SAN DIEGO – Revelation Biosciences Inc. (NASDAQ: REVB ), a $3.26 million market cap clinical life sciences company, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1b clinical trial of its Gemini drug candidate. The company’s stock, currently trading at $0.76, has seen a significant decline of nearly 95% since the start of the year, although according to InvestingPro analysis, the stock appears to be undervalued based on the fair value estimate. The study, which is scheduled to begin in early 2025, aims to evaluate the safety and efficacy of Gemini as a prerequisite treatment for patients with chronic kidney disease (CKD).
The upcoming multi-site, placebo-controlled study will enroll up to 40 subjects in 5 cohorts. The primary focus will be on the safety and tolerability of a single dose of Gemini in patients with CKD. Although the company maintains a healthy current ratio of 1.64 and has more cash than debt, InvestingPro the data indicates a rapid rate of cash spending 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 his pride in reaching this significant milestone and highlighted the company’s commitment to advancing patient care through the use of trained immunity. This next phase of clinical research follows promising results from earlier Phase 1 trials, where Gemini met the primary safety endpoints and demonstrated significant pharmacodynamic activity.
Gemini, administered intravenously, is based on a proprietary formulation designed to reprogram the innate immune system, reducing the damage associated with inflammation. The drug has shown 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 stopping or slowing the progression of CKD.
The success of the phase 1b study is expected to pave the way for a phase 2 trial, aimed at reducing AKI in patients undergoing coronary artery bypass graft and heart valve surgery. As the company moves forward with its clinical programs, it continues to explore Gemini’s potential in various treatment scenarios.
This announcement is based on a press release from Revelation Biosciences. The company cautions that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from expectations. Investors are advised not to place undue reliance on these forward-looking statements, which reflect management’s current expectations as of the date they are made. Despite the current challenges, analysts’ price targets range from $5.50 to $20.00, indicating potential upside. For a deeper insight into REVB’s financial health and 11 additional expert tips, consider subscribing to InvestingPro.
In other recent news, Revelation Biosciences is facing a potential delisting from the Nasdaq stock exchange for failing to meet minimum offering price and shareholder capital requirements. The San Diego-based pharmaceutical company plans to appeal the notices and will request a hearing to maintain its status on the list. Concurrently, the company has entered into contracts to exercise Class D common stock warrants for approximately 2.5 million shares, a strategy that is expected to generate approximately $3.8 million in gross proceeds.
Recently, Revelation Biosciences was ordered to pay a $7.3 million judgment against LifeSci Capital LLC in a legal dispute, but the company confirmed that it has sufficient cash reserves to meet this judgment without affecting its ongoing development and clinical trial programs. In a positive development, the company reported promising Phase 1 clinical trial results for Gemini, its proprietary immune preconditioning therapy. After this news, Roth Capital Partners (WA:) and MKM Partners maintained a buy rating on Revelation Biosciences. These are recent events surrounding the company.
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