Radiopharm (ASX:RAD) Drives Clinical Progress with Ethics Approvals and Strategic Partnerships

Highlights

• Radiopharm received ethics approval to begin the Phase 1 therapeutic trial of RAD202 for HER2-positive cancers.
• The company secured ethics approval to expand the RAD204 trial to additional cancer types.
• Preclinical studies for RAD 402 has been concluded in December quarter, with human trials scheduled for H2 2025.
• Formed a partnership with AtomVie to develop 177Lu-BetaBart for B7-H3-expressing tumors.
• Entered a co-development agreement with Lantheus for radiopharmaceutical trials in Australia.
• Radiopharm Theranostics' American Depositary Shares were listed on Nasdaq under the ticker “RADX”.

Australia-based clinical-stage radiotherapeutics company Radiopharm Theranostics Limited (ASX:RAD) achieved significant milestones in the December quarter, securing ethics approval for clinical trials and forming strategic alliances to advance its clinical pipeline. Notably, the company gained approval to expand its cancer trials, moved closer to first-in-human testing for RAD 402 and achieved a Nasdaq listing for its American Depositary Shares (ADSs), trading under the ticker "RADX" as of 27 November 2024.

Ethics Approval for Clinical Trials

• In November, Radiopharm secured ethics approval from the Australian Human Research Ethics Committee (HREC) for expanding Phase 1 ¹⁷⁷Lu-RAD204 trial to include additional cancer types. This expansion aligns with Radiopharm’s goal of developing RAD204 as a tumour-agnostic radioimmunotherapy and supports the validation of RAD204’s potential for a pan-tumour predictive biomarker approach. The trial could offer a new treatment option for patients with advanced PD-L1-positive cancers.
• In December, the company secured ethics approval in Australia to initiate a Phase 1 trial of ¹⁷⁷LuRAD202 for HER2-positive metastatic solid tumours. The open-label ‘HEAT’ trial will evaluate the safety, tolerability, and early clinical activity of the radiotherapeutic. The trial would take place at multiple sites in Australia, with support from GenesisCare CRO.

RAD 402 Moves Toward First-In-Human Trials

During the quarter, Radiopharm completed preclinical studies for its KLK3-targeting radiotherapeutic, RAD 402. The promising results support progression to First-In-Human trials, which are planned for H2 2025. Meanwhile, GMP manufacturing is underway and expected to be completed by Q1 2025.

Strategic Collaborations Propel Clinical Advancements

At the end of December, Radiopharm announced a strategic co-development partnership with Lantheus Holdings, a US-based, Nasdaq-listed radiopharmaceutical company. The collaboration aims to accelerate radiopharmaceuticals trials in Australia.

Shortly after the reporting period, Radiopharm revealed it had executed a subscription agreement for a private placement of shares to Lantheus, raising US$5 million (approximately AU$8 million) to support ongoing initiatives. In early January, Lantheus became the largest shareholder in RAD.

The company ended the quarter with a cash balance of AU$36.47 million, and its previous guidance of a cash runway through mid-2026 remains unchanged.

 The share price of RAD was AUD 0.025 at the time of writing on 4 February 2025.