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

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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.

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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.

News Market Reaction – REVB

+5.31% 2.0x vol
3 alerts
+5.31% News Effect
+$229K Valuation Impact
$4.54M Market Cap
2.0x Rel. Volume

On the day this news was published, REVB gained 5.31%, reflecting a notable positive market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $229K to the company's valuation, bringing the market cap to $4.54M at that time. Trading volume was elevated at 2.0x the daily average, suggesting notable buying interest.

Data tracked by StockTitan Argus on the day of publication.

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
8 metrics
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

Market Reality Check

Price: $1.1900 Vol: Volume 33,020 is below th...
low vol
$1.1900 Last Close
Volume Volume 33,020 is below the 20-day average of 68,586, indicating muted pre-news trading interest. low
Technical Price at $1.13 is trading below the 200-day MA of $5.71 and sits near the 52-week low of $1.1101 versus a 52-week high of $44.7699.

Peers on Argus

REVB was flat pre-announcement, while several biotech peers in screening (e.g., ...
4 Up

REVB was flat pre-announcement, while several biotech peers in screening (e.g., ELAB, SPRC, XRTX, SLXN) showed upside momentum, suggesting today’s clinical update is more stock-specific than part of a unified sector move.

Previous Clinical trial Reports

5 past events · Latest: Jan 07 (Positive)
Same Type Pattern 5 events
Date Event Sentiment Move Catalyst
Jan 07 GMP manufacturing Positive -1.1% Initiation of GMP manufacturing for Gemini and placebo for later-stage trials.
Nov 20 End-of-Phase 1 prep Positive -0.5% FDA acceptance of end-of-phase 1 package and PRIME safety/efficacy data update.
Sep 10 Top-line data webcast Positive +6.0% Announcement of special webcast reviewing positive PRIME clinical results for Gemini.
Sep 09 Top-line PRIME results Positive -17.4% Groundbreaking top-line PRIME data showing inflammation normalization and safety.
Feb 26 First patient dosed Positive -4.9% Initiation of dosing in PRIME Phase 1b Gemini study in CKD patients.
Pattern Detected

Clinical milestones for Gemini have frequently been followed by negative next‑day moves despite constructive trial updates, with only one of five recent clinical trial headlines producing a positive reaction.

Recent Company History

Over the past year, Revelation has steadily advanced Gemini through its PRIME Phase 1b study in CKD, from first dosing in Feb 2025 to top‑line data in Sep 2025 and subsequent GMP manufacturing initiation in Jan 2026. These updates highlighted safety, inflammation normalization and immunocompetence restoration, plus FDA engagement on the AKI pathway. Yet four of five tagged clinical trial releases saw negative 24‑hour price reactions, suggesting a pattern of selling into positive Gemini‑related news that frames today’s additional PRIME data.

Historical Comparison

-3.6% avg move · Past Gemini clinical-trial headlines moved the stock an average of -3.56% over 24 hours. Today’s PRI...
clinical trial
-3.6%
Average Historical Move clinical trial

Past Gemini clinical-trial headlines moved the stock an average of -3.56% over 24 hours. Today’s PRIME data release, with a pre-news move of 0%, fits within a generally muted-to-negative historical reaction profile.

Clinical-trial news shows a progression from first dosing in PRIME, to positive Phase 1b top-line data, to GMP manufacturing readiness, supporting advancement of Gemini toward pivotal AKI studies.

Regulatory & Risk Context

Active S-3 Shelf · $28,743,000
Shelf Active
Active S-3 Shelf Registration 2025-09-29
$28,743,000 registered capacity

An amended Form S-3/A shelf filed on 2025-09-29 registers shares underlying Class I warrants exercisable at $2.20 per share. If fully exercised for cash, the company could receive up to $28,743,000. The shelf is effective with at least one usage via a 424B3 filed on 2026-02-11, indicating an established framework to tap warrant-related capital.

Market Pulse Summary

The stock moved +5.3% in the session following this news. A strong positive reaction aligns with the...
Analysis

The stock moved +5.3% in the session following this news. A strong positive reaction aligns with the clearly favorable PRIME data showing Gemini normalizing cellular inflammation and restoring immunocompetence for up to 7 days after a single dose. Historically, Gemini trial news averaged a -3.56% move with mixed reactions, so a large gain would mark a break from prior selling into strength. Investors would need to weigh this against the existing capital structure, including warrant-driven funding capacity of up to $28,743,000 under the active shelf.

Key Terms

chronic kidney disease, acute kidney injury, peripheral blood mononuclear cells, toll-like receptor 4 agonist, +1 more
5 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.

AI-generated analysis. Not financial advice.

- 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

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.
Revelation Biosciences

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