REVELATION BIOSCIENCES, INC.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-K

(Mark One)

For the fiscal year ended December 31,2025

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 filed 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 firm 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$3,418,594 as of June 30, 2025.

As of February 23, 2026, the registrant had 3,720,420 shares of common stock, $0.001 par value per share, outstanding.

EXPLANATORY NOTE

On January 28, 2026, we effected the approved 1-for-4 reverse stock split of our outstanding shares of common stock.

On July 7, 2025, we effected the approved 1-for-3 reverse stock split of our outstanding shares of common stock.

On January 28, 2025, we effected the approved 1-for-16 reverse stock split of our outstanding shares of common stock.

On January 25, 2024, we effected the approved 1-for-30 reverse stock split of our outstanding shares of common stock.

Unless otherwise indicated, all share and per-share amounts in this filing reflect the reverse stock splits.

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: 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 U.S. Food and Drug Administration (“FDA”), the European Medicines Agency (“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 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; 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 United States Securities and Exchange Commission (the “SEC”) by Revelation.

Risk Factors Summary

Risks Related to Our Business

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We are a clinical stage biotechnology company and have 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.

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Our audited financial statements contain a going concern qualification as we do not anticipate that our current cash and cash equivalents will be sufficient to sustain operations within one year after the date our audited financial statements for December 31, 2025 were issued, and we will need additional funding to continue our business. If we are unable to secure additional funding, we may be forced to delay, reduce or discontinue our development programs.

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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.

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

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If preclinical studies or clinical studies for our product candidates GEM-AKI and GEM-CKD (“Product Candidates”) are unsuccessful or delayed, we will be unable to meet our future development goals.

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

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Certain of the clinical studies of our Product Candidates 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.

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Significant reductions in FDA staffing and changes in federal regulatory policy may delay or adversely affect the approval and commercialization of our Product Candidates. Recent workforce reductions at the FDA have created uncertainty regarding review timelines, regulatory feedback, and the agency’s operational capacity, which could materially impact our development programs and ability to obtain timely approvals.

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Our Product Candidates and the administration of our Product Candidates 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.

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Compliance with amendments to the FDCA requiring diversity action plans for Phase 3 and pivotal clinical trials may delay initiation of our pivotal studies for GEM-AKI and GEM-CKD, increase enrollment challenges, or require additional time and resources to meet diversity goals, any of which could impact our development timelines.

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

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

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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 Product Candidates and to produce, market and distribute our Product Candidates after clearance or approval is obtained.

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Our Product Candidates, if approved, may not achieve adequate coverage or reimbursement from third‑party payors, and government healthcare reform and cost‑containment efforts could limit the prices we can charge and make our Product Candidates commercially non‑viable.

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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 Product Candidates.

Risks Related to our Reliance on Third Parties

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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 Product Candidates.

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We rely on third parties to manufacture the raw materials, including the active pharmaceutical ingredients that we use to create our Product Candidates.

Risks Related to Our Intellectual Property

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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.

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We may not be able to adequately protect or enforce our intellectual property rights, which could allow competitors to use our technology and reduce the value of our Product Candidates. Even if we obtain patents and other intellectual property protections, enforcing these rights can be expensive, time‑consuming and uncertain(particularly in foreign jurisdictions),and we may be unable to prevent third parties from infringing, misappropriating or otherwise challenging our intellectual property, which could harm our business.

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

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

Risks Related to Ownership of our Shares of Common Stock

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Our stock price has been and may continue to be highly volatile, which could result in substantial losses for investors.

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We will need additional financing to fund our development and clinical programs, and such financing may be unavailable on favorable terms or may be significantly dilutive to existing stockholders.

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The market value for our Common Stock is affected by our continued listing on Nasdaq. Nasdaq has proposed rules which could adversely affect the continued listing of the Company’s common stock.

General Risk Factors

We are subject to several other risks of which other public companies are subject, including without limitation, 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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