Unicycive receives U.S. patent for chronic kidney disease treatment

LOS ALTOS, Calif. - Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a biotechnology company with a market capitalization of $83 million and strong liquidity position, announced Monday it has been granted U.S. Patent 12,377,082 for its investigational drug UNI-494 to treat Chronic Kidney Disease (CKD). According to InvestingPro data, the company maintains more cash than debt on its balance sheet, though it is currently burning through cash reserves.

This is the second patent issued for UNI-494, following an earlier method of use patent for the treatment of Acute Kidney Injury. The company has already completed a Phase 1 clinical study in healthy volunteers for the drug. With a current ratio of 2.18, InvestingPro analysis shows the company’s liquid assets exceed its short-term obligations, providing financial flexibility for continued development.

UNI-494 is a nicotinamide ester derivative that functions as a selective ATP-sensitive mitochondrial potassium channel activator. The compound works by restoring mitochondrial function, which plays a critical role in kidney disease progression.

The U.S. Food and Drug Administration has previously granted UNI-494 Orphan Drug Designation for the prevention of Delayed Graft Function in kidney transplant patients.

"While we are focused on seeking FDA approval of our lead product oxylanthanum carbonate, we are pleased to announce the issuance of another patent for our second investigational drug, UNI-494," said Shalabh Gupta, Chief Executive Officer of Unicycive. The company’s stock has shown significant momentum, posting a 17% gain over the past week and a remarkable 52% return over the last year, according to InvestingPro data.

Gupta noted that this patent is part of a broader intellectual property portfolio for UNI-494, which supports potential partnership opportunities and future development efforts.

Unicycive is a biotechnology company developing treatments for kidney diseases. Its lead investigational drug, oxylanthanum carbonate, is being developed for hyperphosphatemia in chronic kidney disease patients on dialysis.

The information in this article is based on a company press release.

In other recent news, Unicycive Therapeutics, Inc. announced that it has regained compliance with Nasdaq’s minimum share price requirement following a 1-for-10 reverse stock split. This action resolved a previous non-compliance issue with Nasdaq Rule 5550(a)(2), which mandates a minimum bid price for listed companies. In another development, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Unicycive’s New Drug Application for Oxylanthanum Carbonate (OLC), a treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis. The CRL highlighted deficiencies at a third-party manufacturing vendor, though it did not raise concerns about the pre-clinical, clinical, or safety data. Unicycive plans to seek a Type A meeting with the FDA to address these issues. These recent developments could be significant for investors monitoring Unicycive’s regulatory progress and market positioning.

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