**Unicycive Therapeutics, Inc. Reports Financial Results and Operational Updates in Annual Filing**

Unicycive Therapeutics, Inc., a clinical-stage biotechnology company focused on kidney disease, reported a net loss of $26.6 million for the year ended December 31, 2025, compared to a net loss of $36.7 million for the previous year. Research and development expenses decreased by 54% to $9.1 million, primarily due to reduced drug development and clinical costs. General and administrative expenses increased by 69% to $20.4 million, driven by higher marketing expenses related to the potential commercial launch of oxylanthanum carbonate (OLC), as well as increased consulting and professional service costs.

The company's cash and cash equivalents totaled $29.2 million as of December 31, 2025, compared to $26.1 million in the prior year. Net cash used in operating activities was $31.3 million, while net cash provided by financing activities was $46.5 million, primarily from sales of common stock. The company also reported marketable securities valued at $12.1 million. As of March 30, 2026, Unicycive had 21 full-time and one part-time employee.

A key operational development was the resubmission of the New Drug Application (NDA) for OLC to the FDA in December 2025, with a Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026. The initial NDA submission received a Complete Response Letter (CRL) in June 2025 due to deficiencies at a third-party manufacturing vendor. The company held a Type A meeting with the FDA in October 2025 to discuss the resolution of the manufacturing deficiency.

Looking ahead, Unicycive intends to focus on the potential U.S. approval and commercial launch of OLC, while also evaluating additional opportunities in the renal therapeutic landscape. The company anticipates that its current cash will be sufficient to fund operations for more than 12 months from the date of the filing. However, the company expects to incur losses in the future and will be required to raise additional capital to complete clinical trials, pursue product development initiatives, and penetrate markets for the sale of its products.

About Unicycive Therapeutics, Inc.

Unicycive Therapeutics is a clinical-stage biotech focused on developing innovative kidney disease therapies. Its pipeline includes Oxylanthanum Carbonate, a phosphate binder for hyperphosphatemia, and UNI-494, a potential treatment for acute kidney injury and delayed graft function. The company licenses assets, advances clinical trials, and aims to improve patient adherence and outcomes in renal care markets globally.

This description was generated via AI from an annual report. Updated 8 months ago.

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