Unicycive Therapeutics (UNCY) Company presentation summary

Corporate overview and pipeline

• Diversified portfolio focused on kidney disease, with lead asset OLC for hyperphosphatemia in CKD patients on dialysis and UNI-494 in development for acute kidney injury and CKD.

• Strong global intellectual property protection with patents extending potentially to 2035.

• Seasoned management team with a track record in developing and commercializing kidney drugs.

• Cash runway extends into 2027, supported by $57.1 million in cash and $102 million in potential warrant funding.

OLC clinical and regulatory progress

• OLC NDA resubmission accepted by FDA with a PDUFA date of June 29, 2026, following resolution of manufacturing deficiencies.

• Pivotal study showed 69% of evaluable patients achieved target serum phosphate levels (≤5.5 mg/dL) at ≤1500 mg/day.

• OLC demonstrated a favorable safety and tolerability profile, with low rates of treatment-related adverse events and discontinuations.

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

Market opportunity and unmet need

• Hyperphosphatemia market exceeds $1 billion 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, mainly due to high pill burden and poor adherence.

• OLC's nanoparticle technology enables smaller, fewer pills that are swallowed whole, addressing the greatest unmet need in the market.