Samso News: NeuroScientific Biopharmaceuticals Limited – StemSmart™ Delivers Clinical Responses in Fistulising Crohn’s Disease – Time for understaing when to take your position.
- Noel Ong
- 12 hours ago
- 8 min read
Announcement
Successful Clinical Results Achieved under Special Access – 13 January 2026 (view the announcement)
This Samso News on NeuroScientific Biopharmaceuticals Limited is about creating awareness and reminding the community of a story that is making some developments. As I have mentioned previously, the aim for Samso is to start widening our coverage and showcasing other investing opportunities on the ASX.
For the NeuroScientific release, as I read the release, I am reminded of the real cases needed for solutions in the medical field. The rate of success and the cost of investments are typically not insignificant, and hence, it is genuinely interesting to watch the progress of new innovations.
I am drawn to this recent NeuroScientific update not because I believe that it is now an investable story in the ASX but more about wanting to know more about what they are up to now and the potential in the coming future. Stories like how the narrative is now about transitioning from early-stage development into real-world clinical validation, for me, is where you can start feeling the lesser amount of developmental risk.
The journey for Neuroscientific, I feel, is now at a tangible inflection point, where clinical efficacy, regulatory engagement, and manufacturing readiness begin to converge around a scalable therapeutic platform.
NeuroScientific Biopharmaceuticals Limited (ASX: NSB) is an Australian biotechnology company focused on immune-mediated inflammatory diseases. On 13 January 2026, the Company announced successful clinical outcomes from patients treated with its patented StemSmart™ mesenchymal stem cell (MSC) therapy under the Australian Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) for fistulising Crohn’s disease.
What are Mesenchymal stem cells (MSCs)
Mesenchymal stem cells (MSCs), also known as mesenchymal stromal cells or medicinal signaling cells, are multipotent stromal cells that can differentiate into a variety of cell types, including osteoblasts (bone cells), chondrocytes (cartilage cells), myocytes (muscle cells), and adipocytes (fat cells, which give rise to marrow adipose tissue).[1][2][3][4]
The primary function of MSCs is to respond to injury and infection by secreting and recruiting a range of biological factors, as well as modulating inflammatory processes to facilitate tissue repair and regeneration. Extensive research interest has led to more than 80,000 peer-reviewed papers on MSCs.[5]
The treatment program was conducted in Australia under compassionate-use conditions, targeting patients with severe disease and limited effective treatment alternatives. The reported outcomes provide real-world clinical data that directly inform NSB’s planned later-phase clinical development pathway.
The Business of NeuroScientific Biopharmaceuticals Limited: Platform Cell Therapy for Immune-Mediated Inflammatory Diseases
NeuroScientific Biopharmaceuticals is developing patented mesenchymal stem cell technologies targeting chronic inflammatory and immune-mediated conditions with high unmet medical need.
The Company’s lead asset, StemSmart™, is a differentiated MSC platform produced through a patented manufacturing process designed to enhance therapeutic activity, consistency, and clinical response (Figure 1). NSB’s strategy centres on advancing StemSmart™ through regulated clinical pathways, initially in Crohn’s disease, while maintaining optionality across additional inflammatory indications, including transplant immune tolerance, lung inflammatory disease, and graft-versus-host disease.
Figure 1: StemSmart™ Technology for Refractory Crohn’s disease (source: NSB).
Highlights – Clinical Validation Achieved Under Special Access Program
Three of four patients treated in Cohort 1 of the Special Access Program for fistulising Crohn’s disease achieved a successful Clinical Response following StemSmart™ treatment.
The fourth patient demonstrated a partial clinical response, with improvement observed and further assessments ongoing.
Clinical Response was defined as either closure of at least 50% of fistula openings or a reduction in fistula discharge of at least 50%, as assessed by the treating physician or investigator.
These outcomes provide real-world validation of the StemSmart™ MSC platform in patients with severe disease and limited treatment options.
Data generated from the Special Access Program will directly inform the design of later-phase clinical trials, planned to commence in the second half of 2026.
Phase 2 start-up activities are already underway, including commercial manufacturing preparation, clinical trial development, and regulatory planning.
The results support NSB’s positioning within the global Crohn’s disease market, forecast to exceed US$13 billion by 2026.
Leadership Commentary
NSB Chief Executive Officer, Mr Nathan Smith, commented:
“These treatment results provide critical validation of the StemSmart™ MSC platform in presenting a potential therapeutic solution to patients with debilitating fistulising Crohn’s disease that have limited effective treatment options.
This data, along with our previous clinical trial results in refractory Crohn’s disease, provides a strong foundation for our commercialisation plans for StemSmart™ moving forward.
Together, these early outcomes allow us to advance the development of a novel therapeutic in a responsible, informed, and patient-centred fashion as it supports and accelerates our progress toward clinical trial work later this year.”
NSB Chief Medical Officer, Dr Cathy Cole, commented:
“The response rate to StemSmart™ MSC treatment seen in these patients in a realworld setting is exceptional, given the serious, debilitating and long-standing adverse nature of their condition. If you consider that for these fistula patients treated with StemSmart™,
About the Project
The Special Access Program was conducted under the TGA’s SAS Category B pathway, which allows access to unapproved therapies for patients with serious or life-threatening conditions where conventional treatments have failed or are unsuitable.
StemSmart™ is derived from adult human donor bone marrow-sourced MSCs and produced using a patented manufacturing process. The program evaluated patients with non-healing fistulas, with treatment administered weekly over four weeks and clinical assessment conducted at 8–10 weeks post-treatment.
Near-term Milestones to Watch
(Figure 2)
Ongoing clinical assessment of the partial-response patient from Cohort 1.
Integration of Special Access Program data into the final Phase 2 trial design.
Progression of manufacturing technology transfer and clinical trial supply readiness.
Commencement of later-phase clinical trials in fistulising and refractory Crohn’s disease in 2H 2026.
Figure 2: Key Milestones (source: NSB).
Samso Concluding Comments
StemSmart™ is beginning to demonstrate what platform cell therapy can look like when clinical data, regulatory engagement, and manufacturing readiness move in parallel. This announcement does not change the inherent risks of biotechnology development, but it materially improves the quality of the discussion around probability rather than possibility.
Fistulising Crohn’s disease is one of the most challenging manifestations of inflammatory bowel disease, and success here carries implications beyond a single indication. The outcomes reinforce StemSmart™’s positioning as a therapy suited to high-inflammation conditions where conventional treatments struggle.
Fistulizing Crohn's Disease - What is Fistulizing Crohn’s Disease?
Fistulizing Crohn’s disease may present in patients with Crohn’s disease over their lifetime and can occur anywhere along the GI tract, affecting portions such as the small intestine, colon, rectum, or the anus.
It is common for people with fistulas to feel stress, anxiety, and other mental and emotional concerns about body image and intimacy. If you are experiencing these concerns, speak with your healthcare team to discuss options for connecting with a mental health professional who can provide helpful coping strategies. The Foundation’s support programs can also offer connection to others who may have similar experiences.
Importantly, the Company has framed these results within a disciplined development pathway. The focus on informing Phase 2 trial design, rather than overstating commercial timelines, reflects a grounded approach to value creation.
For investors, this is a moment to reassess NeuroScientific through the lens of platform validation rather than pipeline aspiration. As always, it remains a Definite #SamsoDYOR, but the clinical signal is now clearly on the table.
Market implications
NSB is currently valued at just under AUD$50M, and for a company that sits in the "biotech" sector, that is reasonably low. I have learnt that biotech companies that have a market capitalisation of less than AUD $100M to $150M is typically at a stage that is still carrying, what I call, developmental or concept risk. In some way, if I consider where the company is now, it is at a real-world testing stage, and if patients show positive reactions, then that is proof of concept. The share price chart also in some way is reflecting this stage (Figure 3).
Figure 3: The share price chart for NSB as of the 20th January 2026. (source: CommSec).
The ASX release in the blog may be a good start to understanding where NSB could become or is becoming with what appears to the untrained person a positive start to showing the market the validity of its narrative.
We all know that in the world of investing, there are no sure things, and in many cases, positive results can turn for the worse. However, for now, I do think that NSB is worthy of a place in my watchlist.
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