Commission file number 001-37367 ______________________ & OPGEN,& INC. ( Selected Financial Data & 54 Item 7. & New risks emerge from time to time. 3& & & & RISK FACTOR SUMMARY Investing in our securities involves a high degree of risk. Importantly, this summary does not address all of the risks that we face. Biofilm-forming pathogens can be detected by the Unyvero Platform. All fluids are handled within the sealed Application Cartridge. The IAI Application Cartridge The IAI Application Cartridge was launched in April 2017. A version of this product is currently pending FDA clearance. Our operations are located in the United States, Germany, and Austria. Each of these agreements can be extended by mutual agreement between the parties. Outside of the EU, OpGen currently plans to commercialize Unyvero through distributors. Under this agreement, Scholz guarantees that all such rights solely belong to Curetis. We also purchase our collection kits from sole-source suppliers. We are currently in the process of sunsetting our Argus intellectual property. & Class II devices are subject to General Controls as well as additional special controls. There are no regulatory safe harbors to the Maryland anti-kickback law. Among the safe harbors that may be relevant to us is the discount safe harbor. Throughout the COVID-19 pandemic, employee safety is of top priority. ldquo;AMR” means antimicrobial resistance. & We need to raise equity capital to support our business. If we cannot do so successfully, we will not be able to continue as a going concern. A number of special and complex rules apply in calculating this Section 382 limitation. We need to comply with the applicable laws and regulations regarding such other uses. If these collaborations are not successful, our business could be adversely affected. Competition for such employees is intense. We do not have redundant facilities for these products. Such process is complex, time consuming and expensive. We will monitor changes in government enforcement as we grow and expand our business. It is also more expensive for us to obtain director and officer liability insurance. 52& & & Item 1B. Unresolved Staff Comments None. Actual results could differ from those estimates. 333-202478, filed on April 23, 2015). & & & & & & & Accordingly, we express no such opinion. The Company analyzes each arrangement on a case-by-case basis. Options granted have a maximum term of 10 years. The Company will continue to monitor this matter going forward. The trade names/trademarks intangibles are valued using a relief-from-royalty method. The Company had no contract assets as of December 31, 2019. On June 11, 2018, the Company executed an Allonge to the MGHIF Note. In June 2018, another tranche of €3 million was drawn down. The Notes are dated April 22, 2020. Interest accrues on the Notes at the rate of 1.00% per annum. The entire proceeds were used under the Notes for such qualifying expenses. As of December 31, 2020, remaining availability under the ATM Agreement is $5.4 million. There can be no assurance that the NOL carryforward will ever be fully utilized. Ares Genetics received an option fee of approximately $550,000. M R/R/AV(B58IS*2IR#@CI0,]/B[U7U4XTN?Z58AZGZ56UC_ )! R\']:VL48H%J8G_ B6@\'_F&0_K2\'P?X/72H/U_P : MW,4N* U,+_A#?#O_ $"H/U_QI/\\ A#?#O_0*@_7_ ! \'O5^@0 MVJ4__\'PU7JHS_P#\'PU !_! M )[Q?]]BC[);_P#/"[email protected]?9+?\\ YX1?]\\"C0/=/*O\'!#:I$5(((EP1W_M7 M/VUNUU=101E0TKA 6. ,] Each pre-funded warrant
