Radiopharm RAD 101 meets Phase 2b endpoint in brain metastases

Radiopharm Theranostics (Nasdaq: RADX) reported that its imaging agent RAD 101 met the primary endpoint in a Phase 2b clinical trial, with 93% of evaluable patients achieving concordance with MRI imaging in individuals with recurrent brain metastases. An interim analysis of 14 patients also showed 86% sensitivity at a six-month follow-up.

The company said it plans to initiate a Phase 3 multi-center, multi-country registrational trial of RAD 101 in the fourth quarter of 2026. Siemens Healthineers will manufacture and distribute doses of the fluorine-18-labeled compound to support that trial. RAD 101 holds FDA Fast Track Designation.

In its Phase 1 study of RAD 204, a nanobody targeting PD-L1, the first patient dosed at the third cohort level of 90mCi achieved a RECIST-confirmed partial response with tumor shrinkage of up to 43%, remaining progression-free after more than seven months.

Radiopharm ended the June 2026 quarter with $4.1 million in cash, down from $19.2 million at the end of the prior quarter. Net cash outflows from operating activities were $14.97 million, with research and development expenditure and staff costs accounting for 95% of that total.

Following the close of the quarter, the company received a $5.9 million Australian R&D tax incentive, completed a $12.5 million institutional offer, and launched a $6 million Share Purchase Plan, which had already received subscriptions of up to $3 million.

The company also reported progress across four additional clinical programs, including RAD 202 targeting HER2-positive tumors, RV 01 targeting B7H3, RAD 402 for prostate cancer, and RAD 301 for pancreatic cancer, according to a statement based on the company's quarterly business update.

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