Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 14, 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 | 10,013,524 | |
Amendment Flag | false | |
Entity Central Index Key | 0001293818 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
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 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 292,642 | $ 7,440,030 |
Accounts receivable, net | 422,725 | 514,372 |
Inventory, net | 1,198,259 | 1,345,137 |
Prepaid expenses and other current assets | 1,541,074 | 1,355,949 |
Total current assets | 3,454,700 | 10,655,488 |
Property and equipment, net | 3,820,829 | 3,457,531 |
Finance lease right-of-use assets, net | 986 | 3,500 |
Operating lease right-of-use assets | 1,915,049 | 1,459,413 |
Intangible assets, net | 6,842,406 | 7,440,974 |
Strategic inventory | 1,608,890 | 2,300,614 |
Other noncurrent assets | 492,022 | 495,629 |
Total assets | 18,134,882 | 25,813,149 |
Current liabilities | ||
Current maturities of long-term debt | 9,199,764 | 7,023,901 |
Accounts payable | 904,559 | 420,821 |
Accrued compensation and benefits | 381,807 | 1,097,654 |
Accrued liabilities | 1,268,723 | 1,526,204 |
Deferred revenue | 194,687 | 142,061 |
Short-term finance lease liabilities | 1,121 | 3,364 |
Short-term operating lease liabilities | 521,424 | 377,626 |
Total current liabilities | 12,472,085 | 10,591,631 |
Long-term debt, net | 4,850,686 | |
Derivative liabilities | 34,364 | 99,498 |
Long-term finance lease liabilities | 280 | |
Long-term operating lease liabilities | 2,830,282 | 2,566,138 |
Other long-term liabilities | 121,428 | 129,368 |
Total liabilities | 15,458,159 | 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 September 30, 2023 and December 31, 2022 | ||
Common stock, $0.01 par value; 100,000,000 shares authorized; 10,013,524 and 2,899,911 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 100,135 | 28,999 |
Additional paid-in capital | 291,705,905 | 281,167,161 |
Accumulated deficit | (288,451,655) | (272,824,772) |
Accumulated other comprehensive loss | (677,662) | (795,840) |
Total stockholders’ equity | 2,676,723 | 7,575,548 |
Total liabilities and stockholders’ equity | $ 18,134,882 | $ 25,813,149 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2023 | May 04, 2023 | Dec. 31, 2022 | Oct. 03, 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 | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000,000 | 100,000,000 | ||
Common stock, shares outstanding | 10,013,524 | 605,000 | 2,899,911 | 268,000 |
Common stock, shares issued | 10,013,524 | 2,899,911 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue | ||||
Total revenue | $ 699,022 | $ 448,713 | $ 2,348,601 | $ 1,885,663 |
Operating expenses | ||||
Cost of products sold | 618,796 | 1,886,191 | 1,925,566 | 2,824,577 |
Cost of services | 73,174 | 17,239 | 405,582 | 63,450 |
Research and development | 1,201,865 | 2,031,113 | 4,403,488 | 6,621,310 |
General and administrative | 2,034,628 | 2,020,452 | 6,883,588 | 6,779,773 |
Sales and marketing | 336,184 | 1,031,496 | 2,522,471 | 3,252,277 |
Goodwill impairment charge | 6,975,520 | 6,975,520 | ||
Total operating expenses | 4,264,647 | 13,962,011 | 16,140,695 | 26,516,907 |
Operating loss | (3,565,625) | (13,513,298) | (13,792,094) | (24,631,244) |
Other (expense) income | ||||
Interest and other income | 24,977 | 11,174 | 86,301 | 28,147 |
Interest expense | (396,768) | (569,306) | (1,698,564) | (2,618,799) |
Foreign currency transaction (losses) gains | (135,930) | (51,547) | (288,326) | 419,160 |
Change in fair value of derivative financial instruments | 10,389 | 18,995 | 65,800 | 54,623 |
Total other expense | (497,332) | (590,684) | (1,834,789) | (2,116,869) |
Loss before income taxes | (4,062,957) | (14,103,982) | (15,626,883) | (26,748,113) |
Provision for income taxes | ||||
Net loss | (4,062,957) | (14,103,982) | (15,626,883) | (26,748,113) |
Net loss available to common stockholders | $ (4,062,957) | $ (14,103,982) | $ (15,626,883) | $ (26,748,113) |
Net loss per common share – basic (in Dollars per share) | $ (0.46) | $ (5.92) | $ (2.38) | $ (11.4) |
Weighted average shares outstanding – basic (in Shares) | 8,778,152 | 2,382,848 | 6,565,853 | 2,345,794 |
Net loss | $ (4,062,957) | $ (14,103,982) | $ (15,626,883) | $ (26,748,113) |
Other comprehensive income (loss) – foreign currency translation | 78,815 | (536,758) | 118,178 | (2,247,749) |
Comprehensive loss | (3,984,142) | (14,640,740) | (15,508,705) | (28,995,862) |
Product sales | ||||
Revenue | ||||
Total revenue | 558,965 | 359,112 | 1,409,534 | 1,614,435 |
Laboratory services | ||||
Revenue | ||||
Total revenue | 47,135 | 31,016 | 112,810 | 94,515 |
Collaboration revenue | ||||
Revenue | ||||
Total revenue | $ 92,922 | $ 58,585 | $ 826,257 | $ 176,713 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Net loss per common share - diluted | $ (0.46) | $ (5.92) | $ (2.38) | $ (11.40) |
Weighted average shares outstanding - diluted | 8,778,152 | 2,382,848 | 6,565,853 | 2,345,794 |
Condensed Consolidated Statem_3
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 | |||||
Stock compensation expense | 228,367 | 228,367 | ||||
At the market offering, net of offering costs | $ 857 | 988,847 | 989,704 | |||
At the market offering, net of offering costs (in Shares) | 85,732 | |||||
Foreign currency translation | (536,758) | (536,758) | ||||
Net loss | (14,103,982) | (14,103,982) | ||||
Balances at Sep. 30, 2022 | $ 24,169 | 277,865,917 | (1,662,123) | (262,289,652) | 13,938,311 | |
Balances (in Shares) at Sep. 30, 2022 | 2,416,911 | |||||
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 | |||||
Cash bonus taken in the form of stock compensation | 283,554 | 283,554 | ||||
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 | |||||
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 | |||||
Stock compensation expense | (229,483) | (229,483) | ||||
Offering of common stock and warrants, net of issuance costs | $ 30,458 | 30,458 | ||||
Offering of common stock and warrants, net of issuance costs (in Shares) | 3,045,825 | |||||
Foreign currency translation | 78,815 | 78,815 | ||||
Net loss | (4,062,957) | (4,062,957) | ||||
Balances at Sep. 30, 2023 | $ 100,135 | $ 291,705,905 | $ (677,662) | $ (288,451,655) | $ 2,676,723 | |
Balances (in Shares) at Sep. 30, 2023 | 10,013,524 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (15,626,883) | $ (26,748,113) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 1,070,581 | 1,307,590 |
Noncash interest expense | 1,261,495 | 1,973,437 |
Loss on disposal of equipment | 15,988 | |
Stock compensation expense | 138,168 | 727,389 |
Change in inventory reserve | 535,755 | 1,447,626 |
Cash bonus taken in the form of stock compensation | 283,554 | |
Change in fair value of derivative liabilities | (65,800) | (54,623) |
Goodwill impairment charge | 6,975,520 | |
Changes in operating assets and liabilities | ||
Accounts receivable | 91,522 | 386,704 |
Inventory | 290,366 | (600,186) |
Other assets | 86,516 | (326,820) |
Accounts payable | 399,197 | (519,625) |
Accrued compensation and other liabilities | (1,161,958) | (1,250,476) |
Deferred revenue | 54,388 | 210,735 |
Net cash used in operating activities | (12,643,099) | (16,454,854) |
Cash flows from investing activities | ||
Purchases of property and equipment | (799,498) | (186,556) |
Net cash used in investing activities | (799,498) | (186,556) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs | 10,188,158 | |
Proceeds from at the market offering, net of issuance costs | 989,704 | |
Payments on debt | (3,910,010) | (8,697,587) |
Payments on finance lease obligations | (2,523) | (38,925) |
Net cash provided by (used in) financing activities | 6,275,625 | (7,746,808) |
Effects of exchange rates on cash | 15,977 | (1,548,819) |
Net decrease in cash and cash equivalents and restricted cash | (7,150,995) | (25,937,037) |
Cash and cash equivalents and restricted cash at beginning of period | 7,935,659 | 36,632,186 |
Cash and cash equivalents and restricted cash at end of period | 784,664 | 10,695,149 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 1,422,343 | 976,324 |
Supplemental disclosures of noncash investing and financing activities | ||
Right-of-use assets acquired through operating leases | 801,321 | |
Property and equipment transferred to inventory | 152,243 | |
Purchased equipment not yet paid for | $ 94,784 |
Organization
Organization | 9 Months Ended |
Sep. 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 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 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 product. OpGen offers the FDA-cleared Unyvero LRT and LRT BAL Panels 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 responded to all of the FDA’s additional requests on October 20, 2023 in order to continue the FDA review. 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. In October 2023, the Company discontinued its Acuitas AMR Gene Panel diagnostic test (see Note 11). The Company informed customers of the discontinuation and final orders were processed earlier this year. The discontinuance of this product line did not qualify for discontinued operations reporting. |
Going Concern and Management_s
Going Concern and Management’s Plans | 9 Months Ended |
Sep. 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: ● During the three months ended September 30, 2023, the Company implemented certain cash management initiatives, including restructuring its U.S. operations by reducing headcount from 23 to 6 and scaling down operations at OpGen’s U.S. headquarters to the core functions of a U.S. Nasdaq listed company with only minimal marketing and sales support, allowing the Company to conserve cash and focus on the functions needed to pursue potential strategic alternatives. ● 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 (the “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. In addition, Curetis agreed to certain undertakings during the standstill period, including the delivery of a rolling cash flow forecast and to cause a third-party restructuring expert to prepare and deliver a restructuring opinion to the EIB. 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. ● 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 or may be exercised pursuant to the Warrant Inducement Agreement entered into on October 12, 2023, as amended on October 26, 2023 (the “Inducement Agreement”), upon the payment of additional consideration of $0.25 per share of common stock issued upon exercise of any existing warrants. The common warrants not exercised as part of the Inducement Agreement will expire on the five-year anniversary of the date of such stockholder approval (see Note 11). 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 September 30, 2023, stockholder approval for the exercisability of the common warrants in the offering has not yet been obtained; however, pursuant to the Inducement Agreement, the existing common warrants are exercisable until December 31, 2023 upon payment of the exercise price plus additional consideration of $0.25 per share of common stock issued upon exercise of any existing warrants. In addition, the Company’s requirement to hold a stockholders’ meeting to obtain approval for the exercisability of the existing common warrants is not applicable during the offer period under the Inducement Agreement. ● On January 11, 2023, the Company closed a best-efforts public offering pursuant to a securities purchase agreement 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 (the “Pre-funded Warrants”), (iii) Series A-1 common warrants to purchase an aggregate of 2,586,207 shares of common stock (the “Series A-1 Warrants”), and (iv) Series A-2 common warrants to purchase an aggregate of 2,586,207 shares of common stock (the “Series A-2 Warrants,” and together with the Series A-1 Warrants, the “Common Warrants”). Each share of common stock and accompanying Common Warrants were sold at a price of $2.90 per share and accompanying Common Warrants, and each Pre-funded Warrant and accompanying Common Warrants were 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 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 close 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 were exercised and all 33,810 shares of the Company’s Series C Mirroring Preferred Stock were automatically cancelled and ceased to be outstanding following receipt of stockholder approval for the Company’s reverse stock split on November 30, 2022. 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 June 24, 2022, the Company entered into an At-the-Market, or ATM, Offering Agreement (the “2022 ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), 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 Agreement 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 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. OpGen is a guarantor of Curetis’ debt to the EIB and OpGen would likely remain responsible for Curetis’ debt unless it is fully satisfied in connection with the resolution of Curetis’ and Ares Genetics’ insolvency proceedings. If Curetis’ debt is not fully satisfied in connection with the insolvency proceedings, and if the EIB asserts its claims against OpGen, OpGen’s cash reach would be dependent on the remaining amount due, and it is possible that OpGen would need to seek bankruptcy protection in the United States. Even if Curetis’ debt is satisfied in connection with the insolvency proceedings and the EIB does not assert claims against OpGen, OpGen’s cash available to fund its business operations is significantly limited. This has led management to conclude that there is substantial doubt about the Company’s ability to continue as a going concern. To meet its capital needs and improve its liquidity position, the Company has been and continues to actively consider 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
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 nine months ended September 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 September 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 September 30, 2023 and December 31, 2022, the Company had funds totaling $492,022 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: September 30, 2023 December 31, 2022 September 30, 2022 December 31, 2021 Cash and cash equivalents $ 292,642 $ 7,440,030 $ 10,275,654 $ 36,080,392 Restricted cash 492,022 495,629 419,495 551,794 Total cash and cash equivalents and restricted cash in the condensed consolidated statements of cash flows $ 784,664 $ 7,935,659 $ 10,695,149 $ 36,632,186 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, the customer’s current ability to pay its obligation, and reasonable and supportable forecasts from the customer. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for credit losses was $0 as of September 30, 2023 and December 31, 2022. At September 30, 2023, the Company had accounts receivable from three customers which individually represented 24%, 24%, and 11% 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 September 30, 2023, revenue earned from four customers represented 21%, 15%, 12%, and 11% of total revenues. For the three months ended September 30, 2022, revenue earned from three customers represented 29%, 18%, and 11% of total revenues. For the nine months ended September 30, 2023, revenue earned from three customers represented 28%, 17%, and 10% of total revenues. For the nine months ended September 30, 2022, revenue earned from two customers represented 43% and 16% 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: September 30, 2023 December 31, 2022 Raw materials and supplies $ 993,093 $ 1,011,476 Work-in-process 34,638 37,445 Finished goods 1,779,418 2,596,830 Total $ 2,807,149 $ 3,645,751 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 $2,214,185 and $1,694,843 at September 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 nine months ended September 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 nine months ended September 30, 2023 and 2022. Intangible assets As of September 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 and tradenames, developed technology and software, in-process research & development (“IPR&D”), and distributor relationships and consisted of the following as of September 30, 2023 and December 31, 2022: September 30, 2023 December 31, 2022 Subsidiary Cost Accumulated Amortization and Impairment Effect of Foreign Exchange Rates Net Balance Accumulated Amortization and Impairment Effect of Foreign Exchange Rates Net Balance Trademarks and tradenames Curetis $ 1,768,000 $ (592,893 ) $ (74,033 ) $ 1,101,074 $ (469,011 ) $ (62,520 ) $ 1,236,469 Distributor relationships Curetis 2,362,000 (528,064 ) (98,907 ) 1,735,029 (417,728 ) (83,525 ) 1,860,747 A50 – Developed technology Curetis 349,000 (167,211 ) (14,614 ) 167,175 (132,273 ) (12,342 ) 204,385 Ares – Developed technology Ares Genetics 5,333,000 (1,277,401 ) (216,471 ) 3,839,128 (1,010,495 ) (183,132 ) 4,139,373 A30 – In-Process Research & Development Curetis 5,706,000 (5,467,067 ) (238,933 ) — (5,407,699 ) (298,301 ) — $ 15,518,000 $ (8,032,636 ) $ (642,958 ) $ 6,842,406 $ (7,437,206 ) $ (639,820 ) $ 7,440,974 Identifiable intangible assets are amortized on a straight-line basis over their estimated useful lives. The estimated useful lives of the intangibles are: Estimated Useful Life Trademarks and tradenames 10 years Customer/distributor relationships 15 years A50 – Developed technology 7 years Ares – Developed technology 14 years A30 – Acquired in-process research & development Indefinite 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 $187,255 and $182,265 for the three months ended September 30, 2023 and 2022, respectively. Total amortization expense of intangible assets was $561,172 and $546,795 for the nine months ended September 30, 2023 and 2022, respectively. Expected future amortization of intangible assets is as follows: Year Ending December 31, 2023 (October to December) $ 183,255 2024 733,020 2025 733,020 2026 733,020 2027 697,152 Thereafter 3,762,939 Total $ 6,842,406 In accordance with ASC 360-10, Property, Plant and Equipment 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 and Unyvero instruments, (ii) providing laboratory services, (iii) providing collaboration services (e.g., with the Foundation for Innovative New Diagnostics (FIND) on the Unyvero A30 RQ 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 September 30, 2023 and 2022, the Company recognized $78,752 and $110,439 as a reduction of research and development expense related to government grant arrangements, respectively. For the nine months ended September 30, 2023 and 2022, the Company recognized $301,229 and $324,168 as a reduction of research and development expense related to government grant arrangements, respectively. The Company had earned but not yet received $680,302 and $401,436 related to these agreements and incentives included in prepaid expenses and other current assets, as of September 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 operations of the Company’s German subsidiary. 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 11.1 million shares and 1.0 million shares as of September 30, 2023 and 2022, respectively. Adopted accounting pronouncements In June 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Codification (ASC) Update No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The purpose of Update No. 2016-13 is to replace the incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates. Update No. 2016-13 did not have a material impact on the Company's financial position or results of operations. 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. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 9 Months Ended |
Sep. 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: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Product sales $ 558,965 $ 359,112 $ 1,409,534 $ 1,614,435 Laboratory services 47,135 31,016 112,810 94,515 Collaboration revenue 92,922 58,585 826,257 176,713 Total revenue $ 699,022 $ 448,713 $ 2,348,601 $ 1,885,663 Revenues by geography are as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Domestic $ 142,716 $ 135,857 $ 523,978 $ 415,926 International 556,306 312,856 1,824,623 1,469,737 Total revenue $ 699,022 $ 448,713 $ 2,348,601 $ 1,885,663 Deferred revenue Changes to deferred revenue for the period were as follows: Balance at December 31, 2022 $ 142,061 Contracts with customers 198,419 Recognized in the current period (144,031 ) Currency translation adjustment (1,762 ) Balance at September 30, 2023 $ 194,687 Contract assets The Company had no contract assets as of September 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 September 30, 2023 and December 31, 2022. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 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: ● Level 1 - defined as observable inputs such as quoted prices in active markets; ● Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and ● Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions such as expected revenue growth and discount factors applied to cash flow projections. For the three and nine months ended September 30, 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 nine months ended September 30, 2023 was as follows: Description Balance at December 2022 Change in Fair Value Effect of Foreign Exchange Rates Balance at September 30, 2023 Participation percentage interest liability $ 99,498 $ (65,800 ) $ 666 $ 34,364 Total $ 99,498 $ (65,800 ) $ 666 $ 34,364 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 September 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). |
Debt
Debt | 9 Months Ended |
Sep. 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 September 30, 2023 and December 31, 2022: September 30, 2023 December 31, 2022 EIB $ 9,947,611 $ 13,489,178 Total debt obligations 9,947,611 13,489,178 Unamortized debt discount (747,847 ) (1,614,591 ) Carrying value of debt 9,199,764 11,874,587 Less current portion (9,199,764 ) (7,023,901 ) Non-current portion of long-term debt $ — $ 4,850,686 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 €14.4 million (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. In addition, Curetis agreed to certain undertakings during the standstill period, including the delivery of a rolling cash flow forecast and to cause a third-party restructuring expert to prepare and deliver a restructuring opinion to the EIB. 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. As of September 30, 2023, the outstanding borrowings under all tranches were €9.4 million (approximately $9.9 million), including deferred interest payable at maturity of €1.4 million (approximately $1.5 million). Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $396,768 and $569,306 for the three months ended September 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 $1,698,564 and $2,618,799 for the nine months ended September 30, 2023 and 2022, respectively. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders’ equity | Note 7 – Stockholders’ equity As of September 30, 2023, the Company had 100,000,000 shares of authorized common stock and 10,013,524 shares issued and outstanding, and 10,000,000 shares of authorized preferred stock, of which none 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 were exercised and all 33,810 shares of the Company’s Series C Mirroring Preferred Stock were automatically cancelled and ceased to be outstanding following receipt of stockholder approval for the Company’s reverse stock split on November 30, 2022. 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 or may be exercised pursuant to the Warrant Inducement Agreement entered into on October 12, 2023, as amended on October 26, 2023 (the “Inducement Agreement”), upon the payment of additional consideration of $0.25 per share of common stock issued upon exercise of any existing warrants. The common warrants not exercised as part of the Inducement Agreement will expire on the five-year anniversary of the date of such stockholder approval (see Note 11). 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 September 30, 2023, stockholder approval for the exercisability of the common warrants in the offering has not yet been obtained; however, pursuant to the Inducement Agreement, the existing common warrants are exercisable until December 31, 2023 upon payment of the exercise price plus additional consideration of $0.25 per share of common stock issued upon exercise of any existing warrants. In addition, the Company’s requirement to hold a stockholders’ meeting to obtain approval for the exercisability of the existing common warrants is not applicable during the offer period under the Inducement Agreement. 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 (i) 2,710 plus (ii) 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 (iii) 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 (i) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (ii) 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 September 30, 2023, 107,481 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 nine months ended September 30, 2023 and 2022, the Company recognized share-based compensation expense as follows: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Cost of services $ (442 ) $ — $ (442 ) $ 11,101 Research and development (159,742 ) 82,659 (41,914 ) 223,638 General and administrative 74,411 108,672 259,452 387,992 Sales and marketing (143,710 ) 37,036 (78,928 ) 104,658 $ (229,483 ) $ 228,367 $ 138,168 $ 727,389 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. Share-based compensation expense decreased significantly in the quarter ended September 30, 2023 primarily due to reversals resulting from forfeited options and restricted stock units upon the reduction in force in connection with the Company’s cash management efforts (see Note 2). During the three and nine months ended September 30, 2023, the Company did not grant any options, 3,663 options were forfeited, and 1,734 options expired. The Company had total stock options to acquire 102,200 shares of common stock outstanding at September 30, 2023 under all of its equity compensation plans. Restricted stock units During the three months ended September 30, 2023, the Company did not grant any restricted stock units, no restricted stock units vested, and 20,438 were forfeited. During the nine months ended September 30, 2023, the Company granted 100,500 restricted stock units, 33,780 restricted stock units vested, and 20,438 were forfeited. The Company had 89,189 total restricted stock units outstanding at September 30, 2023. Stock purchase warrants At September 30, 2023 and December 31, 2022, the following warrants to purchase shares of common stock were outstanding: Outstanding at Issuance Exercise Price Expiration September 30, 2023 (1) December 31, 2022 (1) February 2015 $ 66,000.00 February 2025 23 23 February 2018 $ 1,625.00 February 2023 — 462 February 2018 $ 1,300.00 February 2023 — 3,848 October 2019 $ 40.00 October 2024 17,700 17,700 October 2019 $ 52.00 October 2024 11,750 11,750 November 2020 $ 50.44 May 2026 12,107 12,107 February 2021 $ 78.00 August 2026 20,834 20,834 October 2022 $ 7.54 April 2028 — 1,224,489 May 2023 $ 0.7785 (2) 10,892,728 — 10,955,142 1,291,213 The warrants listed above were issued in connection with various debt, equity, or development contract agreements. (1) Warrants to purchase fractional shares of common stock resulting from the reverse stock splits effected on August 22, 2019 and January 5, 2023 were rounded up to the next whole share of common stock on a holder by holder basis. (2) Warrants will be exercisable beginning on the date of stockholder approval of the exercisability of the warrants under Nasdaq rules or, pursuant to the Warrant Inducement Agreement entered into on October 12, 2023, as amended on October 26, 2023 (the “Inducement Agreement”), upon the payment of additional consideration of $0.25 per share of common stock issued upon exercise of any existing warrants. The warrants not exercised as part of the Inducement Agreement will expire on the five-year anniversary of the date of such stockholder approval (see Note 11). |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 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. Since the inception of the agreement, the Company had acquired 24 QuantStudio 5 systems, none of which were acquired during the nine months ended September 30, 2023. As of September 30, 2023, the Company has not committed to acquiring additional QuantStudio 5 systems in the next three months. Since the Company decided to discontinue its Acuitas AMR Gene Panel diagnostic test in October 2023, the Company plans to sell or dispose of any surplus of such 24 QuantStudio 5 systems. 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. Curetis does not have any purchase commitments over the next twelve months. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | Note 9 – Leases The following table presents the Company’s ROU assets and lease liabilities as of September 30, 2023 and December 31, 2022: Lease classification September 30, 2023 December 31, 2022 ROU Assets: Operating $ 1,915,049 $ 1,459,413 Financing 986 3,500 Total ROU assets $ 1,916,035 $ 1,462,913 Liabilities Current: Operating $ 521,424 $ 377,626 Finance 1,121 3,364 Noncurrent: Operating 2,830,282 2,566,138 Finance — 280 Total lease liabilities $ 3,352,827 $ 2,947,408 Maturities of lease liabilities as of September 30, 2023 by fiscal year are as follows: Maturity of lease liabilities Operating Finance Total 2023 (October to December) $ 202,289 $ 841 $ 203,130 2024 815,622 280 815,902 2025 725,505 — 725,505 2026 577,456 — 577,456 2027 587,859 — 587,859 Thereafter 1,737,689 — 1,737,689 Total lease payments 4,646,420 1,121 4,647,541 Less: Interest (1,294,714 ) — (1,294,714 ) Present value of lease liabilities $ 3,351,706 $ 1,121 $ 3,352,827 Condensed consolidated statements of operations classification of lease costs as of the three and nine months ended September 30, 2023 and 2022 are as follows: Three months ended September 30, Nine months ended September 30, Lease cost Classification 2023 2022 2023 2022 Operating Operating expenses $ 175,243 $ 139,206 $ 484,546 $ 466,904 Finance: Amortization Operating expenses 847 15,312 2,514 86,119 Interest expense Other expenses — 258 — 1,672 Total lease costs $ 176,090 $ 154,776 $ 487,060 $ 554,695 Other lease information as of September 30, 2023 is as follows: Other information Total Weighted average remaining lease term (in years) Operating leases 6.7 Finance leases 0.3 Weighted average discount rate: Operating leases 9.7 % Finance leases 1.0 % Supplemental cash flow information as of the nine months ended September 30, 2023 and 2022 is as follows: Supplemental cash flow information 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Cash used in operating activities Operating leases $ 484,546 $ 466,904 Finance leases $ — $ 1,672 Cash used in financing activities Finance leases $ 2,523 $ 38,925 ROU assets obtained in exchange for lease obligations: Operating leases $ 801,321 $ — |
License Agreements, Research Co
License Agreements, Research Collaborations and Development Agreements | 9 Months Ended |
Sep. 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 $3,102 and $1,552 for the three months ended September 30, 2023 and 2022, respectively. The total net royalty expense related to this agreement was $7,309 and $5,034 for the nine months ended September 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 €0.13 million in milestone payments (“Amendment 1”). The additional deliverables were completed by June 30, 2023. 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 . increasing the total project revenue to €0.87 million |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 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 was disclosed in Notes 1, 2, and 7 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 October 6, 2023, the Company’s subsidiary, Curetis, received a payment of €0.75 million related to the sale of certain Unyvero A50 systems by Curetis to a strategic partner. Such purchase of systems and payment was made in connection with the negotiation of a potential strategic transaction involving Curetis and the Company’s subsidiary, Ares Genetics, with such strategic partner. The Company used the payment to fund Curetis’ and Ares Genetics’ operations. Following the insolvency filings by Curetis and Ares Genetics, the negotiation of such potential strategic transaction has ceased. On October 11, 2023, the Company entered into a Preferred Stock Purchase Agreement (the “Purchase Agreement”) with a single investor (the “Investor”), pursuant to which the Company agreed to issue and sell to the Investor in a private placement (the “Private Placement”) 1,000 shares of the Company’s Series D Preferred Stock, par value $0.01 per share (the “Preferred Stock”). Each share of preferred stock was sold at a price of $1,000 per share for aggregate gross proceeds of $1.0 million before deducting offering expenses. The Private Placement was conducted in connection with the negotiation of a potential strategic transaction involving the Company and the Investor. The Company intends to use the proceeds of the Private Placement to fund the Company’s operations while it pursues a potential strategic transaction with the Investor. Any such strategic transaction will be pursuant to a definitive agreement entered into by the Company and the Investor. In connection with the ongoing discussions for a potential strategic transaction, the parties anticipate closing the Private Placement as soon as practical. Pursuant to the Purchase Agreement, the Company filed a certificate of designation (the “Certificate of Designation”) with the Secretary of State of the State of Delaware designating the rights, preferences and limitations of the shares of preferred stock on October 11, 2023. The Certificate of Designation provides that the shares of preferred stock have a stated value of $1,000 per share and are convertible into shares of common stock, par value $0.01 per share of the Company at a price of $0.409 per share, subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications, or similar events affecting the common stock. The preferred stock may be converted at any time at the option of the holder. Notwithstanding the foregoing, the Certificate of Designation provides that in no event will the preferred stock be convertible into common stock in a manner that would result in the holder, its permitted transferees and affiliates holding more than 19.99% (together with any shares of common stock otherwise held by the Investor, its permitted transferees and their affiliates) of the then issued and outstanding common stock (the “Ownership Limitation”), prior to the date that the Company’s stockholders approve the issuance of shares of common stock to the holder upon conversion of the preferred stock (the “stockholder approval”). Upon receipt of stockholder approval, the shares of preferred stock will automatically be converted into shares of common stock without further action of the holder thereof. On October 12, 2023, the Company entered into a warrant inducement agreement (the “Inducement Agreement”) with a holder (the “Holder”) of certain existing warrants (the “Existing Warrants”) to purchase shares of common stock, par value $0.01 per share, of the Company. Pursuant to the Inducement Agreement, the Holder agreed to exercise for cash their Existing Warrants to purchase up to 10,892,728 shares of the Company’s common stock at an exercise price of $0.7785 per share, the exercise price per share of the Existing Warrants, during the period from the date of the Inducement Agreement until 7:30 a.m., Eastern Time, on October 26, 2023. Pursuant to an amendment agreement entered into by the Company and Holder on October 26, 2023, the Company agreed to extend the offer period until December 31, 2023. In order to permit the exercise of the Existing Warrants pursuant to the rules of the Nasdaq Capital Market, the Holder agreed to pay as additional consideration $0.25 per share of common stock issued upon exercise of the Existing Warrants. The aggregate gross proceeds to be received by the Company will depend on the number of Existing Warrants actually exercised by the Holder. If all the Existing Warrants are exercised in connection with the Inducement Agreement, the Company would anticipate receiving aggregate gross proceeds of up to approximately $11.2 million from the exercise of the Existing Warrants before deducting financial advisory fees and other expenses payable by us. There is, however, no guarantee that all the Existing Warrants will be exercised by the Holder in accordance with the Inducement Agreement. In consideration of the Holder’s agreement to exercise the Existing Warrants in accordance with the Inducement Agreement, the Company agreed to issue new warrants (the “Inducement Warrants”) to purchase shares of common stock equal to 100% of the number of shares of common stock issued upon exercise of the Existing Warrants (the “Inducement Warrant Shares”). The Inducement Warrants will have an exercise price of $0.336 per share and will be exercisable on the six-month anniversary of the date of issuance and expire on the five-year anniversary of the Inducement Warrant’s first becoming exercisable. As of October 25, 2023, the Holder had exercised 2,000,000 shares of common stock under the Existing Warrants pursuant to the Inducement Agreement for aggregate gross proceeds to the Company of $2.057 million before deducting financial advisory fees and other expenses payable by the Company. On October 18, 2023, the Company discontinued its Acuitas AMR Gene Panel diagnostic test. The Company informed customers of the discontinuation and final orders were processed earlier this year. The Company plans to sell or dispose of its surplus QuantStudio 5 and EZ1 systems and has written off the remaining Acuitas products from its inventory. The discontinuance of this product line did not qualify for discontinued operations reporting. On November 6, 2023, following the Company’s unsuccessful efforts to sell the businesses or assets of its wholly owned subsidiaries Curetis and Ares Genetics or to access additional capital to continue their operations, Curetis filed a petition for insolvency with the district court of Stuttgart, Germany, and Ares Genetics filed a petition for insolvency with the commercial court in Vienna, Austria, Reference Number 38 S 175/23x. The insolvency proceedings of Curetis and Ares Genetics will be adjudicated under the insolvency laws of Germany and Austria, respectively. Dr. Katharina Widhalm-Budak has been appointed insolvency administrator by the Vienna court in Ares Genetics’ insolvency proceeding. The district court of Stuttgart will appoint an insolvency administrator for Curetis’ insolvency proceeding. The insolvency administrators will assume control over the assets and liabilities of Curetis and Ares Genetics, respectively, which effectively eliminates the authority and power of the Company and its officers to act on behalf of the subsidiaries. In the event the preservation and sale of the business in connection with the insolvency proceedings is unsuccessful, the assets of Curetis and Ares Genetics would be liquidated and claims paid in accordance with the insolvency laws of the applicable jurisdiction. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
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 nine months ended September 30, 2023; all intercompany transactions and balances have been eliminated. |
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 September 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 | 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 | 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 | 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 September 30, 2023 and December 31, 2022, the Company had funds totaling $492,022 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: September 30, 2023 December 31, 2022 September 30, 2022 December 31, 2021 Cash and cash equivalents $ 292,642 $ 7,440,030 $ 10,275,654 $ 36,080,392 Restricted cash 492,022 495,629 419,495 551,794 Total cash and cash equivalents and restricted cash in the condensed consolidated statements of cash flows $ 784,664 $ 7,935,659 $ 10,695,149 $ 36,632,186 |
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, the customer’s current ability to pay its obligation, and reasonable and supportable forecasts from the customer. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for credit losses was $0 as of September 30, 2023 and December 31, 2022. At September 30, 2023, the Company had accounts receivable from three customers which individually represented 24%, 24%, and 11% 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 September 30, 2023, revenue earned from four customers represented 21%, 15%, 12%, and 11% of total revenues. For the three months ended September 30, 2022, revenue earned from three customers represented 29%, 18%, and 11% of total revenues. For the nine months ended September 30, 2023, revenue earned from three customers represented 28%, 17%, and 10% of total revenues. For the nine months ended September 30, 2022, revenue earned from two customers represented 43% and 16% of total revenues. |
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: September 30, 2023 December 31, 2022 Raw materials and supplies $ 993,093 $ 1,011,476 Work-in-process 34,638 37,445 Finished goods 1,779,418 2,596,830 Total $ 2,807,149 $ 3,645,751 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 $2,214,185 and $1,694,843 at September 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 | 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 nine months ended September 30, 2023 and 2022, the Company determined that its property and equipment were not impaired. |
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. |
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 nine months ended September 30, 2023 and 2022. |
Intangible assets | Intangible assets As of September 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 and tradenames, developed technology and software, in-process research & development (“IPR&D”), and distributor relationships and consisted of the following as of September 30, 2023 and December 31, 2022: September 30, 2023 December 31, 2022 Subsidiary Cost Accumulated Amortization and Impairment Effect of Foreign Exchange Rates Net Balance Accumulated Amortization and Impairment Effect of Foreign Exchange Rates Net Balance Trademarks and tradenames Curetis $ 1,768,000 $ (592,893 ) $ (74,033 ) $ 1,101,074 $ (469,011 ) $ (62,520 ) $ 1,236,469 Distributor relationships Curetis 2,362,000 (528,064 ) (98,907 ) 1,735,029 (417,728 ) (83,525 ) 1,860,747 A50 – Developed technology Curetis 349,000 (167,211 ) (14,614 ) 167,175 (132,273 ) (12,342 ) 204,385 Ares – Developed technology Ares Genetics 5,333,000 (1,277,401 ) (216,471 ) 3,839,128 (1,010,495 ) (183,132 ) 4,139,373 A30 – In-Process Research & Development Curetis 5,706,000 (5,467,067 ) (238,933 ) — (5,407,699 ) (298,301 ) — $ 15,518,000 $ (8,032,636 ) $ (642,958 ) $ 6,842,406 $ (7,437,206 ) $ (639,820 ) $ 7,440,974 Identifiable intangible assets are amortized on a straight-line basis over their estimated useful lives. The estimated useful lives of the intangibles are: Estimated Useful Life Trademarks and tradenames 10 years Customer/distributor relationships 15 years A50 – Developed technology 7 years Ares – Developed technology 14 years A30 – Acquired in-process research & development Indefinite 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 $187,255 and $182,265 for the three months ended September 30, 2023 and 2022, respectively. Total amortization expense of intangible assets was $561,172 and $546,795 for the nine months ended September 30, 2023 and 2022, respectively. Expected future amortization of intangible assets is as follows: Year Ending December 31, 2023 (October to December) $ 183,255 2024 733,020 2025 733,020 2026 733,020 2027 697,152 Thereafter 3,762,939 Total $ 6,842,406 In accordance with ASC 360-10, Property, Plant and Equipment 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 | Revenue recognition The Company derives revenues from (i) the sale of Unyvero Application cartridges and Unyvero instruments, (ii) providing laboratory services, (iii) providing collaboration services (e.g., with the Foundation for Innovative New Diagnostics (FIND) on the Unyvero A30 RQ 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 | 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 September 30, 2023 and 2022, the Company recognized $78,752 and $110,439 as a reduction of research and development expense related to government grant arrangements, respectively. For the nine months ended September 30, 2023 and 2022, the Company recognized $301,229 and $324,168 as a reduction of research and development expense related to government grant arrangements, respectively. The Company had earned but not yet received $680,302 and $401,436 related to these agreements and incentives included in prepaid expenses and other current assets, as of September 30, 2023 and December 31, 2022, respectively. |
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. |
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. |
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. |
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 operations of the Company’s German subsidiary. 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 | 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 11.1 million shares and 1.0 million shares as of September 30, 2023 and 2022, respectively. |
Adopted accounting pronouncements | Adopted accounting pronouncements In June 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Codification (ASC) Update No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The purpose of Update No. 2016-13 is to replace the incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates. Update No. 2016-13 did not have a material impact on the Company's financial position or results of operations. 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 | 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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: September 30, 2023 December 31, 2022 September 30, 2022 December 31, 2021 Cash and cash equivalents $ 292,642 $ 7,440,030 $ 10,275,654 $ 36,080,392 Restricted cash 492,022 495,629 419,495 551,794 Total cash and cash equivalents and restricted cash in the condensed consolidated statements of cash flows $ 784,664 $ 7,935,659 $ 10,695,149 $ 36,632,186 |
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: September 30, 2023 December 31, 2022 Raw materials and supplies $ 993,093 $ 1,011,476 Work-in-process 34,638 37,445 Finished goods 1,779,418 2,596,830 Total $ 2,807,149 $ 3,645,751 |
Schedule of finite-lived and indefinite-lived intangible assets | Intangible assets include trademarks and tradenames, developed technology and software, in-process research & development (“IPR&D”), and distributor relationships and consisted of the following as of September 30, 2023 and December 31, 2022: September 30, 2023 December 31, 2022 Subsidiary Cost Accumulated Amortization and Impairment Effect of Foreign Exchange Rates Net Balance Accumulated Amortization and Impairment Effect of Foreign Exchange Rates Net Balance Trademarks and tradenames Curetis $ 1,768,000 $ (592,893 ) $ (74,033 ) $ 1,101,074 $ (469,011 ) $ (62,520 ) $ 1,236,469 Distributor relationships Curetis 2,362,000 (528,064 ) (98,907 ) 1,735,029 (417,728 ) (83,525 ) 1,860,747 A50 – Developed technology Curetis 349,000 (167,211 ) (14,614 ) 167,175 (132,273 ) (12,342 ) 204,385 Ares – Developed technology Ares Genetics 5,333,000 (1,277,401 ) (216,471 ) 3,839,128 (1,010,495 ) (183,132 ) 4,139,373 A30 – In-Process Research & Development Curetis 5,706,000 (5,467,067 ) (238,933 ) — (5,407,699 ) (298,301 ) — $ 15,518,000 $ (8,032,636 ) $ (642,958 ) $ 6,842,406 $ (7,437,206 ) $ (639,820 ) $ 7,440,974 |
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: Estimated Useful Life Trademarks and tradenames 10 years Customer/distributor relationships 15 years A50 – Developed technology 7 years Ares – Developed technology 14 years A30 – Acquired in-process research & development Indefinite |
Schedule of expected amortization of intangible assets | Expected future amortization of intangible assets is as follows: Year Ending December 31, 2023 (October to December) $ 183,255 2024 733,020 2025 733,020 2026 733,020 2027 697,152 Thereafter 3,762,939 Total $ 6,842,406 |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 9 Months Ended |
Sep. 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: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Product sales $ 558,965 $ 359,112 $ 1,409,534 $ 1,614,435 Laboratory services 47,135 31,016 112,810 94,515 Collaboration revenue 92,922 58,585 826,257 176,713 Total revenue $ 699,022 $ 448,713 $ 2,348,601 $ 1,885,663 |
Schedule of revenues by geography | Revenues by geography are as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Domestic $ 142,716 $ 135,857 $ 523,978 $ 415,926 International 556,306 312,856 1,824,623 1,469,737 Total revenue $ 699,022 $ 448,713 $ 2,348,601 $ 1,885,663 |
Schedule of changes in deferred revenue | Changes to deferred revenue for the period were as follows: Balance at December 31, 2022 $ 142,061 Contracts with customers 198,419 Recognized in the current period (144,031 ) Currency translation adjustment (1,762 ) Balance at September 30, 2023 $ 194,687 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value of level 3 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 nine months ended September 30, 2023 was as follows: Description Balance at December 2022 Change in Fair Value Effect of Foreign Exchange Rates Balance at September 30, 2023 Participation percentage interest liability $ 99,498 $ (65,800 ) $ 666 $ 34,364 Total $ 99,498 $ (65,800 ) $ 666 $ 34,364 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 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 September 30, 2023 and December 31, 2022: September 30, 2023 December 31, 2022 EIB $ 9,947,611 $ 13,489,178 Total debt obligations 9,947,611 13,489,178 Unamortized debt discount (747,847 ) (1,614,591 ) Carrying value of debt 9,199,764 11,874,587 Less current portion (9,199,764 ) (7,023,901 ) Non-current portion of long-term debt $ — $ 4,850,686 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Schedule of company recognized stock compensation expense | For the three and nine months ended September 30, 2023 and 2022, the Company recognized share-based compensation expense as follows: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Cost of services $ (442 ) $ — $ (442 ) $ 11,101 Research and development (159,742 ) 82,659 (41,914 ) 223,638 General and administrative 74,411 108,672 259,452 387,992 Sales and marketing (143,710 ) 37,036 (78,928 ) 104,658 $ (229,483 ) $ 228,367 $ 138,168 $ 727,389 |
Schedule of outstanding warrants to purchase shares of common stock | At September 30, 2023 and December 31, 2022, the following warrants to purchase shares of common stock were outstanding: Outstanding at Issuance Exercise Price Expiration September 30, 2023 (1) December 31, 2022 (1) February 2015 $ 66,000.00 February 2025 23 23 February 2018 $ 1,625.00 February 2023 — 462 February 2018 $ 1,300.00 February 2023 — 3,848 October 2019 $ 40.00 October 2024 17,700 17,700 October 2019 $ 52.00 October 2024 11,750 11,750 November 2020 $ 50.44 May 2026 12,107 12,107 February 2021 $ 78.00 August 2026 20,834 20,834 October 2022 $ 7.54 April 2028 — 1,224,489 May 2023 $ 0.7785 (2) 10,892,728 — 10,955,142 1,291,213 (1) Warrants to purchase fractional shares of common stock resulting from the reverse stock splits effected on August 22, 2019 and January 5, 2023 were rounded up to the next whole share of common stock on a holder by holder basis. (2) Warrants will be exercisable beginning on the date of stockholder approval of the exercisability of the warrants under Nasdaq rules or, pursuant to the Warrant Inducement Agreement entered into on October 12, 2023, as amended on October 26, 2023 (the “Inducement Agreement”), upon the payment of additional consideration of $0.25 per share of common stock issued upon exercise of any existing warrants. The warrants not exercised as part of the Inducement Agreement will expire on the five-year anniversary of the date of such stockholder approval (see Note 11). |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 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 September 30, 2023 and December 31, 2022: Lease classification September 30, 2023 December 31, 2022 ROU Assets: Operating $ 1,915,049 $ 1,459,413 Financing 986 3,500 Total ROU assets $ 1,916,035 $ 1,462,913 Liabilities Current: Operating $ 521,424 $ 377,626 Finance 1,121 3,364 Noncurrent: Operating 2,830,282 2,566,138 Finance — 280 Total lease liabilities $ 3,352,827 $ 2,947,408 |
Schedule of maturities of lease liabilities | Maturities of lease liabilities as of September 30, 2023 by fiscal year are as follows: Maturity of lease liabilities Operating Finance Total 2023 (October to December) $ 202,289 $ 841 $ 203,130 2024 815,622 280 815,902 2025 725,505 — 725,505 2026 577,456 — 577,456 2027 587,859 — 587,859 Thereafter 1,737,689 — 1,737,689 Total lease payments 4,646,420 1,121 4,647,541 Less: Interest (1,294,714 ) — (1,294,714 ) Present value of lease liabilities $ 3,351,706 $ 1,121 $ 3,352,827 |
Schedule of lease cost classifications | Condensed consolidated statements of operations classification of lease costs as of the three and nine months ended September 30, 2023 and 2022 are as follows: Three months ended September 30, Nine months ended September 30, Lease cost Classification 2023 2022 2023 2022 Operating Operating expenses $ 175,243 $ 139,206 $ 484,546 $ 466,904 Finance: Amortization Operating expenses 847 15,312 2,514 86,119 Interest expense Other expenses — 258 — 1,672 Total lease costs $ 176,090 $ 154,776 $ 487,060 $ 554,695 |
Schedule of other lease information | Other lease information as of September 30, 2023 is as follows: Other information Total Weighted average remaining lease term (in years) Operating leases 6.7 Finance leases 0.3 Weighted average discount rate: Operating leases 9.7 % Finance leases 1.0 % |
Schedule of supplemental cash flow information | Supplemental cash flow information as of the nine months ended September 30, 2023 and 2022 is as follows: Supplemental cash flow information 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Cash used in operating activities Operating leases $ 484,546 $ 466,904 Finance leases $ — $ 1,672 Cash used in financing activities Finance leases $ 2,523 $ 38,925 ROU assets obtained in exchange for lease obligations: Operating leases $ 801,321 $ — |
Going Concern and Management__2
Going Concern and Management’s Plans (Details) $ / shares in Units, € in Millions | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||
Dec. 31, 2023 $ / shares | Oct. 26, 2023 $ / shares shares | Jun. 22, 2023 EUR (€) | May 04, 2023 USD ($) $ / shares shares | Jan. 11, 2023 USD ($) $ / shares shares | Dec. 31, 2022 $ / shares shares | Oct. 03, 2022 USD ($) $ / shares shares | Jun. 24, 2022 USD ($) | May 31, 2023 $ / shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 04, 2023 $ / shares | Jun. 05, 2023 $ / shares | Jan. 26, 2023 EUR (€) | |
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
Principal balance (in Euro) | € | € 3 | ||||||||||||||
Payment of interest (in Euro) | € | € 1 | ||||||||||||||
Common stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||||
Exercise price per share | $ 0.7785 | $ 2.65 | $ 0.7785 | ||||||||||||
Gross proceeds (in Dollars) | $ | $ 3,500,000 | ||||||||||||||
Net proceeds from warrants (in Dollars) | $ | $ 3,000,000 | ||||||||||||||
Payment of additional consideration price | $ 0.25 | ||||||||||||||
Warrants to purchase of common stock (in Shares) | shares | 6,396,903 | 215,000 | |||||||||||||
Existing warrant price | $ 0.7785 | $ 0.7785 | $ 0.7785 | ||||||||||||
Existing warrants period | 5 years | ||||||||||||||
Increase in fair value resulting from warrant modification (in Dollars) | $ | $ 300,000 | ||||||||||||||
Common stock issued (in Shares) | shares | 605,000 | 2,899,911 | 268,000 | 10,013,524 | 2,899,911 | ||||||||||
Warrant issuance and exercisable, description | provide that the existing warrants, as amended, will not be exercisable until six months following the closing date of the offering | ||||||||||||||
Preferred stock, shares issued (in Shares) | shares | |||||||||||||||
Preferred stock stated value per share | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||||||
Net proceeds (in Dollars) | $ | $ 989,704 | ||||||||||||||
Warrants expiry period | five and one-half | ||||||||||||||
Increase in fair value from warrant modification (in Dollars) | $ | $ 300,000 | $ 1,800,000 | |||||||||||||
Consecutive business days | 30 days | ||||||||||||||
NASDAQ minimum bid price | $ 1 | ||||||||||||||
Common Stock [Member] | |||||||||||||||
Going Concern and Management’s Plans [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 | ||||||||||||||
Payment of additional consideration price | $ 0.25 | ||||||||||||||
Pre-funded warrant exercise price | $ 0.01 | ||||||||||||||
Warrants to purchase of common stock (in Shares) | shares | 483,000 | ||||||||||||||
Price per share, common stock | $ 7 | ||||||||||||||
Maximum [Member] | |||||||||||||||
Going Concern and Management’s Plans [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 [Line Items] | |||||||||||||||
Pre-funded warrant exercise price | 0.7685 | ||||||||||||||
Minimum warrant exercise price from prior offerings | 2.65 | $ 41 | |||||||||||||
Series A-1 Warrants [Member] | |||||||||||||||
Going Concern and Management’s Plans [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 [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 [Line Items] | |||||||||||||||
Gross proceeds (in Dollars) | $ | $ 3,340,000 | ||||||||||||||
Pre-funded warrant exercise price | $ 6.8 | ||||||||||||||
Warrants to purchase of common stock (in Shares) | shares | 741,489 | ||||||||||||||
Net proceeds (in Dollars) | $ | $ 3,040,000 | ||||||||||||||
Number of prefunded warrants exercised (in Shares) | shares | 215,000 | ||||||||||||||
2022 ATM Offering [Member] | H.C. Wainwright & Co., LLC [Member] | |||||||||||||||
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
Shares issued (in Shares) | shares | 85,732 | ||||||||||||||
Gross proceeds (in Dollars) | $ | $ 1,030,000 | ||||||||||||||
Maximum offering amount (in Dollars) | $ | $ 10,650,000 | ||||||||||||||
Net proceeds (in Dollars) | $ | $ 990,000 | ||||||||||||||
Securities Purchase Agreement [Member] | |||||||||||||||
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
Common stock issued (in Shares) | shares | 321,207 | ||||||||||||||
Pre-funded warrants to purchase shares of common stock (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 [Line Items] | |||||||||||||||
Common stock, par value | $ 0.01 | ||||||||||||||
Net proceeds from warrants (in Dollars) | $ | $ 6,900,000 | ||||||||||||||
Offering price | $ 2.9 | ||||||||||||||
Gross proceeds from warrants (in Dollars) | $ | $ 7,500,000 | ||||||||||||||
Securities Purchase Agreement [Member] | Maximum [Member] | |||||||||||||||
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
Exercise price per share | 7.54 | ||||||||||||||
Securities Purchase Agreement [Member] | Minimum [Member] | |||||||||||||||
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
Exercise price per share | $ 2.65 | ||||||||||||||
Series A-1 Common Warrants [Member] | |||||||||||||||
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
Warrants to purchase of common stock (in Shares) | shares | 2,586,207 | ||||||||||||||
Series A-2 Common Warrants [Member] | |||||||||||||||
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
Warrants to purchase of common stock (in Shares) | shares | 2,586,207 | ||||||||||||||
Exercise price for pre-funded warrants | $ 0.01 | ||||||||||||||
Series C Mirroring Preferred Stock [Member] | |||||||||||||||
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
Preferred stock, shares issued (in Shares) | shares | 33,810 | 33,810 | 33,810 | ||||||||||||
Preferred stock stated value per share | $ 0.01 | ||||||||||||||
Preferred stock, stated value | 0.01 | ||||||||||||||
Preferred Stock [Member] | |||||||||||||||
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
Price per share, preferred stock | 0.01 | ||||||||||||||
Forecast [Member] | |||||||||||||||
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
Consecutive business days | 10 days | ||||||||||||||
Additional grace period | 180 days | ||||||||||||||
Forecast [Member] | Common Stock [Member] | |||||||||||||||
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
NASDAQ minimum bid price share price | $ 1 | ||||||||||||||
Forecast [Member] | Common Stock [Member] | |||||||||||||||
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
Payment of additional consideration price | $ 0.25 | ||||||||||||||
Investor [Member] | |||||||||||||||
Going Concern and Management’s Plans [Line Items] | |||||||||||||||
Exercise price for pre-funded warrants | $ 7.54 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) shares in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 USD ($) Customers | Sep. 30, 2022 USD ($) Customers | Sep. 30, 2023 USD ($) Customers shares | Sep. 30, 2022 USD ($) Customers shares | Dec. 31, 2022 USD ($) Customers | Dec. 31, 2021 USD ($) | |
Summary of Significant Accounting Policies [Line Items] | ||||||
FDIC limit of insurable cash | $ 250,000 | $ 250,000 | ||||
Restricted cash | 492,022 | $ 419,495 | 492,022 | $ 419,495 | $ 495,629 | $ 551,794 |
Allowance for credit losses | 0 | 0 | 0 | |||
Inventory valuation reserves | 2,214,185 | 2,214,185 | 1,694,843 | |||
Indefinite-lived intangible impairment charge | 5,407,699 | |||||
Amortization of intangible assets | 187,255 | 182,265 | 561,172 | 546,795 | ||
Impairment expense of goodwill | 6,940,549 | |||||
Reduction in research and development expense related to government grant arrangements | $ 78,752 | $ 110,439 | 301,229 | $ 324,168 | ||
Grants earned but not yet received | $ 680,302 | $ 401,436 | ||||
Tax benefit percentage | 50% | |||||
Antidilutive securities excluded from computation of earnings per share, amount (in Shares) | shares | 11.1 | 1 | ||||
Minimum [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Accounts receivable period due | 30 days | |||||
Maximum [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Accounts receivable period due | 90 days | |||||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Number of customers (in Customers) | Customers | 3 | 2 | ||||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer One [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Concentration risk, percentage | 24% | 41% | ||||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer Two [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Concentration risk, percentage | 24% | 21% | ||||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer Three [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Concentration risk, percentage | 11% | |||||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Number of customers (in Customers) | Customers | 4 | 3 | 3 | 2 | ||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer One [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Concentration risk, percentage | 21% | 29% | 28% | 43% | ||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer Two [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Concentration risk, percentage | 15% | 18% | 17% | 16% | ||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer Three [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Concentration risk, percentage | 12% | 11% | 10% | |||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer Four [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Concentration risk, percentage | 11% | |||||
Domestic Tax Authority [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Operating loss carryforwards | $ 232,682,072 | $ 202,015,062 | ||||
Foreign Tax Authority [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Operating loss carryforwards | 170,661,923 | |||||
Germany [Member] | ||||||
Summary of Significant Accounting Policies [Line Items] | ||||||
Operating loss carryforwards | $ 162,712,615 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of reconciliation of cash and cash equivalents and restricted cash - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 292,642 | $ 7,440,030 | $ 10,275,654 | $ 36,080,392 |
Restricted cash | 492,022 | 495,629 | 419,495 | 551,794 |
Total cash and cash equivalents and restricted cash in the condensed consolidated statements of cash flows | $ 784,664 | $ 7,935,659 | $ 10,695,149 | $ 36,632,186 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details) - Schedule of inventories - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory, Net [Abstract] | ||
Raw materials and supplies | $ 993,093 | $ 1,011,476 |
Work-in-process | 34,638 | 37,445 |
Finished goods | 1,779,418 | 2,596,830 |
Total | $ 2,807,149 | $ 3,645,751 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Details) - Schedule of finite-lived and indefinite-lived intangible assets - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Summary of Significant Accounting Policies [Line Items] | ||
Cost | $ 15,518,000 | |
Accumulated Amortization and Impairment | (8,032,636) | $ (7,437,206) |
Effect of Foreign Exchange Rates | (642,958) | (639,820) |
Net Balance | 6,842,406 | 7,440,974 |
Trademarks and tradenames [Member] | Curetis N.V [Member] | ||
Summary of Significant Accounting Policies [Line Items] | ||
Cost | 1,768,000 | |
Accumulated Amortization and Impairment | (592,893) | (469,011) |
Effect of Foreign Exchange Rates | (74,033) | (62,520) |
Net Balance | 1,101,074 | 1,236,469 |
Distributor relationships [Member] | Curetis N.V [Member] | ||
Summary of Significant Accounting Policies [Line Items] | ||
Cost | 2,362,000 | |
Accumulated Amortization and Impairment | (528,064) | (417,728) |
Effect of Foreign Exchange Rates | (98,907) | (83,525) |
Net Balance | 1,735,029 | 1,860,747 |
A50 – Developed technology [Member] | Curetis N.V [Member] | ||
Summary of Significant Accounting Policies [Line Items] | ||
Cost | 349,000 | |
Accumulated Amortization and Impairment | (167,211) | (132,273) |
Effect of Foreign Exchange Rates | (14,614) | (12,342) |
Net Balance | 167,175 | 204,385 |
Ares – Developed technology [Member] | Ares Genetics [Member] | ||
Summary of Significant Accounting Policies [Line Items] | ||
Cost | 5,333,000 | |
Accumulated Amortization and Impairment | (1,277,401) | (1,010,495) |
Effect of Foreign Exchange Rates | (216,471) | (183,132) |
Net Balance | 3,839,128 | 4,139,373 |
A30 – In-Process Research & Development [Member] | Curetis N.V [Member] | ||
Summary of Significant Accounting Policies [Line Items] | ||
Cost | 5,706,000 | |
Accumulated Amortization and Impairment | (5,467,067) | (5,407,699) |
Effect of Foreign Exchange Rates | (238,933) | (298,301) |
Net Balance |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (Details) - Schedule of estimated useful lives of identifiable intangible assets | 9 Months Ended |
Sep. 30, 2023 | |
A50 – Developed technology [Member] | |
Summary of Significant Accounting Policies [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 7 years |
Ares – Developed technology [Member] | |
Summary of Significant Accounting Policies [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 14 years |
A30 – Acquired in-process research & development [Member] | |
Summary of Significant Accounting Policies [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | Indefinite |
Trademarks and Tradenames [Member] | |
Summary of Significant Accounting Policies [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 10 years |
Customer/Distributor Relationships [Member] | |
Summary of Significant Accounting Policies [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 15 years |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies (Details) - Schedule of expected amortization of intangible assets - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Accounting Policies [Abstract] | ||
2023 (October to December) | $ 183,255 | |
2024 | 733,020 | |
2025 | 733,020 | |
2026 | 733,020 | |
2027 | 697,152 | |
Thereafter | 3,762,939 | |
Total | $ 6,842,406 | $ 7,440,974 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers (Details) - Schedule of revenues by type of service - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 699,022 | $ 448,713 | $ 2,348,601 | $ 1,885,663 |
Product sales [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 558,965 | 359,112 | 1,409,534 | 1,614,435 |
Laboratory services [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 47,135 | 31,016 | 112,810 | 94,515 |
Collaboration revenue [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 92,922 | $ 58,585 | $ 826,257 | $ 176,713 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers (Details) - Schedule of revenues by geography - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue from Contracts with Customer [Line Items] | ||||
Total revenue | $ 699,022 | $ 448,713 | $ 2,348,601 | $ 1,885,663 |
Domestic [Member] | ||||
Revenue from Contracts with Customer [Line Items] | ||||
Total revenue | 142,716 | 135,857 | 523,978 | 415,926 |
International [Member] | ||||
Revenue from Contracts with Customer [Line Items] | ||||
Total revenue | $ 556,306 | $ 312,856 | $ 1,824,623 | $ 1,469,737 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers (Details) - Schedule of changes in deferred revenue | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Revenue from Contracts with Customer [Abstract] | |
Balance at beginning | $ 142,061 |
Contracts with customers | 198,419 |
Recognized in the current period | (144,031) |
Currency translation adjustment | (1,762) |
Balance at ending | $ 194,687 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) € in Millions | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||
Jun. 30, 2019 EUR (€) | Sep. 30, 2023 | Dec. 31, 2022 USD ($) | May 23, 2023 | Jul. 09, 2020 EUR (€) | Dec. 31, 2016 EUR (€) | |
Fair Value Disclosures [Line Items] | ||||||
Participation percentage interest | 2.10% | |||||
Goodwill impairment expense | $ | $ 6,940,549 | |||||
Impairment of intangible assets | $ | $ 5,407,699 | |||||
Fair Value, Recurring [Member] | Curetis GmbH [Member] | ||||||
Fair Value Disclosures [Line Items] | ||||||
Participation percentage interest | 2.10% | |||||
European Investment Bank [Member] | Curetis GmbH [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | ||||||
Fair Value Disclosures [Line Items] | ||||||
Disbures equity capital | € 5 | |||||
European Investment Bank [Member] | OpGen's Equity [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | ||||||
Fair Value Disclosures [Line Items] | ||||||
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 Disclosures [Line Items] | ||||||
Unsecured loan financing facility | € 25 | |||||
European Investment Bank [Member] | Fair Value, Recurring [Member] | Curetis GmbH [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | ||||||
Fair Value Disclosures [Line Items] | ||||||
Disbures equity capital | € 5 | |||||
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 Disclosures [Line Items] | ||||||
EIB waived for curetis to have equity capital raised to disburse the third tranche | € 15 | |||||
European Investment Bank [Member] | Fair Value, Recurring [Member] | OpGen's Equity [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | ||||||
Fair Value Disclosures [Line Items] | ||||||
Participation percentage interest | 0.75% | 0.30% | ||||
European Investment Bank [Member] | Fair Value, Recurring [Member] | Curetis GmbH [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | ||||||
Fair Value Disclosures [Line Items] | ||||||
Disbures equity capital | € 5 |
Fair Value Measurements (Deta_2
Fair Value Measurements (Details) - Schedule of fair value of level 3 liabilities measured at fair value on a recurring basis | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Fair Value Disclosures [Line Items] | |
Balance at the beginning of the period | $ 99,498 |
Change in Fair Value | (65,800) |
Effect of Foreign Exchange Rates | 666 |
Balance at the end of the period | 34,364 |
Participation percentage interest liability [Member] | |
Fair Value Disclosures [Line Items] | |
Balance at the beginning of the period | 99,498 |
Change in Fair Value | (65,800) |
Effect of Foreign Exchange Rates | 666 |
Balance at the end of the period | $ 34,364 |
Debt (Details)
Debt (Details) € in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||||||||
Jun. 26, 2023 EUR (€) | Apr. 30, 2023 EUR (€) | May 23, 2022 EUR (€) | Jun. 30, 2019 EUR (€) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2023 EUR (€) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 EUR (€) | Jun. 22, 2023 EUR (€) | Dec. 31, 2022 USD ($) | Jul. 09, 2020 | Apr. 01, 2020 USD ($) | Apr. 01, 2020 EUR (€) | Jun. 30, 2018 EUR (€) | Apr. 30, 2017 EUR (€) | Dec. 31, 2016 EUR (€) | |
Debt [Line Items] | ||||||||||||||||||
Floating rate | 4% | |||||||||||||||||
Disburse tranche amount | € 5 | |||||||||||||||||
Principal amount | € 5 | |||||||||||||||||
Debt fair value | € 14.4 | |||||||||||||||||
Repaid amount | $ | $ 3,910,010 | $ 8,697,587 | ||||||||||||||||
Monthly loan payment on first tranche | € 0.7 | |||||||||||||||||
paid amount to EIB due to agreement | € 1 | |||||||||||||||||
Total debt obligations | $ | $ 9,947,611 | 9,947,611 | $ 13,489,178 | |||||||||||||||
Total interest expense (in Dollars) | $ | 396,768 | $ 569,306 | $ 1,698,564 | $ 2,618,799 | ||||||||||||||
Share-Based Payment Arrangement, Tranche Two [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Principal amount | € 3 | € 3 | ||||||||||||||||
Share-Based Payment Arrangement, Tranche Three [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Principal amount | € 5 | |||||||||||||||||
Curetis N.V.’s Equity [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Percentage of participation percentage interest | 2.10% | |||||||||||||||||
EIB [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Debt term | 5 years | 5 years | ||||||||||||||||
Fund drawn period | 36 months | 36 months | ||||||||||||||||
Total debt obligations | $ | 9,947,611 | $ 9,947,611 | $ 13,489,178 | |||||||||||||||
Deferred interest payable | $ | $ 1,500,000 | |||||||||||||||||
EIB [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Accumulated and deferred interest | € 13.4 | |||||||||||||||||
Repaid amount | 5 | |||||||||||||||||
EIB [Member] | First Tranche [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Debt instrument, interest rate, stated percentage | 6% | |||||||||||||||||
EIB [Member] | OpGen's equity value [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Percentage of participation percentage interest | 0.30% | |||||||||||||||||
EIB [Member] | Three Tranches [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Total debt borrowed | € 18 | |||||||||||||||||
PPI [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Percentage of participation percentage interest | 2.10% | |||||||||||||||||
PPI [Member] | Minimum [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
PPI of OPGEN amended, percentage | 0.30% | 0.30% | ||||||||||||||||
PPI [Member] | Maximum [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
PPI of OPGEN amended, percentage | 0.75% | 0.75% | ||||||||||||||||
EIB debt financing facility [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Debt fair value | $ | $ 15,800,000 | |||||||||||||||||
EIB Loan Facility [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Total debt obligations | $ | $ 9,900,000 | $ 9,900,000 | ||||||||||||||||
Euro Member Countries, Euro | EIB [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Maximum of unsecured loan financing facility | € 25 | |||||||||||||||||
EIB waived for curetis to have equity capital raised to disburse the third tranche | € 15 | |||||||||||||||||
Total debt obligations | € 9.4 | |||||||||||||||||
Deferred interest payable | € 1.4 | |||||||||||||||||
Euro Member Countries, Euro | EIB [Member] | First Tranche [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Unsecured debt | € 10 | |||||||||||||||||
Euro Member Countries, Euro | EIB [Member] | Second Tranche [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Unsecured debt | € 3 | |||||||||||||||||
Euro Member Countries, Euro | EIB [Member] | Third Tranche [Member] | ||||||||||||||||||
Debt [Line Items] | ||||||||||||||||||
Unsecured debt | € 5 |
Debt (Details) - Schedule of lo
Debt (Details) - Schedule of long-term debt and short-term borrowings - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Debt [Line Items] | ||
Total debt obligations | $ 9,947,611 | $ 13,489,178 |
Unamortized debt discount | (747,847) | (1,614,591) |
Carrying value of debt | 9,199,764 | 11,874,587 |
Less current portion | (9,199,764) | (7,023,901) |
Non-current portion of long-term debt | 4,850,686 | |
EIB [Member] | ||
Debt [Line Items] | ||
Total debt obligations | $ 9,947,611 | $ 13,489,178 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2023 | Oct. 26, 2023 | Oct. 12, 2023 | May 04, 2023 | Jan. 11, 2023 | Oct. 03, 2022 | Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Oct. 11, 2023 | May 31, 2023 | Jun. 24, 2022 | |
Stockholders' Equity [Line Items] | ||||||||||||
Common stock share authorized | 100,000,000 | 100,000,000 | 100,000,000 | |||||||||
Common stock issued | 605,000 | 268,000 | 10,013,524 | 10,013,524 | 2,899,911 | |||||||
Common stock outstanding | 10,013,524 | 10,013,524 | 2,899,911 | |||||||||
Preferred shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | |||||||||
Preferred stock shares issued | ||||||||||||
Preferred stock shares outstanding | ||||||||||||
Sale of shares | 85,732 | |||||||||||
Gross proceeds (in Dollars) | $ 3,500,000 | |||||||||||
Net proceeds (in Dollars) | $ 3,000,000 | $ 3,040,000 | ||||||||||
Price per share of common stock (in Dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | |||||||
Preferred stock, par value per share (in Dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||
Pre-funded warrants | 3,890,825 | 215,000 | ||||||||||
Gross proceeds (in Dollars) | $ 3,500,000 | |||||||||||
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 | ||||||||||
Shares of series c mirroring preferred stock | 33,810 | |||||||||||
Warrant exercise price (in Dollars per share) | $ 0.7785 | 2.65 | $ 0.7785 | |||||||||
Exercise price per share (in Dollars per share) | $ 0.01 | |||||||||||
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 | |||||||||||
Additional consideration exercise price (in Dollars per share) | $ 0.25 | |||||||||||
Expire year | five-year | |||||||||||
Pre-funded warrant exercise price (in Dollars per share) | 0.01 | |||||||||||
Warrant exercise price (in Dollars per share) | 0.7785 | |||||||||||
Options forfeited | 3,663 | 3,663 | ||||||||||
Options expired | 1,734 | 1,734 | ||||||||||
Common Stock [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Price per share of common stock (in Dollars per share) | 0.01 | $ 0.01 | ||||||||||
Number of repriced warrants to purchase shares | 741,489 | |||||||||||
Additional consideration exercise price (in Dollars per share) | 0.25 | |||||||||||
2022 ATM Offering [Member] | H.C. Wainwright & Co., LLC [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Gross proceeds (in Dollars) | $ 1,030,000 | |||||||||||
Net proceeds (in Dollars) | $ 990,000 | |||||||||||
Series C Mirroring Preferred Stock [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Shares | 33,810 | |||||||||||
Par value per share (in Dollars per share) | $ 0.01 | |||||||||||
Preferred stock, par value per share (in Dollars per share) | $ 0.01 | |||||||||||
Warrant [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Gross proceeds (in Dollars) | $ 3,340,000 | |||||||||||
Offering price per share of pre-funded warrant (in Dollars per share) | $ 6.8 | |||||||||||
Gross proceeds (in Dollars) | $ 3,340,000 | |||||||||||
Number of pre-funded warrants exercised | 215,000 | |||||||||||
Exercise price of common warrants (in Dollars per share) | $ 0.7785 | |||||||||||
Private Placement [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Warrants issued to purchase common stock | 483,000 | |||||||||||
Stock options [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Stock options to acquire shares of common stock | 102,200 | |||||||||||
Subsequent Event [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Price per share of common stock (in Dollars per share) | $ 0.01 | $ 0.01 | ||||||||||
Preferred stock, par value per share (in Dollars per share) | $ 1,000 | |||||||||||
Warrant exercise price (in Dollars per share) | 0.7785 | |||||||||||
Subsequent Event [Member] | Common Stock [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Additional consideration exercise price (in Dollars per share) | $ 0.25 | |||||||||||
Warrant agreement expire year | five-year | |||||||||||
Chief Financial Officer [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Stock options granted | 10,500 | |||||||||||
Exercise price of stock options (in Dollars per share) | $ 21.6 | $ 21.6 | ||||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
RSUs were forfeited | 20,438 | 20,438 | ||||||||||
Stock units granted | 100,500 | |||||||||||
Stock units vested | 33,780 | |||||||||||
Stock units outstanding | 89,189 | |||||||||||
2015 Plan [Member] | ||||||||||||
Stockholders' Equity [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 (i) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (ii) another lesser amount determined by the Company’s Board of Directors. | |||||||||||
Shares added | 115,996 | 115,996 | ||||||||||
Remaining shares | 107,481 | 107,481 | ||||||||||
Minimum [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Minimum warrant exercise price from prior offerings (in Dollars per share) | 2.65 | $ 41 | ||||||||||
Maximum [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Maximum warrant exercise price from prior offerings (in Dollars per share) | 7.54 | 1,300 | ||||||||||
Warrant exercise price (in Dollars per share) | $ 0.7785 | |||||||||||
First Annual Anniversary [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Vesting award, percentage | 6.25% | |||||||||||
First Annual Anniversary [Member] | Chief Financial Officer [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Vesting award, percentage | 25% | |||||||||||
Common Stock [Member] | Forecast [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Additional consideration exercise price (in Dollars per share) | $ 0.25 | |||||||||||
Common Stock [Member] | Minimum [Member] | 2020 ATM Offering [Member] | H.C. Wainwright & Co., LLC [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Maximum aggregate shares (in Dollars) | $ 10,650,000 | |||||||||||
Exercise Agreement [Member] | PIPE Financing [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Price per share of common stock (in Dollars per share) | 7 | |||||||||||
Price per share of preferred stock (in Dollars per share) | 0.01 | |||||||||||
Securities Purchase Agreement [Member] | ||||||||||||
Stockholders' Equity [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 [Line Items] | ||||||||||||
Price per share of common stock (in Dollars per share) | $ 0.01 | |||||||||||
Shares of common stock | 321,207 | |||||||||||
Par value of common stock (in Dollars) | $ 0.01 | |||||||||||
Price per share of common stock and common warrant (in Dollars per share) | $ 2.9 | |||||||||||
Securities Purchase Agreement [Member] | Pre-funded Warrant [Member] | ||||||||||||
Stockholders' Equity [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 [Line Items] | ||||||||||||
Aggregate warrants | 2,586,207 | |||||||||||
Series A-2 Common Warrants [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Aggregate warrants | 2,586,207 | |||||||||||
Investor [Member] | ||||||||||||
Stockholders' Equity [Line Items] | ||||||||||||
Exercise price of common warrants (in Dollars per share) | $ 7.54 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Schedule of company recognized stock compensation expense - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stockholders' Equity [Line Items] | ||||
Allocated share-based compensation expense | $ (229,483) | $ 228,367 | $ 138,168 | $ 727,389 |
Cost of services [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Allocated share-based compensation expense | (442) | (442) | 11,101 | |
Research and development [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Allocated share-based compensation expense | (159,742) | 82,659 | (41,914) | 223,638 |
General and administrative [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Allocated share-based compensation expense | 74,411 | 108,672 | 259,452 | 387,992 |
Sales and marketing [Member] | ||||
Stockholders' Equity [Line Items] | ||||
Allocated share-based compensation expense | $ (143,710) | $ 37,036 | $ (78,928) | $ 104,658 |
Stockholders' Equity (Details_2
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock - $ / shares | 9 Months Ended | ||
Sep. 30, 2023 | Dec. 31, 2022 | ||
Stockholders' Equity [Line Items] | |||
Shares of Common Stock Subject to Warrants | [1] | 10,955,142 | 1,291,213 |
Warrants Exercise Price One [Member] | February 2015 [Member] | |||
Stockholders' Equity [Line Items] | |||
Exercise Price (in Dollars per share) | $ 66,000 | ||
Expiration | February 2025 | ||
Shares of Common Stock Subject to Warrants | [1] | 23 | 23 |
Warrants Exercise Price Two [Member] | February 2018 [Member] | |||
Stockholders' Equity [Line Items] | |||
Exercise Price (in Dollars per share) | $ 1,625 | ||
Expiration | February 2023 | ||
Shares of Common Stock Subject to Warrants | [1] | 462 | |
Warrants Exercise Price Three [Member] | February 2018 [Member] | |||
Stockholders' Equity [Line Items] | |||
Exercise Price (in Dollars per share) | $ 1,300 | ||
Expiration | February 2023 | ||
Shares of Common Stock Subject to Warrants | [1] | 3,848 | |
Warrants Exercise Price Four [Member] | October 2019 [Member] | |||
Stockholders' Equity [Line Items] | |||
Exercise Price (in Dollars per share) | $ 40 | ||
Expiration | October 2024 | ||
Shares of Common Stock Subject to Warrants | [1] | 17,700 | 17,700 |
Warrants Exercise Price Five [Member] | October 2019 [Member] | |||
Stockholders' Equity [Line Items] | |||
Exercise Price (in Dollars per share) | $ 52 | ||
Expiration | October 2024 | ||
Shares of Common Stock Subject to Warrants | [1] | 11,750 | 11,750 |
Warrants Exercise Price Six [Member] | November 2020 [Member] | |||
Stockholders' Equity [Line Items] | |||
Exercise Price (in Dollars per share) | $ 50.44 | ||
Expiration | May 2026 | ||
Shares of Common Stock Subject to Warrants | [1] | 12,107 | 12,107 |
Warrants Exercise Price Seven [Member] | February 2021 [Member] | |||
Stockholders' Equity [Line Items] | |||
Exercise Price (in Dollars per share) | $ 78 | ||
Expiration | August 2026 | ||
Shares of Common Stock Subject to Warrants | [1] | 20,834 | 20,834 |
Warrants Exercise Price Eight [Member] | October 2022 [Member] | |||
Stockholders' Equity [Line Items] | |||
Exercise Price (in Dollars per share) | $ 7.54 | ||
Expiration | April 2028 | ||
Shares of Common Stock Subject to Warrants | [1] | 1,224,489 | |
Warrants Exercise Price Nine [Member] | May 2023 [Member] | |||
Stockholders' Equity [Line Items] | |||
Exercise Price (in Dollars per share) | $ 0.7785 | ||
Expiration | [2] | (2) | |
Shares of Common Stock Subject to Warrants | [1] | 10,892,728 | |
[1]Warrants to purchase fractional shares of common stock resulting from the reverse stock splits effected on August 22, 2019 and January 5, 2023 were rounded up to the next whole share of common stock on a holder by holder basis.[2]Warrants will be exercisable beginning on the date of stockholder approval of the exercisability of the warrants under Nasdaq rules or, pursuant to the Warrant Inducement Agreement entered into on October 12, 2023, as amended on October 26, 2023 (the “Inducement Agreement”), upon the payment of additional consideration of $0.25 per share of common stock issued upon exercise of any existing warrants. The warrants not exercised as part of the Inducement Agreement will expire on the five-year anniversary of the date of such stockholder approval (see Note 11). |
Leases (Details) - Schedule of
Leases (Details) - Schedule of ROU assets and lease liabilities - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
ROU Assets: | ||
Operating | $ 1,915,049 | $ 1,459,413 |
Financing | 986 | 3,500 |
Total ROU assets | 1,916,035 | 1,462,913 |
Current: | ||
Operating | 521,424 | 377,626 |
Finance | 1,121 | 3,364 |
Noncurrent: | ||
Operating | 2,830,282 | 2,566,138 |
Finance | 280 | |
Total lease liabilities | $ 3,352,827 | $ 2,947,408 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of maturities of lease liabilities | Sep. 30, 2023 USD ($) |
Lease [Line Items] | |
2023 (July to December) | $ 203,130 |
2024 | 815,902 |
2025 | 725,505 |
2026 | 577,456 |
2027 | 587,859 |
Thereafter | 1,737,689 |
Total lease payments | 4,647,541 |
Less: Interest | (1,294,714) |
Present value of lease liabilities | 3,352,827 |
Operating [Member] | |
Lease [Line Items] | |
2023 (July to December) | 202,289 |
2024 | 815,622 |
2025 | 725,505 |
2026 | 577,456 |
2027 | 587,859 |
Thereafter | 1,737,689 |
Total lease payments | 4,646,420 |
Less: Interest | (1,294,714) |
Present value of lease liabilities | 3,351,706 |
Finance [Member] | |
Lease [Line Items] | |
2023 (July to December) | 841 |
2024 | 280 |
2025 | |
2026 | |
2027 | |
Thereafter | |
Total lease payments | 1,121 |
Less: Interest | |
Present value of lease liabilities | $ 1,121 |
Leases (Details) - Schedule o_3
Leases (Details) - Schedule of lease cost classifications - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Finance: | ||||
Total lease costs | $ 176,090 | $ 154,776 | $ 487,060 | $ 554,695 |
Operating Expenses [Member] | ||||
Lease [Line Items] | ||||
Operating | 175,243 | 139,206 | 484,546 | 466,904 |
Finance: | ||||
Amortization | 847 | 15,312 | 2,514 | 86,119 |
Other Expenses [Member] | ||||
Finance: | ||||
Interest expense | $ 258 | $ 1,672 |
Leases (Details) - Schedule o_4
Leases (Details) - Schedule of other lease information | Sep. 30, 2023 |
Weighted average remaining lease term (in years) | |
Operating leases | 6 years 8 months 12 days |
Finance leases | 3 months 18 days |
Weighted average discount rate: | |
Operating leases | 9.70% |
Finance leases | 1% |
Leases (Details) - Schedule o_5
Leases (Details) - Schedule of supplemental cash flow information - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash used in operating activities | ||
Operating leases | $ 484,546 | $ 466,904 |
Finance leases | 1,672 | |
Cash used in financing activities | ||
Finance leases | 2,523 | 38,925 |
ROU assets obtained in exchange for lease obligations: | ||
Operating leases | $ 801,321 |
License Agreements, Research _2
License Agreements, Research Collaborations and Development Agreements (Details) € in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Aug. 01, 2023 | Sep. 22, 2022 EUR (€) | Sep. 30, 2023 USD ($) | Sep. 30, 2023 EUR (€) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2023 EUR (€) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 EUR (€) | |
License Agreements, Research Collaborations and Development Agreements [Line Items] | |||||||||
Research and development contract amount | € 600 | ||||||||
Revenue generated from Amendment 1 | € 130 | ||||||||
Research and development collaboration agreement extended date | May 31, 2024 | ||||||||
Total amount recognized related to collaboration | € 870 | ||||||||
Sandoz Agreement [Member] | |||||||||
License Agreements, Research Collaborations and Development Agreements [Line Items] | |||||||||
Research collaborations and developments agreement terms, descriptions | 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 [Line Items] | |||||||||
Research collaborations and developments agreement terms, descriptions | The agreement has a term of 20 years and may be terminated by Qiagen for convenience with 180 days written notice. | The agreement has a term of 20 years and may be terminated by Qiagen for convenience with 180 days written notice. | |||||||
Siemens Agreement [Member] | |||||||||
License Agreements, Research Collaborations and Development Agreements [Line Items] | |||||||||
Royalty expense (in Dollars) | $ | $ 3,102 | $ 1,552 | $ 7,309 | $ 5,034 | |||||
Siemens Agreement [Member] | Minimum [Member] | |||||||||
License Agreements, Research Collaborations and Development Agreements [Line Items] | |||||||||
Royalty rate | 1.30% | 1.30% | |||||||
Siemens Agreement [Member] | Maximum [Member] | |||||||||
License Agreements, Research Collaborations and Development Agreements [Line Items] | |||||||||
Royalty rate | 40% | 40% | |||||||
Curetis GmbH and FIND [Member] | |||||||||
License Agreements, Research Collaborations and Development Agreements [Line Items] | |||||||||
Research and development contract amount | € 700 | € 42 | |||||||
In Process Research and Development [Member] | |||||||||
License Agreements, Research Collaborations and Development Agreements [Line Items] | |||||||||
Research and development contract amount | € 500 | ||||||||
Software Development [Member] | |||||||||
License Agreements, Research Collaborations and Development Agreements [Line Items] | |||||||||
Research and development contract amount | € 500 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] $ / shares in Units, € in Thousands, $ in Thousands | Oct. 12, 2023 USD ($) $ / shares shares | Oct. 11, 2023 USD ($) $ / shares shares | Oct. 06, 2023 EUR (€) | Oct. 25, 2023 USD ($) shares |
Subsequent Event [Line Items] | ||||
Received a payment (in Euro) | € | € 750 | |||
Preferred stock, per share | $ 1,000 | |||
Sold at price per share | $ 1,000 | |||
Proceeds from Issuance of Preferred Stock and Preference Stock (in Dollars) | $ | $ 1,000 | |||
Common stock per share | $ 0.01 | $ 0.01 | ||
Price per share | $ 0.409 | |||
Affiliates holding percentage | 19.99% | |||
Purchase share (in Shares) | shares | 10,892,728 | |||
Exercise price | $ 0.7785 | |||
Maximum possible gross proceeds from exercise of all existing warrants (in Dollars) | $ | $ 11,200 | |||
Common stock percentage | 100% | |||
Number of warrants exercised (in Shares) | shares | 2,000,000 | |||
Gross proceeds for the warrant inducement (in Dollars) | $ | $ 2,057 | |||
Inducement Warrants [Member] | ||||
Subsequent Event [Line Items] | ||||
Exercise price | $ 0.336 | |||
Series D Preferred Stock [Member] | ||||
Subsequent Event [Line Items] | ||||
Preferred stock, share issued (in Shares) | shares | 1,000 | |||
Preferred stock, per share | $ 0.01 | |||
Warrant [Member] | ||||
Subsequent Event [Line Items] | ||||
Additional consideration required | $ 0.25 |