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- Definition Weighted-average amortization periods for definite-lived intangible assets acquired. No definition available.
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- References No definition available.
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- Definition Weighted average amortization period of finite-lived intangible assets acquired either individually or as part of a group of assets, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Stockholders' Equity |
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Stockholders' Equity Note [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders’ equity | Note 7 – Stockholders’ equity
As of June 30, 2023, the Company had 100,000,000 shares of authorized common stock and 6,967,699 shares issued and outstanding, and 10,000,000 shares of authorized preferred stock, of which none were issued or outstanding.
Following receipt of approval from stockholders at a special meeting of stockholders held on January 17, 2018, the Company filed an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty-five shares. Additionally, following receipt of approval from stockholders at a special meeting of stockholders held on August 22, 2019, the Company filed an additional amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty shares. Following receipt of approval from stockholders at a special meeting of stockholders held on November 30, 2022, the Company filed an additional amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty shares, which reverse stock split was effective January 5, 2023. All share amounts and per share prices in this Quarterly Report have been adjusted to reflect the reverse stock splits.
On June 24, 2022, the Company entered into an At-the-Market Offering with H.C. Wainwright & Co., LLC, as a sales agent, pursuant to which the Company may offer and sell from time to time in an “at the market offering”, at its option, up to an aggregate of $10.65 million of shares of the Company’s common stock through Wainwright. As of December 31, 2022, the Company sold 85,732 shares under the 2022 ATM Offering totaling $1.03 million in gross proceeds and $0.99 million in net proceeds. The Company has not sold any shares under the 2022 ATM Agreement in 2023.
On October 3, 2022, the Company closed a registered direct offering of shares of common stock and Series C Mirroring Preferred Stock pursuant to a Securities Purchase Agreement entered into with a certain institutional investor. In the offering, the Company agreed to issue and sell to the investor (i) 268,000 shares of the Company’s common stock, par value $0.01 per share, (ii) 33,810 shares of the Company’s Series C Mirroring Preferred Stock, par value $0.01 per share and stated value of $0.01 per share, and (iii) pre-funded warrants to purchase an aggregate of 215,000 shares of common stock. Each share of common stock was sold at a price of $7.00 per share, each share of preferred stock was sold at a price of $0.01 per share, and each pre-funded warrant was sold at an offering price of $6.80 per share underlying such pre-funded warrants, for aggregate gross proceeds of $3.34 million before deducting the placement agent’s fees and the offering expenses, and net proceeds of $3.04 million. Under the purchase agreement, the Company also agreed to issue and sell to the investor in a concurrent private placement warrants to purchase an aggregate of 483,000 shares of common stock. In connection with the offering, the Company also entered into a warrant amendment agreement with the investor pursuant to which the Company agreed to amend certain existing warrants to purchase up to 741,489 shares of common stock that were previously issued in 2018 and 2021 to the investor, with exercise prices ranging from $41.00 to $1,300.00 per share as a condition to their purchase of the securities in the offering, as follows: (i) lower the exercise price of the investor’s existing warrants to $7.54 per share, (ii) provide that the existing warrants, as amended, will not be exercisable until six months following the closing date of the offering, and (iii) extend the original expiration date of the existing warrants by five and one-half years following the closing of the offering. The increase in fair value resulting from the warrant modifications is accounted for as an equity issuance cost, resulting in a debit and credit to additional paid in capital for approximately $1.8 million. As of December 31, 2022, all 215,000 pre-funded warrants issued in the offering were exercised. In connection with the Company’s best-efforts public offering consummated in May 2023, the Company amended the exercise price of the existing warrants to $0.7785 per share.
On January 11, 2023, the Company closed a best-efforts public offering pursuant to a Securities Purchase Agreement entered into with a certain institutional investor for the purchase of (i) 321,207 shares of the Company’s common stock, par value $0.01 per share, (ii) pre-funded warrants to purchase up to an aggregate of 2,265,000 shares of common stock, (iii) Series A-1 common warrants to purchase an aggregate of 2,586,207 shares of common stock, and (iv) Series A-2 common warrants to purchase an aggregate of 2,586,207 shares of common stock. Each share of common stock and accompanying Series A-1 Warrant and Series A-2 Warrant (collectively, the “Common Warrants”) was sold at a price of $2.90 per share and accompanying Common Warrants, and each Pre-funded Warrant and accompanying Series A-1 Warrant and Series A-2 Warrant was sold at an offering price of $2.89 per share underlying such Pre-funded Warrants and accompanying Common Warrants, for aggregate gross proceeds of approximately $7.5 million before deducting the placement agent’s fees and the offering expenses, and net proceeds of approximately $6.9 million. The Common Warrants have an exercise price of $2.65 per share. The Series A-1 Warrants were immediately exercisable upon issuance, and will expire five years following the issuance date. The Series A-2 Warrants were immediately exercisable upon issuance, and will expire eighteen months following the issuance date. Subject to certain ownership limitations described in the Pre-funded Warrants, the Pre-funded Warrants were immediately exercisable and could be exercised at a nominal consideration of $0.01 per share of common stock any time until all the Pre-funded Warrants are exercised in full. All Pre-funded Warrants were exercised by February 15, 2023. In connection with the Company’s best-efforts public offering consummated in May 2023, the Company amended the exercise price of the Common Warrants to $0.7785 per share.
On May 4, 2023, the Company closed a best-efforts public offering pursuant to a Securities Purchase Agreement with a certain institutional investor, pursuant to which the Company issued and sold to the Investor (i) 605,000 shares of the Company’s common stock, par value $0.01 per share, (ii) pre-funded warrants to purchase up to an aggregate of 3,890,825 shares of common stock, and (iii) common warrants to purchase up to an aggregate of 4,495,825 shares of common stock. Each share of common stock and accompanying common warrant was sold at a price of $0.7785 per share and accompanying common warrant, and each pre-funded warrant and accompanying common warrant was sold at an offering price of $0.7685 per share underlying such pre-funded warrant and accompanying common warrant, for aggregate gross proceeds of approximately $3.5 million and net proceeds of approximately $3.0 million. The common warrants have an exercise price of $0.7785 per share and will be exercisable beginning on the date of stockholder approval of the exercisability of the warrants under Nasdaq rules. The common warrants will expire on the five-year anniversary of the date of such stockholder approval. Each pre-funded warrant has an exercise price per share of common stock equal to $0.01 per share and may be exercised at any time until the pre-funded warrants are exercised in full. In connection with the offering, the Company also entered into a warrant amendment agreement with the investor pursuant to which the Company amended certain existing warrants to purchase up to 6,396,903 shares of common stock that were previously issued in 2018, 2021, 2022 and 2023 to the investor, with exercise prices ranging from $2.65 to $7.54 per share, in consideration for their purchase of the securities in the offering, as follows: (i) lower the exercise price of the existing warrants to $0.7785 per share, (ii) provide that the existing warrants, as amended, will not be exercisable until the receipt of stockholder approval for the exercisability of the common warrants in the offering, and (iii) extend the original expiration date of the existing warrants by five years following the receipt of such stockholder approval. The increase in fair value resulting from the warrant modifications is accounted for as an equity issuance cost, resulting in a debit and credit to additional paid in capital of approximately $0.3 million. As of June 30, 2023, stockholder approval for the exercisability of the common warrants in the offering has not yet been obtained.
Stock options
In 2008, the Company adopted the 2008 Stock Option and Restricted Stock Plan (the “2008 Plan”), pursuant to which the Company’s Board of Directors could grant either incentive or non-qualified stock options or shares of restricted stock to directors, key employees, consultants and advisors.
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. Following the effectiveness of the 2015 Plan, no further grants will be made under the 2008 Plan. 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 grants of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors and consultants.
Under the 2015 Plan, the aggregate number of shares of the common stock authorized for issuance may not exceed (1) 2,710 plus (2) the sum of the number of shares subject to outstanding awards under the 2008 Plan as of the 2015 Plan’s effective date, that are subsequently forfeited or terminated for any reason before being exercised or settled, plus (3) the number of shares subject to vesting restrictions under the 2008 Plan as of the 2015 Plan’s effective date that are subsequently forfeited. In addition, the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. Following Board of Director approval, 115,996 shares were automatically added to the 2015 Plan in 2023. Shares subject to awards granted under the 2015 Plan that are forfeited or terminated before being exercised or settled, or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2015 Plan. However, shares that have actually been issued shall not again become available unless forfeited. As of June 30, 2023, 81,646 shares remain available for issuance under the 2015 Plan.
In connection with the appointment of Albert Weber as Chief Financial Officer, OpGen granted Mr. Weber an inducement grant of stock options to purchase an aggregate of 10,500 shares of OpGen’s common stock with a grant date of January 3, 2022. The equity award was granted as a component of Mr. Weber’s employment compensation and was granted as an inducement material to his acceptance of employment with OpGen. The options have an exercise price of $21.60, a ten-year term and a vesting schedule of 25% vesting of the award on the first annual anniversary of the date of grant and then 6.25% vesting each quarter thereafter over three additional years. The award is subject to Mr. Weber’s continued service with OpGen through the applicable vesting dates.
For the three and six months ended June 30, 2023 and 2022, the Company recognized share-based compensation expense as follows:
No income tax benefit for share-based compensation arrangements was recognized in the condensed consolidated statements of operations and comprehensive loss due to the Company’s net loss position.
During the three and six months ended June 30, 2023, the Company did not grant any options, no options were forfeited, and no options expired.
The Company had total stock options to acquire 107,597 shares of common stock outstanding at June 30, 2023 under all of its equity compensation plans.
Restricted stock units
During the three months ended June 30, 2023, the Company granted 7,500 restricted stock units, 22,153 restricted stock units vested, and none were forfeited. During the six months ended June 30, 2023, the Company granted 100,500 restricted stock units, 33,780 restricted stock units vested, and none were forfeited. The Company had 109,627 total restricted stock units outstanding at June 30, 2023.
Stock purchase warrants
At June 30, 2023 and December 31, 2022, the following warrants to purchase shares of common stock were outstanding:
The warrants listed above were issued in connection with various debt, equity or development contract agreements.
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- Definition The entire disclosure for equity. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount recognized for the passage of time, typically for liabilities, that have been discounted to their net present values. Excludes accretion associated with asset retirement obligations. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Amount of cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage; including, but not limited to, disposal group and discontinued operations. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of increase (decrease) in cash, cash equivalents, and cash and cash equivalents restricted to withdrawal or usage; including effect from exchange rate change. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The aggregate expense recognized in the current period that allocates the cost of tangible assets, intangible assets, or depleting assets to periods that benefit from use of the assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of increase (decrease) from effect of exchange rate changes on cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage; held in foreign currencies; including, but not limited to, disposal group and discontinued operations. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Amount of expense (income) related to adjustment to fair value of warrant liability. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of cash outflow for principal payment on finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of gain (loss) on sale or disposal of property, plant and equipment assets, including oil and gas property and timber property. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Change in recurring obligations of a business that arise from the acquisition of merchandise, materials, supplies and services used in the production and sale of goods and services. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The increase (decrease) during the reporting period in amount due within one year (or one business cycle) from customers for the credit sale of goods and services. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of increase (decrease) in accrued expenses, and obligations classified as other. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Amount of increase (decrease) in deferred income and obligation to transfer product and service to customer for which consideration has been received or is receivable. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition The increase (decrease) during the reporting period in the aggregate value of all inventory held by the reporting entity, associated with underlying transactions that are classified as operating activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of increase (decrease) in operating assets classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of cash paid for interest, excluding capitalized interest, classified as operating activity. Includes, but is not limited to, payment to settle zero-coupon bond for accreted interest of debt discount and debt instrument with insignificant coupon interest rate in relation to effective interest rate of borrowing attributable to accreted interest of debt discount. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The change in the inventory reserve representing the cumulative difference in cost between the first in, first out and the last in, first out inventory valuation methods, which change has been reflected in the statement of income during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Fair value of share-based compensation granted to nonemployees as payment for services rendered or acknowledged claims. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of cash inflow (outflow) from financing activities, including discontinued operations. Financing activity cash flows include obtaining resources from owners and providing them with a return on, and a return of, their investment; borrowing money and repaying amounts borrowed, or settling the obligation; and obtaining and paying for other resources obtained from creditors on long-term credit. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of cash inflow (outflow) from investing activities, including discontinued operations. Investing activity cash flows include making and collecting loans and acquiring and disposing of debt or equity instruments and property, plant, and equipment and other productive assets. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of cash inflow (outflow) from operating activities, including discontinued operations. Operating activity cash flows include transactions, adjustments, and changes in value not defined as investing or financing activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The cash outflow associated with the acquisition of long-lived, physical assets that are used in the normal conduct of business to produce goods and services and not intended for resale; includes cash outflows to pay for construction of self-constructed assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The cash inflow during the period from additional borrowings in aggregate debt. Includes proceeds from short-term and long-term debt. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Amount of cash outflow for short-term and long-term debt. Excludes payment of lease obligation. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Amount of noncash expense for share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Number of equity instruments other than options outstanding, including both vested and non-vested instruments. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Weighted average price at which grantees can acquire the shares reserved for issuance under the stock option plan. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Summary of Significant Accounting Policies (Details) - Schedule of expected amortization of intangible assets |
Jun. 30, 2023
USD ($)
|
---|---|
Schedule Of Expected Amortization Of Intangible Assets Abstract | |
2023 (July to December) | $ 375,920 |
2024 | 751,840 |
2025 | 751,840 |
2026 | 751,840 |
2027 | 715,051 |
Thereafter | 3,859,891 |
Total | $ 7,206,382 |
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- Definition Amount of amortization for assets, excluding financial assets and goodwill, lacking physical substance with finite life expected to be recognized in fifth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach) No definition available.
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- Definition Amount of amortization for asset, excluding financial asset and goodwill, lacking physical substance with finite life expected to be recognized in the future. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). No definition available.
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- Definition Amount of amortization for asset, excluding financial asset and goodwill, lacking physical substance with finite life expected to be recognized after fifth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). No definition available.
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- Definition Amount of amortization for assets, excluding financial assets and goodwill, lacking physical substance with finite life expected to be recognized in fifth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of amortization for assets, excluding financial assets and goodwill, lacking physical substance with finite life expected to be recognized in fourth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of amortization for assets, excluding financial assets and goodwill, lacking physical substance with finite life expected to be recognized in third fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of amortization for assets, excluding financial assets and goodwill, lacking physical substance with finite life expected to be recognized in second fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Fair Value Measurements (Details) - Schedule of financial assets and liabilities measured at fair value on a recurring basis |
6 Months Ended |
---|---|
Jun. 30, 2023
USD ($)
| |
Fair Value Measurements (Details) - Schedule of financial assets and liabilities measured at fair value on a recurring basis [Line Items] | |
Balance at the beginning of the period | $ 99,498 |
Change in Fair Value | (55,411) |
Effect of Foreign Exchange Rates | 1,569 |
Balance at the end of the period | 45,656 |
Participation percentage interest liability [Member] | |
Fair Value Measurements (Details) - Schedule of financial assets and liabilities measured at fair value on a recurring basis [Line Items] | |
Balance at the beginning of the period | 99,498 |
Change in Fair Value | (55,411) |
Effect of Foreign Exchange Rates | 1,569 |
Balance at the end of the period | $ 45,656 |
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- Definition Effect of foreign exchange rates. No definition available.
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- Definition Amount of increase (decrease) of financial instrument classified as a liability measured using unobservable inputs that reflect the entity's own assumption about the assumptions market participants would use in pricing. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Fair value of financial instrument classified as a liability measured using unobservable inputs that reflect the entity's own assumption about the assumptions market participants would use in pricing. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Leases |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases | Note 9 – Leases
The following table presents the Company’s ROU assets and lease liabilities as of June 30, 2023 and December 31, 2022:
Maturities of lease liabilities as of June 30, 2023 by fiscal year are as follows:
Condensed consolidated statements of operations classification of lease costs as of the three and six months ended June 30, 2023 and 2022 are as follows:
Other lease information as of June 30, 2023 is as follows:
Supplemental cash flow information as of the six months ended June 30, 2023 and 2022 is as follows:
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Fair Value Measurements (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of financial assets and liabilities measured at fair value on a recurring basis | The fair value of level 3 liabilities measured at
fair value on a recurring basis for the six months ended June 30, 2023 was as follows:
|
X | ||||||||||
- Definition Tabular disclosure of assets, including [financial] instruments measured at fair value that are classified in stockholders' equity, if any, by class that are measured at fair value on a recurring basis. The disclosures contemplated herein include the fair value measurements at the reporting date by the level within the fair value hierarchy in which the fair value measurements in their entirety fall, segregating fair value measurements using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- References No definition available.
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Revenue from Contracts with Customers |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Contracts with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from contracts with customers | Note 4 – Revenue from contracts with customers
Disaggregated revenue
The Company provides diagnostic test products and laboratory services to hospitals, clinical laboratories and other healthcare providing customers, and enters into collaboration agreements with government agencies, non-governmental organizations, and healthcare providers. The revenues by type of service consist of the following:
Revenues by geography are as follows:
Deferred revenue
Changes to deferred revenue for the period were as follows:
Contract assets
The Company had no contract assets as of June 30, 2023 and December 31, 2022, which are generated when contractual billing schedules differ from revenue recognition timing. Contract assets represent a conditional right to consideration for satisfied performance obligations that becomes a billed receivable when the conditions are satisfied.
Unsatisfied performance obligations
The Company had no unsatisfied performance obligations related to its contracts with customers at June 30, 2023 and December 31, 2022. |
X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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License Agreements, Research Collaborations and Development Agreements (Details) € in Thousands |
1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
---|---|---|---|---|---|---|---|---|
Aug. 01, 2023
EUR (€)
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Sep. 22, 2022
EUR (€)
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Jun. 30, 2023
USD ($)
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Jun. 30, 2023
EUR (€)
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Jun. 30, 2022
USD ($)
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Jun. 30, 2023
USD ($)
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Jun. 30, 2023
EUR (€)
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Jun. 30, 2022
USD ($)
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License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||
Revenues generated from additional work packages | € 130 | |||||||
Revenues generated from total project volume | 830 | |||||||
Amount recognized related to collaboration | 600 | |||||||
Total amount recognized related to collaboration | € 800 | |||||||
Research and development collaboration agreement extended date | May 31, 2024 | |||||||
Sandoz Agreement [Member] | ||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||
Initial agreement period, description | 36 months and was subsequently extended to January 31, 2025 | 36 months and was subsequently extended to January 31, 2025 | ||||||
Qiagen [Member] | ||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||
Contractual agreement period | 20 years | 20 years | ||||||
Contractual days | 180 days | 180 days | 180 days | 180 days | ||||
Siemens Agreement [Member] | ||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||
Royalty expenses (in Dollars) | $ | $ 2,264 | $ 703 | $ 4,207 | $ 3,482 | ||||
Siemens Agreement [Member] | Minimum [Member] | ||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||
Royalty rate | 1.30% | 1.30% | ||||||
Siemens Agreement [Member] | Maximum [Member] | ||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||
Royalty rate | 40.00% | 40.00% | ||||||
Curetis GmbH and FIND [Member] | ||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||
Initial contract amount | € 700 | |||||||
Amount recognized related to collaboration | € 200 | |||||||
Subsequent Event [Member] | ||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||
Expansion of research and development collaboration | € 500 |
X | ||||||||||
- Definition The amount recognized related to collaboration. No definition available.
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X | ||||||||||
- Definition Contractual agreement period. No definition available.
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X | ||||||||||
- Definition Contractual days. No definition available.
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X | ||||||||||
- Definition Expansion of research and development collaboration. No definition available.
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X | ||||||||||
- Definition The description of initial agreement. No definition available.
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X | ||||||||||
- Definition Initial contract amount. No definition available.
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Research and development collaboration agreement extended date. No definition available.
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X | ||||||||||
- Definition Revenues generated from additional work packages. No definition available.
|
X | ||||||||||
- Definition Revenues generated from total project volume. No definition available.
|
X | ||||||||||
- Definition Amount of income or expense related to royalty payments under a contractual arrangement such as payment for mineral and drilling rights and use of technology or intellectual property. No definition available.
|
X | ||||||||||
- Definition Royalty rate. No definition available.
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X | ||||||||||
- Definition Amount recognized related to collaboration No definition available.
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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- Details
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- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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Leases (Details) - Schedule of lease cost classifications - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Finance: | ||||
Total lease costs | $ 172,344 | $ 184,389 | $ 310,970 | $ 399,920 |
Operating Expenses [Member] | ||||
Leases (Details) - Schedule of lease cost classifications [Line Items] | ||||
Operating | 171,506 | 152,784 | 309,303 | 327,699 |
Finance: | ||||
Amortization | 838 | 31,096 | 1,667 | 70,807 |
Other Expenses [Member] | ||||
Finance: | ||||
Interest expense | $ 509 | $ 1,414 |
X | ||||||||||
- References No definition available.
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Amount of interest expense on finance lease liability. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Amount of amortization expense attributable to right-of-use asset from finance lease. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Amount of lease cost recognized by lessee for lease contract. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Amount of single lease cost, calculated by allocation of remaining cost of lease over remaining lease term. Includes, but is not limited to, single lease cost, after impairment of right-of-use asset, calculated by amortization of remaining right-of-use asset and accretion of lease liability. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Details
|
X | ||||||||||
- Details
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Summary of Significant Accounting Policies |
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies | 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, 2022 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 and its wholly-owned subsidiaries as of and for the three and six months ended June 30, 2023; all intercompany transactions and balances have been eliminated.
Foreign currency
The Company has subsidiaries located in Holzgerlingen, Germany and Vienna, Austria, each of which use currencies other than the U.S. dollar as their functional currency. As a result, all assets and liabilities of the subsidiaries are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive income (loss), a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive income (loss) at June 30, 2023 and December 31, 2022.
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 loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar.
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, inducement expense related to warrant repricing, stock-based compensation, allowances for doubtful accounts 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, determining the fair value of assets acquired and liabilities assumed in business combinations, the estimated useful lives of long-lived assets, and the recoverability of long-lived assets. Actual results could differ from those estimates.
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.
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 $250,000. On March 10, 2023, the Company learned that Silicon Valley Bank (“SVB”), the Company’s primary bank at the time (now a division of First Citizens Bank), was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation as receiver. The Company did not experience any losses in such accounts, but since the Company was exposed to credit risk with the failure of SVB, management diversified the Company’s holdings to minimize credit risk in the future.
At June 30, 2023 and December 31, 2022, the Company had funds totaling $496,894 and $495,629, respectively, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying unaudited condensed consolidated balance sheets.
The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheets:
Accounts receivable
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 30 to 90 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $0 as of June 30, 2023 and December 31, 2022.
At June 30, 2023, the Company had accounts receivable from three customers which individually represented 30%, 25%, and 12% of total accounts receivable. At December 31, 2022, the Company had accounts receivable from two customers which individually represented 41% and 21% of total accounts receivable. For the three months ended June 30, 2023, revenue earned from three customers represented 25%, 19%, and 13% of total revenues. For the three months ended June 30, 2022, revenue earned from two customers represented 57% and 12% of total revenues. For the six months ended June 30, 2023, revenue earned from two customers represented 37% and 16% of total revenues. For the six months ended June 30, 2022, revenue earned from two customers represented 47% and 15% of total revenues.
Inventory
Inventories are valued using the first-in, first-out cost method and stated at the lower of cost or net realizable value and consist of the following:
Inventory includes Unyvero system instruments, Unyvero cartridges, reagents and components for Unyvero and Acuitas kits, and reagents and supplies used for the Company’s laboratory services.
The Company periodically reviews inventory quantities on hand and analyzes the provision for excess and obsolete inventory based primarily on product expiration dating and its estimated sales forecast, which is based on sales history and anticipated future demand. The Company’s estimates of future product demand may not be accurate, and it may understate or overstate the provision required for excess and obsolete inventory. Accordingly, any significant unanticipated changes in demand could have a significant impact on the value of the Company’s inventory and results of operations. Based on the Company’s assumptions and estimates, inventory reserves for obsolescence, expirations, and slow-moving inventory were $2,083,212 and $1,694,843 at June 30, 2023 and December 31, 2022, respectively.
The Company classifies finished good inventory it does not expect to sell or use in clinical studies within 12 months of the unaudited condensed consolidated balance sheets date as strategic inventory, a non-current asset.
Long-lived assets
Property and equipment
Property and equipment 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 future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the three and six months ended June 30, 2023 and 2022, the Company determined that its property and equipment were not impaired.
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.
ROU assets
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 future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done 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 assets exceeds the fair value of the assets. The Company did not identify any impaired ROU assets for the six months ended June 30, 2023 and 2022.
Intangible assets
As of June 30, 2023, the Company’s intangible assets with net balances are all finite-lived.
Finite-lived and indefinite-lived intangible assets
Intangible assets include trademarks, developed technology and software, in-process research & development (“IPR&D”), and distributor relationships and consisted of the following as of June 30, 2023 and December 31, 2022:
Identifiable intangible assets are amortized on a straight-line basis over their estimated useful lives. The estimated useful lives of the intangibles are:
Acquired IPR&D represents the fair value assigned to those research and development projects that were acquired in a business combination for which the related products have not received regulatory approval and have no alternative future use. IPR&D is capitalized at its fair value as an indefinite-lived intangible asset, and any development costs incurred after the acquisition are expensed as incurred. Upon achieving regulatory approval or commercial viability for the related product, the indefinite-lived intangible asset is accounted for as a finite-lived asset and is amortized on a straight-line basis over the estimated useful life. If the project is not completed or is terminated or abandoned, the Company may have an impairment related to the IPR&D which is charged to expense. Indefinite-lived intangible assets are tested for impairment annually and whenever events or changes in circumstances indicate that the carrying amount may be impaired. Impairment is calculated as the excess of the asset’s carrying value over its fair value. During the Company’s annual impairment test for its IPR&D intangible asset at December 31, 2022, it was determined that the infinite-lived intangible asset was impaired because although the Company has an ongoing collaboration utilizing the intangible asset, at the time, the contracted cash flow associated with this collaboration and projected future cash flows did not support the carrying amount. As a result, the Company recorded an impairment charge in the amount of $5,407,699 for the year ended December 31, 2022.
The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets.
Total amortization expense of intangible assets was $187,540 and $182,993 for the three months ended June 30, 2023 and 2022, respectively. Total amortization expense of intangible assets was $373,917 and $375,018 for the six months ended June 30, 2023 and 2022, respectively. Expected future amortization of intangible assets is as follows:
In accordance with ASC 360-10, Property, Plant and Equipment, intangible assets, other than IPR&D as discussed above, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. During the three and six months ended June 30, 2023, the Company identified triggering events that may indicate that the carrying amount of the intangible assets are not recoverable. The triggering events identified include the decline in the Company’s stock price, the receipt of a non-compliance notice from The Nasdaq Stock Market LLC regarding its minimum bid price requirement, and the Company’s inability to repay its debt to the EIB, in full, as originally required. As a result of identifying these potential indicators of impairment, the Company performed a long-lived asset impairment analysis for the three months ended June 30, 2023, and this analysis determined that the fair value of the Company’s assets exceeded their carrying values, so no impairment loss was recorded. During the three and six months ended June 30, 2022, the Company determined that its finite-lived intangible assets were not impaired.
Goodwill
Goodwill represents the excess of the purchase price paid when the Company acquired AdvanDx, Inc. in July 2015 and Curetis in April 2020, over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company conducts an impairment test of goodwill on an annual basis and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. During the year ended December 31, 2022, the Company performed qualitative and quantitative analyses, assessing trends in market capitalization, current and future cash flows, revenue growth rates, and the impact of global unrest and the COVID-19 pandemic on the Company and its performance. Based on the analysis performed, and primarily due to changes in the Company’s stock price and market capitalization in the third quarter of 2022, it was determined that goodwill was impaired. As a result, the Company recorded a goodwill impairment charge in the full amount of $6,940,549 for the year ended December 31, 2022.
Revenue recognition
The Company derives revenues from (i) the sale of Unyvero Application cartridges, Unyvero instruments, and Acuitas AMR Gene Panel test products, (ii) providing laboratory services, (iii) providing collaboration services (e.g., with the Foundation for Innovative New Diagnostics (FIND) on the Unyvero A30 RQ platform) including funded software and license arrangements, and (iv) granting access to subsets of the proprietary ARESdb data asset.
The Company analyzes 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 obligation.
The Company recognizes revenues upon the satisfaction of its performance obligation (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.
Government grant agreements and research incentives
From time to time, the Company may enter into arrangements with governmental entities for the purposes of obtaining funding for research and development activities. The Company recognizes funding from grants and from research incentives received from Austrian government agencies in the condensed consolidated statements of operations and comprehensive loss in the period during which the related qualifying expenses are incurred, provided that the conditions under which the grants or incentives were provided have been met. For grants under funding agreements and for proceeds under research incentive programs, the Company recognizes grant and incentive income in an amount equal to the estimated qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage. The Company classifies government grants received under these arrangements as a reduction to the related research and development expense incurred. The Company analyzes each arrangement on a case-by-case basis. For the three months ended June 30, 2023 and 2022, the Company recognized $88,421 and $111,414 as a reduction of research and development expense related to government grant arrangements, respectively. For the six months ended June 30, 2023 and 2022, the Company recognized $222,359 and $219,879 as a reduction of research and development expense related to government grant arrangements, respectively. The Company had earned but not yet received $618,637 and $401,436 related to these agreements and incentives included in prepaid expenses and other current assets, as of June 30, 2023 and December 31, 2022, respectively.
Research and development costs
Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, and fees paid to consultants and outside service partners.
Stock-based compensation
Stock-based compensation expense is recognized at grant date fair value. The fair value of stock-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. For restricted stock awards with a time-based vesting condition, the fair value, which is fixed at the grant date for purposes of recognizing compensation costs, is determined by reference to the Company’s stock price on the grant date. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. 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.
Warrants
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the instruments’ specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the instruments are free standing financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the instruments meet all of the requirements for equity classification under ASC 815, including whether the instruments are indexed to the Company’s own ordinary shares and whether the instrument holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent period end date while the instruments are outstanding.
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 $232,682,072 and $202,015,062 at December 31, 2022 and 2021, respectively. Despite the NOL carryforwards, which began expiring in 2022, the Company may have state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized.
The Company also has foreign NOL carryforwards of $170,661,923 at December 31, 2022 from their foreign subsidiaries. $162,712,615 of those foreign NOL carryforwards are from the Company’s operations in Germany. Despite the NOL carryforwards, the Company may have a current and future tax liability due to the nuances of German tax law around the use of NOLs within a consolidated group. There is no assurance that the NOL carryforwards will ever be fully utilized.
Loss per share
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.
For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method.
For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) unvested restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 11.2 million shares and 1.0 million shares as of June 30, 2023 and 2022, respectively.
Adopted accounting pronouncements
In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2021-04”). ASU 2021-04 clarifies and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options, including warrants, that remain equity-classified after modification or exchange. ASU 2021-04 requires an entity to treat a modification or an exchange of a freestanding equity-classified written call option that remains equity-classified after the modification or exchange as an exchange of the original instrument for a new instrument and provides guidance on measuring and recognizing the effect of a modification or an exchange. The Company adopted ASU 2021-04 on January 1, 2022. The adoption did not have a material impact on the Company’s consolidated financial statements and related disclosures.
Recently issued accounting standards
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. |
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- References No definition available.
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- Definition The entire disclosure for all significant accounting policies of the reporting entity. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Summary of Significant Accounting Policies (Details) - Schedule of inventories - USD ($) |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Schedule Of Inventories Abstract | ||
Raw materials and supplies | $ 1,254,776 | $ 1,011,476 |
Work-in-process | 28,069 | 37,445 |
Finished goods | 2,061,920 | 2,596,830 |
Total | $ 3,344,765 | $ 3,645,751 |
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- References No definition available.
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- Definition Carrying amount, net of valuation reserves and adjustments, as of the balance sheet date of merchandise or goods held by the company that are readily available for sale. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Amount after valuation and LIFO reserves of inventory expected to be sold, or consumed within one year or operating cycle, if longer. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Aggregated amount of unprocessed materials to be used in manufacturing or production process and supplies that will be consumed. This amount is net of valuation reserves and adjustments. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Carrying amount, net of reserves and adjustments, as of the balance sheet date of merchandise or goods which are partially completed. This inventory is generally comprised of raw materials, labor and factory overhead costs, which require further materials, labor and overhead to be converted into finished goods, and which generally require the use of estimates to determine percentage complete and pricing. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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Organization |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Organization [Abstract] | |
Organization | Note 1 – Organization
OpGen, Inc. (“OpGen” or the “Company”) was incorporated in Delaware in 2001. On April 1, 2020, OpGen completed its business combination transaction (the “Transaction”) with Curetis N.V., a public company with limited liability under the laws of the Netherlands (the “Seller” or “Curetis N.V.”), as contemplated by the Implementation Agreement, dated as of September 4, 2019 (the “Implementation Agreement”), by and among the Company, the Seller, and Crystal GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany and wholly-owned subsidiary of the Company (the “Purchaser”). Pursuant to the Implementation Agreement, the Purchaser acquired all the shares of Curetis GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany (“Curetis GmbH”), and certain other assets and liabilities of the Seller (together, “Curetis”). As of December 31, 2022, Crystal GmbH was dissolved and merged into Curetis GmbH. References to the “Company” include OpGen and its wholly-owned subsidiaries. The Company’s headquarters are in Rockville, Maryland, and the Company’s principal operations are in Rockville, Maryland; Holzgerlingen and Bodelshausen, Germany; and Vienna, Austria. The Company operates in one business segment.
OpGen Overview
OpGen is a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. Along with its subsidiaries, Curetis GmbH and Ares Genetics GmbH, the Company is developing and commercializing 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. OpGen’s current product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, NGS technology and AI-powered bioinformatics solutions for AMR surveillance, outbreak analysis, and antibiotic response prediction including ARESiss, ARESid, ARESasp, and AREScloud.
The focus of OpGen is on its combined broad portfolio of products, which include high impact rapid diagnostics and bioinformatics to interpret antimicrobial resistance (“AMR”) genetic data. OpGen will continue to develop and seek FDA and other regulatory clearances or approvals, as applicable, for the Unyvero UTI and IJI products. OpGen offers the FDA-cleared Unyvero LRT and LRT BAL Panels, the FDA-cleared Acuitas AMR Gene Panel diagnostic test, as well as the Unyvero UTI Panel as a research use only, or RUO, product to hospitals, public health departments, clinical laboratories, pharmaceutical companies, and contract research organizations, or CROs. In addition, following successful completion of a prospective multi-center clinical trial, the UTI product was submitted to the FDA in the second quarter of 2023. The FDA provided an additional information request letter on June 30, 2023. The Company has 180 days from the date of such request letter to respond to the FDA’s requests. OpGen is also commercializing its CE-marked Unyvero Panels in Europe and other global markets via distributors, and, following the signing of a distribution deal with Fisher Healthcare in April 2023, the Company is using a mix of direct and distributor sales in the United States. |
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- References No definition available.
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- Definition The entire disclosure for organization, consolidation and basis of presentation of financial statements disclosure. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) - USD ($) |
Common Stock |
Preferred Stock |
Additional Paid- in Capital |
Accumulated Other Comprehensive Income (Loss) |
Accumulated Deficit |
Total |
---|---|---|---|---|---|---|
Balances at Dec. 31, 2021 | $ 23,225 | $ 276,149,768 | $ 585,626 | $ (235,541,539) | $ 41,217,080 | |
Balances (in Shares) at Dec. 31, 2021 | 2,322,511 | |||||
Issuance of RSUs | $ 54 | (54) | ||||
Issuance of RSUs (in Shares) | 5,375 | |||||
Stock compensation expense | 241,619 | 241,619 | ||||
Foreign currency translation | (483,849) | (483,849) | ||||
Net loss | (6,803,716) | (6,803,716) | ||||
Balances at Mar. 31, 2022 | $ 23,279 | 276,391,333 | 101,777 | (242,345,255) | 34,171,134 | |
Balances (in Shares) at Mar. 31, 2022 | 2,327,886 | |||||
Issuance of RSUs | $ 33 | (33) | ||||
Issuance of RSUs (in Shares) | 3,293 | |||||
Stock compensation expense | 257,403 | 257,403 | ||||
Foreign currency translation | (1,227,142) | (1,227,142) | ||||
Net loss | (5,840,415) | (5,840,415) | ||||
Balances at Jun. 30, 2022 | $ 23,312 | 276,648,703 | (1,125,365) | (248,185,670) | 27,360,980 | |
Balances (in Shares) at Jun. 30, 2022 | 2,331,179 | |||||
Balances at Dec. 31, 2022 | $ 28,999 | 281,167,161 | (795,840) | (272,824,772) | 7,575,548 | |
Balances (in Shares) at Dec. 31, 2022 | 2,899,911 | |||||
Issuance of RSUs | $ 116 | (116) | ||||
Issuance of RSUs (in Shares) | 11,627 | |||||
Stock compensation expense | 211,122 | 211,122 | ||||
Offering of common stock and warrants, net of issuance costs | $ 25,862 | 6,948,188 | 6,974,050 | |||
Offering of common stock and warrants, net of issuance costs (in Shares) | 2,586,207 | |||||
Share cancellation | $ (22) | 22 | ||||
Share cancellation (in Shares) | (2,199) | |||||
Foreign currency translation | 153,067 | 153,067 | ||||
Net loss | (5,736,603) | (5,736,603) | ||||
Balances at Mar. 31, 2023 | $ 54,955 | 288,326,377 | (642,773) | (278,561,375) | 9,177,184 | |
Balances (in Shares) at Mar. 31, 2023 | 5,495,546 | |||||
Issuance of RSUs | $ 222 | (222) | ||||
Issuance of RSUs (in Shares) | 22,153 | |||||
Stock compensation expense | 156,529 | 156,529 | ||||
Offering of common stock and warrants, net of issuance costs | $ 14,500 | 3,169,150 | 3,183,650 | |||
Offering of common stock and warrants, net of issuance costs (in Shares) | 1,450,000 | |||||
Cash bonus taken in the form of stock compensation | 283,554 | 283,554 | ||||
Foreign currency translation | (113,704) | (113,704) | ||||
Net loss | (5,827,323) | (5,827,323) | ||||
Balances at Jun. 30, 2023 | $ 69,677 | $ 291,935,388 | $ (756,477) | $ (284,388,698) | $ 6,859,890 | |
Balances (in Shares) at Jun. 30, 2023 | 6,967,699 |
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- Definition Public offering of common stock and warrants, net of issuance costs. No definition available.
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- Definition Public offering of common stock and warrants, net of issuance costs, shares. No definition available.
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- Definition Stock cancellation. No definition available.
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- Definition Stock cancellation shares. No definition available.
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- Definition Amount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount after tax, before reclassification adjustments of gain (loss) on foreign currency translation adjustments, foreign currency transactions designated and effective as economic hedges of a net investment in a foreign entity and intra-entity foreign currency transactions that are of a long-term-investment nature. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The consolidated profit or loss for the period, net of income taxes, including the portion attributable to the noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Number of shares issued which are neither cancelled nor held in the treasury. No definition available.
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- Definition Number of shares issued during the period related to Restricted Stock Awards, net of any shares forfeited. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Equity impact of the value of new stock issued during the period. Includes shares issued in an initial public offering or a secondary public offering. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Value of stock related to Restricted Stock Awards issued during the period, net of the stock value of such awards forfeited. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of equity (deficit) attributable to parent. Excludes temporary equity and equity attributable to noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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Subsequent Events |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 11 - Subsequent Events
The Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the unaudited condensed consolidated financial statements are issued.
Other than as disclosed in this Note 11 and as may be disclosed elsewhere in the notes to the accompanying unaudited condensed consolidated financial statements, there have been no subsequent events that require adjustment or disclosure in the accompanying unaudited condensed consolidated financial statements.
On July 4, 2023, the Company entered into a Standstill Agreement, by and among Curetis, the Company’s wholly owned subsidiary, as borrower, the Company and Ares Genetics, the Company’s wholly owned subsidiary, as guarantors, and the EIB, as lender, relating to that certain Finance Contract, originally dated December 12, 2016, as amended, by and between Curetis and EIB (the “Finance Contract”). Pursuant to the Standstill Agreement, the EIB agreed that, with respect to each default or event of default relating to €3 million in principal plus accumulated interest that (i) was due and payable on June 22, 2023 under the Finance Contract and (ii) continues to exist as of the date of the Standstill Agreement, the EIB would not take any action or exercise any right under the Finance Contract, including, but not limited to, any right of acceleration or termination, until the earlier of the entry into a definitive agreement for the restructuring of the second tranche and November 30, 2023. As a condition of entering into such standstill agreement, Curetis paid the EIB a partial payment of interest on the second tranche of €1 million on June 22, 2023. In addition, Curetis agreed to certain undertakings during the standstill period, including the delivery of a rolling cash flow forecast on a bi-weekly basis and cause a third-party restructuring expert to prepare and deliver a restructuring opinion to the EIB. The EIB may terminate the Standstill Agreement upon notice to Curetis if, among other customary termination rights, Curetis or the guarantors fail to comply with any undertakings in the Standstill Agreement, the third party expert determines that there are no prospects for a successful restructuring of the second tranche and that it therefore will be unable to issue a restructuring opinion, or the cash flow forecast shows a negative liquidity shortfall during the specified period. |
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- References No definition available.
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- Definition The entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Stockholders' Equity (Details) - USD ($) |
3 Months Ended | 6 Months Ended | 12 Months Ended | |||||
---|---|---|---|---|---|---|---|---|
May 04, 2023 |
Jan. 11, 2023 |
Oct. 03, 2022 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Dec. 31, 2022 |
May 31, 2023 |
Jun. 24, 2022 |
|
Stockholders' Equity (Details) [Line Items] | ||||||||
Common stock share authorized | 100,000,000 | 100,000,000 | 100,000,000 | |||||
Common stock issued | 605,000 | 268,000 | 6,967,699 | 6,967,699 | 2,899,911 | |||
Common stock outstanding | 6,967,699 | 6,967,699 | 2,899,911 | |||||
Preferred shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | |||||
Sale of shares | 85,732 | |||||||
Gross proceeds (in Dollars) | $ 3,500,000 | $ 1,030,000.00 | ||||||
Net proceeds (in Dollars) | $ 3,000,000 | $ 3,040,000.00 | $ 990,000 | |||||
Common stock, par value (in Dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | |||
Stated value per share (in Dollars per share) | $ 0.01 | $ 0.01 | 0.01 | |||||
Pre-funded warrants | 3,890,825 | 215,000 | ||||||
Number of repriced warrants to purchase shares | 6,396,903 | |||||||
Exercise price of common warrants (in Dollars per share) | $ 0.7785 | $ 2.65 | ||||||
Existing warrants description | provide that the existing warrants, as amended, will not be exercisable until six months following the closing date of the offering | |||||||
Common warrant expiration date | expiration date of the existing warrants by five and one-half years | |||||||
Increase in fair value from warrant modification (in Dollars) | $ 300,000 | $ 1,800,000 | ||||||
Common warrants issued | 4,495,825 | |||||||
Price per share of common stock and accompanying common warrant (in Dollars per share) | $ 0.7785 | |||||||
Price per share of pre-funded warrant and common warrants (in Dollars per share) | 0.7685 | |||||||
Pre-funded warrant has an exercise price (in Dollars per share) | $ 0.01 | |||||||
Warrant exercise price | 0.7785 | |||||||
2015 Plan [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Authorized issuance share | 2,710 | 2,710 | ||||||
Stock option, description | In addition, the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. | |||||||
Shares added | 115,996 | 115,996 | ||||||
Remaining shares | 81,646 | 81,646 | ||||||
Common Stock [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Common stock, par value (in Dollars per share) | $ 0.01 | $ 0.01 | ||||||
Number of repriced warrants to purchase shares | 741,489 | |||||||
Minimum [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Minimum warrant exercise price from prior offerings (in Dollars per share) | 2.65 | $ 41 | ||||||
Maximum [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Maximum warrant exercise price from prior offerings (in Dollars per share) | $ 7.54 | $ 1,300 | ||||||
First Annual Anniversary [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Vesting award, percentage | 6.25% | |||||||
Series C Mirroring Preferred Stock [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Shares | 33,810 | |||||||
Par value per share (in Dollars per share) | $ 0.01 | |||||||
Stated value per share (in Dollars per share) | $ 0.01 | |||||||
Warrant [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Gross proceeds (in Dollars) | $ 3,340,000 | |||||||
Offering price per share of pre-funded warrant (in Dollars per share) | $ 6.8 | |||||||
Exercise price of common warrants (in Dollars per share) | $ 215,000 | |||||||
Exercise price of common warrants (in Dollars per share) | $ 0.7785 | |||||||
Pre-funded warrant has an exercise price (in Dollars per share) | $ 6.8 | |||||||
Private Placement [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Warrants issued to purchase common stock | 483,000 | |||||||
Stock options [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Stock options to acquire shares of common stock | 107,597 | |||||||
Common Stock [Member] | Minimum [Member] | H.C. Wainwright & Co., LLC [Member] | 2020 ATM Offering [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Aggregate share (in Dollars) | $ 10,650,000 | |||||||
Exercise Agreement [Member] | PIPE Financing [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
price per share of prefunded warrants and common warrants (in Dollars per share) | $ 7 | |||||||
Price per share of preferred stock (in Dollars per share) | 0.01 | |||||||
Securities Purchase Agreement [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Common stock issued | 321,207 | |||||||
Prefunded warrants | 2,265,000 | |||||||
Prefunded Warrants Offering Price Per Share (in Dollars per share) | $ 2.89 | |||||||
Securities Purchase Agreement [Member] | Common Stock [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Shares of common stock | 321,207 | |||||||
Par value of common stock (in Dollars) | $ 0.01 | |||||||
price per share of PRE-FUNDED warrant and common warrants (in Dollars per share) | $ 2.9 | |||||||
Securities Purchase Agreement [Member] | Pre-funded Warrant [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Prefunded Warrants Offering Price Per Share (in Dollars per share) | $ 2.89 | |||||||
Gross proceeds (in Dollars) | $ 7,500,000 | |||||||
Net proceeds (in Dollars) | $ 6,900,000 | |||||||
Series A-1 Common Warrants [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Aggregate warrants | 2,586,207 | |||||||
Series A-2 Common Warrants [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Exercise price of common warrants (in Dollars per share) | $ 0.01 | |||||||
Aggregate warrants | 2,586,207 | |||||||
Chief Financial Officer [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Stock options granted | 10,500 | |||||||
Exercise price of stock options (in Dollars per share) | $ 21.6 | $ 21.6 | ||||||
Chief Financial Officer [Member] | First Annual Anniversary [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Vesting award, percentage | 25.00% | |||||||
Restricted Stock Units (RSUs) [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Stock units granted | 7,500 | 100,500 | ||||||
Stock units vested | 22,153 | 33,780 | ||||||
Stock units forfeited | ||||||||
Stock units outstanding | 109,627 | |||||||
Investor [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Exercise price of common warrants (in Dollars per share) | $ 7.54 |
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- Definition The number of warrants increase in exercise price of warrant. Excludes change due to standard antidilution provision. No definition available.
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- Definition Number of warrant exercise price per share. No definition available.
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- Definition Number of warrants issued to purchase common stock. No definition available.
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- Definition Warrants to purchase of common stock price per share. No definition available.
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- Definition Description of reason for issuing warrant or right. No definition available.
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- Definition Face amount or stated value per share of common stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The maximum number of common shares permitted to be issued by an entity's charter and bylaws. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Total number of common shares of an entity that have been sold or granted to shareholders (includes common shares that were issued, repurchased and remain in the treasury). These shares represent capital invested by the firm's shareholders and owners, and may be all or only a portion of the number of shares authorized. Shares issued include shares outstanding and shares held in the treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Number of shares of common stock outstanding. Common stock represent the ownership interest in a corporation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Maximum number of excess stock shares permitted to be issued. No definition available.
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- Definition Face amount or stated value per share of preferred stock nonredeemable or redeemable solely at the option of the issuer. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The maximum number of nonredeemable preferred shares (or preferred stock redeemable solely at the option of the issuer) permitted to be issued by an entity's charter and bylaws. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The cash inflow from issuance of rights to purchase common shares at predetermined price (usually issued together with corporate debt). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The number of shares issued or sold by the subsidiary or equity method investee per stock transaction. No definition available.
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- Definition Description of terms of share-based payment arrangement. Includes, but is not limited to, type of award or grantee and reason for issuance. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The number of equity-based payment instruments, excluding stock (or unit) options, that were forfeited during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The number of grants made during the period on other than stock (or unit) option plans (for example, phantom stock or unit plan, stock or unit appreciation rights plan, performance target plan). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The net total number of shares (or other type of equity) under an equity-based award plan, other than a stock option plan, that were granted, vested and forfeited during the reporting period. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition The number of equity-based payment instruments, excluding stock (or unit) options, that vested during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Number of shares authorized for issuance under share-based payment arrangement. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition The difference between the maximum number of shares (or other type of equity) authorized for issuance under the plan (including the effects of amendments and adjustments), and the sum of: 1) the number of shares (or other type of equity) already issued upon exercise of options or other equity-based awards under the plan; and 2) shares (or other type of equity) reserved for issuance on granting of outstanding awards, net of cancellations and forfeitures, if applicable. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Percentage of vesting of award under share-based payment arrangement. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition Number of shares of stock issued as of the balance sheet date, including shares that had been issued and were previously outstanding but which are now held in the treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The number of securities classified as temporary equity that have been sold (or granted) to the entity's shareholders. Securities issued include securities outstanding and securities held in treasury. Temporary equity is a security with redemption features that are outside the control of the issuer, is not classified as an asset or liability in conformity with GAAP, and is not mandatorily redeemable. Includes any type of security that is redeemable at a fixed or determinable price or on a fixed or determinable date or dates, is redeemable at the option of the holder, or has conditions for redemption which are not solely within the control of the issuer. If convertible, the issuer does not control the actions or events necessary to issue the maximum number of shares that could be required to be delivered under the conversion option if the holder exercises the option to convert the stock to another class of equity. If the security is a warrant or a rights issue, the warrant or rights issue is considered to be temporary equity if the issuer cannot demonstrate that it would be able to deliver upon the exercise of the option by the holder in all cases. Includes stock with put option held by ESOP and stock redeemable by holder only in the event of a change in control of the issuer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Debt (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of long-term debt and short-term borrowings | The following table summarizes the Company’s
long-term debt and short-term borrowings as of June 30, 2023 and December 31, 2022:
|
X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Tabular disclosure of information pertaining to short-term and long-debt instruments or arrangements, including but not limited to identification of terms, features, collateral requirements and other information necessary to a fair presentation. No definition available.
|
Fair Value Measurements |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair value measurements | Note 5 – Fair value measurements
The Company classifies its financial instruments using a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include:
For the three and six months ended June 30, 2023, 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.
In 2016, Curetis entered into a contract for an up to €25.0 million senior, unsecured loan financing facility from the EIB (see Note 6). In June 2019, Curetis drew down a third tranche of €5.0 million from the EIB. In return for the EIB waiving the condition precedent of a minimum cumulative equity capital raised of €15.0 million to disburse this €5.0 million tranche, the parties agreed on a 2.1% participation percentage interest (“PPI”). Upon maturity of the tranche, the EIB would be entitled to an additional payment that is equity-linked and equivalent to 2.1% of the then total valuation of Curetis N.V. On July 9, 2020, the Company negotiated an amendment to the EIB debt financing facility. As part of the amendment, the parties adjusted the PPI percentage applicable to the previous EIB tranche of €5.0 million which was funded in June 2019 from its original 2.1% PPI in Curetis N.V.’s equity value upon maturity to a new 0.3% PPI in OpGen’s equity. On May 23, 2022, the Company entered into a Waiver and Amendment Letter which increased the PPI to 0.75% upon maturity between mid-2024 and mid-2025. This right constitutes an embedded derivative, which is separated and measured at fair value with changes being accounted for through profit or loss. The Company determines 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.
The fair value of level 3 liabilities measured at fair value on a recurring basis for the six months ended June 30, 2023 was as follows:
Financial assets and liabilities carried at fair value on a non-recurring basis
The Company does not have any financial assets and liabilities measured at fair value on a non-recurring basis.
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 intangible assets (including goodwill), at fair value on a non-recurring basis when a triggering event requires such evaluation. During the three months ended June 30, 2023, the Company did not record any such impairment expenses. During the year ended December 31, 2022, the Company recorded impairment expense of $6,940,549 related to its goodwill (see Note 3) and $5,407,699 related to its indefinite-lived intangible asset (see Note 3). |
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- References No definition available.
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- Definition The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Revenue | ||||
Total revenue | $ 736,137 | $ 967,205 | $ 1,649,581 | $ 1,436,950 |
Operating expenses | ||||
Cost of products sold | 714,392 | 646,389 | 1,306,770 | 938,386 |
Cost of services | 204,102 | 15,650 | 332,408 | 46,212 |
Research and development | 1,388,792 | 2,273,756 | 3,201,624 | 4,590,197 |
General and administrative | 2,425,007 | 2,134,266 | 4,848,960 | 4,759,319 |
Sales and marketing | 1,160,200 | 1,169,349 | 2,186,287 | 2,220,781 |
Total operating expenses | 5,892,493 | 6,239,410 | 11,876,049 | 12,554,895 |
Operating loss | (5,156,356) | (5,272,205) | (10,226,468) | (11,117,945) |
Other (expense) income | ||||
Interest and other income | 31,215 | 13,851 | 61,323 | 16,972 |
Interest expense | (684,498) | (779,912) | (1,301,796) | (2,049,493) |
Foreign currency transaction (losses) gains | (60,401) | 271,967 | (152,396) | 470,707 |
Change in fair value of derivative financial instruments | 42,717 | (74,116) | 55,411 | 35,628 |
Total other expense | (670,967) | (568,210) | (1,337,458) | (1,526,186) |
Loss before income taxes | (5,827,323) | (5,840,415) | (11,563,926) | (12,644,131) |
Provision for income taxes | ||||
Net loss | (5,827,323) | (5,840,415) | (11,563,926) | (12,644,131) |
Net loss available to common stockholders | $ (5,827,323) | $ (5,840,415) | $ (11,563,926) | $ (12,644,131) |
Net loss per common share – basic (in Dollars per share) | $ (0.93) | $ (2.51) | $ (2.13) | $ (5.43) |
Weighted average shares outstanding – basic (in Shares) | 6,246,326 | 2,328,725 | 5,424,542 | 2,326,485 |
Net loss | $ (5,827,323) | $ (5,840,415) | $ (11,563,926) | $ (12,644,131) |
Other comprehensive (loss) income – foreign currency translation | (113,704) | (1,227,142) | 39,363 | (1,710,991) |
Comprehensive loss | (5,941,027) | (7,067,557) | (11,524,563) | (14,355,122) |
Product sales | ||||
Revenue | ||||
Total revenue | 439,672 | 889,271 | 850,569 | 1,255,323 |
Laboratory services | ||||
Revenue | ||||
Total revenue | 44,003 | 20,570 | 65,676 | 63,499 |
Collaboration revenue | ||||
Revenue | ||||
Total revenue | $ 252,462 | $ 57,364 | $ 733,336 | $ 118,128 |
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- Definition Interest and other income (expense). No definition available.
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- Definition Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The aggregate costs related to goods produced and sold and services rendered by an entity during the reporting period. This excludes costs incurred during the reporting period related to financial services rendered and other revenue generating activities. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Total costs of sales and operating expenses for the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of unrealized gain (loss) recognized in income for derivative asset (liability) after deduction of derivative liability (asset), measured at fair value using unobservable input (level 3) and still held. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount, before tax, of realized and unrealized gain (loss) from foreign currency transaction. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The aggregate total of expenses of managing and administering the affairs of an entity, including affiliates of the reporting entity, which are not directly or indirectly associated with the manufacture, sale or creation of a product or product line. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of the cost of borrowed funds accounted for as interest expense. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The aggregate amount of income or expense from ancillary business-related activities (that is to say, excluding major activities considered part of the normal operations of the business). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition The net result for the period of deducting operating expenses from operating revenues. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount after tax and reclassification adjustments of gain (loss) on foreign currency translation adjustments, foreign currency transactions designated and effective as economic hedges of a net investment in a foreign entity and intra-entity foreign currency transactions that are of a long-term-investment nature, attributable to parent entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The total amount of other operating cost and expense items that are associated with the entity's normal revenue producing operation. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The aggregate costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility, and costs allocated in accounting for a business combination to in-process projects deemed to have no alternative future use. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The aggregate total amount of expenses directly related to the marketing or selling of products or services. No definition available.
|
X | ||||||||||
- Definition Number of [basic] shares or units, after adjustment for contingently issuable shares or units and other shares or units not deemed outstanding, determined by relating the portion of time within a reporting period that common shares or units have been outstanding to the total time in that period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
Stockholders' Equity (Details) - Schedule of company recognized stock compensation expense - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Allocated share-based compensation expense | $ 156,529 | $ 257,403 | $ 367,651 | $ 499,022 |
Cost of services [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Allocated share-based compensation expense | 8,266 | 11,101 | ||
Research and development [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Allocated share-based compensation expense | 47,465 | 73,981 | 117,828 | 140,979 |
General and administrative [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Allocated share-based compensation expense | 79,208 | 138,438 | 185,041 | 279,320 |
Sales and marketing [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Allocated share-based compensation expense | $ 29,856 | $ 36,718 | $ 64,782 | $ 67,622 |
X | ||||||||||
- Definition Allocated share based compensation expense benefit. No definition available.
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
Stockholders' Equity (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity Note [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of company recognized stock compensation expense | For the three and six months ended June 30,
2023 and 2022, the Company recognized share-based compensation expense as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of outstanding warrants to purchase shares of common stock | At June 30, 2023 and December 31, 2022, the following
warrants to purchase shares of common stock were outstanding:
|
X | ||||||||||
- Definition The tabular disclosure of warrants to purchase shares of common stock. No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of allocation of amount expensed and capitalized for award under share-based payment arrangement to statement of income or comprehensive income and statement of financial position. Includes, but is not limited to, corresponding line item in financial statement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
Leases (Details) - Schedule of other lease information |
Jun. 30, 2023 |
---|---|
Weighted average remaining lease term (in years) | |
Operating leases | 6 years 6 months |
Finance leases | 7 months 6 days |
Weighted average discount rate: | |
Operating leases | 9.70% |
Finance leases | 1.00% |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Weighted average discount rate for finance lease calculated at point in time. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
X | ||||||||||
- Definition Weighted average remaining lease term for finance lease, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
X | ||||||||||
- Definition Weighted average discount rate for operating lease calculated at point in time. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
X | ||||||||||
- Definition Weighted average remaining lease term for operating lease, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
Debt (Details) € in Millions |
1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
May 23, 2022
EUR (€)
|
Jul. 09, 2020 |
Apr. 30, 2023
EUR (€)
|
May 23, 2022
EUR (€)
|
Jun. 30, 2019
EUR (€)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2023
EUR (€)
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
EUR (€)
|
Jun. 26, 2023
EUR (€)
|
Jun. 22, 2023
EUR (€)
|
Dec. 31, 2022
USD ($)
|
Jun. 30, 2018
EUR (€)
|
Apr. 30, 2017
EUR (€)
|
Dec. 31, 2016
EUR (€)
|
|
Debt (Details) [Line Items] | |||||||||||||||||
Interest rate payable | 4.00% | ||||||||||||||||
Disburse tranche amount | € 5.0 | ||||||||||||||||
Principal amount | € 5.0 | ||||||||||||||||
Repaid amount | $ | $ 3,907,928 | $ 6,819,405 | |||||||||||||||
Monthly loan payment on first tranche | € 0.7 | ||||||||||||||||
Principal plus accumulated and deferred interest | € 3.0 | ||||||||||||||||
paid amount to EIB due to agreement | € 1.0 | ||||||||||||||||
Total debt obligations | $ | $ 10,071,668 | 10,071,668 | $ 13,489,178 | ||||||||||||||
Total interest expense (in Dollars) | $ | 684,498 | $ 1,301,796 | $ 2,049,493 | ||||||||||||||
Share-Based Payment Arrangement, Tranche Two [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Principal amount | € 3.0 | ||||||||||||||||
Share-Based Payment Arrangement, Tranche Three [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Principal amount | 5.0 | ||||||||||||||||
Curetis N.V.’s Equity [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Percentage of participation percentage interest | 2.10% | ||||||||||||||||
EIB [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Debt term | 5 years | 5 years | |||||||||||||||
Fund drawn period | 36 months | 36 months | |||||||||||||||
Total debt obligations | $ | 10,071,668 | $ 10,071,668 | $ 13,489,178 | ||||||||||||||
Deferred interest payable | $ | 1,400,000 | ||||||||||||||||
Total interest expense (in Dollars) | $ | $ 779,912 | ||||||||||||||||
EIB [Member] | First Tranche [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Debt instrument, interest rate, stated percentage | 6.00% | ||||||||||||||||
EIB [Member] | OpGen's equity value [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Percentage of participation percentage interest | 0.30% | ||||||||||||||||
EIB [Member] | Three Tranches [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Total debt borrowed | € 18.0 | ||||||||||||||||
EIB [Member] | Share-Based Payment Arrangement, Tranche One [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Accumulated and deferred interest | € 13.4 | 13.4 | |||||||||||||||
Repaid amount | € 5.0 | ||||||||||||||||
PPI [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Percentage of participation percentage interest | 2.10% | ||||||||||||||||
PPI [Member] | Minimum [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
PPI of OPGEN amended, percentage | 0.30% | ||||||||||||||||
PPI [Member] | Maximum [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
PPI of OPGEN amended, percentage | 0.75% | ||||||||||||||||
EIB debt financing facility [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Fair value of the EIB debt (in Dollars) | $ | 15,800,000 | 15,800,000 | |||||||||||||||
EIB Loan Facility [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Total debt obligations | $ | $ 10,100,000 | $ 10,100,000 | |||||||||||||||
Euro Member Countries, Euro | EIB [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Maximum of unsecured loan financing facility | € 25.0 | ||||||||||||||||
EIB waived for curetis to have equity capital raised to disburse the third tranche | € 15.0 | ||||||||||||||||
Total debt obligations | € 9.3 | ||||||||||||||||
Deferred interest payable | € 1.3 | ||||||||||||||||
Euro Member Countries, Euro | EIB [Member] | First Tranche [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Unsecured debt | € 10.0 | ||||||||||||||||
Euro Member Countries, Euro | EIB [Member] | Second Tranche [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Unsecured debt | € 3.0 | ||||||||||||||||
Euro Member Countries, Euro | EIB [Member] | Third Tranche [Member] | |||||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||||
Unsecured debt | € 5.0 |
X | ||||||||||
- Definition The amount of agreement paid. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The EIB waived for curetis to have equity capital raised to disburse the third tranche. No definition available.
|
X | ||||||||||
- Definition The fair value of the EIB debt as of the acquisition date. No definition available.
|
X | ||||||||||
- Definition Fund drawn period. No definition available.
|
X | ||||||||||
- Definition Percentage of PPI of OPGEN amended. No definition available.
|
X | ||||||||||
- Definition Percentage of participation percentage interest. No definition available.
|
X | ||||||||||
- Definition Amount of principal plus accumulated and deferred interest. No definition available.
|
X | ||||||||||
- Definition Reflects the effective interest rate as of the balance sheet date on interest-bearing trade payables. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of accumulated interest costs capitalized as part of property, plant and equipment cost basis. No definition available.
|
X | ||||||||||
- Definition Contractual interest rate for funds borrowed, under the debt agreement. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Period of time between issuance and maturity of debt instrument, in PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
|
X | ||||||||||
- Definition Represents the aggregate of total long-term debt, including current maturities and short-term debt. No definition available.
|
X | ||||||||||
- Definition Amount of escrow deposit disbursements related to property acquisition in noncash investing or financing transactions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The increase (decrease) during the reporting period in interest payable, which represents the amount owed to note holders, bond holders, and other parties for interest earned on loans or credit extended to the reporting entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of the cost of borrowed funds accounted for as interest expense for debt. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
X | ||||||||||
- Definition Average amount borrowed under the credit facility during the period. No definition available.
|
X | ||||||||||
- Definition The maximum amount of borrowing capacity under a line of credit that is available as of the balance sheet date for a specific purpose other than for financing goods acquired for inventory or imminent delivery to a customer. No definition available.
|
X | ||||||||||
- Definition Amount of increase (decrease) of the credit facility. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Cash payments for and related to principal collection on loans related to operating activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of cash outflow for short-term and long-term debt. Excludes payment of lease obligation. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Including the current and noncurrent portions, carrying value as of the balance sheet date of uncollateralized debt obligations (with maturities initially due after one year or beyond the operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
Debt (Details) - Schedule of long-term debt and short-term borrowings - USD ($) |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Debt (Details) - Schedule of long-term debt and short-term borrowings [Line Items] | ||
Total debt obligations | $ 10,071,668 | $ 13,489,178 |
Unamortized debt discount | (880,517) | (1,614,591) |
Carrying value of debt | 9,191,151 | 11,874,587 |
Less current portion | (9,191,151) | (7,023,901) |
Non-current portion of long-term debt | 4,850,686 | |
EIB [Member] | ||
Debt (Details) - Schedule of long-term debt and short-term borrowings [Line Items] | ||
Total debt obligations | $ 10,071,668 | $ 13,489,178 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount, after accumulated amortization, of debt discount. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Represents the aggregate of total long-term debt, including current maturities and short-term debt. No definition available.
|
X | ||||||||||
- Definition Amount, after deduction of unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount, after deduction of unamortized premium (discount) and debt issuance cost, of long-term debt classified as current. Excludes lease obligation. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition The fair value amount of long-term debt whether such amount is presented as a separate caption or as a parenthetical disclosure. Additionally, this element may be used in connection with the fair value disclosures required in the footnote disclosures to the financial statements. The element may be used in both the balance sheet and disclosure in the same submission. No definition available.
|
X | ||||||||||
- Details
|
Summary of Significant Accounting Policies (Details) - Schedule of finite-lived and indefinite-lived intangible assets - USD ($) |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 15,518,000 | |
Accumulated Amortization and Impairment | (8,050,916) | $ (7,437,206) |
Effect of Foreign Exchange Rates | (260,702) | (639,820) |
Net Balance | 7,206,382 | 7,440,974 |
Trademarks and tradenames [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,768,000 | |
Accumulated Amortization and Impairment | (564,679) | (469,011) |
Effect of Foreign Exchange Rates | (30,541) | (62,520) |
Net Balance | 1,172,780 | 1,236,469 |
Distributor relationships [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 2,362,000 | |
Accumulated Amortization and Impairment | (502,936) | (417,728) |
Effect of Foreign Exchange Rates | (40,799) | (83,525) |
Net Balance | 1,818,265 | 1,860,747 |
A50 – Developed technology [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 349,000 | |
Accumulated Amortization and Impairment | (159,254) | (132,273) |
Effect of Foreign Exchange Rates | (6,029) | (12,342) |
Net Balance | 183,717 | 204,385 |
Ares – Developed technology [Member] | Ares Genetics [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 5,333,000 | |
Accumulated Amortization and Impairment | (1,216,613) | (1,010,495) |
Effect of Foreign Exchange Rates | (84,767) | (183,132) |
Net Balance | 4,031,620 | 4,139,373 |
A30 – In-Process Research & Development [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 5,706,000 | |
Accumulated Amortization and Impairment | (5,607,434) | (5,407,699) |
Effect of Foreign Exchange Rates | (98,566) | (298,301) |
Net Balance |
X | ||||||||||
- Definition Amount of effect of foreign exchange rates. No definition available.
|
X | ||||||||||
- Definition Accumulated amount of amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount before amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount after amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Details
|
X | ||||||||||
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X | ||||||||||
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
|
Summary of Significant Accounting Policies (Details) shares in Millions |
3 Months Ended | 6 Months Ended | 12 Months Ended | |||
---|---|---|---|---|---|---|
Jun. 30, 2023
USD ($)
Customers
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
Customers
shares
|
Jun. 30, 2022
USD ($)
shares
|
Dec. 31, 2022
USD ($)
Customers
|
Dec. 31, 2021
USD ($)
|
|
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
FDIC limit of insurable cash | $ 250,000 | $ 250,000 | ||||
Restricted cash | 496,894 | $ 441,320 | 496,894 | $ 441,320 | $ 495,629 | $ 551,794 |
Allowance for doubtful accounts receivable | 0 | 0 | $ 0 | |||
Number of customers (in Customers) | Customers | 2 | |||||
Inventory valuation reserves | 2,083,212 | 2,083,212 | $ 1,694,843 | |||
Indefinite-lived intangible impairment charge | 5,407,699 | |||||
Amortization of intangible assets | 187,540 | 182,993 | 373,917 | 375,018 | ||
Impairment expense of goodwill | 6,940,549 | |||||
Reduction in research and development expense related to government grant arrangements | $ 88,421 | $ 111,414 | 222,359 | $ 219,879 | ||
Grants earned but not yet received | $ 618,637 | $ 401,436 | ||||
Tax benefit percentage | 50.00% | |||||
Antidilutive securities excluded from computation of earnings per share, amount (in Shares) | shares | 11.2 | 1.0 | ||||
Minimum [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Accounts receivable period due | 30 days | |||||
Maximum [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Accounts receivable period due | 90 days | |||||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Number of customers (in Customers) | Customers | 3 | 3 | ||||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer One [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Concentration risk, percentage | 30.00% | 41.00% | ||||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer Two [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Concentration risk, percentage | 25.00% | 21.00% | ||||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer Three [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Concentration risk, percentage | 12.00% | |||||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer One [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Concentration risk, percentage | 25.00% | 57.00% | 37.00% | 47.00% | ||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer Two [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Concentration risk, percentage | 19.00% | 12.00% | 16.00% | 15.00% | ||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer Three [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Concentration risk, percentage | 13.00% | |||||
Domestic Tax Authority [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Operating loss carryforwards | $ 232,682,072 | $ 202,015,062 | ||||
Foreign Tax Authority [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Operating loss carryforwards | 170,661,923 | |||||
Germany [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Operating loss carryforwards | $ 162,712,615 |
X | ||||||||||
- Definition Represents period by which accounts receivable are due. No definition available.
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X | ||||||||||
- Definition The amount of grants earned but not yet received. No definition available.
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X | ||||||||||
- Definition The amount of impairment expense expense of goodwill. No definition available.
|
X | ||||||||||
- Definition For the asset that is reclassified back to held and used from held-for-sale, the amount of impairment charge that is recognized on the reclassification date. No definition available.
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X | ||||||||||
- Definition Number of customers. No definition available.
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X | ||||||||||
- Definition Amount of reduction of research and development expense related to government grant arrangements. No definition available.
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Tax benefit percentage. No definition available.
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X | ||||||||||
- Definition Amount of allowance for credit loss on accounts receivable. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition The aggregate expense charged against earnings to allocate the cost of intangible assets (nonphysical assets not used in production) in a systematic and rational manner to the periods expected to benefit from such assets. As a noncash expense, this element is added back to net income when calculating cash provided by or used in operations using the indirect method. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition The amount of cash deposited in financial institutions as of the balance sheet date that is insured by the Federal Deposit Insurance Corporation. No definition available.
|
X | ||||||||||
- Definition For an entity that discloses a concentration risk in relation to quantitative amount, which serves as the "benchmark" (or denominator) in the equation, this concept represents the concentration percentage derived from the division. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of valuation reserve for inventory. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition Amount of operating loss carryforward, before tax effects, available to reduce future taxable income under enacted tax laws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of cash restricted as to withdrawal or usage. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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Revenue from Contracts with Customers (Details) - Schedule of revenues by geography - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Revenue from Contracts with Customers (Details) - Schedule of revenues by geography [Line Items] | ||||
Total revenue | $ 736,137 | $ 967,205 | $ 1,649,581 | $ 1,436,950 |
Domestic [Member] | ||||
Revenue from Contracts with Customers (Details) - Schedule of revenues by geography [Line Items] | ||||
Total revenue | 266,313 | 123,659 | 381,262 | 280,069 |
International [Member] | ||||
Revenue from Contracts with Customers (Details) - Schedule of revenues by geography [Line Items] | ||||
Total revenue | $ 469,824 | $ 843,546 | $ 1,268,319 | $ 1,156,881 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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Condensed Consolidated Balance Sheets (Unaudited) - USD ($) |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Current assets | ||
Cash and cash equivalents | $ 3,237,176 | $ 7,440,030 |
Accounts receivable, net | 619,575 | 514,372 |
Inventory, net | 1,735,122 | 1,345,137 |
Prepaid expenses and other current assets | 1,637,593 | 1,355,949 |
Total current assets | 7,229,466 | 10,655,488 |
Property and equipment, net | 3,849,734 | 3,457,531 |
Finance lease right-of-use assets, net | 1,833 | 3,500 |
Operating lease right-of-use assets | 2,041,010 | 1,459,413 |
Intangible assets, net | 7,206,382 | 7,440,974 |
Strategic inventory | 1,609,643 | 2,300,614 |
Other noncurrent assets | 496,894 | 495,629 |
Total assets | 22,434,962 | 25,813,149 |
Current liabilities | ||
Current maturities of long-term debt | 9,191,151 | 7,023,901 |
Accounts payable | 195,253 | 420,821 |
Accrued compensation and benefits | 1,439,181 | 1,097,654 |
Accrued liabilities | 1,043,123 | 1,526,204 |
Deferred revenue | 27,279 | 142,061 |
Short-term finance lease liabilities | 1,962 | 3,364 |
Short-term operating lease liabilities | 517,602 | 377,626 |
Total current liabilities | 12,415,551 | 10,591,631 |
Long-term debt, net | 4,850,686 | |
Derivative liabilities | 45,656 | 99,498 |
Long-term finance lease liabilities | 280 | |
Long-term operating lease liabilities | 2,987,194 | 2,566,138 |
Other long-term liabilities | 126,671 | 129,368 |
Total liabilities | 15,575,072 | 18,237,601 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity | ||
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at June 30, 2023 and December 31, 2022 | ||
Common stock, $0.01 par value; 100,000,000 shares authorized; 6,967,699 and 2,899,911 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 69,677 | 28,999 |
Additional paid-in capital | 291,935,388 | 281,167,161 |
Accumulated deficit | (284,388,698) | (272,824,772) |
Accumulated other comprehensive loss | (756,477) | (795,840) |
Total stockholders’ equity | 6,859,890 | 7,575,548 |
Total liabilities and stockholders’ equity | $ 22,434,962 | $ 25,813,149 |
X | ||||||||||
- Definition Carrying value as of the balance sheet date of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Amount, after allowance for credit loss, of right to consideration from customer for product sold and service rendered in normal course of business, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred and payable, pertaining to costs that are statutory in nature, are incurred on contractual obligations, or accumulate over time and for which invoices have not yet been received or will not be rendered. Examples include taxes, interest, rent and utilities. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount, after tax, of accumulated increase (decrease) in equity from transaction and other event and circumstance from nonowner source. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of excess of issue price over par or stated value of stock and from other transaction involving stock or stockholder. Includes, but is not limited to, additional paid-in capital (APIC) for common and preferred stock. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Sum of the carrying amounts as of the balance sheet date of all assets that are recognized. Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Sum of the carrying amounts as of the balance sheet date of all assets that are expected to be realized in cash, sold, or consumed within one year (or the normal operating cycle, if longer). Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Represents the caption on the face of the balance sheet to indicate that the entity has entered into (1) purchase or supply arrangements that will require expending a portion of its resources to meet the terms thereof, and (2) is exposed to potential losses or, less frequently, gains, arising from (a) possible claims against a company's resources due to future performance under contract terms, and (b) possible losses or likely gains from uncertainties that will ultimately be resolved when one or more future events that are deemed likely to occur do occur or fail to occur. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Aggregate par or stated value of issued nonredeemable common stock (or common stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable common shares, par value and other disclosure concepts are in another section within stockholders' equity. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
X | ||||||||||
- Definition Amount of deferred income and obligation to transfer product and service to customer for which consideration has been received or is receivable, classified as current. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Fair value, after the effects of master netting arrangements, of a financial liability or contract with one or more underlyings, notional amount or payment provision or both, and the contract can be net settled by means outside the contract or delivery of an asset, expected to be settled after one year or the normal operating cycle, if longer. Includes assets not subject to a master netting arrangement and not elected to be offset. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Total of the carrying values as of the balance sheet date of obligations incurred through that date and payable for obligations related to services received from employees, such as accrued salaries and bonuses, payroll taxes and fringe benefits. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount, after accumulated amortization, of right-of-use asset from finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount after amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Inventories not expected to be converted to cash, sold or exchanged within the normal operating cycle. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition Sum of the carrying amounts as of the balance sheet date of all liabilities that are recognized. Liabilities are probable future sacrifices of economic benefits arising from present obligations of an entity to transfer assets or provide services to other entities in the future. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of liabilities and equity items, including the portion of equity attributable to noncontrolling interests, if any. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Total obligations incurred as part of normal operations that are expected to be paid during the following twelve months or within one business cycle, if longer. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Carrying value as of the balance sheet date of notes payable (with maturities initially due after one year or beyond the operating cycle if longer), excluding current portion. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of lessee's right to use underlying asset under operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of noncurrent assets classified as other. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount, after of valuation reserves and allowances, of inventory, classified as other, expected to be sold, or consumed within one year or operating cycle, if longer. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Amount of liabilities classified as other, due after one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Aggregate par or stated value of issued nonredeemable preferred stock (or preferred stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable preferred shares, par value and other disclosure concepts are in another section within stockholders' equity. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for costs that provide economic benefits in future periods, and amount of other assets that are expected to be realized or consumed within one year or the normal operating cycle, if longer. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition Amount after accumulated depreciation, depletion and amortization of physical assets used in the normal conduct of business to produce goods and services and not intended for resale. Examples include, but are not limited to, land, buildings, machinery and equipment, office equipment, and furniture and fixtures. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount of accumulated undistributed earnings (deficit). Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Reflects the total carrying amount as of the balance sheet date of debt having initial terms less than one year or the normal operating cycle, if longer. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Amount of equity (deficit) attributable to parent. Excludes temporary equity and equity attributable to noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- References No definition available.
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Debt |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt | Note 6 – Debt
The following table summarizes the Company’s long-term debt and short-term borrowings as of June 30, 2023 and December 31, 2022:
EIB Loan Facility
In 2016, Curetis entered into a contract for an up to €25.0 million senior, unsecured loan financing facility from the EIB. The funding could be drawn in up to five tranches within 36 months of entry into the contract, under the EIB amendment, and each tranche is to be repaid upon maturity five years after draw-down.
In April 2017, Curetis drew down a first tranche of €10.0 million from this facility. This tranche had a floating interest rate of EURIBOR plus 4% payable after each 12-month-period from the draw-down-date and another additional 6% interest per annum that is deferred and payable at maturity together with the principal. In June 2018, a second tranche of €3.0 million was drawn down. The terms and conditions are analogous to the first one. In June 2019, Curetis drew down a third tranche of €5.0 million from the EIB. In line with all prior tranches, the majority of interest is also deferred until repayment upon maturity. In return for the EIB waiving the condition precedent of a minimum cumulative equity capital raised of €15.0 million to disburse this €5.0 million third tranche, the parties agreed on a 2.1% PPI. Upon maturity of the tranche, not before approximately mid-2024, and no later than mid-2025, the EIB would be entitled to an additional payment that is equity-linked and equivalent to 2.1% of the then total valuation of Curetis N.V. As part of the amendment between the Company and the EIB on July 9, 2020, the parties adjusted the PPI percentage applicable to the third EIB tranche of €5.0 million, which was funded in June 2019, from its original 2.1% PPI in Curetis N.V.’s equity value upon maturity to a new 0.3% PPI in OpGen’s equity value upon maturity. This right constitutes an embedded derivative, which is separated and measured at fair value with changes being accounted for through income or loss. The EIB debt was measured and recognized at fair value as of the acquisition date. The fair value of the EIB debt was approximately $15.8 million as of the acquisition date. The resulting debt discount will be amortized over the life of the EIB debt as an increase to interest expense.
On May 23, 2022, the Company and the EIB entered into a Waiver and Amendment Letter (the “2022 EIB Amendment”) relating to the amendment of the EIB loan facility, between the EIB and Curetis pursuant to which Curetis borrowed an aggregate amount of €18.0 million in three tranches. The 2022 EIB Amendment restructured the first tranche of approximately €13.4 million (including accumulated and deferred interest) of the Company’s outstanding indebtedness with the EIB. Pursuant to the 2022 EIB Amendment, the Company repaid €5.0 million to the EIB in April 2022. The Company also agreed, among other things, to amortize the remainder of the debt tranche over the twelve-month period beginning in May 2022. Accordingly, the Company agreed to pay a monthly amount of approximately €0.7 million through April 2023. The Amendment also provides for an increase of the PPI applicable to the third tranche under the loan facility from 0.3% to 0.75% beginning in June 2024. The terms of the second and third tranches of the Company’s indebtedness of €3.0 million and €5.0 million, respectively, plus accumulated deferred interest remain unchanged pursuant to the 2022 EIB Amendment. The second tranche became due and payable by the Company to the EIB in June 2023, and the third tranche will become due and payable in June 2024. As the effective borrowing rate under the amended agreement is less than the effective borrowing rate under the previous agreement, a concession is deemed to have been granted under ASC 470-60. As a concession has been granted, the agreement was accounted for as a troubled debt restructuring under ASC 470-60. The amendment did not result in a gain on restructuring as the future undiscounted cash outflows required under the amended agreement exceed the carrying value of the debt immediately prior to the amendment.
On June 26, 2023, the Company announced that its subsidiary Curetis and the European Investment Bank (“EIB”) agreed in principle to certain terms relating to the repayment of the second tranche of Curetis’ loan from the EIB pursuant to that certain Finance Contract, dated December 12, 2016, as amended, by and between Curetis and the EIB (the “Finance Contract”). The second tranche had a principal balance of €3 million plus accumulated and deferred interest. The second tranche was drawn down in June 2018 and matured on June 22, 2023. On July 4, 2023, the EIB and Curetis entered into a Standstill Agreement pursuant to which the EIB agreed that, with respect to each default or event of default relating to such second tranche, the EIB would not take any action or exercise any right under the Finance Contract until the earlier of a restructuring of the second tranche and November 30, 2023. As a condition to entering into the Standstill Agreement, Curetis paid the EIB a partial payment of interest on the second tranche of €1 million on June 22, 2023 (see Note 11).
As of June 30, 2023, the outstanding borrowings under all tranches were €9.3 million (approximately USD $10.1 million), including deferred interest payable at maturity of €1.3 million (approximately USD $1.4 million).
Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $684,498 and $779,912 for the three months ended June 30, 2023 and 2022, respectively. Total interest expense (including accretion of fair value to book value and amortization of debt discounts and financing fees) on all debt instruments was $1,301,796 and $2,049,493 for the six months ended June 30, 2023 and 2022, respectively. |
X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
Subsequent Events (Details) - EUR (€) € in Millions |
Jul. 04, 2023 |
Jun. 22, 2023 |
---|---|---|
Subsequent Events (Details) [Line Items] | ||
Second tranche interest amount paid | € 1 | |
Subsequent Event [Member] | ||
Subsequent Events (Details) [Line Items] | ||
Principal amount of tranche 2 | € 3 |
X | ||||||||||
- Definition Second tranche interest amount paid. No definition available.
|
X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Amount of accumulated interest costs capitalized as part of property, plant and equipment cost basis. No definition available.
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X | ||||||||||
- Details
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Summary of Significant Accounting Policies (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of reconciliation of cash and cash equivalents and restricted cash | The following table provides a reconciliation of cash
and cash equivalents and restricted cash reported within the condensed consolidated balance sheets:
|
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Schedule of inventories | Inventories are valued using the first-in, first-out
cost method and stated at the lower of cost or net realizable value and consist of the following:
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Schedule of finite-lived and indefinite-lived intangible assets | Intangible assets include trademarks, developed technology
and software, in-process research & development (“IPR&D”), and distributor relationships and consisted of the following
as of June 30, 2023 and December 31, 2022:
|
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Schedule of estimated useful lives of identifiable intangible assets | Identifiable intangible assets are amortized on a
straight-line basis over their estimated useful lives. The estimated useful lives of the intangibles are:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of expected amortization of intangible assets | Expected future amortization of intangible
assets is as follows:
|
X | ||||||||||
- Definition Tabular disclosure of estimated useful lives of identifiable intangible assets. No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of reconciliation of cash and cash equivalents and restricted cash. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of amortization expense of assets, excluding financial assets, that lack physical substance, having a limited useful life. No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of assets, excluding financial assets and goodwill, lacking physical substance with a finite life, by either major class or business segment. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Tabular disclosure of the carrying amount as of the balance sheet date of merchandise, goods, commodities, or supplies held for future sale or to be used in manufacturing, servicing or production process. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Leases (Details) - Schedule of maturities of lease liabilities |
Jun. 30, 2023
USD ($)
|
---|---|
Leases (Details) - Schedule of maturities of lease liabilities [Line Items] | |
2023 (July to December) | $ 412,140 |
2024 | 827,660 |
2025 | 734,694 |
2026 | 582,578 |
2027 | 592,981 |
Thereafter | 1,737,688 |
Total lease payments | 4,887,741 |
Less: Interest | (1,380,983) |
Present value of lease liabilities | 3,506,758 |
Operating [Member] | |
Leases (Details) - Schedule of maturities of lease liabilities [Line Items] | |
2023 (July to December) | 410,458 |
2024 | 827,380 |
2025 | 734,694 |
2026 | 582,578 |
2027 | 592,981 |
Thereafter | 1,737,688 |
Total lease payments | 4,885,779 |
Less: Interest | (1,380,983) |
Present value of lease liabilities | 3,504,796 |
Finance [Member] | |
Leases (Details) - Schedule of maturities of lease liabilities [Line Items] | |
2023 (July to December) | 1,682 |
2024 | 280 |
2025 | |
2026 | |
2027 | |
Thereafter | |
Total lease payments | 1,962 |
Less: Interest | |
Present value of lease liabilities | $ 1,962 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of less interest. No definition available.
|
X | ||||||||||
- Definition The amount of operating and finance lease liabilities undiscounted excess amount. No definition available.
|
X | ||||||||||
- Definition Under an operating lease, a single lease cost, generally allocated on a straight line basis over the lease term, is presented in the income statement. No definition available.
|
X | ||||||||||
- Definition The amount of operating and finance lease liability payments due. No definition available.
|
X | ||||||||||
- Definition The amount of operating and finance lease liability payments due after year five. No definition available.
|
X | ||||||||||
- Definition The amount of operating and finance lease liability payments due year five. No definition available.
|
X | ||||||||||
- Definition The amount of operating and finance lease liability payments due year four. No definition available.
|
X | ||||||||||
- Definition Operating and finance lease liability payments due year three. No definition available.
|
X | ||||||||||
- Definition Operating and finance lease liability payments due year two. No definition available.
|
X | ||||||||||
- Definition Operating leases require lease expenses to be recognized on a straight-line basis over the lease term, whereas finance leases. No definition available.
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for finance lease to be paid after fifth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for finance lease to be paid in next fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for finance lease to be paid in fifth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for finance lease to be paid in fourth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for finance lease to be paid in third fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for finance lease to be paid in second fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for operating lease due after fifth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for operating lease to be paid in next fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for operating lease to be paid in fifth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for operating lease to be paid in fourth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for operating lease to be paid in third fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payment for operating lease to be paid in second fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition If disclosed, the amount of imputed interest necessary to reduce an unconditional purchase obligation to present value on an unrecorded unconditional purchase obligation. Reference 1: http://www.xbrl.org/2003/role/recommendedDisclosureRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
Summary of Significant Accounting Policies (Details) - Schedule of reconciliation of cash and cash equivalents and restricted cash - USD ($) |
Jun. 30, 2023 |
Dec. 31, 2022 |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|---|---|
Schedule Of Reconciliation Of Cash And Cash Equivalents And Restricted Cash Abstract | ||||
Cash and cash equivalents | $ 3,237,176 | $ 7,440,030 | $ 16,586,577 | $ 36,080,392 |
Restricted cash | 496,894 | 495,629 | 441,320 | 551,794 |
Total cash and cash equivalents and restricted cash in the condensed consolidated statements of cash flows | $ 3,734,070 | $ 7,935,659 | $ 17,027,897 | $ 36,632,186 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage. Excludes amount for disposal group and discontinued operations. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of cash restricted as to withdrawal or usage. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
Commitments and Contingencies (Details) |
6 Months Ended |
---|---|
Jun. 30, 2023
USD ($)
| |
Quant Studio Five Real Time PCR Systems [Member] | Life Technologies Corporation Supply Agreement [Member] | |
Commitments and Contingencies (Details) [Line Items] | |
Aggregate purchase commitments | $ 32,000 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The minimum amount the entity agreed to spend under the long-term purchase commitment. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
Commitments and Contingencies |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 8 – Commitments and Contingencies
Registration and other stockholder rights
In connection with the various 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.
Supply agreements
In June 2017, the Company entered into an agreement with Life Technologies Corporation, a subsidiary of Thermo Fisher Scientific (“LTC”), to supply the Company with Thermo Fisher Scientific’s QuantStudio 5 Real-Time PCR Systems (“QuantStudio 5”) to be used to run OpGen’s Acuitas AMR Gene Panel tests. Under the terms of the agreement, the Company must notify LTC of the number of QuantStudio 5 systems that it commits to purchase in the following quarter. As of June 30, 2023, the Company had acquired twenty-four QuantStudio 5 systems, none of which were acquired during the six months ended June 30, 2023. As of June 30, 2023, the Company has not committed to acquiring additional QuantStudio 5 systems in the next three months.
Curetis places frame-work orders for Unyvero instruments and for raw materials for its cartridge manufacturing to ensure availability during commercial ramp-up-phase and also to gain volume-scale-effects with regards to purchase prices. Some of the electronic parts used for the production of Unyvero instruments have lead times of several months, hence it is necessary to order such systems with long-term framework-orders to ensure the demands from the market are covered. The aggregate purchase commitments over the next twelve months are approximately $32,000. |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The entire disclosure for commitments and contingencies. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
Leases (Details) - Schedule of ROU assets and lease liabilities - USD ($) |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
ROU Assets: | ||
Operating | $ 2,041,010 | $ 1,459,413 |
Financing | 1,833 | 3,500 |
Total ROU assets | 2,042,843 | 1,462,913 |
Current: | ||
Operating | 517,602 | 377,626 |
Finance | 1,962 | 3,364 |
Noncurrent: | ||
Operating | 2,987,194 | 2,566,138 |
Finance | 280 | |
Total lease liabilities | $ 3,506,758 | $ 2,947,408 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Lease liability. No definition available.
|
X | ||||||||||
- Definition Lease right of use asset. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from finance lease, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount, after accumulated amortization, of right-of-use asset from finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's right to use underlying asset under operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
Fair Value Measurements (Details) € in Millions |
1 Months Ended | 6 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Jun. 30, 2019
EUR (€)
|
Jun. 30, 2023 |
Dec. 31, 2022
USD ($)
|
Jul. 09, 2020 |
Dec. 31, 2016
EUR (€)
|
|
Fair Value Measurements (Details) [Line Items] | |||||
Impairment expense of goodwill (in Dollars) | $ | $ 6,940,549 | ||||
Impairment of intangible assets (in Dollars) | $ | $ 5,407,699 | ||||
Fair Value, Recurring [Member] | Curetis GmbH [Member] | |||||
Fair Value Measurements (Details) [Line Items] | |||||
Participation percentage interest | 2.10% | ||||
European Investment Bank [Member] | Curetis GmbH [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | |||||
Fair Value Measurements (Details) [Line Items] | |||||
Drew down amount | € 5.0 | ||||
European Investment Bank [Member] | Fair Value, Recurring [Member] | Curetis GmbH [Member] | |||||
Fair Value Measurements (Details) [Line Items] | |||||
Unsecured loan financing facility | € 25.0 | ||||
European Investment Bank [Member] | Fair Value, Recurring [Member] | Curetis GmbH [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | |||||
Fair Value Measurements (Details) [Line Items] | |||||
Drew down amount | € 5.0 | ||||
Participation percentage interest | 2.10% | ||||
European Investment Bank [Member] | Fair Value, Recurring [Member] | Curetis GmbH [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | Minimum [Member] | |||||
Fair Value Measurements (Details) [Line Items] | |||||
EIB waived for curetis to have equity capital raised to disburse the third tranche | € 15.0 | ||||
European Investment Bank [Member] | Fair Value, Recurring [Member] | OpGen's Equity [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | |||||
Fair Value Measurements (Details) [Line Items] | |||||
Participation percentage interest | 0.75% | 0.30% | |||
Maturity period | the Company entered into a Waiver and Amendment Letter which increased the PPI to 0.75% upon maturity between mid-2024 and mid-2025. | ||||
European Investment Bank [Member] | Fair Value, Recurring [Member] | Curetis GmbH [Member] | |||||
Fair Value Measurements (Details) [Line Items] | |||||
Drew down amount | € 5.0 |
X | ||||||||||
- Definition Drew down amount. No definition available.
|
X | ||||||||||
- Definition The EIB waived for curetis to have equity capital raised to disburse the third tranche. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Maturity period. No definition available.
|
X | ||||||||||
- Definition Participation percentage interest. No definition available.
|
X | ||||||||||
- Definition Amount of loss from the write-down of an asset representing the future economic benefits arising from other assets acquired in a business combination that are not individually identified and separately recognized. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The amount of impairment loss recognized in the period resulting from the write-down of the carrying amount of a finite-lived intangible asset to fair value. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of uncollateralized debt obligation (with maturities initially due after one year or beyond the operating cycle if longer), excluding current portion. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
|
Going Concern and Management’s Plans |
6 Months Ended | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | ||||||||||||||||
Going Concern and Management’s Plans [Abstract] | ||||||||||||||||
Going Concern and Management’s Plans | 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, and continues to incur, significant losses from operations and negative operating cash flows and has a significant amount of debt coming due through June 2024. The Company has funded its operations primarily through external investor financing arrangements and significant actions taken by the Company, including the following:
On June 5, 2023, the Listing Qualifications Staff of The Nasdaq Stock Market LLC notified the Company that the closing bid price of the Company’s common stock had, for 30 consecutive business days preceding the date of such notice, been below the $1.00 per share minimum required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Marketplace Rule 5550(a)(2). In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), the Company was provided 180 calendar days, or until December 4, 2023, to regain compliance. If at any time before December 4, 2023, the closing bid price of the Common Stock is at least $1 for a minimum of ten (10) consecutive trading days, the Company can regain compliance. If the Company is not in compliance with the minimum bid price requirement by December 4, 2023, the Company may be entitled to an additional 180-day grace period if the Company meets the continued listing requirements for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market at such time.
The Company believes that current cash will be sufficient to repay or refinance the current portion of the Company’s debt and fund operations into September 2023. This has led management to conclude that there is substantial doubt about the Company’s ability to continue as a going concern. In the event the Company is unable to successfully raise additional capital before September 2023, the Company will not have sufficient cash flows and liquidity to finance its business operations beyond September 2023 as currently contemplated. To meet its capital needs and improve its liquidity position, the Company is considering multiple alternatives, including, but not limited to, restructuring or refinancing its debt, seeking additional debt or equity capital, reducing or delaying business activities, selling assets, other strategic financings or transactions and other measures, including obtaining relief under applicable bankruptcy laws. There can be no assurance that the Company will be able to identify or execute on any of these alternatives on acceptable terms or that any of these alternatives will be successful.
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. |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The entire disclosure when substantial doubt is raised about the ability to continue as a going concern. Includes, but is not limited to, principal conditions or events that raised substantial doubt about the ability to continue as a going concern, management's evaluation of the significance of those conditions or events in relation to the ability to meet its obligations, and management's plans that alleviated or are intended to mitigate the conditions or events that raise substantial doubt about the ability to continue as a going concern. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Revenue from Contracts with Customers (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Contracts with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of revenues by type of service | The Company provides diagnostic test products and
laboratory services to hospitals, clinical laboratories and other healthcare providing customers, and enters into collaboration agreements
with government agencies, non-governmental organizations, and healthcare providers. The revenues by type of service consist of the following:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of revenues by geography | Revenues by geography are as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of changes in deferred revenue | Changes to deferred revenue for the period were as
follows:
|
X | ||||||||||
- Definition Tabular disclosure of revenues by type of service. No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of the type of arrangements and the corresponding amounts that comprise the current and noncurrent balance of deferred revenue as of the balance sheet date. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of revenue from external customers by geographic areas attributed to the entity's country of domicile and to foreign countries from which the entity derives revenue. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Revenue from Contracts with Customers (Details) - Schedule of changes in deferred revenue |
6 Months Ended |
---|---|
Jun. 30, 2023
USD ($)
| |
Schedule Of Changes In Deferred Revenue Abstract | |
Balance at beginning | $ 142,061 |
Contracts with customers | 27,134 |
Recognized in the current period | (143,954) |
Currency translation adjustment | 2,038 |
Balance at ending | $ 27,279 |
X | ||||||||||
- Definition Amount of deferred currency translation adjustment. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of obligation to transfer good or service to customer for which consideration has been received or is receivable, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of revenue recognized that was previously reported as deferred or unearned revenue. No definition available.
|
X | ||||||||||
- Definition Cash received from customers as progress payments on projects that have been partially completed. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
Accounting Policies, by Policy (Policies) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basis of presentation and consolidation | 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, 2022 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 and its wholly-owned subsidiaries as of and for the three and six months ended June 30, 2023; all intercompany transactions and balances have been eliminated.
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Foreign currency | Foreign currency The Company has subsidiaries located in Holzgerlingen, Germany and Vienna, Austria, each of which use currencies other than the U.S. dollar as their functional currency. As a result, all assets and liabilities of the subsidiaries are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive income (loss), a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive income (loss) at June 30, 2023 and December 31, 2022. 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 loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar. |
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Use of estimates | 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, inducement expense related to warrant repricing, stock-based compensation, allowances for doubtful accounts 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, determining the fair value of assets acquired and liabilities assumed in business combinations, the estimated useful lives of long-lived assets, and the recoverability of long-lived assets. Actual results could differ from those estimates. |
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Fair value of financial instruments | 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. |
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Cash and cash equivalents and restricted cash | 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 $250,000. On March 10, 2023, the Company learned that Silicon Valley Bank (“SVB”), the Company’s primary bank at the time (now a division of First Citizens Bank), was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation as receiver. The Company did not experience any losses in such accounts, but since the Company was exposed to credit risk with the failure of SVB, management diversified the Company’s holdings to minimize credit risk in the future. At June 30, 2023 and December 31, 2022, the Company had funds totaling $496,894 and $495,629, respectively, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying unaudited condensed consolidated balance sheets. The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheets:
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Accounts receivable | Accounts receivable 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 30 to 90 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $0 as of June 30, 2023 and December 31, 2022. At June 30, 2023, the Company had accounts receivable from three customers which individually represented 30%, 25%, and 12% of total accounts receivable. At December 31, 2022, the Company had accounts receivable from two customers which individually represented 41% and 21% of total accounts receivable. For the three months ended June 30, 2023, revenue earned from three customers represented 25%, 19%, and 13% of total revenues. For the three months ended June 30, 2022, revenue earned from two customers represented 57% and 12% of total revenues. For the six months ended June 30, 2023, revenue earned from two customers represented 37% and 16% of total revenues. For the six months ended June 30, 2022, revenue earned from two customers represented 47% and 15% of total revenues. |
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Inventory | Inventory Inventories are valued using the first-in, first-out cost method and stated at the lower of cost or net realizable value and consist of the following:
Inventory includes Unyvero system instruments, Unyvero cartridges, reagents and components for Unyvero and Acuitas kits, and reagents and supplies used for the Company’s laboratory services. The Company periodically reviews inventory quantities on hand and analyzes the provision for excess and obsolete inventory based primarily on product expiration dating and its estimated sales forecast, which is based on sales history and anticipated future demand. The Company’s estimates of future product demand may not be accurate, and it may understate or overstate the provision required for excess and obsolete inventory. Accordingly, any significant unanticipated changes in demand could have a significant impact on the value of the Company’s inventory and results of operations. Based on the Company’s assumptions and estimates, inventory reserves for obsolescence, expirations, and slow-moving inventory were $2,083,212 and $1,694,843 at June 30, 2023 and December 31, 2022, respectively. The Company classifies finished good inventory it does not expect to sell or use in clinical studies within 12 months of the unaudited condensed consolidated balance sheets date as strategic inventory, a non-current asset. |
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Long-lived assets | Long-lived assets Property and equipment Property and equipment 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 future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the three and six months ended June 30, 2023 and 2022, the Company determined that its property and equipment were not impaired. |
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Leases | 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 | ROU assets 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 future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done 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 assets exceeds the fair value of the assets. The Company did not identify any impaired ROU assets for the six months ended June 30, 2023 and 2022. |
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Intangible assets | Intangible assets As of June 30, 2023, the Company’s intangible assets with net balances are all finite-lived. Finite-lived and indefinite-lived intangible assets Intangible assets include trademarks, developed technology and software, in-process research & development (“IPR&D”), and distributor relationships and consisted of the following as of June 30, 2023 and December 31, 2022:
Identifiable intangible assets are amortized on a straight-line basis over their estimated useful lives. The estimated useful lives of the intangibles are:
Acquired IPR&D represents the fair value assigned to those research and development projects that were acquired in a business combination for which the related products have not received regulatory approval and have no alternative future use. IPR&D is capitalized at its fair value as an indefinite-lived intangible asset, and any development costs incurred after the acquisition are expensed as incurred. Upon achieving regulatory approval or commercial viability for the related product, the indefinite-lived intangible asset is accounted for as a finite-lived asset and is amortized on a straight-line basis over the estimated useful life. If the project is not completed or is terminated or abandoned, the Company may have an impairment related to the IPR&D which is charged to expense. Indefinite-lived intangible assets are tested for impairment annually and whenever events or changes in circumstances indicate that the carrying amount may be impaired. Impairment is calculated as the excess of the asset’s carrying value over its fair value. During the Company’s annual impairment test for its IPR&D intangible asset at December 31, 2022, it was determined that the infinite-lived intangible asset was impaired because although the Company has an ongoing collaboration utilizing the intangible asset, at the time, the contracted cash flow associated with this collaboration and projected future cash flows did not support the carrying amount. As a result, the Company recorded an impairment charge in the amount of $5,407,699 for the year ended December 31, 2022. The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets. Total amortization expense of intangible assets was $187,540 and $182,993 for the three months ended June 30, 2023 and 2022, respectively. Total amortization expense of intangible assets was $373,917 and $375,018 for the six months ended June 30, 2023 and 2022, respectively. Expected future amortization of intangible assets is as follows:
In accordance with ASC 360-10, Property, Plant and Equipment, intangible assets, other than IPR&D as discussed above, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. During the three and six months ended June 30, 2023, the Company identified triggering events that may indicate that the carrying amount of the intangible assets are not recoverable. The triggering events identified include the decline in the Company’s stock price, the receipt of a non-compliance notice from The Nasdaq Stock Market LLC regarding its minimum bid price requirement, and the Company’s inability to repay its debt to the EIB, in full, as originally required. As a result of identifying these potential indicators of impairment, the Company performed a long-lived asset impairment analysis for the three months ended June 30, 2023, and this analysis determined that the fair value of the Company’s assets exceeded their carrying values, so no impairment loss was recorded. During the three and six months ended June 30, 2022, the Company determined that its finite-lived intangible assets were not impaired. Goodwill Goodwill represents the excess of the purchase price paid when the Company acquired AdvanDx, Inc. in July 2015 and Curetis in April 2020, over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company conducts an impairment test of goodwill on an annual basis and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. During the year ended December 31, 2022, the Company performed qualitative and quantitative analyses, assessing trends in market capitalization, current and future cash flows, revenue growth rates, and the impact of global unrest and the COVID-19 pandemic on the Company and its performance. Based on the analysis performed, and primarily due to changes in the Company’s stock price and market capitalization in the third quarter of 2022, it was determined that goodwill was impaired. As a result, the Company recorded a goodwill impairment charge in the full amount of $6,940,549 for the year ended December 31, 2022.
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Revenue recognition | Revenue recognition The Company derives revenues from (i) the sale of Unyvero Application cartridges, Unyvero instruments, and Acuitas AMR Gene Panel test products, (ii) providing laboratory services, (iii) providing collaboration services (e.g., with the Foundation for Innovative New Diagnostics (FIND) on the Unyvero A30 RQ platform) including funded software and license arrangements, and (iv) granting access to subsets of the proprietary ARESdb data asset. The Company analyzes 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 obligation. The Company recognizes revenues upon the satisfaction of its performance obligation (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. |
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Government grant agreements and research incentives | Government grant agreements and research incentives From time to time, the Company may enter into arrangements with governmental entities for the purposes of obtaining funding for research and development activities. The Company recognizes funding from grants and from research incentives received from Austrian government agencies in the condensed consolidated statements of operations and comprehensive loss in the period during which the related qualifying expenses are incurred, provided that the conditions under which the grants or incentives were provided have been met. For grants under funding agreements and for proceeds under research incentive programs, the Company recognizes grant and incentive income in an amount equal to the estimated qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage. The Company classifies government grants received under these arrangements as a reduction to the related research and development expense incurred. The Company analyzes each arrangement on a case-by-case basis. For the three months ended June 30, 2023 and 2022, the Company recognized $88,421 and $111,414 as a reduction of research and development expense related to government grant arrangements, respectively. For the six months ended June 30, 2023 and 2022, the Company recognized $222,359 and $219,879 as a reduction of research and development expense related to government grant arrangements, respectively. The Company had earned but not yet received $618,637 and $401,436 related to these agreements and incentives included in prepaid expenses and other current assets, as of June 30, 2023 and December 31, 2022, respectively. |
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Research and development costs | Research and development costs Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, and fees paid to consultants and outside service partners. |
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Stock-based compensation | Stock-based compensation Stock-based compensation expense is recognized at grant date fair value. The fair value of stock-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. For restricted stock awards with a time-based vesting condition, the fair value, which is fixed at the grant date for purposes of recognizing compensation costs, is determined by reference to the Company’s stock price on the grant date. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. 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.
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Warrants | Warrants The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the instruments’ specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the instruments are free standing financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the instruments meet all of the requirements for equity classification under ASC 815, including whether the instruments are indexed to the Company’s own ordinary shares and whether the instrument holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent period end date while the instruments are outstanding. |
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Income taxes | 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 $232,682,072 and $202,015,062 at December 31, 2022 and 2021, respectively. Despite the NOL carryforwards, which began expiring in 2022, the Company may have state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. The Company also has foreign NOL carryforwards of $170,661,923 at December 31, 2022 from their foreign subsidiaries. $162,712,615 of those foreign NOL carryforwards are from the Company’s operations in Germany. Despite the NOL carryforwards, the Company may have a current and future tax liability due to the nuances of German tax law around the use of NOLs within a consolidated group. There is no assurance that the NOL carryforwards will ever be fully utilized. |
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Loss per share | Loss per share 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. For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) unvested restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 11.2 million shares and 1.0 million shares as of June 30, 2023 and 2022, respectively. |
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Adopted accounting pronouncements | Adopted accounting pronouncements In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2021-04”). ASU 2021-04 clarifies and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options, including warrants, that remain equity-classified after modification or exchange. ASU 2021-04 requires an entity to treat a modification or an exchange of a freestanding equity-classified written call option that remains equity-classified after the modification or exchange as an exchange of the original instrument for a new instrument and provides guidance on measuring and recognizing the effect of a modification or an exchange. The Company adopted ASU 2021-04 on January 1, 2022. The adoption did not have a material impact on the Company’s consolidated financial statements and related disclosures.
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Recently issued accounting standards | Recently issued accounting standards 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. |
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- Definition Entity's cash and cash equivalents accounting policy with respect to restricted balances. Restrictions may include legally restricted deposits held as compensating balances against short-term borrowing arrangements, contracts entered into with others, or company statements of intention with regard to particular deposits; however, time deposits and short-term certificates of deposit are not generally included in legally restricted deposits. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for computing basic and diluted earnings or loss per share for each class of common stock and participating security. Addresses all significant policy factors, including any antidilutive items that have been excluded from the computation and takes into account stock dividends, splits and reverse splits that occur after the balance sheet date of the latest reporting period but before the issuance of the financial statements. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for determining the fair value of financial instruments. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for (1) transactions denominated in a currency other than the reporting enterprise's functional currency, (2) translating foreign currency financial statements that are incorporated into the financial statements of the reporting enterprise by consolidation, combination, or the equity method of accounting, and (3) remeasurement of the financial statements of a foreign reporting enterprise in a hyperinflationary economy. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Disclosure of accounting policy for income taxes, which may include its accounting policies for recognizing and measuring deferred tax assets and liabilities and related valuation allowances, recognizing investment tax credits, operating loss carryforwards, tax credit carryforwards, and other carryforwards, methodologies for determining its effective income tax rate and the characterization of interest and penalties in the financial statements. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Disclosure of accounting policy for leasing arrangement entered into by lessee. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The entire disclosure for change in accounting principle. Includes, but is not limited to, nature, reason, and method of adopting amendment to accounting standards or other change in accounting principle. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Going Concern and Management’s Plans (Details) $ / shares in Units, € in Millions |
1 Months Ended | 6 Months Ended | 12 Months Ended | ||||||
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May 04, 2023
USD ($)
$ / shares
shares
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Jan. 11, 2023
USD ($)
$ / shares
shares
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Oct. 03, 2022
USD ($)
$ / shares
shares
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Jun. 26, 2023
EUR (€)
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Jun. 30, 2023
$ / shares
shares
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Dec. 31, 2022
USD ($)
$ / shares
shares
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Dec. 04, 2023
$ / shares
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Jun. 05, 2023
$ / shares
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Jun. 24, 2022
USD ($)
|
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Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Principal balance (in Euro) | € | € 3 | ||||||||
Principal paid (in Euro) | € | € 1 | ||||||||
Common stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | |||||
Exercise price per share | $ 0.7785 | ||||||||
Gross proceeds (in Dollars) | $ | $ 3,500,000 | ||||||||
Net proceeds (in Dollars) | $ | $ 3,000,000 | $ 3,040,000.00 | $ 990,000 | ||||||
Repriced warrants (in Shares) | shares | 6,396,903 | ||||||||
Existing warrant price | $ 0.7785 | $ 0.7785 | $ 0.7785 | ||||||
Existing warrants period | 5 years | ||||||||
Additional paid in capital (in Dollars) | $ | $ 0.3 | ||||||||
Common stock issued (in Shares) | shares | 605,000 | 268,000 | 6,967,699 | 2,899,911 | |||||
Exercise price of common warrants | $ 0.7785 | $ 2.65 | |||||||
Preferred stock stated value per share | $ 0.01 | $ 0.01 | |||||||
Pre-funded warrants to purchase (in Shares) | shares | 215,000 | ||||||||
Price for pre-funded warrants | $ 0.01 | ||||||||
Gross proceeds (in Dollars) | $ | $ 3,500,000 | $ 1,030,000.00 | |||||||
Warrants expiry period | five and one-half | ||||||||
Increase in fair value from warrant modification (in Dollars) | $ | $ 300,000 | $ 1,800,000 | |||||||
Consecutive business days | 10 days | 30 days | |||||||
NASDAQ minimum bid price | $ 1 | ||||||||
Additional grace period | 180 days | ||||||||
Common Stock [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Shares issued (in Shares) | shares | 605,000 | ||||||||
Common stock, par value | $ 0.01 | $ 0.01 | |||||||
Quantity of pre-funded warrants (in Shares) | shares | 3,890,825 | ||||||||
Quantity of common warrants issued (in Shares) | shares | 4,495,825 | ||||||||
Price to exercise prefunded warrants | $ 0.01 | ||||||||
NASDAQ minimum bid price | $ 7 | ||||||||
Common warrants to purchase (in Shares) | shares | 483,000 | ||||||||
Preferred Stock [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
NASDAQ minimum bid price | $ 0.01 | ||||||||
Maximum [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Exercise price per share | 0.7785 | ||||||||
Maximum warrant exercise price from prior offerings | 7.54 | 1,300 | |||||||
Minimum [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Offering price for prefunded warrants | 0.7685 | ||||||||
Minimum warrant exercise price from prior offerings | $ 2.65 | 41 | |||||||
Series A-1 Warrants [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Warrant issuance and exercisable, description | The Series A-1 Warrants were immediately exercisable upon issuance, and will expire five years following the issuance date. | ||||||||
Series A-2 Warrants [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Warrant issuance and exercisable, description | The Series A-2 Warrants were immediately exercisable upon issuance, and will expire eighteen months following the issuance date. | ||||||||
Warrant [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Exercise price of common warrants | $ 215,000 | ||||||||
Price for pre-funded warrants | $ 6.8 | ||||||||
Gross proceeds (in Dollars) | $ | $ 3,340,000 | ||||||||
Proceeds from issuance of common stock, net of issuance costs (in Dollars) | $ | $ 3,040,000.00 | ||||||||
Warrants repriced (in Shares) | shares | 741,489 | ||||||||
Pre-funded warrants exercised (in Shares) | shares | 215,000 | ||||||||
2022 ATM Offering [Member] | H.C. Wainwright & Co., LLC [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Gross proceeds (in Dollars) | $ | $ 1,030,000.00 | ||||||||
Market offering value (in Dollars) | $ | $ 10,650,000 | ||||||||
Company sold shares (in Shares) | shares | 85,732 | ||||||||
Net proceeds (in Dollars) | $ | $ 990,000 | ||||||||
Securities Purchase Agreement [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Common stock issued (in Shares) | shares | 321,207 | ||||||||
Prefunded warrants (in Shares) | shares | 2,265,000 | ||||||||
Pre-funded warrants offering price per share | $ 2.89 | ||||||||
Securities Purchase Agreement [Member] | Common Stock [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Shares issued par value | 0.01 | ||||||||
Exercise price per common warrant | $ 2.9 | ||||||||
Aggregate gross proceed (in Dollars) | $ | $ 7,500,000 | ||||||||
Net proceeds (in Dollars) | $ | $ 6,900,000 | ||||||||
Series A-1 Common Warrants [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Aggregate warrants (in Shares) | shares | 2,586,207 | ||||||||
Series A-2 Common Warrants [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Aggregate warrants (in Shares) | shares | 2,586,207 | ||||||||
Exercise price of common warrants | $ 0.01 | ||||||||
Series C Mirroring Preferred Stock [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Shares of preferred stock (in Shares) | shares | 33,810 | ||||||||
Preferred stock stated value per share | $ 0.01 | ||||||||
Preferred stock, stated value | 0.01 | ||||||||
Forecast [Member] | Common Stock [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
NASDAQ minimum bid price share price | $ 1 | ||||||||
Investor [Member] | |||||||||
Going Concern and Management’s Plans (Details) [Line Items] | |||||||||
Exercise price of common warrants | $ 7.54 |
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- Definition Warrant issuance and exercisable, description No definition available.
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- Definition Exercise price per share or per unit of warrants or rights outstanding. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Face amount or stated value per share of common stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Total number of common shares of an entity that have been sold or granted to shareholders (includes common shares that were issued, repurchased and remain in the treasury). These shares represent capital invested by the firm's shareholders and owners, and may be all or only a portion of the number of shares authorized. Shares issued include shares outstanding and shares held in the treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The cash inflow from issuance of rights to purchase common shares at predetermined price (usually issued together with corporate debt). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Price of a single share of a number of saleable stocks of a company. No definition available.
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- Definition Number of shares of stock issued as of the balance sheet date, including shares that had been issued and were previously outstanding but which are now held in the treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Number of new stock issued during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Per share increase in exercise price of option. Excludes change due to standard antidilution provision and option granted under share-based payment arrangement. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The number of securities classified as temporary equity that have been sold (or granted) to the entity's shareholders. Securities issued include securities outstanding and securities held in treasury. Temporary equity is a security with redemption features that are outside the control of the issuer, is not classified as an asset or liability in conformity with GAAP, and is not mandatorily redeemable. Includes any type of security that is redeemable at a fixed or determinable price or on a fixed or determinable date or dates, is redeemable at the option of the holder, or has conditions for redemption which are not solely within the control of the issuer. If convertible, the issuer does not control the actions or events necessary to issue the maximum number of shares that could be required to be delivered under the conversion option if the holder exercises the option to convert the stock to another class of equity. If the security is a warrant or a rights issue, the warrant or rights issue is considered to be temporary equity if the issuer cannot demonstrate that it would be able to deliver upon the exercise of the option by the holder in all cases. Includes stock with put option held by ESOP and stock redeemable by holder only in the event of a change in control of the issuer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Period between issuance and expiration of outstanding warrant and right embodying unconditional obligation requiring redemption by transferring asset at specified or determinable date or upon event certain to occur, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Income Statement [Abstract] | ||||
Net loss per common share - diluted (in Dollars per share) | $ (0.93) | $ (2.51) | $ (2.13) | $ (5.43) |
Weighted average shares outstanding - diluted (in Shares) | 6,246,326 | 2,328,725 | 5,424,542 | 2,326,485 |
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- Definition The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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X | ||||||||||
- Definition The average number of shares or units issued and outstanding that are used in calculating diluted EPS or earnings per unit (EPU), determined based on the timing of issuance of shares or units in the period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Leases (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of ROU assets and lease liabilities | The following table presents the Company’s ROU
assets and lease liabilities as of June 30, 2023 and December 31, 2022:
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Schedule of maturities of lease liabilities | Maturities of lease liabilities as of June 30,
2023 by fiscal year are as follows:
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Schedule of lease cost classifications | Condensed consolidated statements of operations
classification of lease costs as of the three and six months ended June 30, 2023 and 2022 are as follows:
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Schedule of other lease information | Other lease information as of June 30, 2023 is
as follows:
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Schedule of supplemental cash flow information | Supplemental cash flow information as of
the six months ended June 30, 2023 and 2022 is as follows:
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- Definition Schedule of maturities of operating and finance leases liabilities. No definition available.
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X | ||||||||||
- Definition The entire disclosure other lease information. No definition available.
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X | ||||||||||
- Definition Schedule of right-of-use assets and lease liabilities. No definition available.
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- Definition Schedule of supplemental cash flow information related to Leases. No definition available.
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X | ||||||||||
- Definition Tabular disclosure of lessee's lease cost. Includes, but is not limited to, interest expense for finance lease, amortization of right-of-use asset for finance lease, operating lease cost, short-term lease cost, variable lease cost and sublease income. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- References No definition available.
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Document And Entity Information - shares |
6 Months Ended | |
---|---|---|
Jun. 30, 2023 |
Aug. 11, 2023 |
|
Document Information Line Items | ||
Entity Registrant Name | OPGEN, INC. | |
Trading Symbol | OPGN | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 8,899,524 | |
Amendment Flag | false | |
Entity Central Index Key | 0001293818 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-37367 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 06-1614015 | |
Entity Address, Address Line One | 9717 Key West Avenue | |
Entity Address, Address Line Two | Suite 100 | |
Entity Address, City or Town | Rockville | |
Entity Address, State or Province | MD | |
Entity Address, Postal Zip Code | 20850 | |
City Area Code | (240) | |
Local Phone Number | 813-1260 | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
X | ||||||||||
- Definition Boolean flag that is true when the XBRL content amends previously-filed or accepted submission. No definition available.
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X | ||||||||||
- Definition Area code of city No definition available.
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X | ||||||||||
- Definition End date of current fiscal year in the format --MM-DD. No definition available.
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X | ||||||||||
- Definition Fiscal period values are FY, Q1, Q2, and Q3. 1st, 2nd and 3rd quarter 10-Q or 10-QT statements have value Q1, Q2, and Q3 respectively, with 10-K, 10-KT or other fiscal year statements having FY. No definition available.
|
X | ||||||||||
- Definition This is focus fiscal year of the document report in YYYY format. For a 2006 annual report, which may also provide financial information from prior periods, fiscal 2006 should be given as the fiscal year focus. Example: 2006. No definition available.
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X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
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X | ||||||||||
- Definition For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD. No definition available.
|
X | ||||||||||
- Definition Boolean flag that is true only for a form used as an quarterly report. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Boolean flag that is true only for a form used as a transition report. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'. No definition available.
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X | ||||||||||
- Definition Address Line 1 such as Attn, Building Name, Street Name No definition available.
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X | ||||||||||
- Definition Address Line 2 such as Street or Suite number No definition available.
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X | ||||||||||
- Definition Name of the City or Town No definition available.
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X | ||||||||||
- Definition Code for the postal or zip code No definition available.
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X | ||||||||||
- Definition Name of the state or province. No definition available.
|
X | ||||||||||
- Definition A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Indicate number of shares or other units outstanding of each of registrant's classes of capital or common stock or other ownership interests, if and as stated on cover of related periodic report. Where multiple classes or units exist define each class/interest by adding class of stock items such as Common Class A [Member], Common Class B [Member] or Partnership Interest [Member] onto the Instrument [Domain] of the Entity Listings, Instrument. No definition available.
|
X | ||||||||||
- Definition Indicate 'Yes' or 'No' whether registrants (1) have 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 registrants were required to file such reports), and (2) have been subject to such filing requirements for the past 90 days. This information should be based on the registrant's current or most recent filing containing the related disclosure. No definition available.
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X | ||||||||||
- Definition Indicate if registrant meets the emerging growth company criteria. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen. No definition available.
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X | ||||||||||
- Definition Indicate whether the registrant is one of the following: Large Accelerated Filer, Accelerated Filer, Non-accelerated Filer. Definitions of these categories are stated in Rule 12b-2 of the Exchange Act. This information should be based on the registrant's current or most recent filing containing the related disclosure. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Two-character EDGAR code representing the state or country of incorporation. No definition available.
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X | ||||||||||
- Definition Boolean flag that is true when the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Boolean flag that is true when the registrant is a shell company as defined in Rule 12b-2 of the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Indicates that the company is a Smaller Reporting Company (SRC). Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Local phone number for entity. No definition available.
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- Definition Title of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Name of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Trading symbol of an instrument as listed on an exchange. No definition available.
|
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in Dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | ||
Preferred stock, shares outstanding | ||
Common stock, par value (in Dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares outstanding | 6,967,699 | 2,899,911 |
Common stock, shares issued | 6,967,699 | 2,899,911 |
X | ||||||||||
- Definition Face amount or stated value per share of common stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The maximum number of common shares permitted to be issued by an entity's charter and bylaws. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Total number of common shares of an entity that have been sold or granted to shareholders (includes common shares that were issued, repurchased and remain in the treasury). These shares represent capital invested by the firm's shareholders and owners, and may be all or only a portion of the number of shares authorized. Shares issued include shares outstanding and shares held in the treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Number of shares of common stock outstanding. Common stock represent the ownership interest in a corporation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Face amount or stated value per share of preferred stock nonredeemable or redeemable solely at the option of the issuer. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition The maximum number of nonredeemable preferred shares (or preferred stock redeemable solely at the option of the issuer) permitted to be issued by an entity's charter and bylaws. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Total number of nonredeemable preferred shares (or preferred stock redeemable solely at the option of the issuer) issued to shareholders (includes related preferred shares that were issued, repurchased, and remain in the treasury). May be all or portion of the number of preferred shares authorized. Excludes preferred shares that are classified as debt. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Aggregate share number for all nonredeemable preferred stock (or preferred stock redeemable solely at the option of the issuer) held by stockholders. Does not include preferred shares that have been repurchased. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- References No definition available.
|
Revenue from Contracts with Customers (Details) - Schedule of revenues by type of service - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Revenue from Contracts with Customers (Details) - Schedule of revenues by type of service [Line Items] | ||||
Total revenue | $ 736,137 | $ 967,205 | $ 1,649,581 | $ 1,436,950 |
Product sales [Member] | ||||
Revenue from Contracts with Customers (Details) - Schedule of revenues by type of service [Line Items] | ||||
Total revenue | 439,672 | 889,271 | 850,569 | 1,255,323 |
Laboratory services [Member] | ||||
Revenue from Contracts with Customers (Details) - Schedule of revenues by type of service [Line Items] | ||||
Total revenue | 44,003 | 20,570 | 65,676 | 63,499 |
Collaboration revenue [Member] | ||||
Revenue from Contracts with Customers (Details) - Schedule of revenues by type of service [Line Items] | ||||
Total revenue | $ 252,462 | $ 57,364 | $ 733,336 | $ 118,128 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Details
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- Details
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- Details
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Leases (Details) - Schedule of supplemental cash flow information - USD ($) |
6 Months Ended | |
---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Cash used in operating activities | ||
Operating leases | $ 309,303 | $ 327,699 |
Finance leases | 1,414 | |
Cash used in financing activities | ||
Finance leases | 1,682 | 28,101 |
ROU assets obtained in exchange for lease obligations: | ||
Operating leases | $ 801,321 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of interest paid on finance lease liability. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of cash outflow for principal payment on finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of cash outflow from operating lease, excluding payments to bring another asset to condition and location necessary for its intended use. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of increase in right-of-use asset obtained in exchange for operating lease liability. Reference 1: http://www.xbrl.org/2003/role/exampleRef
|
License Agreements, Research Collaborations and Development Agreements |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
License Agreements Research Collaborations And Development Agreements Disclosure [Abstract] | |
License agreements, research collaborations and development agreements | Note 10 – License agreements, research collaborations and development agreements
Sandoz
In December 2018, Ares Genetics entered into a service frame agreement with Sandoz International GmbH (“Sandoz”), to leverage Ares Genetics’ database on the genetics of antibiotic resistance, ARESdb, and the ARES Technology Platform for Sandoz’s anti-infective portfolio.
Under the terms of the framework agreement, which had an initial term of 36 months and was subsequently extended to January 31, 2025, Ares Genetics and Sandoz intend to develop a digital anti-infectives platform, combining established microbiology laboratory methods with advanced bioinformatics and artificial intelligence methods to support drug development and life-cycle management. The collaboration, in the short- to mid-term, aims to both rapidly and cost-effectively re-purpose existing antibiotics and design value-added medicines with the objective of expanding indication areas and to overcome antibiotic resistance, in particular with regards to infections with bacteria that have already developed resistance against multiple treatment options. In the longer-term, the platform is expected to enable surveillance for antimicrobial resistant pathogens to inform antimicrobial stewardship and the development of novel anti-infectives that are less prone to encounter resistance and thereby preserve antibiotics as an effective treatment option.
Qiagen
On February 18, 2019, Ares Genetics and Qiagen GmbH, or Qiagen, entered into a strategic licensing agreement for ARESdb and AREStools, in the area of AMR research. The agreement has a term of 20 years and may be terminated by Qiagen for convenience with 180 days written notice.
Ares Genetics has retained the rights to use ARESdb and AREStools for AMR research, customized bioinformatics services, and for the development of specific AMR assays and applications for the Curetis Group (including Ares Genetics), as well as third parties (e.g., other diagnostics companies or partners in the pharmaceutical industry). As the Qiagen research offering is expected to also enable advanced molecular diagnostic services and products, Qiagen’s customers may obtain a diagnostic use license from Ares Genetics.
Under the terms of the original agreement, Qiagen, in exchange for a moderate six figure up-front licensing payment, has received an exclusive RUO license to develop and commercialize general bioinformatics offerings and services for AMR research use only, based on Ares Genetics’ database on the genetics of antimicrobial resistance, ARESdb, as well as on the ARES bioinformatics AMR toolbox, AREStools. Under the agreement, the parties had agreed to a mid-single digit percentage royalty rate on Qiagen net sales, which is subject to a minimum royalty rate that steps up upon certain achieved milestones, which is payable to Ares Genetics. The parties also agreed to further modest six figure milestone payments upon certain product launches. The contract was subsequently amended in May 2021 to a non-exclusive license and a flat annual license fee as well as a royalty percentage on potential future panel-based products that are developed by Qiagen.
Siemens
In 2016, Ares Genetics acquired the GEAR assets from Siemens Technology Accelerator GmbH (“STA”), providing the original foundation to ARESdb. Under the agreement with STA, Ares Genetics incurs royalties on revenues from licensed product sales or sublicensing proceeds. Royalty rates under the Siemens agreement range from 1.3% to 40% depending on the specifics of the licenses and rights provided by Ares Genetics to third parties and whether such third parties may have been originally introduced by Siemens to Ares Genetics. The total net royalty expense related to this agreement was $2,264 and $703 for the three months ended June 30, 2023 and 2022, respectively. The total net royalty expense related to this agreement was $4,207 and $3,482 for the six months ended June 30, 2023 and 2022, respectively.
Foundation for Innovative New Diagnostics (FIND)
On September 20, 2022, Curetis GmbH and FIND entered into a research and development collaboration agreement for a total amount due to Curetis of €0.7 million to develop a simple to use molecular diagnostic test for identification of pathogens and antibiotic resistances in positive blood cultures for deployment in low- and middle-income countries (“LMICs”). On April 4, 2023, the Company entered into an amendment to its research and development collaboration agreement with FIND to expand the deliverables in exchange for an additional €130 thousand in milestone payments, increasing the total project revenue to €830 thousand. The additional deliverables were completed by June 30, 2023. During the three and six months ended June 30, 2023, the Company recognized revenues of €0.2 million and €0.6 million, respectively, related to the collaboration, bringing the total amount recognized through June 30, 2023, to €0.8 million. Following successful completion of the feasibility phase of the collaboration, including the additional deliverables, FIND and Curetis, on August 1, 2023, extended the research and development collaboration agreement through May 31, 2024, to include AMR assay and cartridge development, analytical testing, and software development for an additional €0.5 million. |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Represents the entire disclosure pertaining to License agreements, research collaborations and development agreements. No definition available.
|