Content analysis
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Uncertain | ||
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Litigous | ||
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H.S. freshman Avg
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Financial report summary
?Competition
Celgene • Sarepta Therapeutics • Ionis Pharmaceuticals • Arrowhead Pharmaceuticals • Novartis • Alnylam Pharmaceuticals • Dicerna Pharmaceuticals • Galapagos • Kineta • Arbutus BiopharmaRisks
- Our auditor’s report includes a going concern paragraph.
- We have a limited operating history, have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.
- We have never generated any revenue from product sales, have generated only limited revenue since inception, and may never be profitable.
- We are exposed to interest rate risk, including under our existing loan agreements with our lender.
- Our indebtedness could materially and adversely affect our business, financial condition and results of operations.
- Our debt contains customary default clauses, a breach of which may result in acceleration of the repayment of some or all of this debt.
- We may not be successful in our efforts to identify or discover potential product candidates.
- If future clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
- Even if we complete the necessary preclinical studies and clinical trials, we cannot predict whether or when we will obtain regulatory approval to commercialize a product candidate and we cannot, therefore, predict the timing of any revenue from a future product.
- Even if we obtain regulatory approval for a product candidate, we will still face extensive regulatory requirements and our products may face future development and regulatory difficulties.
- We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
- Certain agreements with our alliance partners may impair or prevent entirely our ability to generate revenues from the development, manufacture and commercialization of certain product candidates.
- We rely on third-party manufacturers to produce the supply of our preclinical product candidates, and we intend to rely on third parties to produce future clinical supplies of product candidates that we advance into clinical trials and commercial supplies of any approved product candidates.
- We rely on limited sources of supply for the drug substance of product candidates and any disruption in the chain of supply may cause a delay in developing and commercializing these product candidates.
- Manufacturing issues may arise that could increase product and regulatory approval costs or delay commercialization.
- We intend to rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
- Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
- If we fail to obtain licenses or comply with our obligations in these agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
- We may be involved in lawsuits to protect or enforce our patents or the patents of our licensees, which could be expensive, time consuming and unsuccessful.
- We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
- The commercial success of our product candidates will depend upon the acceptance of these product candidates by the medical community, including physicians, patients and healthcare payors.
- If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
- Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
- Certain current and future relationships with customers and third-party payors as well as certain of our business operations may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
- Recent and future healthcare legislation may further impact our business operations.
- We face potential product liability, and, if successful claims are brought against us, we may incur substantial liability and costs.
- Business interruptions could delay us in the process of developing our future products.
- The requirements of being a publicly traded company may strain our resources and divert management’s attention.
- We may be at risk of securities class action litigation.
- Sales of a substantial number of our Ordinary Shares in the public market by our existing shareholders could cause our share price to fall.
- We may be unable to comply with the applicable continued listing requirements of Nasdaq.
- We are treated as a U.S. corporation for U.S. federal tax purposes.
- The recently enacted U.S. federal income tax reform bill could adversely affect our business and financial condition.
- Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
- We do not intend to pay dividends on our Ordinary Shares so any returns will be limited to the value of our shares.
- Provisions of Israeli law and our amended and restated articles of association may delay, prevent or otherwise impede a merger with, or an acquisition of, our company, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.
- It may be difficult to enforce a judgment of a U.S. court against us and the Israeli experts named herein in Israel or the United States, to assert U.S. securities laws claims in Israel or to serve process on certain of our officers and directors and these experts.
- Your rights and responsibilities as a shareholder will be governed by Israeli law, which differs in some material respects from the rights and responsibilities of shareholders of U.S. companies.
- We are subject to anti-takeover provisions that could delay or prevent our acquisition by another entity.
- Your rights as a shareholder will change as a result of the Redomiciliation.
- The expected benefits of the Redomiciliation may not be realized.
- The Redomiciliation will result in additional direct and indirect costs, even if it is not completed.
- The Redomiciliation may result in taxes imposed on our shareholders.