GRI Bio, Inc.

The following is a summary of the principal risks described below in Part I, Item 1A. “Risk Factors” in this Annual Report. We believe that the risks described in the “Risk Factors” section are material to investors, but other factors not presently known to us or that we currently believe are immaterial may also adversely affect us. The following summary should not be considered an exhaustive summary of the material risks facing us, and it should be read in conjunction with the “Risk Factors” section and the other information contained in this Annual Report.

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

•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 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. All of our product candidates will require significant additional development before we may be able to seek regulatory approval and launch a product commercially.

•Clinical development involves a lengthy, 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.

•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.

•Failure to obtain or maintain adequate reimbursement or insurance coverage for our approved product candidates, if any, could limit our ability to market those product candidates and decrease our ability to generate revenue.

•Even if we obtain U.S. 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.

Risks Related to Our Intellectual Property

•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.

•We rely on third parties to conduct our clinical trials, manufacture our product candidates and perform other services. 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.

•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

•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.