SAN DIEGO, CALIFORNIA / ACCESS Newswire / January 26, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), announced today that, on January 28, 2026, the Company will implement a 1-for-4 reverse split of its common stock. The reverse stock split will be effective as of the morning of January 28, 2026, and the Company's common stock will trade on a post-split basis at the beginning of trading on the same date under the existing trading symbol "REVB. ...

Core Viewpoint - Revelation Biosciences, Inc. has entered into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to 13,065,000 shares of common stock at a reduced exercise price of $0.86 per share [1]. Group 1 - The company is a clinical-stage life sciences firm focused on rebalancing inflammation [1]. - The existing warrants were issued on September 11, 2025 [1]. - The shares of common stock that can be issued upon exercise of the existing warrants are registered under an effective registration statement on Form S-3 [1].

Core Viewpoint - Revelation Biosciences, Inc. has reached an agreement with the FDA on an approval pathway for its treatment Gemini for Acute Kidney Injury (AKI) [1] Group 1: FDA Agreement - The agreement includes a clinically relevant and objective composite endpoint that comprises death and/or the need for dialysis [1] - Positive data from a single well-controlled Phase 2/3 adaptive design clinical study, involving approximately 300 patients, will be sufficient for the submission of a new drug application (NDA) [1]

Core Viewpoint - Revelation Biosciences Inc. is set to present new clinical data on the therapeutic benefits of Gemini for treating acute kidney injury (AKI) and chronic kidney disease (CKD) at an upcoming conference, highlighting significant improvements in patient conditions [1] Group 1: Clinical Data Presentation - The presentation will include additional positive data from the recently completed PRIME Clinical Study [1] - The conference will take place at the International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2026) in San Diego from March 29 to April 1, 2026 [1] - The data demonstrates normalization of the hyperinflammatory state in stage 3 and 4 CKD patients [1] Group 2: Therapeutic Benefits - The presented data indicates a restoration of immunocompetence in patients with CKD [1]

Core Insights - Revelation Biosciences, Inc. has commenced GMP manufacturing of GEMINI and placebo, which is essential for later stage clinical studies [1][2] - The CEO emphasized the importance of this manufacturing run in advancing the company's pipeline and expediting clinical programs [2] - The company recently met with the FDA to discuss the clinical development and regulatory approval pathway for GEMINI as a treatment for acute kidney injury (AKI) [3] Company Overview - Revelation Biosciences is a clinical-stage life sciences company focused on rebalancing inflammation through its proprietary formulation, GEMINI [7] - GEMINI is a toll-like receptor 4 (TLR4) agonist aimed at treating acute and chronic diseases related to dysregulated inflammation [4] - The company is evaluating GEMINI for multiple applications, including acute kidney injury, chronic kidney disease, severe burn-related hyperinflammation, and post-surgical infection prevention [4] Industry Context - Acute Kidney Injury (AKI) affects over 10% of hospitalized patients and more than 50% of ICU admissions, highlighting the need for new therapies [6] - AKI can lead to severe complications, including chronic kidney disease and increased mortality rates, underscoring the urgency for effective treatments [5][6]

Core Viewpoint - Revelation Biosciences, Inc. has successfully reached a quorum for its Special Meeting scheduled for December 3, 2025, indicating strong shareholder engagement [1] Company Summary - The company is a clinical-stage life sciences firm focused on rebalancing inflammation [1] - Shareholders are reminded that voting is open until 11:59pm ET on December 2, 2025 [1]

Core Insights - Revelation Biosciences, Inc. has successfully submitted and received acceptance for the end-of-phase 1 meeting package to the FDA [1] - The company is on track to hold the meeting later this year, which aims to gather agency feedback on the clinical development and regulatory approval pathway for Gemini as a treatment for acute kidney injury (AKI) [1] Company Developments - The primary focus of the meeting with the FDA is to establish feedback regarding the clinical development of Gemini [1] - The company is positioned as a clinical-stage life sciences entity concentrating on rebalancing inflammation [1]

Financial Position - As of September 30, 2025, Revelation had $12.7 million in cash and cash equivalents, up from $6.5 million as of December 31, 2024, primarily due to net cash proceeds from a public offering and warrant inducement[2]. - The total assets of Revelation as of September 30, 2025, were $12.86 million, compared to $6.62 million as of December 31, 2024[12]. - Revelation's accumulated deficit as of September 30, 2025, was $(46.91) million, up from $(40.51) million as of December 31, 2024[12]. Operating Performance - Net cash used for operating activities for the nine months ended September 30, 2025, was $6.3 million, a significant decrease from $14.6 million for the same period in 2024[2]. - Revelation's net loss for the three months ended September 30, 2025, was $1.9 million, or $(1.77) per share, compared to a net loss of $2.2 million, or $(40.15) per share for the same period in 2024[2][10]. - For the nine months ended September 30, 2025, the net loss was $6.4 million, or $(9.76) per share, compared to a net loss of $13.3 million, or $(354.05) per share for the same period in 2024[2][10]. - Total operating expenses for the three months ended September 30, 2025, were $1.94 million, compared to $1.80 million for the same period in 2024[10]. Development Focus - The company is focused on the development of Gemini, which aims to treat acute kidney injury, chronic kidney disease, and other inflammatory conditions[4][7]. - Revelation plans to meet with the FDA later this year to discuss the clinical development path for Gemini[2]. Fundraising Activities - Revelation received gross proceeds of $9.6 million from warrant inducement in September 2025[5].

Core Insights - Revelation Biosciences, Inc. reported financial results for the three and nine months ended September 30, 2025, highlighting significant corporate developments [1] Financial Performance - The company received gross proceeds of $9.6 million from warrant inducement in September 2025, indicating strong financial backing [1] Clinical Developments - Revelation announced groundbreaking top-line results from the PRIME Clinical Study, which are expected to advance the company's development phase [1] Leadership Commentary - CEO James Rolke emphasized that the outstanding PRIME data and subsequent financing validate the potential of Gemini, positioning the company on solid footing for future advancements [1]

Financial Performance - The company incurred a net loss of $6.4 million for the nine months ended September 30, 2025, compared to a net loss of $13.3 million for the same period in 2024[99]. - The company has incurred recurring losses since inception, with net losses expected to fluctuate significantly based on clinical study timing and expenditures[99]. - The company incurred a net loss of $6.4 million for the nine months ended September 30, 2025, with an accumulated deficit of $46.9 million[122]. - Significant operating and net losses are expected to continue as the company expands research and development activities[122]. Cash Position - As of September 30, 2025, the company had cash and cash equivalents of $12.7 million and an accumulated deficit of $46.9 million[118]. - Cash and cash equivalents available as of September 30, 2025, were $12.7 million, which is insufficient to sustain operations for one year[122]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $6.3 million, a decrease from $14.6 million in the same period of 2024[125][127]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $12.5 million, primarily from a public offering and warrant inducement[129]. - There were no net cash provided by or used in investing activities during the nine months ended September 30, 2025[128]. Expenses - Research and development expenses increased by $0.2 million, from $2.9 million for the nine months ended September 30, 2024, to $3.1 million for the same period in 2025[112]. - General and administrative expenses increased by $0.1 million, from $3.3 million for the nine months ended September 30, 2024, to $3.4 million for the same period in 2025[114]. - Total operating expenses for the nine months ended September 30, 2025, were $6.5 million, compared to $6.2 million for the same period in 2024[110]. - The company expects research and development expenses to increase substantially as it continues the development of product candidates[106]. Revenue Generation - The company has never generated revenue and does not expect to do so until product candidates successfully complete development and obtain regulatory approval[101]. - The company has never generated revenue and does not expect to do so until product candidates receive regulatory approval, which may take several years[122]. Funding and Capital - The company plans to seek additional funding through public or private equity or debt financings[98]. - The company plans to seek additional funding through public or private equity or debt financings to continue operations[123]. - The company may face dilution of existing stockholders' interests if additional capital is raised through equity offerings[121]. Off-Balance Sheet Arrangements - The company has no off-balance sheet arrangements as of September 30, 2025[132].