Spago Nanomedical (SPAGO) investor relations material

Platform overview and clinical progress

• Presented a nanoparticle radiopharmaceutical platform for tumor-agnostic delivery of therapeutic radioisotopes, aiming to address treatment gaps in cancer types underserved by current radioligand therapies.

• Tumorad, the main asset, is completing phase I trials in cancer patients, showing promising tumor uptake and safety profile, particularly in head and neck cancers.

• The technology leverages tumor physiology (vascular leakiness) for delivery, bypassing the need for molecular targeting and enabling broader applicability across solid tumors.

• Tumorad uses lutetium-177, a proven isotope, and demonstrates unprecedented stability in its nanoparticle complex, supporting a first-in-class approach.

• Clinical data show excellent uptake in adenoid cystic carcinoma (ACC) and squamous cell carcinoma, with sustained intratumoral radiation and manageable, asymptomatic blood-based toxicity.

Regulatory and development strategy

• The phase I trial met its primary endpoint (maximum tolerated dose) and is recruiting final patients, with data expected before year-end.

• ACC is the lead indication, with plans to pursue Orphan Drug Designation for accelerated development and market exclusivity.

• Phase IIa is planned to continue in Australia and expand to the U.S., with a pivotal trial potentially requiring only 25–30 patients.

• The trial design allows for expansion into other head and neck cancers and potentially triple-negative breast cancer, leveraging prior imaging agent success.

• Regulatory discussions are ongoing in the U.S., and the company is appointing a U.S. agent to support these efforts.

Market positioning and partnership activities

• ACC represents a niche but high-value market due to lack of gold standard treatments and potential for premium pricing.

• The platform's receptor-independent, master key approach enables treatment of a wide range of solid tumors, supporting a multi-opportunity market.

• Active outreach to U.S. investors and strategic partners is underway, leveraging robust clinical data and growing interest in radiopharmaceuticals.

• The technology's stability and EPR-based mechanism differentiate it from targeted agents, attracting increasing industry interest.

• Australia is favored for trials due to cost-effectiveness, strong infrastructure, and significant cash-back incentives, while the U.S. is targeted for market access and regulatory endorsement.