공고 • Aug 18
Radiopharm Theranostics Schedules End-Of-Phase 2 Meeting With U.S. FDA To Align On Pivotal Phase 3 Trial Design For RAD101 In Diagnosis Of Brain Metastases Radiopharm Theranostics had scheduled an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for October 1st, 2026, to align on the design of a pivotal Phase 3 trial to evaluate RAD101 in patients with suspected recurrence of brain metastases following radiotherapy. RAD101 is the Company's novel Fluorine-18-labeled small-molecule imaging agent that targets fatty acid synthase (FASN) and is being developed to diagnose suspected recurrent brain metastases arising from a range of solid tumors. The focus of the meeting will be to align on the pivotal Phase 3 clinical trial design criteria, including the number of patients to be enrolled along with primary and secondary endpoints. The regulators will also be reviewing the data from the Phase 2b trial of RAD101, which demonstrated 93% concordance between MRI and PET imaging of brain metastases in this patient population with suspected recurrence. The results showed substantial and selective tumor uptake of RAD101, with images confirming metabolic activity in PET compared to equivocal MRI findings. RAD101 has received FDA Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. The company also recently announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm’s upcoming Phase 3 registrational trial in the U.S. In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the Primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care. RAD101 is the Company’s novel imaging small molecule that selectively binds to fatty acid synthase (FASN), a multi-enzyme protein that catalyses de-novo fatty acid synthesis and is overexpressed in cerebral metastasis from solid tumors. Targeting FASN activity may allow for the more accurate detection of cancer cells in the CNS, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies. 공고 • Jul 29
Radiopharm Theranostics Limited has completed a Follow-on Equity Offering in the amount of $4.050001 million. Radiopharm Theranostics Limited has completed a Follow-on Equity Offering in the amount of $4.050001 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 1,281,646
Price\Range: $3.16
Discount Per Security: $0.2212
Transaction Features: Registered Direct Offering 공고 • Jul 25
Radiopharm Theranostics Limited has completed a Follow-on Equity Offering in the amount of AUD 12.5 million. Radiopharm Theranostics Limited has completed a Follow-on Equity Offering in the amount of AUD 12.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 833,333,331
Price\Range: AUD 0.015
Transaction Features: Subsequent Direct Listing 공고 • Apr 20
Radiopharm Theranostics Presents Initial Findings from Phase 1 First-In-Human HEAT Clinical Trial for 177Lu-RAD202 in HER2+ Solid Tumors at American Association for Cancer Research 2026 Radiopharm Theranostics announced that new data from the ongoing Phase 0/1 HEAT trial (NCT06824155), evaluating 177Lu-RAD202, a first-in-class HER2-targeted radiopharmaceutical therapy, will be presented as a poster at the American Association for Cancer Research Annual Meeting 2026, being held April 17–22, 2026 in San Diego, California. 177Lu-RAD202 demonstrated encouraging tumor uptake and a favorable safety profile in the lowest dose cohort. The Data Safety and Monitoring Committee recently approved advancing 177Lu-RAD202 to the next highest dose at 130 mCi. The AACR poster highlights first-in-human safety, biodistribution, dosimetry and tumor uptake clinical findings from the initial lowest dose cohort of three patients with advanced HER2-positive breast and urothelial cancers who had received multiple prior metastatic therapies and were dosed at 30 mCi. Meaningful tumor uptake of 177Lu-RAD202 was observed at the initial and lowest dose level of 30 mCi, particularly in breast cancer lesions. 177Lu-RAD202 was generally well tolerated in the first three treated patients, with predominantly Grade 1–2 treatment-emergent adverse events. No dose-limiting toxicities or treatment discontinuations due to adverse events were observed. Organ-level absorbed radiation doses were within expected and clinically acceptable ranges, supporting continued dose escalation. On April 8, 2026, Radiopharm Theranostics announced the positive recommendation from the Data Safety and Monitoring Committee to advance 177Lu-RAD202 to the third cohort at a dose level of 130 mCi in the Phase 1 ‘HEAT’ clinical trial in patients with HER2-positive advanced solid tumors. 177Lu-RAD202 is a Lutetium-177–labeled single-domain antibody (sdAb) designed to target HER2-expressing tumors. The sdAb format enables deep tumor penetration and rapid systemic clearance, while the beta-emitting isotope 177Lu delivers cytotoxic radiation with potential bystander effects independent of HER2 receptor density. The HEAT trial (HER2-Antibody Therapy with Lutetium-177; (NCT06824155)) is a first-in-human, open-label, multicenter integrated Phase 0/1 study evaluating 177Lu-RAD202 in patients with HER2-positive locally-advanced or metastatic solid tumors. Phase 0 evaluates biodistribution, pharmacokinetics, and radiation dosimetry using an imaging dose. Phase 1 consists of multiple-dose escalation to assess safety, tolerability, tumor targeting, and to determine the recommended Phase 2 dose. RAD202 is a proprietary single-domain monoclonal antibody (sdAb) that targets the Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. In a previous diagnostic study of ten HER2-positive breast cancer patients, RAD202 demonstrated clinical proof-of-concept and had positive safety and biodistribution. 
