RAD Reports AUD 29M Cash, Dose Escalation Approval, and FDA Fast Track in FY25 Update

Clinical Momentum Builds Across Radiopharm’s Pipeline

Radiopharm Theranostics (ASX – RAD, Nasdaq – RADX) has delivered a robust fiscal year 2025 update, underscoring its advancing clinical programs and financial stability. The company’s focus on innovative radiopharmaceuticals for cancer treatment and diagnosis is gaining traction, marked by key regulatory and clinical milestones.

Central to the update is the U.S. FDA’s Fast Track designation for RAD101, a diagnostic agent designed to differentiate recurrent brain metastases from treatment effects. This designation could accelerate regulatory review and potentially expedite patient access to this novel imaging tool.

Dose Escalation and Trial Progress

Radiopharm’s therapeutic candidate RAD204, a nanobody targeting PD-L1 and radiolabeled with Lutetium-177, received clearance from an independent Data and Safety Monitoring Committee to escalate dosing from 40mCi to 60mCi. This dose escalation is expected to enhance therapeutic potential and is being tested across multiple tumor types including lung, breast, melanoma, and endometrial cancers. Enrollment for the second cohort is nearing completion, with data anticipated in the latter half of 2025.

Meanwhile, the Phase 1 HEAT trial for RAD202, targeting HER2-positive solid tumors, has commenced dosing. This trial aims to establish a recommended Phase 2 dose and evaluate safety and preliminary efficacy. Early diagnostic studies have already demonstrated RAD202’s clinical proof-of-concept, setting a promising foundation for therapeutic development.

Expanding Supply Chain and Preclinical Advances

On the supply front, Radiopharm secured agreements with ITM Isotope Technologies Munich SE and Cyclotek to ensure a steady provision of critical radioisotopes Lutetium-177 and Terbium-161. These arrangements underpin ongoing and upcoming clinical trials, including the anticipated Phase 1 study of RV-01, a B7-H3-targeted radiopharmaceutical developed in partnership with MD Anderson Cancer Center, which recently received FDA clearance to proceed.

Additionally, Radiopharm is preparing to initiate a Phase 1 trial for 161Tb-RAD402, targeting prostate cancer, expected to start dosing in Australia by the end of 2025. These developments highlight the company’s expanding pipeline and strategic collaborations.

Financial Health and Outlook

Financially, Radiopharm closed the fiscal year with a cash balance of AUD 29.12 million, up from AUD 18.58 million the previous year, bolstered by a AUD 4.58 million R&D tax incentive receipt. Operating cash outflows totaled AUD 36.67 million, primarily driven by research and development and staff costs. The company confirms a cash runway extending through mid-2026, providing a stable foundation for continued clinical advancement.

CEO Riccardo Canevari emphasized the company’s disciplined execution and clinical progress, noting that the milestones achieved reflect Radiopharm’s commitment to transforming cancer care through precise radiopharmaceutical solutions. The company anticipates further clinical and corporate milestones in the coming months, which will be closely watched by investors and industry observers alike.