Telix Pharmaceuticals Ltd — Interim / Quarterly Report 2020

Aug 20, 2020

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Telix Pharmaceuticals Limited Half-Year Shareholder Update

Dr. Christian Behrenbruch Managing Director and CEO

21[st] August 2020

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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. None of the products or potential products described in this presentation have received a marketing authorization in any jurisdiction.

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Telix Pharmaceuticals Limited (ASX: TLX)

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Company Snapshot

• Late-stage portfolio of Molecularly Targeted Radiation (MTR) products :

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• ✓ Prostate cancer, renal cancer, glioblastoma

• ✓ Significant total addressable market value of US$850M & US$4B for prostate imaging and therapy, respectively

• ✓ Clinically active in 25 countries, global reach

• Accomplished major milestones on the path to commercialisation of TLX591-CDx (prostate cancer imaging)

• ✓ European Marketing Authorization Application submitted (April)

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• ✓ U.S. FDA NDA submission preparation in progress

• ✓ U.S. commercial distribution agreements with Cardinal Health and Pharmalogic

• Acquired a licensed production facility in Seneffe, Belgium ✓ Vertically integrated drug product manufacturing for the European market

• Strong financial position ✓ Cash runway until late 2021, to deliver first 2 commercial products

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Telix Pharmaceuticals Limited (ASX: TLX)

What is MTR? Precise Radiation Delivery

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1. Targeted radiation delivery

2. Systemic administration

3. Dual benefit: imaging and therapy

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Radioactive Antibody or small molecule Isotope binds to a cancer cell (The “Payload”) (The “Targeting Molecule”)

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Prostate cancer Renal cell carcinoma Glioblastoma TLX591-CDx[(1)] TLX250-CDx[(2)] TLX101[(3)]

Telix is targeting agent agnostic (antibody or small molecule)

Administered systemically and binds to cancer cells, wherever they are, including small metastases

Cancer-specific Positron Emission Tomography (PET) images of prostate, renal and brain (GBM) cancers for diagnosis, staging and treatment response assessment

• Notes: (1) Courtesy of Ammar Chaudhry MD, City of Hope, Duarte CA, USA (2) Courtesy of Radboud University Medical Centre, Netherlands (3) Courtesy of ZentralKlinik Bad Berka, Germany

Telix Pharmaceuticals Limited (ASX: TLX)

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‘See It. Treat It’

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See…

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Low dose / diagnostic radionuclide and a PET scanner images the presence of the cancer target

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TLX591
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Treat…

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High dose / therapeutic radionuclide treats the patient Dosing and treatment response guided by imaging

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Telix Pharmaceuticals Limited (ASX: TLX)

Telix’s Clinical Pipeline in Prostate, Kidney, Brain Cancer

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Cancer
Targeting Cell Radioactive
Phase I Phase II Phase III Commercial
Molecule Target Isotope
Small PSMA [(2)] 68Ga TLX591-CDx ( [68] Ga-PSMA-11) Imaging
molecule
Antibody PSMA 177Lu TLX591 ( [177] Lu–rosopatamab) Therapy
TLX591
Antibody CA IX [(3)] 89Zr TLX250-CDx ( [89] Zr–girentuximab) Imaging
Antibody CA IX 177Lu TLX250 ( [177] Lu–girentuximab) Therapy
Small LAT1 [(4)] 124I TLX101-CDx (Research use only) Imaging
molecule
Small LAT1 131I TLX101 ( [131] I-IPA) Therapy
molecule
Prostate
Kidney
(1)
Brain
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Shaded arrows indicate completion expectations in the next 12 months

Notes: (1) Glioblastoma multiforme (GBM) (2) PSMA = Prostate-specific membrane antigen 1

(3) CA IX = Carbonic anhydrase IX (4) LAT1 = Large amino acid transporter 1

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Clinical and Commercial Activity

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Activity Focus Areas

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Pipeline
R&D
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Commercialisation
of TLX591-CDx
(prostate imaging)
Clinical
Trials
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Telix Pharmaceuticals Limited (ASX: TLX)

Key Accomplishments Year to Date

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EU MAA submitted for TLX591-CDx (prostate imaging), NDA preparation

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Phase III meeting with the FDA, finalisation of protocol

Seneffe (Belgium) site acquisition completed for EU manufacturing

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US/EU/AU recruitment, indication expansion, breakthrough designation

Multiple distribution agreements, US and EU

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Active R&D including $500k IMCRC grant for advanced manufacturing

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Key hires to build Telix’s international bench strength, including US-based CMO

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Telix Pharmaceuticals Limited (ASX: TLX)

Financial Dashboard

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H1 2020 H1 2020 H1 2020 Comprehensive Loss Receipts Program Costs

H1 2020 Corporate / Employment Costs

+70% $17.6m H1 2019: $10.4m

+28%

-33%

Flat

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Telix Pharmaceuticals Limited (ASX: TLX)

Half Year Sales Review: TLX591-CDx / illumet [® ] (prostate imaging)

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TLX591-CDx Kit Sales, H1 2020

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500
450
432
400
350
355
336
300
300
287
250
200
200
150
100
50
0
Jan-20 Feb-20 Mar-20 Apr-20 May-20 Jun-20
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• Telix delivered approximately 4,600 individual patient doses prepared from over 1,900 TLX591-CDx prostate cancer imaging kits

• Telix received $2.1m in cash receipts from kit sales for the half, representing a 28% increase over PCP

• Kit pricing remained stable

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Telix Pharmaceuticals Limited (ASX: TLX)

Current Clinical Activity

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STARLITE	Development Stage	Asset	Indication	Status
	Phase III (Therapy)	TLX591	Metastatic castrate-resistant prostate cancer (mCRPC)	Ph III IND preparation in progress – Q4 2020 planned start
	Phase II (x2) (Therapy)	TLX250	Metastatic clear cell renal cell cancer (ccRCC)	IND(s) in final preparation, manufacturing complete
	Phase I/II (Therapy)	TLX101	Recurrent glioblastoma multiform (GBM)	Recruiting
	Phase III (Diagnostic Imaging)	TLX250-CDx	Clear cell renal cell cancer (ccRCC) / indeterminate mass	Recruiting
	Phase I/II (Diagnostic Imaging)	TLX250-CDx	Clear cell renal cell cancer (ccRCC) / indeterminate mass	Recruiting
	Phase II (Registry) (Diagnostic Imaging)	TLX599-CDx	Prostate cancer (registry study)	Recruitment planned to commence Q4 2020
	Phase I (Biodistribution)	TLX592	Prostate cancer	Recruitment planned to commence Q4 2020

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Telix Pharmaceuticals Limited (ASX: TLX)

COVID-19 Impact

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COVID-19 has had a significant impact on the operational and expenditure profile of the business

• Clinical activity: most clinical activity paused March – August, some restart of clinical activity for IPAX-1 and ZIRCON in Europe in July

• Lower program-related (external) costs such as manufacturing, logistics due to reduced clinical activity

• Other than key hires (that had been in long-term recruitment), general hiring freeze to prolong cash runway

• Re-allocation of personnel activities to ‘internal’ (non-clinical tasks such as a regulatory, quality and business systems (QMS, ERP, CRM)

• Severely restricted travel, international team engagement

• Significant service provider delays experienced across all of Telix’s operational activity

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Telix Pharmaceuticals Limited (ASX: TLX)

EU Marketing Authorisation Status (TLX591-CDx)

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Telix has submitted an EU marketing authorisation application (MAA) for TLX591-CDx (prostate cancer imaging)

• Submitted in April 2020, mostly based on pre-COVID-19 effort

• Danish Medicines Agency (DKMA) agreed to serve as reference competent authority (CA)

• 14 countries selected in the first cohort of approval countries, includes EU5 (+UK)

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• Submission complete, now in individual CA review

• Expect ‘consensus’ late-2020 / early 2021

• In discussions with several healthcare authorities for temporary marketing authorisations

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Telix Pharmaceuticals Limited (ASX: TLX)

US NDA Submission Status (TLX591-CDx / illumet [®] )

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Telix is in the final stages of preparing a New Drug Application (NDA) to the US FDA

• Will be submitted this quarter (Q3)

• Delays due to both COVID-19 and management decisions around expanding the product label based on FDA consultation and the availability of new clinical data

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• All clinical data sources, data quality control and statistical analysis complete. Highly supportive of Telix’s submission package

• Currently completing final documentation checks, package QC and preparing for e-publishing

• Close cooperation with US partners (Cardinal Health, Pharmalogic) for market launch

• 30+ IND ‘Letters of Authorisation’ issued to Telix’s Drug Masterfile (DMF) for TLX591-CDx in the H1 of 2020

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Telix Pharmaceuticals Limited (ASX: TLX)

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Other TLX591-CDx Jurisdictions in Progress

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TGA submission preparation in progress, expected to be submitted in Q4 2020. MSAC approval likely mid-2021

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Routine provision of compassionate use access under HealthCanada requests. Currently preparing submission package

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Swissmedic application in progress. A strategic jurisdiction for many countries that follow EU/Swiss regulatory approvals

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Favourable PMDA and MHLW consultations for establishing ‘bridging’ clinical activity in Japan to global marketing authorisation packages

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Telix Pharmaceuticals Limited (ASX: TLX)

ProstACT: Phase III Prostate Cancer Therapy

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Valuable pre-Phase III meeting with the FDA completed (Q3)

• Currently refining the clinical protocol based on FDA feedback

• Very useful / positive feedback with respect to the use of imaging (TLX591-CDx) for patient selection and enrichment

• Expect to send a further package to the FDA in the next 3-4 weeks for an additional pre-IND meeting

• Phase III design has focused considerably:

• ✓ Well defined patient population

✓ Clear proposed end-points

✓ Considerably streamlined patient sample size

• Final protocol expected to be completed in mid-Q4

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• Australian arm of ProstACT expect to commence end-2020 with US patients in Q1 2021 (subject to FDA/TGA allowance)

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Telix Pharmaceuticals Limited (ASX: TLX)

Summary: Commercial and Clinical

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Despite COVID-19, H1 was highly active with significant commercial and program-related progress

• Effective management of Telix’s financial resources despite major operational and clinical impact of COVID-19

• EU MAA submitted on time, US NDA delayed but on track for Q3 submission, other commercially useful jurisdictions in progress

• High level of commercial activity, including building global distribution networks for TLX591-CDx and preparation for market launch activities

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• Global sales continuing to grow for TLX591-CDx

• H2 2020 will be extremely active for the company on both commercial and clinical fronts

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Telix Pharmaceuticals Limited (ASX: TLX)

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R&D Progress

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Telix R&D Strategy

Telix’s innovation strategy combines both in-house technology platform development and collaboration with leading academic centres, with several key objectives:

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• ✓ Product life cycle management to maintain category leadership

• ✓ Platform development – expanding the capabilities and utility of our core portfolio of molecules (and plenty of new IP creation)

• ✓ New clinical application areas, for example – imageguided surgery

• ✓ Indication expansion for existing products under development

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Telix Pharmaceuticals Limited (ASX: TLX)

Meet the ‘Extended Family’

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Core Technology	R&D Enhancement	Technology Collaborators	Development Status
TLX101	TLX102:211At “alpha” variant of TLX101 for multiple myeloma	Osaka University, Japan Universityof Nantes, France	• FDA orphan drug granted • Preparingfor first-in-human
TLX591-CDx	TLX591-Sx(1): Addition of a fluorescing agent for image-guided surgery	German Cancer Found’n (DKFZ) Univ. of Heidelberg, Germany	• IP license option exercised • First investigator-led clinical studies in Q3 2020(Germany)
TLX591-CDx	TLX599-CDx: Chemistry for99mTc for “rest of world” PSMA imaging where PET is not available	Instituto Nacional de Investigaciones Nucleares, Mexico	• Commencing Phase II study in Q3, 2020 (International)
TLX591	TLX592: Antibody Pk-engineered to support use with225Ac “alpha” therapy	Abzena Ltd	• Commencing first-in-human studies in Australia, Q3 2020 (subject to approvals)
TLX250-CDx	Exploration of clinical potential to image other cancers, beyond renal cancer	GenesisCare, Australia Radboud Univ., Netherlands ATONCO, France	• Investigator-led studies ongoing

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Notes: (1) Sx denotes surgical application

Telix Pharmaceuticals Limited (ASX: TLX)

TLX102:[211] At-Phe Indication: Multiple Myeloma

Innovation:

• New chemistry to replace[131] I in TLX101 with[211] At (astatine)

• High-specific activity chemistry, rapid synthesis – new IP portfolio, also benefits commercialisation of TLX101

Rationale:

• LAT-1 is highly expressed in multiple myeloma but disseminated nature of the disease means a short irradiation distance isotope is desired

• Example of a ‘Targeted Alpha Therapy’ (TAT) approach to delivering localized radiation

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Potential benefit:

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(Control)
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• Irradiate abnormal plasma cells with minimal damage to healthy bone marrow

Next steps:

• High promising data in ‘industry standard’ pre-clinical models of MM progression

• Chemistry / planning for clinical evaluation H2, 2021

• Pre-clinical work was completed within 2019/20 R&D budget with additional funding from the Japanese Science & Technology Agency (JST) OPERA program

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Courtesy, University of Nantes
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Telix Pharmaceuticals Limited (ASX: TLX)

TLX591-Sx:[68] Ga-DYE-PSMA-11 Indication: Image-guided surgery for prostate cancer

Innovation:

• Extends the TLX591-CDx platform to a dual-modality tracer that combines PET imaging and optical (fluorescence) imaging in the same molecule

• One injection – two images. PET and optical guidance for minimally-invasive / robotic surgery

Rationale:

• Surgical robotics has become a dominant part of the prostate surgery technology landscape. Modern systems include the ability to perform real-time optical imaging to guide surgical resection and margin assessment

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DaVinci[®] system – Intuitive Surgical

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White light
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Potential benefit:

• Provide both a high-quality pre-operative PET image as well as an intra-operative fluorescent image real-time in the operating theatre

Next steps:

• Currently developing a kit for early clinical research adoption (H1 2021)

• Initial clinical evaluation planned for Q3, 2020 under investigator-led study in Germany

• Will assess initial academic clinical experience before planning and commencing TLX-led clinical development

Fluorescence[(1)]

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Notes: (1) Baranski et al. J Nucl Med. 2018 Apr;59(4):639-645

Telix Pharmaceuticals Limited (ASX: TLX)

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TLX599-CDx:[99m] Tc-HYNIC-PSMA Indication: Prostate cancer imaging, globally

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Innovation:

• New chemistry to extend the utility of PSMA-11 to[99m] Tc to enable imaging of prostate cancer with gamma camera / SPECT imaging

TLX599-CDx TLX591-CDx (SPECT) (PET)

Rationale:

• Outside of developed countries and major cities, PET is less common. However PSMA imaging is needed by millions of men that don’t have access to PET

• PSMA therapy adoption, world-wide, will be significantly driven by the availability of ubiquitous imaging

Potential benefit:

• Access to high volume but price-sensitive markets with a cost-effective product

• Significantly increases patient access, ubiquitous supply chain for[99m] Tc

Next steps:

• Global Ph2 study – the ‘NOBLE’ study (Nobody Left Behind) will commence in Mexico, South Africa, Egypt, Australia, UAE, India and Russia (subject to approvals) and will complete before end-2020

• NOBLE study is within planned 2020 R&D expenditure

• (Left) maximum-intensity projection of[99m] Tc-HYNICPSMA SPECT/CT compared with a maximum-

• intensity projection of[68] Ga-HBED-CC-PSMA PET/CT (right) in the same prostate cancer patient. Courtesy ININ

• Ph III planned for early 2021

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Telix Pharmaceuticals Limited (ASX: TLX)

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Global Clinical Leadership

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Chair
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Dr. Pavel Rumiantsev Russia

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Dr. Ajit Shinto
India
Dr. Peter Tually
Australia
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Dr. Mike Sathekge South Africa

Telix Pharmaceuticals Limited (ASX: TLX)

TLX592:[225] Ac-PSMA Indication: Treatment of[177] Lu-PSMA Progressive Patients

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Innovation:

• TLX591 antibody re-engineered to clear ~10x faster from the body, while maintaining specificity for tumour-expressed PSMA (liver cleared, no exocrine uptake)

• Harnesses Telix’s proprietary RADmAb[®] platform technology

Pk-engineered antibody (RADmAb®)

Rationale:

• Targeted Alpha Therapy (TAT) is becoming an important area of PSMA therapy research,

• particularly in men that are no longer responding to[177] Lu

• Existing small molecule approaches do not appear viable due to unacceptable off-target, renal toxicity

Potential benefit:

• Treatment of patients that are progressing off[177] Lu-PSMA therapy

• As a potential adjuvant for high-risk patients that may have early metastatic disease

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225Ac
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Next steps:

• Commencing initial patient studies in Q3, 2020 (Australia) to assess biodistribution, targeting, Pk modifications

• Preliminary patient studies are within 2020 R&D budget

• Depending on preliminary data, rapid progression to Ph II is possible

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Telix Pharmaceuticals Limited (ASX: TLX)

TLX250-CDx:[89] Zr-girentuximab Indication: Use in Other (Non-Renal Cancer) Indications

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Innovation:

• TLX250-CDx targets Carbonic Anhydrase IX (CA9), a target that is highly expressed in many late-stage cancers

Rationale:

• Explore the utility of TLX250-CDx in other cancers where conventional imaging has limitations

Potential benefit:

• Improved staging, therapy planning

• CA IX may be particularly important in determining responsiveness to immunotherapy[(1) ]

Next steps:

• Multiple investigator-led studies ongoing in ovarian, bladder, urothelial, colorectal, head & neck cancers

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Metastatic ovarian cancer[(2)]

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Infiltrating bladder cancer[(2)]

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Metastatic urothelial cancer (Transition cell)[(2)]

• Notes: (1) Giatromanolaki A et al. British Journal of Cancer (2020) 122:1205–1210 (2) Non-ccRCC TLX250-CDx Images courtesy of Dr Nat Lenzo, GenesisCare

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Telix Pharmaceuticals Limited (ASX: TLX)

R&D Vision: Telix will Integrate Oncology

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Androgen + TLX591 (PCa) – Ph III

Medical Oncology / STARLITE I-O + TLX250 (RCC) – Ph II (x2) Immunology

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XRT + TLX101 (GBM) – Ph I / II XRT + TLX591-CDx (PCa) – Ph II Biology-guided radiation therapy

Interventional Radiation Oncology / Oncology Surgery

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TLX591-OR (PCa/GBM) – Ph I

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TLX591-CDx (PCa) EU MAA (Filed) US NDA (Q3 ‘20)

ZIRCON TLX250-CDx (RCC) – Ph III (breakthrough) Diagnostic Imaging TLX599-CDx (PCa) – Ph II

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Telix Pharmaceuticals Limited (ASX: TLX)

Closer to Home: Telix is Responsibly Re-investing Taxpayer $s

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Patheon /
Taxpayer $s University of Sydney Development of novel Scale-up production of ThermoFisher Project
chelators and industry- antibodies
relevant radiochemistry
strategies
TLX250
AusHealth
Clinical translation of the
biologic treatment ANSTO
ApoMab in ovarian and lung cancer Accessing radiochemistry expertise to characterise TLX591/2
new
radiopharmaceutical
candidates Centre for Applied
Imaging
Preclinical studies exploring Platform
Evaluation of novel SAHMRI in vivo efficacy of novel mAb technologies and prostate Technology
mAb & chelator CSIRO National cancer therapies
combinations Biologics Facility
Research Type Provision of seed Brisbane
funding and advice Radio-
regarding industry need chemistry
Instrumentation Perth Isoclide Medical for biologics iPhase new IP
Supporting novel Technologies P/L
α-emitting Streamlining
radioisotope radiopharmaceutical
Biologics technology production via automation Sydney UoM Centre for Cancer Research PipelineFuture
Exploration into efficacy of
Radiochemistry Adelaide TLX250 treatment against colorectal cancer via a 3-
Melbourne year grant
GenesisCare Future
Preclinical New clinical prostate PeterMac manufacturing
cancer treatment Development of platforms
regimes using workflow for rapid
Novel TLX591-Cdx clinical translation of
Chemistries radiopharmaceuticals
via a 2-year IM CRC PeterMac
grant Preclinical studies University of
Melbourne
demonstrating utility of
Clinical multiple small molecules Investigating the
and biologics in vivo possibilities of DFOsq 89Zr-chelation
technology
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Telix Pharmaceuticals Limited (ASX: TLX)
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Telix Pharmaceuticals Limited (ASX: TLX)

Summary: R&D Impact

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• Telix’s R&D activities are high-impact and cost-effective, harness third party funding and high-quality collaborations

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• Leverage both internal development capabilities and academic key opinion leaders

• Pipeline / indication expansion rationally builds on existing pipeline of molecules and platform technologies

• Significant potential upside in terms of access and new patient populations

• Supports Telix’s objective of category leadership in urologic oncology

• Australia is a strategic R&D asset for Telix, alongside extensive global collaborations. Taxpayer R&D funds are being re-invested

• Positions Telix as a leading player in the field of Targeted Alpha Therapy (TAT), with two clinic-ready programs

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Telix Pharmaceuticals Limited (ASX: TLX)

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Second Half 2020…

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Five Big Events will Define the Next Six Months

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First data
out from TLX101
IPAX-1 trial
Market
TLX591-CDx
launch
readiness NDA submission to
US FDA
TLX591-CDx
Completion of
ZIRCON Phase
III trial
Launch of
ProstACT TLX250-CDx
Prostate program
TLX591
Phase III trial
Kidney program
Glioblastoma program
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Telix Pharmaceuticals Limited (ASX: TLX)
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Summary of 2020 Inflection Points

July – September 2020

April – June 2020

Prostate cancer imaging (TLX591-CDx)

Prostate cancer imaging (TLX591-CDx)

• ✓ US NDA submission imminent

• ✓ European MAA submitted (April)

Prostate cancer therapy (TLX591)

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• ✓ US FDA pre-IND meeting for PROSTACT Phase III RCT (July)

Kidney cancer therapy (TLX250)

• ✓ IND submitted to US FDA for STARLITE Phase II trial

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October – December 2020

Prostate cancer imaging (TLX591-CDx)

• ✓ Commercial launch readiness for early 2021

Prostate cancer therapy (TLX591)

• ✓ PROSTACT Phase III RCT initiated

Kidney cancer imaging (TLX250-CDx)

• ✓ ZIRCON Phase III patient recruitment completed

Kidney cancer therapy (TLX250)

• ✓ STARLITE Phase II trial open

Glioblastoma therapy (TLX101)

• ✓ Preliminary safety and efficacy data available

Telix Pharmaceuticals Limited (ASX: TLX)

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telixpharma.com

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