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Risks

• We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
• Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included elsewhere in this Annual Report on Form 10-K.
• Future sales and issuances of shares of our common stock or rights to purchase shares of our common stock, including common stock purchase warrants and stock options, could result in additional dilution of the percentage ownership of our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
• We are dependent on our lead product candidate, Vicineum for the treatment of BCG-unresponsive NMIBC. If we are unable to obtain marketing approval for or successfully commercialize our lead product candidate, either alone or through an out-license or a commercialization partnership, or experience significant delays in doing so, our business could be materially harmed.
• Vicineum for the treatment of BCG-unresponsive NMIBC may cause undesirable side effects, serious adverse events or have other properties that could delay or halt clinical trials, delay or prevent its regulatory approval, limit the commercial profile of its labeling, if approved, or result in significant negative consequences following any marketing approval.
• The marketing approval process is expensive, time-consuming and uncertain. As a result, we cannot predict when or if we, or any licensees or partners, will obtain marketing approval to commercialize Vicineum for the treatment of BCG-unresponsive NMIBC or any other product candidate.
• Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad, and any approval we are granted for our product candidates in the United States would not assure approval of product candidates in foreign jurisdictions.
• Our commercial success depends upon attaining significant market acceptance of Vicineum for the treatment of BCG-unresponsive NMIBC, if approved, among physicians, patients, third-party payors and the medical community.
• The market opportunity for Vicineum may be limited to those patients who are ineligible for established therapies or for whom prior therapies have failed, and may be small.
• If we are unable to establish sales, marketing and distribution capabilities, we may not be successful in commercializing Vicineum for the treatment of BCG-unresponsive NMIBC, if and when it is approved.
• We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
• Our product candidates for which we intend to seek approval as biological products may face competition from biosimilar products.
• Even if we are able to commercialize Vicineum for the treatment of BCG-unresponsive NMIBC, it may become subject to unfavorable pricing regulations, third-party coverage or reimbursement practices or healthcare reform initiatives, which could harm our business.
• Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of Vicineum for the treatment of BCG-unresponsive NMIBC, if approved.
• We will depend on Qilu for the development and commercialization of Vicineum in the greater China region.
• We depend on the Roche License Agreement for the development and commercialization of EBI-031.
• We may enter into additional commercialization partnerships or out-license agreements with third parties for the commercialization or development of our product candidates. If our commercialization partnership or out-licenses are not successful, we may not be able to capitalize on the market potential of these product candidates.
• If we are not able to establish additional commercialization partnerships, we may have to alter our development and commercialization plans and our business could be adversely affected.
• We rely on third parties to conduct our pre-clinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates.
• If we lose our relationships with CROs, our product development efforts could be delayed.
• Our experience manufacturing Vicineum is limited to our pre-clinical studies and clinical trials. We have no experience manufacturing Vicineum on a commercial scale. We are dependent on third parties for our supply chain, and if we experience problems with any such third parties, the manufacturing of Vicineum could be delayed.
• If we are unable to obtain and maintain patent protection for our technology and products, or if our licensors are unable to obtain and maintain patent protection for the technology or products that we license from them, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
• We may not be able to protect our intellectual property rights throughout the world.
• We have not yet registered our trademarks in all of our potential markets, and failure to secure those registrations could adversely affect our business.
• We depend on our license agreements with Zurich, Micromet and XOMA, and if we cannot meet the requirements under the agreements we could lose important rights to Vicineum, which could have material adverse effect on our business.
• We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
• Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
• We may be subject to claims by third parties asserting that our employees, consultants, independent contractors or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
• If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
• Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
• Even if we obtain marketing approvals for one or more of our product candidates, the terms of such approvals, ongoing regulations and post-marketing restrictions may limit how we manufacture and market such products, which could materially impair our ability to generate revenue.
• Any product candidate, including Vicineum for the treatment of BCG-unresponsive NMIBC, for which we obtain marketing approval will be subject to a strict enforcement of post-marketing requirements and we could be subject to substantial penalties, including withdrawal of our product from the market, if we fail to comply with all regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.
• Our failure to comply with data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
• Our relationships with customers and third-party payors may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
• Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of our product candidates, including Vicineum for the treatment of BCG-unresponsive NMIBC, and affect the prices we may obtain.
• If we participate in the MDRP and fail to comply with our reporting and payment obligations under that or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
• Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the United States and require us to develop and implement costly compliance programs.
• The consequences of the United Kingdom’s withdrawal from the E.U. may have a negative effect on global economic conditions, financial markets and our business.
• If we or our third-party manufacturers fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur significant costs.
• Our employees may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
• The COVID-19 coronavirus could adversely impact our business.
• Our future success depends on our ability to attract, retain and motivate qualified personnel.
• We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
• If we expand our development and regulatory capabilities or implement sales, marketing and distribution capabilities, we may encounter difficulties in managing our growth, which could disrupt our operations.
• We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cyber security incidents, could materially adversely affect our business.
• Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
• Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.