Welcome to our dedicated page for Radiopharm Theranostics SEC filings (Ticker: RADX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
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 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.
Radiopharm Theranostics Ltd director Ian Lawrence Turner has filed an initial Form 3 detailing his equity position in RADX. The filing shows direct ownership of 6,985,292 Ordinary Shares and indirect ownership of 3,000,000 Ordinary Shares held through the Turner Discretionary Trust, where he is the sole beneficiary.
Mr. Turner also holds multiple option awards over Ordinary Shares with exercise prices ranging from 0.0250 to 0.2000 per share and expirations between 2026 and 2030. Footnotes explain that several grants vest in tranches between July 2026 and July 2028, in some cases only if he remains a director or achieves specified milestones.
Radiopharm Theranostics Ltd Managing Director and CEO Riccardo Canevari has filed a Form 3 reporting his initial ownership position. The filing shows direct ownership of 22,679,986 Ordinary Shares, along with multiple option awards over additional Ordinary Shares at exercise prices ranging from $0.025 to $0.60 per share and expirations between 2026 and 2030.
Footnotes state that significant blocks of options granted in 2023, 2024 and 2025 will vest in stages on July 1 of 2026, 2027 and 2028, provided Mr. Canevari remains a Director on those dates.
Radiopharm Theranostics Ltd director Hester Denise Larkin filed an initial ownership report showing direct holdings in ordinary shares and stock options. She holds 644,247 ordinary shares directly. She also holds options to buy ordinary shares, including 275,000 shares at $0.06 per share expiring on August 24, 2026, and larger grants such as 5,333,333 shares at $0.06 per share expiring on September 30, 2029. A December 16, 2024 grant provides 2,666,667 options vesting September 30, 2026 and 2,666,666 vesting September 30, 2027 if she remains a director, alongside additional options at $0.60 per share expiring December 1, 2026.
Radiopharm Theranostics Limited reported that it has dosed the first patient in its first-in-human Phase 1 clinical trial of RAD 402 for advanced prostate cancer. This early-stage study will assess safety, tolerability, whole-body distribution, and initial signs of clinical activity.
RAD 402 is a monoclonal antibody targeting KLK3, radiolabelled with Terbium 161, aiming to selectively attack KLK3-expressing prostate tumors while limiting damage to healthy tissue. Preclinical mouse xenograft data showed strong tumor targeting, minimal bone and marrow uptake, and hepatic clearance, and the company expects to share data from the first two dose levels in the second half of 2026.
Radiopharm Theranostics Limited reported second interim data from its U.S. Phase 2b imaging trial of RAD101 in brain metastases. In 20 treated patients, 90% (18/20) achieved the primary endpoint of concordance between PET imaging with RAD101 and MRI, with significant and selective tumor uptake observed in brain metastases.
The first five patients with six‑month follow-up and/or biopsy data showed an encouraging trend for sensitivity and specificity, key measures of diagnostic accuracy. The company expects final data from the full 30‑patient study by June to help guide a potential pivotal trial. RAD101 has FDA Fast Track Designation for distinguishing recurrent brain metastases from treatment effects.