Radiopharm reports RAD 101 Phase 2b hit, plans Phase 3, cash falls to $4.1M

Radiopharm Theranostics reported on July 31, 2026 that its Phase 2b trial of the imaging agent RAD 101 met its primary endpoint in July 2026, with 93% of patients treated achieving concordance with MRI imaging.¹ An interim analysis of 14 patients from six-month follow-up and biopsy showed 86% (12 of 14) sensitivity.¹

The trial enrolled 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins¹ in a single-arm U.S. study, and RAD 101 has received FDA Fast Track Designation.¹ The company said it anticipates starting a Phase 3, multi-center, multi-country registrational study in the fourth quarter of 2026, with Siemens Healthineers manufacturing and distributing doses of the drug to support that trial.¹

In its RAD 204 program targeting PD-L1, the company reported that the first patient dosed in the third cohort at 90mCi had a durable partial response confirmed by RECIST criteria, with tumor shrinkage of up to 43%, and remained progression-free after more than seven months.¹

On finances, closing cash at quarter end was $4.1 million, down from $19.2 million the prior quarter.¹ Net operating cash outflow for the period was $14.97 million, with R&D and staff costs making up 95% of operating spend.¹ The company said this burn rate is not expected to continue, citing its view that the quarter's outflow is not representative of its go-forward profile, attributing the elevated spending to three factors tied to clinical milestones.¹ After quarter end, the company received a $5.9 million Australian R&D tax incentive and completed a $12.5 million institutional offer, alongside a $6 million Share Purchase Plan already subscribed for up to $3 million.¹ Estimated quarters of funding available at quarter end stood at 0.28.¹