Revenue Generation - OpGen generated $4.0 million in revenue from listing sponsorship and consulting services in the nine months ended September 30, 2025, compared to $196,149 in total revenue for the same period in 2024[138]. - The company did not generate any revenues in the three months ended September 30, 2025, and 2024, due to the scaling down of legacy operations[134]. - The company anticipates generating revenues from CapForce's ventures in cross-border securities trading and digital investment banking activities[131]. Operating Expenses - Total operating expenses for the nine months ended September 30, 2025, decreased approximately 57% to $1.82 million from $4.27 million in the same period in 2024[139]. - General and administrative expenses for the three months ended September 30, 2025, were $701,915, a decrease of approximately 9% from $768,551 in the same period in 2024[135]. Research and Development - Research and development expenses decreased approximately 100% for the nine months ended September 30, 2025, compared to the same period in 2024, aligning with the company's strategic repositioning[139]. Cash and Liquidity - As of September 30, 2025, OpGen had cash and cash equivalents of $0.4 million, down from $1.3 million at December 31, 2024[141]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $(978,685), compared to $(4,637,508) for the same period in 2024[144]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $82,243, compared to $5,118,851 in 2024[148][149]. - The company anticipates funding operations primarily through financing arrangements with AEI Capital Ltd. until the operating business can sustain itself[151]. - The company has no material contractual commitments as of September 30, 2025, other than a continuing liability under a former office lease[150]. - The company has the right to sell up to $7.0 million of additional shares of common stock to AEI Capital Ltd. until December 31, 2025[143]. - As of September 30, 2025, there were no off-balance sheet arrangements[155]. Financial Performance - The company reported a net income of $2.5 million for the nine months ended September 30, 2025, down from $7.6 million in 2024[145][146]. - No cash was used in investing activities during the nine months ended September 30, 2025 or 2024[147]. Corporate Actions - Following the acquisition by AEI Capital Ltd., the company formed a wholly-owned subsidiary, CapForce, to offer listing sponsorship and consultancy services[128]. - In March 2024, the company sold 3,000,000 shares of Series E Convertible Preferred Stock to David E. Lazar for gross proceeds of $3.0 million, with 550,000 shares sold initially for $550,000[143]. - As of September 30, 2024, the company sold 1,079,109 shares of common stock to AEI Capital Ltd. for gross proceeds of $2.0 million[143]. - Curetis and Ares Genetics filed for insolvency in November 2023, leading to their deconsolidation from OpGen's financial statements[125]. Strategic Initiatives - The company implemented cash management initiatives in November 2023, including restructuring U.S. operations and reducing headcount[124].

Revenue and Income - OpGen generated total revenue of $4.0 million in the three months ended June 30, 2025, primarily from listing sponsorship services, compared to $28,000 in the same period of 2024[136]. - The company reported a net income of $3.1 million for the six months ended June 30, 2025, with noncash share-based compensation of $0.2 million and changes in operating assets and liabilities of $(4.0 million)[148]. Operating Expenses - Total operating expenses for the three months ended June 30, 2025 decreased approximately 62% to $597,225 from $1,575,310 in the same period of 2024[137]. - General and administrative expenses for the six months ended June 30, 2025 were $1,108,182, down approximately 66% from $3,252,770 in the same period of 2024[142]. - Research and development expenses decreased approximately 100% for the six months ended June 30, 2025 compared to the same period in 2024, aligning with the company's strategic repositioning[142]. Cash and Financing - As of June 30, 2025, OpGen had cash and cash equivalents of $0.8 million, a decrease from $1.3 million at December 31, 2024[144]. - The company anticipates funding operations primarily through financing arrangements with AEI Capital Ltd., including a $5.0 million gross proceeds transaction in 2024[145]. - For the six months ended June 30, 2025, net cash used in operating activities was $(645,337), compared to $(1,804,262) for the same period in 2024, indicating an improvement[147]. - Net cash provided by financing activities for the six months ended June 30, 2025 was $166,318, while for 2024 it was $820,553, primarily from preferred stock issuance and short-term insurance financing[151]. Strategic Changes - Following the acquisition by AEI Capital Ltd., OpGen formed a wholly-owned subsidiary, CapForce, to offer listing sponsorship and consultancy services[130]. - The company scaled down legacy operations and repositioned itself in the financial services and technology industry, ceasing product sales and laboratory services[141]. - Future funding requirements will focus on revenue growth and operating expenses, with financing opportunities expected to be utilized strategically[153]. Insolvency and Deconsolidation - Curetis and Ares Genetics filed for insolvency in November 2023, leading to their deconsolidation from OpGen's financial statements[126]. Stock and Securities - In March 2024, the company entered into a securities purchase agreement to sell 3,000,000 shares of Series E Convertible Preferred Stock at $1.00 per share, resulting in gross proceeds of $3.0 million[146]. Other Financial Information - The company did not use any cash in investing activities during the six months ended June 30, 2025 or 2024[150]. - The company has no material contractual commitments as of June 30, 2025, other than a continuing liability under a former office lease[152]. - The company did not have any off-balance sheet arrangements as of June 30, 2025[157]. - As a smaller reporting company, the company is not required to provide detailed market risk disclosures[158].

[Information Regarding Forward-Looking Statements](index=4&type=section&id=INFORMATION%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section provides a cautionary statement regarding forward-looking statements, noting actual results may differ due to risks and the company undertakes no obligation to update - Forward-looking statements are identified by words such as **'believe'**, **'may'**, **'will'**, **'estimate'**, **'continue'**, **'anticipate'**, **'design'**, **'intend'**, **'expect'** or their negatives [10](index=10&type=chunk) - Key areas include **liquidity**, **strategic direction**, **potential strategic transactions**, **economic conditions**, **market development**, **capital financing proceeds**, **regulatory compliance**, and **future revenue and expenses** [13](index=13&type=chunk) - The company does not guarantee future results and undertakes **no obligation to update or revise** any forward-looking statement [12](index=12&type=chunk) [Note Regarding Trademarks](index=5&type=section&id=NOTE%20REGARDING%20TRADEMARKS) This section clarifies the company's ownership of 'OpGen' and other trademarks, noting that third-party trademarks do not imply endorsement - **OpGen, Inc.** owns various U.S. federal trademark registrations and applications, including **'OpGen'** [15](index=15&type=chunk) - References to other companies' trademarks do not imply a relationship with, or **endorsement or sponsorship** by, those companies [15](index=15&type=chunk) [PART I. Financial Information](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents the company's unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures [Item 1. Unaudited Condensed Consolidated Financial Statements](index=6&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents the company's unaudited condensed consolidated financial statements for the period ended March 31, 2025, with comparative periods and explanatory notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets and stockholders' equity decreased from December 31, 2024, to March 31, 2025, primarily due to reduced cash and prepaid expenses Balance Sheet Summary | Metric | March 31, 2025 ($) | December 31, 2024 ($) | Change ($) | % Change | | :-------------------------------- | :------------- | :---------------- | :----- | :------- | | Cash and cash equivalents | $1,112,781 | $1,310,653 | $(197,872) | -15.10% | | Total current assets | $2,238,516 | $2,649,227 | $(410,711) | -15.50% | | Total assets | $9,418,517 | $9,862,698 | $(444,181) | -4.50% | | Total current liabilities | $563,487 | $634,181 | $(70,694) | -11.15% | | Total liabilities | $2,364,314 | $2,482,070 | $(117,756) | -4.74% | | Total stockholders' equity | $7,054,203 | $7,380,628 | $(326,425) | -4.42% | [Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20(Loss)%20Income) The company reported no revenue and a net loss for Q1 2025, a significant decline from Q1 2024 which included a large gain on impairment adjustment Statements of Operations Summary | Metric | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 (As Restated) ($) | Change ($) | % Change | | :-------------------------------------- | :-------------------------------- | :---------------------------------------------- | :----- | :------- | | Total revenue | $0 | $168,149 | $(168,149) | -100.00% | | Total operating expenses | $522,846 | $1,913,464 | $(1,390,618) | -72.67% | | Operating loss | $(522,846) | $(1,745,315) | $1,222,469 | -70.04% | | Total other income (expense) | $114,713 | $2,033,282 | $(1,918,569) | -94.36% | | Net (loss) income | $(408,133) | $287,967 | $(696,099) | -241.73% | | Basic (Loss) Earnings Per Share | $(0.04) | $0.16 | $(0.20) | -125.00% | | Diluted (Loss) Earnings Per Share | $(0.04) | $0.15 | $(0.19) | -126.67% | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) Stockholders' equity decreased from December 31, 2024, to March 31, 2025, primarily due to a net loss, partially offset by stock compensation expense Stockholders' Equity Summary | Metric | December 31, 2024 ($) | March 31, 2025 ($) | Change ($) | | :-------------------------- | :---------------- | :------------- | :----- | | Common Stock Amount | $100,708 | $100,713 | $5 | | Additional Paid-in Capital | $300,780,440 | $300,862,143 | $81,703 | | Accumulated Deficit | $(293,500,522) | $(293,908,655) | $(408,133) | | Total Stockholders' Equity | $7,380,628 | $7,054,203 | $(326,425) | - Stock compensation expense contributed **$81,708** to additional paid-in capital during the three months ended March 31, 2025 [20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For Q1 2025, the company used **$197,872** in operating activities due to its net loss, with no investing or financing cash flows, contrasting with Q1 2024 Cash Flow Summary | Cash Flow Activity | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 (As Restated) ($) | Change ($) | | :------------------------------------ | :-------------------------------- | :---------------------------------------------- | :----- | | Net cash used in operating activities | $(197,872) | $(1,084,050) | $886,178 | | Net cash used in investing activities | $0 | $0 | $0 | | Net cash provided by financing activities | $0 | $199,720 | $(199,720) | | **Net decrease in cash, cash equivalents and restricted cash** | **$(197,872)** | **$(884,330)** | **$686,458** | - Cash, cash equivalents, and restricted cash decreased from **$1,612,915** at the beginning of the period to **$1,415,043** at the end [23](index=23&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed disclosures for the financial statements, covering organizational changes, going concern, accounting policies, and subsequent events [Note 1 – Organization](index=10&type=section&id=Note%201%20%E2%80%93%20Organization) OpGen transitioned from precision medicine to financial services after subsidiary insolvencies, forming CapForce for new business lines - OpGen transitioned from a precision medicine company to a financial services and technology company after its subsidiaries, Curetis and Ares Genetics, filed for insolvency in **November 2023** [26](index=26&type=chunk)[29](index=29&type=chunk) - In **March 2024**, David E. Lazar was appointed Chairman and CEO, followed by AEI Capital Ltd. acquiring his Series E Preferred Stock and becoming the controlling stockholder in **July/August 2024** [27](index=27&type=chunk)[28](index=28&type=chunk) - The company formed CapForce International Holdings Ltd. to launch new business lines in **listing sponsorship**, **consultancy services**, and **financial technology** [29](index=29&type=chunk) [Note 2 – Going Concern and Management's Plans](index=11&type=section&id=Note%202%20%E2%80%93%20Going%20Concern%20and%20Management's%20Plans) Despite significant losses and going concern doubts, management plans to fund operations for over 12 months through existing cash and

Revenue and Sales Performance - Total revenue for the year ended December 31, 2024, increased by $1.8 million or 52% to $5,196,149, primarily due to the recognition of listing sponsorship services revenues[138] - Product sales decreased to $169,373 in 2024 from $2,400,053 in 2023, while laboratory services revenue fell to $26,776 from $153,719[138] - Product sales decreased approximately 93% in 2024 compared to 2023, primarily due to the insolvency filings of Curetis and Ares Genetics[140] - Laboratory services revenue decreased approximately 83% in 2024 compared to 2023, attributed to the discontinuation of Ares Genetics' products and services[140] - The Company derived revenues from various sources, including listing sponsorship, consultancy services, and sales of Unyvero Application cartridges during the years ended December 31, 2024 and 2023[153] Operating Expenses - The company incurred total operating expenses of $4,871,432 in 2024, a significant reduction from $34,166,975 in 2023, largely due to scaling down legacy operations[139] - Total operating expenses decreased 86% from $34.2 million in 2023 to $4.9 million in 2024[141] - General and administrative expenses were reduced to $4,542,025 in 2024 from $8,081,664 in 2023, aligning with the company's restructuring efforts[139] - The cost of products sold dropped to $31,636 in 2024 from $3,084,075 in 2023, reflecting the company's shift in focus[139] - Cost of products sold decreased 99% in 2024 compared to 2023, aligning with the reduction in legacy product sales[142] Research and Development - Research and development expenses decreased to $48,820 in 2024 from $4,732,851 in 2023, indicating a strategic pivot away from previous projects[139] - Research and development expenses decreased approximately 99% in 2024 compared to 2023 due to the deconsolidation of Curetis and Ares Genetics[142] Financial Position and Cash Flow - Cash and cash equivalents increased slightly to $1.3 million as of December 31, 2024, compared to $1.2 million in 2023[143] - Net cash used in operating activities was $(4.9) million in 2024, an improvement from $(14.3) million in 2023[144] - Net cash provided by financing activities was $5.0 million in 2024, primarily from preferred stock issuance[148] - The company has no material contractual commitments as of December 31, 2024, following the insolvency filings[149] - The Company anticipates funding its operations primarily through financing arrangements with AEI Capital Ltd., its controlling shareholder[150] Insolvency and Restructuring - In November 2023, Curetis and Ares Genetics filed for insolvency, leading to the deconsolidation of these subsidiaries from the company's financial statements[128][129] - An impairment charge of $1,231,874 was recorded for property and equipment during the year ended December 31, 2023, due to the Company's financial condition[159] - The Company does not have any finite-lived or indefinite-lived intangible asset balances as of December 31, 2024, following the insolvency filings for Curetis and Ares Genetics in 2023[160] Shareholder and Stock Information - The company sold 3,000,000 shares of Series E Convertible Preferred Stock for gross proceeds of $3.0 million in March 2024[130] - AEI Capital Ltd. paid the company $2.45 million in August 2024 for the remaining shares of Series E Preferred Stock, which were subsequently converted into 7,200,000 shares of common stock[131] Accounting and Revenue Recognition - Share-based compensation expense is recognized based on the fair value of stock-based awards expected to vest during the period, with the fair value estimated using the Black-Scholes model[162] - The Company recognizes revenues upon the satisfaction of its performance obligation, reflecting the consideration expected in exchange for goods or services[155] - The Company recorded a change in accounting estimate for leasehold improvement property and equipment, adjusting the balance to $1,230,332 following the identification of a subtenant[159] - As of December 31, 2024 and 2023, the Company did not have any off-balance sheet arrangements[165] - The Company had no material incremental costs to obtain customer contracts in any period presented[156] Inventory and Reserves - As of December 31, 2024, the total inventory reserves were $1,225,975, down from $1,280,805 in 2023, resulting in a net carrying value of zero due to significant uncertainty in future demand[158]

Core Insights - OpGen reported a second quarter earnings per share of -$1.18 [1] - The company's revenue for the same period was $28,000 [1] Financial Performance - Earnings per share: -$1.18 indicating a loss [1] - Revenue: $28,000 reflecting the company's financial performance in Q2 2024 [1]

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section details the company's unaudited financial performance, management's analysis, market risks, and internal controls [Item 1. Unaudited Condensed Consolidated Financial Statements](index=5&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The unaudited condensed consolidated financial statements for the quarter ended March 31, 2024, reflect a significant operational and financial transformation following the November 2023 insolvency and subsequent deconsolidation of its main subsidiaries, Curetis and Ares Genetics. The company swung from a substantial net loss of $5.7 million in Q1 2023 to a net income of $0.4 million in Q1 2024, primarily driven by a $2.1 million one-time gain on lease indemnification and drastically reduced operating expenses. However, revenue plummeted by 82% to $0.17 million. The balance sheet shows a critical liquidity position with cash and cash equivalents at $0.3 million, and the notes highlight a substantial doubt about the company's ability to continue as a going concern [Condensed Consolidated Financial Statements (Balance Sheets, Operations, Stockholders' Equity, Cash Flows)](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the company's key financial statements including balance sheets, statements of operations, stockholders' equity, and cash flows Condensed Consolidated Statements of Operations (Q1 2024 vs Q1 2023) | Metric | Three months ended March 31, 2024 | Three months ended March 31, 2023 | | :--- | :--- | :--- | | **Total Revenue** | **$168,149** | **$913,444** | | Operating Loss | $(1,703,218) | $(5,070,111) | | **Net Income (Loss)** | **$386,033** | **$(5,736,603)** | | Diluted EPS | $0.207 | $(12.53) | Condensed Consolidated Balance Sheets (Assets & Liabilities) | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $267,493 | $1,151,823 | | Total Assets | $2,970,380 | $1,882,274 | | Total Liabilities | $13,682,556 | $13,443,858 | | Total Stockholders' Deficit | $(10,712,176) | $(11,561,584) | Condensed Consolidated Statements of Cash Flows | Metric | Three months ended March 31, 2024 | Three months ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,084,050) | $(4,962,618) | | Net cash used in investing activities | $0 | $(330,446) | | Net cash provided by financing activities | $199,720 | $4,743,649 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanatory notes to the unaudited condensed consolidated financial statements - The company's subsidiaries, Curetis GmbH and Ares Genetics, filed for insolvency in November 2023, leading to their deconsolidation. The assets of these subsidiaries were subsequently sold to third parties in April 2024, and OpGen does not expect to receive any proceeds[25](index=25&type=chunk)[49](index=49&type=chunk)[210](index=210&type=chunk) - Management has concluded there is substantial doubt about the Company's ability to continue as a going concern, as current cash is only sufficient to fund operations into the third quarter of 2024[55](index=55&type=chunk)[239](index=239&type=chunk) - In March 2024, the company secured a **$3.0 million** financing commitment from David E. Lazar through the sale of Series E Preferred Stock. This transaction also involved a new Board of Directors and a plan to settle outstanding EIB debt for **$2.0 million**, which is expected to result in a gain of over **$8 million** upon completion[52](index=52&type=chunk)[125](index=125&type=chunk)[211](index=211&type=chunk) - Effective April 1, 2024, the company assigned its Rockville, MD headquarters lease. The new tenant indemnifies OpGen from future liabilities, resulting in the recognition of a **$2.1 million** gain on lease indemnification in Q1 2024[217](index=217&type=chunk)[234](index=234&type=chunk) - Subsequent to the quarter end, the company effected a **1-for-10 reverse stock split** on May 20, 2024, and regained compliance with Nasdaq's minimum bid price rule, but remains non-compliant with other listing requirements such as minimum stockholders' equity[206](index=206&type=chunk)[207](index=207&type=chunk)[223](index=223&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section details the profound impact of the November 2023 insolvency and deconsolidation of its primary subsidiaries. This event caused an 82% year-over-year revenue decline and a 69% drop in operating expenses for Q1 2024. The company's strategic focus has shifted under new leadership to pursuing a reverse merger or similar transaction. Liquidity is a critical issue, with cash projected to last only into Q3 2024, reinforcing the 'going concern' uncertainty despite new financing commitments [Results of Operations](index=37&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, highlighting key revenue and expense trends - Total revenue for Q1 2024 decreased by **82%** compared to Q1 2023, primarily due to the exclusion of product sales and the complete elimination of collaboration revenue from the deconsolidated subsidiaries[215](index=215&type=chunk)[231](index=231&type=chunk) - Total operating expenses for Q1 2024 decreased by **69%** compared to Q1 2023. This was driven by decreases of **99%** in R&D, **32%** in G&A, and **87%** in Sales & Marketing, reflecting the deconsolidation and scaling down of operations[258](index=258&type=chunk)[259](index=259&type=chunk) - Other income increased to a net income of **$2.1 million** in Q1 2024 from a net expense of **$0.7 million** in Q1 2023. The increase is primarily due to a **$2.1 million** gain on lease indemnification and the cessation of interest expense recognition on the EIB loan, which is now treated as a loan guaranty measured at fair value[234](index=234&type=chunk)[260](index=260&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, funding needs, and capital-raising activities - As of March 31, 2024, the company had cash and cash equivalents of **$0.3 million**, a significant decrease from **$1.2 million** at December 31, 2023[235](index=235&type=chunk) - The company has substantial doubt about its ability to continue as a going concern, as it projects that current cash will only be sufficient to fund operations into the **third quarter of 2024**[239](index=239&type=chunk) - In March 2024, the company entered into an agreement to sell **$3.0 million** of Series E Preferred Stock to David E. Lazar, with funds being received in tranches. The remaining **$2.45 million** is expected in Q3 2024[238](index=238&type=chunk) Sources and Uses of Cash (Q1 2024 vs Q1 2023) | Cash Flow Activity | Three months ended March 31, 2024 | Three months ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,084,050) | $(4,962,618) | | Net cash used in investing activities | $0 | $(330,446) | | Net cash provided by financing activities | $199,720 | $4,743,649 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, OpGen is not required to provide the information for this item - The Company is a smaller reporting company and is not required to provide the information required by this Item[247](index=247&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the company's disclosure controls and procedures and concluded that they were effective as of March 31, 2024. There were no material changes in the company's internal controls over financial reporting during the quarter - Based on an evaluation as of March 31, 2024, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective[248](index=248&type=chunk) - There were no changes in the Company's internal controls over financial reporting during the quarter ended March 31, 2024, that have materially affected, or are reasonably likely to materially affect, these controls[291](index=291&type=chunk) [PART II. OTHER INFORMATION](index=45&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, other required disclosures, and a list of exhibits [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company reports the insolvency proceedings of its former subsidiaries, Curetis and Ares Genetics, which began in November 2023. The assets of these entities were sold by their respective administrators in April 2024. OpGen states it is not party to any other material litigation - In November 2023, subsidiaries Curetis and Ares Genetics filed for insolvency in Germany and Austria, respectively. In April 2024, their assets were sold to Camtech Pte Ltd. and bioMerieux S.A[276](index=276&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the risk factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2023 - The report directs readers to the Risk Factors section included in the Annual Report on Form 10-K for the year ended December 31, 2023[277](index=277&type=chunk) [Other Items (Items 2, 3, 4, 5)](index=45&type=section&id=Other%20Items) The company reports no information for several items: Unregistered Sales of Equity Securities (other than as previously disclosed), Defaults Upon Senior Securities, Mine Safety Disclosures, and Other Information - The company reports nothing under Item 2 (Unregistered Sales of Equity Securities) other than what was disclosed in Current Reports on Form 8-K[278](index=278&type=chunk) - The company reports no defaults upon senior securities (Item 3), no mine safety disclosures (Item 4), and no other information (Item 5)[279](index=279&type=chunk)[280](index=280&type=chunk)[281](index=281&type=chunk) [Item 6. Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including key agreements such as the Certificate of Designation for Series E Preferred Stock, the Securities Purchase Agreement with David Lazar, and settlement agreements with the European Investment Bank and the Curetis insolvency administrator - A list of exhibits filed with the Form 10-Q is provided, including certifications and various material agreements[294](index=294&type=chunk)

Core Insights - OpGen reported a fourth-quarter earnings per share of -$17.67, indicating a loss for the period [3] - The company's revenue for the fourth quarter was $1.07 million, which matched analyst estimates [3] Financial Performance - Earnings per share: -$17.67 [3] - Revenue: $1.07 million, consistent with analyst expectations [3]

Financial Performance - Total revenue for the year ended December 31, 2023, increased by 31% to $3.4 million, compared to $2.6 million in 2022, primarily driven by a 27% increase in product sales [101]. - Product sales reached $2,400,053 in 2023, up from $1,893,862 in 2022, largely due to a one-time sale of 25 sets of Unyvero instruments in Q4 2023 [101]. - Collaboration revenue grew by approximately 60% in 2023, totaling $864,548, compared to $540,798 in 2022, attributed to extensions and expansions of the collaboration with FIND [103]. - The Company reported a net loss of $32.7 million for the year ended December 31, 2023, compared to a net loss of $37.3 million in 2022 [119]. - Net cash used in operating activities was $(14,319,542) in 2023, an improvement from $(20,449,698) in 2022 [118]. - The Company recorded an impairment charge of $849,243 for its Rockville, MD office lease asset and $1,231,874 for property and equipment during the year ended December 31, 2023 [137]. Operational Changes - The company reduced its U.S. operations headcount from 24 to 5 to conserve cash and focus on core functions [86]. - The company plans to identify a privately held company for a reverse merger or similar strategic transaction under new leadership [89]. - The Company anticipates that current cash will only be sufficient to fund operations into the third quarter of 2024, raising substantial doubt about its ability to continue as a going concern [116]. Funding and Financing - The company sold 3,000,000 shares of Series E Convertible Preferred Stock at $1.00 per share, generating gross proceeds of $3.0 million [89]. - The Company raised approximately $7.5 million in gross proceeds from a public offering on January 11, 2023, and $3.5 million from another offering on May 4, 2023 [109][110]. - The Company entered into a Preferred Stock Purchase Agreement on October 11, 2023, to issue 1,000 shares of Series D Preferred Stock for expected gross proceeds of $1.0 million [97]. - The Company plans to use proceeds from the March 2024 Purchase Agreement to settle outstanding debts, with an expected total of $3.0 million from the sale of Series E Preferred Stock [98]. Subsidiary Issues - Curetis and Ares Genetics filed for insolvency, leading to the loss of control over these subsidiaries [86]. - The Company experienced a loss on deconsolidation of subsidiaries amounting to $13.0 million due to insolvency filings of Curetis and Ares Genetics in November 2023 [108]. - The Company filed for insolvency for its subsidiaries, Curetis and Ares Genetics, which eliminated its authority to act on their behalf [114]. Expenses and Liabilities - Total operating expenses decreased by 8% to $34.2 million in 2023 from $37.2 million in 2022, mainly due to reductions in various expense categories [102]. - Research and development expenses fell by approximately 42% to $4,732,851 in 2023, down from $8,173,435 in 2022, due to the completion of clinical trials and understaffing [104]. - Interest expense decreased to $1,838,933 in 2023 from $3,256,410 in 2022, reflecting a reduction in outstanding debt [105]. - As of December 31, 2023, the Company had outstanding liabilities of approximately €9.66 million to the European Investment Bank under the Finance Contract [96]. - As of December 31, 2023, the outstanding borrowings under all tranches of the EIB loan facility were €9.8 million (approximately $10.9 million) [124]. Inventory and Impairments - Inventory reserves for obsolescence, expirations, and slow-moving inventory were $1,280,805 as of December 31, 2023 [136]. - The Company recorded a goodwill impairment charge of $6,940,549 for the year ended December 31, 2022, due to changes in market capitalization and stock price [140]. - An impairment charge of $5,407,699 was recorded for the IPR&D intangible asset in 2022, as projected future cash flows did not support the carrying amount [139]. Revenue Recognition - The Company recognizes revenues upon satisfaction of performance obligations, reflecting the consideration expected in exchange for goods or services [134]. - The Company had no material incremental costs to obtain customer contracts in any period presented [135].

Core Viewpoint - OpGen, Inc. has received a notice from Nasdaq indicating non-compliance with listing rules due to the failure to file its Quarterly Report on Form 10-Q for the period ended March 31, 2024, which may lead to delisting from Nasdaq [1][2]. Compliance Issues - The company previously received notices for non-compliance with Nasdaq Listing Rule 5550(a)(2) regarding the minimum bid price of $1.00 per share and Listing Rule 5250(c)(1) for not timely filing its Annual Report on Form 10-K for the period ended December 31, 2023 [2]. - Nasdaq Hearings Panel has granted the company until June 3, 2024, to regain compliance with both the Minimum Bid Price Rule and the Periodic Filing Rule [2]. Current Status - The notice from Nasdaq does not have an immediate effect on the listing or trading of the company's common stock [3]. - The company is actively working to finalize and file the Form 10-Q as soon as possible to regain compliance with Nasdaq Listing Rules [3]. Company Overview - OpGen, Inc. is a precision medicine company focused on molecular diagnostics and bioinformatics to combat infectious diseases, providing solutions that improve patient outcomes and reduce the spread of multidrug-resistant microorganisms [4].

Core Points - OpGen, Inc. has announced a 1-for-10 reverse stock split of its common stock, effective at 12:01 a.m. EST on May 20, 2024, to comply with Nasdaq's minimum bid price requirement of $1.00 per share [1][2] - The reverse stock split will reduce the number of outstanding shares from approximately 12,624,902 to about 1,262,490 shares, with no change in par value [3] - No fractional shares will be issued; any fractional shares will be rounded up to the nearest whole share [4] Company Information - OpGen, Inc. is a precision medicine company focused on molecular diagnostics and bioinformatics to combat infectious diseases, providing solutions that improve patient outcomes and reduce the spread of multidrug-resistant microorganisms [6]