| ● | our ability to maintain the listing of our ordinary shares and our warrants on Nasdaq; |
| ● | our current and planned pre-clinical and clinical studies and trials involving our product candidates; |
| ● | our projected timeline for regulatory approvals of our product candidates; |
| ● | our strategy, future operations, financial position, projected costs, prospects and plans; |
| ● | our ability to retain or recruit officers, key employees and directors; |
| ● | expectations regarding future partnerships or other relationships with third parties; and |
| ● | our future capital requirements and sources and uses of cash, including our ability to obtain additional capital in the future. |
The forward-looking statements contained in this Annual Report are based on current expectations, forecasts and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks and uncertainties, some of which are beyond our control, and are based on certain assumptions, which, if turning out to be incorrect, may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the following factors:
| ● | we are a development-stage company and have a limited operating history on which to assess our business; |
| ● | we will need to raise substantial additional funding, which may not be available on acceptable terms, or at all, and which will cause dilution to our shareholders; |
| ● | the approach we are taking to discover and develop novel RNAi therapeutics is unproven for oncology and may never lead to marketable products; |
| ● | we do not have experience producing our product candidates at commercial levels, currently have no marketing and sales organization, have an uncertain market receptiveness to our product candidates, and are uncertain as to whether there will be insurance coverage and reimbursement for our potential products; |
| ● | we may be unable to attract, develop and/or retain our key personnel or additional employees required for our development and future success; |
| ● | we may issue additional ordinary shares or other equity securities without your approval, including: (a) up to $15,337,500 of ordinary shares issuable under the ELOC Agreement (which includes shares already issued under that agreement); (b) ordinary shares underlying 659,999 outstanding warrants (as of March 1, 2025); and (c) ordinary shares underlying the A&R Sponsor Promissory Note, the issuance of which would dilute your ownership interest and may depress the market price of our ordinary shares; and |
| ● | those additional factors described in “Item 1A. Risk Factors” below. |
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Summary of Risk Factors
Investing in our securities involves risks. You should carefully consider the risks described in “Item 1A. Risk Factors” before making a decision to invest in our securities. If any of these risks is actualized, our business, financial condition and results of operations would likely be materially adversely affected. In such case, the trading price of our securities would likely decline, and you may lose all or part of your investment. Such risks include, but are not limited to:
| ● | We are a development-stage company and have a limited operating history on which to assess our business. The approach we are taking to discover and develop novel RNAi therapeutics is unproven for oncology and may never lead to marketable products. |
| ● | We will need to raise substantial additional funding, which may not be available on acceptable terms, or at all, and which will cause dilution to our shareholders. |
| ● | The approach we are taking to discover and develop novel RNAi therapeutics is unproven for oncology and may never lead to marketable products. |
| ● | We are heavily dependent on the success of our product candidates, which are in the early stages of preclinical or clinical development. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized. |
| ● | The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed. |
| ● | Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of preclinical activity or earlier studies may not be predictive of future study results. |
| ● | We may find it difficult to enroll patients in our clinical studies, which could delay or prevent clinical studies of our product candidates. |
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| ● | We rely on third parties to conduct our preclinical and clinical studies, and to manufacture the raw materials and products that we use to create our product candidates and to supply us with the medical devices used to administer such products, which entails regulatory and trade secrets-related risks. |
| ● | We do not have experience producing our product candidates at commercial levels, currently have no marketing and sales organization, have an uncertain market receptiveness to our product candidates, and is uncertain as to whether there will be insurance coverage and reimbursement for our potential products. |
| ● | We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced, or more effective than ours, which may adversely affect our financial condition and our ability to successfully commercialize our product candidates. |
| ● | If we are unable to obtain and maintain effective patent rights for our product candidates or any future product candidates, we may not be able to compete effectively in our markets. |
| ● | We may be unable to attract, develop and/or retain our key personnel or additional employees required for our development and future success. |
| ● | Conditions in the Middle East and in Israel may harm our operations. |
| ● | If we fail to maintain compliance with Nasdaq’s continued listing requirements, our securities may be delisted from the Nasdaq Global Market. |
| ● | The price of our ordinary shares and our warrants may be volatile. |
| ● | A substantial number of our ordinary shares may be issued pursuant to the White Lion Purchase Agreement and/or the conversion terms of the A&R Sponsor Promissory Note, which could cause (i) substantial dilution and (ii) the market price of our ordinary shares to decline. |
| ● | We have no current plans to pay cash dividends on our ordinary shares for the foreseeable future. |
| ● | Our recent reverse share split may negatively impact the market for our ordinary shares. |
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