GRI

These forward-looking statements include, but are not limited to, statements about: • our history of losses and need for additional capital to fund our operations, our inability to obtain additional capital on acceptable terms, or at all, our ability to continue as a going concern and to continue our operations, the failure of which could result in our stockholders receiving no value for their investment; • our ability to remain listed on The Nasdaq Capital Market and to maintain compliance with applicable continued listing requirements; • our ability to remediate material weaknesses in our internal controls over financial reporting or to maintain effective internal controls over financial reporting and our evaluations regarding the effectiveness of any compensating controls; • our limited operating history and the difficulties encountered by a small developing company; • the timing of initiation of planned clinical trials; • the timing of any planned Investigational New Drug (INDs) or New Drug Applications (NDAs); • plans to research, develop, and commercialize current and future product candidates; • the ability to enter into new collaborations, and to fulfill obligations under any such collaboration agreements; • the clinical utility, potential benefits and market acceptance of product candidates; • commercialization, marketing and manufacturing capabilities and strategy; • the ability to identify additional products or product candidates with significant commercial potential; • developments and projections relating to our competitors and their industries; • the impact of government laws and regulations; • our ability to protect our intellectual property position and to obtain patent extensions; • estimates regarding future revenue, expenses, capital requirements and need for additional financing; • any statements about the effect, or potential effect, of the reverse stock splits, including the January 2026 Reverse Stock Split (as defined below), on the price or trading of our common stock, par value $0.0001 per share (Common Stock), on The Nasdaq Capital Market; and • statements of belief and any statement of assumptions underlying any of the foregoing.
As used in this Annual Report, unless the context requires otherwise, the “Company,” “GRI Bio,” “we,” “us” and “our” refer to GRI Bio, Inc., including its wholly-owned subsidiary, GRI Bio Operations, Inc.
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 or cease operations entirely.
In particular, we will require substantial additional capital or resources to complete a Phase 2b clinical trial of GRI-0621. • We may utilize our cash and available resources faster than we expect and our estimate regarding the length of time for which our resources will support our planned operations only includes the cost of certain preliminary work towards the initiation of a Phase 2b trial of GRI-0621; this estimate does not include the costs of completing a Phase 2b trial of GRI-0621, which is subject to obtaining substantial additional capital or resources. • Our management has expressed substantial doubt about our ability to continue as a going concern, and the reports of our independent auditors contain explanatory paragraphs regarding this uncertainty.
Risks Related to Research and Development and the Pharmaceutical Industry Our business is highly dependent on the success of our product candidates, GRI-0621 and GRI-0803, and any other product candidates that we may advance into clinical development.
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. • 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.
Food and Drug Administration (FDA) approval of any of our product candidates, if any, we may never obtain approval or commercialize these product candidates outside of the United States, which could limit our ability to realize their full market potential. • We may enter, or attempt to enter, into collaborations with third parties for the development and commercialization of our product candidates, and these collaboration would be important to our business.
If we are unable to enter into collaborations that we deem beneficial, or if these collaborations are not successful, our business could be adversely affected.
It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection. • If we do not obtain patent term extension and data exclusivity or similar protections to extend the term of patent protection covering any product candidates which we may develop, our business may be materially harmed.
Risks Related to Managing Our Business and Operations • If we lose key management personnel, or if we fail to recruit and retain additional highly skilled personnel, our ability to develop current product candidates or identify and develop new product candidates will be impaired, could result in loss of markets or market share and could make us less competitive. • We may be unable to adequately protect our internal information systems, or those used by our contract research organizations (CROs), clinical sites or other contractors or consultants upon which we rely, from cyberattacks, compromises, cybersecurity incidents or other disruptions, which could result in the compromise of confidential, sensitive or proprietary information, lead to operational or service interruption, harm our reputation and subject us to litigation, fines and other significant financial and legal exposure and other material and adverse consequences.
Risks Related to Financing, our Common Stock and Capital Requirements • Future sales and issuances of our securities could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall. • The January 2026 Reverse Stock Split may have caused or cause our stock price to decline relative to its value before the split and has likely reduced the liquidity of shares of our Common Stock. • We will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance initiatives. • Management has determined that our internal controls were not effective as of December 31, 2024, March 31, 2025, June 30, 2025, September 30, 2025 and December 31, 2025 due to material weaknesses.
We have remediated one material weakness and, resources permitting, plan to implement a plan to remediate the remaining material weakness.
However, our efforts at remediation may be unsuccessful and the implementation of additional remediation is dependent upon additional resources and funding being available to us.
If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
MARKET, INDUSTRY AND OTHER DATA This Annual Report contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates, including data regarding the estimated size of such markets and the incidence of certain medical conditions.
The third-party information presented in this Annual Report, and, in particular, any estimates in this Annual Report, as those estimates may relate to projections, involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors, including those discussed under the section entitled “ Item 1A.
Our product candidate, GRI-0621, is an oral inhibitor of type 1 invariant Natural Killer T (iNKT) cells.
The active pharmaceutical ingredient in GRI-0621, tazarotene, is a synthetic retinoid acid receptor-beta and gamma selective agonist.
Tazarotene is approved in the United States for topical treatment of psoriasis and acne.
While there are no approved oral formulations of tazarotene, as of December 31, 2025, it has been evaluated in over 1,700 patients as an oral product for up to 52-weeks.
Some estimate that IPF affects 3 million globally.
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 (PSC), metabolic dysfunction-associated steatohepatitis (MASH), alcoholic liver disease (ALD), systemic lupus erythematosus (SLE), multiple sclerosis (MS), ulcerative colitis (UC) patients as well as other indications.
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-0621 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 pharmacokinetics (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 peripheral blood mononuclear cells (PBMCs) after six weeks and 12 weeks, and from bronchoalveolar lavage fluid (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).
Secondary and exploratory endpoints relating to additional flow cytometry data, TCRseq, and the pharmacodynamic activity of GRI-0621 are being evaluated as analyses become available.
No treatment related serious adverse events were reported for GRI-0621-treated subjects and adverse events were grade 2 (17%) or grade 3 (4%), with dry skin, dry lips, muscle and joint pain as the most common adverse events reported.
There were no increases in cough (0% in the GRI-0621-treated arm compared to 25% in the placebo arm) or gastrointestinal disorders reported in the GRI-0621-treated arm compared to the placebo arm (diarrhea reported in 13% versus 33%, respectively). 80% of the subjects enrolled were taking background pirfenidone or nintedanib.
No changes in liver enzymes, triglycerides or cholesterol were observed over 12 weeks in patients treated with GRI-0621 and standard of care.
Changes from baseline of serum biomarkers of type I, III and VI collagen in GRI-0621-treated subjects were suggestive of an anti-fibrotic effect, with decreases in biomarkers of fibrosis formation and increases in biomarkers of fibrosis resolution, including crosslinked type III collagen, observed after 12 weeks of treatment with GRI-0621.
Changes from baseline in type IV collagen were suggestive of initiation of an alveolar basement membrane repair mechanism, an important step in repair of injured lung tissue.
Reductions in neutrophil and macrophage activity (immune cell biomarkers upregulated in IPF and associated with disease progression) and downregulation of genes associated with fibrosis, disease progression and mortality were also observed in patients treated with GRI-0621 and standard of care.
Placebo-adjusted changes from baseline in Forced Vital Capacity (FVC) were observed to increase by 99 ml in the GRI-0621-treated arm and by 139 ml in the subset taking both GRI-0621 and standard of care compared to placebo plus standard of care.
Breathing tests used to measure FVC are subject to large visit-to-visit variability and are dependent on the patient’s effort, often resulting in data outliers.
To minimize the impact of outliers in this FVC dataset, a post hoc data analysis was performed excluding the data points with the largest gain or loss in FVC over 12 weeks from both arms.
The results of this analysis demonstrated an increase in placebo-adjusted change from baseline in FVC of 54 ml in the GRI-0621-treated arm and an increase of 81 ml in the subset taking both GRI-0621 and standard of care.

and 286 more.

Gone since FY2024

These forward-looking statements include, but are not limited to, statements about: • our history of losses and need for additional capital to fund our operations, our inability to obtain additional capital on acceptable terms, or at all, our ability to continue as a going concern, and our need to liquidate if we fail to obtain adequate funding, which could result in our stockholders receiving no value for their investment; • our ability to remain listed on The Nasdaq Capital Market; • our limited operating history and the difficulties encountered by a small developing company; • expected restructuring-related cash outlays, including the timing and amount of those outlays; • the timing of initiation of planned clinical trials; • the timing of any planned Investigational New Drug (INDs) or New Drug Applications (NDAs); • plans to research, develop, and commercialize current and future product candidates; • the ability to enter into new collaborations, and to fulfill obligations under any such collaboration agreements; • the clinical utility, potential benefits, and market acceptance of product candidates; • commercialization, marketing, and manufacturing capabilities and strategy; • the ability to identify additional products or product candidates with significant commercial potential; • developments and projections relating to our competitors and their industries; • the impact of government laws and regulations; • our ability to protect our intellectual property position; • estimates regarding future revenue, expenses, capital requirements, and need for additional financing; • any statements about the effect, or potential effect, of the reverse stock splits, including the February 2025 Reverse Stock Split (as defined below), on the price or trading of our common stock, par value $0.0001 per share (the Common Stock), on The Nasdaq Capital Market; and • statements of belief and any statement of assumptions underlying any of the foregoing.
As used in this Annual Report, unless the context requires otherwise, the “Company,” “GRI Bio,” “we,” “us” and “our” refer to GRI Bio, Inc.
“ Risk Factors ” in this Annual Report on Form 10-K.
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. • Our auditors have expressed substantial doubt about our ability to continue as a going concern, and we may not be able to continue as a going concern if we do not obtain additional financing.
Risks Related to Research and Development and the Pharmaceutical Industry Our business is highly dependent on the success of our lead product candidate, GRI-0621, and any other product candidates that we may advance into clinical development.
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.
Food and Drug Administration (FDA) approval of any of our product candidates, if any, we may never obtain approval or commercialize these product candidates outside of the United States, which could limit our ability to realize their full market potential. • We currently have no marketing and sales organization and have no experience as a company in commercializing products.
If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenue from any of our product candidates that may be approved. • Our relationships with healthcare providers, physicians, prescribers, purchasers, third-party payors, charitable organizations and patients will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings. • Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations. • Inadequate funding for the FDA, the SEC and/or other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business. • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business, financial condition or results of operations.
It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection. • We may enter into license or other collaboration agreements in the future that may impose certain obligations on us.
If we fail to comply with our obligations under such future agreements with third parties, we could lose license rights that may be important to our future business. • Third-party claims of intellectual property infringement may be costly and time consuming to defend, and could prevent or delay our product discovery, development and commercialization efforts.
If these third parties do not successfully carry out their contractual duties, meet expected timelines or otherwise conduct the trials as required or perform and comply with regulatory or contractual requirements, we may not be able to successfully complete clinical development, obtain regulatory approval or commercialize our product candidates when expected or at all, and our business could be substantially harmed. • Because we rely on third-party manufacturing and supply vendors, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality. • We may in the future seek to enter into collaborations with third parties for the development and commercialization of our product candidates, and our future collaborations will be important to our business.
If we are unable to enter into collaborations, or if these collaborations are not successful, our business could be adversely affected.
Risks Related to Managing Our Business and Operations • If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to develop current product candidates or identify and develop new product candidates will be impaired, could result in loss of markets or market share and could make us less competitive. • We may be unable to adequately protect our internal information systems, or those used by our CROs, clinical sites, or other contractors or consultants upon which we rely, from cyberattacks, compromises, cybersecurity incidents, or other disruptions, which could result in the compromise of sensitive or proprietary information, lead to operational or service interruption, harm our reputation, and subject us to litigation, fines and other significant financial and legal exposure, and other material and adverse consequences.
Risks Related to Financing, our Common Stock and Capital Requirements • We expect the stock price of our Common Stock to be highly volatile. • Future sales and issuances of our securities could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall. • The February 2025 Reverse Stock Split may have caused our stock price to decline relative to its value before the split and likely has reduced the liquidity of shares of our Common Stock.
MARKET, INDUSTRY AND OTHER DATA This Annual Report contains estimates, projections and other information concerning our industry, our business and the markets for our drug candidates, including data regarding the estimated size of such markets and the incidence of certain medical conditions.
We are responsible for all of the disclosure contained in this Annual Report, and we believe these industry publications and third-party research, surveys and studies are reliable.
While we are not aware of any misstatements regarding any third-party information presented in this Annual Report, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors, including those discussed under the section entitled “ Item 1A.
Our lead product candidate, GRI-0621, is an oral inhibitor of type 1 invariant Natural Killer T (iNKT) cells.
GRI-0621 is also an oral formulation of tazarotene, a synthetic RAR-beta and gamma selective agonist, that is approved in the United States for topical treatment of psoriasis and acne.
As of December 31, 2024, it has been evaluated in over 1,700 patients as an oral product for up to 52-weeks.
Some estimate that IPF affects 3 million people globally.
In preliminary 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 (PSC), non-alcoholic steatohepatitis (NASH), alcoholic liver disease (ALD), systemic lupus erythematosus disease (SLE), multiple sclerosis (MS), ulcerative colitis (UC) patients, as well as other indications.
Food and Drug Administration (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 clinical trial application (CTA) from the United Kingdom Medicines and Healthcare Products Regulatory Agency (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 Australian Human Research Ethics Committee (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.
GRI-0803, the lead molecule selected from the library, is a novel oral agonist of type 2 diverse Natural Killer T (dNKT) cells.
We are developing GRI-0803 for the treatment of autoimmune disorders, with much of our preclinical work in SLE or lupus and MS.
Subject to IND clearance, we intend to evaluate GRI-0803 in a Phase 1a and 1b trial initially targeting SLE.
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 is on lupus.
GRI’s pipeline - GRI-0621 and GRI-0803 Our initial focus is developing GRI-0621 for the treatment of IPF.
GRI-0621 is an oral formulation of tazarotene, a synthetic retinoid acid receptor (RAR) -beta and gamma selective agonist that is approved in the United States for topical treatment of psoriasis and acne.
We believe GRI-0621 has the potential to treat multiple fibrotic and related diseases, including other pulmonary fibrotic diseases, NASH, ALD, renal fibrosis, acute-on-chronic liver failure, drug-induced liver injury (DILI) and other acute indications.
We evaluated GRI-0621 in a pilot Phase 2a trial in 14 hepatically impaired chronic liver disease patients.
The study was originally intended to evaluate 60 patients, but 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.
In December 2023, we commenced enrollment in our Phase 2a trial in IPF patients and we expect topline results from this trial to be available in the third quarter of 2025.
We are also developing GRI-0803, a novel orally administered activator of dNKT cells, from which we observed therapeutic benefit in multiple models of autoimmunity.
We are built upon decades of experience studying the activity of Natural Killer T (NKT) cells and their role in health and disease.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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