Leadership Talks with NeuroScientific Biopharmaceuticals (ASX:NSB) CEO Nathan Smith

Описание: In this Leadership Talks session, we speak with Nathan Smith, CEO of NeuroScientific Biopharmaceuticals (ASX:NSB).

With extensive experience in GMP manufacturing and cell therapy business development, Nathan shares how NeuroScientific is positioning StemSmart — its innovative mesenchymal stem cell (MSC) platform — for global markets, starting in Australia with a special access program, then advancing into U.S. clinical development.

Nathan covers key aspects of NeuroScientific’s strategy:

✔ StemSmart Differentiation
Patented manufacturing process produces activated MSCs that deliver stronger potency, proven safety (200+ patients, 1,000+ doses with no adverse events), and demonstrated efficacy in Crohn’s — including 80% clinical response and 50% remission in early Phase II data.

✔ Targeting Fistulising Crohn’s First
Focus on patients with limited treatment options and severe quality-of-life impacts. Current special access program in Perth aims to treat up to 12 patients, generating real-world data to shape Phase II trial design.

✔ Expanding to Global Indications & Markets
Beyond Crohn’s, StemSmart is being scoped for graft-versus-host disease, lung and kidney transplantation, and other high-inflammation conditions. With Crohn’s alone representing a US$20–30B market, the total addressable opportunity for StemSmart could exceed US$50B+.

✔ Pathway to the U.S. & FDA Alignment
Leveraging recent FDA approval of MSC therapies as validation for the product class. Plans include a pre-IND FDA meeting in 2026, with Phase II patient dosing targeted by late 2026, positioning NSB for U.S. and global expansion.

✔ Financial Discipline & Manufacturing Readiness
Market cap ~$60M and cash position ~$7.5M underpin near-term execution. Current tech transfer to QGen in Brisbane will secure manufacturing supply chain, reduce cost per dose, and ensure scalability for clinical trials and eventual commercialisation.

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