Tonix Pharmaceuticals Holding Corp.

Other than as set forth below, as well as other reports and statements that we have filed with the SEC, there were no material changes from the risk factors set forth under Part I, Item 1A., “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. You should carefully consider the risk factors set forth below and in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as well as other reports and statements that we file and have filed with the SEC, in addition to the other information set forth in this report which could materially affect our business, financial condition or future results. The risks and uncertainties described in this report and in our Annual Report on Form 10-K for the year ended December 31, 2024, as well as other reports and statements that we file with the SEC, are not the only risks and uncertainties facing us. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also have a material adverse effect on our financial position, results of operations or cash flows.

Our prospects are dependent on the successful commercialization of Tonmya. If Tonmya is not commercially successful, our business, financial condition and results of operations may be materially adversely affected and the price of our common stock may decline.

We may not able to successfully commercialize Tonmya. Our inability to commercialize Tonmya may be based on, among other things, lack of adequate coverage or reimbursement from third-party payors, including government health administration authorities, pharmacy benefit managers, managed care organizations and other private health insurers; healthcare legislative or regulatory reform measures; lack of market acceptance; serious adverse events or undesirable side effects; existing, or the introduction of new, products targeting the same or similar indication; the failure to adequately maintain the manufacturing, marketing, sales and distribution channels. Any one or combination of these factors would limit our ability to successfully commercialize Tonmya and would harm our business, financial condition, and results of operations.