Radiopharm advances to higher dose level in HER2-positive tumor trial

SYDNEY - Radiopharm Theranostics (ASX:RAD, Nasdaq: RADX), a $45.34 million market cap biotech company with strong liquid assets exceeding short-term obligations, received approval from its Data Safety Monitoring Committee to proceed to a higher dose level in its Phase 1 clinical trial of 177Lu-RAD202, the company announced Wednesday. According to InvestingPro, the company maintains a healthy current ratio of 2.67, indicating solid financial flexibility for its clinical programs.

The committee recommended advancing to a 75mCi dose in the "HEAT" trial, which is evaluating the radiotherapeutic compound in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors.

The recommendation follows review of the first patient cohort treated with 30mCi of the compound, which showed positive safety, pharmacokinetic, and biodistribution data according to the company.

"We are encouraged by the rapid progress of the Phase 1 ’HEAT’ trial of RAD202," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics in the press release statement. The company’s progress is reflected in its market performance, with a 20.83% year-to-date return. InvestingPro analysis reveals 6 additional key insights about the company’s financial position and growth prospects.

The second cohort of patients is expected to be enrolled by the fourth quarter of 2025, with data from the first two cohorts anticipated by year-end 2025.

The Phase 1 study is currently being conducted at clinical centers across Australia. The trial aims to identify the optimal Phase 2 dose for the compound.

RAD202 is a proprietary single domain monoclonal antibody targeting HER2-positive expression in advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors.

Radiopharm Theranostics is developing radiopharmaceutical products for diagnostic and therapeutic applications in oncology, with a pipeline that includes one Phase 2 and three Phase 1 trials in various solid tumor cancers. The company has demonstrated impressive revenue growth of 538.86% in the last twelve months, though InvestingPro data indicates it maintains a Fair overall financial health rating, with particularly strong scores in relative value metrics.

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