Eton Pharmaceuticals, Inc. 10-Q

Item 1A. Risk Factors We operate in a dynamic and rapidly changing environment that involves numerous risks and uncertainties. Certain factors may have a material adverse effect on our business, financial condition, and results of operations, and you should carefully consider them. Other events that we do not currently anticipate or that we currently deem immaterial may also affect our results of operations and financial condition. You should carefully consider the factors discussed in Part I, Item 1A. “Risk Factors” in our 2019 10-K and Part II, Item 1A of our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31 and June 30, 2020 which could materially affect our business, financial condition, cash flows or future results. The risk factors described in our 2019 10-K and 10-Q for the quarterly periods ended March 31 and June 30, 2020 are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, or future results. The risk factor below constitutes an update to the risk factors included in our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 5, 2020 and the risk factor included in our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2020 filed with the SEC on May 14, 2020 and June 30, 2020 filed with the SEC on August 12, 2020. Our business is adversely affected by the ongoing coronavirus pandemic and the impact could be material. The global COVID-19 pandemic has resulted in widespread requirements for individuals to stay in their homes and strained medical facilities worldwide, including certain aspects of our business. For example, we began commercializing our Biorphen product in December 2019, however we have encountered difficulty in creating significant market pull-through demand for Biorphen in 2020 as our in-person sales calls to key personnel at hospitals and surgical centers and introductory product presentation seminars were cancelled as a result of the COVID-19 pandemic. We are working on other promotional efforts to drive further adoption in the market, but we expect that our Biorphen sales and marketing efforts will continue to be adversely affected by the pandemic in 2020. COVID-19 may also affect our ability to complete recruitment and data analysis for our clinical trials and our ability to conduct research and development of our complement programs in our planned timeframe. The extent to which COVID-19 impacts our operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain COVID-19 or treat its impact. In particular, as a result of the COVID-19 pandemic, we may experience disruptions that could severely impact our business, preclinical studies, drug manufacturing and clinical trials including: ● delays or difficulties in enrolling patients in our human factor study for Lamotrigine Oral Suspension (ET-105); ● diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; ● interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures, which may impact the integrity of subject data and clinical study endpoints; ● interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines; ● interruption of, or delays in promoting our products in-person, at conferences and at hospitals due to limitations on travel and in-person gatherings imposed or recommended by federal or state governments 28 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds See the registrant’s current report on Form 8-K filed with the SEC on March 30, 2020. Item 3. Defaults Upon Senior Securities Not applicable. Item 4. Mine Safety Disclosures Not applicable.