On October 5, 2026 Radiopharm Theranostics Limited (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage radiopharmaceutical company, reported the successful completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA or the Agency) regarding RAD101, the Company’s investigational radiopharmaceutical imaging agent for the detection of brain metastases.

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RAD101 is the Company’s novel Fluorine-18-labeled small-molecule imaging agent that targets fatty acid synthase (FASN) and is being developed to diagnose suspected recurrent brain metastases arising from a range of solid tumors. Previously reported data from the Phase 2b clinical trial showed that RAD101 demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial’s primary endpoint.

The Company expects to receive the FDA’s official meeting minutes within approximately 30 days. The minutes will provide the formal record of the meeting and the Agency’s feedback on the proposed pivotal clinical development program. RAD intends to provide a further update following receipt and review of the official minutes.

"The successful completion of our End-of-Phase 2 meeting with the FDA marks a pivotal milestone for RAD101 and an important inflection point in the evolution of our company," said Riccardo Canevari, Chief Executive Officer of Radiopharm. "The discussion was highly constructive and provided meaningful clarity on the regulatory pathway for RAD101, reinforcing our confidence in the program’s potential to address a significant unmet need in brain metastases imaging. We are encouraged by the collaborative dialogue with the Agency and believe this interaction positions us well as we finalize our pivotal development strategy and take the next critical steps toward a potential registration program."

Building on the momentum from the meeting, RAD is moving immediately to advance Phase 3 readiness activities, including clinical and operational planning, in order that the program is positioned to progress efficiently once the Agency’s formal feedback is received.

"RAD101 represents a differentiated imaging approach targeting fatty acid synthase, a compelling biological mechanism that has demonstrated promising clinical potential in brain metastases," continued Mr. Canevari. "As we prepare for pivotal development, we are also evaluating opportunities to engage with potential strategic partners who recognize the value of this program and share our vision for bringing this innovation to patients and clinicians worldwide. Given the scale of the opportunity and the maturity of the asset, we believe now is the appropriate time to explore pathways that could maximize both clinical impact and long-term value creation."

RAD101 has received FDA Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. The company also recently announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm’s upcoming Phase 3 registrational trial in the U.S.

In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the Primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimize patient care.1

About RAD101

RAD101 is the Company’s novel imaging small molecule that selectively binds to fatty acid synthase (FASN), a multi-enzyme protein that catalyses de-novo fatty acid synthesis and is overexpressed in cerebral metastasis from solid tumors. Targeting FASN activity may allow for the more accurate detection of cancer cells in the CNS, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.

(Press release, Radiopharm Theranostics, OCT 5, 2026, View Source [SID1234673201])