NeuroScientific Biopharmaceuticals (ASX: NSB) – A Breakthrough in Stem Cell Technology Aimed at Refractory Crohn’s and Beyond.
- Noel Ong
- Jul 23
- 8 min read
Updated: Jul 23
Announcement
NeuroScientific Biopharmaceuticals Ltd (ASX: NSB) has taken a major strategic step by acquiring StemSmart™, a globally patented and clinically validated stem cell platform. This acquisition adds a powerful, next-generation therapeutic capability to the company’s focus on neuroimmune and inflammatory diseases.
The news marks a turning point for NSB, expanding its pipeline into the high-need space of refractory Crohn’s disease while positioning the company for broader clinical and commercial relevance in cell-based regenerative medicine.
The recent completion of the acquisition of Isopogen WA —secured through an ASX announcement dated 27 June 2025—brings the high-potential StemSmart™ Mesenchymal Stromal Cell (MSC) technology fully into NSB’s hands. What makes this so compelling is the technology’s early clinical success, regulatory foundation, and scalability, especially at a time when the FDA has only recently approved its first MSC therapy, reigniting global enthusiasm in this field.
What are Mesenchymal Stem Cells (MSC)?
MSC are adult stem cells traditionally harvested from bone marrow. MSC can also be
isolated from other tissues.
Figure 1: Mesenchymal Stem Cells (MSC) (source: NSB)
Key Highlights – Breakthrough Stem Cell Tech Acquired
StemSmart™ is a patented MSC manufacturing platform designed to enhance safety and efficacy via proprietary cell media and GMP protocols.
The platform has shown clinical efficacy in Phase 2 trials for biologic-refractory Crohn’s disease and compassionate use programs for steroid-refractory GvHD.
NSB’s Special Access Program (SAS Program) for fistulising Crohn’s disease has now commenced, with results expected to inform progression into formal trials.
MSC therapy under the StemSmart™ platform works best in highly inflammatory environments, ideal for refractory immune diseases where standard treatments have failed.
The addressable market across Crohn’s, transplant rejection, and lung disease is estimated to exceed US$60 billion over the next decade.
NSB holds ~$7.5M in cash, with a market cap of $26.5M (as at 27 June 2025), providing a strong base for near-term execution.
How does Stem Cell technology work?
Stem cells are often called the “body's building blocks”, as they can potentially develop into any tissue or organ.
Mesenchymal stem cells interact with the immune system, adjusting immune responses and reducing inflammation in target tissue, contributing to disease control and tissue repair.
Crohn’s Disease – A Strategic First Focus
NSB is prioritising the treatment of fistulising Crohn’s disease, an aggressive and painful form affecting up to 30% of Crohn’s patients. These individuals are often left with no options other than surgery after failing antibiotics, steroids, and biologics.
What is Crohn’s Disease?
⚬ Life-long chronic inflammation of the gut
⚬ Incurable affecting more than 1 million in the USA alone
⚬ Has a chronic relapsing and remitting course, sometimes life-threatening
⚬ Considered an autoimmune disorder, affecting all age groups, with incidence peaking in early adulthood
⚬ Commonly results in perianal Fistulas
Refractory Crohn’s (life-threatening)
⚬ Unresponsive to conventional therapies (Antibiotics/Steroids/Biologics)
⚬ Surgery only option
⚬ ~30% patients become refractory– don’t respond to therapies
Fistulas
⚬ Sores/ulcers, creating abnormal passageway from intestine to another organ or to
⚬ outside surface of the body
⚬ About 30% of Crohn’s patients will develop fistulas
⚬ Unresolved chronic inflammation
The StemSmart™ Special Access Program, launched in June 2025, is treating fewer than 12 patients with weekly MSC infusions for four weeks, with evaluation at 8–10 weeks. The primary benchmark: a >50% closure of fistula openings or discharge reduction in at least four patients. If achieved, these results will trigger performance milestones and likely fast-track formal trials, potentially under Australia’s Priority Review Pathway.
Previous clinical work using this platform already shows promise—a 78% clinical response rate in a Phase 2 Crohn’s trial and consistent safety across both adult and paediatric patients in GvHD studies.
StemSmart™ – The Technology Behind the Momentum
What differentiates StemSmart™ is its manufacturing process. The platform uses patented proprietary media to prime MSCs for enhanced anti-inflammatory responses, allowing them to:
Reduce inflammation
Regenerate damaged tissue
Moderate immune cell activation
Fight apoptosis and fibrosis
Secrete bioactive factors that promote healing
The technology is GMP-compliant, with an existing TGA product license, providing a clear regulatory path for broader clinical deployment in Australia and beyond.
The consistency of product manufacturing and the ability to reproduce outcomes across trials and patient groups is a critical asset rarely found at this stage in biotech development.
Beyond Crohn’s – Addressing Global Immune and Inflammatory Diseases
While NSB’s initial target is Crohn’s, the scope for StemSmart™ is far greater. Clinical work and preclinical studies already indicate efficacy across:
Graft-versus-host disease (GvHD) – with survival rates in steroid-refractory patients more than doubling.
Kidney transplant rejection – reducing dependency on long-term immunosuppressants.
Lung disorders – including COPD (Chronic Obstructive Pulmonary Disease), interstitial lung disease, and transplant-related rejection.
This strategy taps into Key Addressable Markets:
Crohn’s Disease – US$13.8B by 2026
GvHD – US$5.31B by 2032
Lung Disorders – US$33B by 2034
Kidney Transplant– US$7.2B by 2030
By adopting a multi-indication, multi-market strategy, NSB is creating a diversified clinical and commercial pipeline that adds depth to the platform and de-risks the company’s future trajectory.
Chairman, Robert McKenzie, commented:
“I’m pleased that NSB’s acquisition of Isopogen will allow our StemSmartTM technology to be progressed for the benefit of vulnerable patients with limited treatment options.
Our immediate focus will be on a special access clinical program in fistulising Crohn’s disease, which is challenging to treat and where sustained healing has proven limited with standard therapies. Longer term our desire is to further clinical activities to progress the technology to achieve regulatory approval.
Samso Concluding Comments
NeuroScientific Biopharmaceuticals (ASX: NSB) has made a decisive and potentially transformational move with the acquisition of the StemSmart™ platform. A clinically validated platform that is not just another licensing deal or an early-stage idea makes a world of difference for investors' thinking.
The StemSmart™ platform is also GMP-licensed, and globally patented stem cell technology that’s already been tested in real-world settings with high-need patient groups. In the world of biotech, this is a significant step. For a company with a market capitalisation of just $53.2 million (as of 11th July 2025), this kind of therapeutic leverage is rare.
Figure 2: The NSB share price chart as of 11th July 2025. (source: commsec).
The market is obviously very happy with progress, as shown in Figure 2. The market acceptance is critical in the company's movement forward, as they say no money, no honey.
Focus on Crohn's Disease.
The strategic focus on fistulising Crohn’s disease is both technically sound and commercially smart. This is an area where conventional therapies often fail, and the only option left for many patients is invasive surgery. By targeting an urgent unmet need, NSB is creating a near-term pathway to impact, not only for patients but also for investors watching the biotech sector for genuine catalysts.
What stands out with StemSmart™ is the platform itself. Unlike many cell therapies that stall in translation, this one has already shown reproducibility, safety, and efficacy across multiple studies and disease types—from Crohn’s and GvHD to transplant rejection and COPD. It’s this multi-disease potential, backed by IP and regulatory foundation, that puts NSB in a different category.
Samso's Take on Market Value - An Investor's Need for Positioning in NSB.
I don't want to come across as someone who is pretending to understand all these big words, but as an investor, I can see that there is merit in doing some serious DYOR. A company that has a market cap of just below AUD $54M with a potential for greater confirmation of its business is still cheap. Companies that have discoveries, such as what NSB is trying to validate, are measured in market valuations at significantly higher numbers.
In summary, the broader narrative here is about timing and credibility. With recent global momentum behind MSC therapy—particularly the FDA’s approval of Mesoblast’s product—there is renewed investor interest in cell-based platforms. NSB’s move couldn’t be more timely.
What matters now is execution: delivering results from the Special Access Program, launching formal trials, and building a broader clinical strategy. These will define how the market responds. For those tracking the next wave of Australian biotech innovation, this is one story worth following closely.
The Samso Way – Seek the Research
The acquisition of StemSmart™ by NeuroScientific Biopharmaceuticals (ASX: NSB) exemplifies the kind of grounded innovation Samso looks for—technology backed by human data, regulatory readiness, and intellectual property protection. This is not blue-sky science but a platform with demonstrated clinical efficacy in Crohn’s disease and GvHD, now being deployed in a focused, milestone-driven strategy.
With global regulatory momentum behind MSC therapies and NSB advancing a Special Access Program for fistulising Crohn’s, the fundamentals are aligned for both scientific impact and investor value. This is the type of story that rewards those who genuinely seek the research.
Our mission is simple: cut through the noise and spotlight what matters—genuine stories, grounded insights, and real opportunity.
Our content is well-researched and is only created if the team sees a merit in discussing the company or concept. Investors can explore our three core platforms:
There may be numerous paths to success in investing, but the common thread among successful individuals is that they remain committed to making informed decisions. Equip yourself with the right knowledge and tools, and you will be well on your way to achieving your financial goals.
Most importantly, investors need to be absolutely diligent in understanding their own risk-reward tolerance and capabilities. Never bite off more than you can chew. As they say, Rome wasn’t built in a day, and the Great Wall stood because it took centuries to complete.
The Samso Philosophy:
Stay curious. Stay sharp. And remember—digging deeper always uncovers the real value.
In Life, there is no such thing as a Free Lunch.
Happy Investing, and the only four-letter word you need to know is DYOR.
To support our independent nature of our work, please head over to our Support Page and give us a helping hand in any of the ways listed. This is a new initiate for the Samso Platform, and it was always the concept of Samso when we started this journey in 2018.
Disclaimer
The information or opinions provided herein do not constitute investment advice, an offer or solicitation to subscribe for, purchase or sell the investment product(s) mentioned herein. It does not take into consideration, nor have any regard to your specific investment objectives, financial situation, risk profile, tax position and particular, or unique needs and constraints.
Share to Grow: Your Bonus
Samso has just released an eBook: How to Add Value to your Share Portfolio
A lesson on geological models sought by mining companies that gives insight and an understanding of which portfolios are better - and potentially more lucrative – investments. Click here to download this eBook.
If you find this article informative and useful, please help me share the information. I try and write about topics that are interesting and have the potential to be of investment value. It is not easy to find stories that fit those parameters. If you or your organisation see the benefit of what Samso is trying to achieve and have a need to share your journey, please contact me at noel.ong@samso.com.au.
Samso is a trusted platform that equips dedicated investors with up-to-date industry knowledge and insights from top CEOs and thought leaders. By staying informed on business advancements and market trends, investors can enhance their financial decisions through a combination of expert guidance and their own research.
Comments