This quarterly report includes “forward‑looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are not historical facts and involve risks and uncertainties that could cause actual results to differ materially from those expected or projected. All statements other than statements of historical fact included in this quarterly report, including statements in “Part 1, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations” regarding our’ financial position, business strategy, preclinical and clinical development plans, regulatory interactions and submissions, expected timing of clinical trial initiations and results, capital requirements, financing activities (including potential sales under the ATM Agreement, and Nasdaq listing status and compliance, are forward‑looking statements. Words such as “expect,” “believe,” “anticipate,” “intend,” “estimate,” “seek,” “target,” “plan,” “project,” “could,” “should,” “may,” “might,” “will,” “would,” “potential,” and similar expressions are intended to identify forward‑looking statements, although not all forward‑looking statements contain those identifying words. Forward‑looking statements in this quarterly report may include, for example, statements about:
| • | our current and planned pre‑clinical and clinical studies and trials involving our product candidates (in particular, SIL204), anticipated study designs, and the timing of related regulatory submissions and approvals; |
| • | our market opportunity and competitive position; |
| • | our strategy, future operations, financial position, projected costs, prospects and plans; |
| • | our future capital requirements and sources and uses of cash, including our ability to obtain additional capital, whether through sales under the ATM Agreement, other public offerings, private placements, warrant exercises or alternative financings under our Shelf Registration Statement or otherwise; |
| • | our ability to retain or recruit officers, key employees and directors and to effectively leverage third‑party contract research organizations (CROs) and manufacturers; |
| • | expectations regarding future partnerships or other relationships with third parties; |
| • | our ability to maintain the listing of our ordinary shares and warrants on the Nasdaq Capital Market; and |
| • | expectations regarding the duration for which we will remain an emerging growth company under the JOBS Act and/or a smaller reporting company under the Exchange Act. |
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The forward‑looking statements contained in this quarterly report are based on our current expectations 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, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward‑looking statements, including, among others:
| • | 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 would likely 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 rely on third parties (including CROs and contract manufacturers) whose performance is largely beyond our control; |
| • | we may issue additional ordinary shares or other equity securities without your approval, which would dilute your ownership interest and may depress the market price of our ordinary shares, including: (a) up to $13,170,000 of ordinary shares under the ATM Agreement; (b) up to $100,000,000 of ordinary shares, warrants and/or units under our Shelf Registration Statement (which includes ordinary shares we may sell under the ATM Agreement), subject to the limitation on sales by us in any 12-month period under General Instruction I.B.6 of Form S-3; (c) up to $1,633,000 of ordinary shares that we may issue to the Moringa sponsor upon conversion of the remaining outstanding amount of the A&R Sponsor Promissory Note; (d) up to 33,661 ordinary shares underlying remaining outstanding ordinary warrants and up to 17,284 ordinary shares underlying placement agent warrants, all of which were issued in our January 2025 public offering facilitated by H.C. Wainwright as placement agent; (e) up to 18,464 ordinary shares and 304,212 ordinary shares, issuable under remaining outstanding, and newly issued, investor warrants, respectively, and up to 10,368 ordinary shares and 10,647 ordinary shares, underlying placement agent warrants, respectively, which were issued in warrant exercise inducement transactions facilitated by H.C. Wainwright in late January 2025 and early August 2025, respectively; (f) up to 1,500,000 ordinary shares issuable upon exercise of Series A ordinary warrants and up to 1,055,000 ordinary shares issuable upon exercise of remaining outstanding Series B ordinary warrants, and up to 105,000 ordinary shares underlying placement agent warrants, all of which warrants were issued in our September 2025 public offering facilitated by H.C. Wainwright as placement agent; (g) up to 44,000 ordinary shares, in the aggregate, underlying outstanding public warrants and private warrants; and (h) up to $11.9 million of ordinary shares that remain issuable under our equity line of credit with White Lion Capital, LLC; and |
For further information regarding those important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, please refer to “Part I, Item 1.A Risk Factors” of the 2024 Annual Report. Our securities filings can be accessed on the EDGAR section of the SEC’s website at www.sec.report. Except as expressly required by applicable securities laws, we disclaim any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
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PART I - FI
