerequisite to PSMAPET

  • ✓ Expanded indication: 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 evaluation[2]

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  • Two of the four main Radiology Benefit Managers (RBMs) - AIM Specialty Health[3] and NIA Magellan[4] – are now recommending PSMA-PET representing a significant portion of commercial payor (health insurance) reimbursement policies

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  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).

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  1. National Imaging Associates Magellan Clinical Guidelines For Medical Necessity Review, Advanced Imaging Guideline (Effective 01/01/22)

Telix Pharmaceuticals Limited (ASX: TLX)

Market opportunity expanded Due to growing incidence rates and guideline inclusions

  • US patients with prostate cancer eligible for PSMA-PET imaging

1. Primary staging in newly diagnosed high-risk prostate cancer 2. Biochemical recurrence following prostatectomy or radiation therapy

  1. Monitoring of response to systemic therapy

  2. Patient selection for PSMA targeted radio-ligand therapy (RLT)

US total addressable market (TAM) value

  1. Telix markets = US + EU countries included in MAA submission to Danish Medicines Authority on 30 April 2020.

TAM value including EU

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US (OLD)
146,000
(1) 55,000
(2) 52,000
(3) 22,000
(4) 17,000
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USD $575M USD $900M

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US (NEW)
194,510
57,000
74,000
35,000
28,000
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USD $725M

USD $1,08B

  1. American Cancer Society. Cancer Facts & Figures 2021. Atlanta, GA: American Cancer Society; 2021.

  2. GLOBOCAN 2020 incidence of prostate cancer in Telix EU markets.

  3. US TAM value = USD $750M, EU TAM value = USD $325M.

Telix Pharmaceuticals Limited (ASX: TLX)

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

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  • Collaboration to investigate utility of[99m] Tc-iPSMA SPECT[1] imaging in prostate cancer

  • Global consortium of clinical sites and investigators with experience using[99m] Tc-iPSMA

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  • Geographic focus on developing markets or remote regions where access to PET imaging is limited[2]

  • Isotope ([99] Tc) supply chain well established and inexpensive

  • Rapid expansion planned including APAC

  • Single photon emission computed tomography

  • Worldwide SPECT cameras outnumber PET by 4:1 (MEDraysintell 2020)

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Chair
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Dr. Ryan
Yudistiro
Dr. Akintunde Indonesia
Orunmuyi
Nigeria
Peter Tually
Australia
Dr. Mike Sathekge
South Africa
15
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Telix Pharmaceuticals Limited (ASX: TLX)

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Telix Pharmaceuticals Limited (ASX: TLX)

Building a high-value diagnostics portfolio “Breakthrough Therapy” designation, clinical leadership opportunity

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  • 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 avoids unnecessary surgical intervention

  • Biologics License Application (BLA) consultation process to commence by end-year 2021

  • Opportunity to follow prostate cancer imaging, with a second high-value product for the genitourinary (GU) oncology field

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An example of PET/CT imaging showing the uptake of 89Zr-girentuximab in a primary renal mass. The insert 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)

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

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Eligible Patients

  • Single indeterminate renal mass ≤7cm diameter on CT or MRI suspicious for ccRCC

  • • Scheduled for surgical removal as part of management plan

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Surgical removal
TLX250-CDx
& histology as
PET/CT scan
standard of truth
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  • 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

  • 34 sites participating

  • ✓ 75% 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)

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

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  • Total addressable market value in US and Europe estimated at US$3-400M

  • Potential for market leadership, given limited patient options

  • Addresses a major unmet medical need

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Yearly estimated
Yearly new cases,
number of deaths,
worldwide, both
worldwide, both
sexes, all ages
sexes, all ages
431,288
179,368
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Telix Pharmaceuticals Limited (ASX: TLX)

CA9[1] is an exciting target

New understanding leads to potential for applications beyond kidney cancer

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  • A transmembrane protein and a tumor-associated carbonic anhydrase isoenzyme

  • Over-expressed in mutated ccRCC and many hypoxic solid tumors, with low expression in most normal tissue

  • High expression includes cervix, esophagus, lung, breast, colon, brain, and vulval cancers

  • Imaging is being used to “indication scout” for future therapy applications

Potential Indication Potential Indication Status
Bladder or Urothelial Cancer Commenced
Triple Negative Breast Cancer Commenced
Lung Cancer In planning
Ovarian Cancer In planning
Colorectal Cancer In planning
Head and Neck Cancer In planning
Pancreatic Cancer In planning
  1. Carbonic Anhydrase IX (CAIX / CA9)

Telix Pharmaceuticals Limited (ASX: TLX)

STARLITE 2 Phase II trial of TLX250 for Treatment of ccRCC TLX250 in combination with immunotherapy

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  • Phase II trial of TLX250 plus nivolumab in with ccRCC who have progressed following prior immunotherapy

  • Evaluates TLX250-delivered radiation as an immune system “primer” NCT03849118

  • NCT03849118

  • ✓ Targets carbonic anhydrase IX (CA9)[1] – 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 177Lugirentuximab (TLX250) as assessed by the number of tumours responding to the Telix therapy versus the current standard of care alone

  • 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 (submission in progress)

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CA9 expression is correlated with the presence of tumour-infiltrating lymphocytes, which may confer resistance to immunotherapy. 21

  1. Giatromanolaki et al. British Journal of Cancer . 2020.

Telix Pharmaceuticals Limited (ASX: TLX)

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Telix Pharmaceuticals Limited (ASX: TLX)

ProstACT program overview Multiple opportunities to deliver insights into TLX591

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Radiogenomics study

  • ~50 patients

  • First line mCRPC

  • Rapid recruitment

Treat the scan

Correlation between imaging and therapy to optimise patient selection

Combination with EBRT in oligometastatic early recurrence (Phase II)

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  • ~50 patients

  • Co-funded by GenesisCare

Early data in front line care

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SELECT – radiogenomics study enhances patient selection and supports indication expansion based on a “theranostic” approach

TARGET in partnership with GenesisCare, evaluates TLX591 in a front-line setting

Efficacy data in patients in their first recurrence

Pivotal Phase III study in patients with mCRPC progressing on 1st line novel androgen agents

  • 390 patients

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

GLOBAL (Ph III) – Multiple data read-outs throughout the ProstACT program duration

  • Second line mCRPC

Telix Pharmaceuticals Limited (ASX: TLX)

ProstACT GLOBAL Ph III trial of TLX591 for the treatment of mCRPC[2] overview Study

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TLX591 + Standard of Eligible Patients care therapy • v PSMA avid (defined by TLX591-CDx) • mCRPC Standard of care therapy • Progressed despite prior therapy with NAAD alone

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  • 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[1] )

  • Primary endpoint: radiographic progression-free survival

  • Secondary endpoints include: overall survival, quality of life, safety

  • 2:1 randomisation and enrichment of study population, patient selection with TLX591-CDx

  • ProstACT 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

  • Novel androgen axis drug

Telix Pharmaceuticals Limited (ASX: TLX)

TLX591 differentiation Antibody vs small molecule

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Significantly improved overall survival in a comparable end-stage patient Efficacy population 40+ months vs. 15.3 months[1,2 ] Reduced potential for undesirable 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 Reduced[177] Lu isotope requirement via more targeted dosing/less waste Cost effective COGS ~1/5 of competition, expected to also be available in “cold kit” format[3]

  1. Tagawa et al, Cancer 2019.

  2. Cross-trial comparison, randomised controlled trial (RCT) required for verification.

  3. Modelled from publicly available information.

Telix Pharmaceuticals Limited (ASX: TLX)

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

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TLX591

Antibodies are functionally specific for tumour-expressed PSMA and do not “hit” most endogenous PSMA expression Liver (preferred clearance organ) Fecal excretion

Lacrimal, Parotid, Submandibular (salivary) glands

Spleen, Liver

Kidneys, Small bowel

Bladder

(urinary excretion)

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Small molecule

Small molecule radioligands taken up by endogenous PSMA

Additional off-target effects with small molecule radioligands (not experienced with TLX591):

  • Dry eye

  • Xerostomia

  • Back pain from ganglia irradiation

Data courtesy of Prof. Neil Bander, WCMC.

Telix Pharmaceuticals Limited (ASX: TLX)

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

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  • 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 ([99m] Tc-iPSMA) – PSMA imaging access for patients in developing and remote areas, where PET is not readily available

  • Next-generation alpha therapy: TLX592 (225AcRADmAb®) – high potency, complementary to TLX591

  • Image guided surgery: TLX591-Sx ([68] Ga-PSMA-IRDye) - dual-labelled PET-optical tracer for image guided surgery, enables real-time cancer detection[1]

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

Telix Pharmaceuticals Limited (ASX: TLX)

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

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Localised disease

Radiation therapy +/- ADT Radical prostatectomy PSA Active surveillance

level

Advancing clinical stages Docetaxel, abiraterone (metastatic, non-castrate), apalutamide, enzalutamide, darolutamide (non-metastatic, castrate resistant)

Metastatic castrate resistant

First line:

Docetaxel; Sipuleucel-T; Abiraterone Enzalutamide

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PSMA-617 failures

68Ga / 99mTc imaging

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Asymptomatic
Non-metastatic
Castration-sensitive
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Rising PSA
Radiogenomics and
ADT (non-castrate)
tumour targeting of
TLX591
Combination of EBRT
and TLX591 in early
biochemical recurrence Second line +
Clinical trial
Second line:
Cabazitaxel; Abiraterone
TLX592 ( [225] Ac)
Enzalutamide; Radium 223
Olaparib; Rucaparib
Pivotal Phase III study in patients with
mCRPC progressing on 1st line novel
androgen agents
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Symptomatic
Metastatic
Castration-resistant
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Time / disease progression

Telix Pharmaceuticals Limited (ASX: TLX)

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Telix Pharmaceuticals Limited (ASX: TLX)

IPAX-I Phase I/II trial of TLX101 for the treatment of GBM[1]

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TLX101 in combination with EBRT[2]

  • Multi-centre Phase I/II trial of TLX101 in combination with EBRT in patients with recurrent GBM

  • Primary endpoint: Safety and tolerability

  • NCT03849118Secondary endpoints include: MTD[3] , efficacy, dosimetry

  • 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.

  • ✓ 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, with three patients exhibiting stable disease at day 135 and two with stable disease at day 180

  • ✓ 6/ 10 patients still alive and will be followed until 1 year after dosing for the final OS calculation (May 2022).

  • Glioblastoma Multiforme.

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Baseline PET scan

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Day 45 PET scan post TLX101 therapy

  1. External beam radiation therapy.

  2. Maximum tolerated dose.

.[Telix Pharmaceuticals Limited (ASX: TLX)]

Follow on study IPAX-2 in planning Evaluating the potential of TLX101 in newly-diagnosed patients

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  • Initial dose finding study TLX101 plus standard of care (SOC) in patients with newly diagnosed glioblastoma, after surgery

  • Evaluates the potential for “DNA damage” from targeted radiation using TLX101 to enhance SOC chemotherapy for newly diagnosed glioma NCT03849118

  • NCT03849118

  • Study objectives expected to include:

  • ✓ Maximum tolerated dose

  • ✓ Safety and tolerability in combination with the Stupp regimen (SOC)

  • ✓ 12 months overall survival

  • ✓ Progression free survival at a range of treatment intervals

  • Single-arm, multi-centre trial, expected to enrol 12-15 patients

  • Patients to be treated and monitored for up to 64 weeks

  • Study protocol in final stages of design, IND / ethics approval submissions expected in late 2021 / early 2022

Telix Pharmaceuticals Limited (ASX: TLX)

New hope in a rare disease Progressing development of TLX66 in bone marrow conditioning

  • SALA[1] 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 in the organs and causes them to fail

  • NCT03849118 Prevalence of ~30,000 to 45,000 (US + EU combined) patients, ~US$600M TAM[3] in US and ‘EU5’

  • Current standard of care comprises induction therapy (cyclophosphamide, bortezomib, dexamethasone) plus high dose melphalan BMC[4] , followed by HSCT[5, 6]

  • A novel monoclonal antibody, daratumumab has potential as an initial therapy for patients but is not curative or suitable for all patient populations.

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

  • Primary endpoint: Safety and toxicity of[90] Y-besilesomab as the sole BMC regimen for autologous HSCT in patients with SALA

  • ✓ 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

  • Systemic amyloid light chain amyloidosis.

  • Bone marrow conditioning.

  • https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-002231-18/GB

  • Hematopoietic stem cell transplant.

  • Venner C, et al. Blood. (2012) 119 (19): 4387–4390.

  • Total addressable market.

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Faulty plasma cells

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Free antibody light chain

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Amyloid
protein
accumulates
in organs
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Organ failure, death

Telix Pharmaceuticals Limited (ASX: TLX)

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Future value creation Focus on innovation and growth markets

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Telix Pharmaceuticals Limited (ASX: TLX)

Near-term growth opportunities Expansion into new geographic markets

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  • DuChemBio partnership

  • Launch Illuccix with distribution partner (in progress)

  • NECA HTA[1] completed

  • NOBLE Registry expansion

  • Illuccix kit sales have commenced, pursuing reimbursement

  • National Evidence-based Healthcare Collaborating Agency. Health Technology Assessment.

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  • 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)

Telix Pharmaceuticals Limited (ASX: TLX)

Buildout of the Brussels (Seneffe) manufacturing facility Vertical integration in Europe

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  • Seneffe will serve as the primary EU manufacturing site for Telix’s products

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

  • NCT03849118 export (i.e. TLX101) using Belgian-sourced isotopes

  • NCT03849118 (Belgium is a major global supplier)

  • ✓ One of the deepest isotope production licences in Europe

  • ✓ Provides certainty / control over supply chain

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

  • Allows us to capture the IP that is intrinsic in manufacturing scale-up of this class of drugs

✓ Buildout has commenced

  • ✓ First cyclotron removed October 2021, second scheduled for November 2021

  • ✓ Removed in one piece, with the aim to recycle as much material as possible

  • Build of two new cyclotrons to commence in early 2022

Telix Pharmaceuticals Limited (ASX: TLX)

Future research and innovation focus

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Targeted alpha MTR + 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 insigh imaging into the alpha-emitting cancer immunotreatments for ts gained from imaging, operating room (OR) improved efficacy with radioisotopes therapy in combination link to therapeutic biomarker-driven outcomes patient selection

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Telix Pharmaceuticals Limited (ASX: TLX)

Near-Term Catalysts

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Calendar Q4 2021

• Illuccix EU “clock stop” for final review (end-Nov)

• Illuccix US FDA decision (PDUFA goal date 23 Dec 2021)

• Distributors finalised for EU product launch

  • First ProstACT patients

  • Calendar Q1 2022

• STARLITE 1/2 trials active (FDA IND approval) and recruiting

  • Illuccix EU marketing authorisation decision

• HCPCS reimbursement submission for Illuccix in the US (Jan)

• ZIRCON trial enrolment completed

• IPAX-2 study launched (glioblastoma)

• US, AU Illuccix product launch

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Telix Pharmaceuticals Limited (ASX: TLX)

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Precision Oncology See it. Treat it.

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