OpGen Reports Third Quarter 2023 Financial Results and Provides Business Update

Total revenue for the first nine months of 2023 was approximately $2.35 million compared to approximately $1.89 million in the first nine months of 2022Implemented certain cash management initiatives, including restructuring U.S. operations by reducing headcount during the third quarter of 2023Signed preferred stock purchase agreement with a potential strategic investor in October 2023Entered into a warrant inducement agreement with an institutional investor in October 2023Subsidiaries Curetis GmbH in Germany and Ares Genetics GmbH in Austria filed for insolvency under German and Austrian laws, respectively, in November 2023 ROCKVILLE, Md., Nov. 14, 2023 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, reported its third quarter 2023 financial and operating results. Third Quarter 2023 Financial Results of OpGen, Inc. Total revenue for the third quarter of 2023 was approximately $0.70 million compared to the Company’s revenue of approximately $0.45 million in the third quarter of 2022. Total revenue for the nine months ended September 30, 2023 was approximately $2.35 million compared to the Company’s revenue of approximately $1.89 million in the nine months ended September 30, 2022.Total operating expenses decreased in the third quarter of 2023 to approximately $4.26 million compared to approximately $13.96 million for the third quarter of 2022 primarily due to the Company’s goodwill impairment charge of $6.98 million recorded in the third quarter of 2022. Total operating expenses decreased by approximately 39% in the nine months ended September 30, 2023 to approximately $16.14 million compared to approximately $26.52 million for the same period in 2022.Cash and cash equivalents were approximately $0.29 million as of September 30, 2023, compared with approximately $7.44 million as of December 31, 2022. The Company entered into two agreements in October 2023 to improve its cash position consisting of a preferred stock purchase agreement for $1.0 million in gross proceeds with a potential strategic investor and a warrant inducement agreement with an existing institutional investor that, as of November 14, 2023, resulted in gross proceeds of approximately $2.06 million. Nevertheless, the Company has concluded that there is substantial doubt about the Company’s ability to continue as a going concern. The Company 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. In the reporting quarter and year to date, the Company has seen the following key developments: OpGen 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.In October 2023, OpGen amended its non-exclusive distribution agreement with Fisher Healthcare to allow Fisher Healthcare to sell to existing U.S. Unyvero customers of the Company, which had previously been maintained by the Company’s sales force.In October 2023, OpGen discontinued its FDA cleared Acuitas AMR Gene Panel diagnostic test.In October 2023, OpGen’s German subsidiary Curetis GmbH responded to all of the FDA’s additional requests with regard to Curetis’ De Novo request for the Unyvero UTI urinary tract infection test in order to continue the FDA review.In October 2023, OpGen entered into a preferred stock purchase agreement with a potential strategic investor for gross proceeds of $1.0 million in exchange for 1,000 shares of the Company’s Series D Preferred Stock. In connection with the ongoing discussions for a transaction with such potential strategic investor, the parties anticipate closing the transaction under the preferred stock purchase agreement as soon as practical.On November 6, 2023, following OpGen’s unsuccessful efforts to sell the businesses or assets of its wholly owned subsidiaries Curetis GmbH and Ares Genetics GmbH or to access additional capital to continue their operations, Curetis GmbH and Ares Genetics GmbH filed for insolvency under the applicable German and Austrian laws, respectively. About OpGen, Inc.  OpGen, Inc. (Rockville, Md., U.S.A.) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with our subsidiaries, Curetis GmbH and Ares Genetics GmbH, both of which are subject to insolvency proceedings under German and Austrian laws, respectively, since November 6, 2023, we are 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 antibiotic response prediction including ARESiss, ARESid, ARESasp, and AREScloud. For more information, please visit www.opgen.com Forward-Looking Statements This press release includes statements regarding the third quarter of 2023 and the current business of OpGen. These statements and other statements regarding OpGen’s future plans and goals constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, the risks and uncertainties relating to the insolvency proceedings of Curetis GmbH and Ares Genetics GmbH, our ability to continue to finance our business and operations, the result of any alternatives to mitigate the Company’s cash position, including restructuring or refinancing of our debt, seeking additional debt or equity capital, reducing or delaying our business activities, selling assets, other strategic transactions or other measures, including obtaining relief under U.S. bankruptcy laws, and the terms, value and timing of any transaction resulting from such alternatives, our ability to satisfy debt obligations under our loan with the European Investment Bank, and our liquidity and working capital requirements. For a discussion of the most significant risks and uncertainties associated with OpGen’s business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. OpGen: Oliver Schacht President and CEO [email protected] OpGen Investor & Press Contact: Alyssa Factor Edison Group [email protected]  OpGen, Inc. and SubsidiariesCondensed Consolidated Balance Sheets(unaudited)         September 30, 2023  December 31, 2022 Assets        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 Liabilities and Stockholders’ Equity        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 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           OpGen, Inc. and SubsidiariesCondensed Consolidated Statements of Operations and Comprehensive Loss(unaudited)         Three months ended September 30,  Nine months ended September 30, 2023  2022  2023  2022Revenue               Product sales$558,965  $359,112  $1,409,534  $1,614,435 Laboratory services 47,135   31,016   112,810   94,515 Collaboration revenue 92,922   58,585   826,257   176,713 Total revenue 699,022   448,713   2,348,601   1,885,663 Operating expenses               Cost of products sold 618,796   1,886,191   1,925,566   2,824,577 Cost of services 73,174   17,239   405,582   63,450 Research and development 1,201,865   2,031,113   4,403,488   6,621,310 General and administrative 2,034,628   2,020,452   6,883,588   6,779,773 Sales and marketing 336,184   1,031,496   2,522,471   3,252,277 Goodwill impairment charge —   6,975,520   —   6,975,520 Total operating expenses 4,264,647   13,962,011   16,140,695   26,516,907 Operating loss (3,565,625)  (13,513,298)  (13,792,094)  (24,631,244)Other (expense) income                Interest and other income 24,977   11,174   86,301   28,147 Interest expense (396,768)  (569,306)  (1,698,564)  (2,618,799)Foreign currency transaction (losses) gains (135,930)  (51,547)  (288,326)  419,160 Change in fair value of derivative financial instruments 10,389   18,995   65,800   54,623 Total other expense  (497,332)  (590,684)  (1,834,789)  (2,116,869)Loss before income taxes (4,062,957)  (14,103,982)  (15,626,883)  (26,748,113)Provision for income taxes —   —   —   — Net loss$ (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) $(26,748,113)Net loss per common share – basic and diluted$(0.46) $(5.92) $(2.38) $(11.40)Weighted average shares outstanding – basic and diluted 8,778,152   2,382,848   6,565,853   2,345,794 Net loss$(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)