UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark one)
For the quarterly period ended
or
For the transition period from __________ to __________
Commission File Number
(Exact name of registrant as specified in its charter)
|
(State or other jurisdiction of incorporation or organization) |
(I.R.S. employer identification no.) | |
| (Address of principal executive offices) | (Zip code) |
Registrant’s telephone number, including area code: (
Securities registered or to be registered pursuant to Section 12(b) of the Act.
| Title of each class | Trading Symbols | Name of each exchange on which registered | ||
| OTC Markets Group, Inc. |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |
| ☒ | Smaller reporting company | |||
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
shares of the Company’s common stock, par value $0.01 per share, were outstanding as of November 19, 2025.
OPGEN, INC.
TABLE OF CONTENTS FOR FORM 10-Q
i
INFORMATION REGARDING FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In this quarterly report, we refer to OpGen, Inc. as the “Company”, “OpGen”, “we”, “our” or “us”. All statements, other than statements of historical facts contained herein, including statements regarding our future results of operations and financial position, strategy and plans, and our expectations for future operations, are forward-looking statements. The words “believe”, “may”, “will”, “estimate”, “continue”, “anticipate”, “design”, “intend”, “expect” or the negative version of these words and similar expressions are intended to identify forward-looking statements.
We have based these forward-looking statements on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, strategy, short- and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in Part I Item 1A “Risk Factors” of our most recent annual report on Form 10-K. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances included herein may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
| ● | our liquidity and working capital requirements, including our cash requirements over the next 12 months; |
| ● | our ability to execute upon and achieve the benefits of the Company’s new strategic direction; |
| ● | our ability to identify and realize the benefits of potential strategic transactions; |
| ● | adverse effects on our business condition and results of operations from general economic and market conditions and overall fluctuations in the United States and international markets, including deteriorating market conditions due to investor concerns regarding inflation; |
| ● | our use of proceeds from capital financing transactions; |
| ● | compliance with the U.S. regulations applicable to our business; and |
| ● | our expectations regarding future revenue and expenses. |
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. In addition, neither we nor any other person assumes responsibility for the accuracy and completeness of any of these forward-looking statements. These risks should not be construed as exhaustive and should be read in conjunction with our other disclosures, including but not limited to the risk factors described in Part I Item 1A “Risk Factors” of our most recent annual report on Form 10-K. Other risks may be described from time to time in our filings made under the securities laws. New risks may emerge from time to time. It is not possible for our management to predict all risks. All forward-looking statements in this quarterly report speak only as of the date made and are based on our current beliefs and expectations. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
ii
NOTE REGARDING TRADEMARKS
We own various U.S. federal trademark registrations and applications and unregistered trademarks and servicemarks, including but not limited to OpGen®. All other trademarks, servicemarks or trade names referred to in this quarterly report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this quarterly report are sometimes referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies, products or services.
iii
PART I. FINANCIAL INFORMATION
Item 1. Unaudited Condensed Consolidated Financial Statements
OpGen, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(unaudited)
| September 30, 2025 |
December 31, 2024 |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable, net | ||||||||
| Inventory, net | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Operating lease right-of-use assets | ||||||||
| Investment in equity securities | ||||||||
| Deferred offering costs | ||||||||
| Intangible assets, net | ||||||||
| Restricted cash | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued compensation and benefits | ||||||||
| Accrued liabilities | ||||||||
| Short-term insurance financing | ||||||||
| Current portion of operating lease liabilities | ||||||||
| Total current liabilities | ||||||||
| Operating lease liabilities, net of current portion | ||||||||
| Total liabilities | ||||||||
| Commitments and Contingencies (Note 9) | ||||||||
| Stockholders’ equity: | ||||||||
| Series D Preferred stock, $ par value; shares authorized; shares issued and outstanding at September 30, 2025 and December 31, 2024 | ||||||||
| Common stock, $ par value; shares authorized; and shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( |
) | ( |
) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See accompanying notes to unaudited condensed consolidated financial statements.
1
OpGen, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(unaudited)
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue | ||||||||||||||||
| Product sales | $ | $ | $ | $ | ||||||||||||
| Laboratory services | ||||||||||||||||
| Listing sponsorship services | ||||||||||||||||
| Total revenue | ||||||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of products sold | ||||||||||||||||
| Cost of services | ||||||||||||||||
| Research and development, net | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Sales and marketing | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Operating (loss) income | ( |
) | ( |
) | ( |
) | ||||||||||
| Other income (expense) | ||||||||||||||||
| Interest and other income | ||||||||||||||||
| Interest expense | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Gain on impairment adjustment | ||||||||||||||||
| Gain on extinguishment of debt | ||||||||||||||||
| Gain on settlement of compensation expenses | ||||||||||||||||
| Change in fair value of EIB loan guaranty | ( |
) | ( |
) | ||||||||||||
| Foreign currency transaction (losses) gains | ( |
) | ||||||||||||||
| Total other income (expense) | ||||||||||||||||
| (Loss) income before income taxes | ( |
) | ||||||||||||||
| Provision for income taxes | ||||||||||||||||
| Net (loss) income | $ | ( |
) | $ | $ | $ | ||||||||||
| Net income allocated to preferred stockholders | ( |
) | ( |
) | ( |
) | ||||||||||
| Net (loss) income available to common stockholders | $ | ( |
) | $ | $ | $ | ||||||||||
| (Loss) earnings per share attributable to common stockholders | ||||||||||||||||
| Basic | $ | ( |
) | $ | $ | $ | ||||||||||
| Diluted | $ | ( |
) | $ | $ | $ | ||||||||||
| Weighted average shares outstanding | ||||||||||||||||
| Basic | ||||||||||||||||
| Diluted | ||||||||||||||||
| Net (loss) income | $ | ( |
) | $ | $ | $ | ||||||||||
| Other comprehensive income (loss) - foreign currency translation | ||||||||||||||||
| Comprehensive (loss) income | $ | ( |
) | $ | $ | $ | ||||||||||
See accompanying notes to unaudited condensed consolidated financial statements.
2
OpGen, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(unaudited)
| Common Stock | Preferred Stock | Additional | Accumulated Other Comprehensive |
|||||||||||||||||||||||||||||
| Number of Shares |
Amount | Number of Shares |
Amount | Paid-in Capital |
Income |
Accumulated |
Total | |||||||||||||||||||||||||
| Balances at December 31, 2023 | $ | $ | $ | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||||||||||||||||||
| Issuance of common stock upon vesting of RSUs | - | ( |
) | |||||||||||||||||||||||||||||
| Stock compensation expense | - | - | ||||||||||||||||||||||||||||||
| Offering of preferred stock | - | |||||||||||||||||||||||||||||||
| Reclassification of preferred stock par value to additional paid-in capital (out of period adjustment; see Note 3) | - | - | ( |
) | ||||||||||||||||||||||||||||
| Elimination of translation adjustments of previously dissolved subsidiaries (out of period adjustment; see Note 3) | - | - | ||||||||||||||||||||||||||||||
| Net income (As Restated) | - | - | ||||||||||||||||||||||||||||||
| Balances at March 31, 2024 (As Restated) | $ | $ | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||||||||||||
| Issuance of common stock upon vesting of RSUs | - | ( |
) | |||||||||||||||||||||||||||||
| Stock compensation expense | - | - | ||||||||||||||||||||||||||||||
| Share issuance related to May 2024 Reverse Stock Split | - | ( |
) | |||||||||||||||||||||||||||||
| Share cancellation related to May 2024 Reverse Stock Split | ( |
) | - | |||||||||||||||||||||||||||||
| Offering of preferred stock | - | |||||||||||||||||||||||||||||||
| Net loss | - | - | ( |
) | ( |
) | ||||||||||||||||||||||||||
| Balances at June 30, 2024 | $ | $ | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||||||||||||
| Stock compensation expense | - | - | ||||||||||||||||||||||||||||||
| Cash compensation taken in the form of stock compensation | - | |||||||||||||||||||||||||||||||
| Offering of preferred stock | - | |||||||||||||||||||||||||||||||
| Conversion of preferred stock into common stock | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||
| Issuance of common stock pursuant to equity line of credit | - | |||||||||||||||||||||||||||||||
| Net income | - | - | ||||||||||||||||||||||||||||||
| Balances at September 30, 2024 | $ | $ | $ | $ | $ | ( |
) | $ | ||||||||||||||||||||||||
| Balances at December 31, 2024 | $ | $ | $ | $ | $ | ( |
) | $ | ||||||||||||||||||||||||
| Stock compensation expense | - | - | ||||||||||||||||||||||||||||||
| Issuance of common stock upon vesting of RSUs | - | ( |
) | |||||||||||||||||||||||||||||
| Net loss | - | - | ( |
) | ( |
) | ||||||||||||||||||||||||||
| Balances at March 31, 2025 | $ | $ | $ | $ | $ | ( |
) | $ | ||||||||||||||||||||||||
| Stock compensation expense | - | - | ||||||||||||||||||||||||||||||
| Net income | - | - | ||||||||||||||||||||||||||||||
| Balances at June 30, 2025 | $ | $ | $ | $ | $ | ( |
) | $ | ||||||||||||||||||||||||
| Stock compensation expense | - | - | ||||||||||||||||||||||||||||||
| Net loss | - | - | ( |
) | ( |
) | ||||||||||||||||||||||||||
| Balances at September 30, 2025 | $ | $ | $ | $ | $ | ( |
) | $ | ||||||||||||||||||||||||
See accompanying notes to unaudited condensed consolidated financial statements.
3
OpGen, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(unaudited)
| Nine Months Ended September 30, |
||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net income | $ | $ | ||||||
| Adjustments to reconcile net income to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Change in inventory reserve | ( |
) | ||||||
| Stock compensation expense | ||||||||
| Loss on deconsolidation of subsidiaries | ||||||||
| Change in fair value of EIB loan guaranty | ( |
) | ||||||
| Gain on impairment adjustment | ( |
) | ||||||
| Gain on settlement of compensation expenses | ( |
) | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ( |
) | ||||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Deferred offering costs | ( |
) | ||||||
| Intangible assets | ( |
) | ||||||
| Accounts payable | ( |
) | ||||||
| Accrued compensation and benefits | ( |
) | ( |
) | ||||
| Accrued liabilities | ||||||||
| Operating lease liabilities | ( |
) | ( |
) | ||||
| Deferred revenue | ( |
) | ||||||
| Net cash used in operating activities | ( |
) | ( |
) | ||||
| Cash flows from investing activities: | ||||||||
| Net cash used in investing activities | ||||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from issuance of preferred stock, net of issuance costs | ||||||||
| Proceeds from issuance of common stock, net of issuance costs | ||||||||
| Proceeds from short term insurance financing | ||||||||
| Payments on short term insurance financing | ( |
) | ( |
) | ||||
| Payments on finance lease obligations | ( |
) | ||||||
| Net cash provided by financing activities | ||||||||
| Effects of exchange rates on cash | ||||||||
| Net (decrease) increase in cash, cash equivalents and restricted cash | ( |
) | ||||||
| Cash and cash equivalents and restricted cash at beginning of period | ||||||||
| Cash and cash equivalents and restricted cash at end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow information | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Supplemental disclosures of noncash investing and financing activities | ||||||||
| Settlement of deferred compensation and severance | $ | $ | ||||||
| Issuance of common stock upon conversion of preferred stock | $ | $ | ||||||
See accompanying notes to unaudited condensed consolidated financial statements.
4
OpGen, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements
September 30, 2025
Note 1 – Organization
OpGen, Inc. (“OpGen” or the “Company”) was incorporated in Delaware in 2001. In April 2020, OpGen completed a business combination transaction with Curetis N.V., a public company with limited liability under the laws of the Netherlands, pursuant to which the Company acquired all the shares of Curetis GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany (“Curetis”), and certain other assets and liabilities of Curetis N.V., including Ares Genetics GmbH (“Ares Genetics”), a wholly-owned subsidiary of Curetis.
From inception until November 2023, OpGen operated as a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. The Company, along with its subsidiaries, Curetis and Ares Genetics, developed and commercialized molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. In November 2023, Curetis and Ares Genetics filed petitions for insolvency in their local jurisdictions. The insolvency filings resulted in the elimination of the Company’s authority and power to act on behalf of the subsidiaries and accordingly, this loss of control resulted in the Company deconsolidating the subsidiaries.
In March 2024, as a result of the Company’s efforts to explore a strategic transaction, the Company entered into a securities purchase agreement (the “March 2024 Purchase Agreement”) with David E. Lazar (see Note 8). In connection with the transactions contemplated by the March 2024 Purchase Agreement, the members of the Board of Directors, prior to the closing of such transactions, resigned and a new Board of Directors was appointed, of which Mr. Lazar was appointed Chairman. Furthermore, in April 2024, the Company entered into an employment agreement with Mr. Lazar, pursuant to which the Company engaged Mr. Lazar to act as its Chief Executive Officer (“CEO”).
In July 2024, Mr. Lazar consummated a transaction pursuant to which he sold shares of Series E Preferred Stock together with his rights to purchase the additional 2,450,000 shares of Series E Preferred Stock to AEI Capital Ltd., a private limited company incorporated under the laws of the British Virgin Islands, which forms part of AEI Capital Group, with groupwide assets under management exceeding $3.0 billion (see Note 8). In conjunction with the transaction, Mr. Lazar resigned as CEO, Chairman and Director of the Company, effective August 2024, but he currently maintains a role as President. Subsequently, AEI Capital Ltd. paid the Company $
Following the sale of control to AEI Capital Ltd., the Company further scaled down legacy operations while repositioning itself to operate in the financial services and technology industry. In furtherance of such shift, the Company formed a wholly-owned subsidiary, CapForce International Holdings Ltd.(“CapForce”), which launched a new business line offering listing sponsorship and consultancy services to international companies seeking to list their securities on securities exchanges. Additionally, CapForce contemplates entering the financial technology industry supporting digital investment banking activities and capital table management.
On May 20, 2024, the Company effected a
Subsequent to the Company’s assignment of its headquarters office lease in April 2024, the Company has operated virtually. The Company operates in one business segment.
5
Note 2 – Going Concern and Management’s Plans
The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred significant losses from operations and negative operating cash flows. Historically, the Company has funded its operations primarily through external investor financing arrangements and strategic actions taken by the Company, but, in the near term, the Company anticipates funding its operations primarily through financing arrangements with AEI Capital Ltd., until the Company’s operating business is able to sustain its operations. Through the Company’s financing efforts, which include, among others, securities purchase agreements, warrant inducement agreements, and public offerings, the Company received gross proceeds of approximately $5.0 million in 2024.
The Company has cash and cash equivalents of $0.4 million as of September 30, 2025. In August 2024, the Company and AEI Capital Ltd. entered into a Securities Purchase Agreement (the “August 2024 Securities Purchase Agreement”), pursuant to which the Company has the right, in its sole discretion, to sell to AEI Capital Ltd. shares of the Company’s common stock having an aggregate value of up to $3.0 million. The purchase price for any shares sold under the August 2024 Securities Purchase Agreement is the closing sales price on the Nasdaq Capital Market of the Company’s common stock as of the date immediately prior to the date of sale. In addition, in October 2024, the Company and AEI Capital Ltd. entered into a First Amendment (the “Amendment”) to the August 2024 Securities Purchase Agreement providing for: (1) granting the Company the right, at its sole discretion, to sell two additional tranches of common stock to AEI Capital Ltd. of $3.0 million each, for an aggregate amount of $
On June 5, 2024, the Company received a letter from the listing staff of The Nasdaq Stock Market LLC (“Nasdaq”) that the Company was no longer in compliance with the minimum stockholders’ equity requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Rule”). The Stockholders’ Equity Rule requires companies listed on the Nasdaq Capital Market to maintain stockholders’ equity of at least $
The accompanying unaudited condensed consolidated financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern.
6
Note 3 – Summary of Significant Accounting Policies
Basis of presentation and consolidation
The Company has prepared the accompanying unaudited condensed consolidated financial statements pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) and the standards of accounting measurement set forth in the Interim Reporting Topic of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”). Certain information and note disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the information not misleading. The Company recommends that the unaudited condensed consolidated financial statements be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Company’s latest annual report on Form 10-K. In the opinion of management, all adjustments that are necessary for a fair presentation of the Company’s financial position for the periods presented have been reflected. All adjustments are of a normal, recurring nature, unless otherwise stated. The interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2024 consolidated balance sheet included herein was derived from the audited consolidated financial statements but does not include all disclosures including notes required by GAAP for complete financial statements.
The accompanying unaudited condensed consolidated financial statements include the accounts of OpGen; all intercompany transactions and balances have been eliminated. The accompanying unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2025 include the balance sheet and income statement activity for CapForce, the Company’s wholly-owned subsidiary.
Immaterial Out-of-Period Adjustments
During
the three months ended March 31, 2024, the Company identified an immaterial error related to the calculation of preferred stock
par value and additional paid-in capital for the Company’s Series D convertible preferred stock that impacted the
Company’s previously issued 2023 consolidated financial statements. Management evaluated the effect of the error on the 2023
and 2024 consolidated financial statements and concluded that the error was not material. As a result, in the three months ended
March 31, 2024, the Company recorded an out-of-period adjustment to decrease preferred stock par value and increase additional
paid-in capital, each by approximately $
During the three months ended March 31, 2024, the Company identified an immaterial error related to the inclusion of balances of accumulated other comprehensive loss representing historic translation adjustments of previously dissolved subsidiaries that impacted the Company’s previously issued 2023 and 2022 consolidated financial statements. Management evaluated the effect of the error on the 2022, 2023, and 2024 consolidated financial statements and concluded that the error was not material. As a result, in the three months ended March 31, 2024, the Company recorded an out-of-period adjustment to increase the loss on deconsolidation of subsidiaries and decrease accumulated other comprehensive loss, each by approximately $75.1 thousand.
Restatement of Previously Issued Financial Statements
Subsequent to the filing of the Company’s quarterly report on Form 10-Q for the three months ended March 31, 2024, the Company identified an error relating to the accounting treatment of an indemnification asset in the Company’s previously issued unaudited condensed consolidated financial statements included in the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2024 (the “Affected Period”). As a result, the Company filed an amended and restated quarterly report on Form 10-Q for the quarter ended March 31, 2024 to correct the error in the Affected Period by adjusting the following information for the three months ended March 31, 2024: (i) removing the previously recorded indemnification asset and gain on lease indemnification; and (ii) changing the accounting estimates related to the Company’s operating lease right-of-use asset and leasehold improvement property and equipment and recording a gain on impairment adjustment associated with the Rockville, Maryland office due to the identification of a subtenant during the quarter ended March 31, 2024. In total, the restatement and associated change in accounting estimates resulted in an incremental loss of approximately $
7
Use of estimates
In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying unaudited condensed consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, stock-based compensation, allowances for credit losses and inventory obsolescence, discount rates used to discount unpaid lease payments to present values, deferred tax assets and liabilities and related valuation allowance, the estimated useful lives of long-lived assets, and the recoverability of long-lived assets. Actual results could differ from those estimates.
Segment Reporting
The Company’s chief operating decision maker (“CODM”) is the Company’s Chief Executive Officer. The CODM is assisted in his responsibilities of making decisions regarding resource allocation and performance assessment by the leadership team.
The Company views its operations and manages its business as one operating segment, focused on repositioning itself by offering listing sponsorship and consultancy services to international companies seeking to list their securities on securities exchanges and entering the financial technology industry with a focus on developing and supporting advanced digital investment banking activities, cross-border securities trading, advanced computational model-enabled investment banking advisory, asset management services, and FinTech-enabled capital table management. Segment profit or loss is measured as the Company’s net income (loss) as reported on the Company’s Statement of Operations. The Company monitors its cash and cash equivalents, as reported on the Company’s Balance Sheets, to determine funding for its activities.
The CODM assesses the Company’s performance through revenue goals and the achievement of integration objectives and cost optimization initiatives. In addition to the Company’s Statement of Operations, the CODM is regularly provided with budgeted and forecasted expense information which is used to determine the Company’s liquidity needs and cash allocation.
Foreign currency
The Company previously had foreign subsidiaries that used currencies other than the U.S. dollar as their functional currencies. As a result, all assets and liabilities of the subsidiaries were translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items were translated at the average exchange rates prevailing during the reporting period. Translation adjustments were reported in accumulated other comprehensive income (loss), a component of stockholders’ equity.
Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net income (loss). Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar.
Fair value of financial instruments
Financial instruments classified as current assets and liabilities (including cash and cash equivalents, receivables, accounts payable, deferred revenue, and short-term notes) are carried at cost, which approximates fair value, because of the short-term maturities of those instruments.
8
Cash and cash equivalents and restricted cash
The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limit of $
At September 30, 2025 and December 31, 2024, the Company had funds totaling $
The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows:
| September 30, 2025 |
December 31, 2024 |
September 30, 2024 |
December 31, 2023 |
|||||||||||||
| Cash and cash equivalents | $ | $ | $ | $ | ||||||||||||
| Restricted cash | ||||||||||||||||
| Total cash and cash equivalents and restricted cash in the condensed consolidated statements of cash flows | $ | $ | $ | $ | ||||||||||||
Accounts receivable and Credit concentration
The Company’s accounts receivable result from revenues earned but not yet collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within
At September 30, 2025, the Company had accounts receivable from one customer that individually represented
At December 31, 2023, the Company had accounts receivable totaling $
9
Investments in equity securities
The Company currently has a single investment in equity securities issued by a privately held entity. In the fourth quarter of 2024, CapForce performed part of its listing sponsorship and consulting services and completed the first performance obligation within its agreement with a client, generating proceeds of $
Inventory
Inventory is entirely comprised of the remaining Unyvero system instruments and components and is valued using the first in, first out cost method and stated at the lower of cost or net realizable value. The inventory of approximately $
Long-lived assets
Property and equipment
Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimation of undiscounted cash flows is performed at the lowest possible level for which the Company can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of the assets exceeds the fair value of the assets. In the first quarter of 2024, the Company identified and subsequently entered into an agreement with a subtenant for its office space. As a result, the Company had a change in estimate related to the impairment of its leasehold improvements and recognized a gain of $
Leases
The Company determines if an arrangement is a lease at inception. For leases where the Company is the lessee, right-of-use (“ROU”) assets represent the Company’s right to use the underlying asset for the term of the lease and the lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date of the underlying lease arrangement to determine the present value of lease payments. The ROU asset also includes any prepaid lease payments and any lease incentives received. The lease term to calculate the ROU asset and related lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The Company’s lease agreements generally do not contain any material variable lease payments, residual value guarantees or restrictive covenants.
Lease expense for operating leases is recognized on a straight-line basis over the lease term as an operating expense while expense for financing leases is recognized as depreciation expense and interest expense using the effective interest method of recognition. The Company has made certain accounting policy elections whereby the Company (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12 months or less) and (ii) combines lease and non-lease elements of our operating leases.
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ROU assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimation of undiscounted cash flows is performed at the lowest possible level for which the Company can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of the assets exceeds the fair value of the assets. As a result of the identification of a subtenant for its office space discussed above, the Company had a change in estimate related to the impairment of its right-of-use asset and recognized a gain of $
Intangible assets
Intangible assets represent costs incurred related to the Company’s proprietary platform during the application development stage that are capitalized as finite-lived intangible assets. These costs include external direct costs for infrastructure and services, as well as personnel and related costs for consultants directly involved in the development effort. Once the project is substantially complete and available for use, capitalized costs will be amortized on a straight-line basis over the asset’s estimated useful life.
Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. No impairment was identified in any of the periods presented.
Revenue recognition
The Company derives revenues primarily from offering listing sponsorship and consultancy services to international companies seeking to list their securities on securities exchanges.
Prior to its repositioning, the Company derived revenues from (i) the sale of Unyvero Application cartridges, Unyvero Systems, Acuitas AMR Gene Panel systems and test products, and SARS CoV-2 tests, (ii) providing laboratory services, and (iii) providing collaboration services.
The Company analyzes its contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers, (ii) identification of distinct performance obligations in the contract, (iii) determination of contract transaction price, (iv) allocation of contract transaction price to the performance obligations, and (v) determination of revenue recognition based on timing of satisfaction of the performance obligations.
The Company recognizes revenues upon the satisfaction of its performance obligations (upon transfer of control of promised goods or services to our customers) in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services.
The Company defers incremental costs of obtaining a customer contract and amortizes the deferred costs over the period that the goods and services are transferred to the customer. The Company had no material incremental costs to obtain customer contracts in any period presented.
Deferred revenue results from amounts billed in advance to customers or cash received from customers in advance of services being provided.
Research and development costs, net
Research and development costs are expensed as incurred. Research and development costs primarily consist of fees to expand and innovate CapForce’s digital investment banking platform, salaries and related expenses for personnel, and fees paid to consultants and outside service providers. Prior to the Company’s repositioning, research and development costs also included laboratory supplies and development materials.
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Stock-based compensation expense is recognized at fair value. The fair value of stock-based compensation to employees and directors is estimated on the date of grant including using the Black-Scholes model for stock options. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the award. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur.
Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award.
Income taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized.
Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts.
The Company had federal net operating loss (“NOL”) carryforwards of approximately $
In periods of net loss, basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. The Company’s Series D and E convertible preferred stock contain non-forfeitable rights to dividends and, therefore, are considered to be participating securities; in periods of net income, the calculation of basic earnings per share excludes from the numerator net income attributable to the preferred stock and excludes the impact of those shares from the denominator.
In periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all potential dilutive common shares is anti-dilutive. In periods of net income, diluted earnings per share is computed using the more dilutive of the “two class method” or the “treasury method.” Dilutive earnings per share under the “two class method” is calculated by dividing net income available to common stockholders as adjusted for the participating impacts of the preferred stock, by the weighted-average number of shares outstanding plus the dilutive impact of all other potential dilutive common shares, consisting primarily of common shares underlying common stock options and stock purchase warrants using the treasury stock method. Dilutive earnings per share under the “treasury stock method” is calculated by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the dilutive impact of all potential dilutive common shares, consisting primarily of common shares underlying common stock options and stock purchase warrants using the treasury stock method, and preferred stock using the if-converted method.
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The Company has calculated basic and diluted earnings (loss) per share for the three and nine months ended September 30, 2025 and 2024 as follows:
| Basic | Diluted | |||||||||||||||
| Three months ended September 30, |
Three months ended September 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net (loss) income | $ | ( |
) | $ | $ | ( |
) | $ | ||||||||
| Net income allocated to preferred stock | ( |
) | ||||||||||||||
| Net (loss) income available to common stockholders | $ | ( |
) | $ | $ | ( |
) | $ | ||||||||
| Basic weighted average shares outstanding | ||||||||||||||||
| Dilutive effect of stock preferred stock | ||||||||||||||||
| Dilutive weighted average shares outstanding | ||||||||||||||||
| (Loss) earnings per share | $ | ) | $ | $ | ) | $ | ||||||||||
| Basic | Diluted | |||||||||||||||
| Nine months ended September 30, |
Nine months ended September 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net income | $ | $ | $ | $ | ||||||||||||
| Net income allocated to preferred stock | ( |
) | ( |
) | ||||||||||||
| Net income available to common stockholders | $ | $ | $ | $ | ||||||||||||
| Basic weighted average shares outstanding | ||||||||||||||||
| Dilutive effect of preferred stock | ||||||||||||||||
| Dilutive effect of restricted stock units | ||||||||||||||||
| Dilutive weighted average shares outstanding | ||||||||||||||||
| Earnings per share | $ | $ | $ | $ | ||||||||||||
None of the potential dilutive securities had a dilutive impact during the three months ended September 30, 2025 due to the Company’s net loss.
The number of anti-dilutive
shares, consisting of common shares underlying (i) preferred stock, (ii) common stock options, (iii) restricted stock units and (iv)
stock purchase warrants, which have been excluded from the computation of diluted income per share, was
The number of anti-dilutive shares for both the three and nine months ended September 30, 2024, consisting of common shares underlying (i) preferred stock, (ii) common stock options, (iii) restricted stock units and (iv) stock purchase warrants, which have been excluded from the computation of diluted income per share, was
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Recently issued accounting standards
In July 2025, the FASB issued ASU No. 2025-05: Financial Instruments-Credit Losses which amends Topic 326. Specifically, the ASU provides a practical expedient whereby an entity can assume that current conditions as of the balance sheet date will not change for the remaining life of the asset (e.g., the accounts receivable). This guidance is effective for the Company’s fiscal year ending December 31, 2026 and can be adopted early. The Company is in the process of evaluating the effects of this guidance on its condensed consolidated financial statements.
In September 2025, the FASB issued ASU 2025-06, which amends the guidance on ASC 350-40, Intangibles – Goodwill and Other – Internal-Use Software. Specifically, the ASU modernized the recognition and disclosure framework for internal-use software costs, removing the previous “development stage” model and introducing a more judgment-based approach. The guidance is effective for the Company’s fiscal year ending December 31, 2028 and can be adopted early. The Company is in the process of evaluating the effects of this guidance on its condensed consolidated financial statements.
In September 2025, the FASB issued ASU 2025-07, which, among other things, provides scope clarification for share-based non-cash consideration from a customer in a revenue contract. Specifically, the ASU clarifies that share-based payments from customers in exchange for the transfer of goods or services should be accounted for as non-cash consideration within the scope of ASC 606 as opposed to as a derivative pursuant to ASC 815 or as an equity security pursuant to ASC 321. This guidance is effective for the Company’s fiscal year ending December 31, 2027 and can be adopted early. The Company is in the process of evaluating the effects of this guidance on its condensed consolidated financial statements.
The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows.
Note 4 – Revenue from contracts with customers
Disaggregated revenue
The Company provides listing sponsorship and consulting services to growth-stage private companies and, prior to its repositioning, the Company provided diagnostic test products and laboratory services to hospitals, clinical laboratories and other healthcare providing customers. The revenues by type of service consist of the following:
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Product sales | $ | $ | $ | $ | ||||||||||||
| Laboratory services | ||||||||||||||||
| Listing sponsorship services | ||||||||||||||||
| Total revenue | $ | $ | $ | $ | ||||||||||||
Revenues by geography are as follows:
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Domestic | $ | $ | $ | $ | ||||||||||||
| International | ||||||||||||||||
| Total revenue | $ | $ | $ | $ | ||||||||||||
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Deferred revenue
Changes in deferred revenue for the nine months ended September 30, 2024 were as follows:
| Balance at December 31, 2023 | $ | |||
| Recognized | ( |
) | ||
| Refunded to customers | ( |
) | ||
| Balance at September 30, 2024 | $ |
Note 5 – Investment in equity securities
On January 2, 2024, AEI Capital Ltd., the Company’s controlling stockholder (“AEI Capital”), entered into a Letter of Engagement with a privately held company (the “Client”), pursuant to which AEI Capital agreed to provide certain listing advisory services relating to the preparation and facilitation of an initial public offering for the Client (the “Engagement Agreement”). In consideration for such services, under the Engagement Agreement, AEI Capital is entitled to receive a fee consisting of: (i) 3.5% of the outstanding equity interests of the Client (the “Equity Consideration”) and (ii) $200,000 (the “Cash Consideration,” and collectively, with the Equity Consideration, the “Consideration”).
On October 2, 2024, CapForce, which was organized by the Company for purposes of repositioning itself as a new business in the digital investment banking industry powered by financial technology, entered into an Agreement of Assignment of Mandate with AEI Capital in respect of Direct Listing Sponsorship Advisory Services (the “Assignment Agreement”), pursuant to which AEI Capital assigned its rights and obligations within Clause 3.1 of the Engagement Agreement for the advisory fee equivalent to 2.1% of the outstanding equity interests of the Client and $120,000 to CapForce. As a result, pursuant to the Assignment Agreement, CapForce completed the first performance obligation within the Engagement Agreement in the fourth quarter of 2024, earning proceeds of $
The CEO of AEI Capital Ltd. and OpGen, Inc. serves as a member of the Board of Directors of the Client, making the Client a related party. The Engagement Agreement and Assignment Agreement were conducted in the ordinary course of business and on terms comparable to those with unrelated third parties. The Company’s management and Board of Directors have evaluated the relationship and concluded that appropriate governance and conflict of interest procedures were followed.
As of September 30, 2025, the Company held an investment in the equity securities of the Client valued at $
The Company estimated the fair value of the investment based on an anticipated initial public offering by the Client expected to occur within the next twelve months. The estimated valuation is derived from pricing and valuation metrics provided by the issuer and underwriters in connection with the planned initial public offering. This estimate is subject to significant judgment and market risk and is not based on observable inputs. In the event the final initial public offering valuation results in proceeds to the Company of less than $5.0 million for these shares of equity securities, the Client has contractually agreed to issue additional shares to the Company to ensure that the total value of the equity consideration received for this first performance obligation equals $5.0 million.
The Company accounts for this investment under ASC 321, Investments – Equity Securities. Since the equity securities do not have a readily determinable fair value, the Company has elected the measurement alternative and, accordingly, it is carried at its estimated fair value calculated as its cost less any impairment charges until such time as there is evidence of an orderly transaction. As of September 30, 2025, no fair value adjustments have been recognized, nor have there been any impairment charges. This investment is considered a financial asset that is measured at fair value on a non-recurring basis.
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Note 6 – Fair value measurements
The carrying value of short-term instruments, including cash and cash equivalents, accounts payable and accrued expenses approximate fair value due to the relatively short period to maturity for these instruments. The Company has elected to account for its single investment using the measurement alternative and it is considered a financial instrument accounted for at fair value on a non-recurring basis. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The Company utilizes a three-level valuation hierarchy for disclosures of fair value measurements, defined as follows:
| ● | Level 1 - defined as observable inputs such as quoted prices in active markets; |
| ● | Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and |
| ● | Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions such as expected revenue growth and discount factors applied to cash flow projections. |
For the three and nine months ended September 30, 2025 and 2024, the Company has not transferred any assets between fair value measurement levels.
Financial assets and liabilities measured at fair value on a recurring basis
The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the hierarchy.
Prior to its settlement in August 2024, the Company accounted for its guaranty of the EIB debt (see Note 7) of its previously consolidated subsidiary, Curetis, at fair value. This fair value, in addition to the principal and interest, included a participation percentage interest (“PPI”) right in the debt. The Company concluded this right constituted an embedded derivative, which was separated and measured at fair value with changes being accounted for through profit or loss. The Company determined the fair value of the derivative using a Monte Carlo simulation model. Using this model, level 3 unobservable inputs include estimated discount rates and estimated risk-free interest rates.
Financial assets and liabilities carried at fair value on a non-recurring basis
As disclosed in Note 5, as of September 30, 2025, the Company held an investment in the equity securities of the Client valued at $
Non-financial assets and liabilities carried at fair value on a recurring basis
The Company does not have any non-financial assets and liabilities measured at fair value on a recurring basis.
Non-financial assets and liabilities carried at fair value on a non-recurring basis
The Company measures its long-lived assets, including property and equipment and lease assets, at fair value on a non-recurring basis when a triggering event requires such evaluation. In the three months ended March 31, 2024, the Company recorded a change in accounting estimate on the Company’s leasehold improvement property and equipment and operating lease right-of-use asset, adjusting the balances as of the beginning of the period to approximately $
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Note 7 – Debt
In 2016, the Company’s previously consolidated subsidiary, Curetis, entered into a contract for an up to €
In December 2023, the Company received a notice from the EIB stating that Curetis was in default and pursuant to that certain Guarantee and Indemnity Agreement, between the EIB and the Company, the EIB demanded that the Company, as guarantor, immediately repay the EIB all amounts owed to the EIB. In March 2024, the Company entered into settlement agreements with each of the EIB and Curetis and Curetis’ trustee in insolvency, pursuant to which the Company agreed to pay a total of $2.0 million to settle all outstanding debt and liabilities of the Company to EIB and Curetis. In August 2024, the Company paid and settled its outstanding indebtedness with the EIB and Curetis, which terminated the Guarantee and Indemnity Agreement. Accordingly, upon termination of such Guarantee and Indemnity Agreement, the Company recorded a gain on extinguishment of debt in excess of $
Short-term insurance financing
In May 2025, the Company entered into an agreement to finance a portion of the premium for its directors and officers’ insurance policy for the policy period of May 2025 through May 2026. The agreement provides for financing of approximately $
In May 2024, the Company entered into an agreement to finance a portion of the premium for its directors and officers’ insurance policy for the policy period of May 2024 through May 2025. The agreement provided for financing of approximately $
Note 8 – Stockholders’ equity
Common Stock
As of September 30, 2025, the Company had shares of authorized common stock, of which shares were issued and outstanding, and shares of authorized preferred stock, of which shares were issued and outstanding.
The Company effected a one-for-ten reverse stock split on May 20, 2024. All share amounts and per share prices in this quarterly report have been adjusted to reflect the reverse stock split.
Preferred Stock
In October 2023, the Company entered into a Preferred Stock Purchase Agreement (the “October 2023 Purchase Agreement”) with a single investor, pursuant to which the Company agreed to issue and sell to the investor in a private placement (the “Private Placement”) shares of the Company’s Series D Preferred Stock, par value $ per share (the “Preferred Stock”) at a price of $
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Pursuant to the October 2023 Purchase Agreement, the Company filed a certificate of designation (the “Series D Certificate of Designation”) with the Secretary of State of the State of Delaware designating the rights, preferences and limitations of the shares of preferred stock. The Series D Certificate of Designation provides that the shares of preferred stock have a stated value of $1,000 per share and are convertible into shares of common stock, par value $0.01 per share of the Company at a price of $ per share, subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications, or similar events affecting the common stock. The preferred stock may be converted at any time at the option of the holder. Notwithstanding the foregoing, the Series D Certificate of Designation provides that in no event will the preferred stock be convertible into common stock in a manner that would result in the holder, its permitted transferees, and affiliates holding more than
Lazar and AEI Transactions
In March 2024, the Company entered into the March 2024 Purchase Agreement with David E. Lazar, pursuant to which the Company agreed to sell 3,000,000 shares of Series E Convertible Preferred Stock (“Series E Preferred Stock”) to Mr. Lazar at a price of $1.00 per share for aggregate gross proceeds of $3.0 million. In connection with the transactions contemplated by the March 2024 Purchase Agreement, the members of the Board of Directors, prior to the closing of such transactions, resigned and a new Board of Directors was appointed, of which Mr. Lazar was appointed Chairman.
In July 2024, Mr. Lazar consummated a transaction pursuant to which he sold shares of Series E Preferred Stock together with his rights to purchase the additional shares of Series E Preferred Stock under the March 2024 Purchase Agreement to AEI Capital Ltd. Subsequently, AEI Capital Ltd. paid the Company $2.45 million in August 2024 in exchange for the remaining 2,450,000 shares of Series E Preferred Stock under the terms of the March 2024 Purchase Agreement. All shares of Series E Preferred Stock were subsequently converted into shares of the Company’s common stock in August 2024. As of September 30, 2024, no shares of Series E Preferred Stock remained outstanding. Upon conversion, such shares of Series E Preferred Stock resumed the status of authorized but unissued shares of undesignated preferred stock of the Company. Upon receipt of the funding from AEI Capital Ltd. and pursuant to the Settlement Agreements with the EIB and Curetis and the March 2024 Purchase Agreement, the Company paid and settled its outstanding indebtedness with the EIB and Curetis. Settlement with EIB also terminated that certain Guarantee and Indemnity Agreement, dated as of July 9, 2020, by and between the EIB and the Company, pursuant to which the Company had guaranteed all of Curetis’ debt to the EIB.
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In August 2024, the Company entered into a Securities Purchase Agreement (the “August 2024 Securities Purchase Agreement”) with AEI Capital Ltd., pursuant to which the Company had the right, in its discretion, to sell to AEI Capital Ltd., at any time prior to September 30, 2024, shares of common stock, par value $ per share (the “Shares”), of the Company having an aggregate value of up to $
Stock purchase warrants
The Company has historically issued common stock purchase warrants in connection with various equity or debt offerings or development agreements. These issuances include entering into inducement agreements with holders of existing warrants whereby terms are amended or additional warrants are issued in order to induce exercise of the existing warrants. The Company did not issue any common stock warrants nor were any warrants exercised in the year ended December 31, 2024 or year-to-date through September 30, 2025.
The Company has certain outstanding warrants that will only become exercisable upon stockholder approval; subsequent to receiving stockholder approval, the warrants will be exercisable for a period of five years.
At September 30, 2025 and December 31, 2024, the following warrants to purchase shares of common stock were outstanding:
| Outstanding at | |||||||||||||||
| Issuance |
Exercise Price |
Expiration | September 30, 2025 |
December 31, 2024 |
|||||||||||
| February 2015 | $ | ||||||||||||||
| November 2020 | $ | ||||||||||||||
| February 2021 | $ | ||||||||||||||
| May 2023 | $ | (1) | |||||||||||||
| October 2023 | $ | ||||||||||||||
| (1) |
|
Stock Compensation
2015 Equity Incentive Plan
In April 2015, the Company adopted, and the Company’s stockholders approved, the 2015 Equity Incentive Plan (the “2015 Plan”); the 2015 Plan became effective upon the execution and delivery of the underwriting agreement for the Company’s initial public offering in May 2015. The 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of the Code to employees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides for the grant of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors and consultants. Effective April 1, 2025, which was the ten (10) year anniversary of the adoption of the 2015 Plan, no additional grants may be made under the 2015 Plan.
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Share-Based Compensation
For the three and nine months ended September 30, 2025 and 2024, the Company recognized share-based compensation expense as follows:
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Research and development | $ | $ | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||||
| Sales and marketing | ||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
No income tax benefit for share-based compensation arrangements was recognized in the unaudited condensed consolidated statements of operations and comprehensive income (loss) due to the Company’s anticipated net taxable loss position for the year ended December 31, 2025.
Stock Options
As of September 30, 2025, the Company does t have any unrecognized expense related to its stock options.
The Company did t grant any options during the nine months ended September 30, 2025 or 2024. During the nine months ended September 30, 2025, options were forfeited or expired. During the nine months ended September 30, 2024, options were forfeited and options expired.
The Company had stock options to acquire shares of common stock outstanding at September 30, 2025.
Restricted Stock Units
During the nine months ended September 30, 2025, restricted stock units were granted, restricted stock units vested and no restricted stock units were forfeited.
During the nine months ended September 30, 2024, restricted stock units were granted and vested, and restricted stock units were forfeited.
The Company has restricted stock units outstanding as of September 30, 2025.
As of September 30, 2025, there was approximately $of unrecognized compensation costs related to restricted stock units, which are expected to be recognized over a weighted average period of years.
Note 9 – Commitments and Contingencies
Registration and other stockholder rights
In connection with various of its investment transactions, the Company entered into registration rights agreements with stockholders, pursuant to which the investors were granted certain demand registration rights and/or piggyback and/or resale registration rights in connection with subsequent registered offerings of the Company’s common stock.
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Note 10 – Leases
Maturities of the lease liability for the Company’s lone operating lease as of September 30, 2025 by year are as follows:
| Maturity of Lease Liabilities | ||||
| 2025 (October to December) | $ | |||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| Thereafter | ||||
| Total lease payments | ||||
| Less: interest | ( |
) | ||
| Present value of lease liabilities | $ | |||
For the three and nine months ended September 30, 2025, lease costs of approximately $
The remaining term of the lone operating lease as of September 30, 2025 is
Note 11 – Joint Venture
In April 2025, CapForce entered into a Joint Venture Agreement (the “JV Agreement”) with the European Credit Investment Bank (“ECIB”), a full-fledged, global facing mid-shore investment bank in Labuan, Malaysia licensed by the Labuan Financial Services Authority, pursuant to which the parties agreed to form a joint venture company named CapForce EC Capital Markets Ltd. (the “Joint Venture”) for purposes of developing and operating a stock trading platform (the “Trading Platform”) and digital investment banking platform across Asia and the rest of the world (the “Digital IB Platform,” and together with the Trading Platform, the “Platforms”). The Platforms encompass (i) a community-focused cross-border stock trading platform; (ii) a FinTech-enabled cap table management platform; and (iii) an advanced computational model-enabled investment banking advisory platform for public listing sponsorship and wealth management. Pursuant to the JV Agreement, CapForce will own
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Note 12 – Subsequent Events
The Company evaluates subsequent events and transactions that occur after the balance sheet date up to November 19, 2025, the date that these unaudited condensed consolidated financial statements are issued.
There have been no subsequent events that require adjustment or disclosure in the accompanying unaudited condensed consolidated financial statements.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the unaudited condensed consolidated financial statements and the accompanying notes thereto included in Part I, Item 1 of this quarterly report on Form 10-Q. This discussion contains forward-looking statements, based on current expectations and related to future events and our future financial performance, that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many important factors, including those set forth under Part II. Item 1A “Risk Factors” of this quarterly report on Form 10-Q and Part 1. Item 1A of our annual report on Form 10-K for the year ended December 31, 2024.
Overview
OpGen, Inc. (“OpGen” or the “Company”) was incorporated in Delaware in 2001. On April 1, 2020, OpGen completed its business combination transaction with Curetis N.V., a public company with limited liability under the laws of the Netherlands. As part of the transaction, the Company acquired all the shares of Curetis GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany (“Curetis”), and certain other assets and liabilities of Curetis, including all its shares of Ares Genetics GmbH (“Ares Genetics”). From inception through November 2023, the Company operated as a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. The Company, along with its subsidiaries, Curetis and Ares Genetics, developed and commercialized molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life-threatening infections to improve patient outcomes and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs.
In November 2023, the Company implemented certain cash management initiatives, including restructuring its U.S. operations by reducing headcount and scaling down operations at OpGen’s U.S. headquarters to the core functions of a U.S. Nasdaq listed company, allowing the Company to conserve cash and focus on the functions needed to pursue potential strategic alternatives. In November 2023, Curetis filed a petition for insolvency with the district court of Stuttgart, Germany, and Ares Genetics filed a petition for insolvency with the commercial court in Vienna, Austria. The insolvency proceedings of Curetis and Ares Genetics were adjudicated under the insolvency laws of Germany and Austria, respectively.
The insolvency administrators assumed control over the assets and liabilities of Curetis and Ares Genetics, respectively, which eliminated the authority and power of the Company and its officers to act on behalf of the subsidiaries. The loss of control required that the Company no longer include Curetis and Ares Genetics in its consolidated financial statements and, consequently, the subsidiaries were deconsolidated from the Company’s consolidated financial statements. As part of the insolvency proceedings, in April 2024, all of Curetis’ assets were sold to Camtech Pte Ltd., a Singaporean family office (“Camtech”), and all of Ares Genetics’ assets were sold to bioMerieux S.A.
In March 2024, as a result of the Company’s efforts to explore a strategic transaction, the Company entered into a securities purchase agreement (the “March 2024 Purchase Agreement”) with David E. Lazar. In connection with the transactions contemplated by the March 2024 Purchase Agreement, the members of the Board of Directors, prior to the closing of such transactions, resigned and a new Board of Directors was appointed, of which Mr. Lazar was appointed Chairman. Furthermore, in April 2024, the Company entered into an employment agreement with Mr. Lazar, pursuant to which the Company engaged Mr. Lazar to act as its Chief Executive Officer (“CEO”).
In July 2024, Mr. Lazar consummated a transaction pursuant to which he sold 550,000 shares of Series E Preferred Stock together with his rights to purchase the additional 2,450,000 shares of Series E Preferred Stock to AEI Capital Ltd., a private limited company incorporated under the laws of the British Virgin Islands, which forms part of AEI Capital Group, with groupwide assets under management exceeding $3.0 billion. In conjunction with the transaction, Mr. Lazar resigned as CEO, Chairman and Director of the Company, effective August 2024, but he currently maintains a role as President. Subsequently, AEI Capital Ltd. paid the Company $2.45 million in August 2024 in exchange for the remaining 2,450,000 shares of Series E Preferred Stock. All 3,000,000 shares of Series E Preferred Stock were subsequently converted into 7,200,000 shares of the Company’s common stock in August 2024.
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Following the sale of control to AEI Capital Ltd., the Company further scaled down legacy operations while repositioning itself to operate in the financial services and technology industry. In furtherance of such shift, the Company formed a wholly-owned subsidiary, CapForce International Holdings Ltd. (“CapForce”), which launched a new business line offering listing sponsorship and consultancy services to international companies seeking to list their securities on securities exchanges. Additionally, CapForce contemplates entering the financial technology industry supporting digital investment banking activities and capital table management.
On May 20, 2024, the Company effected a 1-for-10 reverse stock split of its issued and outstanding shares of common stock. All share amounts and per share prices in this quarterly report have been adjusted to reflect the reverse stock split.
Subsequent to the Company’s assignment of its office lease in April 2024, the Company has operated virtually. The Company operates in one business segment.
Financial Overview
Revenue
Prior to the repositioning of our business, we generated revenues from sales of our products, including sales of our products through our distribution partners, such as our Unyvero instruments and consumables. We also generated revenue from sales by Ares Genetics of its AI-powered prediction models and solutions. Revenues generated from our laboratory services related to services that we and our subsidiaries provided to customers. Lastly, our collaboration revenues consisted of revenue received from research and development collaborations that we entered into with third parties, such as our collaboration agreement with the Foundation for Innovative New Diagnostics.
Following the acquisition of a controlling interest in the Company by AEI Capital Ltd. and the formation of CapForce as OpGen’s wholly-owned subsidiary, we generate revenues from CapForce’s listing sponsorship and consulting services, and we anticipate generating revenues from CapForce’s other business ventures including cross-border securities trading, advanced computational model-enabled investment banking advisory and asset management services, and FinTech-enabled capital table management solutions via CapForce’s next generation global digital investment banking platform.
Cost of Products, Cost of Services, and Operating Expenses
Prior to the repositioning of our business, our cost of products consisted of product and inventory costs, including materials costs and overhead, and other costs related to the recognition of revenue. Cost of services related to the material and labor costs associated with providing our services. Research and development expenses consisted primarily of expenses incurred in connection with our clinical and pre-clinical research activities. Selling, general and administrative expenses consisted of public company costs, salaries, and related costs for administrative, sales, and business development personnel.
Following the acquisition of a controlling interest in the Company by AEI Capital Ltd. and the formation of CapForce as OpGen’s wholly-owned subsidiary, the Company’s cost of sales will primarily be subcontractor and advisor fees and technology infrastructure costs associated with providing our services. Research and development expenses consist of fees to expand and innovate CapForce’s digital investment banking platform, and selling, general, and administrative expenses continue to consist of public company costs, salaries, and related costs for administrative and business development purposes.
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Results of operations for the three months ended September 30, 2025 and 2024
Revenues
We did not generate any revenues in the three months ended September 30, 2025 and 2024.
Operating expenses
| Three Months Ended September 30, |
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| 2025 | 2024 | |||||||
| Cost of products sold | $ | - | $ | - | ||||
| Cost of services | - | - | ||||||
| Research and development | - | 488 | ||||||
| General and administrative | 701,915 | 768,551 | ||||||
| Sales and marketing | 270 | 14,846 | ||||||
| Total operating expenses | $ | 702,185 | $ | 783,885 | ||||
Our total operating expenses for the three months ended September 30, 2025 decreased approximately 10% when compared to the same period in 2024. Operating expenses changed as follows:
| ● | Cost of products sold and cost of services: we had no cost of products sold or cost of services for the three months ended September 30, 2025 and 2024 as we had no products sales or laboratory services in those periods due to the Company scaling down its legacy operations and repositioning its business; and |
| ● | Research and development, general and administrative, and sales and marketing: research and development, general and administrative, and sales and marketing expenses decreased approximately 100%, 9%, and 98%, respectively, for the three months ended September 30, 2025 compared to the same period in 2024. The decreases are primarily attributable to the Company continuing to scale down its legacy operations and reposition its business. |
Other income (expense)
| Three Months Ended September 30, |
||||||||
| 2025 | 2024 | |||||||
| Interest and other income | $ | 97,371 | $ | 92,131 | ||||
| Interest expense | (3,916 | ) | (3,238 | ) | ||||
| Gain on extinguishment of debt | - | 9,738,487 | ||||||
| Gain on settlement of compensation expenses | - | 570,785 | ||||||
| Change in fair value of EIB loan guaranty | - | (683,200 | ) | |||||
| Foreign currency transaction losses | - | (2 | ) | |||||
| Total other income (expense) | $ | 93,455 | $ | 9,714,963 | ||||
Our total other income for the three months ended September 30, 2025 consisted primarily of sublease income. Our total other expense for the three months ended September 30, 2024 consisted primarily of the recognition of a gain on extinguishment of debt following the Company’s settlement of the EIB loan guaranty in August 2024, the recognition of a gain on settlement of compensation expenses following the Company’s settlement of deferred and accrued compensation and severance expenses with the Company’s former CEO, David E. Lazar, and the change in fair value of our EIB loan guaranty.
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Results of operations for the nine months ended September 30, 2025 and 2024
Revenues
| Nine Months Ended September 30, |
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| 2025 | 2024 | |||||||
| Product sales | $ | - | $ | 169,373 | ||||
| Laboratory services | - | 26,776 | ||||||
| Listing sponsorship services | 4,000,000 | - | ||||||
| Total revenue | $ | 4,000,000 | $ | 196,149 | ||||
We recognized revenue in the nine months ended September 30, 2025 solely related to our single contract to provide listing sponsorship and consulting services, as CapForce completed the second performance obligation within the Engagement Agreement, earning proceeds of $4.0 million in the Client’s equity. We did not generate any product sales or laboratory services revenue in the nine months ended September 30, 2025, due to the winding down of our legacy precision medicine business and repositioning ourselves in the financial services and technology industry.
Operating expenses
| Nine Months Ended September 30, |
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| 2025 | 2024 | |||||||
| Cost of products sold | $ | - | $ | 31,636 | ||||
| Cost of services | - | 1,575 | ||||||
| Research and development | - | 49,308 | ||||||
| General and administrative | 1,810,097 | 4,021,321 | ||||||
| Sales and marketing | 12,159 | 168,819 | ||||||
| Total operating expenses | $ | 1,822,256 | $ | 4,272,659 | ||||
Our total operating expenses for the nine months ended September 30, 2025 decreased approximately 57% when compared to the same period in 2024. Operating expenses changed as follows:
| · | Cost of products sold and cost of services: cost of products sold and cost of services for the nine months ended September 30, 2025 decreased 100% when compared to the same period in 2024. The decrease in cost of products sold and cost of services aligns with the decrease in product sales and laboratory services during the nine months ended September 30, 2025, which is due to the Company scaling down its legacy operations and repositioning its business; and |
| · | Research and development, general and administrative, and sales and marketing: research and development, general and administrative, and sales and marketing expenses decreased approximately 100%, 55%, and 93%, respectively, for the nine months ended September 30, 2025 compared to the same period in 2024. The decreases are primarily attributable to the Company scaling down its legacy operations and repositioning its business. |
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Other income (expense)
| Nine Months Ended September 30, |
||||||||
| 2025 | 2024 | |||||||
| Interest and other income | $ | 324,059 | $ | 242,799 | ||||
| Interest expense | (8,777 | ) | (4,317 | ) | ||||
| Gain on impairment adjustment | - | 2,079,575 | ||||||
| Gain on extinguishment of debt | - | 9,738,487 | ||||||
| Gain on settlement of compensation expenses | - | 570,785 | ||||||
| Change in fair value of EIB loan guaranty | - | (908,586 | ) | |||||
| Foreign currency transaction gains | 103 | 463 | ||||||
| Total other income | $ | 315,385 | $ | 11,719,206 | ||||
Our total other income for the nine months ended September 30, 2025 consisted primarily of sublease income. Our total other income for the nine months ended September 30, 2024 consisted primarily of the recognition of a gain on extinguishment of debt following the Company’s settlement of the EIB loan guaranty in August 2024, the recording of a gain on impairment adjustment following the identification of a subtenant and the lease assignment, the recognition of a gain on settlement of compensation expenses following the Company’s settlement of deferred and accrued compensation and severance expenses with the Company’s former CEO, David E. Lazar, and the change in fair value of our EIB loan guaranty.
Liquidity and Capital Resources
As of September 30, 2025, we had cash and cash equivalents of $0.4 million compared to $1.3 million at December 31, 2024. Historically, we have funded our operations primarily through external investor financing arrangements and strategic actions taken by us.
The following financing transactions generating gross proceeds of $5.0 million took place during 2024:
| ● | In March 2024, we entered into a securities purchase agreement with David E. Lazar, pursuant to which we agreed to sell 3,000,000 shares of Series E Convertible Preferred Stock to Mr. Lazar at a price of $1.00 per share for aggregate gross proceeds of $3.0 million. Pursuant to the agreement, Mr. Lazar paid a total of $550,000 in exchange for 550,000 shares of Series E Preferred Stock. In July 2024, Mr. Lazar consummated a transaction pursuant to which he sold the 550,000 shares of Series E Preferred Stock together with his rights to purchase the additional 2,450,000 shares of Series E Preferred Stock under the March 2024 Purchase Agreement to AEI Capital Ltd. Subsequently, AEI Capital Ltd. paid the Company $2.45 million in August 2024 in exchange for the remaining 2,450,000 shares of Series E Preferred Stock under the terms of the March 2024 Purchase Agreement. |
| ● | In August 2024, we entered into a securities purchase agreement (the “August 2024 Securities Purchase Agreement”) with AEI Capital Ltd., pursuant to which we have the right, in our sole discretion, to sell to AEI Capital Ltd., at any time prior to September 30, 2024, shares of common stock, par value $0.01 per share, of the Company having an aggregate value of up to $3.0 million. 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 before deducting offering expenses. In October 2024, we entered into a First Amendment (the “Amendment”) to the securities purchase agreement with AEI Capital Ltd. whereby we were: (i) granted the right to sell two additional tranches of common stock to AEI Capital Ltd. of $3.0 million each, for an aggregate amount of $9.0 million under the securities purchase agreement; and (ii) our ability to sell shares of common stock to AEI Capital Ltd. under the securities purchase agreement was extended until December 31, 2025. Accordingly, we have the right, in our sole discretion, to sell to AEI Capital Ltd., at any time and from time to time prior to December 31, 2025, up to $7.0 million of additional shares of common stock. |
In the near term, we anticipate funding our operations primarily through financing arrangements with AEI Capital Ltd., including the August 2024 Securities Purchase Agreement noted above, until our operating business is able to sustain our operations.
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Sources and uses of cash
The following table summarizes the net cash and cash equivalents (used in) provided by operating activities, investing activities and financing activities for the periods indicated:
| Nine months ended September 30, |
||||||||
| 2025 | 2024 | |||||||
| Net cash (used in) provided by | ||||||||
| Operating activities | $ | (978,685 | ) | $ | (4,637,508 | ) | ||
| Investing activities | - | - | ||||||
| Financing activities | 82,243 | 5,118,851 | ||||||
| Net (decrease) increase in cash and cash equivalents | $ | (896,442 | ) | $ | 481,343 | |||
Net cash used in operating activities
Net cash used in operating activities for the nine months ended September 30, 2025 consists primarily of our net income of $2.5 million and non-cash share-based compensation expense of $0.3 million, reduced by changes in operating assets and liabilities of $3.9 million.
Net cash used in operating activities for the nine months ended September 30, 2024 consisted primarily of our net income of $7.6 million and non-cash share-based compensation expense of $0.6 million, reduced by certain non-cash items, including the change in the fair value of the EIB loan guaranty of $10.9 million, gain on impairment adjustment of $2.1 million, and gain on settlement of compensation expenses of $0.6 million.
Net cash used in investing activities
We used no cash in investing activities during the nine months ended September 30, 2025 or 2024.
Net cash provided by financing activities
Net cash provided by financing activities for the nine months ended September 30, 2025 consists solely of proceeds and payments related to our short-term insurance financing.
Net cash provided by financing activities for the nine months ended September 30, 2024 consisted primarily of proceeds from the issuance of preferred stock in connection with the March 2024 Purchase Agreement with David E. Lazar and, subsequently, AEI Capital Ltd., as assignee from Mr. Lazar, and proceeds from the issuance of common stock in connection with the August 2024 Securities Purchase Agreement with AEI Capital Ltd.
Contractual Commitments
Other than the continuing liability under our former headquarters’ office lease, which lease was assigned to a third party in April 2024, the Company has no other material contractual commitments as of September 30, 2025.
Funding requirements
Going forward, our primary use of cash is to fund the Company’s revenue growth and operating expenses, including those costs for general administrative, digital investment banking platform development and maintenance, and corporate purposes. Our future funding requirements will depend on the costs associated with repositioning our business and complying with our obligations as a public company. We cannot provide any assurances that additional financing will not be required in the future to support our operations, but we intend to use financing opportunities strategically to continue strengthening our financial position and, in the near term, we anticipate funding our operations primarily through financing arrangements with AEI Capital Ltd., our controlling shareholder, until our operating business is able to sustain our operations.
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Critical accounting policies and use of estimates
This Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. In our unaudited condensed consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, stock-based compensation, allowances for credit losses and inventory obsolescence, discount rates used to discount unpaid lease payments to present values, valuation of derivative financial instruments measured at fair value on a recurring basis, deferred tax assets and liabilities and related valuation allowance, the estimated useful lives of long-lived assets, and the recoverability of long-lived assets. Actual results could differ from those estimates.
A summary of our significant accounting policies is included in Note 3 “Summary of significant accounting policies” to the accompanying unaudited condensed consolidated financial statements. Certain of our accounting policies are considered critical, as these policies require significant, difficult or complex judgments by management, often requiring the use of estimates about the effects of matters that are inherently uncertain. Our critical policies are summarized in Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our annual report on Form 10-K for the year ended December 31, 2024.
Recently issued accounting pronouncements
See Note 3 “Summary of significant accounting policies” in this quarterly report on Form 10-Q for a full description of recent accounting pronouncements, including the respective expected dates of adoption and effects on our unaudited condensed consolidated financial statements.
Off-balance sheet arrangements
As of September 30, 2025 and December 31, 2024, we did not have any off-balance sheet arrangements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As a smaller reporting company, the Company is not required to provide the information required by this Item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The Company’s management evaluated, with the participation of the Company’s principal executive officer and principal financial officer, the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2025. We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisions regarding disclosure. Based on their evaluation, management has concluded that the Company’s disclosure controls and procedures were effective as of September 30, 2025.
Changes in Internal Control over Financial Reporting
For the quarter ended September 30, 2025, there have been no changes in the Company’s internal controls over financial reporting that have materially affected, or are reasonably likely to materially affect, the Company’s internal controls over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
To the best of our knowledge, we are not currently a party to any legal proceedings that, individually or in the aggregate, are deemed to be material to our financial condition or results of operations.
Item 1A. Risk Factors
Reference is made to the Risk Factors included in our annual report on Form 10-K for the year ended December 31, 2024. There have been no material changes from such Risk Factors.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
There were no unregistered sales of equity securities during the three months ended September 30, 2025.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
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Item 6. Exhibits
|
Exhibit Number |
Description | |
| 31.1* | Certification pursuant to Rule 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| 32.1* | Certification pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
| 101* | Interactive data files pursuant to Rule 405 of Regulation S-T: (i) the Unaudited Condensed Consolidated Balance Sheets, (ii) the Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss), (iii) the Unaudited Condensed Consolidated Statements of Stockholders’ Equity (Deficit), (iv) the Unaudited Condensed Consolidated Statements of Cash Flows and (v) the Notes to the Unaudited Condensed Consolidated Financial Statements. |
| * | Filed or furnished herewith. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| OPGEN, INC. | ||
| By: | /s/ John Tan Honjian | |
| John Tan Honjian | ||
| Chief Executive Officer and Chairman (principal executive officer, principal financial officer, and principal accounting officer) | ||
| Date: | November 19, 2025 | |
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