U.S. FDA granted Fast Track Designation for RAD101 to distinguish between recurrent disease and the treatment effect of brain metastases
Confirmed guidance of Cash Runway through to mid-2026
Radiopharm Theranostics (ASX: RAD,OTC:RDPTF, 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 fiscal year ended June 30, 2025, and provided a corporate update.
"During the last quarter, we continued to execute with discipline and momentum across our pipeline, advancing key milestones within both our therapeutic and diagnostic radiopharmaceutical programs," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "We are encouraged by the pace and efficiency of our development efforts. Notable achievements this quarter include the FDA's Fast Track Designation for RAD101, DSMC clearance to proceed with higher dosing of RAD204, procurement of multiple supply agreements for key radioisotopes and meaningful clinical progress across our clinical pipeline. These milestones reflect our unwavering commitment to delivering precise, targeted radiopharmaceutical solutions that have the potential to transform cancer care. Looking ahead, we anticipate a number of important clinical and corporate milestones throughout the remainder of 2025."
Program and Business Updates
177Lu-RAD204 – Nanobody targeting PD-L1 radiolabeled with Lutetium 177
- In May 2025, Radiopharm shared updates from an independent Data and Safety Monitoring Committee (DSMC), which concluded that Cohort 2 of the Phase 1 study of 177Lu-RAD204 could proceed at a higher dose level. The higher dose level was determined to be 60mCi of Lu177 rather than the 40mCi previously assumed in the protocol. The second cohort of patients is expected to be fully enrolled in the coming weeks and will include expansion to multiple tumor types including Non-Small Cell Lung Cancer, Small-Cell Lung Cancer, Triple-Negative Breast Cancer, Cutaneous Melanoma, Head and Neck Squamous Cell Carcinoma and Endometrial Cancer.
- Data from the first two cohorts of patients in the Phase 1 study of 177Lu-RAD204 are expected in the second half of 2025.
177Lu-RAD202 – Nanobody targeting HER2 radiolabeled with Lutetium 177
- In June 2025, Radiopharm dosed the first patient in its Phase 1 HEAT clinical trial of 177Lu-RAD202. The open-label Phase 1 HEAT clinical trial is a dose escalation trial of 177Lu-RAD202, designed to determine the recommended Phase 2 dose and to evaluate the safety and preliminary clinical activity in individuals with Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in a wide variety of advanced solid tumors.
- Preliminary data from the first two cohorts of patients in the Phase 1 study of 177Lu-RAD202 are expected by the end of 2025.
- Ten HER2-positive breast cancer patients were previously dosed in a Phase 1 diagnostic study of RAD202, which demonstrated clinical proof-of-concept as well as the safety and distribution of RAD202.
18F-RAD101 – Small molecule targeting fatty acid synthase radiolabeled with Fluorine-18
- In June 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for 18F-RAD101 to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origins.
- In April 2025, Radiopharm dosed the first patient in the U.S. Phase 2b imaging study of 18F-RAD101. The multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic performance of 18F-RAD101 in 30 participants with confirmed recurrent brain metastases.
- Interim Data from the Phase 2b study are expected in the second half of 2025.
Ga68-RAD301 – Peptide targeting αvΒ-integrin radiolabeled with Gallium 68
- Enrollment is ongoing in the Phase 1a open label clinical study of the safety and biokinetics of Ga68-RAD301 in healthy human volunteers and participants with pancreatic ductal adenocarcinoma (PDAC).
Preclinical Assets
- In June 2025, Radiopharm reported preclinical data for the Lu177-B7H3-mAb (a joint venture with MD Anderson Cancer Centre), RV-01, demonstrating favorable biodistribution and high tumor uptake.
- RV-01 is a B7-H3-targeted radiopharmaceutical therapy designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues and which when highly expressed is associated with poor prognosis in many cancer types. RV-01 is being developed in partnership with MD Anderson Cancer Center.
- In July 2025, Radiopharm announced FDA clearance of its Investigational New Drug (IND) application for RV-01 enabling a pathway to Phase 1 First-In-Human study initiation in the fourth quarter of 2025.
- Radiopharm plans to submit a package for ethics approval to begin a Phase 1 clinical trial in prostate cancer for 161 Tb-RAD 402, its anti-kallikrein related peptidase 3 monoclonal antibody radiotherapeutic labelled with Terbium 161. The Company expects to begin dosing subjects in this clinical trial in the fourth quarter of 2025 in Australia.
Business Updates
- Radiopharm and ITM Isotope Technologies Munich SE (ITM) entered a supply agreement that will provide Radiopharm with ITM's medical radioisotope, non-carrier-added Lutetium-177. The supply agreement enables usage in the clinical trials of the Lutetium-177-based molecules in the Company's development pipeline, including RAD204, RAD202 and RV-01, for the treatment of solid tumors.
- Radiopharm and Cyclotek entered a supply agreement in which Cyclotek will produce and provide doses of 161 Tb-RAD 402 to support Radiopharm's upcoming Phase 1 clinical trial in prostate cancer in Australia.
Financial update
The following is a summary of the Appendix 4C Cash Flow Report:
- The year-end closing cash balance was $29.12 million, a rise from $18.58 million at the close of the previous year.
- Net cash outflows from operating activities for the year totaled $36.67 million. Direct Research and Development expenditure and Staff Costs comprised over 90% of the total operating expenditure for the year and quarter.
- On July 16, 2025, the Company reported the receipt of $4.58 million for the research and development tax incentive and associated interest for the 2024 financial year.
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 three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. 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
Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
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LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
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