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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.
Radiopharm Theranostics Limited, a clinical-stage radiopharmaceutical company, will present at the NWR Virtual Healthcare Conference. CEO & Managing Director Riccardo Canevari is scheduled to present at 8:30am AEDT on Wednesday, 25 March 2026, via online webinar.
Shareholders, investors and other interested parties can register through the provided Zoom link, with a recording available shortly after the live session. The replay will also be accessible on the company’s website and social media. The filing also reiterates that Radiopharm is listed on ASX (RAD) and NASDAQ (RADX) and outlines its oncology-focused development pipeline.
Radiopharm Theranostics Ltd filed an initial insider report for director Bruce Michael Goodwin. This Form 3 identifies him as a director but does not list any reportable transactions or derivative positions. The filing serves to register his status as an insider for future ownership reporting.
Radiopharm Theranostics Limited reported a larger half-year loss as it accelerated investment in its radiopharmaceutical pipeline. Loss after tax was A$28,243,811 for the half-year to 31 December 2025, compared with A$19,643,011 a year earlier, with the increase mainly driven by higher research and development expenses.
Loss attributable to owners rose to A$26,965,473, up 44.00%. Despite this, net assets increased to A$49,940,027 from A$42,871,904 at 30 June 2025, supported by a A$35 million share placement completed in October 2025. Cash and cash equivalents rose to A$34,515,397 from A$29,116,835, giving the company funding into 2027.
The group reported A$1,385,545 of revenue from contracts with customers and recognised A$4,549,133 in Australian R&D tax incentive income. Multiple clinical programs progressed, including positive interim Phase 2b data for brain metastases imaging agent RAD 101 and ongoing Phase 1 studies for HER2, PD-L1, B7-H3 and prostate cancer radiotherapeutics. The company also established an at-the-market equity facility of up to US$18.9 million for ADS sales on Nasdaq and increased its stake in Radiopharm Ventures, LLC to 87.5%. The interim financial statements received an unmodified review opinion from the independent auditor.