Unicycive Therapeutics Inc (NASDAQ: UNCY) is a clinical-stage biopharmaceutical company focused on developing treatments for kidney disease. The company has generated no product revenue as of the 10-K filed March 30, 2026, and has funded operations primarily through equity financing, including a private placement signed March 13, 2024, and an at-the-market sales agreement with Guggenheim Securities LLC dated November 13, 2024, which together provided net cash from financing activities of $45.1 million during the year ended December 31, 2024. Its lead product candidate, oxylanthanum carbonate (OLC), is a phosphate binder being developed for chronic kidney disease patients on dialysis, seeking FDA approval via the 505(b)(2) pathway referencing Fosrenol (lanthanum carbonate) as the Reference Listed Drug. The FDA issued a Complete Response Letter in June 2025 following the company's NDA submission in September 2024. The company carries an accumulated deficit and relies on external capital raises to fund ongoing development activities.

Revenue model

No product revenue as of the fiscal year ended December 31, 2024. Operations are funded through equity financing, including private placements and at-the-market common stock offerings.

Products and services

Oxylanthanum carbonate (OLC): an oral phosphate binder in development for chronic kidney disease patients on dialysis, pursuing FDA approval via the 505(b)(2) pathway. NDA submitted September 2024; FDA issued a Complete Response Letter in June 2025.

Customers and end markets

End market is chronic kidney disease patients on dialysis. No commercial customers as of the filing date.

Value-chain role

Drug developer reliant on third-party suppliers and contract manufacturers for clinical and commercial-stage production. No in-house manufacturing disclosed.

Geographic exposure

United States, based on FDA regulatory pathway and litigation filed in the Northern District of California. No international commercial operations disclosed.

Source: SEC 10-K, filed 2026-03-30

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