OpGen

OpGen, Inc. is a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. It engages in the development of molecular information products and services for global healthcare settings. The firm's also offers guidance to clinicians about life threatening infections, improving patient outcomes, and decreasing the spread of infections caused by multidrug-resistant microorganisms. Its products include Unyvero, Acuitas AMR Gene Panel and Acuitas Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction. The company was founded on January 22, 2001 and is headquartered in Gaithersburg, MD.

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ROCKVILLE, Md., Oct. 14, 2021 (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, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale of an aggregate of 150,000 shares of convertible preferred stock and warrants to purchase up to an aggregate of 7,500,000 shares of common stock for gross proceeds of $15 million in a registered direct offering. The shares of preferred stock will have a stated value of $100 per share and are convertible into an aggregate of 7,500,000 shares of common stock at a conversion price of $2.00 per share at any time after the Company has received shareholder approval to increase the number of authorized shares of common stock of the Company. The warrants have an exercise price of $2.05 per share, will become exercisable on the later of the date of shareholder approval and six months following the date of issuance, and will expire five years following the initial exercise date. The closing of the offering is expected to occur on or about October 18, 2021, subject to the satisfaction of customary closing conditions.

OpGen Announces $15 Million Registered Direct Offering

The FDA has granted 510(k) clearance to OpGen Inc's (NASDAQ: OPGN) Acuitas AMR Gene Panel. The Company is finalizing preparations for its commercial launch in the U.S. in Q4 of 2021.

OpGen Stock Gains On FDA Approval, Interim Q3 Sales

Shares of OpGen Inc. OPGN, -4.17% rocketed 31.9% in active premarket trading Monday, after the precision medicine company provided a revenue update following the recent Food and Drug Administration clearance of its Acuitas AMR Gene Panel to aid in the diagnosis of severe infections. Trading volume spiked to 5.1 million shares ahead of the open, compared with the full-day average of about 1.8 million shares.

OpGen stock rockets after upbeat revenue update

ROCKVILLE, Md., Oct. 04, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that it has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market the Acuitas® AMR Gene Panel, and is finalizing preparations for its swift commercial launch in the U.S.

OpGen Receives FDA Clearance for Acuitas® AMR Gene Panel

ROCKVILLE, Md., Oct. 04, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that total preliminary unaudited revenue for the third quarter of 2021 was approximately $1.2 million, up from $1.1 million in the third quarter of 2020. Cash as of September 30, 2021 was approximately $25.4 million, an increase from the $13.4 million as of December 31, 2020.

OpGen Provides Business Update and Announces Preliminary Unaudited Revenue and Cash Position for Third Quarter 2021

The stock price of OpGen Inc (NASDAQ: OPGN) increased by over 15% pre-market today. This is why it happened.

OPGN Stock: Why It Noticeably Increased Today

ROCKVILLE, Md., Sept. 30, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that it has initiated the clinical trial for its Unyvero Urinary Tract Infection (UTI) Panel, which allows testing for a broad range of pathogens as well as antimicrobial resistance markers directly from native urine specimens.

OpGen Initiates Clinical Trial for Unyvero Urinary Tract Infection Panel

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- Unyvero reduced the use of inappropriate antibiotic therapy by 45.1%

OpGen Announces Data from Prospective Randomized Controlled Multicenter Clinical Study Using the Unyvero HPN Panel for Hospitalized Patients with Suspicion of Pneumonia

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OpGen, Inc. (OPGN) CEO Oliver Schacht on Q2 2021 Results - Earnings Call Transcript

OpGen, Inc. (OPGN) delivered earnings and revenue surprises of 0.00% and -22.67%, respectively, for the quarter ended June 2021. Do the numbers hold clues to what lies ahead for the stock?

OpGen, Inc. (OPGN) Reports Q2 Loss, Misses Revenue Estimates

Conference call to be held at 4:30 p.m. Eastern Daylight Savings Time today

OpGen Reports Second Quarter 2021 Financial Results and Provides Business Update

OpGen, Inc. (OPGN) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

OpGen, Inc. (OPGN) May Report Negative Earnings: Know the Trend Ahead of Q2 Release

ROCKVILLE, Md., Aug. 04, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or the “Company”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, today announced that it has determined to withdraw from stockholder consideration Proposal 2 set forth in its Definitive Proxy Statement filed with the Securities and Exchange Commission on April 26, 2021, relating to an increase in the number of shares of capital stock authorized for issuance under the Company's Amended and Restated Certificate of Incorporation. In light of the withdrawal of such proposal, the Company has determined to cancel the reconvening of the adjourned portion of its Annual Meeting of Stockholders for the consideration of Proposal 2, which was previously adjourned solely with respect to Proposal 2 to 10:00 a.m. Eastern Time on August 5, 2021. All other proposals in the Company's Definitive Proxy Statement were previously submitted to a vote of stockholders at the Annual Meeting on June 9, 2021, at which all such proposals were approved. The Company plans to continue evaluating alternatives for financing the future development and growth of the Company.

OpGen Announces the Cancellation of Adjourned Portion of Annual Meeting

ROCKVILLE, Md., Aug. 04, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (NASDAQ: OPGN) (“OpGen” or “the Company”) announced today that the Company will provide a business update and report its second quarter 2021 financial results after the close of the U.S. financial markets on Thursday, August 12, 2021. OpGen's management team will host a live conference call and audio webcast at 4:30 p.m. Eastern Time to discuss the Company's financial results and provide an update on business activities.

OpGen to Provide Business Update and Financial Results for the Second Quarter 2021 on August 12th at 4:30 p.m. Eastern Time

- OpGen subsidiary Curetis and its instrument development partner have completed assembly of 10 final pre-series release A30 RQ analyzers

OpGen Achieves Key Development Milestone in Unyvero A30 RQ Platform Program

ROCKVILLE, Md., July 07, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or the “Company”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, today announced that the Company resumed its partially adjourned 2021 annual stockholders meeting (the “Annual Meeting”) on July 7, 2021, solely with respect to Proposal 2 set forth in its Definitive Proxy Statement, dated April 26, 2021, relating to the increase in the Company's authorized shares of common stock. The Company adjourned the Annual Meeting with respect to such proposal to provide its stockholders additional time to vote on Proposal 2. The Annual Meeting will resume with respect to Proposal 2 at 10:00 a.m. Eastern time on August 5, 2021 and will continue to be held at the Company's offices located at 9717 Key West Ave, Suite 100, Rockville, MD 20850.* The record date for determining stockholders eligible to vote at the Annual Meeting will remain the close of business on April 15, 2021.

OpGen Announces Partial Adjournment of Annual Meeting

- Unyvero studies demonstrated potential for therapy adjustment in 42% to 53% of patients with results available 1 to 2 days faster

OpGen Announces Prospective Clinical Data from Unyvero LRT BAL and Acuitas AMR Gene Panel for Isolates Data Presented at World Microbe Forum

ROCKVILLE, Md., June 28, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, today announced that its subsidiary Ares Genetics, which strives to become a leader in bacterial genomics and AI-powered prediction of antimicrobial resistance (AMR), presented an update on the company's R&D pipeline during two virtual seminars held on May 22 and on May 24, 2021. After having recently announced the development of a target enrichment-based, culture free genomic assay for the comprehensive surveillance of AMR pathogens, Dr. Arne Materna, CEO of Ares Genetics, now presented preliminary data of an ongoing multicenter validation of long-read nanopore sequencing of clinical isolates.

OpGen Group Company Ares Genetics Presents R&D Pipeline Updates

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The stock price of OpGen Inc (NASDAQ: OPGN) increased by over 20% pre-market. This is why it happened.

OPGN Stock Price Increases Over 20% Pre-Market: Why It Happened

ROCKVILLE, Md., June 09, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or the “Company”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, today announced that the Company conducted its 2021 annual stockholders meeting (the “Annual Meeting”) and adjourned the meeting solely with respect to Proposal 2 set forth in its Definitive Proxy Statement (the “Proxy Statement”) filed with the Securities and Exchange Commission on April 26, 2021. Proposal 2 is a proposal to amend the Amended and Restated Certificate of Incorporation in order to increase the number of shares of capital stock from 60,000,000 to 110,000,000 shares and the authorized number of shares of common stock from 50,000,000 shares to 100,000,000 shares. All other proposals were passed at the Annual Meeting with strong support from stockholders.

OpGen Announces Partial Adjournment of Annual Meeting for Proposal 2 with All Other Proposals Passed

ROCKVILLE, Md., June 09, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, today announced that its subsidiary Ares Genetics, which strives to become a leader in bacterial genomics and the AI-powered prediction of antimicrobial resistance (AMR), is developing a culture-free, genomic assay for comprehensive AMR surveillance. Dr. Johannes Weinberger, NGS Laboratory Director at Ares Genetics, offered insights into the ongoing assay development activities during a virtual conference presentation on May 26, 2021 sponsored by Twist Bioscience.

OpGen Group Company Ares Genetics Presents at AWS and Twist Bioscience Webinars

ROCKVILLE, Md., June 07, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, today announced that it has submitted an updated 510(k) summary document to the U.S. FDA for its Acuitas AMR Gene Panel for Isolates. This document incorporates all of the FDA's requested updates to various key documents such as the Package Insert, Electronic User Guide, and Operator Manual. Consistent with the FDA's previously communicated timeline, the FDA provided substantive feedback on all of these key documents by the end of May. The FDA previously informed OpGen that it intends to complete its review by the end of August 2021, but that it cannot commit to a timeline and that such timeline can be affected by various factors, including the FDA's other workload and public health priorities.

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