Unicycive Therapeutics (UNCY) Corporate presentation summary

Strategic focus and pipeline

• Diversified portfolio targets kidney diseases, with lead asset OLC for hyperphosphatemia in CKD patients on dialysis.

• OLC is under FDA review with a PDUFA date of June 29, 2026, and is being developed under the 505(b)(2) pathway.

• UNI-494 is in development for acute kidney injury and chronic kidney disease.

• Strong global IP protection with patents extending potentially to 2035.

• Cash runway extends into 2027, supporting approval and launch activities.

Market opportunity and unmet need

• Hyperphosphatemia market exceeds $1B in the US, with over 550,000 dialysis patients and 80% receiving phosphate binders.

• 75% of patients fail to achieve target serum phosphorus levels despite six approved therapies.

• Excessive pill burden and poor palatability drive low adherence and unmet needs.

• Lower pill burden is the greatest unmet need as reported by nephrologists.

Product profile and clinical data

• OLC uses nanoparticle technology for high potency, low pill burden, and palatable formulation.

• Tablets are smaller, swallowed whole, and require fewer pills per day compared to competitors.

• Pivotal study showed no treatment-related serious adverse events and high tolerability.

• 91% of patients achieved phosphate control; 69% did so at ≤1500 mg/day.

• 79% of patients preferred OLC over prior therapy, citing ease of use and satisfaction.