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Unicycive Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update
Globenewswire· 2026-03-30 11:05
Core Insights - Unicycive Therapeutics is undergoing a pivotal year with the FDA's acceptance of the New Drug Application (NDA) resubmission for oxylanthanum carbonate (OLC), targeting a potential approval and launch by June 29, 2026 [2][9] Financial Performance - Research and Development (R&D) expenses decreased to $9.1 million for the year ended December 31, 2025, down from $20.0 million in 2024, primarily due to reduced drug development and clinical trial costs [4] - General and Administrative (G&A) expenses increased to $20.4 million for the year ended December 31, 2025, compared to $12.1 million in 2024, mainly due to higher consulting and commercial launch preparation costs [5] - The net loss attributable to common stockholders for the year ended December 31, 2025, was $26.6 million, or $1.67 per share, a decrease from a net loss of $37.8 million, or $5.65 per share, in 2024, attributed to lower drug development and clinical trial costs [6] Cash Position - As of March 30, 2026, the company reported unaudited cash, cash equivalents, and marketable securities totaling $54.9 million, which is expected to fund operations into 2027 [7][8] Product Development and Market Readiness - OLC is an investigational oral phosphate binder aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis, with the NDA supported by data from three clinical studies and no concerns raised by the FDA regarding the data [9] - The company is actively preparing for a potential commercial launch of OLC in the third quarter of 2026 by strengthening its commercial infrastructure and advancing market readiness initiatives [8][9]