Telix Pharmaceuticals (TLX) Status update summary

Advances in PSMA PET/CT imaging and diagnostic performance

• PSMA PET/CT imaging demonstrates ≥80% sensitivity and ≥90% specificity, outperforming traditional methods and enabling detection of micrometastatic disease as small as 2 mm and at very low PSA values (0.02 ng/mL).

• Recent phase III data in Chinese populations confirm high positive predictive value of gallium PSMA PET, with Illuccix achieving a patient-level PPV of 94.8% and region-level PPV up to 100% in the prostate bed.

• More than two-thirds (67.2%) of patients had a change in treatment plan following TLX591-Px PSMA-PET imaging.

• Combining PSMA PET with MRI enhances diagnostic accuracy and may reduce unnecessary procedures.

• New tracers targeting alternative biomarkers (e.g., GRPR) are under investigation for PSMA-negative cases.

Technology, scalability, and operational considerations

• Gallium-68 platform offers accessible, flexible, and scalable production with multiple generator manufacturers and robust supply chains.

• Cyclotron-produced gallium provides 10-20x higher isotope production compared to generators.

• High-throughput private practices invest in PET/CT infrastructure, integrating imaging, diagnostics, and therapeutics for efficiency.

• Gozellix expands market reach by increasing access to 362 additional cameras and enabling higher scan volumes at 164 sites.

• Efficiency in scheduling, scanning, and data management is critical for large practices, with same-day scanning and protocol optimization.

Regulatory and product status

• Illuccix (68Ga PSMA-11) is approved in multiple global markets; Gozellix is FDA-approved.

• Scintimun is approved in 32 European countries and Mexico; SENSEI is FDA-registered and CE-marked.

• Other drugs and devices, including Zircaix and Pixclara, remain investigational.