The Scientific Imperative: Correcting Decades of Flawed Therapy

For nearly half a century, diabetes treatment has addressed only half of a natural biological system. Conventional insulin formulations replace insulin but omit its essential co-secreted partner—the protein—leaving patients in a state of chronic metabolic imbalance. This omission contributes to the global burden of neuropathy, nephropathy, cardiovascular disease, and cognitive decline, a crisis exceeding $5 trillion annually in combined direct and indirect costs.

The science is unambiguous. Our research demonstrates that the protein binds to the insulin receptor with strong affinity while also uniquely activating GPR146, initiating protective anti-inflammatory, anti-fibrotic, and microvascular pathways that insulin alone cannot reach. This includes sustained nitric oxide production—critical for restoring endothelial function and reversing the microvascular decline at the heart of diabetic complications. When the protein is absent, patients enter a harmful state of hypercortisolemia that dysregulates more than 4,000 genes, affecting lipid metabolism, cellular stress responses, vitamin D activation, and long-term neurological resilience.

Furthermore, the protein’s natural half-life—approximately six times longer than insulin—provides a stabilizing, physiologic signal that insulin-only therapy cannot deliver. The result is a fundamentally more complete, balanced, and protective treatment model that aligns with human physiology rather than fighting against it.

The Financial and Regulatory Advantage

Our algorithm-driven pharmacokinetic modeling indicates that pairing insulin with the protein reduces required insulin mass by over 90%, creating substantial clinical, manufacturing, and economic advantages. This efficiency translates into transformative commercial potential:

A De-risked, High-Return Therapeutic Opportunity

  • We aim to create the first disease-modifying therapy for diabetes—one capable of preventing or delaying the onset of every major diabetic comorbidity.
  • The health-system impact is enormous: $15–30 billion in annual savings from reduced complications alone.
  • Capturing just 5–10% of the existing $30B insulin market represents a multi-billion-dollar revenue stream.

Regulatory Acceleration & Strong IP Protection

  • Our development program is tailored for the FDA’s streamlined 505(b)(2) pathway, leveraging decades of insulin safety data to reduce time, cost, and risk.
  • Our patent estate protects the synergistic formulation, optimized molar ratios, receptor-specific mechanisms, delivery methods, and sustained-release architecture.
  • This creates a durable, defensible market position with significant barriers to entry.

Global Access & Supply Chain Stability

  • Using less insulin alleviates immediate global supply pressure.
  • A lyophilized formulation eliminates cold-chain logistics, enabling global deployment—even in regions with limited infrastructure.
  • A complementary sustained-release format is in development, optimized for the protein’s longer half-life, as long-acting insulin analogs are incompatible with natural physiology.

A Second Major Market: Mammalian Cell Culture

Our parallel patent covering the addition of the protein to mammalian cell-culture media positions utR Biotech to disrupt a market projected at $24B by 2034. This innovation improves cell performance, antibody yields, and therapeutic cell quality—offering a major new revenue channel independent of the clinical diabetes program.

The Ask: Fueling Our Next Inflection Point

We are raising $20–22 million USD to complete IND-enabling studies, finalize product development, and execute the preclinical work necessary to reach our next valuation milestone. We are forming a six-investor syndicate to partner with us in bringing this essential therapy to market.

For inquiries, please contact: dpetch@utrbiotech.com