LOS ALTOS, Calif. - Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a biotechnology firm focused on kidney disease treatments, announced today the issuance of a new U.S. patent for its compound, UNI-494. Granted by the United States Patent and Trademark Office (USPTO), Patent No. 12,036,211 covers a method of treating acute kidney injury or contrast-induced nephropathy and is valid until 2040.
The patent encompasses the use of UNI-494, which is not restricted to a specific salt, dosage, or administration type. UNI-494 is described as a novel nicotinamide ester derivative that selectively activates ATP-sensitive mitochondrial potassium channels. Mitochondrial dysfunction is a known factor in the progression of both acute kidney injury and chronic kidney disease.
UNI-494 is currently undergoing a Phase 1 clinical trial in the United Kingdom, focusing on dose-ranging safety in healthy volunteers. The trial is expected to be completed in the second half of 2024. Additionally, UNI-494 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the prevention of Delayed Graft Function in kidney transplant patients, a form of acute kidney injury.
Acute kidney injury is characterized by a rapid decline in kidney function, with common causes including sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a specific type of acute kidney injury that occurs shortly after kidney transplantation. Statistics indicate that AKI can occur in a significant portion of patients in various healthcare settings, with severe implications for morbidity and mortality.
Dr. Shalabh Gupta, CEO of Unicycive, expressed satisfaction with the patent award, citing it as a crucial element in the company's strategy to lead in the development of kidney disease drugs. The patent is part of Unicycive's broader portfolio aimed at addressing kidney diseases with novel treatments.
The information for this report is based on a press release statement from Unicycive Therapeutics, Inc.
InvestingPro Insights
As Unicycive Therapeutics, Inc. (NASDAQ: UNCY) advances its clinical trials and expands its patent portfolio, investors are closely monitoring the financial health and market performance of the company. Here are some key metrics and insights from InvestingPro that may be of interest:
With a market capitalization of just $16.92 million, Unicycive is a relatively small player in the biotech space. This size can often lead to heightened volatility, as the stock price can be more easily swayed by market sentiment and individual investor actions. Indeed, Unicycive's stock has experienced significant price fluctuations, with a 24.75% price of its 52-week high and a notable -63.41% one-year total return as of the latest data.
The financials reveal challenges as well, with the company's latest twelve months showing an operating loss of -$25.78 million and an adjusted P/E ratio of -0.44. This indicates that Unicycive is not just unprofitable but has been spending more than it earns, which aligns with one of the InvestingPro Tips highlighting the company's rapid cash burn. Furthermore, the lack of revenue growth in the last twelve months, marked at -100%, underscores the developmental stage of the company and the inherent risks involved.
InvestingPro Tips for Unicycive Therapeutics also suggest caution, noting the company's weak gross profit margins and expectations for a drop in net income this year. Additionally, analysts do not anticipate the company will turn a profit this year, which is an essential consideration for potential investors.
For readers interested in a deeper dive into Unicycive's financials and market performance, InvestingPro offers additional insights. There are 11 more InvestingPro Tips available, which can be accessed by visiting https://www.investing.com/pro/UNCY. For those considering an InvestingPro subscription, remember to use coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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