Drug Development and Regulatory Approvals - The New Drug Application (NDA) for oxylanthanum carbonate (OLC) has been accepted by the FDA, with a PDUFA Target Action Date set for June 28, 2025[3] - UNI-494 successfully completed its Phase 1 clinical trial, with plans to request a meeting with the FDA by the end of 2024 to advance to Phase 2[5] - A patent for UNI-494 to treat acute kidney injury (AKI) has been granted, valid until 2040, securing protection for its method of use[6] Clinical Trial Outcomes - In a patient-reported outcome survey during the pivotal clinical trial for OLC, 79% of patients preferred OLC over their prior therapy, and 98% found OLC easy to take[4] - OLC demonstrated the ability to achieve serum phosphate control in over 90% of patients with chronic kidney disease on dialysis during the pivotal clinical trial[7] Financial Performance - Research and Development (R&D) expenses for Q3 2024 were 3.4 million in Q3 2023, primarily due to reduced drug development costs[10] - General and Administrative (G&A) expenses increased to 2.6 million in Q3 2023, mainly due to higher non-cash stock compensation expenses[11] - The net loss attributable to common stockholders for Q3 2024 was 4.4 million in Q3 2023[12] - As of September 30, 2024, cash and cash equivalents totaled $32.3 million, providing sufficient resources to fund operations into 2026[13] Market Position and Index Inclusion - Unicycive was added to the Russell Microcap Index effective July 1, 2024, which includes automatic inclusion in relevant growth and value style indexes[9]
Unicycive(UNCY) - 2024 Q3 - Quarterly Results