Unicycive(UNCY) - 2025 Q4 - Annual Report

Financial Performance - The company reported a net loss of $36.7 million for the year ended December 31, 2024, which decreased to $26.6 million for the year ended December 31, 2025, representing a reduction of 28%[402] - For the year ended December 31, 2025, the company reported a net loss of $26.6 million, with an accumulated deficit of $127.8 million as of the same date[411] - The company has an accumulated deficit of $127.8 million as of December 31, 2025[391] Expenses - Research and development expenses decreased by approximately $10.9 million, or 54%, from $20.0 million in 2024 to $9.1 million in 2025, primarily due to reduced drug development costs[403] - General and administrative expenses increased by $8.3 million, or 69%, from $12.1 million in 2024 to $20.4 million in 2025, driven by higher marketing and consulting costs[404] - Net cash used in operating activities was $31.3 million for the year ended December 31, 2025, primarily due to development costs and corporate expenditures[418] - The company incurred net cash used in investing activities of $12.1 million for the year ended December 31, 2025, mainly due to the purchase of marketable securities[421] Financing Activities - The company sold 3,123,537 shares of common stock at an average price of $6.51 per share, resulting in net proceeds of approximately $19.6 million[395] - The company entered into a sales agreement to offer and sell shares of common stock with an aggregate offering price of up to $100 million, resulting in net proceeds of approximately $45.2 million for the year ended December 31, 2025[410] - Net cash provided by financing activities was $46.5 million during the year ended December 31, 2025, primarily from sales under the sales agreement with Guggenheim Securities LLC[422] Future Plans and Expectations - The company plans to resubmit its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to the FDA, with a target action date set for June 29, 2026[395] - The company expects significant increases in operating expenses as it advances product candidates through clinical development and seeks regulatory approval[391] - The company anticipates future revenue streams from collaboration or licensing agreements, as well as product sales[408] - The company plans to continue its drug discovery efforts and clinical trials, which will significantly influence future capital requirements[414] - The company expects to continue incurring losses and will need to raise additional capital for clinical trials and product development initiatives[413] - The company anticipates that its current cash will be sufficient to fund operations for more than 12 months from the date of the report[412] Market Context - The healthcare costs associated with acute kidney injury (AKI) exceed $9 billion annually in the U.S., highlighting a significant unmet medical need[389] - The company aims to leverage its management team's expertise and network to identify and develop new product candidates beyond kidney disease[386] Accounting Policies - The company accounts for stock-based compensation using the Black-Scholes option-pricing model, recognizing expenses over the requisite service period[429] Off-Balance Sheet Arrangements - The company has no off-balance sheet arrangements as of December 31, 2025[424]