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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): January 17, 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:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 1/1,050th share of common stock at an exercise price of $12,075.00 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.

 


 

 

Item 5.07. Submission of Matters to a Vote of Security Holders.

On January 17, 2025, Revelation Biosciences, Inc. (the “Company”), held a special meeting of stockholders (the “Special Meeting”). At the Special Meeting, the stockholders voted and approved proposals to (1) grant discretionary authority to our board of directors to (i) amend our certificate of incorporation to combine outstanding shares of our common stock into a lesser number of outstanding shares, or a “reverse stock split,” at a specific ratio within a range of one-for-2 to a maximum of a one-for-50 split, with the exact ratio to be determined by our board of directors in its sole discretion; and (ii) effect the reverse stock split, if at all, within one year of the date the proposal is approved by stockholders, (2) approve the change of domicile of the Company from the State of Delaware to the State of Nevada, (3) approve the reservation and issuance of shares of our common stock pursuant to Class F Common Stock Warrants and Class G Common Stock Warrants (the “Warrants”), dated December 3, 2024, entered into between us and certain purchasers in connection with a warrant inducement letter dated the same date, to the extent that issuances under the Warrants may exceed 20% of the Company’s total outstanding shares, which could trigger the share issuance cap under Rule 5635(d) of the Nasdaq Stock Market Rules (the “Exchange Cap”) and (4) approve the adjournment of the Special Meeting to the extent there are insufficient proxies at the Special Meeting to approve the reverse stock split.

 

At the Special Meeting of the Company, a total of 4,139,607 shares of the Company’s common stock, out of a total of 6,464,219 shares of common stock issued and outstanding and entitled to vote at the Special Meeting, as of the record date for the Special Meeting, were present virtually, or represented by valid proxy at the Special Meeting, constituting a quorum.

As previously described in in the Company’s Proxy Statement, holders of the Company’s common stock were entitled to one vote per share on each of the four proposals. On Proposal 3, Sabby Volatility Warrant Master Fund, Ltd., Armistice Capital Master Fund Ltd. and Hudson Bay Master Fund Ltd. (the “Warrant Holders”) are holders of the Warrants (as defined in Proposal 3) are subject to the conversion limitation which is the subject of such proposal. Since they are interested stockholders with respect to such proposal, they have agreed to vote the shares of common stock in the same proportion that non-interested stockholders vote their shares of common stock. As an example, if 50.5% of the shares of common stock are voted FOR Proposal 3, 50.5% of the votes cast by the Warrant Holders will be cast as votes FOR Proposal 3.

 

The following proposals, each as described further in the Proxy Statement, were voted upon by the stockholders:

Proposal 1 Reverse Stock Split

Stockholders approved the board of directors to effect a Reverse Stock Split of the outstanding shares of our common stock within one (1) year of January 17, 2024, at a specific ratio within a range of one-for-2 to a maximum of a one-for-50 split, with the specific ratio to be fixed within this range by the board of directors in its sole discretion without further stockholder approval, based on the votes listed below:

For

Against

Abstain

3,955,277

162,665

21,665

There were no broker non-votes regarding this proposal.

 

Proposal 2 Change of Domicile

The proposal to change the Company's domicile from Delaware to Nevada, notwithstanding 97% of stockholders present voted in favor of the proposal, did not receive the required number of affirmative votes from the outstanding shares to pass at this time, based on the votes listed below:

For

Against

Abstain

2,956,575

73,597

20,134

 

There were 1,089,301 broker non-votes regarding this proposal.

 

 


 

Proposal 3 Approval of the Reservation and Issuance of Shares of Our Common Stock

Stockholders approved the reservation and issuance of shares of our common stock pursuant to the Warrants, dated December 3, 2024, entered into between us and certain purchasers in connection with a warrant inducement letter dated the same date, to the extent that issuances under the Warrants may exceed 20% of the Company’s total outstanding shares, which could trigger the Exchange Cap, based on the votes listed below:

For

Against

Abstain

2,370,106

410,665

269,535

 

There were 1,089,301 broker non-votes regarding this proposal.

 

Proposal 4 Discretionary Authority to adjourn the Special Meeting

Stockholders approved of the adjournment of the Special Meeting to the extent there are insufficient proxies at the Special Meeting to approve the reverse stock split, based on the votes listed below:

For

Against

Abstain

3,947,430

181,210

10,967

 

There were no broker non-votes regarding this proposal.

Item 8.01 Other Events.

On January 21, 2025, the Company issued a press release titled “Revelation Biosciences Starts its PRIME Phase 1b Clinical Study of Gemini in CKD Patients.” A copy of the press release is attached hereto 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

 

Press Release dated January 21, 2025

104

 

Cover Page Interactive Data File (embedded with the Inline XBRL document)


 

 

 


 

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:

January 21, 2025

By:

/s/ Chester S. Zygmont, III

 

 

 

Chester S. Zygmont, III
Chief Financial Officer
(principal financial and accounting officer)

 

 


img220778470_0.jpg

 

Revelation Biosciences Starts its PRIME

Phase 1b Clinical Study of Gemini in CKD Patients

 

– Dosing to Commence Mid-February –

 

– Topline data expected Mid-Year –

 

 

San Diego, CA – January 21, 2025 – Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the treatment of disease, announced today that it has started its PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of escalating doses of intravenously administered Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD). The US based multi-site placebo-controlled study will enroll up to forty patients in five cohorts of single escalating doses.

 

“I am delighted to see the Revelation teams’ hard work culminating with the start of the PRIME study.” said James Rolke, Chief Executive Officer of Revelation. “We look forward to the results and plan to educate the public over the next few months on the importance of the planned biomarkers as it relates to CKD treatment and prevention of AKI.”

 

Top-line data including safety, tolerability, and biomarkers of target activity are expected by mid-year. Data from the PRIME clinical study will support future development in both the GEM-CKD and GEM-AKI programs.

 

About AKI

 

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 have a significant impact on other organs such as the brain, heart, and lungs.

 

About CKD

 

Chronic kidney disease is a pervasive problem in the United States and world-wide. CKD is due to chronic inflammation and can be initiated and propagated in several ways. One prevalent condition is the high blood sugar levels associated with diabetes (either Type 1 or Type 2). High blood sugar is toxic to kidney cells creating stress which imitates the inflammatory process leading to the demise of these cells with subsequent fibrosis ultimately resulting in continuous loss of kidney function over time. High arterial blood pressure is another source of stress that initiates the inflammatory process leading to CKD. Other risk factors include heart disease, obesity, family history of CKD or older age. Progression of chronic kidney damage often leads to end stage renal disease with the need for renal replacement therapy (dialysis or transplantation), resulting in significant morbidity and mortality for affected patients. Kidney diseases are the leading cause of death in the United States.

 


About Gemini

 

Gemini is an intravenously administrated, proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) that reduces the damage associated with inflammation by reprograming the innate immune system to respond to stress (trauma, infection, etc.) in an attenuated manner. Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications. Earlier this year Revelation announced positive Phase 1 clinical data for intravenous treatment with Gemini. The primary safety endpoint was met in the Phase 1 study, and results demonstrated statistically significant pharmacodynamic activity as observed through expected changes in multiple biomarkers including upregulation of IL-10.

 

Gemini is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program), and as pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-PSI program). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program).

 

About Revelation Biosciences, Inc.

 

Revelation Biosciences, Inc. is a clinical stage life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including as a prevention for post-surgical infection, as a prevention for acute kidney injury, and for the treatment of chronic kidney disease.

 

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


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