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Item 1A. Risk Factors

2026-02-26 compared with 2025-03-06 · 193 added, 116 removed, 769 unchanged (29% of the section changed)

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The following discussion should be read in conjunction with our audited financial statements and notes to the financial statements included herein.

Unless the context otherwise requires, references herein to “Program Products” refers to Revelation’s GEM-AKI, GEM-CKD, and GEM-PSI programs.

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

Risks Related to Our Business

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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 Program Products, and any future product candidates.

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 Product 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.

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The net losses we incur may fluctuate significantly from quarter-to-quarter such that a period-to-period comparison of our results of operations may not be a good indication of our future performance.

We have no products approved for marketing in any jurisdiction, and our Program Products are in early stages of development.

We have no products approved for marketing in any jurisdiction, and our Product Candidates 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 Program Products.

We do not anticipate generating revenue from product sales in the next couple of years.

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Raising additional funding may cause dilution to our stockholders.

Developing our Program Products is expensive, and we expect our research and development expenses to increase substantially in connection with our ongoing activities, particularly as we advance our Program Products through clinical studies, manufacturing and regulatory approval.

Developing our Product Candidates is expensive, and we expect our research and development expenses to increase substantially in connection with our ongoing activities, particularly as we advance our Product Candidates 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.

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If we do not raise additional capital, we may not be able to expand our operations or otherwise capitalize on our business opportunities, our business and financial condition will be negatively impacted, and we may need to:

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

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

• seek strategic alliances for research and development programs when we otherwise would not, or at an earlier stage than we would otherwise desire or on terms less favorable than might otherwise be available;

• relinquish, or license on unfavorable terms, our rights to technologies or any product candidates that we otherwise would seek to develop or commercialize ourselves.

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 failures 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.

Unfavorable global economic conditions, including any adverse macroeconomic conditions or geopolitical events 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.

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets.

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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.

Commercialization of Our Product Candidates

If preclinical studies or clinical studies for our Product Candidates 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 Program Products.

Currently, we do not have an active IND with the FDA in the United States for our Product 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.

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(ii) recruit CROs, clinical investigators and patients in a timely manner;

(iii) manufacture sufficient quantities at the required quality of Program Products for use in clinical studies;

(iii) manufacture sufficient quantities at the required quality of Product Candidates 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 Program Products or successfully obtaining regulatory approval, the commercial prospects of our Program Products 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 Program Products, and jeopardize our ability to commence product sales and generate revenues.

If we experience delays in completing any clinical study of our Product Candidates or successfully obtaining regulatory approval, the commercial prospects of our Product Candidates 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 Product Candidates, and jeopardize our ability to commence product sales and generate revenues.

Any of these occurrences may significantly harm our business and financial condition.

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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 Program Products or any future product candidates.

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

Our clinical studies may fail to adequately demonstrate the safety and efficacy of our Product Candidates or any future product candidates.

We are focused on the development of GEM-AKI and GEM-CKD which are in clinical development.

There is a high failure rate for product candidates proceeding through clinical studies.

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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 Program Products.

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 Product 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 Program Products or other future product candidates and receive the necessary regulatory approvals, our business will be materially harmed.

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.

We currently have not conducted any clinical studies in the United States to date.

We have conducted and we plan to conduct additional clinical studies outside the United States, including Europe, Australia, or other foreign jurisdictions.

If we are unable to successfully demonstrate the safety and efficacy of our Product Candidates or other future product candidates and receive the necessary regulatory approvals, our business will be materially harmed.

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 modify their regulatory pathway or conditions previously agreed upon, or may not accept data from such studies.

We have reached agreement with the FDA on the development pathway for GEM-AKI, including a Phase 2/3 adaptive design with a composite endpoint of death and/or need for dialysis.

However, although we have obtained FDA agreement on this pathway, the FDA retains discretion to modify, expand, or restrict the development pathway at any time during development.

The FDA could:

(i) request additional or modified clinical studies;

(ii) change the statistical powering or sample size requirements;

(iii) impose additional safety monitoring or data integrity requirements;

(iv) request additional biomarker or exploratory endpoint data;

or (v) otherwise alter the conditions previously agreed upon.

Any such FDA modifications could materially delay our development timeline, increase costs, or require us to conduct unanticipated additional studies.

Additionally, we currently conduct or plan to conduct clinical studies outside the United States, including Europe, Australia, and 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.

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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.

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 Program Products 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 Program Products.

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 Product Candidates 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 product candidates 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 Product Candidates.

Carrying out later-stage clinical studies and the submission to the FDA of a successful NDA is a complicated process.

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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 Program Products.

Failure to commence or complete, or delays in, our planned clinical studies, could prevent us from or delay us in commercializing our Product 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 Program Products.

In addition, Congress recently amended the FDCA to require sponsors of a Phase 3 clinical trial, or other “pivotal study” of a new drug to support marketing authorization, to design and submit a diversity action plan for such clinical trial.

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Identifying and qualifying patients to participate in clinical studies of our Product Candidates 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 Program Products, 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 Program Products 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.

The timing of our clinical studies depends in part on the speed at which we can recruit patients to participate in testing our Product 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 Product Candidates 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.

In addition, our competitors, some of whom have significantly greater resources than we do, are conducting clinical studies for the same indications and seek to enroll patients in their studies that may otherwise be eligible for our clinical studies or studies, which could lead to slow recruitment and delays in our clinical programs.

Further, since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical studies at the same clinical study sites that some of our competitors use, which could further reduce the number of patients who are available for our clinical studies in these sites.

Our inability to enroll 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 Program Products 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 Program Products and any future product candidates.

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.

The severity and frequency of undesirable side effects caused by our Program Products, 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.

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 Product Candidates and any future product candidates and our business will be harmed.

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.

The severity and frequency of undesirable side effects caused by our Product 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.

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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 Program Products 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 Program Products or any future product candidates or products:

Additionally, if one or more of our Product Candidates 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 Product Candidates or any future product candidates or products:

• we may be required to modify, suspend or terminate our clinical studies;

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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 Program Products 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 Program Products, 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 Program Products have not received regulatory approval.

We do not expect our Program Products or any future product candidate to be commercially available for years, if at all.

Our Program Products are, and any future product candidate will be subject to strict regulation by regulatory authorities in the United States and in other countries.

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 Product Candidates 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 Product 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 Product Candidates have not received regulatory approval.

We do not expect our Product Candidates or any future product candidate to be commercially available for years, if at all.

Our Product Candidates 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 Program Products 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.

Even if our current or future Product Candidates 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.

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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 Program Products, including obtaining regulatory approval to market our product candidates 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, and GEM-PSI.

If we cannot successfully develop, obtain regulatory approval for, and commercialize our Program Products, we may not be able to continue our operations.

The future regulatory approval and commercial success of our Program Products 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 Program Products, including, but not limited to, the clinical studies needed to obtain regulatory approval for commercialization;

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 actions by the current administration, including substantial reductions in the workforce of the FDA, have created increased uncertainty regarding the timing and outcome of regulatory reviews for new drugs and biologics.

These staffing cuts, which have affected key divisions responsible for the review of innovative therapies, may result in longer review times, missed milestones, and inconsistent or delayed feedback from the agency.

In addition, the loss of experienced FDA personnel and potential further restructuring could lead to a loss of institutional knowledge and a reduced ability to resolve complex regulatory questions efficiently.

As a result, we may experience delays in the initiation, conduct, or completion of our clinical trials and in the review and approval of our marketing applications.

These delays could adversely impact our ability to bring our Product Candidates to market, disrupt our development timelines, and increase our costs.

Furthermore, ongoing regulatory uncertainty may negatively affect investor confidence and our ability to raise additional capital on favorable terms, particularly as small and mid-cap biopharmaceutical companies are more vulnerable to such disruptions.

If the FDA’s operational capacity continues to be reduced or if further policy changes are implemented that affect the agency’s review processes, our business, financial condition, and results of operations could be materially and adversely affected.

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 EU.

We are focusing our time and financial resources in the clinical development of GEM-AKI and GEM-CKD.

If we cannot successfully develop, obtain regulatory approval for, and commercialize our Product Candidates, we may not be able to continue our operations.

The future regulatory approval and commercial success of our Product Candidates 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 Product Candidates, including, but not limited to, the clinical studies needed to obtain regulatory approval for commercialization;

• we may not be able to obtain regulatory authorization to proceed with various clinical studies in the United States, and even if we are able to proceed with clinical studies, the regulatory authorities may limit, delay, or put our clinical studies on hold;

• we may not be able to obtain adequate evidence from our clinical studies for our Program Products;

• we may not be able to obtain adequate evidence from our clinical studies for our Product Candidates;

• the results of our clinical studies may not meet the level of statistical or clinical significance required by the FDA or comparable foreign regulatory authorities for marketing approval;

• 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 Program Products;

• 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 Product Candidates;

• the data from clinical studies conducted outside of the United States may not be accepted by the FDA or other regulatory authorities;

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

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

• the regulatory agencies may find deficiencies without manufacturing processes or facilities;

• the CROs, that we retain to conduct our clinical studies may take actions outside of our control that materially adversely impact our clinical studies;

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

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

• the regulatory agencies may change their approval policies or adopt new regulations;

• if approved, our Program Products will likely compete with products that may reach approval for the same indication or use prior to our Program Products, products that are currently approved and the products that are currently marketed products;

• if approved, our Product Candidates will likely compete with products that may reach approval for the same indication or use prior to our Product Candidates, products that are currently approved and the products that are currently marketed products;

• 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 Program Products, 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 Program Products.

If we or any of our future development collaborators are unable to develop, or obtain regulatory approval for, or, if approved, successfully commercialize our Program Products, 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, 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.

Furthermore, even if we do receive regulatory approval to market our Product 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 Product 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 Product 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 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 authorities have fluctuated in recent years as a result.

Average review times at the FDA and comparable foreign regulatory authorities, 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.

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The FDA utilized this risk-based assessment system to assist in determining when and where it was safest to conduct prioritized domestic inspections.

Additionally, on 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.

On 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 a 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.

Regulatory authorities outside the United States adopted similar restrictions or other policy measures in response to the COVID-19 pandemic.

If another prolonged government shutdown occurs, or if global health concerns 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 we obtain regulatory approval for a product candidate, our products and business will remain subject to ongoing regulatory obligations and review.

Even if our Program Products 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.

Even if our Product Candidates 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.

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The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and generate product revenue.

If one or more of our Program Products 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 one or more of our Product Candidates 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 Program Products 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 Program Products.

Even if we obtain FDA or other comparable regulatory agencies approval for any of our Product Candidates 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 Product 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.

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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 Program Products and to produce, market and distribute our Program Products after clearance or approval is obtained.

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.

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 Program Products.

Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of our Product 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 Program Products.

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 Program Products.

We are currently aware of various existing therapies in the market and in development that may in the future compete with our Product Candidates.

Even if approved, we will compete with currently approved therapies and therapies further along in development.

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Our inability to compete effectively in any of these aspects of our business could harm our business, financial condition, results of operations and prospects.

Changes in U.S.

and international trade policies may adversely impact our business and operating results.

From time to time, proposals are made to significantly change existing trade agreements and relationships between the U.S.

and other countries.

In recent years, the U.S.

government has implemented substantial changes to U.S.

trade policies, including import restrictions, increased import tariffs and changes in U.S.

participation in multilateral trade agreements.

Like all U.S.

businesses, we are exposed to the effects of possible supply disruption and increased costs in the event of changes in the policies, laws, rules and regulations of the United States or foreign governments, as well as political unrest or unstable economic conditions in foreign countries.

government has adopted a new approach to trade policy and, in some cases, entered into new trade agreements.

Our supply may in the future be subject to increased import tariffs, which could increase our manufacturing costs and could make our products, if successfully developed and approved, less competitive than those of our competitors whose inputs are not subject to such tariffs.

We may otherwise experience supply disruptions or delays, and our suppliers may not provide us with clinical supply in our required quantities, to our required specifications and quality levels or at attractive prices.

Such disruption could have adverse effects on the development of our Product Candidates and our business operations.

Artificial intelligence is playing an increasingly important role in biotechnology which may have an effect on us.

Artificial intelligence (“AI”) is increasingly playing a role in our industry, being used for target identification, drug discovery, preclinical modeling, and data analysis.

While it is not a significant factor in our current operations, AI may play a future role in our operations based upon our evaluation of its usefulness to us, and there are material risks associated with its use.

AI technologies are inherently complex and evolving.

They may not function as intended, produce accurate results, or provide actionable insights.

The quality of AI outputs depends heavily on the quality and quantity of input data, which in the life sciences context may be limited, biased, incomplete, or subject to regulatory and privacy constraints.

If we utilize AI in the future and our AI systems fail to identify viable therapeutic candidates, predict biological outcomes, or produce reproducible results, our product development efforts may be delayed or unsuccessful.

In addition, the use of AI in regulated environments such as biotechnology and pharmaceuticals may attract increasing scrutiny from regulatory authorities.

Regulatory bodies have not yet established clear guidelines governing the validation, approval, or oversight of AI-generated insights or AI-supported decision-making.

Any failure to comply with future regulatory expectations regarding AI could limit our ability to use such technologies or result in penalties or delays.

We also rely on third-party AI platforms, vendors, and cloud infrastructure.

Any errors, outages, security breaches, or failures by such third parties may disrupt our operations or compromise proprietary data.

Furthermore, as AI technologies become more widely adopted, we may face increased competition from other biotechnology companies leveraging similar tools.

If we are unable to successfully integrate and manage AI within our business, or if AI fails to deliver the expected benefits, our ability to discover and develop new therapies could be materially adversely affected.

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.

We currently rely on, and expect to continue to rely on, third parties, such as CROs, clinical data management organizations, medical institutions, consultants and clinical investigators, to conduct our clinical studies and certain aspects of our research and preclinical testing.

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Some of these raw materials and test components are difficult to source.

Because there are a limited number of suppliers for these raw materials and components, we may need to engage alternate suppliers to prevent a possible disruption of the manufacture of the materials necessary to produce our Program Products for our clinical studies, and if approved, ultimately for commercial sale.

Because there are a limited number of suppliers for these raw materials and components, we may need to engage alternate suppliers to prevent a possible disruption of the manufacture of the materials necessary to produce our Product Candidates for our clinical studies, and if approved, ultimately for commercial sale.

In particular, there is only one supplier for PHAD ® , Avanti Polar Lipids, Inc.

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We do not have any control over the availability of raw materials and components.

If we or our manufacturers are unable to purchase these raw materials or components on acceptable terms, at sufficient quality levels, or in adequate quantities, if at all, the development and commercialization of our product candidates or any future product candidates, would be delayed or there would be a shortage in supply, which would impair our ability to meet our development objectives for our Program Products or generate revenues from the sale of any approved products.

Until such time, if ever, as we establish a manufacturing facility that has been properly validated to comply with FDA or other comparable regulatory agencies cGMP requirements, we will not be able to independently manufacture Program Products for our planned preclinical and clinical programs.

We currently rely on a third-party manufacturer for the production of our clinical study materials., GEM-AKI, GEM-CKD, and GEM-PSI have been and for the near-term will be manufactured by a single third-party manufacturer.

This manufacturer may not be able to scale production to the larger quantities required for large clinical studies and to commercialize GEM-AKI, GEM-CKD, and GEM-PSI, if approved.

Also, the third-party manufacturers may not be able to produce Program Products that meet the quality requirements.

If we or our manufacturers are unable to purchase these raw materials or components on acceptable terms, at sufficient quality levels, or in adequate quantities, if at all, the development and commercialization of our Product Candidates or any future product candidates, would be delayed or there would be a shortage in supply, which would impair our ability to meet our development objectives for our Product Candidates or generate revenues from the sale of any approved products.

Until such time, if ever, as we establish a manufacturing facility that has been properly validated to comply with FDA or other comparable regulatory agencies cGMP requirements, we will not be able to independently manufacture Product Candidates for our planned preclinical and clinical programs.

We currently rely on a third-party manufacturer for the production of our clinical study materials., GEM-AKI and GEM-CKD have been and for the near-term will be manufactured by a single third-party manufacturer.

This manufacturer may not be able to scale production to the larger quantities required for large clinical studies and to commercialize GEM-AKI and GEM-CKD, if approved.

Also, the third-party manufacturers may not be able to produce Product Candidates that meet the quality requirements.

In the event that this third-party manufacturer does not successfully carry out its contractual duties, meet expected deadlines or manufacture our products in accordance with regulatory requirements or if there are disagreements between us and this third-party manufacturer, we will not be able to complete, or may be delayed in completing, the clinical studies required.

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• reliance on the third party for regulatory compliance, quality assurance and safety and pharmacovigilance reporting.

Certain raw materials necessary for the manufacture of our Program Products, such as our active pharmaceutical ingredient, are available only from a single supplier.

Certain raw materials necessary for the manufacture of our Product Candidates, such as our active pharmaceutical ingredient, are available only from a single supplier.

Any significant delay in the acquisition or decrease in the availability of these raw materials from our supplier could considerably delay their manufacture, which could adversely impact the timing of any planned studies or the regulatory approvals.

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We may have little to no control regarding the occurrence of third-party manufacturer incidents.

Any failure to comply with cGMP requirements or other FDA or comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop our Program Products or any future product candidates and market our Program Products following approval.

If our Program Products or any future product candidates are approved by the FDA or other comparable foreign regulatory authorities for commercial sale, we may need to manufacture such product candidate in larger quantities.

We intend to use third-party manufacturers for commercial quantities of our Program Products to the extent we advance this product candidate and other product candidates.

Any failure to comply with cGMP requirements or other FDA or comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop our Product Candidates or any future product candidates and market our Product Candidates following approval.

If our Product Candidates or any future product candidates are approved by the FDA or other comparable foreign regulatory authorities for commercial sale, we may need to manufacture such product candidate in larger quantities.

We intend to use third-party manufacturers for commercial quantities of our Product Candidates to the extent we advance this product candidate and other product candidates.

Our manufacturers may not be able to successfully increase the manufacturing capacity for any of our Product Candidates in a timely or efficient manner, or at all.

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If we are required to change manufacturers for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines.

The delays associated with the verification of a new manufacturer, if we are able to identify an alternative source, could negatively affect our ability to develop product candidates in a timely manner or within budget.

The delays associated with the verification of a new manufacturer, if we are able to identify an alternative source, could negatively affect our ability to develop our Product Candidates in a timely manner or within budget.

We may not be able to obtain and maintain the third-party relationships that are necessary to develop, commercialize and manufacture some or all of our Product Candidates.

We expect to depend on collaborators, partners, licensees, clinical investigators, CROs, manufacturers and other third parties to support our discovery efforts, to formulate product candidates, to conduct clinical studies for some or all of our Program Products, to manufacture clinical and commercial scale quantities of our drug substance, drug product, diagnostic test and to market, sell and distribute any products we successfully develop.

We expect to depend on collaborators, partners, licensees, clinical investigators, CROs, manufacturers and other third parties to support our discovery efforts, to formulate product candidates, to conduct clinical studies for some or all of our Product Candidates, to manufacture clinical and commercial scale quantities of our drug substance, drug product, diagnostic test and to market, sell and distribute any products we successfully develop.

Any problems we experience with any of these third parties could delay the development, commercialization and manufacturing of our Product Candidates, which could harm our results of operations.

We cannot guarantee that we will be able to successfully negotiate agreements for, or maintain relationships with, collaborators, partners, licensees, clinical investigators, CROs, manufacturers and other third parties on favorable terms, if at all.

If we are unable to obtain or maintain these agreements, we may not be able to clinically develop, formulate, manufacture, obtain regulatory approvals for or commercialize our Program Products and any future product candidates, which will in turn adversely affect our business.

If we are unable to obtain or maintain these agreements, we may not be able to clinically develop, formulate, manufacture, obtain regulatory approvals for or commercialize our Product Candidates and any future product candidates, which will in turn adversely affect our business.

We expect to expend substantial management time and effort to enter into relationships with third parties and, if we successfully enter into such relationships, to manage these relationships.

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Our success will depend in significant part on our and our future licensors’, licensees’ or collaborators’ ability to establish and maintain adequate protection of our owned and licensed intellectual property covering the Product Candidates we plan to develop, and the ability to develop these Product Candidates and commercialize the products resulting therefrom, without infringing the intellectual property rights of others.

Our Program Products have been developed in-house and are not subject to any third-party license.

Our Product Candidates have been developed in-house and are not subject to any third-party license.

In addition to taking other steps to protect our intellectual property, we file patent applications to protect inventions we have developed, seeking to protect compositions, methods of use, manufacturing methods, and other aspects of our technology.

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Therefore, we cannot be certain that we or future licensors, licensees or collaborators were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we or future licensors, licensees or collaborators were the first to file for patent protection of such inventions.

Any changes we make to our Program Products or any future product candidates to cause them to have what we view as more advantageous properties may fall outside the coverage of our existing patent applications, and we may need to file new patent applications and/or seek other forms of protection for any such altered product candidates.

The patent landscape surrounding the technology underlying our product candidates is crowded, and there can be no assurance that we will be able to secure patent protection that would adequately cover such altered Program Products or any future product candidates.

Any changes we make to our Product Candidates or any future product candidates to cause them to have what we view as more advantageous properties may fall outside the coverage of our existing patent applications, and we may need to file new patent applications and/or seek other forms of protection for any such altered Product Candidates.

The patent landscape surrounding the technology underlying our Product Candidates is crowded, and there can be no assurance that we will be able to secure patent protection that would adequately cover such altered Product Candidates or any future product candidates.

The patent prosecution process is expensive and time-consuming, and we and our future licensors, licensees or collaborators may not be able to prepare, file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.

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Competitors may use technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we do not have patent protection, or where we do have patent protection, but enforcement is not as strong as that in the United States.

These products may compete with our Program Products or any future product candidates and our patents or other intellectual property rights may not effectively prevent them from competing.

These products may compete with our Product Candidates or any future product candidates and our patents or other intellectual property rights may not effectively prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

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If this occurs, any period during which we have the right to exclusively market our product will be shorter than we would otherwise have expected, and our competitors may obtain approval of and launch products earlier than might otherwise have been the case.

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.

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.

In addition to the protection afforded by any patents that may be granted, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our product candidate discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents.

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We may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development efforts.

Our commercial success depends upon our ability to develop, manufacture, market and sell our Program Products and any future product candidates that we may develop and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and proprietary rights of third parties.

Our commercial success depends upon our ability to develop, manufacture, market and sell our Product Candidates and any future product candidates that we may develop and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and proprietary rights of third parties.

The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights.

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We could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent of a third party.

A finding of infringement could prevent us from commercializing our Program Products or any future product candidates or force us to cease some of our business operations, which could materially harm our business.

We may not be aware of all third-party intellectual property rights potentially relating to our Program Products or any future product candidates.

A finding of infringement could prevent us from commercializing our Product Candidates or any future product candidates or force us to cease some of our business operations, which could materially harm our business.

We may not be aware of all third-party intellectual property rights potentially relating to our Product Candidates or any future product candidates.

As to pending third-party applications, we cannot predict with any certainty which claims will issue, if any, or the scope of any claims that may issue.

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The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage.

• others may be able to make products that are similar to our Program Products and any future product candidates we may develop but that are not covered by the claims of the patents that we may own or license in the future;

• others may be able to make products that are similar to our Product Candidates and any future product candidates we may develop but that are not covered by the claims of the patents that we may own or license in the future;

• we, or our future collaborators, might not have been the first to make the inventions covered by the issued patents and pending patent applications that we may own or license in the future;

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We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.

We are in the early stages of building the full management team and employee base that we anticipate we will need to complete the development of our Program Products and other future product candidates.

As of March 3, 2025, we had 9 employees.

We are in the early stages of building the full management team and employee base that we anticipate we will need to complete the development of our Product Candidates and other future product candidates.

As of February 23, 2026, we had 9 employees.

As we advance our preclinical and clinical development programs for our Product Candidates, seek regulatory approval in the United States and elsewhere and increase the number of ongoing product development programs, we anticipate that we will need to increase our product development, scientific and administrative headcount.

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We may not be successful in our efforts to identify, discover or license additional product candidates.

Although a substantial amount of our effort will focus on the continued clinical testing, potential approval and commercialization of our lead Program Products, the success of our business also depends upon our ability to identify, discover or license additional product candidates.

Although a substantial amount of our effort will focus on the continued clinical testing, potential approval and commercialization of our lead Product Candidates, the success of our business also depends upon our ability to identify, discover or license additional product candidates.

Our research programs or licensing efforts may fail to yield additional product candidates for clinical development for a number of reasons, including (i) lack of financial or personnel resources to acquire or discover additional product candidates;

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It is unclear whether the models will be utilized in any health reform measures in the future.

These laws, and future state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.

Risks Related to Commercialization of Our Program Products and Product Candidates

In 2025, the Trump Administration issued Executive Orders and pursued legislative initiatives that could materially affect our business operations and product development strategy.

On May 12, 2025, President Trump signed an Executive Order requiring that U.S.

prices for prescription drugs not exceed the lowest price ordered in other developed nations (Most-Favored-Nation or “MFN”pricing).

The Administration has secured agreements with over 16 pharmaceutical manufacturers as of January 2026 to implement this pricing on certain products.

If our Product Candidates are approved and commercialized, we may be required to comply with similar pricing requirements or face tariffs or trade restrictions on our products or components.

These pricing limitations could materially reduce our projected revenues, delay our ability to achieve profitability, and affect our business model and strategic decisions regarding which product candidates to prioritize.

Additionally, implementing MFN pricing may require renegotiation of distribution agreements and changes to our commercialization strategy in foreign markets.

In September 2025, President Trump announced a 100% tariff on all "branded or patented" imported drugs effective October 1, 2025, which manufacturers could avoid by building manufacturing facilities in the United States.

This tariff regime significantly increases costs for manufacturers relying on foreign manufacturing, potentially making our reliance on third-party manufacturers for clinical and commercial supply more expensive if those manufacturers do not rapidly establish or expand U.S.

production capabilities.

We may face increased manufacturing costs, supply chain disruptions, or pressure to establish domestic manufacturing facilities even if such facilities are not economically efficient for our current stage of development.

These tariff policies create uncertainty regarding the true cost of goods for any products we may commercialize and could negatively impact our gross margins and financial projections.

Additionally, on May 5, 2025, President Trump signed an Executive Order directing the FDA to streamline and accelerate approval of domestic pharmaceutical manufacturing by eliminating unnecessary regulatory barriers and increasing fees for foreign manufacturing facilities.

While reduced regulatory burdens for domestic manufacturing could theoretically benefit our operations if we build U.S.

facilities, the increased scrutiny and fees applied to foreign manufacturers could increase our supply chain costs and may require us to modify our manufacturing strategy.

On August 13, 2025, President Trump signed an Executive Order establishing a Strategic Active Pharmaceutical Ingredients Reserve, which may affect the availability and cost of critical raw materials, including the PHAD lipid our GEM Product Candidates require.

The Trump Administration has pursued a deregulatory agenda requiring agencies to eliminate 10 existing regulations or guidance documents for every new regulation issued.

This regulatory framework may slow FDA issuance of guidance and reduce the agency's capacity for routine functions, potentially extending our IND review timelines and clinical study authorization processes.

Additionally, uncertainty regarding how FDA will interpret and apply these new policies, combined with reduced agency staffing due to budget constraints, may create delays or unpredictable regulatory outcomes for our clinical programs.

Enhanced FDA oversight of foreign contract manufacturing organizations and contract research organizations may increase the cost of engaging foreign CDMOs and CROs and potentially limit our access to certain foreign suppliers if they do not meet enhanced FDA requirements or choose to cease U.S.

operations due to increased compliance burden.

On October 1, 2025, the Administration launched TrumpRx.gov, a government-operated direct-to-consumer platform allowing individuals to purchase select medications at discounted prices from participating manufacturers.

These initiatives could fundamentally change the traditional pharmaceutical distribution model, bypass traditional pharmacy benefit managers and wholesalers, and require us to establish new compliance and operational infrastructure if we choose to participate.

Alternatively, exclusion from these channels could disadvantage us competitively relative to manufacturers participating in these programs.

In December 2025, Congress expanded the orphan drug exclusion to the Medicare Drug Price Negotiation Program, allowing drugs with multiple rare disease indications to maintain pricing protection if each indication is for a rare disease.

This change may benefit our GEM-AKI program if it qualifies for orphan designation, though it also reflects continued Congressional interest in restricting pharmaceutical pricing through the Medicare program, creating ongoing uncertainty regarding how future policy changes may affect our products if approved.

On December 1, 2025, the U.S.

and United Kingdom announced an agreement to increase net prices of new prescription drugs by 25% in the U.K., reflecting efforts to ensure foreign countries contribute more fairly to pharmaceutical innovation.

These bilateral price negotiations may complicate our international commercialization strategy and pricing discussions in foreign markets, requiring coordination between domestic MFN pricing requirements and foreign price negotiations.

We cannot predict whether these 2025 policy initiatives will be maintained, expanded, modified, or reversed by future administrations or Congress.

The evolving regulatory landscape creates material uncertainty regarding whether and when our manufacturing costs will increase.

Any of these developments could materially and adversely affect our business model, cost structure, development timeline, manufacturing strategy, regulatory approvals, commercialization approach, and financial projections.

We will need to maintain flexibility in our development and commercialization strategies to adapt to these policy changes, but such adaptation may require significant operational and financial adjustments.

Risks Related to Commercialization of Our Product Candidates

As we evolve from a company that is primarily involved in clinical development to a company that is also involved in commercialization, we may encounter difficulties in expanding our operations successfully.

As we advance our Program Products through clinical studies, we will need to expand our development, regulatory, manufacturing, and marketing and sales capabilities and may need to further contract with third parties to provide these capabilities, such as collaborators, distributors, marketers and additional suppliers.

As we advance our Product Candidates through clinical studies, we will need to expand our development, regulatory, manufacturing, and marketing and sales capabilities and may need to further contract with third parties to provide these capabilities, such as collaborators, distributors, marketers and additional suppliers.

We currently have no experience as a Company in or infrastructure for sales, marketing and distribution, and our operations are currently limited to clinical development activities and as our operations expand, we likely will need to manage additional relationships with such third parties.

If our Program Products or any future product candidate is approved, we intend either to establish a sales organization with technical expertise and supporting distribution capabilities to commercialize our Program Products or any future product candidate or to outsource such functions to one or more third parties.

If our Product Candidates or any future product candidate is approved, we intend either to establish a sales organization with technical expertise and supporting distribution capabilities to commercialize our Product Candidates or any future product candidate or to outsource such functions to one or more third parties.

Either of these options would be expensive and time-consuming.

Some or all of these costs may be incurred in advance of any approval of our Program Products or any future product candidate.

Some or all of these costs may be incurred in advance of any approval of our Product Candidates or any future product candidate.

In addition, we may not be able to hire a sales force that is sufficient in size or has adequate expertise in the medical markets that we intend to target.

Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely affect the commercialization of our Program Products and other future product candidates.

Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely affect the commercialization of our Product Candidates and other future product candidates.

Maintaining third-party relationships for these purposes will impose significant added responsibilities on members of our management and other personnel.

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If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our products.

We may seek to establish commercial collaborations for our Program Products and future product candidates, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development plans.

We may seek to establish commercial collaborations for our Product Candidates and future product candidates, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development plans.

Our drug development programs, and the potential commercialization of our Product Candidates will require substantial additional cash to fund expenses.

We may decide to collaborate with other pharmaceutical and biotechnology companies for the development and potential commercialization of our Product Candidates.

For example, we have recently licensed a patent from Vanderbilt University which is the basis of GEM-PSI.

For example, we have licensed a patent from Vanderbilt University.

We face significant competition in seeking appropriate collaborators.

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If we do not have sufficient funds, we may not be able to further develop our Product Candidates or bring them to market and generate product revenue.

We currently have no Program Products approved for marketing.

We currently have no Product Candidates approved for marketing.

We do not have a marketing and sales organization.

If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our Program Products, we may be unable to generate any product revenue.

We have no experience selling and marketing our Program Products, and we currently have no marketing or sales organization.

If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our Product Candidates, we may be unable to generate any product revenue.

We have no experience selling and marketing our Product Candidates, and we currently have no marketing or sales organization.

To successfully commercialize any product candidates that may result from our development programs, we will need to develop these capabilities, either on our own or with others.

If our product candidates receive regulatory approval, we intend to establish a sales and marketing organization independently or by utilizing experienced third parties with technical expertise and supporting distribution capabilities to commercialize our Program Products in major markets, all of which will be expensive, difficult and time consuming.

Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact our ability to commercialize our Program Products.

Our efforts to educate the medical community, including physicians, hospital pharmacists and third-party payors on the benefits of our Program Products may require significant resources and may never be successful.

If any of our Program Products are approved but fail to achieve market acceptance among physicians, patients or third-party payors, we will not be able to generate significant revenues from such product, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

It may be difficult for us to profitably sell our Program Products, if and when approved, if coverage and reimbursement for these Program Products are limited by government authorities and/or third-party payor policies.

In addition to any healthcare reform measures which may affect reimbursement, market acceptance and sales of our Program Products, if approved, will depend on, in part, the extent to which the procedures utilizing our Program Products, performed by health care providers, will be covered by third party payors, such as government health care programs, commercial insurance and managed care organizations.

In the event health care providers and patients accept our Program Products as medically useful, cost effective and safe, there is uncertainty regarding whether our Program Products will be directly reimbursed, reimbursed through a bundled payment or if the product candidates will be included in another type of value-based reimbursement program.

If our Product Candidates receive regulatory approval, we intend to establish a sales and marketing organization independently or by utilizing experienced third parties with technical expertise and supporting distribution capabilities to commercialize our Product Candidates in major markets, all of which will be expensive, difficult and time consuming.

Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact our ability to commercialize our Product Candidates.

Our efforts to educate the medical community, including physicians, hospital pharmacists and third-party payors on the benefits of our Product Candidates may require significant resources and may never be successful.

If any of our Product Candidates are approved but fail to achieve market acceptance among physicians, patients or third-party payors, we will not be able to generate significant revenues from such product, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

It may be difficult for us to profitably sell our Product Candidates, if and when approved, if coverage and reimbursement for these Product Candidates are limited by government authorities and/or third-party payor policies.

In addition to any healthcare reform measures which may affect reimbursement, market acceptance and sales of our Product Candidates, if approved, will depend on, in part, the extent to which the procedures utilizing our Product Candidates, performed by health care providers, will be covered by third party payors, such as government health care programs, commercial insurance and managed care organizations.

In the event health care providers and patients accept our Product Candidates as medically useful, cost effective and safe, there is uncertainty regarding whether our Product Candidates will be directly reimbursed, reimbursed through a bundled payment or if the product candidates will be included in another type of value-based reimbursement program.

Third party payors determine the extent to which new products will be covered as a benefit under their plans and the level of reimbursement for any covered product or procedure which may utilize a covered product.

It is difficult to predict at this time what third party payors will decide with respect to the coverage and reimbursement for our Program Products.

It is difficult to predict at this time what third party payors will decide with respect to the coverage and reimbursement for our Product Candidates.

Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost effectiveness data for the use of our products to the payor.

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If we are unable to obtain insurance at an acceptable cost or otherwise protect against potential product liability claims, we will be exposed to significant liabilities, which may materially and adversely affect our business and financial position.

If we are sued for any injury allegedly caused by our Program Products, our liability could exceed our total assets and our ability to pay the liability.

If we are sued for any injury allegedly caused by our Product Candidates, our liability could exceed our total assets and our ability to pay the liability.

A product liability claim or series of claims brought against us would decrease our cash and could cause our stock price to fall.

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Potential future sales pursuant to registration rights granted by the Company and under Rule 144 may depress the market price for our shares of common stock.

The Company has granted a number of its stockholders’ registration rights with respect to their shares of common stock.

See the section titled “Registration Rights.” Such future sales of our shares of common stock by our existing stockholders, pursuant to and in accordance with the provisions of any registration statement, may have a depressive effect on the market price of our shares of common stock.

The Company has granted a number of its stockholders registration rights with respect to their shares of common stock (See the section titled “Registration Rights.”) Such future sales of our shares of common stock by our existing stockholders, pursuant to and in accordance with the provisions of any registration statement, may have a depressive effect on the market price of our shares of common stock.

Further, in general, under Rule 144 under the Securities Act of 1933, as amended (the “Securities Act”), a person who has satisfied a minimum holding period of between six months and one-year and any other applicable requirements of Rule 144, may thereafter sell such shares publicly.

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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.

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, for failure to hold an annual stockholders meeting, or any other listing standards, we and our stockholders could face significant material adverse consequences including:

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:

• limited availability of market quotations for our securities;

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• a decreased ability to issue additional securities or obtain additional financing in the future.

Nasdaq has proposed, but the SEC has not yet approved, a rule that would require automatic delisting if the market value of a company’s unrestricted publicly held shares remains below $5 million for 30 consecutive trading days.

The proposal would eliminate any cure period and result in an immediate trading suspension.

If adopted in its current form, this rule could increase the risk that our common stock is delisted, which would materially reduce liquidity and market value.

Revelation will continue to incur significant increased expenses and administrative burdens as a public company, which could negatively impact its business, financial condition and results of operations.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors