Unicycive(US:UNCY)2025-11-12 11:39Financial Performance - For the nine months ended September 30, 2025, the company reported a net loss of $11.9 million, compared to a net loss of $15.2 million for the same period in 2024, indicating a reduction in losses [175]. - As of September 30, 2025, the company had an accumulated deficit of $113.2 million [175]. - Net loss for the nine months ended September 30, 2025, was $11.9 million, a decrease of $3.3 million, or 22%, compared to a net loss of $15.2 million in the same period of 2024 [200]. - The company expects to incur substantial additional losses in future periods and will require additional capital to complete clinical trials and product development initiatives [201]. Expenses - Research and development expenses decreased by approximately $81,000, or 3%, from $3.1 million in Q3 2024 to $3.0 million in Q3 2025 [188]. - General and administrative expenses increased by $1.2 million, or 37%, from approximately $3.2 million in Q3 2024 to approximately $4.4 million in Q3 2025 [189]. - Total operating expenses rose by $1.1 million, or 17%, from $6.3 million in Q3 2024 to $7.3 million in Q3 2025 [187]. - Research and development expenses decreased by approximately $7.9 million, or 53%, from $14.7 million in the nine months ended September 30, 2024, to $6.9 million in the same period of 2025 [192]. - General and administrative expenses increased by $7.3 million, or 90%, from $8.1 million in the nine months ended September 30, 2024, to $15.4 million in the same period of 2025 [193]. Cash Flow - Net cash used in operating activities was $23.3 million for the nine months ended September 30, 2025, compared to $22.0 million for the same period in 2024 [206][207]. - Net cash provided by financing activities was $39.9 million during the nine months ended September 30, 2025, compared to $44.7 million in the same period of 2024 [209]. Stock and Financing - The company sold 8,046,736 shares of common stock at an average price of $4.94 per share, resulting in net proceeds of approximately $38.6 million [179]. - The company sold 8,046,736 shares of common stock at an average price of $4.94 per share, resulting in net proceeds of approximately $38.6 million during the nine months ended September 30, 2025 [199]. - Future revenue streams may consist of collaboration or licensing revenue as well as product sales, with potential gross proceeds of up to $130.0 million from a securities purchase agreement [197]. Product Development - The company plans to resubmit the New Drug Application (NDA) for Oxylanthanum Carbonate by year-end 2025 following a Type A meeting with the FDA [180]. - The company is focused on developing Oxylanthanum Carbonate for hyperphosphatemia in chronic kidney disease patients and UNI-494 for acute kidney injury, addressing significant unmet medical needs [171][173]. - The healthcare costs associated with acute kidney injury exceed $9 billion annually in the U.S., highlighting the market potential for UNI-494 if approved [173]. - The company expects significant increases in operating expenses as it advances its product candidates through clinical development and regulatory approval [175]. Compliance and Reporting - The company is utilizing extended transition periods under the JOBS Act for compliance with new accounting standards, which may affect comparability with other public companies [217]. - As an "emerging growth company," the company plans to rely on certain exemptions, including not providing an auditor's attestation report on internal controls until certain revenue thresholds are met, specifically $1.235 billion [218]. - The company has no off-balance sheet arrangements during the reported periods [221]. - As a smaller reporting company, the company is not required to disclose quantitative and qualitative information about market risk [222]. Other Income - Other income increased by $2.8 million, or 36%, from a $7.7 million expense in the nine months ended September 30, 2024, to a $10.4 million income in the same period of 2025 [194].