NSB Details Stem Cell Therapy Hitting 78% Response in Crohn’s Patients With No Options
A stem cell solution for patients who’ve run out of options
Approximately 30% of Crohn’s Disease patients eventually stop responding to standard therapies, leaving them with zero recognised treatment options. In its May 2026 investor presentation, Neuroscientific Biopharmaceuticals (ASX: NSB) detailed StemSmart, its proprietary allogeneic MSC platform developed specifically for these treatment-resistant patients. The presentation coincided with the company’s 26 May 2026 announcement of “Remarkable Results from Patients treated with StemSmart under the Special Access Program,” providing timely context for the clinical progress outlined. NSB is targeting a global Crohn’s Disease market valued at US$13B+, covering an estimated 6 to 8 million patients worldwide.
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What StemSmart actually is — and why it’s different
Mesenchymal stem cells explained
Mesenchymal Stem Cells (MSCs) are naturally occurring cells found in the body that home to sites of inflammation and modulate the immune response. In Crohn’s Disease, the immune system mounts a chronic, misdirected attack on the digestive tract. Rather than simply suppressing symptoms, MSCs have the potential to “reset” the inflammatory environment at the source, offering a mechanistically distinct approach to treatment.
What makes StemSmart different
NSB’s StemSmart product uses an “activated MSC” format, meaning the cells are processed through a proprietary activation method designed to enhance therapeutic activity beyond what standard MSC therapies can achieve. Manufacturing is conducted under TGA accreditation, and the patented process removes non-human proteins from cell products, which the presentation noted improves both clinical efficacy and safety.
StemSmart is allogeneic, meaning it is produced from donor-derived cells rather than a patient’s own cells. This distinction is commercially significant: allogeneic manufacturing enables scalable production, whereas autologous approaches require a separate manufacturing process for each individual patient.
NSB — Key Product Claim
“NSB’s StemSmart™ product has generated strong clinical evidence in patients with severe refractory Crohn’s, providing a potential therapy where none exists currently.”
The clinical evidence building behind StemSmart
Prior Phase 2 trial results
The foundational evidence base for StemSmart comes from a prior Phase 2 clinical study conducted in refractory Crohn’s Disease patients. Management highlighted four headline data points from that study:
- 78% of refractory patients demonstrated clinical response, defined as a reduction in the Crohn’s Disease Activity Index (CDAI) by more than 100 points.
- 44% achieved remission, defined as a reduction in CDAI score to below 150 points.
- All patients enrolled had previously failed biologic therapies.
- No safety events related to treatment with StemSmart were recorded.
Special Access Program — real-world validation
The TGA Special Access Scheme (SAS) is a regulatory pathway that allows patients with limited treatment options to access experimental therapies outside of a formal clinical trial. NSB’s SAS program focused on fistulising Crohn’s Disease, a distinct and severe complication involving abnormal tunnelling between the bowel and the outside skin or other organs — a condition associated with significantly reduced quality of life.
The headline result from the SAS program: 4 out of 5 patients achieved a clinical response, defined as ≥50% fistula closure or discharge reduction. No serious adverse events were reported. The presentation noted that this real-world data is now directly informing the design of the planned Phase 2 clinical trial anticipated in CY2026.
| Program | Patient Type | Key Result | Safety | Status |
|---|---|---|---|---|
| Prior Phase 2 Study | Refractory Crohn’s (failed biologics) | 78% clinical response; 44% remission | No safety events | Completed |
| Special Access Program | Fistulising Crohn’s | 4/5 patients clinical response (≥50% fistula closure) | No serious adverse events | Completed; informing Phase 2 |
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What’s next — the path to Phase 2 and beyond
Two Phase 2 trials in parallel
The May 2026 presentation outlined two distinct Phase 2 programs in parallel development, each targeting a different patient population and regulatory pathway.
Fistulising Crohn’s Disease:
- Australia only
- Australian TGA Clinical Trial Notification pathway
- Open label, single-arm study
- Data intended to support Marketing Authorisation in Australia
Refractory Crohn’s Disease:
- US and Australia
- US FDA Investigational New Drug program
- Randomised, double-blinded, 2-arm study
- Data intended to support partnering for Phase 3 and commercialisation globally
Milestone roadmap
Management presented the following near-to-medium term milestone sequence in the May 2026 investor presentation:
- 2026 — TGA licensure at Q-Gen Cell Therapeutics (manufacturing partner)
- 2026 — Regulatory submissions to support Phase 2 initiation
- 2026 — Phase 2 trial commencement in Australia and the US
- 2027 — Strategic partnership and licensing discussions
- 2027 — Expansion into additional inflammatory indications
- 2028–2029 — Phase 3 preparation
- 2029–2031 — Commercialisation pathway activities
On the financial side, NSB reported approximately A$5.68 million in cash as at 31 March 2026. As at 25 May 2026, the company carried a market capitalisation of approximately A$31.26 million at a share price of A$0.09.
NSB is targeting the least-served segment of a US$13B+ market, with a patented platform, early clinical validation across two distinct programs, and a structured Phase 2 pathway now underway.
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