REVB 10-K & 10-Q changes, risk factors and insider trading

Unless the context otherwise requires, references herein to “ProgramProduct ProductsCandidates” refers to Revelation’s GEM-AKI, GEM-CKD,GEM-AKI and GEM-PSIGEM-CKD programs.

We are not profitable and have incurred net losses since our inception. As of December 31, 2024,2025, we had an accumulated deficit of $40.5$49.4 million. Consequently, predictions about our future success or viability may not be as accurate as they would be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products. We have spent, and expect to continue to spend, significant resources to fund research and development of, conduct clinical studies, and seek regulatory approvals for, our ProgramProduct Products,Candidates, and any future product candidates. We expect to incur substantial and increasing operating losses over the next several years as our research, development, preclinical testing and clinical study activities increase. As a result, our accumulated deficit will also increase significantly. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have, had and will continue to have a material adverse effect on our stockholders’ equity and working capital.

We have no products approved for marketing in any jurisdiction, and our ProgramProduct ProductsCandidates are in early stages of development. We have never generated any revenue from product sales. Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of and obtain the regulatory and marketing approvals necessary to commercialize one or more of our ProgramProduct Products.Candidates. We do not anticipate generating revenue from product sales in the next couple of years. Even if we eventually generate product revenue, we may never be profitable and, if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

Developing our ProgramProduct ProductsCandidates is expensive, and we expect our research and development expenses to increase substantially in connection with our ongoing activities, particularly as we advance our ProgramProduct ProductsCandidates through clinical studies, manufacturing and regulatory approval. We expect to finance future cash needs through public or private equity or debt offerings or product collaborations. We do not have any committed external source of funds. We cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all, and the terms of any financing may adversely affect the interests or rights of our stockholders. Even if we believe that we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations. The issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may affect the value of your investment.

significantly delay, scale back or discontinue research and discovery efforts and the development or commercialization of our Product ProgramsCandidates and future programproduct candidates or cease operations altogether;

Unfavorable global economic conditions, including any adverse macroeconomic conditions or geopolitical events, including the COVID-19 pandemic, the conflict between Ukraine and Russia, and recent bank failuresevents affecting the financial services industry, could adversely affect our business, financial condition, results of operations or liquidity, either directly or through adverse impacts on certain of the third parties on which we rely to conduct certain aspects of our preclinical studies or clinical trials.

Commercialization of Our Program Products and Product Candidates

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

Conducting clinical studies for any product candidates for approval in the United States requires filing an IND and reaching agreement with the FDA on clinical protocols, finding appropriate clinical sites and clinical investigators, securing approvals for such studies from the IRB at each such site, manufacturing clinical quantities of product candidates and supplying drug product or devices to clinical sites. Currently, we do not have an active IND with the FDA in the United States for our ProgramProduct Products.Candidates. If our IND is not approved by the FDA, our clinical development timeline may be negatively impacted, and any future clinical programs may be delayed or terminated.

Even if the clinical studies are approved by FDA or other regulatory agencies, clinical study is expensive and can take many years to complete, and its outcome is inherently uncertain. A failure of one or more of our clinical studies can occur at any time during the clinical study process. We do not know whether future clinical studies, if any, will begin on time, need to be redesigned, enroll an adequate number of patients on time or be completed on schedule, if at all. Clinical studies can be delayed, suspended or terminated for a variety of reasons, including failure to (i) generate sufficient positive preclinical and clinical data; (ii) recruit CROs, clinical investigators and patients in a timely manner; (iii) manufacture sufficient quantities at the required quality of ProgramProduct ProductsCandidates for use in clinical studies; (iv) raise sufficient capital to fund a study; (v) comply with all applicable regulatory requirements, whether in the United States or elsewhere, and (vi) obtain successful regulatory approval from regulatory authorities like the FDA.

If we experience delays in completing any clinical study of our ProgramProduct ProductsCandidates or successfully obtaining regulatory approval, the commercial prospects of our ProgramProduct ProductsCandidates may be harmed, and our ability to generate product revenues from any of these product candidates will be delayed. In addition, any delays in completing our clinical studies will increase our costs, slow down the development and approval process of our ProgramProduct Products,Candidates, and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may significantly harm our business and financial condition. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical studies may also ultimately lead to the denial of regulatory approval of our productProduct candidates.Candidates.

Drug development involves a lengthy and expensive process with uncertain timelines and uncertain outcomes, and the results of prior preclinical or clinical studies are not necessarily predictive of our future results. Our clinical studies may fail to adequately demonstrate the safety and efficacy of our ProgramProduct ProductsCandidates or any future product candidates.

We are focused on the development of GEM-AKI, GEM-CKD,GEM-AKI and GEM-PSIGEM-CKD which are in pre-clinical development working towards early clinical trials.development.

There is a high failure rate for product candidates proceeding through clinical studies. Failure can occur at any time during the clinical study process. Many companies in the pharmaceutical industry have suffered significant setbacks in late-stage clinical studies even after achieving promising results in preclinical testing and earlier-stage clinical studies. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejections as a result of many factors, including changes in regulatory policy during the development period of our ProgramProduct Products.Candidates. Success in preclinical testing and early clinical studies does not ensure that later clinical studies will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate. Frequently, product candidates that have shown promising results in early clinical studies have subsequently suffered significant setbacks in later clinical studies. If we are unable to successfully demonstrate the safety and efficacy of our ProgramProduct ProductsCandidates or other future product candidates and receive the necessary regulatory approvals, our business will be materially harmed.

The Clinical Studies of our ProgramProduct Products’Candidates’ have been and are planned to be conducted outside the United States, and the FDA or comparable foreign regulatory authorities may modify their regulatory pathway or conditions previously agreed upon, or may not accept data from such studies.

WeAdditionally, we currently haveconduct not conducted any clinical studies in the United States to date. We have conducted and weor plan to conduct additional clinical studies outside the United States, including Europe, Australia, orand other foreign jurisdictions. The acceptance of clinical study data by the FDA from clinical studies conducted outside the United States may be subject to certain conditions. In cases where data from clinical studies conducted outside the United States are intended to serve as the sole bases for regulatory approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the United States population and United States medical practices, (ii) the studies were performed by clinical investigators of recognized competence and (iii) the data may be considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Additionally, the FDA’s clinical study requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory bodies have similar approval requirements. In addition, such foreign studies would be subject to the applicable local laws of the foreign jurisdictions where the studies are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from studies conducted outside of the United States or the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional studies, which would be costly and time-consuming and delay aspects of our business plan, and may result in our Program Products’ not receiving regulatory approval or clearance for commercialization in the applicable jurisdiction.

As an organization, we have never conducted pivotal clinical studies, and we may be unable to do so for any Programproduct Productscandidates we may develop.

We will need to successfully complete pivotal clinical studies in order to obtain the approval of the FDA, the EMA or other regulatory agencies to market any of our ProgramProduct Products.Candidates. Carrying out later-stage clinical studies and the submission to the FDA of a successful NDA is a complicated process. As an organization, we have not previously conducted any later stage or pivotal clinical studies and have limited experience in preparing, submitting and prosecuting regulatory filings. We may be unable to conduct clinical studies at preferred sites, enlist clinical investigators, enroll sufficient numbers of participants or begin or successfully complete clinical studies in a timely fashion, if at all. In addition, the design of a clinical study can determine whether its results will support approval of a product, and flaws in the design of a clinical study may not become apparent until the clinical study is well advanced. Because we have limited experience as a company designing clinical studies, we may be unable to successfully and efficiently execute and complete necessary clinical studies in a way that leads to successful regulatory submission and approval. We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop. Failure to commence or complete, or delays in, our planned clinical studies, could prevent us from or delay us in commercializing our ProgramProduct Products.Candidates. 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 ProgramProduct Products.Candidates.

Identifying and qualifying patients to participate in clinical studies of our productProduct candidatesCandidates is critical to our success. The timing of our clinical studies depends in part on the speed at which we can recruit patients to participate in testing our ProgramProduct Products,Candidates, and we may experience delays in our clinical studies if we encounter difficulties in enrollment. Patient enrollment and retention in clinical studies depends on many factors, including the size of the patient population, number and location of the clinical sites, significant adverse events or other side effects observed, if any, the nature of the study protocol, our ability to recruit clinical study investigators with the appropriate competencies and experience, the existing body of safety and efficacy data with respect to the study drug, the number and nature of competing treatments and ongoing clinical studies of competing drugs for the same indication, the proximity of patients to clinical sites, clinicians’ and patients’ perceptions as to the potential advantages of the ProgramProduct ProductsCandidates being studied in relation to other available therapies, including any drugs that may be approved for the indications we are investigating, the eligibility criteria for the study, our ability to obtain and maintain patient consents and the risk that patients enrolled in clinical studies will drop out of the studies before completion.

Our inability to enroll a sufficient number of patients for our clinical studies would result in significant delays or may require us to abandon one or more clinical studies altogether. If we are unable to enroll sufficient number of patients that will complete clinical testing, we will be unable to seek or gain marketing approval for our ProgramProduct ProductsCandidates and any future product candidates and our business will be harmed. Even if we are able to enroll a sufficient number of patients in our clinical studies or studies, delays in patient enrollment may result in increased costs or may affect the timing or outcome of our clinical studies, which could prevent completion of these studies and adversely affect our ability to advance the development of our ProgramProduct ProductsCandidates and any future product candidates.

Our ProgramProduct ProductsCandidates and the administration of our ProgramProduct ProductsCandidates 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.

The severity and frequency of undesirable side effects caused by our ProgramProduct Products,Candidates, could cause us or regulatory authorities to interrupt, delay or halt clinical studies and could result in a more restrictive label, delay or denial of regulatory approval by the FDA or other regulatory agencies. Results of our studies could reveal a high and unacceptable severity and prevalence of these or other side effects. In such an event, our clinical studies could be suspended or terminated, and the FDA or other regulatory agencies could order us to cease further development of or deny or withdraw approval of our productProduct candidatesCandidates for any or all targeted indications. Moreover, during the conduct of clinical studies, patients report changes in their health, including illnesses, injuries and discomforts, to their study doctor. Often, it is not possible to determine whether or not the product candidate being studied caused these conditions.

Drug-related, drug product-related, formulation-related and administration-related side effects could affect patient recruitment, the ability of enrolled patients to complete the clinical study or result in potential product liability claims, which could exceed the insurance coverage. Additionally, if one or more of our ProgramProduct ProductsCandidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result.

If we or others identify undesirable or unacceptable side effects caused by our ProgramProduct ProductsCandidates or any future product candidates or products:

In addition, adverse changes between interim data and final data could significantly harm our business and prospects. Additional disclosure of interim data by us or by our competitors in the future could also result in volatility in the price of our common stock after this offering. Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our Company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical study is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise, appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular drug, drug candidate or our business. If the topline data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our ProgramProduct ProductsCandidates or any future product candidates may be harmed, which could harm our business, financial condition, results of operations and prospects.

Even if we complete the necessary clinical studies, we cannot predict when, or if, we will obtain regulatory approval to commercialize any of our ProgramProduct Products,Candidates, and the approval may be for a more narrow indication than we seek or be subject to other limitations or restrictions that limit its commercial profile.

Our ProgramProduct ProductsCandidates have not received regulatory approval. We do not expect our ProgramProduct ProductsCandidates or any future product candidate to be commercially available for years, if at all. Our ProgramProduct ProductsCandidates are, and any future product candidate will be subject to strict regulation by regulatory authorities in the United States and in other countries. We cannot commercialize a product candidate or diagnostic device until the appropriate regulatory authorities have reviewed and approved such product candidate or diagnostic device. Even if our current or future ProgramProduct ProductsCandidates meet safety and efficacy endpoints in pivotal clinical studies, the regulatory authorities may not complete their review processes in a timely manner, or we may not be able to obtain regulatory approval. Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval. This may include approval of a product candidate for more limited indications than requested or they may impose significant limitations in the form of warnings. In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during the period of product development, clinical studies and the review process.

Our business depends on the success of our ProgramProduct Products,Candidates, including obtaining regulatory approval to market our productProduct candidatesCandidates in the United States and/or other major foreign markets such as the EU.

We are focusing our time and financial resources in the clinical development of GEM-AKI, GEM-CKD,GEM-AKI and GEM-PSI.GEM-CKD. If we cannot successfully develop, obtain regulatory approval for, and commercialize our ProgramProduct Products,Candidates, we may not be able to continue our operations. The future regulatory approval and commercial success of our ProgramProduct ProductsCandidates are subject to a number of risks, including the following:

we may not have sufficient financial and other resources to complete the necessary clinical studies for our ProgramProduct Products,Candidates, including, but not limited to, the clinical studies needed to obtain regulatory approval for commercialization;

we may not be able to obtain adequate evidence from our clinical studies for our ProgramProduct ProductsCandidates;

we cannot be certain of the number of types of clinical studies and non-clinical studies that the regulatory agencies will require in order to approve our ProgramProduct ProductsCandidates;

patients in our clinical studies may suffer serious adverse events for reasons that may or may not be related to our ProgramProduct Products,Candidates, which could delay or prevent further clinical development;

the regulatory agencies may not approve the formulation, labeling or specifications of GEM-AKI,GEM-AKI or GEM-CKD, GEM-PSI, or other future product candidates;

if approved, our ProgramProduct ProductsCandidates will likely compete with products that may reach approval for the same indication or use prior to our ProgramProduct Products,Candidates, products that are currently approved and the products that are currently marketed products; and we may not be able to obtain, maintain or enforce our patents and other intellectual property rights.

Of the large number of drugs and devices in development in the pharmaceutical industry, only a small percentage results in the submission of a marketing authorization to the FDA or comparable foreign regulatory authorities and even fewer are approved for commercialization. Furthermore, even if we do receive regulatory approval to market our ProgramProduct Products,Candidates, any such approval may be subject to limitations on the indicated uses or patient populations for which we may market the products. Accordingly, even if we are able to obtain the requisite financing to continue to fund our development programs, we may be unable to successfully develop or commercialize our ProgramProduct Products.Candidates.

If we or any of our future development collaborators are unable to develop, or obtain regulatory approval for, or, if approved, successfully commercialize our ProgramProduct Products,Candidates, we may not be able to generate sufficient revenue to continue our business.

Disruptions at the FDA and other national and foreign government authorities caused by funding shortages or global health concerns, such as COVID-19,concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.

The ability of the FDA and comparable foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s and foreign regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s and comparable foreign regulatory authorities’ ability to perform routine functions. Average review times at the FDA and comparable foreign regulatory authoritiesauthorities, at times, have fluctuated in recent years as a result. In addition, government funding of other government authorities that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other national and foreign authorities also may slow the time necessary for new biologics or modifications to approved biologics to be reviewed and/or approved by necessary government authorities, which would adversely affect our business. For example, over the last several years, including for 35 days beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory authorities, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

Separately, in response to the COVID-19 pandemic, in March 2020, the FDA announced its intention to postpone most inspections of foreign manufacturing facilities, and on March 18, 2020, the FDA temporarily postponed routine surveillance inspections of domestic manufacturing facilities. Subsequently, in July 2020, the FDA resumed certain on-site inspections of domestic manufacturing facilities subject to a risk-based prioritization system. The FDA utilized this risk-based assessment system to assist in determining when and where it was safest to conduct prioritized domestic inspections. Additionally, onOn April 15, 2021, the FDA began conducting voluntary remote interactive evaluations of certain drug manufacturing facilities and clinical research sites, among other facilities in circumstances where the FDA determines that such remote evaluation would be appropriate based on mission needs and travel limitations. In May 2021, the FDA outlined a detailed plan to move toward a more consistent state of inspectional operations, and in July 2021, the FDA resumed standard inspectional operations of domestic facilities. Since that time, the FDA has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as it adapts to the evolving COVID-19 pandemic.

Regulatory authorities outside the United States have adopted similar restrictions or other policy measures in response to the COVID-19 pandemic. If aanother prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Even if our ProgramProduct ProductsCandidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, distribution, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal and state requirements in the United States and comparable requirements outside of the United States. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, quality of product or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring recall or withdrawal of the product from the market.

If one or more of our ProgramProduct ProductsCandidates is approved for marketing in the United States or other countries, we may be subject, directly or indirectly, to United States or other countries equivalent federal and state healthcare fraud and abuse laws, false claims laws, physician payment transparency laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

Even if we obtain FDA or other comparable regulatory agencies approval for any of our ProgramProduct ProductsCandidates and begin commercializing those products in the United States or other countries, our operations may be directly or indirectly through our relationships with physicians, patients, third-party payors and customers, subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our business or financial arrangements and relationships through which we research, market, sell and distribute our ProgramProduct Products.Candidates. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include, among others, the United States Anti-Kickback Statute, the False Claims Act, the United States Health Insurance Portability and Accountability Act of 1996, and the Sunshine Act and analogous state laws. Ensuring that our internal operations and business arrangements with third parties comply with all applicable healthcare laws and regulations will likely be costly.

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 ProgramProduct ProductsCandidates and to produce, market and distribute our ProgramProduct ProductsCandidates after clearance or approval is obtained.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory clearance or approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA or other comparable regulatory agencies regulations and guidance are often revised or reinterpreted by the FDA or other comparable regulatory agencies in ways that may significantly affect our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of our ProgramProduct Products.Candidates. We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future.

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 ProgramProduct Products.Candidates.

The pharmaceutical industry in which we operate is intensely competitive and subject to rapid and significant technological change. We are currently aware of various existing therapies in the market and in development that may in the future compete with our ProgramProduct Products.Candidates.

Revelation is a clinical-stage life science company that is focused on rebalancing inflammation to optimize health using its proprietary formulation Gemini. We are developing a pipeline of potential high-value products based on Gemini. Gemini is our proprietary formulation of PHAD an established TLR4 agonist that can stimulate the human body’s innate immune response to prevent and treat disease. Our current Gemini based programs consist of: GEM-AKI, which is being developed as a potential therapy for the prevention and treatment of acute kidney injury; and GEM-CKD, which is being developed as a potential therapy for the prevention and treatment of chronic kidney disease; and GEM-PSI, which is being developed for the prevention and treatment of post surgical infection.disease.

Since our inception, we have devoted substantially all of our resources to organizing and staffing our Company, business planning, raising capital, and research and development of GEM-AKI, GEM-CKD and GEM-PSI, our productProduct candidates.Candidates.

We have funded our operations since our inception to December 31, 20242025 through the issuance and sale of our capital stock, from which we have raised net proceeds of $56.7$69.2 million. Our current cash and cash equivalents balance will not be sufficient to complete all necessary product development or future commercialization efforts. We anticipate that our current cash and cash equivalents balancebalance, which includes approximately $10.7 million as of December 31, 2025, combined with approximately $6.7 million in net proceeds received in January 2026 in connection with a warrant inducement transaction, will not be sufficient to sustain operations within one-year after the date that our audited financial statements for December 31, 20242025 were issued, which raises substantial doubt about our ability to continue as a going concern.

We have incurred recurring losses since our inception, including a net loss of $8.9 million for the year ended December 31, 2025 and $15.0 million for the year ended December 31, 2024 and $0.1 million for the year ended December 31, 2023, respectively.2024. As of December 31, 20242025 we had an accumulated deficit of $40.5$49.4 million. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future if and as we:

We have never generated revenue and do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for GEM-AKI,our GEM-CKD,Product GEM-PSICandidates or other product candidates, which we expect will not be for at least several years, if ever. Accordingly, until such time as we can generate significant revenue from sales of GEM-AKI,Product GEM-CKD, GEM-PSICandidates or other product candidates, if ever, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

On January 28, 2025,2026, the Company effected a 1-for-161-for-4 reverse stock split of our outstanding shares of common stock, which had been approved at athe special2025 annual meeting of stockholders.stockholders on June 23, 2025. All share numbers included herein have been adjusted to reflect this reverse split.

Research and development expenses consist primarily of costs incurred for the development of our product candidates GEM-AKI, GEM-CKD and GEM-PSI.candidates. Our research and development expenses consist primarily of external costs related to clinical development, costs related to contract research organizations, costs related to consultants, costs related to acquiring and manufacturing clinical study materials, costs related to contract manufacturing organizations and other vendors, costs related to the preparation of regulatory submissions, costs related to laboratory supplies and services, and personnel costs. Personnel and related costs consist of salaries, employee benefits and stock-based compensation for personnel involved in research and development efforts.

We expect our research and development expenses to increase substantially for the foreseeable future as we continue the development of GEM-AKI,Product GEM-CKD and GEM-PSICandidates and continue to invest in research and development activities. The process of conducting the necessary clinical research and product development to obtain regulatory approval is costly and time consuming, and the successful development of GEM-AKI,Product GEM-CKD and GEM-PSICandidates and any future product candidates is highly uncertain. To the extent that our product candidates continue to advance into larger and later stage clinical studies, our expenses will increase substantially and may become more variable.

The actual probability of success for GEM-AKI,Product GEM-CKD and GEM-PSICandidates or any future product candidate may be affected by a variety of factors, including the safety and efficacy of our product candidates, investment in our clinical programs, manufacturing capabilitycapability, regulatory and staffing developments at the FDA and competition with other products. As a result, we are unable to determine the timing of initiation, duration and completion costs of our research and development efforts or when and to what extent we will generate revenue from the commercialization and sale of GEM-AKI,Product GEM-CKD and GEM-PSICandidates or any future product candidate.

Other Income (Expense) Income,, Net

Other income (expense) income,, net for 2025 primarily consists of the interest income from our cash balances in savings accounts, foreign currency transaction gains and losses, and the change in fair value of the warrant liability,liability. During 2024, other income (expense), net also included the LifeSci Capital LLC judgment expense and reimbursement of legal costs, clinical trial related settlement expenses with A-IR Clinical Research Ltd., foreign currency transaction gainsLtd, and losses, interest expense and interest income from our cash balancesexpenses in savingsconnection accounts.with the deferred underwriting commissions.

Research and development expenses decreasedincreased by $0.6$0.5 million, from $3.5 million for the year ended December 31, 2024 to $4.1 million for the year ended December 31, 2023 to $3.5 million for the year ended December 31, 2024.2025. The decreaseincrease was primarily due to decreases of $2.1 million in other program expenses and $0.3 million in manufacturing expenses, offset by increases of $1.5$0.5 million in clinical study expenses related to GEM-AKI,GEM-AKI and GEM-CKD and GEM-PSI$0.4 andmillion $0.5of personnel expenses, offset by a decrease of $0.4 million in personnelmanufacturing expenses. Other program expenses include pre-clinical costs and clinical preparation costs primarily for programs GEM-AKI, GEM-CKD and GEM-PSI.

General and administrative expenses decreasedincreased by $0.1$0.6 million, from $4.5 million for the year ended December 31, 2023 to $4.4 million for the year ended December 31, 2024.2024 to $5.0 million for the year ended December 31, 2025. The decreaseincrease was primarily due to a decrease of $0.6 million in legal and professional fees, offset by an increase of $0.5 million in legal and professional fees and an increase of $0.3 million in personnel expenses, offset by a $0.1 million decrease in other general and administrative expenses.

Other Income (Expenseexpense) Income,, Net

Other income (expense) income,, net was $8,536,410income of $0.2 million for the year ended December 31, 2023,2025, related primarily to the change in fair value of the warrant liability, foreign currency transaction gains and losses, and interest income fromon our cash balances in savings accounts.accounts and foreign currency transactions gains and losses. Other income (expense) income,, net was ($7,063,427)expense of approximately $7.1 million for the year ended December 31, 2024, primarily related to the LifeSci Capital LLC judgment expense and reimbursement of legal costs, clinical trial related settlement expenses with A-IR Clinical Research Ltd.Ltd., and expenses in connection with the deferred underwriting commissions, offset by interest income from our cash balances in savings accounts.

Our use of cash is to fund operating expenses, which consist primarily of research and development expenditures related to ourthe therapeuticProduct productCandidates candidates,or GEM-AKI,other GEM-CKDproducts and GEM-PSI.candidates. We plan to increase our research and development expenses substantially for the foreseeable future as we continue the clinical development of our current and future product candidates. At this time, due to the inherently unpredictable nature of product development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval, and commercialize our current product candidate or any future product candidates. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or any future license agreements which we may enter into or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast the timing and amounts of milestone, royalty and other revenue from licensing activities, which future product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

We have incurred recurring losses since our inception, including a net loss of $15.0$8.9 million for the year ended December 31, 2024.2025. As of December 31, 20242025 we had an accumulated deficit of $40.5$49.4 million, a stockholders’ equity of $4.7$8.9 million and available cash and cash equivalents of $6.5$10.7 million. We expect to continue to incur significant operating and net losses, as well as negative cash flows from operations, for the foreseeable future as we continue to complete all necessary product development or future commercialization efforts. We have never generated revenue and do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for GEM-AKI,the GEM-CKD,Product GEM-PSICandidates or other product candidates, which we expect will not be for at least several years, if ever. We do not anticipate that our current cash and cash equivalents balancebalance, which includes $10.7 million as of December 31, 2025, combined with approximately $6.7 million in net proceeds received subsequent to December 31, 2025 in connection with a warrant inducement transaction, will be sufficient to sustain operations within one-year after the date that our audited financial statements for December 31, 20242025 were issued, which raises substantial doubt about our ability to continue as a going concern.

During the year ended December 31, 2024,2025, net cash used in operating activities was $18.3$8.3 million, which consisted of a net loss of $15.0$8.9 million andoffset aprimarily netby change of $3.4$0.6 million in ourstock-based netcompensation operating assets and liabilities.expense.

During the year ended December 31, 2023,2024, net cash used in operating activities was $7.3$18.3 million, which consisted of a net incomeloss of $0.1$15.0 million and a net change of $8.1 million comprised of the change in fair value of the warrant liability, stock-based compensation expense and depreciation expense, offset by a net change of $1.0 million in our net operating assets and liabilities.liabilities of $3.4 million.

During the year ended December 31, 2023,2025, there was there was no cash used in investing activities.

During the year ended December 31, 2024,2025, net cash provided by financing activities was $12.8$12.5 million, fromand was primarily due to net proceeds of $5.4$3.4 million received in connection with the FebruaryMay 20242025 Public Offering (definedand below), $0.2$8.7 million received from exercises of the Class D Common Stock Warrants (defined below),in net proceeds of $3.5 million received in connection with the Class DH Warrant Inducement (defined below) and net proceeds of $3.7 million received in connectionSeptember with the Class E Warrant Inducement (defined below).2025.

The following table summarizes our contractual obligations as of December 31, 20242025 and the effects of such obligations are expected to have on our liquidity and cash flow in future periods:

We have entered into an operating lease for laboratory and office space in San Diego, California. The table above includes future minimum lease payments under the non-cancelable lease arrangement.

We recognize the compensation expense related to stock options, third-party warrants, restricted stock awards (“RSAs”), and restricted stock unitunits (“RSURSUs”) awards granted, based on the estimated fair value of the awards on the date of grant. The fair value of employee stock options and third-party warrants are generally determined using the Black-Scholes option-pricing model using various inputs, including estimates of historic volatility, term, risk-free rate, and future dividends. The fair value of RSAs and RSUs is determined based on the Company’s stock price on the date of grant. The grant date fair value of the stock-based awards, which may have graded vesting, is recognized using the straight-line method over the requisite service period of each stock-based award, which is generally the vesting period of the respective stock-based awards. The Company recognizes forfeitures as they occur.

Revelation’s common stock and Public Warrants are listed on the Nasdaq Capital Market listing tier (“Nasdaq Capital Market”) under the symbols “REVB” and “REVBW,” respectively. IfIn general, if Nasdaq delists the Revelation common stock and Public Warrants from trading on its exchange for failure to meet the listing standards such as the minimum public stockholders equity requirement, minimum bid price, minimum market value of publicly-held shares, for failure to hold an annual stockholders meeting, or any other listing standards, we and our stockholders could face significant material adverse consequences including:

We have funded our operations since our inception to MarchJune 31,30, 2026 through the issuance and sale of our capital stock, from which we have raised net proceeds of $75.9 million. Our current cash and cash equivalents balance will not be sufficient to complete all necessary product development or future commercialization efforts. We anticipate that our current cash and cash equivalents balance will not be sufficient to sustain operations within one-year after the date that our unaudited condensed consolidated financial statements for MarchJune 31,30, 2026 were issued, which raises substantial doubt about our ability to continue as a going concern.

We have incurred recurring losses since our inception, including a net loss of $3.0$6.3 million for the threesix months ended MarchJune 31,30, 2026 and $2.1$4.5 million for the threesix months ended MarchJune 31,30, 2025. As of MarchJune 31,30, 2026 we had an accumulated deficit of $52.4$55.8 million. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future if and as we:

Other income (expense), net primarily consists of interest income from our cash balances in savings accounts and foreign currency transaction gains and losses.losses, in addition to other gains or losses resulting from transactions that do not relate to our continuing operations, if any.

Research and development expenses increased by $0.5$0.6 million, from $0.9$1.3 million for the three months ended MarchJune 31,30, 2025 to $1.4$1.9 million for the three months ended MarchJune 31,30, 2026. The increase was primarily due to increases of $0.1$0.7 million in program expenses related to GEM-AKI, $0.3$0.2 million in manufacturing expenses related to GEM-AKI, $0.2$0.1 million of other expenses related to the new facility, and $0.1 million in personnel expenses, offset by a $0.2$0.5 million decrease in program expenses related to GEM-CKD.

General and administrative expenses increased by $0.5$0.6 million, from $1.2$1.1 million for the three months ended MarchJune 31,30, 2025 to $1.7 million for the three months ended MarchJune 31,30, 2026. The increase was primarily due to increases of $0.3$0.5 million in personnel expenses, including stock-based compensation, and $0.2$0.1 million in professional fees and costs related to the new facility lease.fees.

Since our inception to MarchJune 31,30, 2026, we have funded our operations from the issuance and sale of our common stock, preferred stock and warrants, from which we have raised net proceeds of $75.9 million. As of MarchJune 31,30, 2026, we had available cash and cash equivalents of $14.1$11.5 million and an accumulated deficit of $52.4$55.8 million.

We have incurred recurring losses since our inception, including a net loss of $3.0$6.3 million for the threesix months ended MarchJune 31,30, 2026. As of MarchJune 31,30, 2026 we had an accumulated deficit of $52.4$55.8 million, a stockholders’ equity of $13.0$10.1 million and available cash and cash equivalents of $14.1$11.5 million. We expect to continue to incur significant operating and net losses, as well as negative cash flows from operations, for the foreseeable future as we continue to complete all necessary product development or future commercialization efforts. We have never generated revenue and do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for the Product Candidates or other product candidates, which we expect will not be for at least several years, if ever. We do not anticipate that our current cash and cash equivalents balance will be sufficient to sustain operations within one year after the date that our unaudited financial statements for MarchJune 31,30, 2026 were issued, which raises substantial doubt about our ability to continue as a going concern.

The unaudited condensed consolidated financial statements for MarchJune 31,30, 2026, have been prepared on the basis that we will continue as a going concern, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability for us to continue as a going concern.

During the threesix months ended MarchJune 31,30, 2026, net cash used in operating activities was $3.2$5.8 million, which consisted of a net loss of $3.0$6.3 million, adjusted for non-cash items of $0.5$1.0 million, including stock-based compensation expense, non-cash lease expense and depreciation expense, and a net change of $0.7$0.4 million in our net operating assets and liabilities.

During the threesix months ended MarchJune 31,30, 2025, net cash used in operating activities was $2.8$4.7 million, which consisted of a net loss of $2.1$4.5 million, adjusted for non-cash items of $0.2 million, including the change in fair value of the warrant liability, stock-based compensation expense and depreciation expense, and a net change of $1.0$0.5 million in our net operating assets and liabilities.

During the threesix months ended MarchJune 31,30, 2026, net cash used in investing activities consisted of the purchase of property and equipment.

During the threesix months ended MarchJune 31,30, 2025, there was no net cash provided by or used in investing activities.

During the threesix months ended MarchJune 31,30, 2026, net cash provided by financing activities was $6.7 million and was due to net proceeds received from the Class I Warrant Inducement in January 2026.

During the threesix months ended MarchJune 31,30, 2025, there was no net cash provided by financing activities.activities was $3.4 million from the May 2025 Public Offering.

As of MarchJune 31,30, 2026, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K.arrangements.

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with the generally accepted accounting principles in the United States (“GAAP”). The preparation of the consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions about future events that affect the amounts of assets and liabilities reported, disclosures about contingent assets and liabilities, and reported amounts of revenue and expenses. These estimates and assumptions are based on management’s best estimates and judgment. Management regularly evaluates its estimates and assumptions using industry experience and other factors; however, actual results could differ materially from these estimates and could have an adverse effect on our consolidated financial statements. As of MarchJune 31,30, 2026, there have been no material changes to our existing critical accounting policies and estimates discussed in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2025.