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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.
Radiopharm Theranostics Limited, an Australian radiopharmaceutical R&D company, has filed a Form F-3 to register the resale by existing investors of up to 940,000 American Depositary Shares (ADSs), representing 281,999,998 ordinary shares. This includes 140,999,999 ordinary shares purchased in an October 2025 private placement and up to 140,999,999 ordinary shares underlying options from that transaction, each option exercisable at A$0.039 until October 31, 2027.
The selling shareholders will receive all proceeds from any ADS sales, while Radiopharm would only receive cash if the options are exercised. Each ADS represents 300 ordinary shares and trades on Nasdaq under the symbol “RADX”, with ordinary shares listed on the ASX as “RAD”. Following the offering, 3,826,216,158 ordinary shares will be outstanding. Radiopharm highlights that it is both an emerging growth company and a foreign private issuer, which allows reduced U.S. reporting and governance requirements.
Radiopharm Theranostics Limited may offer and sell up to $50,000,000 of American Depositary Shares (ADSs) representing ordinary shares and warrants under a shelf registration. Within this, a separate sales agreement prospectus covers up to $22,400,000 of ADSs that can be issued from time to time, with any unsold portion remaining available under the base shelf.
The company expects to use any net proceeds to fund development of its radiopharmaceutical drug candidates and for general corporate purposes, including potential acquisitions, working capital and clinical and commercial spending. Radiopharm is an Australian foreign private issuer focused on precision oncology, with ADSs listed on Nasdaq under “RADX” and ordinary shares on the ASX under “RAD.” In October 2025 it completed a private placement of 1,166,666,667 ordinary shares for approximately A$35 million, with attached options exercisable at A$0.039 until October 31, 2027.
Radiopharm Theranostics Limited furnished a report on Form 6-K as a foreign private issuer, providing to the SEC an announcement it published on the Australian Securities Exchange.
The attached exhibit is titled "RAD101 interim Phase 2b data - 92% achieve primary endpoint," highlighting interim Phase 2b data for RAD101 where 92% achieved the primary endpoint. The company also states that this Form 6-K, including the exhibit, is furnished rather than filed for Exchange Act purposes and is not incorporated into other U.S. securities law filings unless specifically referenced.
Radiopharm Theranostics Limited (RADX) submitted a Form 6-K to make U.S. investors aware of two announcements it released to the Australian Securities Exchange on November 25, 2025. The announcements are titled “Final Director’s Interest Notice - LA” and “Final Director’s Interest Notice - PH,” which typically relate to the final disclosure of a director’s holdings or changes in interests. Copies of these notices are attached to the Form 6-K as exhibits, but the information is furnished rather than filed, meaning it is not automatically incorporated into other U.S. securities law filings unless specifically referenced.