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Radiopharm Theranostics Limited (RADX) reports that shareholders at a General Meeting on September 11, 2026 approved all resolutions by poll. The resolutions ratified prior issues of First Tranche placement shares and ADS shares, and approved the issue of Second Tranche placement shares, placement attaching options, SPP shares and SPP attaching options, shortfall options, ADR warrants and agent warrants.
Shareholders also approved issues of SPP shares and attaching options to directors Paul Hopper, Ian Turner and Bruce Goodwin, and to Chief Executive Officer and director Riccardo Canevari. Support across all resolutions was high, with poll results generally showing more than 94% of votes cast in favor of each proposal.
Radiopharm Theranostics Ltd (RADX) reported positive initial results from a Phase 1 imaging trial of its radiopharmaceutical candidate RAD301 in healthy volunteers and patients with Pancreatic Ductal Adenocarcinoma. RAD301 targets the αvβ6-integrin receptor using Gallium-68, aiming for more tumor-specific imaging in pancreatic cancer.
The trial showed a favorable safety profile and significant, selective tumor uptake in pancreatic cancer metastases, with low background uptake in liver, lung and bowel, which are common metastatic sites. These data support continued clinical development of RAD301, including a potential Phase 2 imaging trial, and reinforce αvβ6-integrin as a promising diagnostic and therapeutic target. RAD301 has previously received FDA Orphan Drug Designation.
Radiopharm Theranostics Ltd (RADX) is reported to have a significant shareholder group led by Lantheus Omega, LLC, together with Lantheus Medical Imaging, Inc. and Lantheus Holdings, Inc., which collectively beneficially own 792,958,513 Ordinary Shares, or 17.3% of the class. This stake includes (i) 149,625,180 shares issued on August 23, 2024, (ii) 133,333,333 shares issued on January 20, 2025, (iii) 255,000,000 shares issued on December 9, 2025 and (iv) options to purchase 255,000,000 shares at an exercise price of AUD$0.039 per share expiring on October 31, 2027.
The reporting group has no sole voting or dispositive power but may be deemed to share voting and dispositive power over all 792,958,513 shares held of record by Lantheus Omega, LLC. They state that they no longer beneficially own more than 20% of Radiopharm’s outstanding Ordinary Shares and that they do not hold the securities with the purpose or effect of changing or influencing control of the company, changing their reporting posture from a Schedule 13D to a Schedule 13G.
Radiopharm Theranostics Ltd (RADX) discloses that Lantheus Omega, LLC, Lantheus Medical Imaging, Inc. and Lantheus Holdings, Inc. jointly report beneficial ownership of 792,958,513 Ordinary Shares (including options), or 20.9% of the company as of July 27, 2026.
This position consists of 149,625,180 Ordinary Shares acquired on August 23, 2024 at AUD$0.05 per share plus 149,625,180 options at AUD$0.05 (subsequently replaced), 133,333,333 shares acquired on January 20, 2025 at AUD$0.06 per share, and 255,000,000 shares acquired on December 9, 2025 at AUD$0.03 per share, together with 255,000,000 options issued on December 9, 2025 with an exercise price of AUD$0.039 per share expiring October 31, 2027.
The ownership percentage is calculated using 3,544,216,160 Ordinary Shares outstanding as of June 30, 2026 plus the 255,000,000 shares issuable upon option exercise. Lantheus describes this as a strategic investment tied to a $2.0 million upfront asset purchase and three separate $5.0 million private placements and notes potential future purchases or sales of RADX shares depending on market and business conditions.
Radiopharm Theranostics Ltd (RADX) reported a sharp deterioration in results for the year ended 30 June 2026. Revenue from contracts with customers fell 23.8% to $2,767,888, while loss attributable to owners increased 50.3% to $55,149,150, driven mainly by substantially higher research and development spending.
The group’s total loss was $56,950,494 and net assets declined to $22,323,683 from $42,871,904. Cash reserves dropped to $4,138,074 (30 June 2025: $29,116,835) after net operating cash outflows of $52,782,838. Net tangible assets per share were a negative 0.45 cents (2025: negative 0.16 cents), reflecting balance sheet strain.
R&D expenses rose to $49,962,899 (2025: $27,515,194), focused on programs including NanoMab, R&D Ventures, Diaprost and Pivalate – Imperial. Ownership in Radiopharm Ventures, LLC increased to 87.5%. Audited financial statements are expected by the end of September 2026 and are anticipated to include a material uncertainty in relation to going concern. On 24 July 2026 the company announced an institutional offer of A$12.5 million and a A$6 million Share Purchase Plan.
Radiopharm Theranostics Ltd (RADX) reports, via a Form 6-K, that it has furnished to U.S. investors an announcement filed with the Australian Securities Exchange detailing changes in directors’ interests following the expiry of listed options expiring 24 Aug 2026 for four directors. The notices show updated direct and indirect holdings for Riccardo Canevari, Paul Hopper, Ian Turner and Hester Larkin in the company’s shares and options after these listed options expired.
Radiopharm Theranostics Ltd (RADX) reported a clinical milestone, dosing the first patient in the second cohort of its First-In-Human Phase 1/2a trial of RV-01 (177Lu-Betabart) in B7-H3 expressing solid tumors. Advancement to the second cohort at a 70 mCi dose followed a positive recommendation from the independent Safety and Monitoring Committee. RV-01, developed through a joint venture with MD Anderson Cancer Center, is a 177Lutetium-tagged monoclonal antibody targeting the B7-H3 immune checkpoint. The ongoing Phase 1/2a trial in the U.S. is a dose-escalation and expansion study designed to assess safety, biodistribution, pharmacokinetics, radiation dosimetry and preliminary anti-tumor activity, with a planned enrollment of 61 participants across multiple advanced solid tumor types.
Radiopharm Theranostics Ltd (RADX) reported that an independent Data Safety and Monitoring Committee recommended advancing its 177Lu-RAD202 Phase 1 ‘HEAT’ clinical trial to Cohort 4 at a higher dose level of 180mCi in patients with HER2-positive advanced solid tumors. This recommendation follows review of safety data and supports the favorable safety profile observed so far. The HEAT study is being conducted at clinical centers across Australia, with the prior dose level of 130mCi announced in April 2026. RAD202 is a proprietary single-domain monoclonal antibody targeting HER2, a validated oncology target, and previously demonstrated clinical proof-of-concept with positive safety and biodistribution in a diagnostic study involving ten HER2-positive breast cancer patients.
Radiopharm Theranostics Limited reported that it has scheduled an End-of-Phase 2 meeting with the U.S. FDA on October 1, 2026 to discuss the pivotal Phase 3 trial design for RAD101, its Fluorine-18-labeled imaging agent for suspected recurrent brain metastases after radiotherapy. A Phase 2b trial of RAD101 demonstrated 93% concordance between MRI and PET imaging across all evaluable lesions, meeting the study’s primary endpoint and showing substantial, selective tumor uptake. RAD101 has FDA Fast Track Designation for distinguishing recurrent disease from treatment effects in brain metastases from various solid tumors, and Radiopharm has partnered with Siemens Healthineers to manufacture and distribute 18F-RAD101 doses for the planned U.S. Phase 3 registrational trial, with the company indicating it is on track to be Phase 3-ready by year-end 2026.
Radiopharm Theranostics Limited is convening a virtual extraordinary general meeting on 11 September 2026 at 11:00 am Melbourne time via the Automic Investor Portal. The meeting seeks shareholder approval for a multi‑component capital raise involving placements, a share purchase plan and several option and warrant classes.
Shareholders are asked to ratify the prior issue of 408,839,531 First Tranche Placement Shares and 384,493,800 ADS Shares, approve Second Tranche Placement Shares, and authorize free attaching options and shortfall options. Attaching Options and SPP Attaching Options have an exercise price of A$0.018 and expire on 31 July 2029. Additional resolutions cover issuing ADR Warrants at US$3.79 per ADS and Agent Warrants at US$3.95 per ADS, as well as up to 7,333,334 SPP Shares and an equal number of SPP Attaching Options to four directors, all of which the board recommends shareholders approve.