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Radiopharm Theranostics Limited filings document foreign private issuer reports that furnish Australian Securities Exchange announcements to the SEC. The Form 6-K record covers quarterly activities and Appendix 4C cash-flow reports, along with clinical updates for the company's oncology radiopharmaceutical programs.
Disclosures address RAD 101 brain-metastasis imaging, 177Lu-RAD202 in HER2-positive solid tumors, radiotherapeutic assets RV-01 and RAD 402, trial data presentations, safety-monitoring committee recommendations, cash-flow reporting, and Exchange Act furnishing status for exhibits attached to its public notices.
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.
Radiopharm Theranostics Limited reported ASX quotation of 408,839,531 RAD ordinary fully paid shares, issued for cash at AUD 0.015 per share, as part of a placement previously outlined in an Appendix 3B dated 24 July 2026.
Following this quotation, RAD ordinary shares on issue total 4,337,549,491. The company also describes further securities yet to be issued to complete the transaction, including 40,000,000 additional RAD ordinary shares, 448,839,531 options expiring 31 July 2029 with a 0.018 exercise price, and ADR warrants expiring 31 July 2029 with exercise prices of USD 3.95 and USD 3.79.
Radiopharm Theranostics, a clinical-stage radiopharmaceutical company, reported quarterly cash flow and a business update for the quarter ended June 30, 2026. Lead imaging agent RAD 101 delivered positive Phase 2b data, with 93% of evaluable patients meeting the primary endpoint and interim six‑month follow‑up showing 86% (12/14) sensitivity. The company plans a Phase 3 multi-center, multi-country registrational trial in Q4 2026, supported by a manufacturing and distribution partnership with Siemens Healthineers. Early Phase 1 signals included a RECIST‑confirmed Partial Response in the third cohort of RAD 204, while RAD 202, RAD 301 and other pipeline assets continued to progress, leaving six active clinical programs.
Financially, closing cash was $4.1 million, down from $19.2 million in the prior quarter, driven by net operating cash outflows of $14.97 million, of which research and development and staff costs represented 95%. Based on this burn rate, estimated funding available was 0.28 quarters. After quarter end, liquidity was bolstered by receipt of a $5.9 million Australian R&D Tax Incentive, a $12.5 million institutional equity offer and a $6 million Share Purchase Plan (subscribed up to $3 million), alongside access to a US$18.9 million At‑The‑Market Facility. The board believes the company can secure sufficient equity and non‑dilutive capital and expects operations to continue, with scope to delay discretionary spending.
Radiopharm Theranostics Limited completed a registered direct offering of 1,281,646 ADSs, each representing 300 ordinary shares, at US$3.16 per ADS, raising aggregate gross proceeds of approximately US$4.1 million before fees. In a concurrent private placement, it agreed to issue investors unregistered warrants to purchase up to 1,281,646 ADSs, exercisable at US$3.79 per ADS and expiring on July 31, 2029, following shareholder approval of the underlying ordinary shares.
The company also received firm commitments of approximately A$6.7 million (US$4.7 million) from Australian institutional and professional investors in an Australian Placement, where issuance of 40.0 million ordinary shares for A$0.6 million will be subject to shareholder approval under ASX rules. A Share Purchase Plan for shareholders in Australia and New Zealand may raise up to an additional A$6 million (US$4.2 million). Under the Australian Placement and the Share Purchase Plan, participants are expected to receive one option per new ordinary share, with an exercise price of A$0.018 and expiry on July 31, 2029, subject to shareholder approval. Proceeds are intended to fund preparation for the RAD101 registrational Phase 3 study, completion of RAD204 dose escalation, advancement of RAD202, RAD402 and RV01 programs, strategic partnering initiatives, and general corporate purposes.
Radiopharm Theranostics Limited issued 384,493,800 new RAD ordinary fully paid shares for cash at AUD 0.01500000 per share, to be quoted on ASX from 28 July 2026 as part of a placement previously outlined in an Appendix 3B.
The company states that further securities remain to be issued under that transaction, including 448,839,531 additional ordinary shares, 448,839,531 options expiring 31-Jul-2029 with an exercise price of 0.018, and ADR warrants of 64,082 and 1,281,646 expiring 31-Jul-2029 with exercise prices of USD 3.95 and USD 3.79.
Following quotation of the new shares, RAD ordinary fully paid shares on issue will total 3,928,709,960, alongside multiple quoted option series such as RADAN options, which number 387,179,525 and have various expiries and exercise prices.
Radiopharm Theranostics Limited is raising capital through a US registered direct offering and concurrent Australian transactions. The company agreed to sell 1,281,646 American Depositary Shares (ADSs), representing 384,493,800 ordinary shares, at US$3.16 per ADS to raise approximately US$4.1 million in gross proceeds.
In a concurrent private placement, investors will receive unregistered warrants to purchase up to 1,281,646 ADSs at an exercise price of US$3.79 per ADS, expiring on July 31, 2029, exercisable after shareholder approval. Separately, Australian institutional and professional investors have provided firm commitments for approximately A$6.7 million in a private placement, and a Share Purchase Plan could raise up to an additional A$6 million, both with one option (exercise price A$0.018, expiring July 31, 2029) for every new ordinary share subscribed, subject to shareholder approval.
The company expects to seek the necessary approvals at an extraordinary general meeting on or about September 11, 2026, and intends to use proceeds to advance the RAD101 registrational study, progress multiple therapeutic programs, support strategic partnering initiatives, and for general corporate purposes.