Radiopharm Theranostics Ltd Stock Price, News & Analysis

Radiopharm Theranostics (NASDAQ: RADX) received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its Phase 1 'HEAT' clinical trial of 177Lu-RAD202 to a higher dose level. The trial, targeting HER2-positive advanced solid tumors, will progress to 75mCi dosing, skipping the planned 40mCi level after successful completion of the first 30mCi cohort.

The DSMC's review confirmed positive safety, pharmacokinetic, and biodistribution data from the initial cohort. The company expects to enroll the second cohort by Q4 2025 and remains on track to share data from the first two cohorts by year-end 2025. The study is being conducted across clinical centers in Australia.

Radiopharm Theranostics (NASDAQ: RADX), a clinical-stage biopharmaceutical company, reported significant progress across its radiopharmaceutical pipeline for FY2025. Key developments include FDA Fast Track Designation for RAD101 for brain metastases treatment differentiation, positive DSMC recommendation for RAD204 dose escalation to 60mCi, and advancement in the Phase 1 'HEAT' trial of RAD202 for HER2-positive tumors.

The company maintains a strong financial position with cash balance of $29.12 million, up from $18.58 million year-over-year, providing runway through mid-2026. Notable achievements include IND clearance for RV-01, strategic supply agreements with ITM and Cyclotek for radioisotopes, and progression across multiple clinical trials with data readouts expected in H2 2025.

Radiopharm Theranostics (NASDAQ:RADX) has received FDA clearance for its Investigational New Drug (IND) application for Betabart (RV-01), a Lu177-B7H3 monoclonal antibody targeting aggressive solid tumors. The company plans to initiate its first-in-human Phase 1 clinical trial in Q4 2025.

RV-01, developed through a joint venture with MD Anderson Cancer Center, is designed with high affinity for the 4Ig isoform of B7H3, which is highly expressed in tumors but not in healthy tissues. The drug's hepatic clearance pathway and shortened half-life may offer advantages over other radiotherapeutics, potentially minimizing hematological toxicities and kidney-related side effects.

Radiopharm Theranostics (ASX:RADX) has appointed renowned medical oncologist Dr Oliver Sartor to its Scientific Advisory Board. Dr Sartor currently serves as Director of Radiopharmaceutical Clinical Trials and Chair of the Genitourinary Cancer Disease Group at the Mayo Clinic.

Dr Sartor brings extensive experience in prostate cancer research and radiopharmaceutical therapies, having authored over 500 peer-reviewed publications and led multiple pivotal Phase 3 trials resulting in FDA approvals. His previous roles include positions at Tulane Cancer Center, LSU Health Sciences Center, and Dana-Farber/Harvard Medical School.

Radiopharm Theranostics (NASDAQ:RADX) has signed a clinical supply agreement with Cyclotek for the production of ¹⁶¹Tb-labeled RAD 402 for an upcoming Phase 1 clinical trial in prostate cancer. RAD 402, an anti-KLK3 monoclonal antibody radiotherapeutic, targets KLK3 which is highly expressed in prostate tissue with limited expression elsewhere.

The agreement marks a crucial step toward initiating the first company-sponsored Phase I trial using Terbium-161 in prostate cancer, scheduled for 2H 2025. The preclinical data package is complete, showing safety and promising biodistribution. Notably, ¹⁶¹Tb offers potential advantages over ¹⁷⁷Lu through additional Auger and conversion electrons alongside β-radiation, potentially improving antitumoral therapeutic efficacy.

Radiopharm Theranostics (RADX) has received FDA Fast Track Designation for RAD101, their novel imaging molecule designed to differentiate between recurrent brain metastases and treatment effects in solid tumors. RAD101 targets fatty acid synthase (FASN), a protein overexpressed in many solid tumors including cerebral metastases. The designation highlights the critical need for better diagnostic tools in managing brain metastases, which affects over 300,000 U.S. patients annually. Currently in Phase 2 clinical trials, Radiopharm expects to release topline results in H2 2025. The Fast Track status enables more frequent FDA communication, potential rolling review, and possible Priority Review eligibility.

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®.