TLR4

SAN DIEGO--( BUSINESS WIRE )--Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”) a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the prevention and treatment of disease, announced today new preclinical data on the potential therapeutic benefit of Gemini for the prevention of acute kidney injury (AKI) that was presented at the International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2024) taking place in San Diego on March 12-15, 2024. Gemini is the Company’s proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist, in development for prevention of AKI. A copy of the presentation and poster presented at the AKI and CRRT 2024 Conference can be found on Revelation’s website . Results from Bilateral Rat Model of Ischemia Reperfusion Induced AKI In a clinically relevant bilateral rat model of ischemia reperfusion (I/R) induced acute kidney injury (AKI), animals were dosed intravenously with PHAD at 0.07 or 0.35mg/kg at 24 hours and/or 48 hours prior to I/R surgery. In addition to clinical observation, rats were evaluated for markers of kidney function at 24 and/or 72 hours post-surgery, and markers of kidney damage at 72 hours post-surgery. In this model, Gemini pretreatment (0.35mg/kg) significantly: Preserved kidney function with a more rapid return to base line relative to untreated control animals, with statistically significant reductions in serum creatinine (p<0.01 at 24 hours, p<0.02 at 72 hours) and serum blood urea nitrogen (BUN) (p<0.02 at 72 hours). Reduced overall damage (necrosis) of the cortical (p<0.02) and medullary tubules (p<0.01) relative to the untreated group. Significantly reduced markers of local inflammation at 24 and/or 72 hours as measured by concentrations of urinary and serum c-reactive protein (CRP) (p<0.01) and IL-6 (p<0.05). Significantly reduced markers of cellular inflammation as observed via reduced neutrophilic inflammation with a single dose of 0.35mg/kg (p<0.02). The improved kidney function, reduced necrosis and reduced inflammatory biomarkers observed in this study are attributed to the immunostimulatory preconditioning effect of Gemini which includes strong upregulation of IL-10, a key cytokine responsible for resolution of inflammation. “These results demonstrate that Gemini has the potential to reduce tissue damage and improve kidney function in ischemic reperfusion induced acute kidney injury and potentially other inflammatory diseases,” said James Rolke, Chief Executive Officer of Revelation. “In addition to this, we are excited to have initiated our Phase 1 clinical study with Gemini in February 2024 and we look forward to starting studies in patients later this year.” About Gemini Gemini is a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) for systemic administration. It is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-SSI program), and as pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program). Revelation believes Gemini works through trained immunity, which redirects and attenuates the innate immune response to external stress (infection, trauma, etc.). Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications. About Revelation Biosciences Inc. Revelation Biosciences, Inc. is a life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including GEMINI-SSI as a prevention for post-surgical infection, GEMINI-AKI as a prevention for acute kidney injury, and GEMINI-CKD for the treatment of chronic kidney disease. 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 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.

– Prophylactic administration of Gemini (Intravenous PHAD®) reduces tissue damage and improves kidney function in a rat model of bilateral ischemic reperfusion induced acute kidney injury (AKI) - SAN DIEGO--(BUSINESS WIRE)-- Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”) a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the prevention and treatment of disease, announced today new preclinical data on the potential therapeutic benefit of Gemini for the prevention of acute kidney injury (AKI) that was presented at the International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2024) taking place in San Diego on March 12-15, 2024. Gemini is the Company’s proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist, in development for prevention of AKI. A copy of the presentation and poster presented at the AKI and CRRT 2024 Conference can be found on Revelation’s website. Results from Bilateral Rat Model of Ischemia Reperfusion Induced AKI In a clinically relevant bilateral rat model of ischemia reperfusion (I/R) induced acute kidney injury (AKI), animals were dosed intravenously with PHAD at 0.07 or 0.35mg/kg at 24 hours and/or 48 hours prior to I/R surgery. In addition to clinical observation, rats were evaluated for markers of kidney function at 24 and/or 72 hours post-surgery, and markers of kidney damage at 72 hours post-surgery. In this model, Gemini pretreatment (0.35mg/kg) significantly: Preserved kidney function with a more rapid return to base line relative to untreated control animals, with statistically significant reductions in serum creatinine (p<0.01 at 24 hours, p<0.02 at 72 hours) and serum blood urea nitrogen (BUN) (p<0.02 at 72 hours). Reduced overall damage (necrosis) of the cortical (p<0.02) and medullary tubules (p<0.01) relative to the untreated group. Significantly reduced markers of local inflammation at 24 and/or 72 hours as measured by concentrations of urinary and serum c-reactive protein (CRP) (p<0.01) and IL-6 (p<0.05). Significantly reduced markers of cellular inflammation as observed via reduced neutrophilic inflammation with a single dose of 0.35mg/kg (p<0.02). The improved kidney function, reduced necrosis and reduced inflammatory biomarkers observed in this study are attributed to the immunostimulatory preconditioning effect of Gemini which includes strong upregulation of IL-10, a key cytokine responsible for resolution of inflammation. “These results demonstrate that Gemini has the potential to reduce tissue damage and improve kidney function in ischemic reperfusion induced acute kidney injury and potentially other inflammatory diseases,” said James Rolke, Chief Executive Officer of Revelation. “In addition to this, we are excited to have initiated our Phase 1 clinical study with Gemini in February 2024 and we look forward to starting studies in patients later this year.” About Gemini Gemini is a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) for systemic administration. It is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-SSI program), and as pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program). Revelation believes Gemini works through trained immunity, which redirects and attenuates the innate immune response to external stress (infection, trauma, etc.). Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications. About Revelation Biosciences Inc. Revelation Biosciences, Inc. is a life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including GEMINI-SSI as a prevention for post-surgical infection, GEMINI-AKI as a prevention for acute kidney injury, and GEMINI-CKD for the treatment of chronic kidney disease. For more information on Revelation, please visit . 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 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.

-Top-line data including safety, tolerability, and biomarker activity anticipated this summer- -This Phase 1 clinical study data will support further development across multiple indications- SAN DIEGO--(BUSINESS WIRE)-- Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”) a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the prevention and treatment of disease, announced today that it has commenced a first in human Phase 1 clinical study (RVL-HV02) to evaluate escalating doses of intravenously administered Gemini. The study is being conducted in Australia and is enrolling healthy individuals 18 to 55 years of age. Top-line data including safety, tolerability, and biomarkers of target activity are expected this summer. Data from this Phase 1 clinical study will support future development across multiple indications. Gemini is the Company’s proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with PHAD potentially preconditions the innate immune system to respond to a subsequent stress, such as ischemia (loss of blood flow) or bacterial infection. Gemini is initially being developed for two target indications: as a pretreatment to prevent or reduce the severity of acute kidney injury (AKI) due to cardiac surgery and as a pretreatment to reduce the incidence, duration, and severity of post-surgical infection. Preclinical studies using models of AKI have demonstrated pretreatment with Gemini can reduce the severity and duration of AKI. Additionally, preclinical studies using models of bacterial infection have demonstrated pretreatment with PHAD can reduce the overall rate and severity of infection. “AKI is a significant and increasingly frequent health problem, especially in patients with co-morbidities such as diabetes. There are no approved therapies for preventing AKI.” said James Rolke, Chief Executive Officer of Revelation. “In addition, post-surgical infections and the continuous emergence of global antibiotic resistance necessitates the need for new therapies including those that can prevent infection. The start of this study is an important step toward bringing a potential new therapy for these unmet needs.” About Gemini Gemini is a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) for systemic administration. It is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-SSI program), as pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program). Revelation believes Gemini works through trained immunity, which redirects and attenuates the innate immune response to external stress (infection, trauma, etc.). Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications. About Revelation Biosciences Inc. Revelation Biosciences, Inc. is a life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including GEMINI-SSI as a prevention for post-surgical infection, GEMINI-AKI as a prevention for acute kidney injury, and GEMINI-CKD for the treatment of chronic kidney disease. For more information on Revelation, please visit . 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 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.