Radiopharm Theranostics Achieves Primary Endpoint in 92% of Patients at Interim Analysis of RAD 101 Phase 2b Imaging Trial in Brain Metastases

Rhea-AI Summary

Radiopharm Theranostics (ASX:RADX) reported interim Phase 2b imaging results for RAD 101 in brain metastases showing 92% concordance (11/12 patients) with MRI and selective tumor uptake on PET imaging.

The company noted 50% trial enrollment, U.S. FDA Fast Track designation for RAD 101, and cited an independent U.S. market opportunity estimate of $500M+ annually. Management plans a webinar on Dec 15–16, 2025 and stated a goal to start a pivotal study by end of 2026.

Positive

• 92% concordance with MRI (11/12 patients)
• Received FDA Fast Track designation
• 50% enrollment achieved in Phase 2b trial
• Independent estimate of >b>$500M U.S. market opportunity

Negative

• Interim dataset is small: only 12 evaluable patients
• Trial is only 50% enrolled, still early-stage evidence
• Pivotal trial start by end-2026 is a future target, not guaranteed

Key Figures

Primary endpoint success 92% (11/12 patients) Interim Phase 2b RAD 101 imaging trial in brain metastases

Interim evaluable patients 12 patients U.S. Phase 2b RAD 101 imaging trial interim analysis

Concordance definition Agreement between MRI and Pivalate images Primary endpoint definition in RAD 101 trial

U.S. brain metastases incidence More than 300,000 patients annually Suspected or recurrent brain/cerebral metastases in the U.S.

RAD 101 U.S. market More than $500 million annually Independent commercial assessment of RAD 101 opportunity

Phase 2b enrollment 50% enrollment achieved RAD 101 brain metastases imaging trial status mentioned in article

Current share price $4.26 Pre-news trading level vs 52-week range $3.4962–$50.82

52-week drawdown -91.62% vs high Price vs 52-week high before interim data release

Market Reality Check

$4.26 Last Close

Volume Volume 840 vs 20-day average 17,112 indicates very limited trading ahead of this release. low

Technical Shares at $4.26, trading below the $5.05 200-day moving average and far under the $50.82 52-week high.

Peers on Argus

Biotech peers showed mixed moves, with PSTV -6.2%, BRNS -8.2%, ACRV -3.8%, TPST -1.58%, and RENB up 19.33%, suggesting stock-specific rather than sector-driven dynamics for RADX.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 18	Phase 1 approval	Positive	-4.8%	Approval to initiate first-in-human Phase 1 trial of RAD 402 in prostate cancer.
Nov 17	Enrollment update	Positive	+2.6%	Phase 2b RAD101 trial reached 50% enrollment with encouraging early imaging data.
Nov 12	Dose escalation	Positive	+2.0%	DSMC cleared 177Lu-RAD204 Phase 0/1 trial to escalate to 90 mCi third cohort.
Oct 20	Clinical updates	Positive	-19.8%	Positive early data across four programs and outlined milestones through 2026.
Oct 20	Equity financing	Negative	-19.8%	A$35m placement and A$5m SPP at discount with attaching options increased funding.

Pattern Detected

Recent clinical updates often moved the stock but with mixed direction; positive trial news sometimes aligned with gains, but there were notable selloffs on good clinical updates and financings.

Recent Company History

Over the last six months, Radiopharm reported several clinical milestones and one sizeable financing. On Jun 24 it signed a supply deal for ¹⁶¹Tb‑labeled RAD 402, followed by DSMC-driven dose escalation for 177Lu‑RAD202 on Oct 1. A combined A$40m capital raise on Oct 20 coincided with broader positive program updates but a sharp share price drop. Subsequent October–November releases on RAD101, RAD204, and RAD402 showed advancing trials with mixed short-term price reactions. Today’s RAD 101 interim Phase 2b data build directly on the Nov 17 enrollment update.

Market Pulse Summary

The stock is surging +227.9% following this news. A strong positive reaction aligns with the clearly favorable interim data showing 92% (11/12) primary endpoint concordance for RAD 101 in brain metastases. Historically, clinical trial news for this company produced an average move of 3.8%, with both rallies and selloffs. With shares trading far below the $50.82 52-week high pre-release, investors would likely weigh upside from RAD 101’s >$500M U.S. opportunity against past volatility around clinical milestones and prior equity raises.

Key Terms

phase 2b medical

"interim data from the first twelve patients in its U.S. Phase 2b clinical imaging trial"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

pet imaging medical

"as assessed by PET imaging of brain metastases"

PET imaging is a noninvasive medical scan that works like a molecular camera, using tiny radioactive tracers to reveal biological activity inside the body—for example metabolism, blood flow, or the presence of specific proteins. It matters to investors because PET results guide diagnosis, show whether a drug reaches its intended target and how patients respond, and therefore affect clinical trial success, regulatory approval, reimbursement decisions and demand for scanners, tracers and related services.

fast track designation regulatory

"RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation"

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

AI-generated analysis. Not financial advice.

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, Dec. 15, 2025 (GLOBE NEWSWIRE) -- 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.

¹ Concordance definition: “Agreement or correlation between MRI and Pivalate images”

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

WEBINAR DETAILS

AUSTRALIA
Date: Tuesday 16 December 2025
Time: 10:00am AEDT

USA
Date: Monday 15 December 2025
Time: 6.00pm EST

Presenters:

• Riccardo Canevari – CEO & Managing Director
• Dr Dimitris Voliotis – Chief Medical Officer
• Dr Harshad Kulkarni – BAMF Health, Grand Rapids, MI
  

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.

² 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

About RAD101
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 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 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:
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 

Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com

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

FAQ

What interim result did Radiopharm report for RAD 101 in brain metastases (RADX) on Dec 15, 2025?

Interim Phase 2b data showed 92% concordance (11/12 patients) between RAD 101 PET and MRI.

Has RAD 101 for brain metastases received any FDA designations for RADX?

Yes; RAD 101 has received FDA Fast Track designation for distinguishing recurrent disease from treatment effect.

How far along is the RAD 101 Phase 2b trial for RADX as of Dec 15, 2025?

The company reported 50% patient enrollment in the Phase 2b imaging trial.

What market opportunity did Radiopharm cite for RAD 101 in the U.S. (RADX)?

Independent commercial assessments estimated a U.S. market opportunity of $500 million+ annually.

When is Radiopharm planning further clinical development for RAD 101 (RADX)?

Management stated a goal to initiate a pivotal study by end of 2026 (stated target).

When is the Radiopharm webinar about RAD 101 and how can I attend (RADX)?

Webinar scheduled for Dec 15, 2025 at 6:00pm EST (US) / Dec 16, 2025 at 10:00am AEDT (Australia); registration via the company webinar link.