Core Insights - Unicycive Therapeutics has received FDA acceptance for its New Drug Application (NDA) for oxylanthanum carbonate (OLC), targeting a potential approval date of June 28, 2025, aimed at treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis [1][3] - The company is preparing for the commercial launch of OLC in the second half of 2025, emphasizing its high potency and low pill burden as a best-in-class option for patients [2][3] - Unicycive has successfully completed the Phase 1 trial for its second asset, UNI-494, which targets acute kidney injury (AKI), and plans to advance to Phase 2 clinical development [2][3] Drug Development Progress - The NDA for OLC has been accepted by the FDA, with a PDUFA target action date set for June 28, 2025 [1][3] - Patient-reported outcomes from the pivotal clinical trial indicate that 79% of patients preferred OLC over previous therapies, with 98% finding it easy to take [3] - The Phase 1 trial for UNI-494 was completed successfully, showing good tolerability and rapid metabolism, which will inform the dosing for potential Phase 2 trials [3][4] 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 [5] - General and Administrative (G&A) expenses increased to 2.6 million in Q3 2023, mainly due to higher non-cash stock compensation [6] - The net loss attributable to common stockholders for Q3 2024 was 4.4 million in Q3 2023 [7] Cash Position - As of September 30, 2024, the company reported cash and cash equivalents of $32.3 million, which is expected to fund operations into 2026 [8][13] Market Position - Unicycive Therapeutics has been added to the Russell Microcap® Index effective July 1, 2024, which enhances its visibility and market presence [4]
Unicycive Announces Third Quarter 2024 Financial Results and Provides Business Update