OpGen’s Subsidiary Curetis Meets All Remaining Key Milestones in R&D Collaboration with FIND

Rhea-AI Summary

OpGen, Inc. (Nasdaq: OPGN) has achieved significant milestones in its R&D collaboration with FIND, leading to a milestone payment of approximately $0.3 million. This follows the successful delivery of a comprehensive report confirming all project requirements were met under the initial agreement. The collaboration focuses on the development of the Unyvero A30 panel, which includes 33 diagnostic targets, optimized for use in low- and middle-income countries (LMICs). Prototypes designed for challenging environments have been developed, marking progress in enhancing medical diagnostics in those regions. Both OpGen and FIND express optimism about future collaboration to improve testing for bloodstream infections in LMIC hospitals.

Positive

• Received approximately $0.3 million milestone payment from FIND.
• Successful completion of key milestones in R&D collaboration.
• Development of Unyvero A30 panel tailored for LMICs, enhancing diagnostic capabilities.

Negative

• None.

• Triggers milestone payment of approximately $0.3 million

ROCKVILLE, Md., April 26, 2023 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, reported today that its German subsidiary Curetis GmbH has met the remaining key milestones under the initial research and development (“R&D”) collaboration agreement with FIND. Following the delivery of a comprehensive milestone report at the end of first quarter of 2023, FIND confirmed that all requirements have been met successfully. Under the recently announced expansion of the collaboration, the originally planned Next Generation Sequencing (“NGS”) strain analysis will be complemented with isolates from other sub-Saharan African countries. Completion of the deliverables triggered a milestone payment of approximately $0.3 million.

The R&D collaboration to date has successfully addressed the development and initial wet-lab testing of a sample-in to result-out Unyvero A30 panel with 33 targets, including fully integrated sample preparation. Multiple Unyvero A30 instrument adaptations were made to optimize for use in the challenging environments of low- and middle- income countries (LMICs). Instrument prototypes have been designed, built and tested for operation in high-dust, extended temperature range and power-out scenarios.

Andreas Boos, Chief Technology Officer at Curetis GmbH commented: “We are excited to have successfully delivered the final milestones from the first phase of our collaboration agreement and look forward to working on the next set of deliverables under the expanded scope of our R&D partnership with FIND.”

Johannes Bacher, Chief Operating Officer of OpGen added: “We believe the successful first phase of our development collaboration puts us in an ideal position towards development of a robust solution optimized for use in LMICs, a goal we would like to pursue during a potential next phase of this collaboration under a new agreement with FIND.”

Dr. Cecilia Ferreyra, Director, FIND AMR Programme remarked that, “We have evaluated the final milestone data from Curetis on the Unyvero A30 and have confirmed that the adapted prototype test meets the quality and accuracy requirements for use in low- and middle-income countries. We look forward to potential continued collaboration to expand testing for blood stream infections in LMIC hospitals so that people can be linked to the care they need as soon as possible.”

About OpGen, Inc. 

OpGen, Inc. (Rockville, Md., U.S.A.) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with our subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s current product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction including ARESiss, ARESid, ARESasp, and AREScloud, as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.

For more information, please visit www.opgen.com.

Forward-Looking Statements

This press release includes statements regarding milestones under OpGen’s collaboration with FIND.
These statements and other statements regarding OpGen’s future plans and goals 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 results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, the success of our commercialization efforts, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the fact that we may not effectively use proceeds from recent financings, , our ability to satisfy debt obligations under our loan with the European Investment Bank, the effect of the military action in Russia and Ukraine on our distributors, collaborators and service providers, our liquidity and working capital requirements, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. 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.

OpGen:
Oliver Schacht
President and CEO
InvestorRelations@opgen.com

OpGen Investor & Press Contact:
Alyssa Factor
Edison Group
afactor@edisongroup.com

FAQ

What is the significance of the $0.3 million milestone payment for OpGen (OPGN)?

The $0.3 million milestone payment signifies successful completion of key milestones in the R&D collaboration with FIND, aiding OpGen's financial position.

What are the key developments in OpGen's research collaboration with FIND as of April 2023?

As of April 2023, OpGen's collaboration with FIND has led to the successful development of the Unyvero A30 panel, optimized for low- and middle-income countries.

How does the Unyvero A30 panel cater to low- and middle-income countries?

The Unyvero A30 panel is designed with adaptations for use in challenging environments, featuring robust prototypes that can perform in high-dust and extreme temperature conditions.

What future plans does OpGen have regarding its collaboration with FIND?

OpGen aims to pursue further collaboration with FIND to expand testing for bloodstream infections in hospitals in low- and middle-income countries.