Telix Pharmaceuticals (TLX) investor relations material

Pipeline overview and program updates

• Robust, multi-indication radiopharma pipeline spans prostate, kidney, brain, and other cancers, with additional pan-cancer and hematology assets in early development.

• 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 additional programs in minibody/nanobody formats and FAP-targeted assets.

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

• BiPASS trial in prostate cancer diagnostics aims to reduce unnecessary biopsies and is aligned with an NDA submission for a new indication.

Clinical trial data and development milestones

• TLX591 (radioantibody) and TLX597 (small molecule) are advancing in prostate cancer, with TLX597 showing favorable dosimetry and high PSA response rates in ongoing phase II/III trials.

• LUTEON and LUTEON-ATLAS studies in kidney cancer are evaluating fractionated dosing of lutetium-177 girentuximab in third-line RCC, with early data suggesting improved survival and manageable toxicity.

• IPAX BrIGHT (glioblastoma) is a pivotal phase III trial combining TLX101 with lomustine, with prior studies showing median OS up to 32.2 months and favorable safety.

• BiPASS phase III completed enrollment for non-invasive prostate cancer diagnosis using Ga-PSMA-11 PET + mpMRI, potentially reducing up to 50% of unnecessary biopsies.

• Early TLX400 FAP data in medullary thyroid cancer show 80% disease control and prolonged survival in heavily pretreated patients.

R&D strategy and innovation priorities

• Emphasis on integrated theranostics: combining diagnostics and therapeutics for precision oncology and patient selection.

• Modality-agnostic and target-agnostic approaches leverage antibodies, small molecules, and minibodies to optimize delivery and efficacy.

• Investment in vertical integration of manufacturing and isotope supply to ensure reliability and scalability.

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

• Focus on expanding into new disease areas and next-generation radiopharmaceuticals, including GEP-NETs, lung, and pan-cancer FAP.