SAN DIEGO – Revelation Biosciences Inc. (NASDAQ: REVB), a clinical-stage life sciences company with a market capitalization of $3.26 million, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1b clinical trial of its drug candidate Gemini. The company’s stock, currently trading at $0.76, has experienced a significant decline of nearly 95% year-to-date, though according to InvestingPro analysis, the stock appears undervalued based on its Fair Value assessment. The study, set to begin in early 2025, aims to evaluate the safety and efficacy of Gemini as a preconditioning treatment for patients with chronic kidney disease (CKD).
The upcoming multi-site, placebo-controlled study will involve up to 40 subjects across 5 cohorts. The primary focus will be on the safety and tolerability of a single dose of Gemini in CKD patients. While the company maintains a healthy current ratio of 1.64 and holds more cash than debt, InvestingPro data indicates a rapid cash burn rate that investors should monitor. Additionally, secondary and exploratory endpoints will measure pharmacokinetics and the drug’s ability to modulate the innate immune response, which will be assessed using various biomarkers.
Revelation’s CEO, James Rolke, expressed pride in reaching this significant milestone and highlighted the company’s commitment to advancing patient care by leveraging trained immunity. This next phase of clinical research follows promising results from earlier Phase 1 trials, where Gemini met primary safety endpoints and showed significant pharmacodynamic activity.
Gemini, administered intravenously, is based on a proprietary formulation designed to reprogram the innate immune system, reducing damage related to inflammation. The drug has demonstrated potential in multiple preclinical studies for various indications, including reducing the severity and duration of acute kidney injury (AKI) and post-surgical infection, as well as halting or slowing the progression of CKD.
The success of the Phase 1b study is expected to pave the way for a Phase 2 trial, aiming to reduce AKI in patients undergoing coronary artery bypass graft and cardiac valve surgery. As the company moves forward with its clinical programs, it continues to explore Gemini’s potential across different treatment scenarios.
This announcement is based on a press release statement from Revelation Biosciences. The company cautions that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those anticipated. Investors are advised not to place undue reliance on these forward-looking statements, which reflect management’s current expectations as of the date of their publication. Despite current challenges, analyst price targets range from $5.50 to $20.00, suggesting potential upside. For deeper insights into REVB’s financial health and 11 additional ProTips, consider subscribing to InvestingPro.
In other recent news, Revelation Biosciences is facing potential delisting from the Nasdaq due to noncompliance with the minimum bid price and stockholders’ equity requirements. The San Diego-based pharmaceutical firm plans to appeal these notices and will request a hearing to maintain its listing status. In parallel, the company has entered into agreements to exercise Class D Common Stock Warrants for approximately 2.5 million shares, a strategy expected to generate around $3.8 million in gross proceeds.
Recently, Revelation Biosciences was ordered to pay a $7.3 million court judgment to LifeSci Capital LLC over a legal dispute, but the company has confirmed it has ample cash reserves to meet this judgment without impacting its ongoing development and clinical trial programs. In a positive development, the company reported promising results from a Phase 1 clinical trial for Gemini, its proprietary immune preconditioning therapy. Following this news, Roth Capital Partners (WA:) and MKM Partners maintained their Buy rating on Revelation Biosciences. These are the recent developments surrounding the company.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
