NeuroScientific Biopharmaceuticals Limited (ASX:NSB) Remarkable Results from Patients Treated with StemSmart™ Under the Special Access Program

26 May 2026

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Highlights:

• Completion of NSB’s Special Access Program provides exceptional outcomes for Fistulising Crohn’s Disease patients treated with StemSmart™
• Five (5) patients in total received NSB’s StemSmart™ MSC product under the Special Access Program, with all showing improvement and 4 of 5 (80%) achieving a successful Clinical Response, with no serious adverse events
• Clinical Response is defined as either the closure of ≥50% of fistula openings, or a ≥50% decrease in fistula discharge in a patient, as assessed by the treating physician or qualified investigator
• NSB’s StemSmart™ MSC product demonstrated clinically meaningful therapeutic results in younger adults living with the debilitating complications of fistulising Crohn’s disease who are resistant to currently available approved therapies
• Following the exceptional results of the Special Access Program, NSB has initiated development of a pivotal Phase 2 clinical trial in fistulising Crohn’s disease, taking place in Australia and anticipated to commence 2H CY2026
• This Australia-only Phase 2 clinical trial will aid in NSB’s pursuit of achieving Marketing Authorisation in Australia and will be conducted in parallel with the broader refractory Crohn’s disease Phase 2 clinical trial for the US & Australia
• StemSmart™ is a patented stem cell technology positioned as a platform cell therapy, with additional clinical opportunities in organ transplant immune tolerance, lung inflammatory disease, and graft-vs-host disease (GvHD)
• Results set the foundation for the Company’s anticipated entry into the global Crohn’s disease market, valued at ~US$13 billion

Overview:

NeuroScientific Biopharmaceuticals Limited, an innovative Australian biotechnology company developing novel technologies targeted at immune-mediated inflammatory diseases, is pleased to announce exceptional outcomes for patients with fistulising Crohn’s disease from the Company’s Special Access Program using its patented StemSmart™ mesenchymal stem cell (‘MSC’) therapy.

Of the five patients aged 18-49 treated with StemSmart™, all responded to MSC therapy, with 4 (80%) achieving a Clinical Response defined by either the closure of ≥50% of fistula openings or a decrease of ≥50% in fistula discharge. All patients experienced a reduction in fistula discharge, with 4 patients achieving the threshold for Clinical Response, while the remaining patient showed a partial response. No serious adverse events were observed.

This positive clinical response was further supported by internationally recognised scoring systems for Crohn’s disease. All patients showed improvement across the Crohn’s Disease Activity Index (CDAI), Perianal Disease Activity Index (PDAI) and Inflammatory Bowel Disease Questionnaire (IBDQ) Quality of Life Index. Radiological imaging via MRI indicated a trend toward healing of fistulas for all patients. All patients also had at least one seton removed, which is a significant indicator of fistula healing.

Each of the patients was approved by the TGA for treatment using StemSmart™ under the Special Access Scheme (‘SAS’) Category B pathway, initially starting in October CY2025. This pathway provides potential treatment options for patients where existing conventional therapies have been ineffective or where no effective alternatives exist.

An exceptional result in a difficult-to-treat patient population

The patients participating in the Special Access Program were younger adults living with fistulising Crohn’s disease — one of the most severe and debilitating complications of inflammatory bowel disease, and a complex, chronic condition that is often resistant to conventional treatments.

NSB Chief Medical Officer, Dr Cathy Cole, commented: “A clinical response rate of 80% to a novel treatment for a serious, debilitating and long-standing medical condition, that largely affects younger adults, is exceptional. Considering these fistula patients receiving StemSmart™ were treated in a real-world setting and had limited treatment options available, the response is outstanding and offers hope for clinical recovery when there was previously little. We can confidently proceed to our phase 2 trials informed on frequency and timing of doses of MSC and MRI assessments. In keeping with our total experience to date, there are no safety concerns.”

Phase 2 clinical trial initiated

As a result of the successful Special Access Program, NSB has initiated development of a Phase 2 clinical trial specifically for fistulising Crohn’s disease patients in Australia, planned to commence by 2H CY2026. The data from the Special Access Program and earlier clinical work will inform key methodological factors including induction considerations, dosing schedules, and the timing of MRI scans. This Australia-only trial will be developed in parallel with the previously announced Phase 2 clinical trial in the US & Australia for the broader indication of refractory Crohn’s disease.

NSB Chief Executive Officer, Mr Nathan Smith, commented: “The outstanding results from the initial patients in the Special Access Program have highlighted the opportunity for NSB to conduct an Australian clinical trial for fistulising Crohn’s disease; an incredibly debilitating condition with a patient population that has very few effective treatment options available to them. The pivotal data generated from this planned trial will assist NSB in its aim to obtain Marketing Authorisation for StemSmart™ to potentially benefit Australian patients and provide a pathway to commercialisation of our technology earlier than previously forecasted.”

Company Notes:

NSB Non-Executive Chairman, Mr Robert McKenzie, added: “Our medical & scientific teams’ response to these initial results indicates that NSB is making momentous progress. The clinical success of StemSmart™ in this difficult to treat patient group is significant and reinforces NSB’s commitment to the development of StemSmart™ for the benefit of patients.”

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