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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 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 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 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.
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.
Radiopharm Theranostics reported half-year fiscal 2026 results and clinical updates, highlighting progress across multiple radiopharmaceutical programs and a strengthened cash position.
Interim Phase 2b data for RAD 101 in brain metastases showed that 92% of evaluable participants met the primary MRI concordance endpoint. RAD 101 holds FDA Fast Track Designation and its U.S. trial aims to complete enrollment in the first quarter of 2026. Phase 1 programs RAD 202 (HER2) and RAD 204 (PD-L1) continued, with RAD 202 cleared by the Data Safety and Monitoring Committee to escalate to a 75mCi dose.
The company also advanced preclinical assets RV-01 (B7H3) and RAD 402 (KLK3), and is planning a Phase 2 imaging trial for RAD 301 in loco-regional pancreatic cancer, which already has FDA Orphan Drug Designation. Quarterly cash flow data show operating outflows of A$13.38 million, license fee payments of A$4.55 million, equity proceeds of A$35.26 million and period-end cash and cash equivalents of A$34.52 million, which the company states provide runway into 2027.
Radiopharm Theranostics Limited (RDPTF) reported a challenging year ending June 30, 2025, with a total comprehensive loss of A$37.88 million and negative operating cash flows of approximately A$36.65 million. The group recorded accumulated losses of A$145.73 million and significant research and development investment, including R&D expenses of A$27.52 million (line item) and intangible assets on the balance sheet of A$49.09 million.
The company generated other income including an R&D tax incentive (A$9.37 million recognised) and raised cash from financing activities (A$45.43 million reported in one table). Key governance and management details are disclosed, including CEO Riccardo Canevari and a Board with named directors and option/share holdings. The filing also discloses material contingent consideration balances, significant finance expenses and assumptions used in impairment and contingent consideration models.
Radiopharm Theranostics Limited submitted a Form 6-K as a foreign private issuer to provide U.S. investors with information it released on the Australian Securities Exchange. The filing furnishes as an exhibit a Public Notice dated September 17, 2025 titled “Corporate Governance Statement and Appendix 4G.”
The attached materials relate to the company’s corporate governance disclosures and associated compliance appendix. The Form 6-K and its exhibit are furnished, not filed, under U.S. securities laws, meaning they are not automatically incorporated by reference into other Securities Act filings unless specifically referenced.
Radiopharm Theranostics Limited submitted a Form 6-K to provide U.S. investors with a copy of an announcement it lodged with the Australian Securities Exchange. The filing mainly furnishes an exhibit describing a key opinion leader webinar titled “Pivalate (Brain Mets) key opinion leader webinar.”
The document clarifies that this Form 6-K, including the attached exhibit, is furnished rather than filed under U.S. securities laws and will only be incorporated into other U.S. filings if specifically referenced.