CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Certain information included in this Report may be deemed to be “forward-looking statements.” Forward-looking statements are often characterized by the use of forward-looking terminology such as “may,” “will,” “expect,” “anticipate,” “estimate,” “continue,” “believe,” “predict,” “should,” “intend,” “project” or other similar words, but are not the only way these statements are identified.
These forward-looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, statements that contain projections of results of operations or of financial condition, expected capital needs and expenses, statements relating to the research, development, completion and use of our product candidates, and all statements (other than statements of historical facts) that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future.
Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among other things:
| ● | the regulatory pathways that we may elect to utilize in seeking European Medicines Agency, or EMA, the U.S. Food and Drug Administration, or FDA, and other regulatory approvals; |
| ● | our ability to drive revenue growth, enhance research and development capabilities, and improve financial performance is subject to uncertainties; |
| ● | that our financial position raises substantial doubt about our ability to continue as a going concern; |
| ● | our ability to maintain listing and effectively comply with the listing requirements of the Nasdaq; |
| ● | changes in technology and market requirements; |
| ● | potential delays or obstacles in launching or completing clinical trials, including our expectations regarding the timing of commencing further clinical trials, the process entailed in conducting each such trial, including dosages, and the order of such trials with each of our product candidates or whether such trials will be conducted at all; |
| ● | competitive companies, technologies and our industry; |
| ● | the development and commercialization, if any, of any other product candidates that we may seek to develop; |
| ● | products that may not be approved by regulatory agencies; |
| ● | technologies that may not be validated or accepted by the scientific community; |
| ● | the inability to retain or attract key employees; |
| ● | unforeseen scientific difficulties with products in development; |
| ● | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; |
| ● | higher-than-expected product costs; |
| ● | results in the laboratory that do not translate to clinical success; |
| ● | insufficient patent protection; possible adverse safety outcomes; |
| ● | our ability to establish and maintain strategic partnerships and other corporate collaborations; |
| ● | risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; |
| ● | delays in developing or introducing new technologies, products, or applications; |
| ● | competitive pressures that could reduce market share or pricing; |
| ● | the overall global political and economic environment in the countries in which we operate; |
| ● | security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel; and |
| ● | those factors referred to in “Item 3.D. Risk Factors,” “Item 4. Information on the Company,” and “Item 5. Operating and Financial Review and Prospects” in the 2025 Annual Report, as well as in the 2025 Annual Report generally. |
These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in this Report in greater detail under Item 3.D. “Risk Factors” in the 2025 Annual Report and elsewhere in the 2025 Annual Report. You should not rely upon forward-looking statements as predictions of future events. Readers are urged to carefully review and consider the various disclosures made throughout this Report which are designed to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.
You should not put undue reliance on any forward-looking statements. Any forward-looking statements in this Report are made as of the date hereof, and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
