The Fort Worth Press - Independent Market Assessment Results Show $94 Billion Total Addressable Market for Gemini in Stage 2 and Stage 3 Acute Kidney Injury

The independent market assessment evaluated Gemini for the treatment of Stage 2 and Stage 3 Acute Kidney Injury (AKI), 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 intensive care units (ICUs).

To conduct the rigorous and unbiased assessment, Revelation engaged a top-tier biopharma consulting firm that specializes in drug market access, pricing, and commercial strategy. The firm has worked on over 500 launch-related projects and with more than 300 clients, including most of the top 20 biopharmaceutical companies. Its expertise is not just from its experienced internal team, but also from its close ties to a network of current and former payers across major markets. Revelation selected the firm for its reputation for producing independent findings and its experience evaluating market opportunities for treatments in the hospital inpatient setting.

"The analysis and feedback from key hospital leaders in the report reinforce our conviction in the potential market opportunity for Gemini as well as what it can do for patients and the hospitals treating them," said James Rolke, Chief Executive Officer, Revelation Biosciences.

Findings from the independent analysis based on interviews with key Pharmacy and Therapeutics (P&T) committee members across multiple hospitals include:

• High unmet medical need and no FDA-approved treatment for AKI

• AKI incurs the highest medical expenditure in the USA after oncology and cardiovascular

• Severe AKI can cost hospitals $100,000 to over $300,000 per patient

• AKI is a key driver of hospital readmissions with current standard of care

• Medical professionals are highly interested in a new treatment for AKI

• Gemini should gain wide hospital formulary adoption

• Gemini's use in AKI would be supported by both clinicians and hospital economic decision makers

• "This is probably third highest expenditure in the country after oncology and cardiovascular." - Critical Care Nephrologist

• "There isn't really anything that treats this." - Regional Pharmacy Director of a large health system

• Regarding what the cost of Gemini could be: "I'd say anywhere from $50,000 to $75,000 would be good." - Rev Cycle Manager at a midsize health system

• "A new drug in development in this space would be a welcome drug." - Pharmacy Director of a large health system

• "But the problem is there's missing tools in the toolbox." - COO of a midsize hospital

"After our productive and very successful meeting with the FDA in December 2025, we have begun building the infrastructure to begin our Phase 2/3 study. Similar to earlier studies that showed Gemini significantly reduced cellular inflammation and restored immunocompetence without immunosuppression, we believe Gemini has the potential to treat the problem, not just mask their symptoms," Mr. Rolke concluded.

Some of the things the P&T committee members mentioned in the interviews include:

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 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 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 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: [email protected]

Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences, Inc.
Email: [email protected]

SOURCE: Revelation Biosciences, Inc.

View the original press release on ACCESS Newswire

A.Nunez--TFWP