Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — J.P. Morgan Healthcare Conference 2023
33 slides from Telix Pharmaceuticals's conference presentation, Jan 12, 2023
Slide 1: Telix Pharmaceuticals
Telix Pharmaceuticals J.P. Morgan Healthcare Conference San Francisco, 9-12 January 2023 ASX: TLX
Slide 2: Disclaimer
Disclaimer The information contained in this presentation is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. No representation or warranty, express or implied,
Slide 3: Telix: A global leader in radiopharmaceuticals
Telix: A global leader in radiopharmaceuticals Theranostics for oncology and rare diseases COMMERCIAL STAGE INDUSTRY LEADING IMAGING PORTFOLIO THERANOSTIC PIPELINE • Late-stage imaging and • Illuccix® for prostate cancer therapeutic assets imaging launched in U.S. & AU/NZ • Supported by extensive •
Slide 4: The theranostic approach
The theranostic approach Using imaging and therapy to deliver personalized, precision medicine 01 02 03 04 Targeted radiation drug Intravenous injection Targeted delivery See it. Treat it. 4
Slide 5: Our point of difference
Our point of difference Harnessing the power of targeted radiation throughout the patient journey Systemically delivered, targeted radiation is transforming Telix is delivering targeted radiation across the continuum cancer care from diagnosis to treatment From a ‘box’ To a ‘shot’ • Portfolio of ima
Slide 6: Building on a transformative year
Building on a transformative year Major milestones delivered in 2022, value creating catalysts ahead Key milestones in 2022 Revenue from U.S. Illuccix® sales 2023 catalysts Q2 to Q4 2022 (US$M)3 • US$100.4M revenue from U.S. • Illuccix® - continued sales of Illuccix® since launch1 in Q4 2022 revenue
Slide 7: Core pipeline: Oncology and rare diseases
Core pipeline: Oncology and rare diseases Prostate PSMA1 PHASE 1 PHASE 2 PHASE 3 COMMERCIAL 68Ga Imaging Small molecule TLX591-CDx (68Ga-PSMA-11, Illuccix®) Antibody 177Lu Therapy TLX591 (177Lu-rosopatamab) Kidney CAIX2 PHASE 1 PHASE 2 PHASE 3 COMMERCIAL 89Zr Imaging Antibody TLX250-CDx (89Zr-girent
Slide 8: Research pipeline: novel targets and technologies
Research pipeline: novel targets and technologies ASSET TARGET ISOTOPE DESCRIPTION STATUS Immuno-oncology 177Lu TLX250 + Merck KGaA DNA Damage Response Inhibitor (DDRi) candidate in Phase Ib study (STARSTRUCK) TLX250 Combo CAIX patients with CAIX-expressing solid tumors to commence 1H 2023 Targeted
Slide 9: Growth strategy
Growth strategy Delivering long-term value to shareholders and patients Commercial Unlock the value in Global supply chain Future pipeline: diagnostics portfolio therapeutic pipeline and manufacturing research & innovation Revenue from first product Clinical milestones across Expanding in-house Robu
Slide 10: Illuccix® commercial update
Illuccix® commercial update
Slide 11: Illuccix® prostate cancer imaging agent
Illuccix® prostate cancer imaging agent Continued U.S. sales momentum in first nine months since launch ILLUCCIX NETWORK COVERAGE • Q4 2022 revenue from U.S. sales of Illuccix of US$50.5M (AU$76.8M), up 39% on Q3 20221 • Diversified customer base with growth across hospitals, independent imaging cen
Slide 12: 68Ga-PSMA-11 positron emission tomography (PET)
68Ga-PSMA-11 positron emission tomography (PET) Current and potential uses in clinical practice P R I M A R Y S TA G I N G BIOCHEMICAL RECURRENCE LONGITUDINAL MANAGEMENT1 68Ga-PSMA-11 Bone scan Baseline After therapy 1. Illuccix is not currently indicated to monitor for this indication. Note: Images
Slide 13: Our clinical mission: support the patient every step of the way
Our clinical mission: support the patient every step of the way Localized disease Advancing clinical stages Metastatic castrate resistant • Radiation therapy +/- ADT • Docetaxel, abiraterone (metastatic, First line: IIT studies • Radical prostatectomy non-castrate), apalutamide, • Docetaxel; sipuleu
Slide 14: Continuous innovation in urologic oncology
Continuous innovation in urologic oncology Solutions across the continuum of imaging, surgery and therapy for prostate cancer ADDITIONAL RADIO/IMAGE ILLUCCIX TO TAL - B O D Y P R O S TAT E PSMA IMAGING GUIDED SURGERY FOR BgRT2 PET SCAN CANCER THERAPY MODALITIES PSMA SPECT tracer, TLX599-CDx with Par
Slide 15: Prostate cancer therapy program
Prostate cancer therapy program
Slide 16: Prostate-specific membrane antigen (PSMA) program
Prostate-specific membrane antigen (PSMA) program A differentiated approach in the emerging field of PSMA therapy Product candidates Scientific rationale TLX591 (177Lu-rosopatamab) • Antibodies are functionally specific for tumor- TLX592 (225Ac–RADmAb®) expressed PSMA • Superior internalization and
Slide 17: PSMA competitive landscape
PSMA competitive landscape TLX591 Telix approach is highly differentiated Liver (preferred clearance organ) ANTIBODY (TLX591) SMALL MOLECULES Functionally specific for tumor- expressed PSMA, does not “hit” most Taken up by endogenous PSMA Fecal endogenous PSMA excretion Small molecule Off-target eff
Slide 18: ProstACT program overview
ProstACT program overview Multiple opportunities to deliver insights into TLX591, across multiple patient segments Radiogenomics study Combination with EBRT1 in Phase III study in patients with (Phase I) oligometastatic early recurrence mCRPC2 progressing on first line (Phase II) novel androgen agen
Slide 19: ProstACT GLOBAL study overview
ProstACT GLOBAL study overview U.S. and EU patient enrolment commencing in 2023 RUN-IN P H AS E I I I Summary Stratification Group A • Total patients: ~392 • Prior NAAD therapy Group A 76 mCi 177Lu-DOTA- 76 mCi 177Lu-DOTA- • “Run-in” to accommodate new scale-up in csPRC1 • Disease burden rosopatamab
Slide 20: Radiation retention in tumor with antibody therapy
Radiation retention in tumor with antibody therapy Demonstrates high retention of 177Lu in the tumor Lower tumor burden High tumor burden • Biodistribution data indicates TLX591 antibody is retained in the tumor with high activity remaining at two weeks and beyond • Longer-term retention of TLX591 i
Slide 21: Renal cancer imaging and CAIX program
Renal cancer imaging and CAIX program 21
Slide 22: Carbonic Anhydrase IX (CAIX) program
Carbonic Anhydrase IX (CAIX) program Phase III imaging study complete, potential to develop as a pan-cancer target Product candidate Scientific rationale Targeting Agent: girentuximab TLX250-CDx (89Zr-DFO-girentuximab) • CAIX expressed in up to 95% of ccRCC and many hypoxic / IgG1 monoclonal antibod
Slide 23: TLX250-CDx: Imaging agent with high commercial potential
TLX250-CDx: Imaging agent with high commercial potential Strong results support potential for TLX250-CDx to change standard of care Top-line data reported in November 20221 Planning for FDA regulatory approval in 2024 • Primary endpoint met: Sensitivity of ≥84% and specificity of • Phase III data de
Slide 24: The role of TLX250-CDx in the patient journey
The role of TLX250-CDx in the patient journey Identification and characterization of ccRCC Potential future use New Renal cancer Active surveillance for Previously treated renal mass diagnosis known renal mass ccRCC high risk • Identification of patients with • Confirm clear cell histology, • For th
Slide 25: U.S. market opportunity >$500M
U.S. market opportunity Identification and characterization of ccRCC Potential future use New incidental Renal cancer Active surveillance for Previously treated renal mass diagnosis known renal mass ccRCC high risk • Estimated 73,994 incidental • 79,000 patients will be • Prevalence unknown • 599,00
Slide 26: Potential new tumor targets and combination therapies
Potential new tumor targets and combination therapies Reinforces effectiveness of CAIX as a therapeutic target Current clinical studies Current clinical studies Potential for indication expansion: of TLX250-CDx of TLX250 (renal cancer) Literature reports of CAIX expression STARLITE Glioblastoma Head
Slide 27: Neuro-oncology program
Neuro-oncology program © Telix
Slide 28: Glioblastoma / LAT-1 program
Glioblastoma / LAT-1 program Target: Large amino acid transporter 1 (LAT-1) Product candidates Development status (Dx) Dx: TLX101-CDx (18F-FET) 505(b)2 New Drug Application (NDA) package Tx: TLX101 (131I-IPA) for U.S. FDA submission in 2023 Targeting Molecule Development status (Tx) Small molecule •
Slide 29: TLX101-CDx: Value proposition for glioma imaging
TLX101-CDx: Value proposition for glioma imaging Potential to lead with first commercial FET-PET imaging agent for U.S. market Reduce and/or replace Provide key information surgical biopsies at initial • FET-PET has the potential to provide a rapid and conclusive diagnosis 1 diagnosis to enable opti
Slide 30: IPAX results: final, 1-year follow up
IPAX results: final, 1-year follow up Promising data warrants investigation in a front-line setting • IPAX-1 multi-centre Phase I trial of TLX101 in combination with external beam radiation therapy (EBRT) in patients with recurrent GBM completed in 2021 • Final data confirmed safety and tolerabilit
Slide 31: Upcoming milestones
Upcoming milestones €) Telix
Slide 32: Upcoming catalysts
Upcoming catalysts New Drug ProstACT Illuccix® - Biologics License GLOBAL patient Four key continued Application (NDA) Application (BLA) for brain cancer recruitment and catalysts revenue growth submission for data readout and global imaging TLX250-CDx (TLX101-CDx) ProstACT rollout SELECT EXPECTED M
Slide 33: Contact details
Contact details: Kyahn Williamson SVP Investor Relations and Corporate Communication kyahn.williamson@telixpharma.com 33
Telix Pharmaceuticals — J.P. Morgan Healthcare Conference 2023 on 6ix