The Albany Gazette - Revelation Biosciences, Inc. Releases Corporate Update Letter to Stockholders

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 Development

In 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; and

• Positive 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; and

• Lastly, 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 4^th 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 AKI

We 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 market

AKI 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 million

• We 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 AKI

• The 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 Opportunities

In 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 Operations

As 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 Thoughts

The 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, CEO

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

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