Medicinova (MNOV)

Risks

• If we fail to obtain the capital necessary to fund our operations, we will be unable to develop and commercialize our product candidates.
• We do not have any products that are approved for commercial sale and therefore do not expect to generate any revenues from product sales in the foreseeable future, if ever.
• Because the results of early clinical trials are not necessarily predictive of future results, our product candidates we advance into clinical trials in any indication may not have favorable results in later clinical trials, if any, or receive regulatory approval.
• Our attempts to develop MN-001 (tipelukast) in NASH and IPF may detract from our efforts to develop other product candidates and may limit the effectiveness of our product development efforts as a whole.
• In order to commercialize a therapeutic drug successfully, a product candidate must receive regulatory approval after the successful completion of clinical trials, which are long, complex and costly, have a high risk of failure and can be delayed or terminated at any time.
• We are subject to stringent regulation of our product candidates, which could delay the development and commercialization of our product candidates.
• Even if our product candidates receive regulatory approval, they may still face future development and regulatory difficulties.
• Any product candidates that we advance into clinical trials may cause undesirable side effects or have other properties that could delay or prevent regulatory approval or commercialization or limit its commercial potential.
• Delays in the commencement or completion of clinical trials, or suspension or termination of our clinical trials, could result in increased costs to us and delay or limit our ability to obtain regulatory approval for our product candidates.
• The loss of any rights to develop and market any of our product candidates could significantly harm our business.
• We rely on third parties to conduct our clinical trials, and we may incur additional development costs, experience delays in the commencement and completion of clinical trials, and be unable to obtain regulatory approval for or commercialize our product candidates on our anticipated timeline if these third parties do not successfully carry out their contractual duties or meet expected deadlines.
• We rely on third party manufacturers to produce our product candidates, which may result in delays in our clinical trials and the commercialization of products, as well as increased costs.
• We may not be able to manufacture our product candidates in commercial quantities, which would prevent us from commercializing our product candidates.
• Our product candidates, if approved for sale, may not gain acceptance among physicians, patients and the medical community, thereby limiting our potential to generate revenues.
• If our products are not accepted by the market or if users of our products are unable to obtain adequate coverage of and reimbursement for our products from government and other third party payers, our revenues and profitability will suffer.
• We are dependent on our management team, particularly our President and Chief Executive Officer, and our experienced scientific staff, and if we are unable to retain, motivate and attract key personnel, our product development programs may be delayed and we may be unable to develop successfully or commercialize our product candidates.
• If we are unable to establish sales, marketing and distribution capabilities, whether independently or with third parties, we will be unable to commercialize our product candidates successfully.
• Health care reform measures could adversely affect our business.
• We may be sued for product liability, which could result in substantial liabilities that exceed our available resources and damage our reputation.
• We expect that our results of operations will fluctuate, which may make it difficult to predict our future performance from period to period.
• We will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
• We may be subject to information technology systems failures, network disruptions, breaches in data security and computer crime and cyber-attacks.
• Our ability to compete may decline if we do not adequately protect our proprietary rights.
• Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete.
• A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business.
• We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
• Our stock price may be volatile, and you may not be able to resell our shares at a profit or at all.
• Our common stock may be delisted on the NASDAQ Global Market or the JASDAQ Market of the Tokyo Stock Exchange.
• The sale of additional common stock under our existing at-the-market issuance sales agreement may cause substantial dilution to our existing stockholders and/or the price of our common stock to decline.
• We may become involved in securities class action litigation that could divert management’s attention and harm our business.
• Future sales of our common stock may cause our stock price to decline and may make it difficult for us to raise additional capital or for you to sell your shares.
• Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of us more complicated and the removal and replacement of our directors and management more difficult.