Revelation Biosciences, Inc.

SAN DIEGO--( BUSINESS WIRE )--Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage biopharmaceutical company focused on harnessing the power of trained immunity for the prevention and treatment of disease by developing and commercializing therapeutics that modulate the innate immune system, today reported its three and six months ended June 30, 2024 financial results. Corporate Highlights Completed dosing of its first in human phase 1 clinical study of Gemini Announced positive phase 1 clinical data of Gemini met the primary safety endpoint and showed statistically significant biomarker activity “The Revelation team has worked hard in the first half of 2024 to continue to build the foundation for successful advancement of Gemini and we were excited to share that the primary endpoint to evaluate the safety and tolerability of escalating doses of Gemini was met, a maximum tolerated dose in healthy volunteers was identified and statistically significant dose dependent upregulation of key biomarkers was observed, demonstrating the immunostimulatory preconditioning effect of Gemini,” said James Rolke, Chief Executive Officer of Revelation. “During the second half of 2024, we look forward to building on this momentum with the start of a Phase 1b study in CKD patients.” Results of Operations As of June 30, 2024, Revelation had $12.1 million in cash and cash equivalents, compared to $12.0 million as of December 31, 2023. The increase in cash and cash equivalents was primarily due to net cash received from financing activities, offset primarily by cash used for operating activities. Based on current operating plans and projections, Revelation believes that its current cash and cash equivalents are sufficient to fund operations through 2024. Revelation’s net cash used for operating activities for the six months ended June 30, 2024 was $5.3 million compared to net cash used for operating activities of $3.6 million for the same period in 2023. Revelation’s net loss for the three months ended June 30, 2024 was $8.4 million, or $5.13 basic and diluted net loss per share compared to a net loss of $1.4 million, or $5.83 basic and diluted net loss per share for the same period in 2023. Revelation’s net loss for the six months ended June 30, 2024 was $11.1 million, or $8.13 basic and diluted net loss per share compared to net income of $4.7 million, or $24.52 basic net earnings per share and $23.89 diluted net earnings per share for the same period in 2023, respectively. 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-PSI 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 clinical stage 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 as a prevention for post-surgical infection, as a prevention for acute kidney injury, and 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. REVELATION BIOSCIENCES, INC. Condensed Consolidated Statements of Operations Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Operating expenses: Research and development $ 1,394,929 $ 909,278 $ 2,112,511 $ 1,434,551 General and administrative 1,127,468 1,023,752 2,312,024 2,118,326 Total operating expenses 2,522,397 1,933,030 4,424,535 3,552,877 Loss from operations (2,522,397 ) (1,933,030 ) (4,424,535 ) (3,552,877 ) Other income (expense): Change in fair value of warrant liability 4,416 423,239 72,843 8,168,174 Other income (expense), net (5,871,838 ) 61,621 (6,719,560 ) 95,728 Total other income (expense), net (5,867,422 ) 484,860 (6,646,717 ) 8,263,902 Net (loss) earnings $ (8,389,819 ) $ (1,448,170 ) $ (11,071,252 ) $ 4,711,025 Net (loss) earnings per share, basic $ (5.13 ) $ (5.83 ) $ (8.13 ) $ 24.52 Weighted-average shares used to compute net (loss) earnings per share, basic 1,635,234 248,369 1,362,534 192,149 Net (loss) earnings per share, diluted $ (5.13 ) $ (5.83 ) $ (8.13 ) $ 23.89 Weighted-average shares used to compute net (loss) earnings per share, diluted 1,635,234 248,369 1,362,534 197,167 REVELATION BIOSCIENCES, INC. Condensed Consolidated Balance Sheets June 30, 2024 December 31, 2023 ASSETS Current assets: Cash and cash equivalents $ 12,073,058 $ 11,991,701 Deferred offering costs — 71,133 Prepaid expenses and other current assets 125,743 84,691 Total current assets 12,198,801 12,147,525 Property and equipment, net 70,774 65,084 Total assets $ 12,269,575 $ 12,212,609 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 1,281,323 $ 1,359,898 Accrued expenses 8,454,139 1,152,460 Deferred underwriting commissions 1,382,848 2,911,260 Warrant liability 10,844 141,276 Total current liabilities 11,129,154 5,564,894 Total liabilities 11,129,154 5,564,894 Stockholders’ equity: Common Stock, $0.001 par value; 500,000,000 shares authorized at June 30, 2024 and December 31, 2023 and 1,643,395 and 264,537 issued and outstanding at June 30, 2024 and December 31, 2023, respectively 1,643 265 Additional paid-in-capital 37,677,132 32,114,552 Accumulated deficit (36,538,354 ) (25,467,102 ) Total stockholders’ equity 1,140,421 6,647,715 Total liabilities and stockholders’ equity $ 12,269,575 $ 12,212,609

-Gemini administration induced statistically significant, dose dependent changes in key biomarkers of activity- -Gemini was safe and well tolerated at pharmacologically active doses- -Phase 1 results enable 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, today announced safety and biomarker data for its Phase 1 clinical study (RVL-HV02). The primary endpoint to evaluate the safety and tolerability of escalating doses of Gemini was met and a maximum tolerated dose in healthy volunteers was identified. Additionally, statistically significant dose dependent upregulation of key biomarkers demonstrating the immunostimulatory preconditioning effect of Gemini were observed. The study, which enrolled 40 healthy individuals 18 to 55 years of age, was conducted in Australia and evaluated escalating doses (placebo, low, mid and high dose) of intravenously administered Gemini. This press release features multimedia. View the full release here: (Graphic: Business Wire) Administration of Gemini induced significant, dose dependent changes in key circulatory biomarkers of activity that reflect the expected pharmacology of Gemini-specific toll-like receptor 4 (TLR4) stimulation. Intravenous Gemini induced significant increases in interleukin-1RA (IL-1RA) (p<0.001 at mid and high dose, Figure 1), neutrophil gelatinase lipocalin (NGAL) (p<0.01 at mid and high dose, Figure 2), c-reactive protein (CRP) (p<0.001 at mid and high dose, Figure 3), and IL-6 (p<0.01 at high dose, Figure 4). Significant, dose dependent mobilization of innate immune cell populations was observed, specifically neutrophils (p<0.001 at mid-dose and high dose) and monocytes (p<0.001 at mid and high dose). Importantly, Gemini administration did not induce significant increases in serum TNF-α (p=0.51 at the highest dose) and IL-1β (p=0.89 at the highest dose). This attenuated pro-inflammatory activity and corresponding significant upregulation of beneficial cytokines is unique to Gemini and facilitates the reprogramming of the innate immune response for resolution of inflammation and promotion of the healing process. These changes in biomarkers are consistent with the changes observed in preclinical models in which Gemini demonstrated remarkable activity (ischemia/reperfusion model of acute kidney injury and unilateral ureteral obstruction model of kidney injury) and are highly predictive of clinical efficacy, thus demonstrating the potential for Gemini in our target indications including prevention of AKI following cardiac surgery and prevention of infection following surgery. Figures 1 through 4 illustrate the reprogramming of the innate immune response after Gemini administration in multiple biomarkers of TLR4 stimulation. IL-1RA has anti-inflammatory properties, as it binds to the IL-1 receptor, blocking IL-1α and IL-1β, major drivers of the inflammation cascade. NGAL sequesters iron and is an important defense for preventing excessive oxidative damage resulting from injury and/or ongoing inflammation. CRP plays an important role in resolving acute inflammation through increased phagocytosis, clearing cellular debris. IL-6 at low concentrations facilitates multiple activities associated with the resolution of inflammation, including stimulation of IL-1RA and IL-10. IL-10 levels trended higher with increasing dose but did not reach significance vs placebo (data not shown). While significance was not observed at the time points evaluated, IL-10 activity is inferred by the significant upregulation of IL-1RA as well as the lack of significant upregulation of TNF-α, as both activities are impacted by IL-10. Gemini administration was generally well-tolerated. The frequency and severity of adverse events corresponded with increased dose, with the mid-level dose being established as the maximum tolerated dose in healthy volunteers. Adverse events observed included transient headache, chills, body aches/pain, and vomiting, and are consistent with preclinical findings and the expected pharmacology of the drug. Gemini administration did not result in significant changes in clinical safety markers (e.g. markers of organ function including creatinine, BUN, etc.) or hematologic parameters (aside from immune cell mobilization). There were no clinically significant findings with other safety measures including vital signs, ECG, urinalysis and physical exam. These results and the maximum tolerated dose will be used to guide dose level selection in a planned randomized, placebo-controlled Phase 1b study in patients with chronic kidney disease. “We are pleased that the biomarker data generated in healthy volunteers is consistent with our preclinical studies. This confirms the potential utility of Gemini as a single-dose preconditioning therapy in our target indications.” said James Rolke, Chief Executive Officer of Revelation. “With this new data, we are excited and committed to moving rapidly into a Phase 1b study in patients late 2024.” For more information on Revelation, please visit . About Gemini 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 as a single dose preconditioning therapy for two target indications: as a pretreatment to prevent or reduce the severity of acute kidney injury due to cardiac surgery (GEMINI-AKI program) and as a pretreatment to reduce the incidence, duration, and severity of post-surgical infection (GEMINI-PSI program). In addition, Gemini has the potential to be a long-term 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.). Preclinical studies evaluating models of AKI or bacterial infection have demonstrated pretreatment with Gemini can reduce the severity and duration of AKI or bacterial infection, respectively. Additionally, preclinical studies evaluating a model of CKD demonstrate the potential of Gemini as a treatment to prevent kidney tissue scarring following the onset of severe inflammation. About the Phase 1 Study Data Analysis For all reported biomarkers except IL-1RA, the reported p-values were based on a two-tailed t-test assuming equal variances between data sets and an alpha of 0.05 for the peak change from baseline in treated subjects (by dose vs peak change in baseline in placebo subjects). For IL-1RA, a two-tailed t-test assuming equal variances between data sets and an alpha of 0.05 using a binary responder analysis of no change vs baseline and change vs. baseline was used. For each analysis there were 9 subjects in the placebo group, 12 subjects in the low dose group, 13 subjects in the mid dose group and 5 subjects in the high dose group. About Revelation Biosciences, Inc. Revelation Biosciences, Inc. is a clinical stage 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 as a prevention for post-surgical infection, as a prevention for acute kidney injury, and 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 forthcoming- 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 completed enrollment and dosing of its first in human Phase 1 clinical study (RVL-HV02). The study, which was conducted in Australia, evaluated escalating doses of intravenously administered Gemini and enrolled 40 healthy individuals 18 to 55 years of age. The forthcoming top-line data will include primary end points of safety and tolerability along with exploratory endpoints including multiple biomarkers of activity to demonstrate stimulation of the innate immune response. If positive, the data from this Phase 1 clinical study will support future program development of Gemini 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. “We are grateful to our investigator and the participants who enrolled in this study,” said James Rolke, Chief Executive Officer of Revelation. “Completion of our Phase 1 enrollment is a significant milestone for the advancement of Gemini to address multiple critical unmet needs, and we are looking forward to announcing the forthcoming topline safety and activity data soon.” For more information on Revelation, please visit . 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-PSI 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 clinical stage 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 as a prevention for post-surgical infection, as a prevention for acute kidney injury, and 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.