Core Viewpoint - Revelation Biosciences, Inc. will participate in the 38th Annual Roth Conference, highlighting its focus on rebalancing inflammation to optimize health [1][3]. Group 1: Company Overview - Revelation Biosciences, Inc. is a clinical-stage life sciences company that utilizes its proprietary formulation, Gemini, to address various health issues [3]. - The company is currently evaluating Gemini for multiple applications, including treatment for acute kidney injury, chronic kidney disease, prevention of post-surgical infection, and reduction of hyperinflammation and infection associated with severe burns [3]. Group 2: Conference Participation - James Rolke, the CEO, and Chester S. Zygmont, III, the CFO, will attend the Roth Conference on March 23rd and 24th, 2026, with a fireside chat scheduled for March 24 at 2:00 p.m. PT [1]. - The fireside chat will be available via live webcast and can be accessed later on the company's investor relations section of its website [2].

Financial Performance - Net loss for the three months ended December 31, 2025 was $2.5 million, or $(1.65) per share, compared to a net loss of $1.7 million, or $(59.76) per share for the same period in 2024[5] - Net loss for the year ended December 31, 2025 was $8.9 million, or $(23.95) per share, compared to a net loss of $15.0 million, or $(1,052.16) per share for the year ended December 31, 2024[5] - Total operating expenses for the year ended December 31, 2025 were $9.1 million, up from $8.0 million in 2024[12] Cash Position - As of December 31, 2025, Revelation had $10.7 million in cash and cash equivalents, an increase from $6.5 million as of December 31, 2024[4] - Net cash used for operating activities for the twelve months ended December 31, 2025 was $8.3 million, a significant decrease from $18.3 million for the same period in 2024[5] - The company believes its current cash and cash equivalents are sufficient to fund operations into the first quarter of 2027[4] Clinical Developments - Revelation announced positive results from the PRIME Clinical Study in late-stage chronic kidney disease patients[7] - Revelation is developing Gemini as a treatment for acute kidney injury and chronic kidney disease, with ongoing clinical evaluations[6] Equity Position - Total stockholders' equity increased to $8.9 million as of December 31, 2025, compared to $4.7 million in 2024[14] - The company received net proceeds of $6.7 million from a warrant inducement in January 2026[7]

Financial Condition - As of December 31, 2025, the company had an accumulated deficit of $49.4 million, indicating ongoing financial challenges [235]. - The company has incurred net losses since inception and does not anticipate generating revenue from product sales in the next couple of years [239]. - Current cash and cash equivalents are insufficient to sustain operations within one year, raising substantial doubt about the company's ability to continue as a going concern [236]. - The company may not be able to raise additional funding on acceptable terms, which could negatively impact its operations and product development efforts [240]. - The company is exposed to significant clinical study and product liability risks, which could adversely affect its financial condition and operations [375]. - The company is subject to significant increased expenses and administrative burdens as a public company, impacting its financial condition and results of operations [414]. Research and Development - The company expects to incur substantial and increasing operating losses over the next several years as research and development activities expand [235]. - The company anticipates significant increases in research and development expenses as it advances its Product Candidates through clinical studies and regulatory approval [241]. - The company has no products approved for marketing and is in the early stages of development for its Product Candidates, GEM-AKI and GEM-CKD [239]. - The company has not previously conducted pivotal clinical studies and may face challenges in executing necessary clinical studies for regulatory approval [253]. - Patient enrollment in clinical studies is critical, and difficulties in recruitment could lead to significant delays or abandonment of studies [255]. - The company may face delays in clinical studies due to various factors, which could harm the commercial prospects of its Product Candidates [247]. - The company relies on third parties for conducting certain elements of preclinical and clinical studies, which poses risks to obtaining regulatory approval [253]. - The company plans to rely on third-party manufacturers for commercial quantities of its Product Candidates, which may affect manufacturing capacity and lead to delays in regulatory approval or commercial launch [300]. Regulatory Challenges - The company must submit a diversity action plan to the FDA for any Phase 3 trial, which could affect planning and timing if not approved [254]. - Regulatory approval for product candidates may be delayed or limited, affecting commercialization timelines [264]. - Reductions in FDA staffing and changes in regulatory policy could adversely impact the approval process for product candidates [265]. - Disruptions at the FDA due to funding shortages or health concerns could hinder timely reviews and approvals, negatively impacting the company [272]. - The company faces ongoing regulatory obligations and reviews even after obtaining product approvals, which may require significant time and resources for compliance [275]. - Legislative or regulatory healthcare reforms may increase costs and complicate the approval process for product candidates [280]. Competition and Market Risks - The pharmaceutical industry is highly competitive, with competitors potentially offering more effective or cheaper products [281]. - Competitors with greater resources may hinder patient recruitment for the company's clinical studies, leading to further delays [256]. - The company may face significant competition in establishing commercial collaborations for its Product Candidates, which are essential for funding development and commercialization [367]. - The evolving regulatory landscape creates material uncertainty regarding manufacturing costs, which could adversely affect the company's business model and financial projections [361]. Intellectual Property - The company may face challenges in obtaining and maintaining effective patent rights for its Product Candidates, impacting competitive positioning [312]. - The patent prosecution process is costly and time-consuming, and there is uncertainty regarding the issuance and enforceability of patents, which may affect the company's ability to protect its intellectual property [317]. - The company faces significant challenges in enforcing intellectual property rights in foreign jurisdictions, particularly in developing countries, which may hinder the protection of patents and proprietary rights [321]. - Changes in U.S. and international patent law could weaken the company's ability to obtain and enforce patents, impacting the value of its intellectual property [333]. Operational Risks - The company relies on third-party manufacturers for raw materials and production, which poses risks if these suppliers fail to meet quality or quantity requirements [295]. - There is a significant reliance on a single supplier for certain raw materials, which could lead to delays in manufacturing if issues arise [298]. - The company may face challenges in managing third-party relationships for clinical studies, which could impact the timeline for regulatory approvals [293]. - The company expects to expend significant management resources to establish and maintain relationships with third parties, which may not guarantee timely fulfillment of obligations [307]. Compliance and Legal Risks - The company is subject to various healthcare fraud and abuse laws, and non-compliance could result in substantial penalties [279]. - Compliance with healthcare laws and regulations will involve substantial costs, and non-compliance could lead to significant penalties and reputational harm [382]. - The company is subject to U.S. and international export and import controls, which could impair its ability to compete in markets [390]. Human Resources - The company had 9 employees as of February 23, 2026, indicating a need for organizational expansion to support product development [343]. - The company anticipates needing to increase product development, scientific, and administrative headcount as it advances its product candidates and seeks regulatory approval [344]. - The company is highly dependent on retaining key personnel, and competition for qualified individuals in the biotechnology and pharmaceutical industries is intense [340]. Market Conditions - Unstable market conditions could adversely affect the company's financial performance and growth strategy, making financing more difficult and costly [389]. - The company may experience volatility in its common stock price due to various factors, including disappointing development results and changes in market conditions [402]. - The company has granted registration rights to stockholders, which may lead to future sales that could depress the market price of its common stock [405].

Core Viewpoint - Revelation Biosciences, Inc. will implement a 1-for-4 reverse stock split effective January 28, 2026, with trading under the existing symbol "REVB" starting on the same date [1]. Group 1 - The reverse stock split will reduce the number of outstanding shares by a factor of four [1]. - The reverse split is intended to increase the per-share price of the common stock [1]. - The effective date for the reverse stock split is set for the morning of January 28, 2026 [1].

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

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

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

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

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

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