We are a commercial-stage biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals. (Incorporated in Australia)

Note: Our ordinary shares are listed on the Australian Securities Exchange under the symbol “TLX” – see prospectus.

Our mission is to be the global leader in radiopharmaceuticals by combining therapeutic and diagnostic modalities for the benefit of patients, an innovative precision medicine concept generally referred to as “theranostics”. We have an extensive pipeline of theranostic radiopharmaceutical product candidates with a focus in urologic oncology (prostate and kidney), neuro-oncology (glioma), musculoskeletal oncology (sarcoma) and bone marrow conditioning.

Our theranostic approach is intended to use imaging and therapy together to “see and treat” cancer and rare diseases, to both better inform treatment decisions and deliver personalized therapy for patients. Our products are designed to deliver targeted radiation to cancer cells with precision via a systemic radioactive infusion in order to treat tumors regardless of where they are in the body. This targeted radiation uses a radioactive isotope as a payload, which is attached to a targeting agent (such as a small molecule or antibody) with an affinity for targeted biomarkers on the surface of cancerous or diseased cells. Depending on the choice of radioisotope payload, we can deliver the payload as an imaging agent or as a therapy. The specificity of the targeting agent is designed to concentrate radiation at the tumor sites and to limit off-target tissue exposure. 

Our prostate cancer portfolio includes Illuccix, our commercially available gallium 68-labelled prostate-specific membrane antigen, or PSMA, prostate cancer imaging agent. Illuccix was approved by the Australian Therapeutic Goods Administration, or TGA, in November 2021, the U.S. Food and Drug Administration, or FDA, in December 2021, and Health Canada in October 2022. We have built a highly effective, specialist commercial team, which we believe has been integral to the commercial success of Illuccix to date. As of March 31, 2024, we have generated A$824.3 million in revenue from product sales of Illuccix since the commercial launch in April 2022 and 98% of this revenue has been generated from sales in the United States. The revenues generated from sales of Illuccix, the costs associated with such sales and our operating and other expenses resulted in a loss of A$104.1 million and a profit of A$5.2 million for the years ended December 31, 2022 and 2023, respectively, and a loss of A$8.5 million and a profit of A$18.0 million for the three months ended March 31, 2023 and 2024, respectively. Following the successful commercial launch of Illuccix, we believe that we have demonstrated our ability to develop and commercialize innovative and highly impactful products that address high unmet needs for cancer patients.

We intend to leverage our commercial revenues as a source of funding for the development of additional high-value, near-term therapeutic and diagnostic product candidates in our pipeline. These product candidates include TLX591, a radio antibody-drug conjugate, or rADC, being evaluated in a pivotal Phase 3 clinical trial for the treatment of patients with prostate cancer for which we expect to report initial interim data in the first half of 2025, and two innovative imaging agents, TLX250-CDx for kidney (renal) cancer and TLX101-CDx for brain (glioma) cancer.

Note: Operating income and “revenue from customers” are in U.S. dollars – (converted from  Australian dollars) – for the 12 months that ended March 31, 2024.