Unicycive Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update

LOS ALTOS, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2025, and provided a business update.

“This year is shaping up to be pivotal for Unicycive, underscored by the U.S. Food and Drug Administration’s acceptance of our New Drug Application resubmission for OLC and the potential for approval and launch later this year,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “With hyperphosphatemia still uncontrolled in nearly 75% of U.S. patients with chronic kidney disease undergoing dialysis, OLC, if approved, has the potential to offer a meaningful new treatment option characterized by a differentiated clinical profile and reduced pill burden compared to currently available phosphate binders.”

Key Highlights & Upcoming Milestones

Financial Results for the Year Ended December 31, 2025

Research and Development (R&D) expenses were $9.1 million for the year ended December 31, 2025, compared to $20.0 million for the same period in 2024. The decrease in research and development expenses was primarily due to a decrease in drug development as well as clinical trial costs.

General and Administrative (G&A) expenses were $20.4 million for the year ended December 31, 2025, compared to $12.1 million for the same period in 2024. The increase was primarily due to an increase in consulting, professional services, and commercial launch preparation costs.

Other income was $3.0 million for the year ended December 31, 2025 compared to Other expense of $4.6 million in the same period in 2024 due primarily to a decrease in the fair value of the Company’s warrant liability.

Net loss attributable to common stockholders for the year ended December 31, 2025 was $26.6 million, or $1.67 per share of common stock, compared to a net loss attributable to common stockholders of $37.8 million, or $5.65 per share of common stock for the same period in 2024. The decreased net loss for the year ended December 31, 2025, was attributable primarily to the decrease in drug development and clinical trial costs.

As of March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled $54.9 million. The Company believes that it has sufficient resources to fund planned operations into 2027.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contacts:

Kevin Gardner

LifeSci Advisors

kgardner@lifesciadvisors.com

Media Contact:

Layne Litsinger

Real Chemistry

llitsinger@realchemistry.com

SOURCE: Unicycive Therapeutics, Inc.