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 March 31, 2022 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 inc ...

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 ...

OpGen, Inc. (OTC:OPGN) Q4 2021 Earnings Conference Call March 29, 2022 4:30 PM ET Company Participants Joe Green – Investor Relations Oliver Schacht – President and Chief Executive Officer Albert Weber – Chief Financial Officer Conference Call Participants Yi Chen – H.C. Wainwright Ben Haynor – Alliance Global Partners Nidhi Singh – Edison Group Operator Welcome to the OpGen Fourth Quarter and Full Year 2021 Earnings Call and Business Update. Today, OpGen Management will provide an update on the company’s c ...

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, ...

OpGen, Inc. (OTC:OPGN) Q3 2021 Earnings Conference Call November 11, 2021 4:30 PM ET Company Participants Oliver Schacht - President & Chief Executive Officer Albert Weber - Chief Financial Officer Conference Call Participants Max Jacobs - Edison Group Ben Haynor - Alliance Global Partners Operator Welcome to the OpGen Third Quarter 2021 Earnings Call and Business Update. At this time, all participants are in a listen-only mode. Following management's prepared remarks, there will be a Q&A session. As a remi ...

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 June 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, INC. ...

OpGen, Inc. (OTC:OPGN) Q2 2021 Earnings Conference Call August 12, 2021 4:30 PM ET Company Participants Megan Paul - IR Oliver Schacht - President and Chief Executive Officer Tim Dec - Chief Financial Officer Conference Call Participants Max Jacobs - Edison Group Ben Haynor - Alliance Global Operator Welcome to the OpGen Second Quarter 2021 Earnings Call and Business Update. At this time, all participants are in a listen-only mode. Following management's prepared remarks, there will be a Q&A session. As a r ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) OpGen's Q1 **2021** saw revenue increase and cash rise significantly from financing, despite a widened operating loss and substantial net loss [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20at%20March%2031%2C%202021%20and%20December%2031%2C%202020) Total assets increased to **$75.2 million**, driven by a significant rise in cash to **$39.4 million**, with stockholders' equity also growing substantially Condensed Consolidated Balance Sheet Highlights (unaudited) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $39,397,437 | $13,360,463 | | Total current assets | $42,773,526 | $16,887,643 | | Total assets | $75,155,598 | $49,751,045 | | **Liabilities & Equity** | | | | Total current liabilities | $6,573,201 | $7,372,030 | | Total liabilities | $29,124,317 | $28,559,790 | | Total stockholders' equity | $46,031,281 | $21,191,255 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20three%20months%20ended%20March%2031%2C%202021%20and%202020) Revenue increased to **$0.83 million**, but rising operating expenses and a **$7.8 million** warrant expense resulted in a **$14.9 million** net loss Condensed Consolidated Statements of Operations (unaudited) | Metric | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :--- | :--- | :--- | | Total revenue | $829,716 | $616,933 | | Total operating expenses | $7,090,934 | $4,611,419 | | Operating loss | $(6,261,218) | $(3,994,486) | | Warrant inducement expense | $(7,755,541) | $— | | Net loss | $(14,850,591) | $(3,949,294) | | Net loss per common share | $(0.50) | $(0.53) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20for%20the%20three%20months%20ended%20March%2031%2C%202021%20and%202020) Stockholders' equity increased to **$46.0 million**, primarily from stock offerings and warrant exercises, partially offset by a net loss - Raised **$23.5 million** net from an offering of common stock and warrants[21](index=21&type=chunk) - Received **$9.1 million** net from common stock warrant exercises[21](index=21&type=chunk) - Recognized a **$7.8 million** non-cash inducement expense related to a warrant repricing, which was added to additional paid-in capital[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20three%20months%20ended%20March%2031%2C%202021%20and%202020) Operating activities used **$5.0 million**, while financing activities provided **$32.3 million**, leading to a net cash increase of **$25.9 million** Cash Flow Summary (unaudited) | Cash Flow Activity | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,965,928) | $(2,344,742) | | Net cash used in investing activities | $(850,885) | $(2,201,057) | | Net cash provided by financing activities | $32,305,045 | $13,265,207 | | **Net increase in cash** | **$25,859,234** | **$8,761,232** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the Curetis business combination, management's going concern doubt despite financing, and the discontinuation of the FISH product line - On **April 1, 2020**, OpGen completed its business combination with Curetis N.V., acquiring Curetis GmbH and other assets[27](index=27&type=chunk) - Management has concluded that **substantial doubt** exists about the Company's ability to continue as a **going concern**, as current cash is projected to fund operations only into the **second quarter of 2022**[32](index=32&type=chunk) - The company is discontinuing its QuickFISH and PNA FISH product portfolio, with the exit to be completed by **June 30, 2021**[29](index=29&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the Curetis acquisition and FISH exit, Q1 **2021** revenue increase, rising expenses, significant capital raise, and ongoing going concern doubt - The company's focus is on its combined portfolio from the Curetis acquisition, including Unyvero, Acuitas, and ARES platforms, while exiting the FISH business by **June 30, 2021**[155](index=155&type=chunk) Q1 2021 vs Q1 2020 Revenue | Revenue Source | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Product sales | $613,918 | $366,933 | | Laboratory services | $97,726 | $— | | Collaboration revenue | $118,072 | $250,000 | | **Total revenue** | **$829,716** | **$616,933** | - Despite raising significant funds in early **2021**, management concludes there is **substantial doubt** about the company's ability to continue as a **going concern**, with cash sufficient to fund operations only into **Q2 2022**[179](index=179&type=chunk) - The FDA review for the Acuitas AMR Gene Panel (Isolates) has been delayed due to the COVID-19 pandemic, with the FDA intending to complete its review by the end of **August 2021**, though this timeline is not guaranteed[164](index=164&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a **smaller reporting company**, OpGen is not required to provide quantitative and qualitative disclosures about market risk - As a **smaller reporting company**, OpGen is not required to provide quantitative and qualitative disclosures about market risk[189](index=189&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls were **effective** as of **March 31, 2021**, excluding the recently acquired Curetis business - Management concluded that as of **March 31, 2021**, the company's disclosure controls and procedures were **effective**[191](index=191&type=chunk) - The evaluation of controls excluded Curetis and its subsidiaries, which were acquired in **April 2020**, as an assessment of their internal controls has not yet been completed[191](index=191&type=chunk)[192](index=192&type=chunk) [PART II. OTHER INFORMATION](index=35&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - None[193](index=193&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The report refers to the Risk Factors section of the Annual Report on Form **10-K** for a discussion of potential risks - The company directs investors to the Risk Factors detailed in its Annual Report on Form **10-K** for the fiscal year ended **December 31, 2020**[194](index=194&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[195](index=195&type=chunk) [Defaults Upon Senior Securities](index=35&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[196](index=196&type=chunk) [Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[197](index=197&type=chunk) [Other Information](index=35&type=section&id=Item%205.%20Other%20Information) The company reported no other information - None[198](index=198&type=chunk) [Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form **10-Q**, including warrants, securities purchase agreements, and officer certifications

| --- | --- | --- | |-----------------------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | OpGen | | | | | | | | Corporate Overview May 2021 | | | | | | | | | | | | | | | | | | | | | | | ©2021 OpGen, Inc. 1 Forward looking statements disclaimer This presentation contains forward-looking statements that are subject to many risks and uncertainties. These statements, among other things, relate to our business strategy, goals and expectations concerning our products, f ...