GRI Bio, Inc.

This prospectus contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this prospectus are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would” or the negative of these words or other comparable terminology. 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 regain compliance with applicable continued listing requirements;

•our ability to remediate any material weakness in our internal controls over financial reporting or to maintain effective internal controls over financial reporting;

•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 INDs or 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 following the offering;

•any statements about the effect, or potential effect, of the reverse stock splits, including the February 2025 Reverse Stock Split, on the price or trading of our Common Stock on The Nasdaq Capital Market;

•our ability to complete the reasonable best efforts offering; and

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Risk Factors” and elsewhere in this prospectus. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this prospectus may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this prospectus to conform these statements to new information, actual results or to changes in our expectations, except as required by law.

You should read this prospectus and the documents that we reference in this prospectus and have filed with the SEC as exhibits to this registration statement of which this prospectus forms a part with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.