Unicycive Therapeutics (UNCY) Investor presentation summary

Clinical trial results and safety profile

• Achieved study objective by demonstrating tolerability and safety of OLC in CKD patients on hemodialysis.

• Treatment-related discontinuation rate was 1.4% in the evaluable population, with total discontinuations due to adverse events at 6%, lower than the 14% rate for Fosrenol.

• Most common treatment-related adverse events were diarrhea (9%) and vomiting (6%), with no treatment-related serious adverse events.

• OLC safety profile compares favorably to Fosrenol and other phosphate binders.

• 90% of OLC-treated patients achieved effective serum phosphate control at the end of titration; 69% controlled at ≤1,500 mg/day.

Product profile and advantages

• OLC is being developed under the FDA's 505(b)(2) pathway for hyperphosphatemia treatment.

• Expected to share a similar label to Fosrenol but offers smaller, swallowable tablets and fewer pills.

• Utilizes proprietary nanoparticle technology to enhance potency and reduce pill burden.

• Immediate release tablets are swallowed whole, improving palatability.

• Strong global intellectual property protection is in place.

Clinical trial design and patient demographics

• Open-label, non-comparator pivotal trial design agreed with FDA; primary endpoint was tolerability based on adverse event-related discontinuations.

• Safety population included 86 patients; 71 were evaluable for the primary endpoint.

• Majority of patients previously used Renvela, Phoslo, Auryxia, or Velphoro as phosphate binders.

• Mean patient age was 62.4 years; 45% female and 55% male.