NeuroScientific Biopharmaceuticals (NSB) investor relations material

Market opportunity and unmet need

• Global Crohn's disease market exceeds US$13 billion, with 6–8 million patients worldwide and a rising disease burden.

• Up to 30% of patients become refractory to standard therapies, facing limited durable treatment options.

• Fistulising Crohn's disease causes severe complications, often leading to surgery when therapies fail.

• Targeting patients who have exhausted current options, especially those with severe, treatment-resistant disease.

StemSmart™ technology and clinical results

• StemSmart™ is a purpose-built mesenchymal stem cell therapy designed for severe, treatment-resistant Crohn's disease.

• Demonstrated 78% clinical response and 44% remission in prior studies with refractory patients; no serious safety events reported.

• Special Access Program data shows 4 out of 5 patients with fistulising Crohn's achieved significant clinical response.

• Manufactured under TGA accreditation, with a proprietary activation process enhancing therapeutic activity.

Clinical development and regulatory pathway

• Phase 2 clinical trials planned in Australia (open-label, single-arm) and US/Australia (randomised, double-blind, two-arm).

• Data from these trials will support marketing authorisation in Australia and global partnering for Phase 3 and commercialisation.

• Real-world data from the Special Access Program is informing trial design and patient selection.