Radiopharm Advances Multiple Trials and Secures $8M Placement Amid Nasdaq Debut
Radiopharm Theranostics has secured key ethics approvals to expand its clinical trial portfolio, completed significant preclinical milestones, and raised A$8 million through a strategic placement, while maintaining its cash runway to mid-2026.
- Ethics approvals granted for Phase 1 RAD202 and expanded RAD204 trials
- Preclinical completion of RAD402 with human trials planned for H2 2025
- Strategic partnerships with AtomVie and Lantheus, including co-development and manufacturing deals
- A$8 million placement by Lantheus increases its stake to 12.16%
- Nasdaq listing of American Depositary Shares (RADX) completed in November 2024
Clinical Trial Progress Accelerates
Radiopharm Theranostics (ASX: RAD) has reported a productive quarter ending December 31, 2024, marked by multiple ethics approvals that expand its clinical development footprint. Notably, the company received ethics clearance to initiate a Phase 1 therapeutic trial of RAD202 targeting HER2-positive metastatic solid tumors, including breast and gastric cancers. This trial, supported by GenesisCare CRO, aims to evaluate safety and preliminary efficacy, building on promising preclinical data demonstrating tumor uptake and therapeutic potential.
In parallel, Radiopharm secured approval to broaden its Phase 1 trial of RAD204, a PD-L1-targeting radiotherapeutic, to include five additional cancer types beyond its initial focus on non-small cell lung cancer. This expansion underscores the company’s ambition to develop RAD204 as a tumor-agnostic radioimmunotherapy, potentially addressing a wider patient population with advanced PD-L1-positive cancers.
Pipeline Advancement and Strategic Collaborations
The company also completed preclinical studies for RAD402, a KLK3-targeting radiotherapeutic designed for advanced prostate cancer, with human trials slated for the second half of 2025. Leveraging the radionuclide Terbium-161, RAD402 demonstrated favorable safety and biodistribution profiles, supporting its progression to first-in-human studies.
Strategic partnerships continue to bolster Radiopharm’s development capabilities. A collaboration with AtomVie Global Radiopharma aims to develop and manufacture 177Lu-BetaBart, targeting B7-H3-expressing tumors, with a Phase I/II trial planned in the US by mid-2025. Additionally, a co-development agreement with Lantheus focuses on advancing radiopharmaceutical trials in Australia, with Lantheus funding clinical costs and providing milestone payments.
Capital and Market Developments
Post-quarter, Radiopharm completed a private placement raising approximately A$8 million from Lantheus, which now holds a 12.16% stake in the company. The placement price of A$0.06 per share represented a 150% premium to the prior trading price, reflecting strong investor confidence. This capital injection extends Radiopharm’s cash runway to mid-2026, supporting ongoing clinical and development activities.
Complementing its ASX listing, Radiopharm’s American Depositary Shares (ADSs) commenced trading on Nasdaq under the ticker RADX in November 2024. This dual listing enhances the company’s visibility among US and international investors, positioning it well for future capital market engagement.
Financial Overview and Governance
Radiopharm ended the quarter with $36.47 million in cash, down from $46.46 million the previous quarter, reflecting $8.74 million in operating cash outflows primarily driven by research and development and staff costs. Financing activities included repayment of an advance related to R&D rebates. The company’s financial discipline and recent capital raise provide a solid foundation for its ambitious clinical programs.
Governance was strengthened with the appointment of Noel Donnelly as a Non-Executive Director. Donnelly brings extensive biopharmaceutical industry experience, including leadership roles in finance and strategy, which will support Radiopharm’s growth trajectory.
Bottom Line?
Radiopharm’s robust clinical progress and strategic capital partnerships set the stage for critical trial readouts and potential market inflection points in 2025.
Questions in the middle?
- How will early clinical data from the expanded RAD204 trial influence Radiopharm’s development strategy?
- What impact will Lantheus’s increased shareholding have on Radiopharm’s operational and commercial plans?
- Can the upcoming RAD402 human trials validate the preclinical promise and open new therapeutic avenues?
