Radiopharm Theranostics Limited (RADX) has administered the first patient in the company’s Phase 1 clinical trial of RAD 402, a radiotherapeutic designed to target the KLK3 protein expressed on prostate cancer cells. The trial, which began in Australia after receiving approval from the Bellberry Human Research Ethics Committee in November 2025, marks the first time the drug will be tested in humans and represents a key de‑risking step for the company’s pipeline.
RAD 402 is a monoclonal antibody that has been radiolabeled with terbium‑161 (Tb161). The isotope delivers both beta particles and Auger electrons, allowing the therapy to deliver a high radiation dose to KLK3‑positive tumors while sparing surrounding healthy tissue. By focusing on KLK3 rather than the more widely expressed PSMA target, RAD 402 offers a differentiated mechanism that could reduce off‑target toxicity and improve therapeutic index in patients with advanced prostate cancer.
The company’s financial profile supports continued development of the program. As of June 30, 2025, Radiopharm reported trailing‑12‑month revenue of $2.35 million, total assets of $56.49 million, and debt of $20.97 million. Recent capital raises of approximately A$59 million are expected to fund operations through several milestones into 2027, giving the company runway to pursue the next phases of its radiopharmaceutical pipeline.
Management emphasized the significance of the milestone. CEO Riccardo Canevari said, "Dosing the first patient in our Phase 1 study of RAD 402 marks an important step forward for Radiopharm and for patients with advanced prostate cancer." He added, "RAD 402 is a differentiated, first‑in‑class, next‑generation radiotherapeutic designed to selectively target KLK3‑expressing tumors while minimizing off‑target exposure."
The trial is supported by supply agreements with TerThera for Tb161 production and with Cyclotek for radiolabeling, ensuring a reliable supply chain for the investigational product. Initial safety and biodistribution data from the first two dose levels are expected in the second half of 2026, providing a critical catalyst for assessing the therapy’s clinical profile and informing future development decisions.
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