Unicycive Therapeutics (UNCY) H.C. Wainwright 4th Annual Kidney Virtual Conference summary

Business overview and clinical focus

• Lead asset OLC targets hyperphosphatemia in chronic kidney disease patients on dialysis, with a second candidate, UNI-494, in phase I for acute and chronic kidney disease.

• Hyperphosphatemia leads to cardiovascular risks and bone complications due to high phosphate levels in late-stage kidney disease.

• Existing treatments require high pill burdens and have issues with pill size, taste, and adherence.

Regulatory update and path to approval

• FDA issued a Complete Response Letter (CRL) due to a third-party manufacturing vendor issue, not related to drug safety or efficacy.

• Two manufacturing vendors are prepared, with ongoing discussions with FDA to determine the fastest approval path.

• Management expects to provide an update in the coming weeks, aiming for clarity from the FDA before giving full guidance.

Commercialization and launch strategy

• Commercial launch is planned within weeks of approval, with current efforts focused on market readiness and physician awareness.

• Sales force hiring and infrastructure build-out are contingent on approval, with targeted outreach to a concentrated prescriber base.

• Awareness campaigns and publications are ongoing to educate physicians ahead of launch.