Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — Investor Day (June 2025)
127 slides from Telix Pharmaceuticals's investor day presentation, Jun 11, 2025
Slide 1: Telix Investor Day Presentation Materials
Telix Pharmaceuticals Limited ACN 616 620 369 55 Flemington Road North Melbourne Victoria, 3051 Australia ASX ANNOUNCEMENT Telix Investor Day Presentation Materials Melbourne (Australia) and Indianapolis, IN (U.S.) – 11 June 2025. Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the C
Slide 2: Legal Notices
Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website
Slide 3: Investor Day 11 June 2025
Glioblastoma patient (salvage) with clinically stable disease 18 months from initiation of TLX101 therapy Growth opportunities T=0 10 months Telix’s competitive advantage Investor Day 11 June, 2025 ASX: TLX | NASDAQ: TLX 16 months 18 months Patient representative scans - individual results may vary.
Slide 4: Disclaimer
Disclaimer This presentation should be read together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX) and the U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our webs
Slide 5: Introduction
Introduction Kyahn Williamson SVP Investor Relations and Corporate Communications 3
Slide 6: Today’s presenters – Telix
Today’s presenters – Telix Kyahn Williamson Christian Behrenbruch David N. Cade, MD Richard Valeix SVP IR and Corporate Managing Director and Group Chief Medical Officer CEO, Therapeutics Communications Group CEO Kevin Richardson Paul Schaffer Pamela Habib, MD David Liu, MD CEO, Precision Medicine C
Slide 7: Physician presenters
Physician presenters Joseph Osborne, MD Oliver Sartor, MD John de Groot, MD Professor of Radiology Director of Transformational Professor of Neurology, Weill Cornell Medicine Prostate Cancer Research Neuro-Oncology LCMC Hospitals, New Orleans, LA University of California San Francisco Presenters are
Slide 8: Agenda
Agenda • Introductions • CEO Welcome and Vision • Key trends in radiopharma development • Precision Medicine & indication expansion in the PSMA market • Zircaix: Adding depth to our commercial focus & KOL discussion • Therapeutics • Urologic oncology & KOL discussion • Q&A & break • Urologic oncolog
Slide 9: Vision
Vision Dr. Christian Behrenbruch Managing Director and Group CEO 7
Slide 10: Telix: Defining the future of radiopharma
Telix: Defining the future of radiopharma We are leading the theranostic medicine modality A global radiopharmaceutical company with: Established global Deep theranostic pipeline – Manufacturing, isotope and commercial footprint multiple near-term catalysts distribution partnerships Only company wit
Slide 11: Our growth strategy
Our growth strategy Our mission is to be the global leader in theranostic radiopharmaceuticals Deliver Build Grow Expand our late-stage the next generation of our industry-leading our global therapeutic pipeline radiopharmaceuticals precision medicine infrastructure for business product delivery 9
Slide 12: Building competitive advantage
Building competitive advantage Telix’s key differentiators Commitment to precision Differentiated therapeutic medicine candidates Leveraging the clinical and commercial benefits Opportunity to address unmet need across the for a theranostic approach patient journey, multiple shots on goal Specialist
Slide 13: Global product delivery infrastructure is key to success
Global product delivery infrastructure is key to success Our in-house capability and capacity continues to grow • Telix continues to invest in production infrastructure, including cyclotron installation + ARTMS QIS® technology x2 • Localized manufacturing for major markets • Equipped to deliver pati
Slide 14: U.S. coverage
U.S. coverage Together with partners able to deliver radiopharmaceuticals, at scale, across the U.S. Strategic partner pharmacy network Telix-owned network 12
Slide 15: Investing for sustainable growth
Investing for sustainable growth Our financial strategy aligns to our growth opportunities Revenue growth potential Earnings growth potential Three 2021 – 2024 2025 - 2027 2028 and beyond phases of Transition to commercial Diversify and grow revenue Transition to higher value Tx growth stage with fi
Slide 16: Growth opportunities
Growth opportunities Today’s session highlights “select” growth opportunities across the portfolio E Enabling core business PSMA imaging market expansion Zircaix®1 Deepening our relationship with the urologist G Driving Growth Urologic oncology Innovation across multiple therapeutic settings T New t
Slide 17: Key trends in radiopharma development
Key trends in radiopharma development Dr. Paul Schaffer Chief Technology Officer 15
Slide 18: The value of radiopharma-specific R&D
The value of radiopharma-specific R&D Global expertise and leading-edge technology to harness the key trends in radiopharma ‘Chemistry & Physics (CTO) Benefits of in-house R&D • Targetry & novel • Medical physics • Drug development, optimized for radiopharma radioisotopes • Artificial Intelligence (
Slide 19: Trend #1: New isotopes entering the clinic
Trend #1: New isotopes entering the clinic Targeting vector Opportunity to harness the varying properties of isotopes Chelator Linker Emitters1 β+/ β α Auger Radiometal 11C 67Cu 211At 58mCo 18F 89Sr 212/213Bi 71Ge 64Cu 90Y 212Pb 103Pd Choice of radioisotope Choice of targeting agent 68Ga 131I 223Ra
Slide 20: Trend #2: Evolution of manufacturing processes
Trend #2: Evolution of manufacturing processes Securing supply chain also includes smarter scale-up Supply chain excellence Last mile • Secure supply of medically important delivery, patient isotopes confidence • Investment in novel production Isotope production technologies to support scale-up • Bu
Slide 21: Trend #3: Targeting vectors no longer straight-out-of-the-box
Trend #3: Targeting vectors no longer straight-out-of-the-box Antibody engineering creates new possibilities to modulate tumor binding and PK1 Targeting vector Small Nanobody scFv Diabody Minibody scFv-Fc IgG△CH2 IgG molecule/ Chelator peptide Linker Radiometal 1.6 15 28 55 80 100 130 150 Mainly cle
Slide 22: Trend #4: Dosimetry will supercharge personalized medicine
Trend #4: Dosimetry will supercharge personalized medicine1 Software and AI will further unlock its potential • Dosimetry is the scientific measurement, calculation, and assessment of the absorbed radiation dose • Used to ensure safety and effectiveness of exposure to: • Assess the distribution of r
Slide 23: Quantitative intelligence for drug design and adaptive therapy
Quantitative intelligence for drug design and adaptive therapy Optimizing the diagnosis–therapy chain through quantitative feedback and learning1 Disease Detected2 Proprietary know-how, Personalized Treatment algorithms 𝑫(𝒓𝑻 , 𝑻𝑫 ) = Ã(𝒓𝒔 , 𝑻𝑫 ) ∙ 𝑺(𝒓𝑻 ← 𝒓𝑺 ) 𝒓𝑺 Isotopes Ai 2x 4x…
Slide 24: Precision Medicine
Precision Medicine Kevin Richardson CEO, Precision Medicine 22
Slide 25: Commercial performance
Commercial performance Driven by Illuccix sales and RLS Radiopharmacies revenue Total revenue Q1 2025 US$M1 • Illuccix now approved in 17 countries1 +62% • Gozellix now available in the U.S. YoY • Q1 2025: Continued growth: $151 million from global sales of Illuccix: 186 • up 35% over the prior year
Slide 26: Precision medicine growth strategy
Precision medicine growth strategy We are proactively expanding our global market opportunity Expand product offerings Expand geographies Expand Expandindications indications • Launch Zircaix and Pixclara • Illuccix global rollout • Label expansion studies in the U.S. • Global regulatory filings for
Slide 27: Precision medicine portfolio
Precision medicine portfolio Expanding commercial portfolio 1. Brand names subject to final regulatory approval. 25
Slide 28: Illuccix global rollout
Illuccix global rollout Commercialization and marketing authorizations progressing in major global markets Europe Middle East and Africa: • Decentralized submission approved by BfArM as Reference Member State for European Economic Area (EEA) Concerned Member States1 • Marketing Authorizations grante
Slide 29: Expanding our addressable market through clinical leadership
Expanding our addressable market through clinical leadership Planned label expansion studies across the portfolio Study name Focus Potential outcomes PSMA PET for Ph 3 study of PSMA PET + MRI • Personalize biopsy diagnosis of compared to SOC for the detection • Remove the need to biopsy prostate can
Slide 30: Our strategy to build a leading PSMA imaging portfolio
Our strategy to build a leading PSMA imaging portfolio Underpinned by a commitment to innovation to better serve patients and customers DIFFERENTIATE THROUGH INNOVATION EXPAND THE MARKET New products and technologies, to meet the evolving needs of Increase clinical utilization through customers and
Slide 31: Telix PSMA multi-product strategy
Telix PSMA multi-product strategy Gozellix next-generation in PSMA imaging excellence • Telix has built a reputation for industry leading reliability, flexibility and service, AND clinical accuracy • Gozellix further differentiates Telix as the only provider with two FDA-approved PSMA-PET imaging ag
Slide 32: PSMA imaging today, a $2.5B to $3.5B addressable market
PSMA imaging today, a $2.5B to $3.5B addressable market Driven by current label indications and guidelines Localized disease Non-metastatic castration-resistant Metastatic castration-resistant Current indications 2) Current indication: Suspected recurrence 1) Current indication: Initial staging prio
Slide 33: Most PSMA scans are performed when recurrence is suspected
Most PSMA scans are performed when recurrence is suspected PSA test, followed by MRI, biopsy is the standard for diagnosis Localized disease Non-metastatic castration-resistant Metastatic castration-resistant Current indications 2) Current indication: Suspected recurrence 1) Current indication: Init
Slide 34: Expansion into diagnosis enhances the opportunity
Expansion into diagnosis enhances the opportunity PSMA-PET with the patient at the start of their diagnosis journey Localized disease Non-metastatic castration-resistant Metastatic castration-resistant Current indications 2) Current indication: Suspected recurrence 1) Current indication: Initial sta
Slide 35: New and guideline-driven indications for PSMA imaging
New and guideline-driven indications for PSMA imaging Potential to bring the total addressable market up to ~$6.7 billion in the U.S. New indication (subject to FDA approval) Estimated annual scans in the U.S. to reach ~1.7 million scans with a total • PSMA-PET for diagnosis (PI-RADS4 scores 2-4) ad
Slide 36: Over one million men get a biopsy every year
Over one million men get a biopsy every year “The most disruptive and transformative advancements in medicine are those that minimize patient trauma, reduce recovery time and lower cost while improving outcomes” – John Abele, Founder Boston Scientific Transperineal biopsy Intravenous injection Penis
Slide 37: Unmet need: Improving the diagnostic pathway in prostate cancer
Unmet need: Improving the diagnostic pathway in prostate cancer Opportunity to improve accuracy, minimize invasive biopsy Men with elevated PSA values Biopsies carry real risks4 will often be recommended for Areas of biopsy6 • Hematuria, rectal bleeding, MRI1, followed by biopsy hematospermia Base (
Slide 38: Current diagnosis pathway
Current diagnosis pathway Opportunity to improve triage Low sensitivity of MRI leads to high rate of biopsy prior to biopsy, and accuracy of biopsy procedure Triage to biopsy • Most men will not undergo biopsy Symptoms or mpMRI1 PI-RADS3 1 & 2 (normal/benign) • High risk men may have a template elev
Slide 39: A personalized diagnostic pathway with PSMA-PET
A personalized diagnostic pathway with PSMA-PET Smarter triage BEFORE biopsy. Integrating imaging WITH biopsy. Risk stratification Image-guided biopsy Symptoms or PSMA-PET + Potential high risk Staging and surgical elevated PSA mpMRI (PI-RADS3 5) planning PSMA-PET at diagnosis aims to: • Improve pre
Slide 40: A patient’s journey
A patient’s journey 1990 – 2025 Multiple biopsies until cancer is detected PSA Biopsy Biopsy MRI PSA MRI Clinical (up to 14+) (up to 14+) 2026 & beyond No biopsy or precision biopsy PSA MRI 60% 40% Clinical PSMA Precision No biopsy biopsy 38
Slide 41: Zircaix: Adding depth to our commercial focus on urology
Zircaix: Adding depth to our commercial focus on urology Brand name subject to final regulatory approval. 39
Slide 42: TLX250-CDx (Zircaix): Highly accurate in detecting ccRCC
TLX250-CDx (Zircaix): Highly accurate in detecting ccRCC Phase 3 ZIRCON trial validates CAIX as a novel target1 Product candidate Current status TLX250-CDx (89Zr-DFO-girentuximab) BLA under FDA review FDA Breakthrough Therapy designation2 Expanded access program active in the Payload: 89Zr U.S. T1/2
Slide 43: A clear value proposition in the diagnosis of ccRCC
A clear value proposition in the diagnosis of ccRCC1 Unmet need • Conventional imaging (CT, MRI, ultrasound) is limited in Indeterminate renal mass or suspected RCC characterizing tumor malignancy and identifying (ccRCC) CT or MRI to exclude • Unnecessary surgeries (nephrectomies) and invasive medic
Slide 44: Telix’s commitment to renal cancer patients
Telix’s commitment to renal cancer patients Aiming to transform the management of patients with ccRCC Transform To other carbonic anhydrase IX Grow (CAIX) expressing cancers Increase adoption and market harnessing data generated from Enable current ongoing studies opportunity through guideline TLX25
Slide 45: Market opportunity for diagnosis of ccRCC
Market opportunity for diagnosis of ccRCC $500M+ initial U.S. opportunity, further expansion potential in staging and recurrence U.S. TAM Upside to TAM from Annual potential scans estimate 170,000+ scans multiple scans per patient, active surveillance Potential clinical utilization: Initial opportun
Slide 46: Building on proven success: Elevating value in urology care
Building on proven success: Elevating value in urology care Zircaix, Illuccix and Gozellix share common referral stakeholders Patient Presentation Imaging Treatment/Management Primary Care Medical Urologist Physician Oncologist Radiologist /Nuclear Radiation Medicine Physician Oncologist Interventio
Slide 47: KOL perspective: Renal
KOL perspective: Renal Joseph Osborne, MD Chief of Molecular Imaging and Therapeutics and Professor of Radiology at Weill Cornell Medicine 45
Slide 48: Unmet need in diagnosis of ccRCC
Unmet need in diagnosis of ccRCC The most common – and one of the most aggressive – forms of renal cancer Need for early & accurate diagnosis / treatment Stage I Adrenal gland Gerota’s facia Tumor <7 cm in greatest • Up to 85% of RCCs are ccRCC1,2 dimension and limited to kidney; • ccRCC causes ~90%
Slide 49: Small renal masses (<2cm) are often malignant
Small renal masses (<2cm) are often malignant1 Risk statistics by tumor size (in 1cm increments) Benign vs. Malignant Low vs. High Grade 1. Thompson, J.H. et al., (2009). J Urol Benign tumors vs RCC according to size Low vs high grade tumors in 1,523 patients in patients treated surgically for renal
Slide 50: TLX250-CDx: Highly accurate in detecting ccRCC
TLX250-CDx: Highly accurate in detecting ccRCC1 Phase 3 ZIRCON trial validates CAIX as a novel target 89Zr-girentuximab ZIRCON study results summary • IgG1 CAIX-targeting mAb Sensitivity & specificity • Payload: 89Zr, positron emitter with T1/2 Sensitivity: 86% | Specificity: 87% (primary endpoints;
Slide 51: TLX250-CDx: Expanded access program
TLX250-CDx: Expanded access program Case study: Clinical utility in real-world setting Clinical background: Positive 89Zr-girentuximab AVID 89Zr-girentuximab scan History of prostate cancer with XRT 2017, recurrence in many nodes in 2020 N2M1a - on Outcome: ADT and darolutamide Management change Pat
Slide 52: Case study: ~1cm renal lesion
Case study: ~1cm renal lesion Detection of small ccRCC renal lesions Clinical background Right superior kidney Fused MIP PET positive patient • 40-yr-old male with 1.2cm renal lesion • PET positive ccRCC highly likely Diagnostic CT • Similar sized cyst negative for uptake Lesion • Partial nephrectom
Slide 53: Case study: Negative TLX250-CDx case
Case study: Negative TLX250-CDx case Detection of absence of ccRCC • Negative 89Zr- girentuximab molecular imaging suggests benign or non- ccRCC • CAIX IHC staining confirms absence of ccRCC 6 cm Oncocytoma CA-IX PET negative – CA-IX IHC negative Illustrative case study only. Individual outcomes may
Slide 54: Scintimun: Scintigraphic imaging of osteomyelitis
Scintimun: Scintigraphic imaging of osteomyelitis Approved and marketed in over 30 countries in Europe and Rest of World Product candidate Product status 99mTc-besilesomab, also Marketing authorization granted known as TLX66-CDx in Europe / Rest of World (33 countries) U.S. market feasibility assess
Slide 55: Q&A
Q&A 53
Slide 56: Therapeutics
Therapeutics Richard Valeix CEO, Therapeutics 54
Slide 57: Therapeutics strategy: Building pipeline depth and breadth
Therapeutics strategy: Building pipeline depth and breadth Aiming for three pivotal stage assets, advancing next-gen products to expand opportunity Urology: prostate and kidney Brain and rare cancers Pan-tumor Progress β 177Lu-TLX591 β 177Lu-TLX250 β 131I-TLX101 multiple Potential first radiolabelle
Slide 58: Expanded opportunity across the pipeline
Expanded opportunity across the pipeline High unmet medical need, significant potential value creation Prostate cancer Kidney cancer Brain Total U.S. market opportunity1 Px Tx Px Tx Px Tx TLX591 TLX250 TLX101 TLX592 TLX252 TLX102 US$24.9B US$8.0B Px US$6.7B Px US$0.8B US$ US$16.9B 15.5B Px US$ US$0.
Slide 59: Late-stage pipeline
Late-stage pipeline 1. Cluster of differentiation 66. 57
Slide 60: Early-stage pipeline
Early-stage pipeline “Next generation” products 1. Platelet derived growth factor receptor alpha. 58
Slide 61: Momentum across the therapeutics pipeline
Momentum across the therapeutics pipeline Upcoming catalysts Deliver Build Grow Expand Deliver our late-stage Build the next generation of Grow our industry- Expand our therapeutic pipeline radiopharmaceuticals leading precision global medicine business infrastructure for IPAX-Linz (TLX101) data TLX
Slide 62: Urologic oncology: Innovation across multiple therapeutic settings
Urologic oncology: Innovation across multiple therapeutic settings 60 60
Slide 63: TLX591: First-in-class rADC for advanced prostate cancer
TLX591: First-in-class rADC for advanced prostate cancer A differentiated approach in the emerging field of PSMA therapy Product candidate Clinical trials TLX591 (177Lu-rosopatamab tetraxetan) Linker: DOTA Targeting agent / target Antibody / • Phase 3 ProstACT Global trial dosing Prostate-specific m
Slide 64: TLX591: Novel PSMA therapy addressing key unmet needs
TLX591: Novel PSMA therapy addressing key unmet needs Potential to overcome limitations of small molecule approach Lutetium (177Lu) mAbs are distinguished by their internalization, rosopatamab tetraxetan MOA1 long retention & functional selectivity 42.3 months median OS demonstrated S U R V I V AL i
Slide 65: ProstACT Global trial
ProstACT Global trial1 Design and status update Part 1: Dosimetry & Safety Part 2: Randomized Treatment Lead-In (n = 30) Expansion (n = 490) TLX591 + SOC Eligibility Primary Primary 76mCi 76mCi • abiraterone • Confirmed • Dosimetry • enzalutamide • rPFS 2 weeks mCRPC • docetaxel • AEs/SAEs Key Secon
Slide 66: KOL perspective: TLX591
KOL perspective: TLX591 Oliver Sartor, MD Director of Transformational Prostate Cancer Research LCMC Hospitals, New Orleans, LA 64
Slide 67: TLX591 rADC vs small molecule RLT characteristics
TLX591 rADC vs small molecule RLT characteristics Key differences underpin PSMA tumor targeting, internalization, retention TLX591 rADC RLT Radiopharmaceutical TLX5911-4 Small Molecule5 description Recommended 2 x 76 mCi 6 x 200 mCi6 adult dose (14 days apart) (6 weeks apart) Small molecule† Antibod
Slide 68: Patient pain points and unmet needs
Patient pain points and unmet needs TLX591 has the potential to overcome current challenges Patient burden Why TLX591? Three core differentiators 6 infusions over 30 weeks → Clinical burden 2-dose regimen Hepatic Antibody (14 days apart) clearance avoids High off-target organ diffusion → reduces cli
Slide 69: TLX591 targeting unmet needs for mCRPC patients
TLX591 targeting unmet needs for mCRPC patients Hormone sensitive Castration resistant 177Lu-PSMA-617 peptide therapy approved but … TLX591 target initial patient population: • Opportunity to improve on efficacy 55k incident U.S. mCPRC patients per • Opportunity to reduce off-target organ diffusion
Slide 70: Demonstrated anti-tumor effect and overall survival benefit
Demonstrated anti-tumor effect and overall survival benefit1,2 Clinical development and current efficacy data • To date: evaluated in 242 prostate cancer 1.0 Overall Survival (OS)2 1.0 patients in eight Ph1/2 studies 0.8 • Evidence of anti-tumor effect and a clear dose- 0.8 0.6 response profile for
Slide 71: Initial biodistribution
Initial biodistribution TLX591 in the blood is rapidly cleared by the liver Distribution of 177Lu-TLX591 over 13 days1* 68Ga-PSMA-11 Baseline 4h 24h 4 days 7 days 13 days 177Lu-TLX591 seen in the vascular 177Lu-TLX591 seen at metastatic space and liver (SPECT) sites and liver (SPECT) Administration
Slide 72: Biodistribution: 177Lu-PSMA-617
Biodistribution: 177Lu-PSMA-617 Distribution of 177Lu-PSMA-617 over 5 days1 (SPECT) Early uptake is seen in the salivary glands and bladder, as well as within metastatic lesions in the neck and abdomen 4h 24h 2 days 5 days Administration of 177Lu-PSMA-617 Patient representative scans - individual re
Slide 73: Recap: Safety data reported from ProstACT SELECT study
Recap: Safety data reported from ProstACT SELECT study1 Safety and tolerability profile Hematologic AE profile Hematologic laboratory profile • Grade 3 thrombocytopenia (25%) and neutropenia (38%) Anemia events in line with profile expected for this class of therapy • Grade 4 thrombocytopenia (25%)
Slide 74: Dosing regimen for TLX591
Dosing regimen for TLX591 Designed to manage hematologic toxicity Days 24-hr blood circulation 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Protocol Site Visit 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 2 weeks between treatments • Day 0 TLX591 solution for injection • Slow intravenous (IV) injection (5 to 15 minute
Slide 75: Hematologic profile is predictable and consistent
Hematologic profile is predictable and consistent Data suggests manageable hematologic toxicity profile1 Hematological safety profile • The change in platelet count following the administration of TLX591 was predictable, transient and manageable • Consistent with prior clinical experience across mul
Slide 76: Cumulative injected activity
Cumulative injected activity mCRPC Dose per Total Cumulative Administration Patient Management Tx Setting Treatment Tx Period Radiation Exposure Every 2 wks for 2 cycles • Treatment room or treatment chair • No special toileting 1L / 2L 76 mCi 2 weeks 152 mCi required TLX591 • Minimal safety require
Slide 77: Liver, kidney and red marrow radiation doses in ProstACT SELECT
Liver, kidney and red marrow received radiation doses below recommended thresholds in ProstACT SELECT study1,2 32 Liver radiation threshold (32 Gy)3† 25 Salivary gland threshold (25 Gy)3† 20 Kidney radiation threshold (23 Gy)4† 15 Liver and bone marrow have the ability to Dose (Gy) recover quickly f
Slide 78: Radiation doses for 177Lu-PSMA-617
Liver, kidney and red marrow received radiation doses for 177Lu-PSMA-6171 32 Liver radiation threshold (32 Gy)2† 25 Salivary gland threshold (25 Gy)2† 20 Kidney radiation threshold (23 Gy)3† 15 Dose (Gy) 10 5 Bone marrow radiation threshold (2 Gy)2† 0 Salivary Thyroid Eyes Bladder Colon Stomach Hear
Slide 79: Q&A
Q&A 77
Slide 80: TLX592
TLX592 é‘ €) Telix
Slide 81: TLX592: 225Ac-PSMA therapy leveraging next generation antibody
TLX592: 225Ac-PSMA therapy leveraging next generation antibody Safety, PK, and dosimetry demonstrated in the CUPID trial1 Product candidate Clinical trials TLX592 (225Ac-PSMA-RADmAb) • Phase 1/2 first-in-human therapeutic study in planning, anticipated to commenced in H2 Targeting molecule / target
Slide 82: TLX592: Next-generation alpha therapy candidate
TLX592: Next-generation alpha therapy candidate Antibody with novel properties to facilitate rapid clearance1 Target Prostate-Specific Membrane • RADmAb® is a proprietary antibody engineered for use Antigen (PSMA) – expressed by the majority of prostate cancers with 225Ac for targeted alpha therapy
Slide 83: TLX592: Safety profile, pharmacokinetics and dosimetry
TLX592: Safety profile, pharmacokinetics and dosimetry CUPID study data presented at ASCO-GU 2025 Pharmacokinetics Absorbed radiation doses • 64Cu-PSMA-RADmAb blood clearance rate: • Whole-body effective dose (mean ± SD mSv/MBq): T½=19.86+1.96h at 20 mg • Group 3: 0.043 ± 0.007 • 64Cu-PSMA-RADmAb bi
Slide 84: TLX090
Scan after first dose of TLX090 TLX090 Patient representative scans – 82 individual results may vary.
Slide 85: TLX090: A proprietary formulation of Samarium-153
TLX090: A proprietary formulation of Samarium-153 Advancing development as a treatment for metastatic bone pain Product candidate Current status / planned clinical activity TLX090 (153Sm-DOTMP) Phase 1 bridging study targeting FDA Orphan Drug designation commencement in 2025 Targeting molecule / tar
Slide 86: TLX090: Next-generation, bone-seeking radiopharmaceutical
TLX090: Next-generation, bone-seeking radiopharmaceutical Advancing development as a treatment for metastatic bone pain Metastatic Prostate Cancer Patient TLX090 (153Sm DOTMP) • Bone-seeking small molecule, proven isotope platform + Left ilium and femur tumors novel chelator seeks to improve tolerab
Slide 87: Clinical utility: Treating metastatic bone pain
Clinical utility: Treating metastatic bone pain Significant unmet medical need and opportunity to improve quality of life Palliative utility (low dose, single dose) Bone metastases occurs when cancer cells spread from their original site to a bone • Patients with multifocal bone metastases often exp
Slide 88: TLX090 Clinical profile
TLX090 Clinical profile Phase 1 data demonstrate favorable early safety profile and encouraging efficacy signal Patient with mCRPC bone mets treated with TLX090. Pain relief and symptom improvement Tumor shows 19% decrease in absorbed dose within 8 • Consistent pain reduction: All patients experienc
Slide 89: TLX090 SOLACE trial: Metastatic bone pain
TLX090 SOLACE trial: Metastatic bone pain Phase 1 bridging study planned to commence in 20251 Single dose 153-Sm-DOTMP for treatment of metastatic bone pain Part A: Dose Escalation Part B: Dosimetry/Safety; (n = 9-12) Dose Selection (n = 18) • Phase 1 bridging study links to first-generation 16 week
Slide 90: TLX250
TLX250-CDx (PET Imaging of CAIX) TLX250 TLX250 (CAIX 177Lu Therapy) Illustration of TLX250-CDx binding to carbonic anhydrase IX Images from STARLITE-2 study. 88 Credit: Memorial Sloan Kettering Cancer Center.
Slide 91: TLX250: First-in-class rADC for kidney cancer
TLX250: First-in-class rADC for kidney cancer Large opportunity across ccRCC and other CAIX-expressing tumors Product candidate Linker: DOTA Payload: 177Lu Clinical trials TLX250 (177Lu-DOTA-girentuximab) T1/2: 6.7 days • STARLITE-1 (Phase 1b/2) – enrolling Targeting molecule / target patients1 Anti
Slide 92: TLX250: Validated in ccRCC, pan-cancer potential
TLX250: Validated in ccRCC, pan-cancer potential Positioned to be first CAIX-targeting rADC to market TOP: 89Zr-girentuximab PET/CT at baseline showing uptake in TLX250 (177Lu-girentuximab) a sacral metastatic lesion in a patient with ccRCC. • Monoclonal antibody targeting Carbonic Anhydrase IX (CAI
Slide 93: Established clinical proof of concept for renal cancer therapy
Established clinical proof of concept for renal cancer therapy Encouraging safety/tolerability profile, preliminary efficacy signal (monotherapy) Previously studied in end-stage patients with advanced renal cell carcinoma: • Phase 1: Dose escalation study to identify safety & MTD in 23 patients with
Slide 94: Typical patient journey for a metastatic kidney cancer patient
Typical patient journey for a metastatic kidney cancer patient Major unmet needs include enhancing efficacy of combination treatments and late-line treatment First Line therapy Second Line therapy Third Line and beyond Diagnosis and surgery 27k US patients per year 13k US patients per year 6k US pat
Slide 95: TLX250: Development pathway
TLX250: Development pathway Study name Indication Phase Status STARLITE-1 Treatment-naïve 1b/2 • Enrolling patients ClinicalTrials.gov ID: advanced ccRCC • TLX250 in combination with cabozantinib and NCT05663710 nivolumab Advanced or • MTD of TLX250 established when STARLITE-2 2 ClinicalTrials.gov I
Slide 96: Brain cancer
Glioblastoma patient (salvage) with clinically stable disease 18 months from initiation of TLX101 therapy Brain cancer T=0 10 months TLX101 16 months 18 months Patient representative scans - individual results may vary. Credit A. Braat, Utrecht.
Slide 97: TLX101-CDx (Pixclara) for imaging glioma
TLX101-CDx (Pixclara) for imaging glioma Unmet need for delineating progressive disease from treatment-induced changes Payload: 18F Product candidate Current status T1/2: 110 mins TLX101-CDx (Pixclara1) • Preparing to re-file U.S. NDA 18F-floretyrosine or 18F-FET • Expanded access program active in
Slide 98: TLX101: Potential first systemic radiotherapy in glioblastoma
TLX101: Potential first systemic radiotherapy in glioblastoma Promising therapeutic profile, simple IV administration solves major challenge in GBM treatment Product candidate Planned clinical activity TLX101 (131I Iodofalan) Payload: 131I • Planned initiation of pivotal trial in Australia T1/2: 8.0
Slide 99: TLX101: Novel treatment candidate for glioblastoma (GBM)
TLX101: Novel treatment candidate for glioblastoma (GBM) Promising therapeutic profile, IV delivery addresses a challenge in GBM TLX101 is an iodine-labelled small molecule, Iodofalan (131I), targeting the L- TLX101: Iodofalan (131I) Type amino acid transporter 1 (LAT1) 131I payload • Validated targ
Slide 100: Significant unmet need in glioblastoma
Significant unmet need in glioblastoma Initial focus on recurrent GBM patients with limited treatment options • Most common and most aggressive primary brain tumor Glioblastoma patient flow – Over 14,500 U.S. patients diagnosed each year Diagnosed – Most patients progress after ~7 months Gold standa
Slide 101: TLX101: Development pathway
TLX101: Development pathway Study name Indication (GBM) Phase Status IPAX-1 First recurrence 1 Completed ClinicalTrials.gov ID: Demonstrated mOS of 13 months from the initiation NCT03849105 of treatment, or 23 months from initial diagnosis1 IPAX-2 Newly diagnosed 1 Recruiting ClinicalTrials.gov ID:
Slide 102: Addressing brain malignancies with alpha and beta therapy candidates
Addressing brain malignancies with alpha and beta therapy candidates Two treatment candidates addressing distinct unmet needs TLX101 TLX102 • TLX101 and TLX102 are ideal to treat brain malignancies because Phenylalanine Phenylalanine they cross the blood-brain barrier, Targeting agent (targets LAT1
Slide 103: TLX102: 211At labelled follow-on product
TLX102: 211At labelled follow-on product High potency isotope with shorter path length provides potential to expand adoption Product candidate Planned clinical activity TLX102 (211At astato-l-phenylalanine) Payload: 211At • First-in-human study targeting T1/2: 7 hours commencement in 2026 Targeting
Slide 104: KOL perspective: TLX101
KOL perspective: TLX101 John de Groot, MD Division Chief of Neuro-Oncology at University of California San Francisco 102
Slide 105: Glioblastoma: where are we now?
Glioblastoma: where are we now? 2 drug approvals in 25 years 20 15 Survival (months) Bev for rGB Lomustine TMZ for nGB 10 Carmustine TMZ for rAA Radiotherapy Gliadel TTF 5 1 FDA Approvals 0 1970 1980 1990 2000 2010 2020 1st CT Rano Criteria 1st MRI McDonald Criteria: MR steroids 339/78 Levin Criteri
Slide 106: Evidence-based management of adult glioblastoma
Evidence-based management of adult glioblastoma • Maximum safe resection • Conventionally fractionated limited-field radiotherapy • Chemotherapy • Concurrent daily temozolomide with radiotherapy • 6-12 cycles post-radiotherapy temozolomide • Single agent bevacizumab at recurrence • Tumor treating fi
Slide 107: Glioblastoma is increasing and overall survival rates remain low
Glioblastoma is increasing and overall survival rates remain low Annual Incidence in US1 Average Survival (US)1 1-year survival, 3-year survival, 5-year survival 1. NCI SEER Database, 2025 105
Slide 108: LAT1 is a validated target upregulated in brain malignancies
LAT1 is a validated target upregulated in brain malignancies Role in drug transport, cell proliferation, and survival LAT1 is a transmembrane transporter1 that is LAT1 Overexpression Is Correlated With Ki67, a Marker of Cell Proliferation, in Human Gliomas4 • Integral to the transport of large neutr
Slide 109: TLX101: Potential first-in-class systemic radiotherapy for GBM
TLX101: Potential first-in-class systemic radiotherapy for GBM Novel approach passes blood-brain barrier, enabling effective treatment with IV administration TLX101: Iodofalan (131I) Mechanism of action • Radiolabelled IPA delivers systemic radiation directly to tumor 131I payload • Binds to LAT1 re
Slide 110: Why is TLX101 promising? (1/2)
Why is TLX101 promising? Compassionate use case of glioblastoma patient with Courtesy of Dr. Braat UMC Utrecht durable partial response after four treatments (1/2) MRI T1ce TLX101 SPECT MRI T1ce MRI T1ce Baseline Oct 2023 TLX101 #1 & #2 Jan 2024 Aug 2024 [18F]-FET [18F]-FET [18F]-FET Note: Sample pa
Slide 111: Why is TLX101 promising? (2/2)
Why is TLX101 promising? Compassionate use case of glioblastoma patient with Courtesy of Dr. Braat UMC Utrecht durable partial response after four treatments (2/2) MRI T1ce TLX101 SPECT after dose #3 MRI T1ce MRI T1ce After 2x [131I]IPA Feb 2025 Apr 2025 [18F]-FET TLX101 SPECT after dose #4 [18F]-FE
Slide 112: Summary of IPAX-1 results
Summary of IPAX-1 results TLX101 plus EBRT was associated with acceptable safety profile and specific tumor targeting in patients with recurrent GBM Safety and Radiological tumor Metabolic tumor Survival tolerability profile response (at 3-mo response (at 3-mo outcomes F/U, MRI) F/U, 18F-FET PET) •
Slide 113: Summary of IPAX-Linz top line results
Summary of IPAX-Linz top line results1 Further substantiates safety profile and efficacy signal generated in IPAX-1 Patient population Safety profile and Survival outcomes Next steps tolerability • 8 total rGBM • Adaptive dosing • Median OS: 32.2 • 6 GBq total dose patients treated regimen of up to
Slide 114: IPAX-BrIGHT: Study design
IPAX-BrIGHT: Study design A pivotal, global registration enabling trial in recurrent glioblastoma Part 1: Dosimetry/safety Data review Part 2: Randomization Part 1a Part 1b Eligible TLX101 + Lomustine TLX101 + Lomustine Screen TLX101 + Patients Safety/Dosimetry Lead- Dose Expansion 1:1 Lomustine in
Slide 115: TLX66: Opportunity to improve outcomes for AML patients
TLX66: Opportunity to improve outcomes for AML patients A potent, low morbidity option for bone marrow conditioning Payload: 90Y Product candidate Current status / planned clinical activity T1/2: 2.66 days TLX66, 90Y-besilesomab • Phase 2 investigator-initiated trial in FDA orphan drug designation p
Slide 116: TLX300: Radiolabelled olaratumab advancing to clinical trials
TLX300: Radiolabelled olaratumab advancing to clinical trials Strong scientific, clinical and commercial rationale for development Product candidate Clinical trial TLX300 (-olaratumab) Phase 1 ZOLAR imaging study recruiting, trial Targeting molecule / target aims to Antibody / • Evaluate the safety,
Slide 117: Q&A
Q&A
Slide 118: Pan cancer: Spotlight on two key targets (CAIX and FAP)
Kratochwil et al. J Nuc Med. 2019. 68Ga-FAPI PET/CT: Tracer Uptake in 28 Different Kinds of Cancer. Pan cancer: Spotlight on two key targets (CAIX and FAP) 116
Slide 119: CAIX + FAP: Potential multi-blockbuster opportunity
CAIX + FAP: Potential multi-blockbuster opportunity Exploring multi-indication asset strategies leveraging validated pan-tumor targets Two well-validated targets with pan-cancer potential1, 2 FAP targeting FAP CAIX small molecule (fibrosis) Glioblastoma Multiforme Head and Neck Carcinoma Nasopharyng
Slide 120: TLX252: Next generation alpha emitter entering clinic
TLX252: Next generation alpha emitter entering clinic CAIX-targeting 225Ac-labelled rADC for the treatment of patients with advanced cancer Product candidate Planned clinical activity TLX252 (225Ac-DOTA-girentuximab) Phase 1 study in CAIX positive cancers: Targeting molecule / target • Planning to c
Slide 121: Clinical utility of 225Ac-TLX252
Clinical utility of 225Ac-TLX252 Significant unmet medical need for patients with CAIX-expressing tumors and opportunity to overcome hypoxia-driven treatment resistance • Patients with tumors expressing high levels of CAIX, a marker of tumor hypoxia, have significantly poorer overall survival, short
Slide 122: TLX252 Phase 1 study in CAIX-positive cancers
TLX252 Phase 1 study in CAIX-positive cancers Utilizing the theranostic pairing of imaging and alpha therapy to personalize treatment Patient population Patient selection & treatment planning Truly personalized patient treatment CAIX-expressing tumors Telix’s 89Zr-Girentuximab (TLX250-CDx) Imaging w
Slide 123: FAP expression suggests potential target for pan-cancer theranostic
FAP expression suggests potential target for pan-cancer theranostic Opportunity to treat spectrum of tumors with single target • FAP present on more than 90% of epithelial SNMMI Image cancers, identified as a potential target for of the Year molecular imaging and therapy 2019 • Broad expression on t
Slide 124: TLX400: Next generation FAPi therapy with pan-tumor potential
TLX400: Next generation FAPi therapy with pan-tumor potential Payload: 177Lu Product candidate Planned clinical activity T1/2: 6.7 days 177Lu-DOTAGA.Glu.(FAP) 2 Planned to commence clinical development program in 2026: Pan- Targeting molecule / target cancer basket study + lead indication Fibroblast
Slide 125: TLX400: FAP-targeting candidate with pan-tumor potential
TLX400: FAP-targeting candidate with pan-tumor potential Next generation asset designed to overcome historical limitations of FAP therapy Clinically-validated therapeutic and companion diagnostic TLX400: 177Lu- • Designed to overcome limitations of current (first generation) FAP targeted radiotherap
Slide 126: Telix is leading the next generation of radiopharmaceuticals
Telix is leading the next generation of radiopharmaceuticals We have multiple drivers of value creation Commercial Pipeline Industry-leading execution Development manufacturing and supply chain ✓ Proven track record of ✓ Multiple near-term ✓ Manufacturing, isotope commercial delivery with catalysts
Slide 127: Contact
Contact: Kyahn Williamson SVP Investor Relations and Corporate Communications kyahn.williamson@telixpharma.com Illustration showing TLX250 binding to carbonic anhydrase IX and internalization