Unicycive Therapeutics (UNCY) H.C. Wainwright 28th Annual Global Investment Conference summary

Regulatory and approval status

• Pursuing a 505(b)(2) pathway with composition of matter exclusivity until 2031.

• FDA issued two CRLs due to third-party manufacturing deficiencies, not product efficacy or safety.

• Only remaining approval hurdle is a pending FDA inspection of a fill-finish vendor; no outstanding product or label issues.

• A second compliant manufacturing vendor is ready as a backup, with all necessary stability and compliance data prepared.

• Vendor inspection is the sole gating item, and the company is actively engaging with FDA and officials to expedite the process.

Product profile and clinical highlights

• Oxylanthanum Carbonate targets phosphate lowering in dialysis patients, addressing high pill burden and poor adherence.

• Clinical trials showed 69% of patients achieved target phosphate levels with three pills daily.

• Product offers improved palatability and potency compared to existing options, avoiding metallic taste and chewing issues.

• Designed to create a paradigm shift in phosphate management for dialysis patients.

Manufacturing and supply chain

• Primary drug substance vendor is compliant and inspected; deficiency is with a subcontractor supplying commercial grade product.

• Second fill-finish vendor is also compliant and ready to be activated if needed, with a switch possible within days.

• Plans include using two vendors post-approval to ensure supply redundancy and national launch readiness.