REVELATION BIOSCIENCES INC

1 vavageord

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-K

(Mark One)

For thefiscal year ended December 31,2023

OR

For the transition period from to

Commission File Number:001-39603

(Exact Name of Registrant as Specified in its Charter)

Registrant’s telephone number, including area code: (650)800-3717

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

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes ☐No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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.☐

Indicate by check mark whether the registrant has fi led a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting fi rm that prepared or issued its audit report.☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No☒

The aggregate market value of voting common equity held by non-affiliates of the registrant was 7,314,347 as of June 30, 2023.

As of March 18, 2024, the registrant had 1,632,935 shares of common stock, $0.001 par value per share, outstanding.

EXPLANATORY NOTE

On January 25, 2024, we effected the approved 1-for-30 reverse stock split of our outstanding shares of common stock. Unless specifically provided otherwise herein, the share and per share information that follows in this Annual Report, reflects the effect of the reverse stock split.

On February 1, 2023, we effected the approved 1-for-35 reverse stock split of our outstanding shares of common stock.

On January 10, 2022, Petra Acquisition, Inc., a Delaware corporation and our predecessor company (“Petra”), consummated the business combination (the “Business Combination”), pursuant to the terms of the agreement and plan of merger, dated as of August 29, 2021 (the “Business Combination Agreement”), by and among Petra, Petra Acquisition Merger, Inc., a Delaware corporation and wholly-owned subsidiary of Petra (“Merger Sub”), and Revelation Biosciences, Inc. (“Old Revelation”). Pursuant to the Business Combination Agreement, on the Closing Date, (i) Merger Sub merged with and into Old Revelation (the “Merger”), with Old Revelation as the surviving company in the Merger, and, after giving effect to such Merger, Old Revelation was renamed Revelation Biosciences Sub, Inc. and became a wholly-owned subsidiary of Petra (“Revelation Sub”) and (ii) Petra changed its name to “Revelation Biosciences, Inc.” (“Revelation” or the “Company” f/k/a Petra Acquisition, Inc.).

FREQUENTLY USED TERMS

References in this Annual Report on Form 10-K, unless otherwise noted, “we,” “us,” “our,” “Revelation” and the “Company” refer to Revelation Biosciences, Inc. and its subsidiary.

In this document:

“AKI” means acute kidney injury.

“ANDA” means abbreviated new drug application.

“API” means Active Pharmaceutical Ingredient.

“Business Combination” means the business combination pursuant to the Business Combination Agreement.

“Business Combination Agreement” means the Agreement and Plan of Merger, dated as of August 29, 2021, by and among Petra, Merger Sub and Old Revelation.

“CCPA” means California Consumer Privacy Act.

“CDC” means Centers for Disease Control and Prevention.

“Charter” means Revelation’s current third amended and restated certificate of incorporation as filed with the Secretary of State of the State of Delaware on January 10, 2022.

“CKD” means chronic kidney disease.

“Class A Common Stock Warrant” means warrants issued as part of a private placement in January 2022 which are exercisable for one share of common stock at an exercise price of $3,454.50 per share until July 25, 2027.

“Class A Placement Agent Common Stock Warrant” means warrants issued as part of a private placement in January 2022 which are exercisable for one share of common stock at an exercise price of $3,454.50 per share until July 25, 2027.

“Class B Common Stock Warrant” means warrants issued as part of the July 2022 Public Offering which are exercisable for 1/1,050 of a share of common stock at an exercise price of $630.00 per share until July 28, 2027.

“Class B Placement Agent Common Stock Warrant” means warrants issued as part of the July 2022 Public Offering which are exercisable for one share of common stock at an exercise price of $787.50 per share until July 25, 2027.

“Class C Common Stock Warrant” means warrants issued as part of the February 2023 Public Offering which are exercisable for 1/30 of a share of common stock at an exercise price of $160.80 per share until February 14, 2028.

“Class D Pre-Funded Warrant” means warrants issued as part of the February 2024 Public Offering which are exercisable for one share of common stock at an exercise price of $0.0001 per share, which did not have an expiration date.

“Class D Common Stock Warrant” means warrants issued as part of the February 2024 Public Offering which are exercisable for one share of common stock at an exercise price of $4.53 per share until February 5, 2029.

“CMS” means Centers for Medicare & Medicaid Services.

“Common Stock” means common stock of Revelation, $0.001 par value.

“cGCP” or “GCP” means the current Good Clinical Practices.

“cGLP” or “GLP” means the current Good Laboratory Practices.

“cGMP” or “GMP” means the current Good Manufacturing Practices.

“CMO” means contract manufacturing organization.

“CRO” means contract research organization.

“DAMP” means damage-associated molecular patterns.

“DGCL” means the Delaware General Corporation Law.

“DSMB” means data safety monitoring board.

“EEA” means the European Economic Area.

“EMA” means the European Medicines Agency.

“EU” means the European Union.

“Exchange Act” means the Securities Exchange Act of 1934, as amended.

“FCA” means the False Claims Act.

“FDA” means the U.S. Food and Drug Administration.

“FDASIA” means Food and Drug Administration Safety and Innovation Act.

“FD&C Act” means Federal Food, Drug, and Cosmetic Act.

“FINRA” means Financial Industry Regulatory Authority.

“GAAP” refers to the generally accepted accounting principles in the United States.

“GEM-AKI” formerly known as REVTx-300, means Revelation’s therapeutic product candidate being developed as a treatment and prevention of acute kidney injury.

“GEM-CKD” formerly known as REVTx-300, means Revelation’s therapeutic product candidate being developed as a treatment and prevention of chronic kidney disease.

“GEM-SSI” formerly known as REVTx-100, means Revelation’s therapeutic product candidate being developed for the prevention and treatment of surgical site infections.

“GDPR” means the General Data Protection Regulation ((EU) 2016/679).

“HHS” means the U.S. Department of Health and Human Services.

“HIPAA” means the Health Insurance Portability and Accountability Act of 1996.

“IND” means Investigational New Drug Application.

“IPO” means our initial public offering, which was consummated on October 13, 2020.

“IRB” means institutional review board.

“JOBS Act” means the Jumpstart Our Business Startup Act of 2012, as amended.

“July 2022 Public Offering” means the Company’s public offering pursuant to the registration statement filed on Form S-1, and subsequently amended (File No. 333-266108), that closed on July 28, 2022 in which it sold 7,937 shares of its common stock for a price of $630.00 per share, 8,333,334 Class B Common Stock Warrants exercisable for 1/1,050 of a share of common stock with an exercise price of $630.00 per share and 556 Class B Placement Agent Common Stock Warrants exercisable for one share of common stock with an exercise price of $787.50 per share.

“February 2023 Public Offering” means the Company’s public offering pursuant to the registration statement filed on Form S-1, and subsequently amended (File No. 333-268576), that closed on February 13, 2023 in which it sold an aggregate of 96,287 shares of its common stock, pre-funded warrants to purchase up to an aggregate of 11,214 shares of common stock and 6,450,000 Class C Common Stock Warrants exercisable for 1/30 of a share of common stock with an exercise price of $160.80 per share, at a combined offering price of $144.90 per share of common stock and two Class C Common Stock Warrants, or $144.8970 per pre-funded warrant and two Class C Common Stock Warrants.

“February 2024 Public Offering” means the Company’s public offering pursuant to the registration statement filed on Form S-1, and subsequently amended (File No. 333-276232), that closed on February 5, 2024 in which it sold an aggregate of 128,470 shares of its common stock, pre-funded warrants to purchase up to an aggregate of 1,236,530 shares of common stock and 2,730,000 Class D Common Stock Warrants exercisable for a share of common stock with an exercise price of $4.53 per share, at a combined offering price of $4.53 per share of common stock and two Class D Common Stock Warrants, or $4.5299 per pre-funded warrant and two Class D Common Stock Warrants.

“LPS” means a major component of gram-negative bacterial cell membrane, lipopolysaccharide.

“MPLA” means monophosphoryl lipid A.

“MRSA” means methicillin-resistant Staphylococcus aureus resistant infection.

“Nasdaq” means The Nasdaq Stock Market, LLC.

“Nasdaq Capital Market” means The Nasdaq Stock Market, LLC’s Nasdaq Capital Market listing tier.

“NASH” means non-alcoholic steatohepatitis.

“NDA” means New Drug Application.

“PAMP” means pathogen-associated molecular patterns.

“Petra” means Petra Acquisition, Inc., our predecessor, prior to the Business Combination.

“PCT” means the Patent Cooperation Treaty.

“PHAD®” means phosphorylated hexaacyl disaccharide.

“PMA” means Premarket Approval Application.

“Private Warrants” means the warrants sold by Petra prior to its IPO.

“Program Products” refers to Revelation’s product candidates (GEM-SSI, GEM-AKI, and GEM-CKD).

“Public Warrants” means the warrants underlying the Units sold in the IPO.

“RSU” means restricted stock unit.

“SEC” means the United States Securities and Exchange Commission.

“Securities Act” means the Securities Act of 1933, as amended.

“Sunshine Act” means the Physician Payment Sunshine Act.

“SSI” means surgical site infection.

“TLR” means Toll-like receptors.

“TLR-4” means Toll-like receptor 4.

“Units” means units of Petra issued in our IPO consisting of one share of common stock and one Public Warrant, which traded on the Nasdaq Capital Market with the ticker symbol “REVBU” until their mandatory separation on January 13, 2023.

“USPTO” means U.S. Patent and Trademark Office.

FORWARD-LOOKING STATEMENTS

This Annual Report 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 potential impact that global health crises may have on Revelation’s suppliers, vendors, regulatory agencies, employees and the global economy as a whole; 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.

Risk Factors Summary

Risks Related to Our Business

•

We have a limited operating history and no products approved for commercial sale. We have incurred net losses since our inception, we anticipate that we will continue to incur significant losses for the foreseeable future, and even if we were to generate revenue, we may never achieve or maintain profitability.

i

Risks Related to the Product Development, Regulatory Approval, Manufacturing and Commercialization of Our Program Products and Product Candidates

•

If preclinical studies or clinical studies for our Program Products are unsuccessful or delayed, we will be unable to meet our future development goals.

•

The results of prior preclinical or clinical studies are not necessarily predictive of our future results.

•

The Clinical Studies of our Program Products’ have been and are planned to be conducted outside the United States, and the FDA or comparable foreign regulatory authorities may not accept data from such studies.

•

Our Program Products and the administration of our Program Products may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.

•

Our business depends on the success of our Program Products, including obtaining regulatory approval to market our product candidates in the United States and/or other major foreign markets such as the European Union.

•

Even if we obtain regulatory approval for a product candidate, our products and business will remain subject to ongoing regulatory obligations and review.

•

Legislative or regulatory healthcare reforms in the United States or other countries may make it more difficult and costly for us to obtain regulatory clearance or approval of our Program Products and to produce, market and distribute our Program Products after clearance or approval is obtained.

•

We face intense competition in an environment of rapid technological change and the possibility that our competitors may develop products and drug delivery systems that are similar, more advanced or more effective than ours, which may adversely affect our financial condition and our ability to successfully market or commercialize our Program Products.

Risks Related to our Reliance on Third Parties

•

We rely on third parties to conduct certain elements of our preclinical and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our Program Products.

•

We rely on third parties to manufacture the raw materials, including the active pharmaceutical ingredients that we use to create our therapeutic product candidate, and to manufacture the diagnostic devices, including the antibodies used for testing.

Risks Related to Our Intellectual Property

•

If we are unable to obtain and maintain effective patent rights for our product candidates or any future product candidates, we may not be able to compete effectively in our markets. If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us.

•

We may not be able to protect our intellectual property rights throughout the world.

•

We may not have sufficient patent lifespan to effectively protect our products and business.

•

If we are unable to maintain effective proprietary rights for our Program Products or any future product candidates, we may not be able to compete effectively in our markets.

Risks Related to Our Business Operations

•

Our future success depends in part on our ability to retain our senior management team, directors and other key employees and to attract, retain and motivate other qualified personnel.

ii

General Risk Factors

We are subject to several other risks of which other public companies are subject, including without limitation, the volatility of our common stock price; our ability to comply with corporate governance laws and financial reporting standards; and our ability to maintain an effective system of internal controls.

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