Radiopharm Theranostics Ltd Stock Price, News & Analysis

Radiopharm Theranostics (RADX) has initiated its Phase 1 'HEAT' clinical trial by dosing the first patient with 177Lu-RAD202, a novel radiotherapeutic targeting HER2-positive solid tumors. The open-label trial aims to determine the optimal Phase 2 dosage and evaluate safety and preliminary clinical efficacy in patients with HER2-expressing advanced cancers. The treatment shows promise based on previous clinical proof-of-concept data from 10 HER2-positive breast cancer patients, which demonstrated safety and biodistribution of RAD202. The therapy targets HER2, a protein overexpressed in breast cancer and other solid tumors, and could potentially provide a new treatment option for patients who have progressed or cannot tolerate current standard therapies. The trial is being conducted across Australian clinical centers, with St John of God Murdoch Hospital being the first center to administer the treatment.

Radiopharm Theranostics (RADX) reported favorable preclinical data for its Lu177-B7H3-monoclonal antibody RV01, showing promising biodistribution and high tumor uptake. The therapy, developed with MD Anderson Cancer Center, targets B7-H3 protein expressed in solid tumors. Key advantages include a shorter half-life of 1-2 days compared to traditional mAbs' week-long half-life, and liver excretion rather than kidney elimination, potentially reducing toxicity risks. The data completes the preclinical package required for IND submission to the FDA in mid-2025, with Phase 1 basket study initiation planned for Q4 2025. Previous studies showed complete regression of solid tumors and evidence of immune system stimulation.

ITM Isotope Technologies Munich and Radiopharm Theranostics (NASDAQ: RADX) have signed a supply agreement for non-carrier-added Lutetium-177 (n.c.a. 177Lu). Under the agreement, Radiopharm will use ITM's n.c.a. 177Lu across its clinical pipeline, including RAD 204 (PD-L1-targeting nanobody, Phase 1), RAD 202 (HER2-targeting nanobody, Phase 1), and RV01 (B7-H3-targeting monoclonal antibody, preclinical) for solid tumor treatment.

ITM's n.c.a. 177Lu is a market-approved radioisotope that can be linked to tumor-specific targeting molecules. The company holds a U.S. Drug Master File with the FDA and has EU marketing authorization under the brand name EndolucinBeta®.

Radiopharm Theranostics (RADX) has received approval from the Data Safety and Monitoring Committee (DSMC) to proceed with dose escalation in its Phase 1 clinical trial of 177Lu-RAD204 for PD-L1 positive advanced cancers. The DSMC reviewed the first cohort of four patients treated with 30mCi and confirmed positive safety, pharmacokinetic, and biodistribution data.

The second cohort will receive an increased dose of 60mCi (higher than the previously planned 40mCi). The trial is expanding beyond Non-Small Cell Lung Cancer to include multiple tumor types such as Small-Cell Lung Cancer, Triple-negative Breast Cancer, Cutaneous Melanoma, head and neck cancer, and Endometrial Cancer. The company expects to complete enrollment of the first two cohorts by mid-2025, with four clinical trial sites actively recruiting in Australia.

Radiopharm Theranostics (RADX), a clinical-stage biopharmaceutical company specializing in oncology radiopharmaceuticals, has announced its participation in the upcoming D. Boral Capital Inaugural Global Conference. The event is scheduled for May 14, 2025, in New York City. The company's management team will be available for one-on-one meetings with interested parties, who can arrange meetings by contacting John Perez at jperez@dboralcapital.com. Radiopharm focuses on developing innovative treatments for areas with high unmet medical needs in oncology.

Radiopharm Theranostics (ASX:RAD) presented new data at EMIM 2025 demonstrating positive results for their RAD202 program targeting HER2-positive tumors. The imaging data showed that 68Ga-RAD202 specifically binds to HER2 in xenografts with high tumor-to-background ratio, while the removal of His-tag improved tumor-to-organ ratio for PET imaging.

Treatment with 177Lu-RAD202 demonstrated significant results, including tumor volume reduction and extended survival benefits. Notably, fractionated dosing proved more effective than single-dose therapy. The therapy was well-tolerated in preclinical studies.

These findings support an ongoing First-In-Human Phase I therapeutic trial of 177Lu-RAD202 in HER2-positive solid tumors, currently recruiting in Australia. The trial aims to evaluate safety and preliminary activity in patients with advanced HER2-positive solid tumors who have progressed on standard care or cannot tolerate current treatments.

Radiopharm Theranostics (NASDAQ: RADX) has announced successful clinical trial results for RAD 101 (18F-Pivalate) in detecting brain metastases. The study, published in the European Journal of Nuclear Medicine and Molecular Imaging, demonstrated effective detection using a novel hybrid imaging approach combining PET and Multiparametric MRI.

The trial included 22 patients (12 treatment-naïve and 10 previously treated with brain radiation), showing successful detection of brain metastases regardless of tumor origin, with high tumor-to-background ratio. RAD 101, targeting fatty acid metabolism in solid tumors, has shown promising results in detecting cerebral metastases.

The company is currently conducting a Phase 2b clinical trial in the United States to evaluate RAD 101's diagnostic performance in patients with suspected recurrent brain metastases from solid tumors. This advancement could potentially improve upon current standard-of-care Contrast Enhanced MRI, which has sensitivity in distinguishing disease progression from radiotherapy effects.

Radiopharm Theranostics (NASDAQ:RADX) has secured a US$5.0 million (A$8.0 million) private placement from Lantheus Holdings Inc., strengthening their strategic partnership. The placement consists of 133 million shares at A$0.060 per share, representing a significant 150% premium to the last traded price of A$0.024.

Following this investment, Lantheus becomes Radiopharm's largest shareholder, increasing its stake to 12.16% of the company. The placement replaces 6-month options issued in August 2024, with settlement expected within 7 days. The funds will be directed towards developing Radiopharm's clinical pipeline in oncology radiopharmaceuticals.

Radiopharm Theranostics (ASX:RAD) has entered into a strategic co-development partnership with Lantheus to advance clinical development of radiopharmaceuticals in Australia. The collaboration will initially focus on a basket clinical trial targeting multiple solid tumors. Under the agreement, Lantheus will cover all clinical development costs, and Radiopharm will receive up to USD 2 million in milestone payments for achieving key objectives in the first imaging trial, including ethics committee approval, first patient dosing, and completion of patient enrollment. Radiopharm will lead the clinical development efforts in Australia, leveraging its infrastructure and experience in the field.