(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]

Financial Performance - Total revenue for the three months ended June 30, 2022, increased approximately 19% to $967,205 compared to $811,615 in the same period in 2021[155] - Total revenue for the six months ended June 30, 2022 decreased approximately 12% to $1,436,950 compared to $1,641,331 in the same period of 2021[159] - Product sales saw a significant increase of approximately 189% in the 2022 period, primarily due to a one-time sale of Unyvero A50 instrument systems and increased domestic Unyvero sales[155] - Product sales increased approximately 50% to $1,255,323 in the 2022 period, primarily due to a one-time sale of Unyvero A50 instrument systems[161] - Laboratory services revenue decreased approximately 86% to $63,499 in the 2022 period, mainly due to a reduction in COVID testing services[161] Operating Expenses - Total operating expenses for the three months ended June 30, 2022, decreased approximately 10% to $6,239,410 from $6,950,126 in the same period in 2021[156] - Total operating expenses for the six months ended June 30, 2022 decreased approximately 11% to $12,554,895 compared to $14,041,060 in 2021[160] - Research and development expenses decreased approximately 19% to $4,590,197 in the 2022 period, attributed to reduced payroll costs from streamlining operations[162] - Total other expense for the six months ended June 30, 2022 decreased significantly to $(1,526,186) from $(9,537,423) in 2021, primarily due to lower warrant inducement expenses[163] Cash and Financing - Cash and cash equivalents as of June 30, 2022 were $16.6 million, down from $36.1 million at December 31, 2021[164] - Net cash used in operating activities for the six months ended June 30, 2022 was $11,700,904, compared to $12,559,210 in the same period of 2021[169] - The company raised net proceeds of approximately $48 million during 2021 to fund operations[154] - The company is considering multiple alternatives for capital needs, including additional equity financings and debt financings[168] - The company entered into a 2022 ATM Agreement allowing for the sale of up to $10.65 million of common stock, with no shares sold as of June 30, 2022[167] Debt and Borrowings - As of June 30, 2022, the outstanding borrowings were €16,392,331 ($17,026,715), including deferred interest of €1,634,551 ($1,697,808) due at maturity[174] - The Company repaid €5.0 million to the EIB in April 2022 as part of the 2022 EIB Amendment, which restructured approximately €13.35 million of indebtedness[174] - The PPI of the third tranche under the loan facility will increase from 0.3% to 0.75% starting June 2024[174] - The terms of the second and third tranches of indebtedness of €3.0 million and €5.0 million remain unchanged[174] Product Development and Regulatory Compliance - The Unyvero LRT test can detect over 90% of common pneumonia-causing agents and provides results in less than five hours, addressing a medical need costing over $10 billion annually in the U.S. healthcare system[142] - The Acuitas AMR Gene Panel detects 28 genetic antimicrobial resistance markers from 26 different pathogens, providing valuable diagnostic information for clinicians[148] - The Unyvero UTI test is currently available as a research use only kit in the U.S., with over 1,000 patient samples enrolled in a clinical trial expected to conclude in H2-2022[142] - Ares Genetics' ARESdb database now covers over 78,000 bacterial isolates sequenced using NGS technology, enhancing the company's bioinformatics offerings[145] - The company continues to seek FDA and other regulatory clearances for its Unyvero UTI and IJI products, while ensuring compliance with the new EU IVDR regulations[149] Company Classification - The Company did not have any off-balance sheet arrangements as of June 30, 2022, and December 31, 2021[178] - The Company was classified as an "emerging growth company" until December 31, 2020, and is now a non-accelerated filer under SEC rules[179] Product Testing and Development - The Unyvero A30 RQ device is designed for low-to-mid-plex testing and has completed final verification and validation testing, with ongoing partnering discussions[147]

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]

Revenue Performance - Total revenue for the three months ended March 31, 2022, decreased approximately 43% to $469,745 compared to $829,716 in the same period in 2021[154] - Product sales decreased by approximately 40% in the 2022 period, primarily due to the discontinuation of the FISH product line[155] - Laboratory services revenue decreased by approximately 56% in the 2022 period, attributed to a decline in COVID testing services[155] - Collaboration revenue decreased by approximately 49% in the 2022 period, mainly due to the end of a contract with the New York State DOH in Q3 2021[155] Operating Expenses - Total operating expenses for the three months ended March 31, 2022, decreased approximately 11% to $6,315,485 compared to $7,090,934 in the same period in 2021[156] - Cost of products sold decreased approximately 47% for the three months ended March 31, 2022, compared to the same period in 2021, primarily due to the discontinuation of the FISH product line, despite a 76% increase in direct sales in the U.S.[28] - Cost of services decreased approximately 71% for the three months ended March 31, 2022, compared to the same period in 2021, mainly due to the conclusion of a contract with the New York State DOH in Q3 2021[28] - Research and development expenses decreased approximately 18% for the three months ended March 31, 2022, compared to the same period in 2021, primarily due to reduced payroll-related costs[28] - General and administrative expenses decreased approximately 1% for the three months ended March 31, 2022, compared to the same period in 2021, mainly due to lower consulting and legal costs[28] - Sales and marketing expenses increased approximately 17% for the three months ended March 31, 2022, compared to the same period in 2021, primarily due to the expansion of the sales force[28] Cash and Financing - As of March 31, 2022, cash and cash equivalents were $30.6 million, down from $36.1 million at December 31, 2021[158] - Net cash used in operating activities for the three months ended March 31, 2022, was $(5,041,400), compared to $(4,965,928) for the same period in 2021[162] - Outstanding borrowings under all tranches as of March 31, 2022, were €22,482,127 ($24,957,409), including deferred interest payable at maturity of €4,482,127 ($4,975,609)[168] - The company expects to restructure the repayment of the first tranche of €10 million, with a proposed amortization plan starting in May 2022[168] - The company is considering multiple alternatives to meet capital needs, including additional equity financings and debt financings, with substantial doubt about its ability to continue as a going concern if additional capital is not raised[161] Product Development - The Acuitas AMR Gene Panel detects 28 genetic antimicrobial resistance markers from 26 different pathogens and received FDA clearance on September 30, 2021[149] - The Unyvero LRT test can detect over 90% of common causative agents of hospitalized pneumonia and provides results in less than five hours[141] - The Unyvero UTI test is currently available as a research use only kit in the U.S. and has initiated a multi-center clinical trial[141] - Ares Genetics' ARESdb database now covers more than 78,000 bacterial isolates sequenced using NGS technology[144] - The Unyvero A30 RQ device is designed for low-to-mid-plex testing and has completed final verification and validation testing[146]

Financial Data and Key Metrics Changes - Overall revenue for Q1 2022 was approximately $470,000, a 43% decrease from Q1 2021, primarily due to the discontinuation of the legacy FISH product line and lower Unyvero revenues due to COVID restrictions [18][19][20] - U.S. direct product sales increased by 76% year-over-year, reaching $154,000 compared to $87,000 in Q1 2021, indicating strong growth in this segment [20] - Net loss available to common shareholders in Q1 2022 was $6.8 million, or $0.15 per share, significantly lower than the $14.9 million or $0.50 per share in Q1 2021 [25] Business Line Data and Key Metrics Changes - Laboratory service revenues declined due to decreased demand for COVID testing services, which is expected to recover as countries reopen [21] - Collaboration revenue also declined due to the completion of the New York State Department of Health project in September 2021, but ongoing discussions for new collaborations are expected to contribute positively in the future [22] Market Data and Key Metrics Changes - The international distribution business for Unyvero products saw fluctuating revenues primarily due to ongoing COVID lockdowns, but expansion is expected as restrictions ease [29][30] - The agreement with Menarini to increase minimum purchase commitments by 50% in the coming year and over 80% by the end of the fifth year indicates a positive outlook for international sales [31][57] Company Strategy and Development Direction - The company is focused on commercialization and expanding its product offerings, particularly the Unyvero and Acuitas AMR Gene Panel, with expectations of 50% or higher growth in U.S. direct sales for 2022 [28][60] - Strategic R&D programs are a major focus, including ongoing clinical trials and the development of the A30 platform, which positions the company for future growth [27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recovery of demand for core products as COVID-related restrictions ease, anticipating a shift back to normal testing volumes [21] - The company expects to continue its strategic partnerships and licensing discussions, which could further enhance revenue growth [33][61] Other Important Information - The company plans to restructure its debt with the European Investment Bank, allowing for greater flexibility in cash management [34][35] - Ares Genetics is expanding its services and collaborations, which are expected to drive growth in the coming quarters [39][41] Q&A Session Summary Question: Can you provide additional details on the 76% growth in direct sales in the U.S.? - Management indicated that the growth is based on molecular products, excluding the FISH products, and anticipates a year-over-year growth of 50% or higher for 2022 [64] Question: How many hospitals are currently evaluating the Acuitas AMR Gene Panel? - There are over a dozen active conversations and a handful of commercial agreements, with more than 60 active funnel opportunities in the U.S. [66] Question: Can you elaborate on the Menarini agreement and its implications? - The Menarini agreement has increased minimum purchase commitments significantly, and they will take full ownership of the installed Unyvero systems, which is expected to drive growth [70][73] Question: Will AREScloud be offered as a bundled option for existing products? - AREScloud will be offered flexibly, allowing customers to choose between various services, which could enhance margins and customer retention [85][88]

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, 2021 ☐ 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 re ...

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _____________________________ 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 September 30, 2021 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, ...

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