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

We have incurred significant net losses since inceptioninception, and we expect to continue to incur significant net losses for the foreseeable future. We have never been, and may never be, profitable.

•advance our lead product candidate, GRI-0621, and our other product candidates through clinical development, and, if successful, later-stage clinical trials (in particular and without a partner, we will incur substantial additional expense to complete a Phase 2b clinical trial of GRI-0621);

•experience delays or interruptions to preclinical studies, clinical trials, our receipt of services from our third-party service providers on whom we rely, or our supply chain due to pandemics, supply chain and labor shortages, international tariff policies or trade wars, labor strikes, work stoppages or boycotts, natural disasters and geopolitical conflicts, such as the conflicts in Ukraine and the Middle East;

To become and remain profitable, we must develop and eventually commercialize products with significant market potential. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials, obtaining marketing approval for product candidates, manufacturing, marketing,marketing and selling products for which we may obtain marketing approval and satisfying any post-marketing requirements. We may never succeed in any or all of these activities and, even if we do, we may never generate revenue that is significant enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business,business or continue our operations.

We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs, future commercialization efforts or other operations.operations or cease operations entirely. In particular, we will require substantial additional capital or resources to complete a Phase 2b clinical trial of GRI-0621.

Developing biotechnology and biopharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive,expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception. We expect our expenses to increase in connection with our ongoing activities, particularly as we conduct our planned clinical trials of GRI-0621, GRI-0803 and any other product candidates that we may develop or seek regulatory approvals for and, if approved, launch and commercialize. InWe particular, we do notalso expect to be able to continue our clinical trials or development efforts without raising additional funds. We also expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in order to maintain our continuing operations. IfIn particular, we are unableexpect to raiserequire substantial additional capital when needed or on acceptable terms, we may be forced to delay,complete reduce,a orPhase eliminate2b oneclinical or moretrial of our research and drug development programs or future commercialization efforts.GRI-0621.

As of December 31, 2024,2025, we had approximately $5.0$8.2 million in cash and cash equivalents and an accumulated deficit of approximately $39.7$51.7 million. If we secure additional funds, weWe expect to devote substantial financial resources to our planned activities, particularly as we conduct our clinical trialstrial of GRI-0621 andGRI-0621, GRI-0803, advance our discovery programs andand, continuesubject ourto productobtaining developmentthe efforts.requisite additional capital or resources, complete a clinical trial of GRI-0621.

Based on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into the secondfirst quarter of 2025.2027. We have based these estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. In particular, these estimates assume only the commencement of preliminary work towards the initiation of a Phase 2b trial of GRI-0621; we would require substantial additional capital or resources in order to complete a Phase 2b clinical trial of GRI-0621. Our future capital requirements and the period for which our existing resources will support our operations may vary significantly from what we expect, and we will require additional funding to recommence development of our product candidates.expect. Our spending levels will vary based on new and ongoing developmentdevelopment, corporate activities, and corporateour activities.ability to raise funds or resources for a Phase 2b clinical trial of GRI-0621. Because the length of time and activities associated with development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development, and assuming approval, marketing and commercialization activities.

We willmay also need to raise additional funds in the near term in order to maintain compliance with Nasdaq’s continued listing requirements and continue operations. However, additional funding may not be available on acceptable terms, if at all. Until we can generate sufficient revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements. If we raise additional funds through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Further, to the extent that we raise additional capital through the sale of Common Stock or securities convertible or exchangeable into Common Stock, our stockholders’ ownership interest will be diluted. In addition, any debt financing may subject us to fixed payment obligations and covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures,expenditures or declaring dividends. If we raise additional capital through marketing and distribution arrangements or collaborations, strategic alliances,alliances or licensing arrangements with third parties, we may have to relinquish certain valuable intellectual property or other rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. We also may be required to seek collaborators for any of our product candidates at an earlier stage than otherwise would be desirable or relinquish our rights to product candidates or technologies that we otherwise would seek to develop or commercialize ourselves. Market volatility resulting from inflation, pandemics, geopolitical events or other financial markets factors could also adversely impact our ability to access capital as and when needed. If we are unable to secure adequate additional funding,funding when needed or on acceptable terms, we will need to reevaluate our operating plans and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back or eliminate some or all of our development programs, relinquish rights to our technology on less favorable terms than we would otherwise choose or cease operations entirely. These actions could materially impact our business, results of operations, our future prospects and the value of shares of our Common Stock, and as a result, our stockholders may receive no value for their investment. In addition, attempting to secure additional financing diverts the time and attention of management from day-to-day activities and distract from our discovery and product development efforts.efforts, which could also detrimentally affect these efforts and our prospects.

Our auditorsmanagement havehas expressed substantial doubt about our ability to continue as a going concern, and weour auditors have included explanatory paragraphs in their audit reports about our ability to continue as a going concern. We may not be able to continue as a going concern if we do not obtain additional financing.

We have incurred losses since inception and, to date, have financed our operations by issuing equity and debt securities. We anticipate that we will continue to incur losses and generate negative operating cash flows in the foreseeable future as we continue to develop our product drug candidates and that we will require additional funding to support our planned operating activities. In particular, these estimates assume only the commencement of preliminary work towards the initiation of a Phase 2b trial of GRI-0621; we would require substantial additional capital or resources in order to complete a Phase 2b clinical trial of GRI-0621. The reportreports of our independent registered public accounting firmfirms on our financial statements as of and for the yearyears ended December 31, 2024 includesand anDecember 31, 2025 include explanatory paragraphparagraphs indicating that there is substantial doubt about our ability to continue as a going concern. Until such time, if ever, in whichwhen we can generate substantial product revenue, we expect we may continue to fund our operations and capital funding needs through equity offerings, debt financings or other capital sources, including strategic licensing, collaboration or other similar agreements. As stated above, if we are unable to secure adequate additional funding, we will need to reevaluate our operating plans and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back or eliminate some or all of our development programs,programs or relinquish rights to our technology on less favorable terms than it would otherwise choose. These actions could materially impact our business, results of operations, our future prospects and the value of shares of our Common Stock, and, as a result, our stockholders may receive no value for their investment.

Our business is highly dependent on the success of our lead product candidate,candidates, GRI-0621,GRI-0621 and GRI-0803, and any other product candidates that we may advance into clinical development. All of our product candidates will require significant additional development before we may be able to seek regulatory approval and launch a product commercially.

We currently have no products that are approved for commercial sale and may never be able to develop marketable products. BecauseIf GRI-0621 isor ourGRI-0803 lead product candidate, if GRI-0621 encountersencounter safety or efficacy problems, additional development delays, regulatory issues or other problems, our development plans and business would be significantly harmed. Before we can generate any revenue from sales of our lead product candidate, GRI-0621, GRI-0803 or any of our other product candidates, we must undergo additional clinical development, regulatory review,review and approval in one or more jurisdictions. These efforts will require substantial investment, and we may not have the financial resources to continue development of our product candidates.

•further delays in submitting INDsIND applications or comparable foreign applications or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced;

•further delays in enrolling subjects in clinical trials, including due to pandemics, labor shortages or other geopolitical events;

•delays and changes in regulatory requirements, policypolicies and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our technology in particular; or

Clinical development involves a lengthy, complex,complex and expensive process, with an uncertain outcome. In addition, the results of preclinical studies and early-stage clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials and interim or topline results of our clinical trials may not be representative of final results of our clinical trials.

A product candidate can fail at any stage of testing, even after observing promising signals of activity in earlier preclinical studies or clinical trials. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. In addition, initial success in clinical trials may not be indicative of results obtained when such trials are completed. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. A number of companies in biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. In general, most product candidates that commence clinical trials are never approved as productsproducts, and there can be no assurance that any of our clinical trials will ultimately be successful or support further clinical development of GRI-0621, GRI-0803 or any of our other product candidates.

•manufacturing costs, formulation issues, pricing or reimbursement issues,issues or other factors that make a product candidate uneconomical; and

In 2022, Congress 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. The action plan must describe appropriate diversity goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them. Although none of our product candidates hashave reached Phase 3 of clinical development, we must submit a diversity action plan to the FDA by the time we submit a Phase 3 trial, or pivotal study, protocol to the agency for review, unless we are able to obtain a waiver for some or all of the requirements for a diversity action plan. It is unknown at this time how the diversity action plan may affect the planning and timing of any future Phase 3 trial for our product candidates. However, initiation of such trials may be delayed if the FDA objects to our proposed diversity action plans for any future Phase 3 trial for our product candidates, and we may experience difficulties recruiting a diverse population of patients in attempting to fulfill the requirements of any approved diversity action plan.

In addition, the standards that the FDA and comparable foreign regulatory authorities use when regulating our product candidates require judgment and can change, which makes it difficult to predict with certainty how they will be applied. Any analysis we perform of data from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We may also encounter unexpected delays or increased costs due to new government regulations. Examples of such regulations include future legislation or administrative action, or changes in FDA policy during the period of product development and FDA regulatory review. We cannot predict whether legislative changes will be enacted, or whether FDA or foreign regulations, guidance or interpretations will be changed, or what the impact of such changes, if any, may be. For example, in April 20232023, the European Commission issued a proposal for a new directive and a new regulation, which will revise and replace the existing general pharmaceutical legislation. If adopted and implemented as currently proposed, these revisions will significantly change several aspects of drug development and approval in the EU. As of the date of this Annual Report, these rules are still pending finalization.

Identifying and qualifying patients to participate in clinical studies of our product candidates is critical to our success. The timing of completion 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 again experience delays in our clinical trials if we again encounter difficulties in enrollment. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA.

We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The enrollment of patients depends on many factors, including:

For example, when we previously evaluated GRI-0621 in a pilot Phase 2a trial in hepatically impaired chronic liver disease patients, the study was originally intended to evaluate 60 patients but due to recruitment challenges and updated guidance from the FDA regarding the design of NASH clinical studiesstudies, we made the administrative decision to halt the study after enrolling 14 patients. InThis addition, we previously expected topline results from ourpilot Phase 2a trial forwas not resumed. In addition, the topline results of our recently completed Phase 2a clinical trial investigating GRI-0621 towere bedelayed availabledue in thepart fourthto quarterprior ofdelays 2024in andenrollment for this has since been delayed to the third quarter of 2025 primarily as a result of delayed enrollment. Enrollment in this trial continues to be somewhat unpredictable.trial.

Further, we are initially developing GRI-0621 for the treatment of IPF, which is an orphan indication. As a result, we have and may again encounter difficulties enrolling subjects in our clinical trials of GRI-0621 due, in part, to the small size of this patient population or the burden of safety labs included in the clinical protocol. In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition may reduce the number and types of patients available to us,us because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials inat such clinical trial site.sites.

Further, timely enrollment in clinical trials is reliant on clinical trial sites which may be adversely affected by global health matters, including, among other things, pandemics, supply and labor shortagesshortages, international trade policy and geopolitical events. These delays and potential delays to development timelines may adversely affect our business, prospects and results of operations.

Interim, topline and preliminary data from our clinical trials (including topline data from our recently completed Phase 2a trial for GRI-0621) that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we publicly disclose interim, preliminary or topline data from our clinical studies,studies (including recent disclosures of interim data and the topline data from our Phase 2a clinical trial for GRI-0621), which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analysis of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, topline or preliminary results of clinical trials we reportreport, including for our Phase 2a clinical trial for GRI-0621, may differ from final results reported for those studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final, complete data are available.

Likewise, in light of the fact that our previous evaluation of GRI-0621 in a pilot Phase 2a trial in hepatically impaired chronic liver disease patients was originally intended to evaluate 60 patients and that we made the administrative decision to halt the study after enrolling 14 patients due to recruitment challenges and updated guidance from the FDA regarding the design of NASH clinical studies, our disclosuredisclosures that GRI-0621 was observed to be well-tolerated and showed improvements in liver function tests, serum CK-18, and in iNKT cell activity in this limited number of patients is qualified by the fact that the study was underpowered to meet its endpoints with statistical significance. Our observations from this terminated pilot Phase 2a trial and our recent interim or topline results for GRI-0621 may not be indicative of results from any potential future preclinical studies or clinical trials.

Changes in regulatory requirements, FDA guidance or unanticipated events during our preclinical studies and clinical studies may force us to amend preclinical studies and clinical study protocols. The FDA or comparable foreign regulatory authorities may also impose additional preclinical studies and clinical study requirements. Amendments or changes to our clinical study protocols, including changes to endpoints, would require resubmission to the FDA or comparable foreign regulatory authorities and IRBsInstitutional Review Boards for review and approval, which may increase the cost or delay the timing or successful completion of clinical studies. Similarly, amendments to our preclinical studies may increase the cost or delay the timing or successful completion of those preclinical studies. If we experience delays completing, or if we terminate, any of our preclinical or clinical studies, or if we are required to conduct additional preclinical or clinical studies, the commercial prospects for our product candidates may be harmed and our ability to recognize product revenue will be delayed.

We face an inherent risk of product liability as a result of testing GRI-0621, GRI-0803 and any of our other product candidates in clinical trials and will face an even greater risk if we commercialize any products. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical trials, manufacturing, marketing or sale. As an oral formulation of an active ingredient that has previously been approved by the FDA only for topical administration, in particular, GRI-0621 may be subject to the identification of new serious adverse events as it is administered to larger numbers of research subjects in order to evaluate its safety/effectiveness in chronic use indications and in new patient populations. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. Even a successful defense of these claims would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

We expect to utilize the FDA’s Section 505(b)(2) pathway for our lead product candidate, GRI-0621, and if that pathway is not available, the development of ourthis product candidate will likely take significantly longer, cost significantly more and entail significantly greater complexity and risk than currently anticipated, and, in any case, may not be successful.

We intend to develop and seek approval for GRI-0621, and potentially other candidates that we may develop, pursuant to the FDA’s 505(b)(2) pathway. If the FDA determines that we may not use this regulatory pathway, then we would need to seek regulatory approval via a “full” or “stand-alone” New Drug Application (NDA) under Section 505(b)(1) of the FDCA. This would require us to conduct additional clinical trials, provide additional safety and efficacy data and other information,information and meet additional standards for regulatory approval including possibly nonclinical data. If this were to occur, the time and financial resources required to obtain FDA approval, as well as the development complexity and risk associated with these programs, would likely substantially increase, which could have a material adverse effect on our business and financial condition.

The Drug Price Competition and Patent Term Restoration Act of 1984, informally known as the Hatch-Waxman Act, added Section 505(b)(2) to the FDCA. Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies and information that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Section 505(b)(2), if applicable to certain of our product candidates under the FDCA, would allow an NDA we submit to the FDA to rely in part on data in the public domain or the FDA’s prior conclusions regarding the safety and effectiveness of approved compounds. Such an approach could expedite the development programs for GRI-0621. In addition, although 505(b)(2) applicants have significant flexibility in the types of studies, data,data and information they may submit in a 505(b)(2) NDA to support the requirements for NDA approval, establish a favorable benefit-risk profile for the new drug product,product and demonstrate the new drug’s substantial evidence of effectiveness for its proposed intended use(s), the applicant bears the burden of establishing a scientific bridge between its drug product and each listed drug that the applicant seeks to rely upon and that the studies it is proposing to conduct are scientifically justified. If the FDA disagrees with thean applicant’s proposed development plan for the follow-on drug product, it may require the sponsor to perform additional studies or measurements, including nonclinical and clinical studies, to support the change from the approved product. The FDA also may request or require studies to incorporate additional clinical endpoints than what the sponsor proposes. The extent of data necessary to establish the safety and/or effectiveness of the new product, such as the effects of changing the drug’s route of administration from topical to oral, are therefore scientifically driven and determined on a case-by-case basis. There can be no assurance that the studies and clinical trials we propose to the FDA to establish the safety and effectiveness of GRI-0621 for the treatment of IPF, or any future candidates we may develop using the 505(b)(2) NDA pathway, will be deemed sufficient to support all of the differences between our product candidate and the relevant listed drug. For example, we may be required to collect more safety data than we anticipate in order to gain approval of an oral formulation of an active ingredient that has previously been approved by the FDA only for topical administration.

Manufacturers and their facilities are required to comply with extensive FDA and comparable foreign regulatory authority requirements, including ensuring that quality control and manufacturing procedures conform to cGMPs and applicable electronic package-level tracing requirements. We and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMPs and adherence to commitments made in any marketing application, and previous responses to inspection observations. Accordingly, we and others with whom we work must continue to expend time, money,money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.

We must also comply with requirements concerning advertising and promotion for any of our product candidates for which we hope to obtain marketing approval. The FDA strictly regulates marketing, labeling, advertising,advertising and promotion of products that are placed on the market. Products may be promoted only for the approved indications and in accordance with the provisions of the approved label. However, companies may share truthful and not misleading information that is not inconsistent with the labeling, and the FDA has recently published a draft guidance with recommendations for how drug manufacturers can share scientifically sound and clinically relevant information on unapproved uses with health care providers so long as such presentations are not promotional. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

•injunctions, consent decrees,decrees or the imposition of civil or criminal penalties.

Any government investigation of alleged violations of law would be expected to require us to expend significant time and resources in response and could generate adverse publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to develop and commercialize our products and our value and our operating results would be adversely affected. In addition, the policies of the FDA and of other regulatory authorities may changechange, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

Even if GRI-0621, GRI-0803 or any other product candidate we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients and third-party payors, such as Medicare and Medicaid programs and managed care organizations,organizations and others in the medical community. In addition, the availability of coverage by third-party payors may be affected by existing and future health care reform measures designed to reduce the cost of health care. If the product candidates we develop do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable.

•the prevalence and severity of any side effects, as well as the language and scope of any labeled warnings (including boxed warnings), precautions,precautions or contraindications.

Sales of medical products also depend on the willingness of physicians to prescribe the treatment, which is likely to be based on a determination by these physicians that the products are safe, therapeutically effective and cost effective. In addition, the inclusion or exclusion of products from treatment guidelines established by various physician groups and the viewpoints of influential physicians can affect the willingness of other physicians to prescribe the treatment. We cannot predict whether physicians, physicians’ organizations, hospitals, other healthcare providers, government agencies or private insurers will determine that outour products are safe, therapeutically effective and cost effective as compared with competing treatments. If any product candidate is approved but does not achieve an adequate level of acceptance by such parties, we may not generate or derive sufficient revenue from that product candidate and may not become or remain profitable. If government and other third-party payors do not provide coverage and adequate reimbursement levels for any products we commercialize, market acceptance and commercial success would be reduced.

The pricing, coverage,coverage and reimbursement of our approved products, if any, must be sufficient to support our commercial efforts and other development programs, and the availability and adequacy of coverage and reimbursement by third-party payors, including governmental and private insurers, are essential for most patients to be able to afford medical treatments. Sales of our approved products, if any, will depend substantially, both domestically and abroad, on the extent to which the costs of our approved products, if any, will be paid for or reimbursed by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations,organizations or government payors and private payors. If coverage and reimbursement are not available, or are available only in limited amounts, we may have to subsidize or provide products for free or we may not be able to successfully commercialize our products.

In addition, there is significant uncertainty related to the insurance coverage and reimbursement for newly approved products. In the United States, the principal decisions about coverage and reimbursement for new drugs are typically made by the CMS, an agency within the HHS, as CMS decides whether and to what extent a new drug will be covered and reimbursed under Medicare. Private payors tend to follow the coverage reimbursement policies established by CMS to a substantial degree. It is difficult to predict what CMS will decide with respect to reimbursement for novel product candidates such as ours and what reimbursement codes our product candidates may receive if approved.

In order to market any products outside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval procedures vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking foreign regulatory approvals could result in significant delays, difficulties,difficulties and costs for us and may require additional preclinical studies or clinical trials which would be costly and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our products in those countries. Satisfying these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. In addition, our failure to obtain regulatory approval in any country may delay or have negative effects on the process for regulatory approval in other countries. We do not have any product candidates approved for sale in any jurisdiction, including international markets, and we do not have experience as a company in obtaining regulatory approval in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, our ability to realize the full market potential of our products will be harmed.

We have no internal sales, marketing,marketing or distribution capabilities. We have no prior experience as a company in the marketing, sale and distribution of pharmaceutical productsproducts, and there are significant risks involved in building and managing a sales organization, including our ability to hire, retain and incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our sales, marketing and distribution capabilities would adversely impact the commercialization of any product candidates that may obtain approval. We may also choose to collaborate with third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems. We may not be able to enter into collaborations or hire consultants or external service providers to assist us in sales, marketing and distribution functions on acceptable financial terms, or at all. In addition, our product revenues and our profitability, if any, may be lower if we rely on third parties for these functions than if we were to market, sell and distribute any products that we develop ourselves. We likely will have little control over these third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. If we are not successful in commercializing any approved product candidates that we may have, either on our own or through arrangements with one or more third parties, we may not be able to generate any future product revenue and we would incur significant additional losses.

Healthcare providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical products. Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal AKS and the federal False Claims Act, which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products. In particular, the research of our product candidates, as well as the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials. See the section entitledentitled, “Item 1. Business — Government Regulation and Product Approval — Other U.S. Healthcare Laws and Regulations.”

It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, reputational harm, possible exclusion from participation in federal and state funded healthcare programs, contractual damages and the curtailment or restricting of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business isare found to be not in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. Any action for violation of these laws, even if successfully defended, could cause significant legal expenses and divert management’s attention from the operation of the business. Prohibitions or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way.

Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example, changes to our manufacturing arrangements; additions or modifications to product labeling; the recall or discontinuation of our products; or additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not achieve or sustain profitability. See the section entitledentitled, “Item 1. Business — Government Regulation and Product Approval — Pharmaceutical Coverage, Pricing and Reimbursement & Healthcare Reform.”

Moreover, increasing efforts by governmental and third-party payors in the United States and abroad, including in Canada and Europe, to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates. There has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs,programs and reform government program reimbursement methodologies for drugs. Most recently, inIn August 2022, former President Biden signed into the law the IRAIRA, which among other things, contains multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States.

Among other things, the IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. A manufacturer of drugs or biological products covered by Medicare Parts B or D must now pay a rebate to the federal government if their drug product’s price increases faster than the rate of inflation. This calculation is made on a drug product by drug product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D. Additionally, starting for payment year 2026, CMS is negotiating drug prices annually for a select number of single source Part D drugs without generic or biosimilar competition. CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028. If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease. CMS has begun to implement these new authorities and entered into the first set of agreements with pharmaceutical manufacturers to conduct price negotiations in October 2023 and ultimately announcing the first round of negotiated prices for the first 10ten drugs in August 2024; those negotiated “maximum fair prices” will be effective as of January 1, 2026 (payment year 2026). CMS is currently engaged in its second round of negotiations and published the next 15 drugs selected for negotiation in January 2025. However, the IRA’s impact on the biopharmaceutical industry in the United States remains uncertain, in part because multiple large pharmaceutical companies and other stakeholders (e.g., the U.S. Chamber of Commerce) have initiated federal lawsuits against CMS arguing the program is unconstitutional for a variety of reasons, among other complaints. The outcome of such ongoing lawsuits, as well as potential legislative changes enacted by Congress or programmatic changes implemented at CMS by the Trump Administration, may impact the IRA drug price negotiation programprogram. For example, the One Big Beautiful Bill Act (OBBBA), which President Trump signed into law in July 2025, modified the future.IRA’s exclusion protecting orphan drugs designated for a single rare disease indication from required pricing negotiations by expanding it to apply to drugs designated for multiple rare diseases and by prohibiting Medicare price negotiations until seven years after an orphan drug, or 11 years after an orphan biologic, is approved for a non-orphan indication, which will significantly delay pricing negotiations for certain high-priced and widely used drugs.

TheIn mid-2022, the FTC in mid-2022 also launched sweeping investigations into the practices of the PBM industry, and published interim reports with its findings in mid-2024 and January 2025, that could lead to additional federal and state legislative or regulatory proposals targeting such entities’ operations, pharmacy networks,networks or financial arrangements, including in the current 2025-2026 congressional session. Both the U.S. Congress and state legislatures are increasingly scrutinizing the industry and proposing novel regulatory approaches to address various perceived public policy concerns. Significant efforts to change the PBM industry as it currently exists in the United States may affect the entire pharmaceutical supply chain and the business of other stakeholders, including biopharmaceutical product developers like us. Further, in September 2023, the FTC issued a policy statement articulating its view that certain “improper” patent listings by drug developers in FDA’s Orange Book represent an unfair trade practice and indicated that industry should be prepared for potential enforcement actions based on its analysis. The FTC followed that action in November 2023 by publicly calling out over 100 “improper” patent listings made by ten large pharmaceutical companies and initiating an FDA administrative process with respect to those patents. The controversy regarding the appropriateness of listing such patents has led to numerous lawsuits alleging anticompetitive conduct by biopharmaceutical companies. It remains to be seen whether the FTC under the Trump Administration will continue to prioritize the policy issue of “improper” patent listings or whether Congress may take any legislative actions related to this issue. Accordingly, regulatory and government interest in biopharmaceutical industry business practices continues to expand and pose a risk of uncertainty.

These laws,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. Additionally, we expect to experience pricing pressures in connection with the sale of any future approved product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, cost containment initiatives and additional legislative changes.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government shutdowns, government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees,fees and statutory, regulatory,regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including from December 22, 2018 through January 25, 2019, the U.S. government has shut down several times, and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC,SEC and other government employees and stop critical activities. IfIt is often unclear how long a shutdown will last and what impacts it may have on the federal agencies that have jurisdiction over our various operations. Additionally, regulatory agencies including the FDA have experienced significant disruptions which are expected to continue under the Trump Administration relating to funding restrictions, personnel reductions, deregulation policies and executive orders affecting policy decisions. Ongoing uncertainty or a prolonged government shutdown or slowdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future governmentdisruptions shutdownsto the FDA and other agencies could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations. There have been U.S. government shutdowns historically, and recent government shutdowns have been threatened; itIt is oftenalso unclear if or how longthe a shutdownFDA will lastchoose andto whator impactsbe itable mayto haveimplement onor enforce its regulations in the federalfuture, agenciesincluding those that have jurisdictionsubstantial overimpact on our various operations.business.

In addition, three decisions from the U.S. Supreme Court issued in July 2024 may lead to an increase in litigation against regulatory agencies that could create uncertainty and thus negatively impact our business. The first decision overturned established precedent that required courts to defer to regulatory agencies’ interpretations of ambiguous statutory language. The second decision overturned regulatory agencies’ ability to impose civil penalties in administrative proceedings. The third decision extended the statute of limitations within which entities may challenge agency actions. These cases may result in increased litigation by industry against regulatory agencies, including but not limited to the FDA and SEC, and may impact how such agencies choose to pursue enforcement and compliance actions. However, the specific, lasting effects of these decisions, which may vary within different judicial districts and circuits, is unknown. We also cannot predict the extent to which FDA and SEC regulations, policies,policies and decisions may become subject to increasing legal challenges, delays,delays and changes.

We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions,sanctions and other trade laws and regulations. We can face serious consequences for violations.

Among other matters, United States.U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions,sanctions and other trade laws and regulations (collectively, “Trade Laws”) prohibit companies and their employees, agents, clinical research organizations,organizations (CROs), legal counsel, accountants, consultants, contractors,contractors and other partners from authorizing, promising, offering, providing, soliciting,soliciting or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm,harm and other consequences. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. We also expect our non-U.S. activities to increase in time. We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents,agents or partners, even if we do not explicitly authorize or have prior knowledge of such activities.

Our research and development activities and our third-party manufacturers’ and suppliers’ activities involve the controlled storage, use,use and disposal of hazardous materials, including the components of our product candidates and other hazardous compounds. We and our manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage, handling,handling and disposal of these hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use are stored at our and our manufacturers’ facilities pending their use and disposal. We cannot eliminate the risk of contamination, which could cause an interruption of our commercialization efforts, research and development efforts and business operations; environmental damage resulting in costly clean-up; and liabilities under applicable laws and regulations governing the use, storage, handling,handling and disposal of these materials and specified waste products. Although we believe that the safety procedures utilized by us and our third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of specified materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently,frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance. We do not currently carry hazardous waste insurance coverage.

We are a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing innovative therapies that target serious diseases associated with dysregulated immune responses leading to inflammatory, fibrotic,fibrotic and autoimmune disorders. Our goal is to be an industry leader in developing therapies to treat these diseases and to improve the lives of patients suffering from such diseases.

Our lead product candidate, GRI-0621, is an oral inhibitor of type 1 iNKT cells. GRI-0621 is also an oral formulation of tazarotene, a synthetic RAR-betaretinoid acid receptor-beta and gamma selective agonist, that is approved in the United States for topical treatment of psoriasis and acne. AsWhile there are no approved oral formulations of tazarotene, as of December 31, 2024,2025, it has been evaluated in over 1,700 patients as an oral product for up to 52-weeks. We are developing GRI-0621 for the treatment of severe fibrotic lung diseases such as IPF, a life-threatening progressive fibrotic disease of the lung that affects approximately 140,000 people in the United States, with up to 40,000 new cases per year in the United States. Some estimate that IPF affects 3 million people globally. While there are currently two approved therapies for the treatment of lung fibrosis, neither has been associated with improvements in overall survival, and both therapies have been associated with significant side effects leading to poor therapeutic adherence. In preliminary and topline data from our trials to date with GRI-0621, and earlier trials with oral tazarotene, we have observed GRI-0621 to be well-tolerated and to inhibit iNKT cell activity in subjects. We and others have shown that activated iNKT are upregulated in IPF, PSC,primary MASH,sclerosing ALD,cholangitis, metabolic dysfunction-associated steatohepatitis, alcoholic liver disease, SLE, MS, UCulcerative patients,colitis patients as well as other indications. In these patients activated iNKT cells are correlated with more severe disease. The FDA has cleared our IND application for GRI-0621 for the treatment of IPF and we plan to evaluate GRI-0621 in a randomized, double-blind, multi-center Phase 2a biomarker study, for which we commenced enrollment in December 2023. Based on our current projections, we expect topline results from this trial to be available in the third quarter of 2025. Additionally, on March 1, 2024, we received authorization of our CTA from the United Kingdom MHRA to initiate the Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in the United Kingdom. On September 24, 2024, we received approval from the HREC to initiate the Phase2a biomarker study evaluating GRI-0621 for the treatment of IPF in Australia, after previously receiving authorization on our CTA from the Australian MHRA.

Our product candidate portfolio also includes GRI-0803 and a proprietary library of 500+ compounds. GRI-0803, the lead molecule selected from the library, is a novel oral agonist of dNKTtype cells.2 Wediverse areNatural developingKiller GRI-0803T cells and would be developed for the treatment of autoimmune disorders, with much of our preclinical work in SLE or lupus and MS. In lupus, the immune system mistakenly attacks its own healthy tissues, especially joints and skin, but can affect almost every organ and tissue of the body. The condition can be fatal,fatal and often causes debilitating bouts of fatigue and pain that prevent nearly half of adult patients from working. Lupus affects between 160,000 –- 200,000 patients in the United States, with around 80,000 – 100,000 patients in the United States suffering from kidney nephritis, one of the most serious manifestations of SLE, typically within five years of diagnosis. There is no cure for lupus, but medical interventions and lifestyle changes can help control it. SLE treatment consists primarily of immunosuppressive drugs that inhibit the activity of the immune system. Only two drugs have been approved for lupus in the past 50 years, and new treatment options are sorely needed. SubjectIn order to INDfocus clearance,our resources on our GRI-0621 program, we previously limited our development of GRI-0803 pending additional funding. We intend to complete IND-enabling studies and file an IND application to evaluate GRI-0803 in a Phase 1a and 1b trial initiallyin targetinghealthy SLE.volunteers in 2026. We expect to file an IND with respect to this Phase 1a and 1b trial in 2025. We will continue to evaluate indications to select the best fit for further development of the program, but our initial focus iswould be on lupus.

On FebruaryJanuary 11,15, 2025,2026, our stockholders approved the FebruaryJanuary 20252026 Reverse Stock Split within a range of not less than one-for-two and not more than one-for-23one-for-30, and our Board subsequently approved the FebruaryJanuary 20252026 Reverse Stock Split at the ratio of one-for-17.one-for-28. Following these approvals, we filed an amendment to our Charter with the Secretary of State of the State of Delaware to effect the FebruaryJanuary 20252026 Reverse Stock Split as of 4:01 p.m. Eastern Time on FebruaryJanuary 21,23, 2025.2026. Shares of our Common Stock began trading on a post-split basis on FebruaryJanuary 24,26, 2025.2026. The FebruaryJanuary 20252026 Reverse Stock Split had the effect of reducing the aggregate number of outstanding shares of Common Stock from 8,933,36615,960,229 outstanding shares on a pre-reverse split basis as of January 23, 2026 to a total of 525,358570,002 shares outstanding on a post-reverse split basis.basis as of January 23, 2026.

Previously, on January 29, 2024, we effected a reverse stock split of our Common Stock at a ratio of one-for-seven, and on June 17, 2024, we effected a reverse stock split of our Common Stock at a ratio of one-for-13.one-for-13 and on February 21, 2025 we effected a reverse stock split of our Common stock at a ratio of on-for seventeen.

H.C. Wainwright & Co., LLC (Wainwright) acted as the exclusive placement agent for the Warrant Repricing Transaction pursuant to an engagement agreement between us and Wainwright, dated as of October 21, 2024. In addition to a cash fee, management fee, and reimbursement of certain accountable and non-accountable expenses, we also issued to Wainwright or its designees warrants to purchase up to an aggregate of 3,140114 shares of Common Stock (the October 2024 PA Warrants) as compensation for its placement agent services. The October 2024 PA Warrants are immediately exercisable, expire on October 22, 2029,2029 and have an exercise price of $21.25$595.00 per share.

As of December 31, 2024,2025, we have sold 325,61860,003 shares of our Common Stock in the ATM Offering at a weighted-average price of $11.07$102.75 per share, raising $3.6$6.2 million of gross proceeds and net proceeds of $3.5$5.9 million, after deducting commissions to the sales agent and other ATM Offering related expenses. On DecemberJanuary 20,9, 2024,2026, we filed a prospectus supplement to our registration statement on Form S-3 (File No. 333-279348) to increase the amount of shares of Common Stock that we may offer and sell under the Sales Agreement and applicable registration statement to an aggregate offering price of up to $0.3$7.4 million, which amount does not include the shares of Common Stock having an aggregate gross sales price of approximately $3.6$6.2 million that were sold under the ATM Offering through DecemberJanuary 20,8, 2024,2026, in accordance with the limitations set forth in Instruction I.B.6 of Form S-3. Since December 31, 2025, the Company has sold 947,342 shares of Common Stock with an aggregate gross sales price of $6,474.

Our consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP).GAAP. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Research and development expenses include personnel costs associated with research and development activities, including third-partythird party contractors to perform research, conduct clinical trials and manufacture drug supplies and materials.

Our research and development expenses have consisted primarily of costs related to our development program for our lead product candidatecandidate, GRI-0621. These expenses include:

•expenses incurred under agreements with contract research organizations, contract manufacturing organizations and research laboratories in connection with our preclinical development, process development, manufacturing and clinical development activities as well as consultants that support the implementation of our clinical and nonclinicalnon-clinical studies.

OtherInterest Income

We are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of any fiscal year for so long as either (1) the market value of our shares of Common Stock held by non-affiliates does not equal or exceed $250.0 million as of the prior June 30th, or (2) our annual revenues did not equal or exceed $100.0 million during such completed prior fiscal year and the market value of our shares of Common Stock held by non-affiliates did not equal or exceed $700.0 million as of the prior June 30th. To the extent we take advantage of any reduced disclosure obligations, it may make comparison of our financial statements with other public companies difficult or impossible.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the JOBS Act) and may remain an emerging growth company for up to five years. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not applicable to emerging growth companies. These exemptions include:

Research and development expenses were $3.8$6.8 million and $3.2$3.8 million for the years ended December 31, 20242025 and 2023,2024, respectively. The $0.6$3.0 million increase in research and development expenses was primarily due to increases of $0.7$2.9 million in expenses related to the registration development program of GRI-0621, offset$0.1 bymillion in personnel expense, including stock-based compensation and a $0.1 million decreaseincrease in personnelconsulting expense.fees.

General and administrative expenses were $4.5$5.2 million and $8.2$4.5 million for the years ended December 31, 20242025 and 2023,2024, respectively. The $3.7$0.7 million decreaseincrease was primarily due to aan decreaseincrease of $3.4 million in accounting, legal, investment banking and other fees as a result of the Merger and the cost of being a public company, a decrease of $0.4$0.7 million in personnel costs, andincluding astock-based decreasecompensation $0.1 million in consulting expenses, offset by an increase of $0.1 million in insurance expense and an increase of $0.1 million in other general and administrative expenses.expense.

The change in fair value of $0.2 million$3,000 represents a decrease in the fair value of the warrants outstanding during the year ended December 31, 2024.2025.

Interest Income (Expense), net

Interest income was $21,000 and $25,000 for the yearyears ended December 31, 2024. Interest expense, net, was $2.1 million for the year ended December 31, 20232025 and related2024, to the Bridge Notes.respectively.

For the years ended December 31, 20242025 and 2023,2024, $8.6$10.2 million and $9.0$8.6 million were used in operating activities, respectively. The $0.4$1.6 million decrease was primarily due to a $4.8$3.8 million decreaseincrease in our net loss and a decrease of $1.0$0.2 million in cash used for prepaid and other expenses and operating lease liabilities, offset by a $2.3$0.8 million net decreaseincrease in non-cash adjustments, including stock based compensation expense and the amortization of debt discounts and debt issuance costs,expense, and a $3.2$1.6 million increasedecrease in cash used for the payment of accounts payable.payable and accrued liabilities.

Net cash provided by financing activities was $11.8$13.4 million during the year ended December 31, 20242025 and was primarily related to $9.5$13.0 million of proceeds from the FebruaryApril 20242025 Purchase Agreement and the JuneDecember 20242025 Purchase Agreement,Agreement $3.6and $2.6 million of proceeds from the ATM Offering and $0.8 million of proceeds from the exercise of certain Series B Common Warrants.Offering. These proceeds were offset by $2.0$2.2 million in stock issuance costs.

Net cash provided by financing activities was $10.8$11.8 million for the year ended December 31, 20232024 and was primarily due to of $12.3$9.5 million from the February 2024 Purchase Agreement and the June 2024 Purchase Agreement, $3.6 million of proceeds from the EquityATM SPA,Offering $1.3and $0.8 million of proceeds from the fundingexercise of thecertain secondSeries trancheB ofCommon the Bridge Notes and $0.9 million of cash acquired in the connection with the Merger.Warrants. These proceeds were offset by $3.0$2.0 million in costs associated with the Merger, the payment of $0.2 million of debt issuance costs related to the Bridge Notes and $0.5 million of stock issuance costs related the Equity SPA.costs.

For a description of the transactions contemplated by the February 2024 Securities Purchase Agreement, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — February 2024 Securities Purchase Agreement.” The net proceeds from the offering were $4.4 million, after deducting placement agent fees and offering expenses of $1.1 million.

ThereExcept as set forth below, there have been no material changes from the risk factors previously disclosed in the Annual Report.

Our product candidate, GRI-0621, which received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) on June 18, 2026 for the treatment of IPF, is an oral inhibitor of type 1 iNKT cells. GRI-0621 is also an oral formulation of tazarotene, a synthetic retinoid acid receptor-beta and gamma selective agonist, that is approved in the United States for topical treatment of psoriasis and acne. While there are no approved oral formulations of tazarotene, as of MarchJune 31,30, 2026, it has been evaluated in over 1,700 patients as an oral product for up to 52-weeks. We are developing GRI-0621 for the treatment of severe fibrotic lung diseases such as IPF, a life-threatening progressive fibrotic disease of the lung that affects approximately 140,000 people in the United States, with up to 40,000 new cases per year in the United States. Some estimate that IPF affects 3 million globally. While there are currently two approved therapies for the treatment of lung fibrosis, neither has been associated with improvements in overall survival, and both therapies have been associated with significant side effects leading to poor therapeutic adherence. In preliminary and topline data from our trials to date with GRI-0621, and earlier trials with oral tazarotene, we have observed GRI-0621 to be well-tolerated and to inhibit iNKT cell activity in subjects. We and others have shown that activated iNKT are upregulated in IPF, primary sclerosing cholangitis, metabolic dysfunction-associated steatohepatitis, alcoholic liver disease, SLE, MS, ulcerative colitis patients as well as other indications. In these patients activated iNKT cells are correlated with more severe disease.

We most recently evaluated GRI-0621 in a randomized, double-blind, multi-center, 2-arm Phase 2a clinical trial for the treatment of patients diagnosed with IPF. The primary endpoint for this Phase 2a trial was safety and tolerability of oral GRI-0621GRI-0621, administered as a single daily dose, as assessed by clinical labs, vital signs and adverse events after 12 weeks of treatment. Secondary endpoints were baseline changes in serum biomarkers, differentially expressed genes measured by ribonucleic acid sequencing (RNAseq), T cell receptor sequencing (TCRseq), and flow cytometry in PBMC samples collected at week six and week 12; an assessment of the PK of GRI-0621 at the week 12 visit of treatment (steady state); and a determination of the pharmacodynamic activity of oral GRI-0621 as measured by inhibition of immune cell activation in blood after six weeks and 12 weeks, and from BAL fluid after 12 weeks of treatment. Concurrently, a sub-study examined the number and activity of immune cells in BAL fluid in eight subjects (across various centers). Additional exploratory endpoints for the trial included assessment of the effect of GRI-0621 on pulmonary function at baseline and after six weeks and 12 weeks of treatment. 35 patients were enrolled in the trial and randomly assigned to a placebo arm and a GRI-0621 treatment arm, of which 19 patients completed treatment in the treatment arm and nine patients completed treatment in the placebo arm. Based on topline results available to date, the clinical trial met its primary endpoint and the secondary endpoints measured to date (as described below). Continued analyses of exploratory endpoints, including RNAseq, TCRseq, and the pharmacodynamic activity of GRI-0621, remain consistent with and supportive of previously reported findings. We have filed additional patent applications based, in part, on these data.

Our product candidate portfolio also includes GRI-0803 and a proprietary library of 500+ compounds. GRI-0803, the lead molecule selected from the library, is a novel oral agonist of type 2 diverse Natural Killer T cells and would be developed for the treatment of autoimmune disorders, with much of our preclinical work in SLE or lupus and MS. In lupus, the immune system mistakenly attacks its own healthy tissues, especially joints and skin, but can affect almost every organ and tissue of the body. The condition can be fatal and often causes debilitating bouts of fatigue and pain that prevent nearly half of adult patients from working. Lupus affects between 160,000 - 200,000 patients in the United States, with around 80,000 – 100,000 patients in the United States suffering from kidney nephritis, one of the most serious manifestations of SLE, typically within five years of diagnosis. There is no cure for lupus, but medical interventions and lifestyle changes can help control it. SLE treatment consists primarily of immunosuppressive drugs that inhibit the activity of the immune system. Only two drugs have been approved for lupus in the past 50 years, and new treatment options are sorely needed. In order to focus our resources on our GRI-0621 program, we previously limited our development of GRI-0803 pending additional funding. We intend to complete IND-enabling studies and file an IND application to evaluate GRI-0803 in a Phase 1a and 1b trial in healthy volunteers in 2026.the first half of 2027. We expect to continue to evaluate indications to select the best fit for further development of the program, but our initial focus would be on lupus.

On January 15, 2026, our stockholders approved the January 2026 Reverse Stock Split within a range of not less than one-for-two and not more than one-for-thirty, and our Board of Directors subsequently approved the January 2026 Reverse Stock Split at the ratio of one-for-twenty-eight. Following these approvals, we filed an amendment to our CharterAmended and Restated Certificate of Incorporation, as amended, with the Secretary of State of the State of Delaware to effect the January 2026 Reverse Stock Split as of 4:01 p.m. Eastern Time on January 23, 2026. Shares of our Common Stock began trading on a post-split basis on January 26, 2026. The January 2026 Reverse Stock Split had the effect of reducing the aggregate number of outstanding shares of Common Stock from 15,960,229 outstanding shares on a pre-reverse split basis as of January 23, 2026 to a total of 570,002 shares outstanding on a post-reverse split basis as of January 23, 2026.

The December 2025 Pre-Funded Warrants were exercisable for one share of Common Stock at a price of $0.0028 per share, were exercisable immediately and expired when exercised in full. The Series F Common Warrants are exercisable into one share of Common Stock at a price per share of $21.00 and are immediately exercisable. The Series F Common Warrants will expire on December 12, 2030. As of MarchJune 31,30, 2026, all of the December 2025 Pre-Funded Warrants have been exercised.

The April 2025 Pre-Funded Warrants were exercisable for one share of Common Stock at a price of $0.0028 per share, were exercisable immediately and expired when exercised in full. Each Series E Common Warrant is exercisable into one share of Common Stock at a price per share of $89.60 and is immediately exercisable. The Series E-1 Common Warrants will expire on the five-year anniversary of the date of issuance. The Series E-2 Common Warrants will expire on the 18-month anniversary of the date of issuance. The Series E-3 Common Warrants will expireexpired on the nine-month anniversary of the date of issuance.

As of MarchJune 31,30, 2026, we have sold 1,147,3671,748,549 shares of our Common Stock in the ATM Offering at a weighted-average price of $11.32$8.22 per share, raising $13.0$14.4 million of gross proceeds and net proceeds of $12.4$13.7 million, after deducting commissions to the sales agent and other ATM Offering related expenses. During the three months ended MarchJune 31,30, 2026, we sold 1,087,364601,182 shares of Common Stock in the ATM Offering at a weighted average price of $6.27$2.32 per share for gross proceeds of $6.8$1.4 million and net proceeds of $6.5$1.3 million. During the six months ended June 30, 2026, we sold 1,688,546 shares of Common Stock in the ATM Offering at a weighted average price of $4.86 per share for gross proceeds of $8.2 million and net proceeds of $7.9 million.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Research and development expenses were $0.4 million and $1.6$1.9 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The $1.2$1.5 million decrease in research and development expenses was primarily due to a decrease of $1.1$1.5 million in expenses related to the registration development program of GRI-0621 due to the completion of the Phase 2a clinical trial and a $0.1 million decrease in consulting fees.trial.

General and administrative expenses were $1.6$1.2 million and $1.4$1.0 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The $0.2 million increase was primarily related to a $0.1 million decrease in personnel expenses, including stock-based compensation expenses, offset by a $0.4$0.2 million increase in public company expenses.

Interest income was $5,000 in each of the three months ended MarchJune 31,30, 2026 and 2025.

Since inception, we have incurred losses and expect to continue to incur losses for the foreseeable future. We incurred net losses of $2.0$3.6 million and $3.0$5.9 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $53.7$55.3 million.

We have financed our working capital requirements to date through the issuance of Common Stock, warrants, convertible notes and promissory notes. As of MarchJune 31,30, 2026, we had $11.0$10.9 million in cash.

For the threesix months ended MarchJune 31,30, 2026 and 2025, $3.7$5.1 million and $1.7$4.9 million were used in operating activities, respectively. The $1.9$0.2 million increase was primarily due to a $1.8$1.7 million increase in cash used for accounts payable, a $0.9$0.5 million increase in cash used for accrued expenses, a $0.2 million increasedecrease in non-cash adjustments, primarily related to stock-based compensation expenses, and $0.1$0.2 million decrease in cash used for prepaid and other assets and operating lease liabilities, offset by a $1.0$2.3 million decrease in net loss.

Net cash provided by financing activities was $6.5$7.8 million for the threesix months ended MarchJune 31,30, 2026 and was primarily related to $6.8$8.2 million in proceeds from the ATM Offering, offset by $0.3$0.4 million of stock issuance costs.

Net cash usedprovided inby financing activities was $11,000$5.0 million for the threesix months ended MarchJune 31,30, 2025 and was primarily related to the payment$5.0 million in proceeds from the April 2025 Offering and $0.9 million in proceeds from the ATM Offering, offset by $0.9 million of stock issuance costs related to the April 2025 Purchase Agreement.costs.

As of MarchJune 31,30, 2026, we have sold 1,147,3671,748,549 shares of our Common Stock in the ATM Offering at a weighted-average price of $11.32$8.22 per share, raising $13.0$14.4 million of gross proceeds and net proceeds of $12.4$13.7 million, after deducting commissions to the sales agent and other ATM Offering related expenses. On January 30, 2026, we filed a prospectus supplement to our registration statement on Form S-3 (File No. 333-279348) to increase the amount of shares of Common Stock that we may offer and sell under the Sales Agreement and applicable registration statement to an aggregate offering price of up to $60.0 million, which amount does not include the shares of Common Stock having an aggregate gross sales price of approximately $12.6 million that were sold under the ATM Offering through January 29, 2026, in accordance with the limitations set forth in Instruction I.B.6 of Form S-3.

Our net losses were $2.0$3.6 million and $3.0$5.9 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had $11.0$10.9 million in cash and an accumulated deficit of $53.7$55.3 million. We expect to devote substantial financial resources to our planned activities, particularly as we prepare for, initiate, and conduct our planned clinical trials of GRI-0621 and GRI-0803, advance our discovery programs and continue our product development efforts. In addition, we expect to incur additional costs associated with operating as a public company.

Based on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to fund ourout currently planned operating expenses and capital expenditure requirements intothrough the second quarter of 2027. InHowever, particular,this theseestimate estimatesassumes assumethat we only continue the continuation of preliminary work towards the initiation of aadditional Phaseclinical 2b trialstudies of GRI-0621; we would not be able to complete the additional clinical studies for GRI-0621, which will require substantial additional capital or resources in order to complete a Phase 2b clinical trial of GRI-0621.resources.