Unicycive Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update

Core Insights - Unicycive Therapeutics has requested a Type A meeting with the FDA to address the Complete Response Letter (CRL) regarding oxylanthanum carbonate (OLC) [1][9] - Recent pivotal study data published in the Clinical Journal of the American Society of Nephrology indicates that OLC was well tolerated and achieved serum phosphate control in over 90% of patients with a low pill burden [1][9] - The company ended Q2 2025 with $22.3 million in cash, providing a financial runway into the second half of 2026 [1][8] Business Update - The CEO of Unicycive highlighted progress in addressing deficiencies noted by the FDA related to a third-party manufacturing vendor, which was not linked to OLC [2] - The company remains committed to improving treatment options for managing hyperphosphatemia in dialysis patients, given the high rates of non-compliance with existing therapies [2] Financial Results - Research and Development (R&D) expenses for Q2 2025 were $1.8 million, a decrease from $4.9 million in Q2 2024, primarily due to reduced drug development costs [4] - General and Administrative (G&A) expenses increased to $5.2 million in Q2 2025 from $2.5 million in Q2 2024, mainly due to higher consulting and professional services for commercial launch preparation [5] - Other income for Q2 2025 was $0.5 million, a significant decrease from $17.3 million in Q2 2024, attributed to changes in the fair value of warrant liability [6] - The net loss attributable to common stockholders for Q2 2025 was $6.4 million, compared to a net income of $3.0 million in Q2 2024, primarily due to changes in warrant liability [7] Cash Position - As of June 30, 2025, Unicycive had cash and cash equivalents totaling $22.3 million, which is expected to fund operations into the second half of 2026 [8]