Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — J.P. Morgan Healthcare Conference 2024
31 slides from Telix Pharmaceuticals's conference presentation, Jan 8, 2024
Slide 1: Telix Pharmaceuticals - J.P. Morgan Healthcare Conference
TLX250-CDx (PET Imaging of CAIX) Telix Pharmaceuticals TLX250 (CAIX 177Lu Therapy) J.P. Morgan Healthcare Conference San Francisco, January 8 - 11, 2024 ASX: TLX Illustration of TLX250-CDx binding to carbonic Images anhydrase from STARLITE-2 study. IX Credit: Memorial Sloan Kettering Cancer Center.
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 leading "theranostic" radiopharma company
Telix: A leading “theranostic” radiopharma company Deep pipeline focused on oncology and rare diseases INDUSTRY LEADING COMMERCIAL STAGE INVESTING FOR PIPELINE IMAGING (DIAGNOSTIC) FUTURE GROWTH PORTFOLIO ● Late-stage therapeutic and ● Significant growth from ● Commercial revenue funds diagnostic “t
Slide 4: Q4 2023: Total revenue update
Q4 2023: Total revenue update U.S. sales driving consistent, strong growth 160.0 140.0 148.1 133.6 120.0 120.7 Total Revenue (AUD) 100.0 100.1 FY2023 Total 80.0 Revenue 79.0 (unaudited)1 60.0 57.1 40.0 $502.5M 20.0 Up 214% from $160.1M in 0.0 Q3 2022 Q4 2022 Q1 2023 Q2 2023 Q3 2023 Q4 2023 FY2022 1.
Slide 5: Deep radiopharma expertise
Deep radiopharma expertise Broad development toolkit enables development of first-in-class / best-in-class assets Targeting Radioactive Innovation and development expertise isotope agent drives pipeline candidate selection: ⚫ Deep understanding of radiation biology ⚫ First-in-class or best-in-class
Slide 6: Core pipeline: Oncology and rare diseases
Core pipeline: Oncology and rare diseases TARGETING Dx/ ISOTOPE PHASE 1 PHASE 2 PHASE 3 COMMERCIAL UPCOMING MILESTONES AGENT Tx 177Lu ProstACT GLOBAL interim Antibody Tx readout: Q1 2025 TLX591 (177Lu rosopatamab tetraxetan) Phase 1 CUPID trial results: H1 Prostate Antibody α (alpha) Tx TLX592 (alph
Slide 7: A strong foundation for growth
A strong foundation for growth R&D program to drive value creation Progress late-stage pipeline Commercialize diagnostics ● Phase 3 ProstACT GLOBAL trial for prostate cancer therapy (TLX591) ● Planned launch of Zircaix™ and Pixclara™1 ● Phase 2 STARLITE trials and Phase 1b STARSTRUCK trial of TLX250
Slide 8: Building a vertically integrated business
Building a vertically integrated business World-class innovation and manufacturing infrastructure Equipped to deliver Liege (Quality control) Continuing to invest patient doses globally in-house development and production capacity ⚫ Global supply chain Herstal (GMP and secondary packaging) ⚫ Isotope
Slide 9: Prostate cancer therapy program
Prostate cancer therapy program Illustration of TLX591 binding to PSMA
Slide 10: TLX591: Phase 3 prostate cancer therapy
TLX591: Phase 3 prostate cancer therapy First-in-class radio-antibody drug conjugate (rADC) targeting PSMA Product Scientific rationale TLX591 (177Lu rosopatamab • Antibodies are functionally specific for tumor- tetraxetan) expressed PSMA • High internalization and long retention with high Targeting
Slide 11: TLX591 data generated to date
TLX591 data generated to date Demonstrated evidence of anti-tumor effect and overall survival benefits1,2 • Previously evaluated in 242 prostate cancer 1.0 Overall Survival (OS)2 1.0 >50% PSA Decline patients in eight Ph1/2 studies 0.8 • Evidence of anti-tumor effect and a clear dose- 0.8 0.6 respon
Slide 12: TLX591 safety data reported from SELECT study
TLX591 safety data reported from SELECT study1 Safety and tolerability profile confirmed Hematologic AE profile Key observations Hematologic laboratory profile Anemia ⚫ Grade 3 thrombocytopenia (25%) and neutropenia (38%) events in line with profile expected for this class of therapy ⚫ Grade 4 throm
Slide 13: ProstACT GLOBAL trial design
ProstACT GLOBAL trial design First patient recruited, designed to integrate with real-world standard of care ProstACT N = ~400 patients GLOBAL Randomization stratification • SoC – ARPI2 or taxane Phase 2/3 trial in patients with • Disease burden Group A mCRPC1 progressing on 1st line • Visceral dise
Slide 14: TLX591: benefits rival small molecule-based approach
TLX591: benefits rival small molecule-based approach Promising overall survival seen in early phase studies1 Efficacy Dosing schedule enables combination with concurrent therapies Patient No dry eye, no xerostomia (salivary gland ablation), no ganglia irradiation comfort Implications for alpha thera
Slide 15: TLX592: "Next gen" alpha therapy for prostate cancer
TLX592: "Next gen" alpha therapy for prostate cancer RADmAb® PK engineered antibody with novel properties to facilitate rapid clearance Product Scientific rationale TLX592 (225Ac-RADmAb) • RADmAb® is a proprietary antibody engineered for use with 225Ac for targeted alpha therapy • Faster elimination
Slide 16: TLX592: CUPID study dosing final cohort
TLX592: CUPID study dosing final cohort Taking TLX592 into patients with a “theranostic” approach Early signs of encouraging tumor discrimination • TLX592 is being developed as a targeted alpha therapy, complementary to TLX591 • May be suitable for patients with very early-stage metastatic disease w
Slide 17: Supporting patients and physicians throughout the journey
Supporting patients and physicians throughout the journey Solutions across the prostate cancer patient care continuum Potential expanded utility Current 1) Current indication: Initial 2) Current indication: based on current guidelines1 3) Current indication: indication staging prior to definitive th
Slide 18: Other therapeutic programs
Other therapeutic programs Illustration of TLX250 binding to CAIX
Slide 19: Core pipeline: clinical highlights
Core pipeline: clinical highlights Recent updates and progress ProstACT SELECT ProstACT GLOBAL ProstACT GLOBAL CUPID (TLX592) PROSTATE CANCER positive interim readout APAC dosing patients expected to open at dosing final THERAPY U.S. sites in H1 20241 cohort TLX250-CDx OPALESCENCE Zircaix™ U.S. Prog
Slide 20: TLX250: Phase 2 renal cancer therapy
TLX250: Phase 2 renal cancer therapy Potential to further develop as a “pan-cancer” solid tumour therapeutic targeting CAIX Targeting Agent: Product Scientific rationale girentuximab TLX250 (177Lu-DOTA- • CAIX expressed in up to 95% of ccRCC1 and IgG1 monoclonal girentuximab) many hypoxic / resistan
Slide 21: CAIX expression is associated with poor clinical outcomes
CAIX expression is associated with poor clinical outcomes Studies in progress reinforce potential of CAIX as a therapeutic target CAIX expression TLX250-CDx detection of CAIX expressing tumors “Theranostic” trials of Fused TLX250-CDx and TLX250 PET +ve CT PET/CT ccRCC ZIRCON • Phase 2 imaging study
Slide 22: TLX101: Phase 2 brain cancer therapy
TLX101: Phase 2 brain cancer therapy Large amino acid transporter 1 (LAT-1) program Product Scientific rationale TLX101 (131I-IPA) • A novel approach that is readily able to pass through the blood-brain barrier • IPAX-1 trial demonstrated median OS of 13 Targeting molecule months from the initiation
Slide 23: TLX300: Soft tissue sarcoma therapy
TLX300: Soft tissue sarcoma therapy Leveraged clinically established targeting antibody olaratumab Product Scientific rationale TLX300 (olaratumab) • STS is a radiation susceptible cancer that may be inherently amenable to systemic radionuclide therapy1 Targeting molecule • Ability to target PDGFRα2
Slide 24: Radiolabelled olaratumab (TLX300) advancing to clinical trials
Radiolabelled olaratumab (TLX300) advancing to clinical trials Strong scientific, clinical and commercial rationale for development Olaratumab (Lartruvo®) was commercialized by High unmet medical need for treatment of STS Lilly as a “naked” antibody1 ⚫ In-licensed from Lilly in April 2022 with exclu
Slide 25: TLX66 program
TLX66 program Whole-body imaging 24h post Phase 2 therapeutic clinical trial to commence in H1 2024 infusion of 111In-labelled TLX66 Product Scientific rationale TLX66 (90Y-DTPA-besilesomab) • The target of TLX66 – cluster of differentiation 66, or CD66 – is a well Targeting molecule validated leuko
Slide 26: TLX66: Clinical data in 98 patients
TLX66: Clinical data in 98 patients Excellent safety profile and encouraging efficacy signals Encouraging long-term RFS and OS in high-risk AML patients TLX66 has been tested in 98 patients (including children) with a range of (RFS and OS >10 years in most patients)1 hematological malignancies: • Ph
Slide 27: Kidney and brain cancer imaging for "theranostics"
Kidney and brain cancer imaging for “theranostics” Illustration of TLX101-CDx binding to LAT-`1
Slide 28: TLX250-CDx (Zircaix) for imaging of kidney cancer
TLX250-CDx (Zircaix™) for imaging of kidney cancer Antibody-based PET imaging targeting CAIX Antibody: High unmet need: Market Girentuximab opportunity >US$500M1 ● Binds with high specificity to ● ccRCC is the most common CAIX and is internalized and aggressive form of ● Extensive safety experience
Slide 29: TLX101-CDx (Pixclara) for imaging of glioma
TLX101-CDx (Pixclara™) for imaging of glioma Unmet need for delineating progressive disease from treatment-induced changes ROC analysis of 80 Preparing to file U.S. NDA for TLX101-CDx (18F- floretyrosine): patients with grade 3/4 glioma or brain metastases • Initial indication: Characterizing recurr
Slide 30: Telix is pioneering the next generation of radiopharmaceuticals
Telix is pioneering the next generation of radiopharmaceuticals Therapeutic pipeline underpinned by deep understanding of drug development Summary Surgical / Imaging Interventional Therapeutics ⚫ Pioneers in radiopharmaceutical drug Oncology development, team with a collective 320+ years experience
Slide 31: Contact details
Contact details: Kyahn Williamson SVP Investor Relations and Corporate Communication kyahn.williamson@telixpharma.com
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