Welcome to our dedicated page for Radiopharm Theranostics SEC filings (Ticker: RADX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Radiopharm Theranostics Limited (RADX) SEC filings page provides access to the company’s U.S. regulatory disclosures as a foreign private issuer. Radiopharm files reports on Form 20‑F and Form 6‑K under the Securities Exchange Act of 1934, often furnishing Australian Securities Exchange announcements as exhibits for U.S. investors.
Recent Form 6‑K filings reference clinical and corporate milestones, such as interim Phase 2b data for 18F‑RAD101 in brain metastases, progress in Phase 1 trials of 177Lu‑RAD202 and 177Lu‑RAD204, ethics approval for the RAD402 prostate cancer trial, and U.S. FDA IND clearance for RV‑01 (Betabart). Other 6‑K submissions include notices of annual and extraordinary general meetings, results of shareholder votes, director interest notices, quarterly cash flow reports and presentations to investors.
Through this page, users can review how Radiopharm reports on its radiopharmaceutical pipeline, including imaging and therapeutic candidates targeting FASN, HER2, PD‑L1, αvβ6‑integrin, KLK3 and B7H3. Filings may also reference capital raisings, cash runway commentary and supply agreements for key radioisotopes used in clinical trials.
Stock Titan enhances these documents with AI-powered summaries that highlight the main points of lengthy filings, helping readers quickly understand trial updates, board and governance changes, and financing terms. Real‑time ingestion from EDGAR means new 6‑K and 20‑F submissions appear promptly, while integrated views of director interest notices and meeting results help track governance and potential insider‑related changes without manually reading every exhibit.
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.
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.