Radiopharmaceutical developer Telix files for NASDAQ debut

2024-05-17

临床2期并购临床1期临床3期上市批准

Australian biotech Telix will attempt to make it through the seemingly shrinking IPO window, which has only seen one successful exit so far this quarter. But fresh off an M&A spree and with three cancer treatments in mid- to late-stage testing, the radiopharma hopes to reinvigorate investor enthusiasm. For more financial analysis, see Vital Signs: Taking the temperature on a cooling IPO cycle.

Telix filed its intent on Friday to make its NASDAQ debut. The filing provides a glimpse at the firm’s pipeline of radiopharmaceuticals – one of the more popular areas of dealmaking the past few years – and its recent spending to bulk out its isotope manufacturing capabilities.

Along with its therapeutic and diagnostic portfolio – one of its imaging agents has already secured FDA approval – Telix has a radioisotope supplier agreement with Bayer. For more, see - Vital Signs: Mapping the slim pickings in radiopharmaceuticals.

Pipeline programmes

In the past two months, Telix has signed away about $98.6 million in combined cash and stock deals to acquire IsoTherapeutics Group, ARTMS, and QSAM Biosciences to pad its production capacity, as well as its pipeline.

Through its takeout of the latter, Telix gained Samarium-153-DOTMP, a kit-based, bone-seeking targeted radiopharmaceutical intended to manage pain in paediatric patients with bone metastases or those who are receiving osteosarcoma therapy. According to ClinicalTrials.gov, the candidate is expected to complete a Phase I trial by November.

Within Telix’s internal pipeline, its lead programme is TLX591 (177Lu rosopatamab tetraxetan), a radio antibody-drug conjugate (rADC) in the pivotal Phase III ProstACT GLOBAL study. The trial is expected to enrol 430 patients with PSMA-positive, metastatic castration-resistant prostate cancer, and report initial interim data in the first half of 2025.

The biotech’s second rADC, TLX250 (177Lu-DOTA-girentuximab), is in a pair of investigator-sponsored Phase II trials in patients with advanced metastatic kidney cancer.

The company is also developing TLX101, a systemic and blood-brain barrier-penetrant small molecule radiotherapeutic that targets the LAT1 receptor to treat glioblastoma. In addition to a Phase I safety study, the candidate is being evaluated in the investigator-led Phase II IPAX Linz trial, which is expected to read out in the first half of 2025.

Telix’s final portfolio programme is TLX300, a preclinical antibody-directed, targeted radiation candidate directed against PDGFRα, which is intended to treat soft tissue sarcoma. A first-in-human study is expected to start this half.

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