Radiopharm Theranostics Selected for Late-Breaking Oral Presentation of Positive Data from Interim Analysis of U.S. Phase 2b Imaging Trial of RAD101 at 2026 Society of Neuro-Oncology Annual Meeting

Positive Phase 2b RAD101 imaging data, FDA Fast Track status and a planned Phase 3 trial advance Radiopharm’s brain metastases program.

Rhea-AI Summary

Radiopharm Theranostics (RADX) reported positive interim data from its U.S. Phase 2b imaging trial of 18F‑RAD101 in suspected recurrent brain metastases, which has been selected for a late‑breaking oral presentation at the 2026 Society of Neuro-Oncology Annual Meeting.

The trial met its primary endpoint, with 93% concordance between RAD101 PET and MRI across all evaluable lesions, and preliminary data from 14 patients with six‑month follow‑up and/or biopsy show 86% sensitivity, a secondary objective. RAD101 has FDA Fast Track Designation for distinguishing recurrent disease from treatment effects in brain metastases. Radiopharm plans an FDA meeting on October 1, 2026 to align on a global pivotal Phase 3 trial protocol and has partnered with Siemens Healthineers to manufacture and distribute 18F‑RAD101 for this study. The company cites a U.S. brain metastases imaging total addressable market of about $600 million with no approved PET products.

Positive

• 93% concordance between RAD101 PET and MRI met the Phase 2b primary endpoint
• Preliminary 86% sensitivity in 14 patients supports RAD101’s diagnostic performance goal
• RAD101 holds FDA Fast Track Designation for distinguishing recurrence from treatment effect in brain metastases
• FDA meeting on October 1, 2026 to align on pivotal global Phase 3 trial protocol
• Partnership with Siemens Healthineers to manufacture and distribute 18F‑RAD101 for the U.S. Phase 3 trial
• Company cites a U.S. brain metastases imaging $600 million total addressable market with no approved PET products

Negative

• None.

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Market Reaction – RADX

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Key Figures

MRI-PET Concordance: 93% Sensitivity: 86% Evaluable Patients: 14 patients +3 more

MRI-PET Concordance

93%

Phase 2b RAD101 imaging trial; primary endpoint

Sensitivity

86%

Preliminary secondary objective with 14 evaluable patients

Evaluable Patients

14 patients

Six-month follow-up and/or biopsy data

Trial Population

30 evaluable individuals

U.S. multi-center Phase 2b imaging trial

FDA Meeting

October 1, 2026

Planned meeting on RAD101 Phase 3 protocol

Total Addressable Market

~$600 million

Brain metastases imaging

Historical Context

2 past events · Latest: Aug 17

2 events

1. Aug 17

   FDA meeting plan

   24h Move

   +4.3%

   Company scheduled FDA meeting to align on RAD101 pivotal Phase 3 design

2. Jul 31

   Business update

   24h Move

   -1.6%

   RAD101 interim analysis reported 93% concordance and 86% sensitivity

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

fasn, fast track designation, stereotactic radiosurgery

3 terms

fasn medical

"targeting fatty acid synthase (FASN) radiolabelled with Fluorine-18"

FASN (fatty acid synthase) is a cellular enzyme that builds long-chain fatty acids, important building blocks for cell membranes and energy storage. Investors watch FASN because high activity or abnormal levels can signal disease processes or serve as a drug target, so changes in research results, clinical trials or diagnostic use can affect the value of companies developing therapies or tests—think of it as a factory machine whose output influences the health and prospects of a business.

fast track designation regulatory

"RAD101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

stereotactic radiosurgery medical

"suspected relapse after stereotactic radiosurgery (SRS)"

A highly focused form of radiation treatment that delivers a single or few high-dose beams to a precise spot in the body—often used for small tumors or abnormalities in the brain and spine—without making an incision. Think of it like a medical “sniper” versus a general area “spray”: it concentrates energy on the target while limiting damage to nearby tissue. Investors care because its adoption, device sales, regulatory approvals, and insurance coverage can meaningfully affect revenue and growth prospects for medical-equipment makers, hospitals, and specialty clinics.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint

Meeting with FDA planned on October 1^st to align on RAD101Phase 3 pivotal trial protocol

Brain Metastases Imaging has ~$600 million total addressable market, and there are no currently approved PET products

SYDNEY, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that positive data from an interim analysis of the Company’s Phase 2b imaging clinical trial (NCT06777433) of 18F-RAD101 (RAD101) in participants with suspected recurrent brain metastases from solid tumors has been selected for a late-breaking oral presentation at the  31^st Annual Meeting of the Society of Neuro-Oncology (SNO26), taking place from November 12-15, 2026 in Philadelphia.

RAD101 is Radiopharm’s novel imaging small molecule targeting fatty acid synthase (FASN) radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins. The data from these findings will be used to support the initiation of a pivotal multi-center, global Phase 3 imaging trial.

“Having these data selected for a late-breaking oral presentation at SNO26 is a meaningful recognition of the potential clinical importance of RAD101,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “The neuro-oncology community understands better than anyone the challenges associated with distinguishing active brain metastases from treatment effects using current imaging approaches. Knowing whether metastatic disease is present can fundamentally alter a patient's treatment path and prognosis. We believe these data underscore RAD101’s potential to address a significant unmet need by helping physicians make more informed decisions and potentially changing the course of disease management for patients with suspected recurrent brain metastases.”

Previously reported results from the Phase 2b imaging trial of RAD101 for all assessed lesions showed 93% concordance between MRI and PET imaging of brain metastases in this patient population with suspected recurrence. The results showed substantial and selective tumor uptake of RAD101. Images confirm metabolic activity in PET compared to equivocal MRI findings. Additionally, 14 patients with evaluable six-month follow-up and/or biopsy data show preliminary 86% sensitivity, representing a strong positive trend (a secondary objective). Sensitivity measures an imaging test's ability to correctly identify patients with 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 tumors outside of the central nervous system. 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 

RAD101 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. 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 pivotal trial in the U.S.

About the Phase 2b Clinical Trial of RAD101

The U.S. multi-center, open-label, single arm Phase 2b clinical trial is assessing the diagnostic
performance of 18F-RAD101 in 30 evaluable individuals with suspected recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 PET-positive lesions and those equivocal lesions seen in conventional imaging (MRI with gadolinium) in participants with known brain metastases and suspected relapse after stereotactic radiosurgery (SRS). Secondary endpoints are sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation-associated changes in previously SRS-treated brain metastases.

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.

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 five Phase 1 trials in a variety of solid tumor cancers including lung, breast, prostate and brain. Learn more at radiopharmtheranostics.com.

Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.

For more information:

Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com

Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com

Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au

Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm  
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/

¹ A hybrid [18F]fluoropivalate PET-multiparametric MRI to detect and characterise brain tumour metastases based on a permissive environment for monocarboxylate transport | European Journal of Nuclear Medicine and Molecular Imaging

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is RAD101 and how does it work in brain metastases imaging?

RAD101 is a novel imaging small molecule that selectively binds to fatty acid synthase (FASN), a multi‑enzyme protein involved in de‑novo fatty acid synthesis that is overexpressed in cerebral metastases from solid tumors. Targeting FASN activity may allow more accurate detection of cancer cells in the central nervous system, providing a clinically relevant method for imaging brain metastases.

What are the key design features of the U.S. Phase 2b trial of RAD101?

The U.S. Phase 2b trial is a multi-center, open-label, single-arm study evaluating 18F‑RAD101 in 30 evaluable individuals with suspected recurrent brain metastases from solid tumors of different origins. The primary objective is concordance between RAD101 PET-positive lesions and equivocal lesions on gadolinium‑enhanced MRI after stereotactic radiosurgery. Secondary endpoints include sensitivity and specificity in distinguishing tumor recurrence from radiation-associated changes.

What previous clinical data support RAD101 beyond this Phase 2b interim analysis?

Positive data from an Imperial College London Phase 2a imaging trial of 18F‑RAD101 in patients with brain metastases, including both stereotactic radiosurgery pre‑treated and treatment‑naïve patients, showed significant tumor uptake that was independent of tumor origin. The study also indicated that PET‑MRI may potentially provide a non‑invasive prediction of overall survival, supporting further, larger studies.

What is the clinical need RAD101 aims to address in brain metastases?

In the U.S., more than 300,000 patients are diagnosed annually with cerebral metastases and incidence is rising. Contrast‑enhanced MRI is the preferred imaging modality but has limitations, particularly in follow‑up surveillance after treatment such as stereotactic radiosurgery. The company states that differentiating active brain metastases from treatment effects is challenging and can fundamentally alter treatment decisions, and RAD101 is intended to help address this diagnostic gap.

When and where will the RAD101 Phase 2b interim data be presented?

The interim data have been selected for a late-breaking oral presentation at the 31st Annual Meeting of the Society of Neuro-Oncology (SNO26), which will take place from November 12–15, 2026 in Philadelphia.