Telix Pharmaceuticals (TLX) Status Update summary

Urology therapeutic strategy and pipeline

• Focus on prostate, kidney, and bladder cancers with dynamic market potential and significant unmet needs.

• Comprehensive urology portfolio includes both beta and alpha isotope therapies, addressing multiple tumor types and stages.

• Lead asset TLX591 for prostate cancer is in phase III, with interim readout expected by end of H1 2025.

• Next-generation pipeline features TLX592 (alpha for prostate), TLX090 (bone metastases), and TLX252 (CA9-targeted alpha therapy).

• Expansion beyond urology targets pan-cancer opportunities with CA9 and FAP, aiming for broad solid tumor coverage.

Kidney cancer (CA9 program) insights

• CA9 is expressed in over 90% of clear cell renal cancers, validated by phase III ZIRCON trial.

• Lutetium girentuximab shows robust disease control and potential as first radio-antibody drug conjugate for renal cell carcinoma.

• Pivotal trial for TLX250 planned for late-line setting, with positive FDA feedback and launch targeted for H2 2025.

• Combination with immunotherapy is promising, supported by preclinical synergy data and ongoing STARLITE clinical trials.

• Monotherapy addresses unmet need in late-line metastatic disease, aiming for improved progression-free survival.

Prostate cancer program and clinical development

• TLX591 (beta) and TLX592 (alpha) are advanced radio-antibody therapies for metastatic castration-resistant prostate cancer.

• TLX591 offers high tumor targeting, minimal off-target toxicity, and convenient two-dose regimen.

• Phase III ProstACT Global trial allows combination with standard of care, focusing on radiographic progression-free survival and overall survival.

• Real-world data show limited survival benefit from current therapies, highlighting need for more effective, patient-friendly options.

• Alpha therapies may offer advantages in resistant or low-PSMA-expressing tumors and could be used in combination with beta therapies.