Benitec Biopharma Ltd

Management believes that these facilities are suitable and adequate to meet our anticipated needs.

• Our product candidates and the process for administering our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any potential marketing approval.
• If we are unable to successfully develop related diagnostics for our therapeutic product candidates, or experience significant delays in doing so, we may not achieve marketing approval or realize the full commercial potential of our therapeutic product candidates.
• Even if we complete the necessary preclinical studies and clinical trials for a product candidate, we cannot predict when or if we will obtain regulatory approval to commercialize a product candidate or the approval may be for a narrower indication than we expect.
• Funding and staffing disruptions at the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
• Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny.
• Even if we obtain and maintain approval for our product candidates from the FDA, we may never obtain approval for our product candidates outside of the United States, which would limit our market opportunities and adversely affect our business.
• Our future prospects may also depend on our ability to successfully develop a pipeline of additional product candidates beyond our initial product candidate, and we and our collaborators may not be successful in efforts to use our platform technologies to identify or discover additional product candidates.
• We may not be able to obtain orphan drug exclusivity, where relevant, in all markets for our product candidates.
• Risks Related to Our Reliance on Third Parties
• Our prospects for successful development and commercialization of our products are dependent to varying degrees upon the research, development, commercialization, and marketing efforts of our collaborators.
• We rely on third parties to conduct our preclinical studies and clinical trials.
• Because we rely on third-party manufacturing and supply partners, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality.
• We and our licensees or collaborators may disagree over our right to receive payments under any potential collaboration agreements with them, potentially resulting in costly litigation and loss of reputation.
• We have only limited experience in regulatory affairs and intend to rely on consultants and other third parties for regulatory matters, which may affect our ability or the time we require to obtain necessary regulatory approvals.
• Risks Related to Commercialization of Our Product Candidates
• If we are unable to enter into agreements with third parties to commercialize our product candidates or establish sales and marketing capabilities to market and sell our product candidates, we may be unable to generate any revenues.
• Physicians, patients, third-party payers or others in the medical community may not be receptive to our product candidates, and we may not generate any future revenue from the sale or licensing of our product candidates.
• We face competition from entities that have developed or may develop product candidates for our target disease indications, including companies developing novel treatments and technology platform based on modalities and technology similar to ours.
• A variety of risks outside of our control associated with international operations could adversely affect our business.
• Legislative and regulatory reforms affecting drug pricing and healthcare reimbursement may adversely affect our ability to commercialize our product candidates profitably.
• The insurance coverage and reimbursement status of newly approved products is uncertain.
• Changes in U.S. tax law may materially adversely affect our financial condition, results of operations and cash flows.
• Our relationships with third-party payers, healthcare professionals and customers in the United States and elsewhere may be subject to anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to significant penalties.
• Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research may damage public perception of our product candidates or compromise our ability to conduct our business or obtain regulatory approvals for our product candidates.
• Risks Related to Our Business Operations
• We may not successfully engage in strategic transactions or enter into new collaborations, which could adversely affect our ability to develop and commercialize product candidates, impact our cash position, increase our expenses and present significant distractions to our management.
• Any inability to attract and retain qualified key management and technical personnel would impair our ability to implement our business plan.
• Our collaborations with outside scientists and consultants may be subject to restriction and change.
• We may experience difficulties in managing our growth and expanding our operations.
• Our employees, independent contractors, principal investigators, CROs, consultants and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and insider trading.
• We could face potential product liability and, if successful claims are brought against us, we may incur substantial liability and costs.
• We and our development partners, third-party manufacturers and suppliers use biological materials and may use hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.
• We may use our limited 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.
• Our internal computer and information technology systems, or those of our collaborators and other development partners, third-party CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a disruption of our product development programs.
• Our current laboratory operations are concentrated in one location, and any events affecting this location may seriously compromise our ability to operate our business and continue the development of our product candidates.
• The investment of our cash and cash equivalents is subject to risks which may cause losses and affect the liquidity of these investments.
• Risks Related to Our Intellectual Property
• If we are unable to obtain or protect sufficient intellectual property rights related to our product candidates, we may not be able to obtain exclusivity for our product candidates or prevent others from developing similar competitive products.
• We rely on license relationships with a number of third parties for portions of our intellectual property.
• If we fail to comply with our obligations in the 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.
• Our results of operations will be affected by the level of royalty payments that we are required to pay to third parties.
• The licenses we may grant to our collaborators and other licensees to use our ddRNAi and other technology may be exclusive to the development of product candidates for certain conditions.
• Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
• We may not be successful in obtaining or maintaining necessary rights to gene therapy product components and processes for our development pipeline through acquisitions and in-licenses.
• We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful, and issued patents covering our product candidates could be found invalid or unenforceable if challenged in court.
• We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
• We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
• Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
• Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
• Our success depends, in part, on our ability to protect our intellectual property and our technologies outside the United States.
• Risks Related to an Investment in Our Common Stock
• A number of our stockholders hold significant amounts of our common stock and unexercised warrants to acquire common stock, and therefore could exert significant influence over us.
• The market price and trading volume of our common stock may be volatile and may be affected by economic conditions beyond our control.
• An active trading market for our common stock may not continue to develop or may not be liquid enough for you to sell your shares of our common stock quickly or at market price.
• If securities or industry analysts do not continue to publish research or reports, or if they publish adverse or misleading research or reports, regarding us, our business or our market, our stock price and trading volume could decline.
• If we fail to establish and maintain proper internal financial reporting controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired.
• We have restated certain of our prior issued interim financial statements, which has resulted in unanticipated costs and may lead to additional risks and uncertainties, including loss of investor confidence and, as a result, the value of our common stock.
• We have never declared or paid dividends on our common stock and we do not anticipate paying dividends in the foreseeable future.
• Future sales and issuances of our common stock or rights to purchase common stock could result in substantial dilution to the percentage ownership of our stockholders.
• Our corporate governance structure may prevent our acquisition by another company at a premium over the public trading price of our shares.
• We have a limited number of unreserved, authorized shares.
• Although we are required to use our reasonable best efforts to have an effective registration statement covering the issuance of shares of common stock underlying certain of our outstanding warrants at the time that holders of our warrants exercise their warrants, we cannot guarantee that a registration statement will be effective, in which case holders of our warrants are entitled to a cashless exercise of their warrants.