Unicycive Therapeutics Announces Third Quarter 2024 Financial Results and Business Update

Unicycive Therapeutics, Inc., a clinical-stage biotechnology company focused on developing therapies for kidney diseases, unveiled its financial results for the quarter ending September 30, 2024. Alongside the financial update, the company shared significant advancements in its business operations.

Unicycive’s recent milestones include the acceptance of its New Drug Application (NDA) for oxylanthanum carbonate (OLC) by the U.S. Food and Drug Administration (FDA). This acceptance sets a Prescription Drug User Fee Act (PDUFA) Target Action Date for June 28, 2025, potentially paving the way for OLC’s approval as a treatment for hyperphosphatemia in chronic kidney disease patients on dialysis.

Dr. Shalabh Gupta, the Chief Executive Officer of Unicycive, expressed enthusiasm about the progress made by the company. He highlighted the significance of OLC’s potential approval in 2025, emphasizing its potential as a best-in-class option for patients facing challenges in adherence to current treatment regimens.

The company also reported successful outcomes from the Phase 1 trial of UNI-494, a candidate targeting acute kidney injury. The positive results from the trial are expected to propel the advancement of UNI-494 into Phase 2 clinical development, with plans to engage further with the FDA by the end of the year.

Among the financial highlights, Unicycive disclosed that Research and Development (R&D) expenses for the quarter were $3.0 million, showing a decrease compared to the same period in the previous year. General and Administrative (G&A) expenses amounted to $3.2 million, reflecting an increase primarily due to non-cash stock compensation expenses. Other Income stood at $2.2 million for the quarter, higher than the corresponding period last year.

As of September 30, 2024, the company reported cash and cash equivalents totaling $32.3 million, indicating a strong financial position to sustain operations well into 2026.

Unicycive has been diligent in its efforts, with key accomplishments including the grant of a patent for UNI-494 to treat acute kidney injury by the United States Patent and Trademark Office, and the addition of UNCY to the Russell Microcap® Index effective July 1, 2024.

The company’s commitment to innovation and progress in the field of kidney disease treatment is underscored by these latest developments, signaling a promising trajectory for Unicycive Therapeutics in the biotechnology landscape.

This news article is based on the Form 8-K filed with the Securities and Exchange Commission on November 13, 2024, by Unicycive Therapeutics, Inc.

For further updates and in-depth information, please refer to the official press release issued by Unicycive Therapeutics, Inc. on November 13, 2024.

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This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Unicycive Therapeutics’s 8K filing here.

About Unicycive Therapeutics

Unicycive Therapeutics, Inc, a biotechnology company, engages in developing novel therapies for kidney diseases in the United States. It is developing Renazorb for treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis; and UNI 494, which is in Phase 1 clinical trials for treatment of acute kidney injury.