Episode Description
Welcome to the latest episode of On the Couch.
In this episode, Henry Jennings from Marcus Today sits down with Nathan Smith, CEO of Neuroscientific Biopharmaceuticals, to unpack how a differentiated mesenchymal stem cell therapy is progressing from acquisition to patient impact in refractory Crohn's disease.
With promising real-world data via special access programs, a clear regulatory path, and lean execution, the company is preparing for a focused Phase 2 push in 2026.
Topics covered in this episode:
- What the StemSmart MSC platform is – and why differentiation matters
- Special access program results in fistulising Crohn's
- Prior early-phase data and how it informs trial design
- Market size for refractory Crohn's and broader inflammatory targets
- Regulatory steps, including pre-IND and TGA interactions
- Manufacturing tech transfer with QGen and licensure plans
- 2026 milestones across CRO onboarding, trial initiation, and IP expansion
- Cash runway to trial start and approach to raising capital
- Competitive landscape and lessons from Mesoblast's US approval
- A CEO's take on what actually drives market value
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