LOS ALTOS, Calif. - Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a biotech firm focusing on kidney disease therapies, has reported successful completion of the single ascending dose (SAD) portion of its ongoing Phase 1 clinical trial for UNI-494, a drug candidate aimed at preventing delayed graft function (DGF) after kidney transplantation. This announcement follows the recent orphan drug designation granted by the FDA for UNI-494.
The SAD study results, presented at the 29th International Conference on Advances in Critical Care Nephrology on Monday, showed that UNI-494 was well-tolerated up to a 160 mg single dose. Based on safety, tolerability, and pharmacokinetic data, a dose of 80 mg twice daily is now being administered in the multiple ascending dose (MAD) portion of the trial.
In a preclinical study, UNI-494 demonstrated statistically significant results in reducing kidney functional and tubular injury markers in a rat model of DGF, which is a common complication post-kidney transplantation and can lead to poor graft function and patient survival. The drug is a novel nicotinamide ester derivative that activates ATP-sensitive mitochondrial potassium channels, which are believed to play a critical role in acute kidney injury and chronic kidney disease.
Unicycive expects to complete the Phase 1 trial and report full results in the second half of this year. The company is also developing another drug candidate, oxylanthanum carbonate (OLC), for hyperphosphatemia in chronic kidney disease patients on dialysis.
The information in this article is based on a press release statement from Unicycive Therapeutics, Inc.
InvestingPro Insights
As Unicycive Therapeutics (NASDAQ: UNCY) makes headway in its clinical trials, investors and stakeholders are closely monitoring the financial health and market performance of the company. Unicycive's commitment to addressing kidney disease therapies is reflected in its strategic research and development efforts. Yet, the financial landscape presents a mixed picture that potential investors should consider.
InvestingPro data indicates a market capitalization of $49.7 million for Unicycive, reflecting the company's size in the biotech industry. Despite a challenging revenue growth rate, which has decreased by 29.02% over the last twelve months as of Q1 2023, the company maintains a gross profit margin of 100%. This suggests that while the company's revenue is contracting, it is still able to maintain high margins on the products it sells. However, it's important to note that the operating income margin stands at a starkly negative 2931.26%, indicating significant operational costs relative to the revenue.
InvestingPro Tips highlight that Unicycive holds more cash than debt on its balance sheet, which is a positive sign for liquidity and financial stability. However, the company is quickly burning through its cash reserves, which raises concerns about long-term sustainability. Moreover, two analysts have revised their earnings downwards for the upcoming period, and there is a general consensus that sales may decline in the current year. The stock price has experienced significant volatility, with a strong return over the last three months of 130.65%, yet a one-year price total return of -34.1%.
These financial metrics and analyst insights can aid investors in making informed decisions. For a deeper analysis, including additional InvestingPro Tips, visit https://www.investing.com/pro/UNCY. There are 14 more tips available on InvestingPro that could provide further insights into Unicycive's financial health and market performance. To access these insights and more, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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