Revelation Biosciences Inc. Presents Additional Positive Data from Prime Clinical Study

Revelation Biosciences (NASDAQ:REVB) presented additional PRIME study data showing that a single dose of Gemini durably normalized cellular inflammation and restored immunocompetence in stage 3–4 CKD patient samples.

Rhea-AI Summary

Revelation Biosciences (NASDAQ:REVB) presented additional PRIME study data showing that a single dose of Gemini durably normalized cellular inflammation and restored immunocompetence in stage 3–4 CKD patient samples.

Key findings: >85% had elevated cytokines predose, >60% had IL-1b/IL-6 elevations, and Gemini reduced elevated cytokines and restored LPS responsiveness through 7 days post‑dose.

Positive

• >85% of patients had elevated cytokines predose
• >60% had elevated IL‑1b and IL‑6 predose
• Single Gemini dose normalized inflammation through 7 days
• Gemini restored LPS responsiveness in immunoparalyzed patients

Negative

• None.

Argus Mar 30 session

+5.31% close to close Open Argus

Details

News Market Reaction – REVB

On Mar 30, the day this news came out, REVB closed 5.31% above the previous close.

Data tracked by StockTitan Argus for the Mar 30 session.

Key Figures

Patients with elevated cytokine: >85% of CKD patients Elevated IL-1b and IL-6: >60% of patients Effect duration: 7 days +5 more

Patients with elevated cytokine

>85% of CKD patients

PRIME study baseline inflammatory status

Elevated IL-1b and IL-6

>60% of patients

Predose inflammatory cytokine profile in PRIME

Effect duration

7 days

Gemini normalization of inflammation after single dose

Immunoparalysis at baseline

>60% of patients

Non-responsive to stimulation predose in PRIME

Disease stages

Stage 3 and 4 CKD

Target population for PRIME Gemini study

52-week range

$1.1101–$44.7699

Pre-news 52-week low and high for REVB

Current price

$1.13

Pre-news share price on publication date

Shelf warrant proceeds

$28,743,000

Maximum cash if all registered Class I warrants exercised

Previous Clinical trial Reports

5 past events · Latest: Jan 07

Same Type 5 events

1. Jan 07

   GMP manufacturing

   24h Move

   -1.1%

   Initiation of GMP manufacturing for Gemini and placebo for later-stage trials.

2. Nov 20

   End-of-Phase 1 prep

   24h Move

   -0.5%

   FDA acceptance of end-of-phase 1 package and PRIME safety/efficacy data update.

3. Sep 10

   Top-line data webcast

   24h Move

   +6.0%

   Announcement of special webcast reviewing positive PRIME clinical results for Gemini.

4. Sep 09

   Top-line PRIME results

   24h Move

   -17.4%

   Groundbreaking top-line PRIME data showing inflammation normalization and safety.

5. Feb 26

   First patient dosed

   24h Move

   -4.9%

   Initiation of dosing in PRIME Phase 1b Gemini study in CKD patients.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

chronic kidney disease, acute kidney injury, peripheral blood mononuclear cells, toll-like receptor 4 agonist, +3 more

7 terms

chronic kidney disease medical

"in stage 3 and 4 chronic kidney disease (CKD) patients peripheral blood"

Chronic kidney disease is a long-term, progressive loss of kidney function that reduces the organs’ ability to filter waste, control fluid levels and balance body salts. For investors, CKD matters because it creates sustained demand for tests, drugs, dialysis machines and transplants; advances in treatment or regulatory decisions can meaningfully change revenue prospects for companies—like a car that needs ongoing repairs, it creates predictable, long-term market needs.

acute kidney injury medical

"for the treatment of acute and chronic inflammation-driven diseases such as acute kidney injury (AKI)"

A sudden decline in how well the kidneys remove waste and balance fluids, often developing over hours or days; think of it like an engine that abruptly loses power and can’t filter efficiently. It matters to investors because it can drive higher medical costs, alter clinical trial results, trigger regulatory scrutiny, lead to drug label changes or recalls, and affect revenue and liability for healthcare and life sciences companies.

peripheral blood mononuclear cells medical

"in stage 3 and 4 chronic kidney disease (CKD) patients peripheral blood mononuclear cells."

Peripheral blood mononuclear cells (PBMCs) are a mixed group of immune cells—like white blood cells—drawn from a blood sample that researchers use to study immune response, test vaccines, or develop cell-based therapies. They matter to investors because results derived from PBMC tests can indicate whether a drug or therapy is engaging the immune system as intended, much like a car’s dashboard lights reveal how well the engine components are working.

toll-like receptor 4 agonist medical

"phosphorylated hexaacyl disaccharide, a toll-like receptor 4 agonist, in development"

A toll-like receptor 4 (TLR4) agonist is a drug or compound that activates TLR4, a sensor on immune cells that detects danger and starts an immune response. Think of it as a key that turns on an alarm system to boost the body’s defenses; when used with vaccines or cancer drugs it can make them work stronger or longer. Investors care because TLR4 agonists can raise a therapy’s effectiveness, affect safety profiles, and influence regulatory approval and commercial value.

cytokine medical

"had at least one elevated cytokine predose and (>60%) of these patients"

Small proteins produced by cells that act as chemical messengers to coordinate immune and inflammatory responses, like text messages or traffic signals telling cells when to activate, calm down, or move. Investors care because cytokines are common drug targets and biomarkers; changes in cytokine activity can determine a therapy’s effectiveness, safety, regulatory approval, and market potential, so trial results or safety signals tied to cytokines often drive stock moves.

immunoparalysis medical

"(>60%) of patients were also found to be non-responsive to stimulation (immunoparalysis) predose."

Immunoparalysis is a state after severe infection, injury, or prolonged critical illness when the immune system becomes unusually weak and cannot mount normal defenses against new germs. For investors, it matters because it drives demand for diagnostics, therapies, and hospital resources, affects clinical trial outcomes and regulatory decisions, and can change a healthcare product’s market size and reimbursement prospects—think of it as a company’s safety team being temporarily shut down.

lps stimulation medical

"Gemini significantly restored normal responsiveness to LPS stimulation"

LPS stimulation is a laboratory test in which immune cells are exposed to lipopolysaccharide (LPS), a molecule from the outer wall of certain bacteria, to trigger an inflammatory response. Investors watch LPS stimulation results because they show whether a drug or therapy alters immune activation, helping predict safety, dosing and effectiveness; think of it as ringing a doorbell to see how strongly the immune system 'answers.'

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- A majority of CKD patients present with cellular inflammation and immunoparalysis predose -

-Gemini durably normalizes cellular inflammation and restores immunocompetence -

SAN DIEGO, CA / ACCESS Newswire / March 30, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company focused on innovative solutions for acute and chronic disease, presented additional positive data analysis from the PRIME Study at the International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2026) in San Diego (March 29 - April 1, 2026). Presented datademonstrated the capability of Gemini to normalize the hyperinflammatory state and restore immunocompetence up to 7 days after a single dose, in stage 3 and 4 chronic kidney disease (CKD) patients peripheral blood mononuclear cells. Gemini is the Company's proprietary formulation of phosphorylated hexaacyl disaccharide, a toll-like receptor 4 agonist, in development for the treatment of acute and chronic inflammation-driven diseases such as acute kidney injury (AKI) and CKD.

In the PRIME study, a majority of patients (>85%) had at least one elevated cytokine predose and (>60%) of these patients had elevated inflammatory cytokines IL-1b and IL-6. Treatment with Gemini significantly reduced the number of elevated cytokines at all measured timepoints post-dose out to 7 days (p<0.01 at 2 hours, p<0.02 at 24 hours, and p<0.03 at168 hours) following a single dose of Gemini verses no significant change in placebo. In addition, a majority (>60%) of patients were also found to be non-responsive to stimulation (immunoparalysis) predose. Gemini significantly restored normal responsiveness to LPS stimulation (p<0.02 at 24 hours, p<0.03 at 168 hours) and trended (p=0.06) to improved responsiveness to HMGB1. No significant responses were observed for placebo.

Acute and chronic inflammatory disease is driven by increased cytokine production, as a result of activation of innate immune cells. This dysregulation in cellular activity contributes to perpetuation and progression of disease. Data from the PRIME clinical study demonstrate that treatment with a single dose of Gemini can durably normalize inflammation at the cellular level, and restored immunocompetence.

"We are pleased to have had the opportunity to share our compelling clinical data for the treatment of inflammatory disease in this forum," said James Rolke, Chief Executive Officer of Revelation. "This engagement with key opinion leaders and health care providers treating AKI is another step in our effort to initiate our planned pivotal clinical study in AKI later this year."

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 program) and Revelation intends to initiate a pivotal Phase 2/3 clinical study in AKI later this year. In addition to AKI, Gemini is also being developed as a treatment for chronic kidney disease (GEM-CKD program). Due to its unique biology, Gemini has the potential to be a treatment for any disease associated with dysregulated inflammation. The potential of Gemini 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 AKI

Acute Kidney Injury or AKI, also known as acute renal failure, is defined as a rapid loss of kidney function. AKI causes a build-up of waste products in blood and makes it more difficult for kidneys to maintain the correct balance of fluid in the body. AKI can also significantly impact other organs such as the brain, heart, and lungs. Severe AKI requiring dialysis significantly increases the likelihood of worse outcomes including longer time in an ICU, potential to develop chronic kidney disease, and death.

AKI is a major cause of morbidity and mortality, affecting more than 20% of all hospitalized patients and more than 50% of patients admitted to intensive care units. Renal replacement therapy (dialysis) is still the only therapeutic option in the treatment of the consequences of severe AKI and is required in approximately 20% of all critically ill patients. Despite the fact that these patients show high mortality rates, up to 40% of patients who survive such an episode develop chronic kidney disease or end-stage renal disease. As such, new therapies to treat AKI are urgently needed.

About Revelation Biosciences, Inc.

Revelation Biosciences, Inc. is a clinical stage life sciences company focused on innovative solutions for acute and chronic disease using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including the treatment of acute kidney injury and chronic kidney disease. Gemini has the potential to treat any acute or chronic condition driven by dysregulated inflammation.

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.

Company Contacts

Mike Porter
Investor Relations
Porter LeVay & Rose Inc.
Email: mike@plrinvest.com

Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.com

SOURCE: Revelation Biosciences, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Revelation Biosciences (REVB) announce about the PRIME study on March 30, 2026?

They reported that a single Gemini dose durably normalized cellular inflammation and restored immune responsiveness through seven days. According to the company, results came from stage 3–4 CKD patient peripheral blood mononuclear cells presented at AKI & CRRT 2026.

How common were elevated cytokines in PRIME study patients according to REVB?

More than 85% of PRIME study patients had at least one elevated cytokine predose. According to the company, over 60% showed elevated inflammatory cytokines IL‑1b and IL‑6 before treatment.

What immune effect did a single Gemini dose produce in the PRIME study (REVB)?

A single Gemini dose significantly reduced the number of elevated cytokines and restored LPS responsiveness. According to the company, these effects persisted at all measured timepoints up to seven days post‑dose.

Does the PRIME data suggest Gemini could treat inflammation-driven kidney disease (REVB)?

The PRIME data indicate Gemini can normalize hyperinflammation and restore immunocompetence at the cellular level. According to the company, this supports development for acute and chronic inflammation‑driven diseases like AKI and CKD.

Will REVB start a pivotal AKI trial after PRIME results in 2026?

The company said it plans to initiate a planned pivotal AKI study later in 2026. According to the company, the AKI trial start is part of efforts following PRIME study engagement with key opinion leaders.