Radiopharm Theranostics Reports Business Update
Phase 3 imaging trial of RAD101 in recurrent brain metastases from solid tumors expected to initiate in 1Q27 following
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Phase 3 imaging trial of RAD101 in recurrent brain metastases from solid tumors expected to initiate in 1Q27 following successful end-of-phase 2 meeting with U.S. Food and Drug Administration
Reported positive Phase 1 imaging data for RAD301, supporting advancement toward Phase 2 development in pancreatic ductal adenocarcinoma
Advanced to fourth dosing cohort in ongoing Phase 1 ‘HEAT’ study of RAD202 in HER2+ solid tumors
SYDNEY, Nov. 02, 2026 (GLOBE NEWSWIRE) — Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced financial results for the quarter ended September 30, 2026, and provided a corporate update.
“We continue to execute on multiple value-driving catalysts across our portfolio, with the successful End-of-Phase 2 meeting for RAD101 representing a particularly important milestone as we prepare to enter a pivotal Phase 3 study,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “The progress achieved this quarter reflects both the growing maturity of our pipeline and the differentiated potential of our radiopharmaceutical platform. From advancing RAD202, RAD204 and RV-01 in the clinic to reporting positive Phase 1 imaging data for RAD301, we are steadily building a robust body of clinical evidence across several high-value oncology targets. With multiple upcoming clinical, regulatory and scientific milestones anticipated over the coming months, we believe Radiopharm is well positioned to continue generating momentum as we work to develop the next generation of precision cancer therapies for patients with significant unmet needs.”
Program and Business Updates
18F-RAD101 – Small molecule targeting fatty acid synthase radiolabeled with Fluorine-18
RAD101 is currently being prepared for a pivotal, multi-center, global Phase 3 imaging trial following a productive End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) in individuals with confirmed recurrent brain metastases from solid tumors of different origins. 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 October 2026, the Company announced the successful completion of an EOP2 meeting with the FDA for RAD101 for the detection of brain metastases. Previously reported Phase 2b clinical data showed that RAD101 demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial’s primary endpoint.
- RAD101 was selected for a late-breaking oral presentation of interim Phase 2b imaging data for its trial in participants with suspected recurrent brain metastases from solid tumors at the 31st Annual Meeting of the Society of Neuro-Oncology (SNO26) taking place from November 12-15, 2026, in Philadelphia, Pennsylvania. The data from these findings are supportive for the initiation of the Phase 3 imaging trial.
177Lu-RAD204 – Nanobody targeting PD-L1 radiolabeled with Lutetium 177
RAD204 is being evaluated in a Phase 1 study in PD-L1-driven cancers, including Non-Small Cell Lung Cancer (NSCLC), Small-Cell Lung Cancer (SCLC), Triple-negative Breast Cancer (TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC) and Endometrial Cancer.
- The Company continues to make progress in dosing patients in the 90mCi third cohort of the Phase 1 study. Data from each of the cohorts of the Phase 1 study will be used to inform the recommended dose for the planned Phase 2 trial.
177Lu-RAD202 – Nanobody targeting HER2 radiolabeled with Lutetium 177
The Company continues to evaluate RAD202 in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. RAD202 has demonstrated clinical proof-of-concept with positive safety and biodistribution.
- In August 2026, the Company received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance RAD202 to the next dose level of 180mCi in the fourth cohort of the Phase 1 ‘HEAT’ clinical trial in patients with HER2-positive advanced solid tumors.
Lu177-RV 01 – monoclonal antibody targeting 4Ig isoform of B7H3 radiolabeled with Lutetium 177
RV-01 (Betabart) is a monoclonal antibody targeting the 4Ig isoform of B7H3, an immune checkpoint protein that is highly expressed in tumors and not in healthy tissue. In multiple preclinical studies, RV-01 has shown tumor shrinkage and prolonged survival. This is the first radiopharmaceutical therapeutic developed by Radiopharm Ventures, a joint venture between Radiopharm Theranostics and the MD Anderson Cancer Center.
- In August 2026, the Company dosed the first patient in the second cohort of its First-In-Human (FIH) Phase 1/2 clinical trial of RV-01 in patients with B7-H3 expressing tumors. The dosing of the first patient came following a positive recommendation from the Safety and Monitoring Committee (SMC) to advance to the 70mCi dose.
- The Phase 1/2a clinical trial of RV-01 is a dose escalation and expansion trial designed to evaluate the safety, biodistribution, radiation dosimetry and preliminary anti-tumor activity of RV-01 in B7-H3 expressing tumors. The trial will determine the recommended dose of RV-01 to move forward in future studies. The Phase 1/2a study is currently being conducted at clinical centers across the U.S.
Tb161-RAD 402 – Monoclonal antibody targeting KLK3 radiolabeled with Terbium 161
RAD402 is a monoclonal antibody targeting Kallikrein Related Peptidase 3 (KLK3) radiolabeled with the radionuclide 161Tb for the treatment of prostate cancer. In preclinical mouse models, RAD 402 showed strong tumor targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody.
- The Company continues to progress its First-In-Human (FIH) Phase 1 clinical trial of RAD402, designed to evaluate the safety, tolerability, whole-body distribution, and preliminary clinical activity of RAD402 in patients with advanced prostate cancer. The dose escalation Phase 1 study is designed to determine the Maximum Tolerated Dose and recommended Phase 2 dose for expansion.
Ga68-RAD301 – Peptide targeting αvB-integrin radiolabeled with Gallium 68
RAD301 is being evaluated in a Phase 1 imaging trial in patients with Pancreatic Ductal Adenocarcinoma (PDAC). The αvB-integrin is a cellular marker for tumor invasion and metastatic growth, which correlates with decreased survival in several carcinomas, particularly pancreatic. RAD301 has previously received Orphan Drug Designation (ODD) from the FDA and data from the Phase 1 trial is supportive of continuing its development.
- In September 2026, the Company announced positive data from the Phase 1 trial of RAD301 in patients with pancreatic ductal adenocarcinoma. RAD301 demonstrated a favorable safety profile in all evaluable participants as well as favorable biodistribution and significant tumor uptake in pancreatic cancer metastases, which supports the potential of αvβ6-integrin as a target for future therapeutic development and potentially as a theranostic pair.
Radiopharm Ventures
Subsequent to 30 September, Radiopharm increased its ownership In Radiopharm Ventures from 87.5% to 93.75% as the result of continuous participation in the program.
Financial Updates
COMPLETION OF A$12.5 MILLION INSTITUTIONAL OFFER AND A$6 MILLION SHARE PURCHASE PLAN
During the quarter, Radiopharm completed a A$12.5 million institutional placement and a A$3 million Share Purchase Plan (SPP) to strengthen its financial position to support the preparation and readiness to commence the RAD101 registrational Phase 3 study, the completion of RAD204 dose escalation, while progressing RAD202, RAD402 and RV01 therapeutic programs and supporting ongoing strategic partnering initiatives.
R&D TAX REFUND
In July, Radiopharm received its research and development (R&D) tax refund for the 2025 financial year, totaling to A$5,885,131, including A$104,475 interest. The refund is received as part of the Australian Government’s R&D tax incentive, which provides companies engaging in appropriate and eligible activities with a refundable tax offset of up to 43.5%.
R&D ADVANCE
Subsequent to 30 September, Radiopharm received $8,000,000 from Rockford Capital under a funding facility secured against Radiopharm’s anticipated FY26 Research and Development Tax Incentive (RDTI).
QUARTERLY RESULTS
Closing cash at the end of the quarter was $7.5 million, increasing from $4.1 million at the end of the prior quarter. Net cash outflows from operating activities during the period was $10.7 million with direct Research and Development expenditure and staff costs accounting for 93% of the operating expenditure for the quarter, excluding receipt of the R&D tax refund.
In compliance with Listing Rule 4.7C, payments to related parties and their associates, as detailed in item 6.1 of Appendix 4C, encompass remuneration for director fees to executive and non-executive directors, conducted in the ordinary course of business at commercial rates, excluding reimbursements for out-of-pocket expenses.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and five Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at radiopharmtheranostics.com.
Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com
Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
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