Unicycive Therapeutics Reports $36.7 Million Net Loss for Fiscal Year 2024

Unicycive Therapeutics, Inc., a clinical-stage biotechnology company focused on developing therapies for kidney disease, reported a net loss of $36.7 million for the fiscal year ending December 31, 2024, compared to a net loss of $30.5 million in the previous year. The company's accumulated deficit reached $101.3 million as of December 31, 2024. The increase in losses was attributed to a 55% rise in research and development expenses, which totaled $20.0 million, primarily driven by higher drug development costs. General and administrative expenses also rose by 42% to $12.1 million, reflecting increased consulting and professional service costs.

In terms of revenue, Unicycive generated $675,000 in licensing revenue in 2023, but reported no licensing revenue in 2024. The decrease was due to the absence of upfront payments from licensing agreements, as the company had previously received $675,000 from a deal with Lotus International Pte Ltd. in February 2023. The company anticipates potential future licensing revenue as it continues to negotiate business development arrangements.

Strategically, Unicycive is advancing its two primary product candidates: Oxylanthanum Carbonate, a phosphate binder for treating hyperphosphatemia in chronic kidney disease patients, and UNI-494, a novel drug for acute kidney injury. The company has submitted a New Drug Application (NDA) for Oxylanthanum Carbonate, with a Prescription Drug User Fee Act (PDUFA) date set for June 28, 2025. Additionally, Unicycive has entered into exclusive licensing agreements with Lee’s Pharmaceutical and Lotus Pharmaceutical for the development and commercialization of Oxylanthanum Carbonate in various Asian markets, receiving upfront payments totaling $1.7 million.

Operationally, Unicycive's workforce has expanded, with 22 full-time employees as of March 28, 2025. The company has also increased its leased office space to accommodate growth. Financially, Unicycive has raised significant capital through private placements, including $130 million in gross proceeds from a securities purchase agreement in March 2023 and $50 million from a similar agreement in March 2024. The company also plans to utilize a sales agreement with Guggenheim Securities to offer up to $50 million in common stock.

Looking ahead, Unicycive's management expects to continue incurring losses as it advances its product candidates through clinical trials and regulatory processes. The company is actively seeking additional capital to support its operations and product development initiatives. The successful commercialization of Oxylanthanum Carbonate and UNI-494 will be critical for Unicycive's future financial performance, as the company has yet to generate product revenue.