Telix Pharmaceuticals (TLX) investor relations material

Portfolio and Clinical Pipeline Overview

• Neuro-oncology portfolio includes TLX101-Tx (iodine-based, phase III IPAX BrIGHT trial), TLX102 (astatine-based, early development), and TLX101-Px (Pixclara), a first-in-class imaging agent under regulatory review in the US and Europe.

• Lead candidates cross the blood-brain barrier, are administered intravenously, and offer less invasive alternatives to current therapies.

• Portfolio features both beta and alpha therapies, with in-house manufacturing and distribution capabilities.

• Theranostic approach combines imaging and therapy, with imaging agent also serving as a patient selection tool.

• Advancing late-stage and next-generation assets targeting LAT1 and LAT2 transporters.

Clinical Trial Updates and Outcomes

• TLX101-Tx has shown favorable safety and efficacy in malignant glioma trials, with no dose-limiting toxicities observed.

• IPAX-2 (newly diagnosed patients) completed enrollment with good tolerability; results expected later this year.

• IPAX BrIGHT phase III trial is dosing recurrent glioblastoma patients globally, with overall survival as the primary endpoint and regulatory approvals in seven European countries; US expansion pending FDA clearance.

• Case studies highlight near-complete responses, ongoing tumor regression, and improved quality of life in heavily pretreated patients.

• Clinical trial participation is recommended due to limited standard of care for recurrent GBM.

Imaging Advancements and Diagnostic Accuracy

• TLX101-Px (Pixclara) combined with MRI achieves 93% sensitivity and 94% specificity for glioma detection.

• Amino acid PET tracers like TLX101-Px improve diagnostic accuracy over standard MRI, aiding clinical decision-making and differentiating between treatment-related changes and true disease progression.

• MRI is standard for glioma imaging but up to 40% of scans are equivocal for disease progression.

• Pixclara is under FDA review with a target approval date in mid-September and is included in NCCN guidelines.

• Imaging agent also serves as a patient selection tool for therapeutic candidates.