OpGen says Curetis expects near-term FDA decision on clearance of Unyvero LRT
OpGen provided a business update for the Curetis Group and announced that key milestones in the planned business combination have been achieved. Curetis recently announced that it has filed its formal response to the FDA's Additional Information Request letter regarding Curetis' filing for 510 clearance of the Unyvero LRT - Lower Respiratory Tract Application Cartridge for bronchoalveolar lavage samples. The formal response addressed all additional information requested by the FDA regarding the original submission filed on July 23, 2019. Curetis now expects a near term clearance decision. It is estimated that BAL specimens account for half of the samples obtained for the diagnosis of lower respiratory tract infections. The comprehensive LRT BAL panel covers the most clinically relevant microbial and fungal pathogens and antibiotic resistances in this indication area. The European Investment Bank, has advised Curetis GmbH that the proposed merger between Curetis and OpGen has been formally approved, subject to appropriate loan guarantees and legal documentation. On October 28, 2019, OpGen completed a $9.4M public offering. Curetis has advised OpGen that the completion of this equity financing meets the interim financing requirement specified in the September 4, 2019 Implementation Agreement between OpGen and Curetis N.V. On November 12, 2019, OpGen filed a Form S-4 with the Securities and Exchange Commission. The Form S-4 filing is currently under review by the SEC. Once finalized, the Form S-4 will serve two purposes - the proxy statement to be sent to the OpGen stockholders seeking approval of the proposed business combination, and the registration of the shares of OpGen common stock to be issued to Curetis N.V. following approval by the stockholders of OpGen and the shareholders of Curetis N.V. For the nine-month period ending September 30, 2019, Curetis Group reported total revenue of EUR1.4M, a 16% increase from the EUR1.2M reported in the prior year period. OpGen and Curetis entered into a definitive agreement to combine businesses on September 4, 2019. The closing of the transaction under such definitive agreement has not yet occurred and is subject to a number of significant closing conditions, including receipt of approval from the stockholders of OpGen, Inc. and the shareholders of Curetis, N.V. Until the closing occurs, each of OpGen and Curetis are operating as stand-alone businesses.