Radiopharm Theranostics Ltd SEC Filings

Theranostics Limited reported changes to its capital structure involving lapses and new grants of unquoted options. Several tranches of RADAN and RADAJ options, totaling 8,540,000, 17,305,743, 10,666,666 and 712,301 respectively, ceased on dates in 2025 and early 2026 after conditions for exercise were not satisfied, with no consideration paid.

The company also issued 2,666,666 new RADAN options on 30 June 2026 under an employee incentive scheme, ranking equally with existing RADAN options. Following these changes, issued capital includes 3,544,216,160 RAD ordinary fully paid shares and 423,691,934 RADAN options on issue, alongside other option series with various expiries and exercise prices.

Theranostics Limited reported that 505,598 unquoted RADAN options expired on 31 May 2026 without being exercised or converted, meaning these potential shares will no longer be issued. No consideration was paid in connection with the cessation.

After this change, the company reports 3,544,216,160 RAD ordinary fully paid shares on issue, alongside multiple series of outstanding options, including 421,025,268 RADAN options and several other option classes with varying expiry dates and exercise prices.

Radiopharm Theranostics Ltd executive Dimitris Voliotis, the Chief Medical Officer, reported his initial holdings of stock options in a Form 3. These options give him the right to buy Ordinary Shares at an exercise price of $0.025 per share.

The filing shows three option positions over Ordinary Shares: one over 7,657,334 shares with an exercise date of July 1, 2028, and two over 7,657,333 shares each with exercise dates of July 1, 2027 and July 1, 2026. All three option positions are scheduled to expire on July 1, 2030 and are held directly. The filing does not report any purchases or sales, only these existing derivative holdings.

Radiopharm Theranostics Ltd director Paul Hopper has filed an initial Form 3 listing his ownership in Ordinary Shares and options. The filing shows direct ownership of 53,900,000 Ordinary Shares, plus additional indirect holdings through Kilinwata Investments Pty Ltd and his spouse. It also details multiple Option (right to buy) positions over Ordinary Shares with exercise prices between 0.0250 and 0.2000 and expirations ranging from 2026 to 2030, including grants that vest only if he remains a Director on specified future dates.

Radiopharm Theranostics Ltd filed an initial Form 3 for Chief Financial Officer Aaron James Laurita, establishing his existing equity position. He directly holds 26,357 Ordinary Shares and an option to buy 17,857 Ordinary Shares at an exercise price of $0.2000 per share, expiring on November 30, 2026. The filing records holdings rather than new share purchases or sales.

Radiopharm Theranostics reported its quarterly cash flow and business update, highlighting rapid clinical progress alongside heavy spending. Closing cash at the end of the quarter was A$19.2 million, down from A$34.5 million, after net operating cash outflows of A$14.9 million.

Direct research and development of A$11.8 million plus staff costs of A$2.37 million made up 95% of operating spend, reflecting accelerated investment across its radiopharmaceutical pipeline. Key milestones included completing enrolment in the Phase 2b trial of imaging agent RAD 101, where interim data showed 90% concordance with MRI in 18 of 20 evaluable subjects, and advancing RAD 202 with encouraging early safety and tumor uptake data.

The company also initiated first-in-human trials for radiotherapeutic assets RV-01 and RAD 402 and continues multiple Phase 1 programs. Estimated funding runway is 1.29 quarters, but management points to an A$-equivalent At-The-Market facility allowing up to US$18.9 million in ADR issuance and an expected ~A$5 million Australian R&D tax incentive to extend liquidity.

Radiopharm Theranostics Limited reported initial first-in-human findings from its Phase 0/1 HEAT clinical trial of 177Lu-RAD202, a HER2-targeted radiopharmaceutical for advanced solid tumors. In the initial lowest dose cohort of three heavily pre-treated HER2-positive patients given 30 mCi, 177Lu-RAD202 showed encouraging tumor uptake and a favorable safety profile. Based on these data, the independent Data Safety and Monitoring Committee recently recommended advancing to the next dose level, allowing escalation to the third cohort at 130 mCi. The HEAT trial is an open-label, multicenter study in HER2-positive locally-advanced or metastatic solid tumors, building on earlier diagnostic proof-of-concept for RAD202 in HER2-positive breast cancer.

Radiopharm Theranostics completed enrollment in its U.S. Phase 2b imaging trial of RAD 101 for diagnosing recurrent brain metastases from solid tumors. Interim data showed 90% concordance between 18F‑RAD101 and MRI, which is the study’s primary endpoint. A primary endpoint readout is expected in June 2026, and the company plans to advance RAD 101 into a U.S. Phase 3 pivotal trial and engage with the FDA on the regulatory path. RAD 101 targets fatty acid synthase, which is overexpressed in many solid tumors, and has received FDA Fast Track Designation for distinguishing recurrent disease from treatment effects in brain metastases.

Radiopharm Theranostics reports that an independent Data Safety and Monitoring Committee has recommended advancing its Phase 1 ‘HEAT’ trial of radiotherapeutic candidate 177Lu-RAD202 to Cohort 3 at a dose of 130mCi in HER2-positive advanced solid tumors.

The decision follows favorable safety data that allowed faster progression from Cohort 2. A prior dose level of 75mCi was announced earlier, and the company states it remains on track to complete Phase 1 dose escalation by the end of 2026. RAD202 previously showed proof-of-concept and positive safety in a ten-patient HER2-positive breast cancer study.