Neuroscientific to Acquire Leading Stem Cell Technology

NeuroScientific Biopharmaceuticals Ltd (ASX:NSB) to acquire StemSmart^TM patented Stem Cell technology (StemSmart), for the manufacture of life-changing cellular medicine, Mesenchymal Stromal Cells (MSC), from Isopogen WA Ltd (Isopogen WA).

About StemSmart Acquisition

• Early indications from the Phase 2 trial in refractory Crohn’s disease suggest StemSmart^TM MSC is potent, efficacious and safe (refer to Annexure 1 for a summary of the details and findings from the Phase 2 trial).
• StemSmart™ MSC is derived from adult human donor bone marrow. The MSCs are isolated and grown in culture, before the patented StemSmart™ manufacturing process is applied to improve the cells’ clinical efficacy.
• StemSmart™ MSC works by interacting with a patient’s immune system to modulate immune responses.
• MSCs respond to inflammation by secreting factors that reduce the activation and proliferation of immune cells and down-regulate their production of inflammatory mediators.
• Patients both locally and interstate have already received StemSmart™ MSC therapy on compassionate grounds, for a variety of serious and life-threatening clinical conditions, with multiple strong positive clinical responses.
• Special Access Program in fistulising Crohn’s disease to commence immediately following completion of the Acquisition (defined below).

The Growing Importance of Stem Cell Therapy

• Stem cell therapy is a cornerstone of modern medicine. Stem Cells have the unique ability to develop into different cell types in the body and are often hailed as the body’s master cells.
• Stem cell therapies are rapidly gaining global recognition as a transformative therapeutic modality.
• The US FDA recently approved the first mesenchymal stromal cell (MSC) therapy (Mesoblast ASX Announcement 19.12.2024 (ASX: MSB)). This decision paves the way for renewed enthusiasm and global investment in clinical research of MSC therapies.

StemSmart Key Addressable Markets

• Crohn’s Disease: Global market US$13.8 billion by 2026¹;
• Kidney Transplant: Global market for organ transplant immuno-suppressants, increasing to US$7.2 billion by 2030² (majority for renal);
• Lung Disorders: Global market US$33 billion by 2034³; and
• GvHD: Global market increasing to US$0.640 billion in 2026⁴.

StemSmart^TM and Crohn’s Disease

• The StemSmart^TM MSC patented technology’s immediate focus will be to undertake a Special Access Program (“Program”) in fistulising Crohn’s disease. There is a strong need for alternative and effective treatments for Crohn’s Disease, with fewer side effects.
• Fistulas are one of the most severe and debilitating complications associated with Crohn’s disease.
• Fistulising Crohn’s disease is challenging to treat, and sustained healing has proven limited with standard therapies. If successful, this Program is intended to progress to a Phase 1/2 clinical trial.
• Previously, a Phase 2 trial of 18 patients with refractory Crohn’s disease who received StemSmart^TM MSC therapy demonstrated promising results, with the majority of patients experiencing clinical improvement and many, clinical remission (refer to Annexure 1 for a summary of the details and findings from the Phase 2 trial).

Acquisition of StemSmart

• NSB proposing to acquire 100% of the issued capital of Isopogen WA, which holds or has the right to exploit the StemSmart^TM patented Stem Cell technology (StemSmart).
• Binding share sale agreements have already been signed with the Key Sellers of Isopogen WA (defined below), who collectively hold 51.4% of the issued capital of Isopogen WA.

Capital Raising and Proposed Appointments

• Firm commitments received to raise $3.5 million (before costs) at a share price of $0.035 each via a placement to professional, sophisticated and qualifying investors.
• Proposed appointments of Robert McKenzie and Paul Fry to the board of directors and Marian Sturm as Chief Scientific Adviser.
• Post completion cash on hand of approximately A$7.5million.

NeuroScientific founding Director, Dr Anton Uvarov said,“We’re incredibly excited to add mesenchymal stem cell technology to our growing portfolio. This acquisition not only complements our existing pipeline of therapeutic peptides, but also strategically positions us at the forefront of next-generation biologics. Stem cell therapies are rapidly gaining global recognition as a transformative therapeutic modality, especially with recent FDA approvals highlighting their clinical potential. We see this as a powerful opportunity to expand our impact in regenerative medicine and deliver innovative solutions to patients across a range of conditions.”

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