GRI BIO Inc

GRI BIO, INC.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (Annual Report) contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. Some of the statements in the sections captioned “Item 1. Business,” “Item 1A. Risk Factors,” “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and elsewhere in this Annual Report contain 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,” 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 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, particularly in light of our current non-compliance with Nasdaq’s $1.00 bid price rule and Nasdaq’s currently applicable stockholders’ equity requirements;

•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 the Company’s competitors and their industries;

•the impact of government laws and regulations;

•the Company’s ability to protect its 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 split of our common stock, par value $0.0001 per share (the Common Stock), at a ratio of one-for-seven effected on January 29, 2024 (the January 2024 Reverse Stock Split) on the price or trading of our Common Stock or our ability to maintain the listing of our Common Stock on The Nasdaq Capital Market;and

•statements of belief and any statement of assumptions underlying any of the foregoing.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Item 1A. Risk Factors” and elsewhere in this Annual Report. 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 Annual Report 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 Annual Report to conform these statements to new information, actual results or to changes in our expectations, except as required by law.

You should read this Annual Report and the documents that we reference in this Annual Report and have filed with the U.S. Securities and Exchange Commisstion (the SEC) as exhibits to the Annual Report with the understanding that our actual future results, levels of activity, performance, and events and circumstances may be materially different from what we expect.

As used in this Annual Report, unless the context requires otherwise, the “Company,” “GRI Bio,” “we,” “us” and “our” refer to GRI Bio, Inc.