Unicycive(UNCY) - 2024 Q4 - Annual Report

Financial Performance - The company reported a net loss of $36.7 million for the year ended December 31, 2024, an increase of 20$30.5 million in 2023[383]. - The company has an accumulated deficit of $101.3 million as of December 31, 2024[383]. - The company incurred a net loss of$36.7 million for the year ended December 31, 2024, with an accumulated deficit of $101.3 million as of the same date[409]. - The company expects to continue incurring losses and will require additional capital for clinical trials and product development[410]. - Cash used in operating activities for the year ended December 31, 2023, was$18.3 million, with a net loss of $30.5 million[417]. Expenses - Research and development expenses rose by approximately$7.1 million, or 55%, from $12.9 million in 2023 to$20.0 million in 2024, primarily due to increased drug development costs[399]. - General and administrative expenses increased by approximately $3.5 million, or 42$8.5 million in 2023 to $12.1 million in 2024, driven by higher consulting and professional services costs[400]. - Net cash used in operating activities was$28.6 million for the year ended December 31, 2024, primarily due to development costs and corporate expenditures[416]. Revenue - The company generated approximately $1.6 million in licensing revenue to date, with a significant decrease of$0.7 million, or 100%, in licensing revenues for the year ended December 31, 2024[398][405]. Capital and Financing - The company raised approximately $50 million through a private placement of Series B Convertible Preferred Stock and an additional$50 million through a sales agreement for common stock[408]. - Net cash provided by financing activities was $45.1 million for the year ended December 31, 2024, primarily from the private placement and public offering[419]. - The company anticipates needing to raise substantial additional capital, which may lead to dilution for existing shareholders[411]. Clinical Development - The company completed a Phase I clinical study in healthy volunteers with UNI-494 in 2024, targeting acute kidney injury[379]. - The company expects operating expenses to increase significantly as it advances product candidates through clinical development and seeks regulatory approval[383]. - The company plans to use proceeds from a securities purchase agreement, which may provide up to$130.0 million, to support the NDA submission for Oxylanthanum Carbonate and its commercial launch in the U.S.[406]. - Oxylanthanum Carbonate is being developed as a next-generation phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis[379]. Compliance and Notices - The company received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement, with a compliance period extended until July 7, 2025[387][388]. Investing Activities - Net cash used in investing activities was $72,000 for the year ended December 31, 2024, due to office furniture purchases[418]. - The company received advances of$210,000 from a stockholder in February 2023, which were fully repaid in March 2023[414].