REVBW Revelation Biosciences Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 10, 2025

 

 

REVELATION BIOSCIENCES, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-39603	84-3898466
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
4660 La Jolla Village Drive Suite 100
San Diego, California				92122
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 800-3717

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, par value $0.001 per share		REVB		The Nasdaq Stock Market LLC
Redeemable warrants, each exercisable for a 1/16,800th share of common stock at an exercise price of $193,200.00 per share		REVBW		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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Item 8.01 Other Events.

On February 10, 2025, Revelation Biosciences, Inc. (the “Company”) made an updated corporate presentation available to the public, the corporate presentation can be found on the Company’s website. A copy of the presentation is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

 

The information in Item 8.01 and in Exhibit 99.1 will not be treated as “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. This information will not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or into another filing under the Exchange Act, unless that filing expressly incorporates this information by reference.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Corporate Presentation dated February 10, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

			REVELATION BIOSCIENCES, INC.
Date:	February 11, 2025	By:	/s/ Chester S. Zygmont, III
			Chester S. Zygmont, III Chief Financial Officer (principal financial and accounting officer)

 

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Rebalancing inflammation to optimize health NASDAQ: REVB www.revbiosciences.com

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This presentation 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 investors 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 risk that our preclinical studies will not demonstrate sufficient positive data to support commencement of clinical trials; 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 Gemini or any other 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; the ability of Revelation to obtain further financing 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. Forward-Looking Statements

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Gemini™ Platform 1 Gemini is our proprietary formulation platform intended to optimize PHAD’s route of administration appropriate for a specific condition 2 Initially focused on acute indications to leverage existing IND and acute clinical data

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Gemini Has Large Market Potential AKI $6 Billion 5M total patients CKD $9.25 Billion 37M total patients PSI $3.125 Billion 6.25M total patients MARKET $18+ Billion POTENTIAL

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How Gemini Works

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GEM-AKI and GEM-CKD Gemini For Acute Kidney Injury and Chronic Kidney Disease 6

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Gemini was well tolerated, induced trained immunity with significant anti-inflammatory cytokine up regulation Gemini stimulated a robust significant induction of IL-1RA and IL-10 Phase 1 biomarker data consistent with preclinical animal model data Positive Phase 1 Clinical Results in Healthy Volunteers P<0.0001 P<0.0001 P<0.0001 P<0.03 P<0.01 IL1RA IL-10

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PRIME – PRotective IMmunostimulatory Evaluation A Phase 1b, Randomized, Placebo Controlled, Single Blind, Single-Ascending Dose in Stage 3 and Stage 4 CKD Patients Design Single dose, dose escalation 5 cohorts, 8 subjects per cohort 1:4 placebo vs drug (up to 40 patients) Follow for 7 days Readouts Safety, tolerability, PK, and activity biomarkers Key biomarkers of activity: IL-10, IL-1RA, and TGF-b Demonstration of attenuated immune cell response to second stress Status Study Initiated Jan 2025 Topline data 1st half 2025 PRIME Phase 1b Clinical Study in CKD Patients

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GEM-PSI Gemini for Post-Surgical Infection 9

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Work with Vanderbilt shows faster clearance and increased survival from systemic infection after treatment with PHAD Similar data for gram negative bacteria DOI: 10.1097/CCM.0000000000003967 PHAD Pretreatment Protects Against Severe Systemic Infection S. Aureus Clearance Lung Kidney Spleen CFU/g CFU/g CFU/g Vehicle PHAD Vehicle PHAD Vehicle PHAD Survival after Intravenous S. aureus Percent Survival Days Post Infection Vehicle PHAD

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Financial Overview 11

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Relevant Market Information (as of 2/4/2025) Stock Price $4.46 Common Stock Outstanding 905,228 Market Cap $4.0M Fully Diluted Share Count 1,411,290 Financial Summary Balance Sheet and P&L (as of 12/12/2024) Cash $7.1 M Stockholders’ Equity $6.0 M Quarterly Burn Rate $2.2 M

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Enormous market potential ($18+ Billion) Experienced Management with multiple FDA approvals (8 approvals) Rapidly derisking the Gemini platform Product candidates that can significantly help many people Why You Should Invest in REVB

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Thank You! For more information, please visit www.revbiosciences.com 14

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Supplemental Information 15

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Gemini stimulates TLR4 via the TRIF pathway which is the anti-inflammatory pathway Gemini TLR4 stimulation trains the immune cells to tolerate future stress via an anti-inflammatory response The anti-inflammatory response is beneficial for many diseases/conditions including AKI, CKD, PSI and many more How Gemini Works

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Gemini administration in healthy animals resulted in Neutrophils migration from circulation with subsequent rebound Upregulation of IL-10 and IL-1RA, anti-inflammatory cytokines critical to resolution of inflammation Upregulation of IL-6, a necessary first step in the establishment of trained immunity Absent or minimal detection of IL-1b and TNF-a, key cytokines associated with chronic inflammation Gemini Induces TLR4 Innate Immune Response

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Treatment with Gemini resulted in a significant dose-dependent reduction in fibrosis 1DOI: 10.1093/ndt/15.suppl_6.72 Gemini Treatment Reduces Fibrosis in an AKI Model

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Reduction in fibrosis driven by reduced pro-inflammatory cytokines and increased anti-inflammatory cytokines TGF-β is pro-fibrotic and is directly linked to the propagation of fibrosis1 IL-10 is a key driver for the reduction and resolution of inflammation NGAL is an important defense for preventing excessive oxidative damage resulting from injury/ongoing inflammation 1DOI: 10.1093/ndt/15.suppl_6.72 Gemini Treatment Reduces Fibrosis in a CKD Model * P < 0.05 vs. group2 TGF-β IL-10 NGAL

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Pretreatment with Gemini significantly reduced multiple markers of local inflammation at 24 and/or 72 hours in urine Pretreatment with Gemini significantly reduced CRP at 72 hours in serum Pretreatment with Gemini also significantly reduced markers of cellular inflammation as observed via reduced neutrophilic inflammation Additional markers of reduced cellular inflammation observed Gemini’s Anti-Inflammatory Effect in an Ischemia/Reperfusion Model Urinary CRP at 24 hours Urinary IL-6 at 24 hours p<0.01 p<0.05 Neutrophilic Inflammation at 72 hours Serum CRP at 72 hours p<0.01 p<0.02

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Kidney Function at 24 and 72 hours Kidney Injury at 72 hours Gemini pretreatment significantly preserved kidney function with return to base line faster relative to untreated control animals Additional renal function findings included improved creatinine clearance and excretion relative to the untreated group Gemini reduced injury to the cortical and medullary tubules as measured by histopathology Gemini did not significantly lower cortical or medullary tubular degeneration or tubular protein casts relative to the untreated group Change in BUN Change in Creatinine p<0.02 p<0.02 p<0.04 Acute Cortical Tubular Necrosis Medullary Tubular Necrosis p<0.02 p<0.01 Gemini Reduces AKI in an Ischemia/Reperfusion Model

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PHAD Reduces AKI in a Unilateral Ischemia/Reperfusion Model DOI: 10.1152/ajprenal.00248.2022 Vanderbilt University ran the same preclinical model and got similar results

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PHAD Reduces AKI in a Bilateral Ischemia/Reperfusion Model DOI: 10.1152/ajprenal.00248.2022 Vanderbilt University ran the same preclinical model and got similar results

v3.25.0.1

Document And Entity Information	Feb. 10, 2025
Document Information [Line Items]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 10, 2025
Entity Registrant Name	REVELATION BIOSCIENCES, INC.
Entity Central Index Key	0001810560
Entity Emerging Growth Company	false
Entity File Number	001-39603
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	84-3898466
Entity Address, Address Line One	4660 La Jolla Village Drive
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92122
City Area Code	(650)
Local Phone Number	800-3717
Entity Information, Former Legal or Registered Name	Not Applicable
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Common Stock [Member]
Document Information [Line Items]
Title of 12(b) Security	Common stock, par value $0.001 per share
Trading Symbol	REVB
Security Exchange Name	NASDAQ
Redeemable Warrants, Each Exercisable For A 1/16,800th Share Of Common Stock At An Exercise Price Of $193,200.00 Per Share [Member]
Document Information [Line Items]
Title of 12(b) Security	Redeemable warrants, each exercisable for a 1/16,800th share of common stock at an exercise price of $193,200.00 per share
Trading Symbol	REVBW
Security Exchange Name	NASDAQ

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