Entera Bio (ENTX) risk factors, FY2024 10-K

Risks Related to Our Financial Position

1. 01We have incurred significant losses since our inception and anticipate that we will continue to incur substantial losses for the next several years
2. 02Management has performed an analysis of our ability to continue as a going concern. In addition, our independent registered public accounting firm has raised substantial doubt as to our ability to continue as a going concern
3. 03Due to our limited resources and access to capital, we must and have in the past decided to prioritize development of certain product candidates; these decisions may prove to have been wrong and may adversely affect our current and any potential future revenues
4. 04We will require substantial additional funding, which may not be available to us on acceptable terms, or at all, and, if not available, may require us to delay, reduce or cease our product development activities and operations
5. 05our need to implement additional internal systems and infrastructure, including financial and reporting systems to support our current operations as a public company
6. 06We have a limited operating history and no history of late stage clinical studies and commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability and making an investment in our Ordinary Shares unsuitable for many investors
7. 07Raising additional capital may cause dilution to our shareholders, and these financings, or disputes with shareholders in connection therewith, may restrict our operations or require us to relinquish substantial rights or result in unanticipated legal or other costs
8. 08The requirements of being a public company may strain our resources and distract our management, which could make it difficult to manage our business, particularly after we are no longer a non-accelerated filer

Risks Related to Our Business and the Development of Our Product Candidates

1. 09All of our product candidates are in preclinical or clinical development and we have not yet successfully completed the development of any product candidates
2. 10attracting, hiring and retaining qualified personnel
3. 11We depend on enrollment of patients in our clinical trials for our product candidates. If we are unable to enroll an adequate number of volunteers or patients in our clinical trials, our research and development efforts could be materially adversely affected
4. 12We may not be successful in our efforts to use and expand our N-Tab™ platform, to other product candidates
5. 13We manage our business and develop our technology with a small number of employees and key advisors with deep functional domain expertise, and, in the event of their loss or unavailability, we may not be able to grow our business or develop and commercialize our products
6. 14We expect to grow our organization to supplement and expand our senior management, clinical development and regulatory capabilities and marketing infrastructure, and we may experience difficulties in managing these changes and this growth, which could disrupt our operations
7. 15Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading
8. 16We are subject to risks related to restrictive data privacy regulations governing the collection, use, processing and cross-border transfer of personal information
9. 17Global economic conditions may negatively affect us and may magnify certain risks that affect our business

Risks Related to Regulatory Approval of Our Product Candidates

1. 18Clinical drug development is expensive, time consuming and uncertain. Development programs are subject to regulatory requirements, unanticipated delays and we may ultimately not be able to obtain regulatory approvals for the commercialization of our product candidates
2. 19the approval policies or regulations of such authorities may significantly change in a manner rendering our or any of our future development partners’ clinical data insufficient for approval
3. 20our competitors may develop therapeutics or other treatments that are superior to or less costly than our own with the result that our products, even if they are successfully developed, manufactured and approved, may not generate significant revenues
4. 21The commencement and completion of clinical trials can be delayed or prevented for a number of reasons
5. 22inaccurate interpretations by us of the FDA’s guidance for the clinical and regulatory path for our product candidates
6. 23upon a breach or pursuant to the terms of any agreement with, or for any other reason by, current or future collaborators that have responsibility for the clinical development of any of our product candidates
7. 24The results of previous clinical trials may not be predictive of future results, our progress in trials for one product candidate may not be indicative of progress in trials for other product candidates, and our trials may not be designed so as to support regulatory approval
8. 25Even if regulatory approvals are obtained for our product candidates, we will be subject to ongoing government regulation. If we fail to comply with applicable current and future laws and government regulations, it could delay or prevent the promotion, marketing or sale of our products
9. 26refuse to allow us to enter into supply contracts, including government contracts
10. 27Healthcare legislative changes may harm our business and future prospects
11. 28Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our future business activities could be subject to challenge under one or more of such laws

Risks Related to Commercialization of Our Product Candidates

1. 29We are likely to face significant competition, and if our competitors’ products are more effective, safer or less expensive than ours, our commercial opportunities will be negatively affected. Our lead product candidates, if approved, would compete with existing products
2. 30We are subject to manufacturing risks that could substantially increase our costs and limit supply of our products
3. 31Even if approved, if any of our product candidates do not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, our revenue generated from their sales will be limited
4. 32potential product liability claims
5. 33Even if we obtain regulatory approval of any of our product candidates in a major pharmaceutical market such as the United States or the EU, we may never obtain approval or commercialize our products in other major markets, which would limit our ability to realize their full market potential
6. 34The successful commercialization of our product candidates, if approved, will depend in part on the extent to which governmental authorities and third-party payors establish adequate coverage and reimbursement levels and pricing policies
7. 35neither experimental nor investigational
8. 36We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or at the commercial stage; and our product liability insurance may not cover all damages from such claims
9. 37the inability to commercialize any products we develop

Risks Related to Our Dependence on Third Parties

1. 38We are highly dependent upon our ability to enter into agreements with collaborators to develop, commercialize and market our products
2. 39The Israel-Hamas War may cause us to fail to meet contractually obligated deadlines with our collaboration partners or otherwise strain our relationships with current collaborators or other business partners
3. 40We may not be able to secure and maintain research institutions to conduct our clinical trials
4. 41Independent clinical investigators and CROs that we engage to conduct our clinical trials may not devote sufficient time or attention to our clinical trials or be able to repeat their past success
5. 42the possibility that we may not be able to secure a manufacturer or manufacturing capacity in a timely manner and on satisfactory terms in order to meet our manufacturing needs
6. 43We maintain our cash at financial institutions, often in balances that exceed federally insured limits.]

Risks Related to Our Intellectual Property

1. 44If we fail to establish, maintain, defend and enforce intellectual property rights with respect to our technology, our business, prospects, financial condition and results of operations may be materially adversely affected
2. 45We may become involved in proceedings to protect or enforce our proprietary rights, which could be expensive and time consuming, and may ultimately be unsuccessful
3. 46Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. We may face claims that we are violating the intellectual property rights of others
4. 47We may not be able to protect and enforce our intellectual property rights throughout the world
5. 48Changes in U.S. patent law could diminish the value of our future patents, if issued, thereby impairing our ability to protect our product candidates
6. 49Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our Ordinary Shares to decline
7. 50Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
8. 51We may not be able to protect the confidentiality of our technology, which, if disseminated, could negatively impact our plan of operations
9. 52We may be subject to claims by third parties asserting that we or our employees, consultants or contractors have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property
10. 53If trademarks and trade names related to our product candidates are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected

Risks Related to Our Ordinary Shares

1. 54The price of our Ordinary Shares may be volatile, and holders of our Ordinary Shares could lose all or part of their investment
2. 55the limited trading volume of our Ordinary Shares; and
3. 56We do not know whether a market for our Ordinary Shares will be sustained and as a result, it may be difficult for holders of our Ordinary Shares to sell their securities
4. 57Future sales by our shareholders may adversely affect our stock price and our ability to raise funds in new stock offerings
5. 58The market price of our Ordinary Shares could be negatively affected by future sales of our securities
6. 59We have never paid, and we currently do not intend to pay dividends
7. 60We may not have sufficient insurance to cover our liability in any current or future litigation claims either due to coverage limits or as a result of insurance carriers seeking to deny coverage of such claims
8. 61We cannot predict whether investors will find our Ordinary Shares less attractive as a result of our reliance on these exemptions. If some investors find our Ordinary Shares less attractive as a result, there may be a less active trading market for our Ordinary Shares and our stock price may be more volatile
9. 62Our Ordinary Shares may be delisted from the Nasdaq Capital Market if we are unable to maintain compliance with Nasdaq’s continued listing standards
10. 63If securities or industry analysts do not publish research or reports or publish unfavorable research about our business, our share price and trading volume could decline

Risks Relating to Our Incorporation and Location in Israel

1. 64Legislative developments in Israel may have an adverse effect on the Company’s business
2. 65Security, political and economic instability in the Middle East may harm our business
3. 66Our operations may be disrupted by the obligations of personnel to perform military service
4. 67Our business is subject to currency exchange risk and fluctuations between the U.S. dollar and other currencies may negatively affect our earnings and results of operations
5. 68Provisions of Israeli law and our Articles may give rise to withholding obligations or delay, prevent or make difficult a change of control and therefore depress the price of our shares
6. 69Our Articles provide that our directors are elected on a staggered basis such that a potential acquirer cannot readily replace our entire Board at a single general shareholders meeting
7. 70Your rights and responsibilities as a shareholder are governed by Israeli law, which may differ in some respects from the rights and responsibilities of shareholders of U.S. companies
8. 71Our business could be negatively affected as a result of actions of activist shareholders, and such activism could impact the trading value of our securities