Unicycive(US:UNCY) Globenewswireยท2025-11-12 12:05Core Insights - Unicycive Therapeutics is advancing its lead investigational treatment, oxylanthanum carbonate (OLC), for patients with hyperphosphatemia and plans to resubmit the New Drug Application (NDA) by the end of 2025 following positive discussions with the FDA [2][8] - The company reported a net loss of $6.0 million for the quarter ended September 30, 2025, an increase from a net loss of $4.1 million in the same period of 2024, primarily due to increased labor and professional services costs [6][9] - Unicycive ended Q3 2025 with $42.7 million in cash, providing a runway into 2027, which positions the company well for regulatory approval and potential product launch [7][9] Financial Results - Research and Development (R&D) expenses for Q3 2025 were $3.0 million, a slight decrease from approximately $3.1 million in Q3 2024, attributed to reduced professional services and drug development costs [4] - General and Administrative (G&A) expenses increased to $4.4 million in Q3 2025 from $3.2 million in Q3 2024, mainly due to higher labor and consulting costs [5] - Other income decreased to $1.3 million in Q3 2025 from $2.2 million in Q3 2024, primarily due to changes in the fair value of warrant liability [6] Upcoming Milestones - The company is on track to resubmit the NDA for OLC by year-end 2025, with a potential new Prescription Drug User Fee Act (PDUFA) date in the first half of 2026 [8] - New data presented at the ASN Kidney Week 2025 indicates that OLC significantly reduces pill burden, with a 7-fold decrease in pill volume and a 2-fold reduction in pill count compared to existing phosphate binders [2][8]