Radiopharm Theranostics Ltd (RADX) is identified as the issuer in a Schedule 13G reporting that Regal Partners Funds Management Pty Limited and Regal Partners Limited each list beneficial ownership of 157,139,443 shares, or 3.34% of the class. The reported position includes 145,146,643 Ordinary Shares and 39,976 American Depositary Shares, each representing 300 Ordinary Shares.
The reporting persons list shared voting and dispositive power over 157,139,443 shares, with sole voting and dispositive power of 0. The signature block identifies Alexandra Rose and Kathleen Liu as Company Secretary.
Radiopharm Theranostics Limited completed an End-of-Phase 2 meeting with the U.S. FDA regarding RAD101’s proposed pivotal clinical development program for brain metastases imaging. The company expects the FDA’s official meeting minutes within approximately 30 days; those minutes will provide the formal record of the meeting and the Agency’s feedback. Radiopharm says it is carrying out Phase 3 readiness activities while awaiting that feedback.
Previously reported Phase 2b results showed 93% concordance with MRI across all evaluable lesions, meeting the trial’s primary endpoint. Radiopharm also said Siemens Healthineers will manufacture and distribute 18F-labeled RAD101 doses for the upcoming U.S. Phase 3 registrational trial. RAD101 has FDA Fast Track Designation to distinguish recurrent disease from treatment effect in brain metastases originating from solid tumors.
Radiopharm Theranostics Ltd reported that 24,000,000 RADAN options expired without exercise or conversion on September 30, 2026; the company stated it was not paying consideration for the cessation. Director Riccardo Canevari separately reported disposal of 24,000,000 unlisted options expiring September 30, 2026, with an exercise price of $0.06. His direct option holdings after the change were 163,301,188, and his reported share interests were 23,918,875 direct and 2,650,000 indirect.
Radiopharm Theranostics Ltd reported a total comprehensive loss of A$56.33 million for fiscal 2026, with accumulated losses of A$199.66 million as of June 30, 2026. Operating activities used A$52,782,838 in cash, compared with A$36,645,477 in fiscal 2025; financing activities provided A$33,374,878. Cash and cash equivalents were A$4,138,074 as of June 30, 2026.
The clinical-stage radiotherapeutics company has no product candidates approved for commercial sale and no product revenue, and does not expect significant revenue until regulatory approval and sales begin. Management forecasts current cash will fund operations through fiscal 2027, with the forecast dependent on assumptions including access to additional funding. Radiopharm disclosed a material uncertainty that may cast significant doubt on its ability to continue as a going concern; its directors nevertheless prepared the financial statements on a going-concern basis.
Radiopharm established an at-the-market facility with Leerink Partners in December 2025, under which it may offer and sell up to US$9,300,000 of ADSs. The company describes the facility as open-market, with no discount or warrant coverage; each ADS represents 300 ordinary shares.
Radiopharm Theranostics Ltd (RADX) reported its corporate governance framework for the financial year ended June 30, 2026, through an Appendix 4G and Corporate Governance Statement. The board comprises three independent and three non-independent directors; Chair Paul Hopper is non-independent.
At June 30, 2026, the company reported 20 people across its organization: 11 men and nine women. The statement says the Audit and Risk Committee reviewed the risk management framework during the reporting period. The board does not consider an internal audit function appropriate or necessary at this stage in the company’s development.
Radiopharm Theranostics Limited registered up to 1,345,728 ADSs for resale from time to time by the Selling Shareholders, representing 403,718,400 ordinary shares issuable upon exercise of Warrants. Each ADS represents 300 ordinary shares.
The Selling Shareholders receive all proceeds from ADS sales. Radiopharm may receive up to approximately US$5.1 million upon exercise of Warrants issued to the Selling Shareholders.
Radiopharm Theranostics Ltd (RADX) furnished a Form 6-K providing Australian Appendix 3Y notices detailing changes in directors’ interests following participation in a Securities Purchase Plan approved at an extraordinary general meeting on September 11, 2026.
Director Bruce Goodwin now indirectly holds 2,777,778 shares and 2,777,778 options. Ian Turner holds 3,752,817 direct shares and 23,179,148 direct options, plus 9,010,253 indirect shares and 1,625,978 indirect options, totaling 12,763,070 shares and 24,805,126 options. Paul Hopper holds 53,900,000 direct shares and 26,142,000 direct options, plus 96,599,206 indirect shares and 11,795,296 indirect options, totaling 150,499,206 shares and 37,937,296 options. Riccardo Canevari holds 23,918,875 direct shares and 187,301,188 direct options, plus 2,650,000 indirect shares, totaling 26,568,875 shares and 187,301,188 options. No interests were traded during a closed period requiring prior written clearance.
Radiopharm Theranostics Limited (RADX) reported positive interim results from a U.S. Phase 2b imaging trial of its PET tracer 18F‑RAD101 in patients with suspected recurrent brain metastases. RAD101 PET showed 93% concordance with MRI across all evaluable lesions, meeting the study’s primary endpoint, and data have been selected for a late‑breaking oral presentation at the 2026 Society of Neuro‑Oncology meeting.
The company plans to meet the FDA on October 1, 2026 to align on the protocol for a pivotal, multi‑center global Phase 3 imaging trial, supported in the U.S. by a manufacturing and distribution partnership with Siemens Healthineers. Preliminary analysis in 14 patients with six‑month follow‑up and/or biopsy showed 86% sensitivity, a secondary objective, in a U.S. market the company estimates at about $600 million for brain metastases imaging with no currently approved PET products.
Radiopharm Theranostics Limited (RADX) has filed a Form F-3 to register for resale up to 1,345,728 American Depositary Shares, representing 403,718,400 ordinary shares, issuable upon exercise of warrants held by selling shareholders from a July 2026 private placement. The ADSs trade on Nasdaq under “RADX” and each ADS represents 300 ordinary shares. The selling shareholders will receive all proceeds from any ADS resales; Radiopharm will not receive sale proceeds but may receive up to US$5.1 million if the registered warrants are exercised, and will also receive proceeds from any option exercises. The F-3 also describes the July 2026 private placement that raised approximately US$3.3 million and an additional Australian placement raising A$6.7 million, and presents an adjusted capitalization table as of December 31, 2025 showing higher cash and equity after these financings. The company highlights that investing in its ADSs involves a high degree of risk and directs investors to detailed risk factors in its Form 20-F.