Cytosorbents Corp 10-Q

Item 1A. Risk Factors. For a discussion of risks that affect the Company’s business, please refer to Part I, Item IA, “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the SEC on March 5, 2020. There have been no material changes to the risk factors as previously disclosed in the Company’s Annual Report on Form 10-K, except as follows: A pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, may materially and adversely affect our business and operations. The outbreak of COVID-19 originated in Wuhan, China in December 2019 and has since spread around the globe. On March 11, 2020, the World Health Organization declared the outbreak a pandemic. The COVID-19 pandemic is affecting the United States and global economies, has affected and is likely to continue to affect our operations and those of third parties on which we rely, including potential disruptions in our raw material supply, the manufacturing and commercialization of CytoSorb, and the conduct of current and future clinical trials. In addition, the COVID-19 pandemic has affected and is likely to continue to affect the operations of the U.S. Food and Drug Administration and other health authorities, which could result in delays of reviews and approvals, including with respect to CytoSorb and our product candidates. The evolving COVID-19 pandemic has impacted and is likely to continue to directly or indirectly impact our clinical trials, including but not limited to, the pace of enrollment and anticipated start and completion date of these trials, for at least the next several months and possibly longer. For example, patients may avoid or be unable to travel to hospitals for elective procedures or health emergencies, or clinical trial staff may no longer be able to work on site at hospitals, or hospitals may halt clinical trial activity in favor of spending scarce resources on COVID-19 patients. In particular, due to delays caused by the COVID-19 pandemic, analysis of the study data and issuance of top-line data for the 289 enrolled patients, fifteen-center randomized, controlled study (“REMOVE”) using CytoSorb during valve replacement open heart surgery in patients with infective endocarditis is now anticipated to be available in the fourth quarter of 2020 (rather than by mid-2020 that was initially anticipated), with full analysis of data expected in early 2021. There may also be further delays in patient enrollment in the REFRESH 2, TISORB, and CYTATION clinical trials as a result of the COVID-19 pandemic. In addition, COVID-19 disruptions to our workforce, including but not limited to federal, state and local responses to the pandemic, could materially impact our productivity, including our ability to manufacture CytoSorb, or to develop our product pipeline. As of the date of this filing, our manufacturing facilities remain operational and we have resumed certain research and development activities that were temporarily suspended as a result of the COVID-19 pandemic. The overall impact of the COVID-19 pandemic across our business, healthcare systems, and the global economy is complex, highly uncertain, and subject to change. These effects could have a material negative impact on our liquidity, capital resources, operations, and business as well as those third parties on which we rely. For example, although the Company is currently well-capitalized, a protracted COVID-19 pandemic and a volatile stock market could make it difficult to raise additional capital, if needed, which could negatively impact our liquidity. To date, during certain periods of the COVID-19 pandemic, our stock price fluctuated significantly, and such volatility may continue. ​ 32 Table of Contents Item 2. Unregistered Sales of Equity Securities and Use of Proceeds. None. ​ Item 3. Defaults Upon Senior Securities. None. ​ Item 4. Mine Safety Disclosures. Not applicable. ​