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SAN DIEGO - Revelation Biosciences, Inc. (NASDAQ:REVB), a micro-cap biotech company with a market capitalization of just $4.8 million, announced Tuesday that its Phase 1b PRIME clinical study of Gemini in stage 3 and 4 chronic kidney disease (CKD) patients met its primary safety endpoint while demonstrating significant anti-inflammatory activity. According to InvestingPro data, the company maintains a healthy current ratio of 3.42, indicating strong short-term liquidity despite recent market challenges.
The study showed Gemini reduced inflammatory activity and restored normal cellular response to stimuli in peripheral blood mononuclear cells (PBMCs) isolated from patients, with effects lasting up to seven days after a single dose. While the clinical results appear promising, InvestingPro analysis reveals the company is quickly burning through cash, with negative free cash flow of $17.7 million in the last twelve months.
"Gemini significantly reduced inflammation relative to placebo in patients with high background PBMC activity," the company said in a press release, noting that inflammation was reduced to levels comparable to healthy subjects.
The study enrolled 40 patients aged 32 to 78 years across three U.S. clinics specializing in CKD care. Patients were divided into five cohorts receiving different dose levels.
In approximately half of the patients who showed significant background inflammation, Gemini not only reduced inflammatory markers but also corrected immunoparalysis typical to chronic disease, restoring normal cell function that remained evident a week after dosing.
At the target dose, Gemini was well-tolerated with only mild adverse events reported, including transient headache, chills, loose stool, and body aches. Three severe adverse events occurred at the highest dose (above target) but resolved within three hours.
James Rolke, Chief Executive Officer of Revelation, called the results "a game-changer in the treatment of acute and chronic inflammation."
The company plans to discuss advancement of the program at an End of Phase 1 meeting with the FDA later this year and will host a webcast Wednesday to review the data.
In other recent news, Revelation Biosciences, Inc. announced it will implement a 1-for-3 reverse stock split on July 7, 2025. This decision follows stockholder approval at a special meeting held on June 23. The reverse stock split is designed to increase the market price of Revelation’s common stock. The company aims to regain compliance with the Nasdaq Capital Market’s minimum bid continued listing requirements. Revelation’s shares will continue trading under the symbol REVB but will have a new CUSIP number: 76135L705. These developments reflect the company’s efforts to address market listing standards.
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