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.
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.
JPMorgan Chase & Co. filed an amended Schedule 13G reporting beneficial ownership of 145,679,951 ordinary shares of Radiopharm Theranostics Limited, as represented by American Depositary Shares. This holding represents 4.0% of the class as of 12/31/2025.
JPMorgan reports sole power to vote and dispose of all 145,679,951 shares, with no shared voting or dispositive power. The firm certifies the securities were acquired and are held in the ordinary course of business and not for the purpose of changing or influencing control of the issuer.
Radiopharm Theranostics Limited reports that it has increased its ownership stake in Radiopharm Ventures, LLC, its joint venture with The University of Texas MD Anderson Cancer Center, from 75% to 87.5%. The joint venture is focused on developing cancer radiopharmaceuticals and has shown promising progress in its therapeutic pipeline.
The lead asset, Betabart (RV01), a 177Lu‑labelled monoclonal antibody targeting the B7H3 immune checkpoint protein, received Investigational New Drug clearance from the U.S. Food and Drug Administration in July 2025. The first patient in the Phase 1 dose‑escalation therapeutic trial is expected to be dosed in Q1 2026. Two additional preclinical candidates have also delivered early positive results and are advancing toward final candidate selection for use across multiple solid tumor types.
Radiopharm Theranostics Limited received a Schedule 13G from Australian investment entities affiliated with Regal Partners, disclosing beneficial ownership of 320,694,680 Ordinary Shares and equivalents as of 12/31/2025. This represents 9.05% of the outstanding class of Ordinary Shares and American Depositary Shares (ADSs).
The position includes 293,421,980 Ordinary Shares and 90,909 ADSs, with each ADS representing three hundred Ordinary Shares. Regal entities report no sole voting or dispositive power, but shared voting and shared dispositive power over 320,694,680 shares.
The Regal entities certify that the securities were acquired and are held in the ordinary course of business and not for the purpose of changing or influencing control of Radiopharm Theranostics.