Full Press Release Details
Theranostics Achieves Primary Endpoint in 92% of Patients at Interim Analysis of RAD 101 Phase 2b Imaging Trial in Brain Metastases
92% of evaluable patients at interim analysis
treated with RAD 101 achieved concordance¹ with MRI imaging (the primary endpoint) with significant and selective tumor uptake in
suspected or recurrent brain metastases
Company to host webinar on Tuesday, December
16 at 10:00 am AEDT (Australia) / Monday, December 15 at 6:00 pm EST (U.S.)
Sydney, Australia- 15 December 2025 - Radiopharm Theranostics
(ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative
oncology radiopharmaceuticals for areas of high unmet medical need, today announced interim data from the first twelve patients in its
U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases. RAD 101 is Radiopharm's novel, small-molecule imaging agent
targeting fatty acid synthase (FASN) and radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from
solid tumors of different origins, also known as the Pivalate technology.
The interim analysis showed that 92% (11/12) of the patients treated
with RAD 101 achieved concordance with MRI (the primary endpoint) as assessed by PET imaging of brain metastases. The results showed significant
and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain metastases compared to equivocal MRI findings.
"These compelling interim data significantly strengthen confidence
in the success of our Phase II trial of RAD 101 and provide a strong foundation for initiating a pivotal study by the end of 2026,"
said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "Integrating RAD 101 PET (Pivalate) with standard
MRI has the potential to transform patient management and enable better treatment decisions for the more than 300,000 patients in the
U.S. diagnosed with brain metastases each year. Independent commercial assessments estimate RAD 101's U.S. market opportunity at
more than $500 million annually, positioning it to become one of the top three imaging agents in the market."
The Company recently achieved 50% patient enrollment in the Phase 2b
trial evaluating RAD 101 imaging in brain metastases and RAD 101 has received U.S. Food and Drug Administration (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.
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.
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred
method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.²
Date: Tuesday 16 December 2025
Date: Monday 15 December 2025
Register for the webinar at the link below: https://us02web.zoom.us/webinar/register/WN_aV5mGG4aT0embNN8JgzDOw
Please submit any questions to: matt@nwrcommunications.com.au
Upon registering attendees will receive an email containing information
about joining the webinar. A recording will be available at the above link soon after the conclusion of the live session, with the replay
to also be made available via Radiopharm's website and social media channels.
About the Phase 2 Clinical Trial of RAD101
The U.S. multi-center, open-label, single
arm Phase 2b clinical trial is evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain
metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 positive
lesions and those seen in conventional imaging (MRI with gadolinium) in participants with suspected recurrent brain metastases.
Secondary endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in
previously stereotactic radiosurgery (SRS)-treated brain metastases.
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
RAD101 is the Company's novel imaging small molecule that targets
fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including
cerebral metastasis. Targeting FASN activity may allow for the more accurate detection of cancer cells, 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 na ve 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.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics
company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas
of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly
differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program
includes one Phase 2 and four Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn
more at radiopharmtheranostics.com.
Authorised on behalf of the Radiopharm Theranostics board of directors
by Chairman Paul Hopper.
For more information:
CEO & Managing Director
Precision AQ (Formerly Stern IR)
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia