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Wednesday, January 18, 2023

OpGen prelim revenue below views

 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, today announced preliminary unaudited revenue for 2022. Preliminary revenue for full year 2022 was approximately $2.7 million, which falls within the most recent guidance range the Company had provided in its Q3 earnings call. The year-end cash position as of December 31, 2022 amounted to approximately $7.4 million. On January 11, 2023, the Company successfully closed a public offering of securities raising gross proceeds of $7.5 million and net proceeds of approximately $6.8 million after deduction of placement agent commission and transaction related expenses.

OpGen also provides the following updates on important aspects of its business and reported on the accomplishment of key milestones in Q4-2022 and early 2023:

  • Closed a $7.5 million public offering of approximately 2.6 million shares of common stock, or pre-funded warrants in lieu thereof, at $2.90 each, along with accompanying Series A-1 and Series A-2 warrants with an exercise price of $2.65 per share.
  • Implemented a 1 for 20 reverse stock split to regain compliance with Nasdaq’s minimum bid price rule in advance of the February 2023 deadline.

  • Achieved several key milestones and deliverables under the collaboration with the Foundation for Innovative New Diagnostics (FIND), which triggered a milestone payment in early 2023.

  • Following successful completion of patient sample enrollment into the Unyvero Urinary Tract Infection (UTI) clinical trial in the U.S., OpGen completed its initial analysis and published strong top-line data with an overall weighted average sensitivity of 96.4% and an overall weighted average specificity of 97.4%. The Company also initiated the full data analysis and began preparation of its FDA submission package which is expected to be submitted in the coming months. Furthermore, OpGen began next generation sequencing of over 1,000 bacterial isolates from its UTI clinical trial.

  • OpGen initiated a collaboration with Swiss-based BioVersys by training their internal team, as well as members of the clinical research organization (CRO) that will be supporting the BioVersys phase II clinical trial, on the Unyvero platform and use of the Unyvero HPN pneumonia panel.

  • Signed second Acuitas AMR Gene Panel customer contract and successfully installed first two Acuitas systems.

  • Progressed multiple potential commercial agreements and contracts for Acuitas as well as Unyvero LRT BAL and UTI in the U.S. and intend to obtain signatures subject to customer approval. First commercial purchase orders from new customer accounts were already received and processed in Q4-2022.

  • Launched ARESiss next generation sequencing service from OpGen’s Rockville, Maryland lab and successfully executed large pilot project on isolates from the UTI trial.

  • Ares added several new commercial customer accounts for ARES services globally.

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