AUS
NZ
UK
CA
USA
IND
_06_02_2026_06_11_16_866149.png)
_07_03_2026_03_50_21_133108.jpg)
NeuroScientific Biopharmaceuticals Limited has published its Quarterly Activities Report, showcasing notable advancements in its Crohn's Disease clinical trials. The company revealed encouraging outcomes from patients treated with its StemSmart™ technology, potentially setting the stage for further trials and future market approval.
Key Points
- NeuroScientific Biopharmaceuticals Limited (NSB)
- 80% of patients treated with StemSmart™ for fistulising Crohn’s Disease achieved a clinical response.
- Cash and cash equivalents totaled $4.6 million as of June 30, 2026.
- Upcoming FDA pre-IND meeting and TGA audit of Q-Gen are crucial for advancing clinical trials.
StemSmart™ Demonstrates Clinical Response in Special Access Scheme Patients
In the recent reporting period, NeuroScientific Biopharmaceuticals announced successful clinical outcomes using its StemSmart™ technology in patients with fistulising Crohn’s disease. Five patients treated under the Therapeutic Goods Administration's (TGA) Special Access Scheme showed an 80% clinical response rate, with four patients experiencing at least a 50% reduction in fistula openings or discharge. This highlights StemSmart™’s potential as an effective treatment option for a condition with limited therapies.
Clinical efficacy was further supported by improvements in the Crohn’s Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI). All patients had at least one seton removed, indicating significant healing progress. Importantly, no serious adverse events were reported during treatment, reinforcing the safety profile of StemSmart™ and offering hope to patients with unmet medical needs.
Phase 2 Clinical Trials Planned Following Positive SAS Outcomes
Building on these promising results, NeuroScientific is preparing two Phase 2 clinical trial programs targeting Crohn's disease. The first will be an open-label, single-arm study in Australia focusing on fistulising Crohn’s disease, conducted under the TGA Clinical Trial Notification (CTN) pathway. Success in this trial could streamline the path to marketing authorisation in Australia and accelerate StemSmart™’s commercialisation.
The second trial will target refractory Crohn’s disease and will be a randomised, double-blinded, two-arm study across Australian and US sites. Developed under the US FDA Investigational New Drug (IND) program, this trial aims to attract global partnerships for Phase 3 development. Both trial designs will be informed by data from SAS patients, previous studies, and ongoing expert consultations.
Progress in Manufacturing Technology Transfer with Q-Gen
NeuroScientific is advancing the technology transfer of its StemSmart™ manufacturing process to Q-Gen Cell Therapeutics, a critical step to ensure regulatory compliance for clinical and commercial production. The company is currently in the validation phase, conducting engineering runs to demonstrate Q-Gen’s ability to produce StemSmart™ meeting potency and release criteria.
Q-Gen’s TGA-licensed facility and over 25 years of expertise provide a reliable and scalable supply chain. The transfer program is expected to complete in the second half of 2026, pending successful validation and TGA audit. This milestone is vital for NeuroScientific’s operational readiness and aligns with its strategic clinical trial and market entry objectives.
Financial Status Supports Clinical Development Initiatives
As of June 30, 2026, NeuroScientific reported $4.6 million in cash and cash equivalents, providing sufficient funding to support planned clinical development and manufacturing activities related to StemSmart™. This financial position is crucial as the company advances its Phase 2 trials and technology transfer efforts.
Investors may view this stability positively, reflecting NeuroScientific’s capacity to execute its operational strategy effectively. The company’s pursuit of additional partnerships and collaborations could further enhance its financial outlook.
Significance of Upcoming FDA Pre-IND Meeting and TGA Audit
Looking forward, NeuroScientific is preparing for a key FDA pre-IND meeting and a TGA audit of Q-Gen scheduled for the next quarter. These events are pivotal for progressing clinical programs. Feedback from the FDA pre-IND meeting will help refine the refractory Crohn's disease trial design to meet regulatory standards.
The TGA audit will evaluate Q-Gen’s readiness to manufacture StemSmart™ in compliance with Good Manufacturing Practice (GMP) standards. Successful outcomes could boost investor confidence and potentially expedite clinical trial initiation and market entry, making these developments critical to monitor.
Strategic Role of StemSmart™ in Crohn’s Disease Treatment
NeuroScientific’s StemSmart™ technology offers an innovative approach to treating immune-mediated inflammatory diseases, especially Crohn’s disease, which currently has limited effective treatments. The positive clinical responses observed in SAS patients highlight StemSmart™’s potential to fulfill a significant unmet medical need and become a key therapeutic option.
The company’s focus on advancing this technology aligns with biotechnology sector trends favoring novel solutions for chronic conditions. By progressing clinical trials and securing regulatory approvals, NeuroScientific aims to establish itself as a leader, potentially transforming treatment paradigms for Crohn’s disease patients.
