The Radiopharm Theranostics Limited (RADX) SEC filings page provides access to the company’s U.S. regulatory disclosures as a foreign private issuer. Radiopharm files reports on Form 20‑F and Form 6‑K under the Securities Exchange Act of 1934, often furnishing Australian Securities Exchange announcements as exhibits for U.S. investors.
Recent Form 6‑K filings reference clinical and corporate milestones, such as interim Phase 2b data for 18F‑RAD101 in brain metastases, progress in Phase 1 trials of 177Lu‑RAD202 and 177Lu‑RAD204, ethics approval for the RAD402 prostate cancer trial, and U.S. FDA IND clearance for RV‑01 (Betabart). Other 6‑K submissions include notices of annual and extraordinary general meetings, results of shareholder votes, director interest notices, quarterly cash flow reports and presentations to investors.
Through this page, users can review how Radiopharm reports on its radiopharmaceutical pipeline, including imaging and therapeutic candidates targeting FASN, HER2, PD‑L1, αvβ6‑integrin, KLK3 and B7H3. Filings may also reference capital raisings, cash runway commentary and supply agreements for key radioisotopes used in clinical trials.
Stock Titan enhances these documents with AI-powered summaries that highlight the main points of lengthy filings, helping readers quickly understand trial updates, board and governance changes, and financing terms. Real‑time ingestion from EDGAR means new 6‑K and 20‑F submissions appear promptly, while integrated views of director interest notices and meeting results help track governance and potential insider‑related changes without manually reading every exhibit.
Radiopharm Theranostics Ltd executive Dimitris Voliotis, the Chief Medical Officer, reported his initial holdings of stock options in a Form 3. These options give him the right to buy Ordinary Shares at an exercise price of $0.025 per share.
The filing shows three option positions over Ordinary Shares: one over 7,657,334 shares with an exercise date of July 1, 2028, and two over 7,657,333 shares each with exercise dates of July 1, 2027 and July 1, 2026. All three option positions are scheduled to expire on July 1, 2030 and are held directly. The filing does not report any purchases or sales, only these existing derivative holdings.
Radiopharm Theranostics Ltd director Paul Hopper has filed an initial Form 3 listing his ownership in Ordinary Shares and options. The filing shows direct ownership of 53,900,000 Ordinary Shares, plus additional indirect holdings through Kilinwata Investments Pty Ltd and his spouse. It also details multiple Option (right to buy) positions over Ordinary Shares with exercise prices between 0.0250 and 0.2000 and expirations ranging from 2026 to 2030, including grants that vest only if he remains a Director on specified future dates.
Radiopharm Theranostics Limited reports leadership changes in its finance and corporate governance functions. Mr Phillip Hains has resigned as Chief Financial Officer and Joint Company Secretary. Under the company’s service agreement with Acclime Australia, Mr Aaron Laurita has been nominated to assume the Chief Financial Officer role.
The company has also appointed Ms Amritha Sushil of Acclime Australia as a new Joint Company Secretary, joining existing Joint Company Secretary Mr Nathan Jong. Both Ms Sushil and Mr Jong will be responsible for communications between Radiopharm Theranostics and the ASX. These changes take effect immediately.
Radiopharm Theranostics Ltd filed an initial Form 3 for Chief Financial Officer Aaron James Laurita, establishing his existing equity position. He directly holds 26,357 Ordinary Shares and an option to buy 17,857 Ordinary Shares at an exercise price of $0.2000 per share, expiring on November 30, 2026. The filing records holdings rather than new share purchases or sales.
Radiopharm Theranostics reported its quarterly cash flow and business update, highlighting rapid clinical progress alongside heavy spending. Closing cash at the end of the quarter was A$19.2 million, down from A$34.5 million, after net operating cash outflows of A$14.9 million.
Direct research and development of A$11.8 million plus staff costs of A$2.37 million made up 95% of operating spend, reflecting accelerated investment across its radiopharmaceutical pipeline. Key milestones included completing enrolment in the Phase 2b trial of imaging agent RAD 101, where interim data showed 90% concordance with MRI in 18 of 20 evaluable subjects, and advancing RAD 202 with encouraging early safety and tumor uptake data.
The company also initiated first-in-human trials for radiotherapeutic assets RV-01 and RAD 402 and continues multiple Phase 1 programs. Estimated funding runway is 1.29 quarters, but management points to an A$-equivalent At-The-Market facility allowing up to US$18.9 million in ADR issuance and an expected ~A$5 million Australian R&D tax incentive to extend liquidity.
Radiopharm Theranostics Limited reported initial first-in-human findings from its Phase 0/1 HEAT clinical trial of 177Lu-RAD202, a HER2-targeted radiopharmaceutical for advanced solid tumors. In the initial lowest dose cohort of three heavily pre-treated HER2-positive patients given 30 mCi, 177Lu-RAD202 showed encouraging tumor uptake and a favorable safety profile. Based on these data, the independent Data Safety and Monitoring Committee recently recommended advancing to the next dose level, allowing escalation to the third cohort at 130 mCi. The HEAT trial is an open-label, multicenter study in HER2-positive locally-advanced or metastatic solid tumors, building on earlier diagnostic proof-of-concept for RAD202 in HER2-positive breast cancer.
Radiopharm Theranostics completed enrollment in its U.S. Phase 2b imaging trial of RAD 101 for diagnosing recurrent brain metastases from solid tumors. Interim data showed 90% concordance between 18F‑RAD101 and MRI, which is the study’s primary endpoint. A primary endpoint readout is expected in June 2026, and the company plans to advance RAD 101 into a U.S. Phase 3 pivotal trial and engage with the FDA on the regulatory path. RAD 101 targets fatty acid synthase, which is overexpressed in many solid tumors, and has received FDA Fast Track Designation for distinguishing recurrent disease from treatment effects in brain metastases.
Radiopharm Theranostics reports that an independent Data Safety and Monitoring Committee has recommended advancing its Phase 1 ‘HEAT’ trial of radiotherapeutic candidate 177Lu-RAD202 to Cohort 3 at a dose of 130mCi in HER2-positive advanced solid tumors.
The decision follows favorable safety data that allowed faster progression from Cohort 2. A prior dose level of 75mCi was announced earlier, and the company states it remains on track to complete Phase 1 dose escalation by the end of 2026. RAD202 previously showed proof-of-concept and positive safety in a ten-patient HER2-positive breast cancer study.
Radiopharm Theranostics Limited filed a Form 6-K to furnish an announcement that it has signed a clinical supply agreement with Siemens Healthineers for RAD101 in the U.S. Siemens will radiolabel and distribute 18F-labeled RAD101 to support a planned multi-center global Phase 3 registrational trial.
Interim data from a Phase 2b trial showed 90% concordance (18 of 20 patients) between RAD101 PET imaging and MRI, the study’s primary endpoint, with significant and selective tumor uptake in brain metastases. Early six-month follow-up in five evaluable patients indicates a positive trend for sensitivity and specificity. RAD101 has received U.S. FDA Fast Track Designation for distinguishing recurrent brain metastases from treatment effects, and topline Phase 2b data are expected in the first half of 2026.
Radiopharm Theranostics Ltd director Noel Donnelly has reported his initial derivative holdings in the company. He holds options to buy 5,333,333 Ordinary Shares at an exercise price of $0.0600 per share, expiring on September 30, 2029, granted on December 16, 2024.
According to the grant terms, 2,666,667 options will vest on September 30, 2026 and 2,666,666 options will vest on September 30, 2027, provided he remains a director on those dates.