Curetis Expects Near-Term U.S. FDA Decision on 510(k) Clearance of Unyvero LRT for BAL Specimens
European Investment Bank approves business combination transaction
$9.4 million interim financing completed
GAITHERSBURG, Md., Dec. 02, 2019 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN) today 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(k) clearance of the Unyvero LRT – Lower Respiratory Tract Application Cartridge for bronchoalveolar lavage (BAL) 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.
Milestones in Planned Business Combination
- The European Investment Bank (the “EIB”), 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 $9.4 million 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 “SEC”). 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.
Curetis Group Financial Results
For the nine-month period ending September 30, 2019, Curetis Group reported total revenue of €1.4 million, a 16% increase from the €1.2 million reported in the prior year period. Total comprehensive loss of the period was €16.3 million for the 2019 nine-month period compared with €17.9 million in the comparable 2018 period. The 2019 nine-month Curetis financial and business report can be found here. Commercial order volume and fees contractually committed and received by Curetis and Ares Genetics in 2019 have more than tripled from €1.1 million in 2018 to approximately €3.4 million in 2019. This increase in orders includes orders for Unyvero instruments and cartridges, and Ares Genetics’ laboratory and advanced bioinformatics services, as well as contractual fees for access to certain rights.
Evan Jones, Chairman & CEO of OpGen, stated, “We are pleased with the progress Curetis has made towards expanding the claims for their Unyvero LRT BAL test, and the successful accomplishment of key milestones that are required to complete the planned business combination of OpGen and Curetis. We are currently preparing documentation for both OpGen and Curetis to seek approval from stockholders and shareholders, and continuing conversations with other lenders of the parties. The meetings to support these approvals are anticipated to take place early in the first quarter of 2020.”
OpGen and Curetisentered 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.
No Offer or Solicitation
This press release is neither an offer to purchase, nor a solicitation of an offer to sell, any securities or the solicitation of any vote in any jurisdiction pursuant to the proposed transactions or otherwise, nor shall there be any sale, issuance or transfer or securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Additional Information and Where to Find It
In connection with the transactions contemplated by the Implementation Agreement (the definitive agreement related to the proposed business combination between the Company and Curetis GmbH), a Registration Statement on Form S-4 has been filed with the SEC and is under review. Investors and security holders are encouraged to read the registration statement and any other relevant documents filed with the SEC, including the proxy statement/prospectus that will be part of the final registration statement, when they become available, because they will contain important information about the proposed transaction. The final proxy statement/prospectus will be mailed to stockholders of the Company. Investors and security holders will be able to obtain the documents free of charge at the SEC’s website, www.sec.gov, or from the Company at its website, www.opgen.com.
OpGen, Inc. is a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. We are developing molecular information products and services for global healthcare settings, helping to guide clinicians with more rapid and actionable information about life threatening infections, improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs.
Our molecular diagnostics and informatics products, product candidates and services combine our Acuitas molecular diagnostics and Acuitas Lighthouse informatics platform for use with our proprietary, curated MDRO knowledgebase. We are working to deliver our products and services, some in development, to a global network of customers and partners. The Acuitas AMR Gene Panel (RUO) is intended for Research Use Only and is not for use in diagnostic procedures. The Acuitas Lighthouse Software is not distributed commercially for antibiotic resistance prediction and is not for use in diagnostic procedures. For more information, please visit www.opgen.com.
This press release provides an update on the parties’ progress toward meeting closing conditions under the announced business combination agreement between Curetis N.V. and OpGen that has not yet closed, the status of the Curetis LRT BAL specimen 510(k) FDA submission, and provides interim nine-month financial results for the Curetis Group. These statements constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause the future to differ materially from expectations. We cannot assure you that the proposed business combination transaction with Curetis N.V., which is subject to significant conditions to close, will occur. For a discussion of the most significant risks and uncertainties associated with OpGen's business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Vice President, Marketing
FischTank Marketing and PR
Source: OpGen, Inc.