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On track to complete enrollment of first two cohorts of RAD204 following positive recommendation from DSMC to escalate dose to 60mCi of Lu177
On track to complete enrollment of the first cohort of Phase 1 ‘HEAT’ trial of RAD202 for treatment of advanced HER2-positive solid tumors
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
SYDNEY, Australia, July 29, 2025 (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 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
177Lu-RAD202 – Nanobody targeting HER2 radiolabeled with Lutetium 177
18F-RAD101 – Small molecule targeting fatty acid synthase radiolabeled with Fluorine-18
Ga68-RAD301 – Peptide targeting αvΒ-integrin radiolabeled with Gallium 68
Preclinical Assets
Business Updates
Financial update
The following is a summary of the Appendix 4C Cash Flow Report:
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: [email protected]
Anne Marie Fields
Precision AQ (formerly Stern IR)
E: [email protected]
Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: [email protected]
Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
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