ROCKVILLE, Md., April 29, 2024 (GLOBE NEWSWIRE) -- OpGen, Inc. (NASDAQ:OPGN, "OpGen" or "the Company"))) announced today that it entered into an agreement to sell its commercial customer contracts and installed base of Unyvero systems to Camtech Pte Ltd ("Camtech"), a Singaporean family office for $218,000. The transaction follows Camtech's prior acquisition of all of Curetis GmhH's ("Curetis"), the Company's subsidiary, Unyvero assets, rights and businesses, as part of Curetis' insolvency proceedings. In a ...

Business Operations - The Company discontinued its Acuitas AMR Gene Panel diagnostic test on October 18, 2023, with final orders processed earlier this year [145]. - Curetis and Ares Genetics filed for insolvency on November 6, 2023, following unsuccessful efforts to sell their businesses or access additional capital [146]. - The Unyvero Lower Respiratory Tract test detects over 90% of common pneumonia-causing agents in hospitalized patients and provides results in under five hours [147]. - The Unyvero UTI test is currently being developed for FDA clearance, with a De Novo classification request submitted in April 2023 [148]. - The Unyvero A50 system tests for up to 130 diagnostic targets in under five hours and has been FDA-cleared since 2018 [152]. - The Company has a distribution agreement with Fisher Healthcare, allowing them to sell to existing U.S. Unyvero customers [153]. - Revenue is generated from product sales, laboratory services, and collaboration revenue, including AI-powered solutions from Ares Genetics [156]. Financial Performance - The Company recognized revenues of €42 thousand and €0.6 million during the three and nine months ended September 30, 2023, related to a collaboration with FIND, totaling €0.87 million [150]. - Total revenue for the three months ended September 30, 2023, increased approximately 56% to $699,022 compared to $448,713 in the same period in 2022 [158]. - Product sales rose to $558,965, a 55% increase from $359,112 in the prior year, driven by higher international Unyvero system and cartridge sales [160]. - Laboratory services revenue increased by approximately 52% to $47,135, attributed to enhanced sequencing and analysis services [160]. - Collaboration revenue surged by approximately 59% to $92,922, primarily due to a collaboration agreement with FIND [160]. - Total revenue for the nine months ended September 30, 2023, increased approximately 25% to $2,348,601 compared to $1,885,663 in the same period in 2022 [163]. Operating Expenses - Total operating expenses for the three months ended September 30, 2023, decreased approximately 69% to $4,264,647 from $13,962,011 in the same period in 2022 [159]. - Research and development expenses decreased approximately 41% to $1,201,865, mainly due to reduced payroll costs and the conclusion of a clinical trial [161]. - Total other expense for the three months ended September 30, 2023, decreased to $497,332 from $590,684 in the same period in 2022, primarily due to reduced interest expenses [162]. Cash Flow and Liquidity - As of September 30, 2023, cash and cash equivalents were $0.3 million, down from $7.4 million at December 31, 2022 [168]. - On October 11, 2023, the company entered into a Preferred Stock Purchase Agreement for aggregate gross proceeds of $1.0 million [173]. - OpGen's cash available to fund its business operations is significantly limited, raising substantial doubt about the Company's ability to continue as a going concern [177]. - For the nine months ended September 30, 2023, net cash used in operating activities was $(12,643,099), compared to $(16,454,854) for the same period in 2022, indicating a reduction in cash outflow [179]. - The principal source of liquidity is from financing activities, including issuances of equity and debt securities, with net cash provided by financing activities of $6,275,625 for the nine months ended September 30, 2023 [179]. - The Company has created additional banking relationships to diversify its holdings after regaining access to accounts at Silicon Valley Bank [178]. - Future disruptions in financial institutions could adversely affect the Company's ability to access cash and cash equivalents, impacting its financial position [178]. Debt and Obligations - The net loss for the nine months ended September 30, 2023, was $15.6 million, improved from a net loss of $26.7 million in the same period of 2022 [180]. - As of September 30, 2023, outstanding borrowings under all tranches were €9.4 million (approximately $9.9 million), including deferred interest of €1.4 million (approximately $1.5 million) [184]. - The Company has entered into a Standstill Agreement with the EIB regarding €3 million in principal plus accumulated interest due on June 22, 2023, delaying any action until November 30, 2023 [186]. - The first tranche of approximately €13.4 million was fully repaid by April 2023, following a restructuring agreement with the EIB [185]. - The third tranche of €5.0 million will become due in June 2024 unless restructured along with the second tranche [187].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______. Commission file number 001-37367 OPGEN, INC. (Exact name of registrant as specified in its charter) Delaware 06-1614015 (State or other jurisdiction of incorpo ...

As filed with the Securities and Exchange Commission on July 14, 2023 Registration No. 333-______________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 OPGEN, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 8071 (Primary Standard Industrial Classification Code Number) 06-1614015 (I.R.S. Employer Identification Number) 9717 Key West Avenue, Suite 100 Rockville, MD 20850 (301) 869-9683 (Address, inclu ...

Revenue Sources - OpGen's revenue is generated from three sources: product sales, laboratory services, and collaboration revenue, with a focus on molecular diagnostics and informatics for infectious diseases [137]. - Total revenue for the three months ended March 31, 2023, increased approximately 94% to $913,444 compared to $469,745 in the same period in 2022 [139]. - Product sales rose by approximately 12% to $410,897, driven by additional cartridge and master mix sales [141]. - Collaboration revenue surged approximately 691% to $480,874, primarily due to a collaboration agreement with FIND [141]. Product Development and Testing - The Unyvero LRT test detects over 90% of common pneumonia-causing pathogens in hospitalized patients, addressing a medical need that incurs over $10 billion annually in U.S. healthcare costs [129]. - The Unyvero UTI test has completed enrollment of over 1,800 patient samples and is seeking FDA marketing authorization, which would make it the first rapid sample-to-answer UTI test cleared in the U.S. [130]. - The Acuitas AMR Gene Panel detects 28 genetic AMR markers in under 3 hours and has been installed in two commercial customer sites, with expectations for more contracts in 2023 [130]. - Ares Genetics' ARESdb database now covers over 130,000 bacterial isolates sequenced using NGS technology, providing valuable data for AMR research and diagnostics [131]. - The Unyvero A30 RQ system is designed for low-to-mid-plex testing and has completed verification and validation testing, with ongoing partnering discussions [133]. Financial Performance - Total operating expenses decreased approximately 5% to $5,983,555 compared to $6,315,485 in the same period in 2022 [140]. - Research and development expenses decreased approximately 22% to $1,812,831, attributed to reduced payroll costs and the conclusion of a clinical trial [142]. - Net cash used in operating activities for the three months ended March 31, 2023, was $4,962,618, a slight improvement from $5,041,400 in the same period in 2022 [147]. - As of March 31, 2023, cash and cash equivalents were $7.0 million, down from $7.4 million at December 31, 2022 [144]. - Outstanding borrowings under all tranches of the EIB loan facility were €10.7 million (approximately $11.6 million) as of March 31, 2023 [152]. - The company raised approximately $7.5 million in gross proceeds from a public offering closed in January 2023 [145]. - The company is considering multiple alternatives to meet capital needs, including additional equity and debt financings [144]. Regulatory and Compliance - OpGen is focused on regulatory clearances for its Unyvero UTI and IJI products, as well as compliance with the new IVDR in the EU, allowing continued commercialization of existing CE-IVD-marked products until at least 2026 [135]. - The company has ceased commercial operations for its SARS-CoV-2 test kit in 2023, following its previous CE-IVD-marking in 2022 [130]. - The company is classified as a smaller reporting company and is not required to disclose market risk information [159]. - Recent accounting pronouncements are detailed in Note 3 of the Form 10-Q, including expected adoption dates and effects on financial statements [156]. Partnerships and Collaborations - The company has received €0.7 million in funding from FIND for the development of the Unyvero A30 RQ platform, with total project revenue potential increased to €830,000 [130]. - OpGen's subsidiary Curetis has established distribution partnerships in 12 European countries and China to accelerate the commercialization of its products [134].

As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. 333-271190 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 OPGEN, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 8071 (Primary Standard Industrial Classification Code Number) 06-1614015 (I.R.S. Employer Identification Number) 9717 ...

As filed with the Securities and Exchange Commission on April 7, 2023 Registration No. 333-____________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 OPGEN, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 8071 (Primary Standard Industrial Classification Code Number) 06-1614015 (I.R.S. Employer Identification Number) 9717 Key West Avenu ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______. Commission file number 001-37367 OPGEN, INC. (Exact name of registrant as specified in its charter) Delaware 06-1614015 (State or other jurisdiction of incorp ...

Financial Data and Key Metrics Changes - In Q4 2022, total revenue was approximately $722,000, a decrease from $1.4 million in Q4 2021, while total revenue for the full year 2022 was approximately $2.6 million compared to $4.3 million in 2021, aligning with recent guidance [25][27] - Operating expenses in Q4 2022 amounted to $10.7 million, up from $7.2 million in Q4 2021, primarily due to a $5.4 million impairment of indefinite-lived in-process R&D and tangible assets [28] - The company ended 2022 with approximately $7.4 million in cash, a significant decrease from $36.1 million at the end of 2021, and is closely monitoring cash consumption [13][16] Business Line Data and Key Metrics Changes - Sales and marketing expenses for the full year 2022 increased by approximately 16% to $4.3 million, attributed to the expansion of sales and business development teams and increased on-site expenses due to lifted COVID restrictions [12] - R&D expenses in Q4 2022 were $1.6 million, a 35% reduction from $2.9 million in Q4 2021, and full year R&D expenses were $8.2 million, down nearly 25% from $10.9 million in 2021 [30] Market Data and Key Metrics Changes - The company anticipates significant revenue growth opportunities in the U.S., particularly with Unyvero product sales and Ares Genetics services, with a strong business development funnel [18] - Hospitals are experiencing a backlog of investment needs post-COVID, leading to longer contract completion times, impacting the signing of new contracts [19][62] Company Strategy and Development Direction - The company is focused on expanding its commercial pipeline for the AMR Gene panel and Unyvero products, with ongoing discussions with hospitals [33] - A commercial collaboration agreement with BioVersys was signed for the deployment of the Unyvero platform in a Phase 2 clinical trial [24] - The company is exploring non-dilutive partnership opportunities, particularly in China, to leverage local market potential for the Unyvero A30 platform [41][51] Management's Comments on Operating Environment and Future Outlook - Management noted that the operating expenses remained in line with expectations, with a projected net cash consumption of around $4.5 million to $5 million per quarter for 2023 [16] - The company expects to recognize significant revenue from collaborations and new customer contracts in 2023, with a revenue guidance range of approximately $4 million to $5 million [35][68] Other Important Information - The company completed a 1-for-20 reverse stock split in January 2023 and regained compliance with NASDAQ's minimum bid price rule [44] - The company has a commercial distribution agreement in place with a Chinese distributor, with potential purchase commitments over an 8-year period of up to $180 million [45] Q&A Session Summary Question: What kind of contribution can be expected from Ares Genetics in FY '23? - Management indicated that traction is being seen for the U.S.-based next-gen sequencing lab, with a major project completed involving sequencing over 1,200 isolates [55] Question: Could you provide an update on the progress of the FIND collaboration? - Management confirmed that the feasibility stage collaboration is on track to conclude soon, with a remaining milestone payment of roughly €300,000 [56] Question: What is the potential in China for the pneumonia product and the Unyvero A30 platform? - Management reiterated the potential for up to $180 million in revenue over an 8-year period post-NMPA approval, with no significant competition currently visible [59][61] Question: Do you expect the hospitals' product review time frame to be shortened significantly this year? - Management expressed hope for normalization in review times but acknowledged the backlog of capital expenditure in hospitals due to COVID [62] Question: Could you comment on the trend of gross margin going forward? - Management stated that gross margins for consumables are expected to remain in the 60% to 70% range, with no anticipated changes [63]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 OPGEN, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) As filed with the Securities and Exchange Commission on January 5, 2023 Registration No. 333-268648 8071 (Primary Standard Industrial Classification Code Number) 06-1614015 (I.R.S. Employer Identification Number) 9717 ...