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 ...

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 March 31, 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 incorp ...

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]

(Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q For the transition period from to Commission File Number 001-37367 OPGEN, INC. 9717 Key West Avenue, Suite 100, Rockville, MD 20850 (Address of principal executive offices) (Zip code) Registrant's telephone number, including area code: (240) 813-1260 Securities registered or to be registered pursuant to Section 12(b) of the Act ...

Financial Data and Key Metrics Changes - Revenue for Q3 2022 was $0.4 million, down from $1.2 million in Q3 2021, primarily due to the absence of a comparable project from the New York State Department of Health and lower international revenue from univariable systems [11][12] - Operating expenses increased to $14 million in Q3 2022 from $6.3 million in Q3 2021, largely due to a $7 million goodwill impairment charge [12] - Net loss available to common stockholders was $14.1 million or $0.30 per share in Q3 2022, compared to $6.1 million or $0.16 per share in Q3 2021 [12] Business Line Data and Key Metrics Changes - The company signed its first two commercial contracts for the Acuitas AMR gene panel in Q2 and Q3 2022, with expectations for increased revenue from these contracts in the future [14] - The RS genetics subsidiary launched isolate sequencing services in the US, with potential revenue generation expected but not yet recognized [20][21] Market Data and Key Metrics Changes - The company anticipates revenue from products and services globally for 2022 to be in the range of $2.5 to $3 million, lower than expected but with significant revenue growth potential in 2023 [14] - The company is exploring additional strategic and tactical equity and debt financing opportunities to strengthen its cash position [13] Company Strategy and Development Direction - The company is focused on expanding its commercial pipeline, particularly with the Acuitas AMR gene panel and the universal UTI product, with several ongoing discussions with hospitals [14] - The company plans to continue its progress in both commercial and R&D fronts, with key milestones expected in 2023 [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future growth opportunities, particularly in product sales and collaborations, despite current challenges [13] - The company is confident in regaining compliance with NASDAQ's minimum bid price requirement by February 2023 [14] Other Important Information - The company has a commercial contract worth potentially up to $180 million over eight years pending approval from China's National Medical Products Administration [15] - A special meeting of stockholders is scheduled for November 30, 2022, to vote on a proposal for a reverse stock split [14] Q&A Session Summary Question: Clarification on Acuitas AMR gene panel installations and obligations - Management confirmed that contracts have defined minimum purchase obligations and that installations must be completed before revenue recognition can begin [19] Question: Revenue generation from RS genetics isolate sequencing services - Management indicated that while revenue recognition is not expected immediately, the sales funnel for these services is growing [20][21] Question: Revenue expectations from collaboration agreements with BNR and bio versus - Management expects revenue recognition to begin with the bio versus clinical trial in early 2023, while the BNR collaboration is an R&D effort without immediate revenue generation [22][23]

FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 or ☐ TRANSITION REPORT PURSUANT TO 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 inco ...

Financial Data and Key Metrics Changes - The company reported Q2 2022 revenue of approximately $967,000, a 19% increase from the same period last year, while the first half of 2022 revenue totaled $1.4 million compared to $1.6 million in the first half of 2021 [32][33] - Product sales in Q2 2022 increased by approximately $582,000, representing a 189% year-over-year increase, primarily driven by sales of Unyvero instruments [33] - The net loss available to common stockholders in Q2 2022 was $5.8 million or $0.13 per share, significantly lower than $7.1 million or $0.19 per share in Q2 2021 [39] Business Line Data and Key Metrics Changes - The company completed two commercial contracts for the Acuitas AMR Gene Panel with major hospitals, marking a significant step in commercialization efforts [12][13] - Ares Genetics launched new genome sequencing services globally, including ARESid and ARESiss Express, aimed at minimizing the spread of AMR pathogens [16] - The Unyvero urinary tract infection (UTI) panel clinical trial has enrolled over 1,300 patient samples, with expectations to complete enrollment by the end of Q2 2022 [19][20] Market Data and Key Metrics Changes - The company has seen positive revenue growth in its international distribution business, particularly with the Menarini partnership, which has increased minimum purchase commitments by over 50% for the coming 12 months [48] - A distribution agreement with Leader Life Sciences in the UAE and Qatar is expected to generate approximately $1 million in revenue over three years [22][48] - The company is expanding its commercial presence in various regions, including Asia Pacific and Latin America, despite ongoing COVID-related restrictions in some markets [73] Company Strategy and Development Direction - The company is focused on expanding its commercial pipeline for the Acuitas AMR Gene Panel and increasing sales both in the U.S. and internationally [50] - Plans include the opening of a new NGS service lab in Rockville, Maryland, to enhance capabilities and support upcoming commercial launches [59] - The company aims to deepen strategic collaborations and partnerships, particularly in the NGS and diagnostics sectors [53][62] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth in product sales and the strong business development pipeline, particularly for Ares Genetics [46][66] - The company anticipates continued revenue growth globally for 2022, projecting an increase of around 25% compared to the previous year [54] - Management highlighted the importance of ongoing discussions with hospitals and direct customers to drive future sales [50] Other Important Information - The company ended the first half of 2022 with approximately $16.6 million in cash, a decrease from $36.1 million at the end of 2021 [41] - A new ATM agreement allows the company to sell up to approximately $10.7 million worth of common stock, with modest sales activity reported [44][55] - The company is currently awaiting a response from NASDAQ regarding a request for an additional 180-day period to regain compliance with the minimum bid price rule [65] Q&A Session Summary Question: Can you provide an update on the sales cycle for Acuitas AMR and the 60 entities targeted? - Management indicated a sales cycle of six to twelve months, with recent agreements taking between six months to less than 60 days from first draft to closing [71][72] Question: Can you elaborate on international traction and geographic details? - Management emphasized the focus on the Menarini partnership and the addition of international distribution partnerships, particularly in Europe and Latin America [73][74] Question: Can you provide context on the first half decline in revenue? - Management explained that the decline was influenced by the sunset of the FISH business and the conclusion of a non-recurring collaboration project, despite growth in underlying product sales [78]