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Radiopharm Theranostics Limited filings document foreign private issuer reports that furnish Australian Securities Exchange announcements to the SEC. The Form 6-K record covers quarterly activities and Appendix 4C cash-flow reports, along with clinical updates for the company's oncology radiopharmaceutical programs.
Disclosures address RAD 101 brain-metastasis imaging, 177Lu-RAD202 in HER2-positive solid tumors, radiotherapeutic assets RV-01 and RAD 402, trial data presentations, safety-monitoring committee recommendations, cash-flow reporting, and Exchange Act furnishing status for exhibits attached to its public notices.
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 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 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.
Radiopharm Theranostics Limited reports that it has dosed the first patient in its first‑in‑human Phase 1/2a clinical trial of 177Lu‑BetaBart (RV-01), a radiopharmaceutical developed through Radiopharm Ventures, the joint venture with The University of Texas MD Anderson Cancer Center.
The Phase 1/2a study is a dose escalation and expansion trial designed to evaluate safety, biodistribution, pharmacokinetics and radiation dosimetry of 177Lu‑BetaBart, as well as preliminary anti‑tumor activity, and to determine a recommended dose for later studies. The trial aims to enroll 61 participants with advanced solid tumors, including castrate resistant prostate, colorectal, lung, head and neck, ovarian, cervical, endometrial, triple negative breast and esophageal squamous cell cancers.
Preclinical animal studies of RV-01 have shown tumor shrinkage and prolonged survival, and 177Lu‑BetaBart targets the 4Ig isoform of B7‑H3, an immune checkpoint molecule overexpressed across several tumor types. Management describes this as the first radiotherapeutic agent from the joint venture to enter the clinic, highlighting progress in the company’s radiotherapeutic pipeline.