Telix Pharmaceuticals (TLX) investor relations material

Pipeline overview and program updates

• Expanded portfolio includes late-stage and early-stage assets across prostate, kidney, brain, and pan-cancer indications, targeting PSMA, CAIX, LAT1, and FAP.

• Multiple FDA-approved products: Illuccix, Gozellix, Pixclara, and Scintimun, with ongoing global launches and label expansions.

• Three phase III trials are ongoing: ProstACT Global (prostate), LUTEON (kidney), and IPAX BrIGHT (glioblastoma), with robust clinical pipeline including TLX591-Tx, TLX597-Tx, TLX250-Tx, and TLX101-Tx.

• Strategic acquisition of ITM expands commercial reach, radioisotope manufacturing, and entry into the NET market.

• Early-stage innovation includes minibody programs for lung cancer and pan-cancer FAP-targeted assets.

Clinical trial data and development milestones

• ProstACT Phase 3 for TLX591-Tx in prostate cancer is enrolling globally, with Part 1 safety and dosimetry completed and FDA alignment for Part 2.

• TLX597-Tx Phase 2 OPTIMAL-PSMA trial explores dose intensification in mAPMR prostate cancer, showing high PSA response rates and favorable dosimetry.

• LUTEON studies in kidney cancer leverage CA9 targeting, with fractionated dosing strategies to maximize efficacy and minimize toxicity.

• IPAX BrIGHT (glioblastoma) combines TLX101 with lomustine, aiming for improved survival in first recurrence; early compassionate use data show encouraging disease control and median OS up to 32.2 months.

• BiPASS Phase 3 completed enrollment for non-invasive prostate cancer diagnosis using Ga-PSMA-11 PET + mpMRI, targeting pre-biopsy diagnostic use and potentially impacting up to 1 million patients annually in the U.S.

R&D strategy and innovation priorities

• Integrated theranostic approach leverages imaging and therapy for precision oncology, supporting patient selection and treatment optimization.

• Modality-agnostic development enables selection of optimal targeting agents and radioisotopes for each indication.

• Early imaging studies de-risk therapeutic development and support patient selection.

• Focus on expanding into new targets (GEP-NETs, lung, pan-cancer FAP) and next-generation radiopharmaceuticals.

• Vertical integration of manufacturing and supply chain ensures reliable isotope and product delivery globally.