US Market News
4日前
Revelation Biosciences Expands Acute Kidney Injury Advisory BoardJune 1, 2026 9:00 AM
ACCESS NewswireSAN DIEGO, CA / ACCESS Newswire / June 1, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company developing innovative solutions to treat acute and chronic disease, today announced the expansion of its Acute Kidney Injury (AKI) Advisory Board, with the addition of two new members, Dr. Peter Pickkers and Dr. Lui Forni, ahead of its upcoming Phase 2/3 clinical trial. The distinguished panel comprises internationally recognized nephrologists and critical care physicians who will guide the company's clinical strategy, monitor trial progress, and advance Gemini as a treatment for AKI. Drawing on their collective expertise, the board will help shape the most effective study design to address the significant unmet medical need in AKI and ultimately improve patient outcomes.Peter Pickkers, MD, PhDDr. Pickkers is an internist-intensivist and professor of Experimental Intensive Care Medicine. His research focuses on (pharmacological) modulation of the innate immune response, sepsis, and organ dysfunction, especially the kidney. Dr. Pickkers is Professor of Intensive Care Medicine at the Radboud University Medical Center Nijmegen, the Netherlands. He qualified as MD (1991) and completed his residency in Internal and Intensive Care Medicine at the Radboud University Nijmegen. In 2000 he received his doctorate, titled ‘Vascular effects of diuretics', cum laude. His research focuses on pharmacological modulation of the innate immune response in translational models and patients, and the consequences for organ function, with a focus on the kidney and brain. Up to now, 28 PhD's were completed under his supervision. With over 2000 endotoxemia experiments performed, he leads the most active group using this human in vivo model of inflammation worldwide. He has given invited lectures on all major meetings in the field of intensive care medicine and nephrology, and he cooperates with various international experts in the field of sepsis and nephrology and has participated in several guideline and steering committees. Dr. Pickkers is also on the editorial board of Intensive Care Medicine, Intensive Care Medicine Experimental and Shock.Lui Forni, MD, PhD, JFICMIProfessor Lui Forni trained at St George's Hospital Medical School before training at the London Postgraduate Medical Schools. His Registrar Training was at St Thomas', followed by ICU and Nephrology training at St Thomas' and St George's. He was a consultant Intensivist/Nephrologist at the Western Sussex Hospitals Trust for over 10 years before moving to his current post as Professor of intensive care medicine at the Royal Surrey County Hospital NHS Foundation Trust. Research interests include pre-operative assessment of high-risk surgical candidates, renal replacement therapy, diagnosis, pathophysiology, and treatment of acute kidney injury and predictive modeling in acute medical admissions. Professor Forni has been the UK Principal Investigator for several international studies and is currently the lead investigator for a UK study. He has been an advisor for NCEPOD and was a founding member of the ESICM AKI group, of which he was elected chair of the section in 2013, and is currently a member of the executive council of the ESICM serving as general secretary, having previously been research chair. He has been a faculty member for the ESICM and the ICS, as well as lecturing nationally and internationally. In 2023, Dr. Forni was made Professor of Acute Medicine and Critical Care at the School of Medicine at the University of Surrey. Professor Forni is a referee for over 20 journals and is on the editorial board of several.About GeminiGemini is the Company's proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with Gemini rebalances the innate immune response and has been demonstrated to have the potential to treat acute and chronic diseases associated with dysregulated inflammation. Gemini is currently being evaluated as a potential treatment for acute kidney injury (GEM-AKI); Gemini is also being developed as a treatment for chronic kidney disease (GEM-CKD), as a treatment to reduce hyperinflammation and infection associated with severe burn (GEM-PBI), and as a treatment to prevent post-surgical infection (GEM-PSI). The potential of Gemini to correct dysregulated inflammation has been demonstrated in multiple preclinical models of AKI, CKD, and infection, as well as in two Phase 1 clinical studies. See additional detail here.About Revelation Biosciences, Inc.Revelation Biosciences, Inc. is a clinical-stage life sciences company focused on rebalancing inflammation using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini as a treatment for acute kidney injury, a treatment of chronic kidney disease, prevention of post-surgical infection, and a treatment to reduce hyperinflammation and infection associated with severe burn.For more information, please visit www.RevBiosciences.com.Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate," "believe," "expect," "estimate," "plan," "outlook," and "project" and other similar expressions. We caution investors that forward-looking statements are based on management's expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth, profitability, and retain its key employees; the possibility that Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation's product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such studies are positive or whether they can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation's balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.Company ContactsMike Porter
Investor Relations
Porter LeVay & Rose Inc.
Email: mike@plrinvest.comChester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.comSOURCE: Revelation Biosciences, Inc.View the original press release on ACCESS NewswireOriginal: Revelation Biosciences Expands Acute Kidney Injury Advisory Board
US Market News
4週前
Revelation Biosciences, Inc. Releases Corporate Update Letter to StockholdersMay 11, 2026 9:00 AM
ACCESS NewswireSAN DIEGO, CA / ACCESS Newswire / May 11, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company developing innovative solutions to treat acute and chronic disease, released its 2026 annual meeting proxy materials today, which included a corporate update letter to its stockholders from James Rolke, Chief Executive Officer of Revelation, the body of the letter follows.Dear Stockholders:As you know, Revelation is a clinical stage company working to develop a high-impact, potentially lifesaving drug called Gemini for the treatment of acute kidney injury (AKI). While our passionate team is dedicated and hardworking, we couldn't accomplish anything without the financial support of our investors and stockholders and, to this end, the team and I are truly grateful. We take very seriously our obligation to deliver on and exceed our stated objectives while being very mindful of - and maximizing the value of - every dollar spent.I'm a firm believer in open, honest and transparent communication. As a stockholder myself, I believe our stock is significantly undervalued given our current phase of development, the strong data supporting our mechanism of action, the potential addressable AKI market and the potential of Gemini for the treatment of other acute and chronic diseases. Thus the purpose of this letter is to reflect on the significance of these points and to discuss the future planned development of Gemini for the benefit of patients and, ultimately, the stockholder value it is expected to create.Current Phase of DevelopmentIn December 2025 we had a very productive and successful meeting with the FDA regarding the approval pathway for Gemini as a treatment for AKI. The key agreements were:A clinically relevant and objective composite endpoint comprising death and/or dialysis; andPositive data from a single well-controlled Phase 2/3 adaptive design clinical study comprised of approximately 300 patients can be submitted to the FDA as a part of a new drug application (NDA).The significance of this outcome cannot be overstated: a positive outcome from a single study is all that's necessary for approval of Gemini for treating AKI. In addition to this incredible win, the benefits of getting the greenlight for the adaptive design study are multi-fold:In the normal paradigm, the time between Phase 2 and 3 can be greater than 1 year with all the associated financial burn; whereas in our planned adaptive design the time between Phase 2 and 3 is measured in days, saving time and money;The adaptive design gives us the opportunity to evaluate multiple dosing regimens in the Phase 2 portion to identify the safest dosing regimen;The adaptive design also allows us to reevaluate the sample size required to achieve our primary endpoint in the Phase 3 portion of the study, increasing our chance of success; andLastly, the Phase 2 data from placebo and the safest dosing regimen that moves forward to Phase 3 counts toward the final analysis.All of this means a faster, less expensive study-and a greater likelihood of success. During 2026, we are building the infrastructure necessary to begin our adaptive design clinical study by the 4th quarter. Completed and ongoing activities include the establishment of a top-tier scientific advisory board; engaging an outstanding clinical research organization specializing in renal studies; conducting the necessary nonclinical studies for late stage clinical studies and NDA submission; and the manufacture of drug product and placebo for our Phase 2/3 clinical study.Strong Data Supports Gemini's Mechanism of Action and Use in AKIWe have shown in our preclinical and our Phase 1b clinical study that Gemini stimulates Toll-like receptor-4 (TLR4) on the surface of immune cells to initiate the production of an array of cytokines, which are molecules released by cells that "tell" other cells how to behave. In an inflamed patient, these cytokines act to "turn down" the inflammatory response without turning it off, so Gemini doesn't suppress the immune response, but rebalances it (a little inflammation is necessary for healing). Additionally, unlike antibody therapies or steroids, which target one inflammation pathway, Gemini, by releasing multiple cytokines, targets multiple pathways, which results in a durable, robust response.The ability of Gemini to stimulate an array of cytokines and rebalance excessive inflammation has been demonstrated clinically in patients and in preclinical models of AKI, all of which support the proposed endpoints in the pending Phase 2/3 adaptive study:In our Phase 1b PRIME clinical study in stage 3 and 4 chronic kidney disease (CKD) patients, Gemini significantly reduced cellular inflammation out to at least 7 days and restored immunocompetence (e.g., normal ability to respond to stimulus, without immunosuppression).Gemini significantly reduced inflammation in a unilateral urethral obstruction (UUO) model of AKI and in an ischemia/reperfusion (I/R) model of AKI.In healthy volunteers, Gemini upregulated the same cytokine profile observed in healthy animals of the same species used in the preclinical models.AKI is a significant unmet medical need and a massive potential marketAKI is defined as a rapid loss of kidney function. It causes a build-up of waste products in blood and makes it more difficult for the kidneys to maintain the correct balance of fluid in the body; it can also significantly impact other organs, such as the brain, heart, and lungs. Severe AKI requiring dialysis increases the likelihood of worse outcomes, including longer time in an intensive care unit (ICU), CKD, and death.AKI is a major cause of morbidity and mortality, which according to publicly available data affects more than 10% of all hospitalized patients and more than 50% of patients admitted to ICUs. Renal replacement therapy (dialysis) is still the only current therapeutic option for severe AKI and is required in approximately 20% of all critically ill patients. AKI is associated with high mortality rates, and even among those who survive, up to 40% later develop CKD or progress to end-stage renal disease. As such, new therapies to treat AKI are urgently needed.Some relevant statistics:The patient population is in excess of 2.3 millionWe believe that the market potential is more than $5 billion based upon the potential savings to the healthcare system from Gemini treatment opposed to current standard of care (dialysis)In the USA alone approximately 34 million people are admitted to the hospital each year for kidney problems, 20% with some form of AKIThe only available treatment is dialysis (American Hospital Association)We are on track to make Gemini the first available treatment for AKI that is not dialysis. Future OpportunitiesIn addition to AKI, based on the remarkable results from our PRIME study, we believe Gemini will be highly beneficial to patients with CKD. I am sure you all have family or friends who, unfortunately, suffer from some form of CKD, which is propagated by excess inflammation due to conditions such as heart disease, high blood pressure, high blood sugar, obesity and old age. These diseases and conditions cause organ damage, including damage to kidneys and, in the industrial world, more than 10% of the population suffers from some form of CKD. According to a recent CDC study, kidney failure is diagnosed in 360 people in the USA every day. The CDC found 15% of American adults (37 million people) are afflicted with CKD. The same study estimates annual expenditure on CKD is $87 billion.While our initial focus is on acute and chronic kidney disorders driven by inflammation, Gemini's unique ability to rebalance excess inflammation could potentially be applied to similar acute or chronic conditions, which we will continue to evaluate based upon available resources.The Revelation team is strategic: we continuously seek potential opportunities, including joint ventures, out licensing and partnerships, to further the development of new patentable, high-impact, high-value drugs. The expansion of our pipeline will provide for longer term growth and increased stockholder value.Results of OperationsAs of December 31, 2025, Revelation had $10.7 million in cash and cash equivalents, compared to $6.5 million as of December 31, 2024. The increase in cash and cash equivalents was primarily due to net cash proceeds from the May 2025 public offering and the September 2025 warrant inducement, offset by cash used for operating activities. Based on current operating plans and projections, Revelation believes its current cash and cash equivalents are sufficient to fund operations into the first quarter of 2027.Net cash used for operating activities for the twelve months ended December 31, 2025 was $8.3 million, compared to net cash used for operating activities of $18.3 million for the same 2024 period. Net loss for the three months ended December 31, 2025 was $2.5 million, or $1.65 net loss per share, compared to a net loss of $1.7 million, or $59.76 net loss per share, for the same 2024 period. Net loss for the year ended December 31, 2025 was $8.9 million, or $14.35 net loss per share, compared to net loss of $15.0 million, or $1,052.16 net loss per share for the year ended December 31, 2024.The reduction of our net loss in 2025 from 2024 was primarily related to the LifeSci Capital LLC judgment expense and reimbursement of legal costs, clinical trial related settlement expenses with A-IR Clinical Research Ltd., and expenses in connection with the deferred underwriting commissions. Final ThoughtsThe Revelation team is confident in the incredible potential of Gemini, as we have convincingly demonstrated in our preclinical and clinical studies its ability to rebalance inflammation and restore normal cellular response. Gemini might possibly treat a host of additional conditions and diseases, as mentioned above, and may perhaps have even more unknown applications. We continue to compile data while working toward approval and ultimately commercialization.We look forward to beginning our pivotal study in AKI patients later this year, and we have sufficient capital to operate into 2027, thanks to our careful management of expenses and our visceral aversion to debt.As stockholders ourselves, management is focused on delivering meaningful returns as we bring Gemini through development and approval culminating at commercialization. As we have done, we will continue to publish news and make up-to-date information available on our website. We see our stockholders as our partners, and we want to honor this partnership with hard work and transparency.We hope you decide to stay with Revelation as we enter into this exciting pivotal clinical phase of advancing Gemini to approval. If you have any questions, please reach out to us.Many thanks for your continued support.Sincerely yours,
James Rolke, CEOAbout GeminiGemini is the Company's proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with Gemini rebalances the innate immune response and has been demonstrated to have the potential to treat acute and chronic diseases associated with dysregulated inflammation. Gemini is currently being evaluated as a potential treatment for acute kidney injury (GEM-AKI); Gemini is also being developed as a treatment for chronic kidney disease (GEM-CKD), as a treatment to reduce hyperinflammation and infection associated with severe burn (GEM-PBI), and as a treatment to prevent post-surgical infection (GEM-PSI). The potential of Gemini to correct dysregulated inflammation has been demonstrated in multiple preclinical models of AKI, CKD, and infection, as well as in two Phase 1 clinical studies. See additional detail here.About Revelation Biosciences, Inc.Revelation Biosciences, Inc. is a clinical-stage life sciences company focused on rebalancing inflammation using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini as a treatment for acute kidney injury, a treatment of chronic kidney disease, prevention of post-surgical infection, and a treatment to reduce hyperinflammation and infection associated with severe burn.For more information, please visit www.RevBiosciences.com. Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate," "believe," "expect," "estimate," "plan," "outlook," and "project" and other similar expressions. We caution investors that forward-looking statements are based on management's expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth, profitability, and retain its key employees; the possibility that Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation's product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such studies are positive or whether they can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation's balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.Company Contacts
Mike Porter
Investor Relations
Porter LeVay & Rose Inc.
Email: mike@plrinvest.comChester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.comSOURCE: Revelation Biosciences, Inc.View the original press release on ACCESS NewswireOriginal: Revelation Biosciences, Inc. Releases Corporate Update Letter to Stockholders
US Market News
4週前
Revelation Biosciences, Inc. Announces Financial Results For the Three Months Ended March 31, 2026May 7, 2026 4:15 PM
ACCESS NewswireSAN DIEGO, CA / ACCESS Newswire / May 7, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company developing innovative solutions to treat acute and chronic disease, today reported its financial results for the three months ended March 31, 2026.Corporate HighlightsAnnounced agreement with FDA on a single adaptive Phase 2/3 study for approval of Gemini for treatment of acute kidney injuryReceived net proceeds of $6.7 million from warrant inducement in January 2026Participated in a fireside chat at the 38th Annual ROTH Conference, during which management discussed the Company's developments and strategic prioritiesPresented additional positive data analysis from the PRIME Study at the International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2026) in San Diego (March 29 - April 1, 2026)Initiated discussions with potential clinical research organizations for the single adaptive Phase 2/3 study"The incredible momentum achieved in 2025 is continuing in 2026," said James Rolke, Chief Executive Officer of Revelation. "Our focus remains on getting our pivotal clinical study of Gemini in acute kidney patients underway for the benefit of those patients and ultimately to deliver significant value for our shareholders."Results of OperationsAs of March 31, 2026, Revelation had $14.1 million in cash and cash equivalents, compared to $10.7 million as of December 31, 2025. The increase in cash and cash equivalents was primarily due to net cash proceeds from the January 2026 warrant inducement, offset by cash used for operating activities. Based on current operating plans and projections, Revelation believes its current cash and cash equivalents are sufficient to fund operations through the first quarter of 2027.Net cash used for operating activities for the three months ended March 31, 2026 was $3.2 million compared to net cash used for operating activities of $2.8 million for the same period in 2025. Net loss for the three months ended March 31, 2026 was $3.0 million, or $2.71 basic and diluted net loss per share compared to net loss of $2.1 million, or $25.34 basic and diluted net loss per share for the three months ended March 31, 2025.About GeminiGemini is the Company's proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with Gemini rebalances the innate immune response and has been demonstrated to have the potential to treat acute and chronic diseases associated with dysregulated inflammation. Gemini is currently being evaluated as a potential treatment for acute kidney injury (GEM-AKI); Gemini is also being developed as a treatment for chronic kidney disease (GEM-CKD), as a treatment to reduce hyperinflammation and infection associated with severe burn (GEM-PBI), and as a treatment to prevent post-surgical infection (GEM-PSI). The potential of Gemini to correct dysregulated inflammation has been demonstrated in multiple preclinical models of AKI, CKD, and infection, as well as in two Phase 1 clinical studies. See additional detail here.About Revelation Biosciences, Inc.Revelation Biosciences, Inc. is a clinical-stage life sciences company focused on rebalancing inflammation using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini as a treatment for acute kidney injury, a treatment of chronic kidney disease, prevention of post-surgical infection, and a treatment to reduce hyperinflammation and infection associated with severe burn.For more information, please visit www.RevBiosciences.com.Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate," "believe," "expect," "estimate," "plan," "outlook," and "project" and other similar expressions. We caution investors that forward-looking statements are based on management's expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth, profitability, and retain its key employees; the possibility that Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation's product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such studies are positive or whether they can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation's balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.REVELATION BIOSCIENCES, INC.
Consolidated Statements of Operations Three Months Ended
March 31, 2026 2025 Operating expenses: Research and development $1,376,861 $858,830 General and administrative 1,715,639 1,236,157 Total operating expenses 3,092,500 2,094,987 Loss from operations (3,092,500) (2,094,987)Other income (expense): Change in fair value of warrant liability - 1,417 Other income (expense), net 83,449 42,485 Total other income (expense), net 83,449 43,902 Net loss $(3,009,051) $(2,051,085) Deemed dividends (5,681,616) - Net loss attributable to common stockholders (8,690,667) (2,051,085)Net loss per share, basic and diluted $(2.71) $(25.34)Weighted-average shares used to compute net loss per share, basic and diluted 3,207,720 80,943 REVELATION BIOSCIENCES, INC.
Consolidated Balance Sheets March 31,
2026 December 31,
2025 ASSETS Current assets: Cash and cash equivalents $14,113,415 $10,700,331 Prepaid expenses and other current assets 92,620 111,297 Total current assets 14,206,035 10,811,628 Property and equipment, net 140,717 18,067 Operating lease right-of-use asset 666,589 722,288 Other assets 30,941 30,941 Total assets $15,044,282 $11,582,924 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $828,203 $577,501 Accrued expenses 468,082 1,397,644 Operating lease liability 120,861 23,013 Total current liabilities 1,417,146 1,998,158 Operating lease liability, net of current portion 638,183 723,771 Total liabilities 2,055,329 2,721,929 Commitments and Contingencies (Note 4) Stockholders' equity: Common Stock, $0.001 par value; 500,000,000 shares authorized; 3,908,420 and 1,583,969 issued and outstanding at March 31, 2026 and December 31, 2025, respectively 3,908 1,584 Additional paid-in-capital 65,413,383 58,278,698 Accumulated deficit (52,428,338) (49,419,287)Total stockholders' equity 12,988,953 8,860,995 Total liabilities and stockholders' equity $15,044,282 $11,582,924 Company ContactsMike Porter
Investor Relations
Porter LeVay & Rose Inc.
Email: mike@plrinvest.comChester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.comSOURCE: Revelation Biosciences, Inc.View the original press release on ACCESS NewswireOriginal: Revelation Biosciences, Inc. Announces Financial Results For the Three Months Ended March 31, 2026
US Market News
3月前
Revelation Biosciences, Inc. Announces Financial Results For the Three and Twelve Months Ended December 31, 2025February 26, 2026 4:15 PM
ACCESS NewswireSAN DIEGO, CA / ACCESS Newswire / February 26, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company focused on rebalancing inflammation to optimize health, today reported its financial results for the three and twelve months ended December 31, 2025.Corporate HighlightsAnnounced Positive Results from PRIME Clinical Study in late-stage chronic kidney disease patientsAnnounced agreement with FDA on a single adaptive Phase 2/3 study for approval of Gemini for treatment of acute kidney injuryReceived net proceeds of $6.7 million from warrant inducement in January 2026Clinical data on the potential therapeutic benefit of Gemini for the treatment of acute kidney injury (AKI) and chronic kidney disease (CKD) will be presented at the International Conference on Advances in Critical Care Nephrology in San Diego (March 29 - April 1, 2026)"2025 was a positive year for Revelation with significant advancement of the Gemini program," said James Rolke, Chief Executive Officer of Revelation. "We look forward to building on this momentum in 2026 to expeditiously bring Gemini to patients in need and adding to shareholder value."Results of OperationsAs of December 31, 2025, Revelation had $10.7 million in cash and cash equivalents, compared to $6.5 million as of December 31, 2024. The increase in cash and cash equivalents was primarily due to net cash proceeds from the May 2025 public offering and the September 2025 warrant inducement, offset by cash used for operating activities. Based on current operating plans and projections, Revelation believes its current cash and cash equivalents are sufficient to fund operations into the first quarter of 2027.Net cash used for operating activities for the twelve months ended December 31, 2025 was $8.3 million compared to net cash used for operating activities of $18.3 million for the same period in 2024. Net loss for the three months ended December 31, 2025 was $2.5 million, or $(1.65) basic and diluted net loss per share, compared to a net loss of $1.7 million, or $(59.76) basic and diluted net loss per share for the same period in 2024. Net loss for the year ended December 31, 2025 was $8.9 million, or $(23.95) basic and diluted net loss per share compared to net loss of $15.0 million, or $(1,052.16) basic and diluted net loss per share for the year ended December 31, 2024.About GeminiGemini is the Company's proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with Gemini rebalances the innate immune response and has been demonstrated to have the potential to treat acute and chronic diseases associated with dysregulated inflammation. Gemini is currently being evaluated as a potential treatment for acute kidney injury (GEM-AKI); Gemini is also being developed as a treatment for chronic kidney disease (GEM-CKD), as a treatment to reduce hyperinflammation and infection associated with severe burn (GEM-PBI), and as a treatment to prevent post-surgical infection (GEM-PSI). The potential of Gemini to correct dysregulated inflammation has been demonstrated in multiple preclinical models of AKI, CKD, and infection, as well as in two phase 1 clinical studies. See additional detail here.About Revelation Biosciences, Inc.Revelation Biosciences, Inc. is a clinical stage life sciences company focused on rebalancing inflammation using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini as a treatment for acute kidney injury, a treatment of chronic kidney disease, prevention of post-surgical infection, and a treatment to reduce hyperinflammation and infection associated with severe burn.For more information, please visit www.RevBiosciences.com.Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management's expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation's product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation's balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.REVELATION BIOSCIENCES, INC.
Consolidated Statements of Operations Three Months Ended
December 31, Year Ended
December 31, 2025 2024 2025 2024 Operating expenses: Research and development $964,189 $605,504 $4,063,857 $3,548,996 General and administrative 1,607,398 1,148,384 5,006,957 4,426,113 Total operating expenses 2,571,587 1,753,888 9,070,814 7,975,109 Loss from operations (2,571,587) (1,753,888) (9,070,814) (7,975,109)Other income (expense): Change in fair value of warrant liability 87 2,557 2,158 81,441 Other income (expense), net 60,493 25,612 155,007 (7,144,868)Total other income (expense), net 60,580 28,169 157,165 (7,063,427)Net loss $(2,511,007) $(1,725,719) $(8,913,649) $(15,038,536) Deemed dividends - - (5,951,528) - Net loss attributable to common stockholders (2,511,007) (1,725,719) (14,865,177) (15,038,536)Net loss per share, basic and diluted $(1.65) $(59.76) $(23.95) $(1,052.16)Weighted-average shares used to compute net loss per share, basic and diluted 1,524,011 28,876 620,785 14,293 REVELATION BIOSCIENCES, INC.
Consolidated Balance Sheets December 31,
2025 December 31,
2024 ASSETS Current assets: Cash and cash equivalents $10,700,331 $6,499,018 Prepaid expenses and other current assets 111,297 66,699 Total current assets 10,811,628 6,565,717 Property and equipment, net 18,067 56,332 Operating lease right-of-use asset 722,288 - Other assets 30,941 - Total assets $11,582,924 $6,622,049 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $577,501 $783,621 Accrued expenses 1,397,644 1,130,046 Operating lease liability 23,013 - Total current liabilities 1,998,158 1,913,667 Operating lease liability, net of current portion 723,771 - Total liabilities 2,721,929 1,913,667 Commitments and Contingencies (Note 4) Stockholders' equity: Common Stock, $0.001 par value; 500,000,000 shares authorized at December 31, 2025 and December 31, 2024 and 1,583,969 and 43,526 issued and outstanding at December 31, 2025 and December 31, 2024, respectively 1,584 44 Additional paid-in-capital 58,278,698 45,213,976 Accumulated deficit (49,419,287) (40,505,638)Total stockholders' equity 8,860,995 4,708,382 Total liabilities and stockholders' equity $11,582,924 $6,622,049 Company ContactsMike Porter
Investor Relations
Porter LeVay & Rose Inc.
Email: mike@plrinvest.comChester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.comSOURCE: Revelation Biosciences, Inc.View the original press release on ACCESS NewswireOriginal: Revelation Biosciences, Inc. Announces Financial Results For the Three and Twelve Months Ended December 31, 2025
US Market News
4月前
Revelation Biosciences Inc. Announces 1-for-4 Reverse Stock Split Effective January 28, 2026January 26, 2026 2:55 PM
ACCESS NewswireSAN 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." The CUSIP number for the common stock following the reverse stock split will be 76135L804.The reverse stock split is intended to increase the market price per share of the Company's common stock to regain compliance with the minimum bid continued listing requirement of The Nasdaq Capital Market. Proportionate adjustments will be made to the conversion and exercise prices of the company's warrants, restricted stock unit awards, stock options and to the number of shares issued and issuable under the Company's equity incentive plans.Information for StockholdersUpon the effectiveness of the reverse stock split, each four shares of the Company's issued and outstanding common stock will be automatically combined and converted into one issued and outstanding share of common stock. The reverse stock split will affect all stockholders uniformly and will not alter any stockholder's relative interest in the Company's equity, except to the extent that the reverse stock split would have resulted in a stockholder owning a fractional share. Holders of common stock otherwise entitled to a fractional share as a result of the Reverse Stock Split because they hold a number of shares not evenly divisible by the Reverse Stock Split ratio will be rounded up to the nearest whole share. The reverse stock split will not change the par value of the common stock or modify the rights or preferences of the common stock. The Company's transfer agent, Continental Stock Transfer & Trust Co., will maintain the book-entry records for the Company's common stock. Registered stockholders holding pre-split shares of the Company's common stock electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares via a broker, bank, trust or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to such broker's particular processes, and will not be required to take any action in connection with the reverse stock split. Continental Stock Transfer & Trust Co. can be reached at (212) 509-4000 or (800)-509-5586.About Revelation Biosciences, Inc.Revelation Biosciences, Inc. is a clinical stage life sciences company focused on rebalancing inflammation using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini as a treatment for acute kidney injury, a treatment of chronic kidney disease, prevention of post-surgical infection, and a treatment to reduce hyperinflammation and infection associated with severe burn.For more information, please visit www.RevBiosciences.com.Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management's expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation's product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation's balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.Company ContactsMike Porter
Investor Relations
Porter LaVay & Rose Inc.
Email: mike@plrinvest.comChester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.comSOURCE: Revelation Biosciences, Inc.View the original press release on ACCESS NewswireOriginal: Revelation Biosciences Inc. Announces 1-for-4 Reverse Stock Split Effective January 28, 2026
subslover
4月前
Revelation Biosciences Reaches Agreement with FDA on Gemini Approval Pathway for AKI
- Single Phase 2/3 Adaptive Study Design -
- Clinically Relevant, Objective Composite Endpoint -
SAN DIEGO, CA / ACCESS Newswire / January 21, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company that is focused on rebalancing inflammation, announced that the Company has reached agreement with the FDA on an approval pathway for Gemini as a treatment for Acute Kidney Injury (AKI). The two key agreements were 1) a clinically relevant and objective composite endpoint comprising death and/or need for dialysis, and 2) positive data from a single well-controlled Phase 2/3 adaptive design clinical study, comprising approximately 300 patients, would be sufficient for submission of a new drug application (NDA). This agreement significantly advances Gemini toward becoming a paradigm altering treatment available for patients suffering from AKI, a significant unmet medical need.
"We are grateful for the collaborative feedback from FDA on the Gemini program, which provides us a clear and expedient path forward for seeking approval of Gemini as a treatment for AKI," said, James Rolke, Chief Executive Officer of Revelation. "As we enter this exciting phase of development, the Revelation team will remain focused on completing the key activities required for the successful execution of this pivotal study."
Revelation reached agreement with FDA on a single adaptive clinical study design with a clearly defined and achievable patient-centered endpoint. The advantage of an adaptive design Phase 2/3 study is the ability to transition rapidly from Phase 2 to Phase 3, with an opportunity to sufficiently power the Phase 3 portion of the study. The planned adaptive Phase 2/3 design will be a randomized, double-blind, placebo-controlled study, and will be comprised of two parts. Part 1 will evaluate different dosing regimens vs placebo and part 2 will be conducted as a Phase 3 study using the safest dosing regimen identified in part 1. Data from both part 1 and part 2 can be used in the primary and secondary endpoint analyses. The primary endpoint will be a composite of measures including death and/or the need for dialysis.
The American Hospital Association states that approximately 34 million people are admitted to US hospitals each year. It was found that 20% or approximately 6.8 million patients admitted to hospitals had AKI by the University of Florida. The CDC says Medicare in 2015 alone had an annual expenditure of over $10 billion and growing for AKI, with spending for AKI related costs of approximately $42,077 per patient. The only treatment for severe AKI is dialysis which increases the potential for worse outcomes including death, therefore Gemini could be the first available therapy for this significant unmet medical need. This data is an indication of how large the AKI market is and the potential for Gemini.
Over the course of 2026, Revelation will continue to build the infrastructure required to successfully conduct this clinical study, including engagement of a top-tier clinical research organization specializing in hospital-based renal studies, establishing an expert panel of scientific advisors, and completing the manufacture of clinical drug supply. Revelation is working expeditiously toward initiating the Phase 2/3 study.
About Gemini
Gemini is the Company's proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with Gemini rebalances the innate immune response and has been demonstrated to have the potential to treat acute and chronic diseases associated with dysregulated inflammation. Gemini is currently being evaluated as a potential treatment for acute kidney injury (GEM-AKI). Gemini is also being developed as a treatment for chronic kidney disease (GEM-CKD), as a treatment to reduce hyperinflammation and infection associated with severe burn (GEM-PBI), and as a treatment to prevent post-surgical infection (GEM-PSI). The potential of Gemini to correct dysregulated inflammation has been demonstrated in multiple preclinical models of AKI, CKD, and infection, as well as in two phase 1 clinical studies. See additional detail here.
About AKI
Acute Kidney Injury or AKI, also known as acute renal failure, is defined as a rapid loss of kidney function. AKI causes a build-up of waste products in blood and makes it more difficult for kidneys to maintain the correct balance of fluid in the body. AKI can also significantly impact other organs such as the brain, heart, and lungs. Severe AKI requiring dialysis significantly increases the likelihood of worse outcomes including longer time in an ICU, potential to develop chronic kidney disease, and death.
AKI is a major cause of morbidity and mortality, affecting more than 10% of all hospitalized patients and more than 50% of patients admitted to intensive care units. Renal replacement therapy (dialysis) is still the only therapeutic option in the treatment of the consequences of severe AKI and is required in approximately 20% of all critically ill patients. AKI is associated with high mortality rates, and even among those who survive, up to 40% later develop chronic kidney disease or progress to end-stage renal disease. As such, new therapies to treat AKI are urgently needed.
About Revelation Biosciences, Inc.
Revelation Biosciences, Inc. is a clinical stage life sciences company focused on rebalancing inflammation using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini as a treatment for acute kidney injury, a treatment of chronic kidney disease, prevention of post-surgical infection, and a treatment to reduce hyperinflammation and infection associated with severe burn.
For more information on Revelation, please visit www.RevBiosciences.com.
Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management's expectations and are only predictions or statements of current expectations and involve known and