Unicycive Announces Second Quarter 2024 Financial Results and Provides Business Update

Core Viewpoint - Unicycive Therapeutics is progressing towards submitting a New Drug Application (NDA) for its lead drug candidate, oxylanthanum carbonate (OLC), by the end of August 2024, following positive results from its pivotal trial [1][2]. Group 1: Clinical Development and Milestones - The pivotal trial for OLC demonstrated significant tolerability and safety, with a low discontinuation rate of 1.4% due to treatment-related adverse events [3]. - OLC achieved phosphate control in 90% of patients at the end of titration, indicating its effectiveness in managing hyperphosphatemia in chronic kidney disease patients on dialysis [2][3]. - A new patent for UNI-494 was granted, targeting acute kidney injury (AKI), with enrollment in the Phase 1 dose-ranging study completed [2][3]. - Initial results from a patient-reported outcome survey indicated that 79% of patients preferred OLC over their previous therapy, highlighting its user-friendliness and patient satisfaction [3]. Group 2: Financial Performance - Research and Development (R&D) expenses increased to $4.9 million for the quarter ended June 30, 2024, compared to $2.3 million for the same period in 2023, primarily due to higher drug development costs [5]. - General and Administrative (G&A) expenses rose to $2.5 million from $2.1 million year-over-year, attributed to increased non-cash stock compensation costs [6]. - The company reported a net income of $3.0 million for the quarter, a significant improvement from a net loss of $4.4 million in the same quarter of the previous year [7]. Group 3: Cash Position and Future Outlook - As of June 30, 2024, the company had cash and cash equivalents totaling $41.8 million, which is expected to fund operations into 2026 [8]. - Unicycive's inclusion in the Russell Microcap® Index effective July 1, 2024, enhances its visibility and access to capital markets [3].