TGA Approves First Patients for StemSmart™ Crohn’s Program; $6.9M Cash on Hand

Regulatory Milestone in Crohn’s Disease Program

NeuroScientific Biopharmaceuticals (ASX – NSB) has taken a significant step forward in its clinical development of StemSmart™, its proprietary mesenchymal stromal cell (MSC) therapy, by securing Therapeutic Goods Administration (TGA) approval for the initial three patients in its Special Access Program targeting fistulising Crohn’s disease. This approval, granted post-quarter, marks a pivotal moment as the company moves toward a Phase 2 clinical trial anticipated in 2026. The Special Access Program is designed to provide treatment options for patients with severe and treatment-resistant forms of Crohn’s disease, a market projected to reach US$13.8 billion globally by 2026.

Strengthening Leadership with Clinical and Manufacturing Expertise

In parallel with clinical progress, NeuroScientific has bolstered its leadership team with two key appointments. Dr Catherine Cole, a distinguished haematologist and oncologist with extensive experience in bone marrow transplantation and regulatory advisory roles, has been named Chief Medical Officer. Her clinical insights, particularly in graft versus host disease (GvHD), align well with StemSmart™’s therapeutic potential. Additionally, Nathan Smith has joined as CEO, bringing a wealth of experience in cell and gene therapy commercialization and GMP manufacturing. His expertise is expected to be instrumental as the company scales up production and navigates regulatory pathways.

Manufacturing Scale-Up Partnership

To support clinical and commercial ambitions, NeuroScientific has partnered with Q-Gen Cell Therapeutics, a leading Australian biologic manufacturer with extensive cell therapy manufacturing capabilities. The transfer of StemSmart™’s patented manufacturing process to Q-Gen commenced during the quarter, enabling the company to prepare for larger-scale clinical trials and eventual market supply. This move addresses a critical bottleneck in cell therapy development, reliable and scalable GMP manufacturing.

Broader Clinical Potential and Pipeline Progress

Beyond Crohn’s disease, historical data from renal transplantation studies acquired through the Isopogen WA Ltd acquisition reinforce StemSmart™’s potential in preventing and treating graft failure and rejection. While these studies involved small patient numbers, the positive outcomes provide a foundation for further clinical exploration. Meanwhile, the company’s EmtinB™ program, targeting degenerative optic conditions such as glaucoma, has advanced formulation and preclinical pharmacology work, moving closer to clinical readiness with a focus on intravitreal administration.

Financial Position and Outlook

NeuroScientific reported a cash balance of approximately A$6.9 million at the end of September 2025, with disciplined expense management despite increased staff and administrative costs. The company is preparing for capital-intensive activities in the coming year, including clinical trial initiation and manufacturing scale-up. Investors will be watching closely how these investments translate into clinical milestones and regulatory progress.