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ASX ANNOUNCEMENT 24 March 2026 Radiopharm Theranostics Achieves Primary Endpoint In 90% of Patients At Second Interim Analysis of RAD 101 Phase 2b Imaging Trial in Brain Metastases 90% of patients dosed with RAD 101 and

Key Takeaway: Radiopharm Theranostics announced positive results from the second interim analysis of its Phase 2b clinical trial of RAD 101 in patients with brain metastases. The trial showed that 90% of the 20 evaluated patients achieved concordance with MRI imaging, meeting the primary endpoint. Additionally, the early data from five patients indicated an encouraging trend in sensitivity and specificity for the imaging agent. The company looks forward to final results from the full study, which will guide future trials.

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POSITIVE FACTORS

  • 90% concordance achieved between PET imaging and MRI in trial participants.
  • Early data suggests promising trends in sensitivity and specificity.
  • FDA Fast Track Designation received for RAD 101.

Full Press Release Details

Theranostics Achieves Primary Endpoint In 90% of Patients At Second Interim Analysis of RAD 101 Phase 2b Imaging Trial in Brain Metastases
of patients dosed with RAD 101 and evaluable at interim analysis achieved concordance with MRI imaging (the primary endpoint)
five patients with available data from six-month follow-up and biopsy show encouraging trend for Sensitivity and Specificity (secondary
to host webinar on March 25 at 9:00 am AEDT (Sydney, Melbourne) / Tuesday, March 24 at 6:00 pm EST (U.S.)
Sydney, Australia-24
March 2026 - 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 the second
interim data from twenty 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.
interim analysis showed that 90% (18/20) of the patients dosed with RAD101 achieved concordance between PET imaging and MRI (the primary
endpoint). The results showed significant and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain
metastases compared to equivocal MRI findings.
the first five patients with evaluable six-month follow-up and/or biopsy data show a positive trend for sensitivity and specificity (the
secondary objectives). Sensitivity and specificity are two of the fundamental hallmarks of any diagnostic test including in imaging.
They measure an imaging test's ability to correctly identify patients with a disease (sensitivity,
true positive rate), as well as patients without the disease (specificity, true negative rate).
strength and consistency of these interim results further validate the potential of RAD 101 to address one of the most challenging diagnostic
gaps in neuro-oncology," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "With 90% concordance
demonstrated to date and encouraging early signals in sensitivity and specificity, we are increasingly confident in RAD 101's ability
to support more accurate and timely treatment decisions for patients with brain metastases. We look forward to the final data readout
from the full 30-patient study by June, which will guide our path toward a pivotal trial and, ultimately, toward bringing this important
imaging agent to the clinicians and patients who need it."
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.
Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
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 optimise patient care.1
Wednesday 25 March 2026
Tuesday 24 March 2026
submit any questions to: matt@nwrcommunications.com.au
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.
the Phase 2 Clinical Trial of RAD101
multicenter, 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.
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.
Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
Radiopharm Theranostics
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.
on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper.
CEO & Managing Director
AQ (Formerly Stern IR)
Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia

Frequently Asked Questions

What was the primary endpoint achieved in the RAD 101 trial?

90% of patients reached concordance between PET and MRI imaging.

What does RAD 101 target in brain metastases?

RAD 101 targets fatty acid synthase (FASN) for detecting cancer cells.

When will final data from the RAD 101 study be available?

Final data is expected by June from the full 30-patient study.

What is the significance of the RAD 101 results?

Results indicate potential for more accurate treatment decisions in neuro-oncology.

How many patients were evaluated in the interim analysis?

Twenty patients were evaluated in the second interim analysis.

Last updated: Mar 24, 2026