ROCKVILLE, Md., Nov. 10, 2022 (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 2022 financial and operating results. Management will host an investor call to discuss quarterly results and provide a business update.
Oliver Schacht, President & CEO of OpGen, commented, "During the third quarter we reached multiple agreements and entered into collaborations with various partners. These include our research collaboration agreement with the Belgian National Reference Center (BNRC), an R&D collaboration with FIND, our second commercial installation of the Acuitas AMR Gene Panel, a new commercial contract for Unyvero in the U.S., and a collaboration agreement with BioVersys. We are seeing progress on both the R&D and commercial fronts and look forward to the upcoming progress."
Mr. Schacht continued, "As we proceed through 2022 and move into the calendar year of 2023, we have several upcoming catalysts and milestones to look forward to, including our UTI clinical trial data read-out and anticipated subsequent FDA submission, proceeds from the FIND collaboration as well as its potential future extension and expansion, and several potential new commercial contracts with U.S. customers across Unyvero and Acuitas products. We look forward to announcing these potential milestones as we continue to focus on building shareholder value."
Third Quarter 2022 Financial Results of OpGen, Inc.
In the third quarter and year to date, the Company reached the following key milestones:
In terms of guidance, the Company anticipates:
Conference Call Information
OpGen's management will host a conference call today, November 10, at 4:30 p.m. EST, to discuss the third quarter financial results and business activities, as well as answer analyst questions.
| Conference Call Details | ||
| U.S. Dial-in Number: | 1-877-704-4453 | |
| International Dial-in Number: | 1-201-389-0920 | |
| Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1569725&tp_key=91a31a2b1f | ||
| Conference ID: | 13732787 | |
Following the conclusion of the conference call, a replay will be available through November 24th, 2022. The live, listen-only webcast of the conference call may also be accessed by visiting the Investors section of the Company's website at www.opgen.com.
A replay of the webcast will be available following the conclusion of the call and will be archived on the Company's website for 90 days. Replay access information is below:
| Replay Details | ||
| U.S. Dial-in Number: | 1-844-512-2921 | |
| International Dial-in Number: | 1-412-317-6671 | |
| Replay PIN: | 13732787 | |
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, 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, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, NGS technology and AI-powered bioinformatics solutions for AMR surveillance, outbreak analysis, and antibiotic response prediction including ARESiss, ARESid, and AREScloud, as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.
For more information, please visit www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding OpGen's third quarter 2022 financial results 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 success of our commercialization efforts, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the fact that we may not effectively use proceeds from recent financings, the continued realization of expected benefits of our business combination transaction with Curetis GmbH, the continued impact of COVID-19 on the Company's operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, our ability to satisfy debt obligations under our loan with the European Investment Bank, the effect of the military action in Russia and Ukraine on our distributors, collaborators and service providers, our liquidity and working capital requirements, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. 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, Inc. | |||||||
| Consolidated Balance Sheets | |||||||
| (unaudited) | |||||||
| September 30, 2022 | December 31, 2021 | ||||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 10,275,654 | $ | 36,080,392 | |||
| Accounts receivable, net | 665,313 | 1,172,396 | |||||
| Inventory | 771,864 | 1,239,456 | |||||
| Prepaid expenses and other current assets | 1,678,729 | 1,250,331 | |||||
| Total current assets | 13,391,560 | 39,742,575 | |||||
| Property and equipment, net | 3,054,990 | 4,011,748 | |||||
| Finance lease right-of-use assets, net | 4,347 | 90,467 | |||||
| Operating lease right-of-use assets | 1,472,934 | 1,814,396 | |||||
| Goodwill | — | 7,453,007 | |||||
| Intangible assets, net | 12,001,036 | 14,530,209 | |||||
| Strategic inventory, net | 2,614,805 | 3,472,337 | |||||
| Other noncurrent assets | 419,495 | 551,794 | |||||
| Total assets | $ | 32,959,167 | $ | 71,666,533 | |||
| Liabilities and Stockholders' Equity | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 682,592 | $ | 1,307,081 | |||
| Accrued compensation and benefits | 1,391,145 | 1,621,788 | |||||
| Accrued liabilities | 1,046,865 | 1,965,845 | |||||
| Deferred revenue | 194,960 | — | |||||
| Short-term notes payable | 8,342,715 | 14,519,113 | |||||
| Short-term finance lease liabilities | 6,748 | 43,150 | |||||
| Short-term operating lease liabilities | 346,629 | 459,792 | |||||
| Total current liabilities | 12,011,654 | 19,916,769 | |||||
| Note payable | 4,108,421 | 7,176,251 | |||||
| Derivative liabilities | 146,207 | 228,589 | |||||
| Long-term finance lease liabilities | 1,121 | 3,644 | |||||
| Long-term operating lease liabilities | 2,631,957 | 2,977,402 | |||||
| Other long term liabilities | 121,496 | 146,798 | |||||
| Total liabilities | 19,020,856 | 30,449,453 | |||||
| Stockholders' equity | |||||||
| Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at September 30, 2022 and December 31, 2021, respectively | — | — | |||||
| Common stock, $0.01 par value; 100,000,000 shares authorized; 48,338,500 and 46,450,250 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 483,386 | 464,503 | |||||
| Additional paid-in capital | 277,406,700 | 275,708,490 | |||||
| Accumulated deficit | (262,289,652 | ) | (235,541,539 | ) | |||
| Accumulated other comprehensive (loss)/income | (1,662,123 | ) | 585,626 | ||||
| Total stockholders' equity | 13,938,311 | 41,217,080 | |||||
| Total liabilities and stockholders' equity | $ | 32,959,167 | $ | 71,666,533 | |||
| OpGen, Inc. | |||||||||||||||
| Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||
| (unaudited) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Revenue | |||||||||||||||
| Product sales | $ | 359,112 | $ | 643,887 | $ | 1,614,435 | $ | 1,479,270 | |||||||
| Laboratory services | 31,016 | 192,753 | 94,515 | 643,602 | |||||||||||
| Collaboration revenue | 58,585 | 402,492 | 176,713 | 757,591 | |||||||||||
| Total revenue | 448,713 | 1,239,132 | 1,885,663 | 2,880,463 | |||||||||||
| Operating expenses | |||||||||||||||
| Cost of products sold | 1,886,191 | 648,298 | 2,824,577 | 1,544,932 | |||||||||||
| Cost of services | 17,239 | 203,314 | 63,450 | 446,232 | |||||||||||
| Research and development, net | 2,031,113 | 2,382,303 | 6,621,310 | 8,055,384 | |||||||||||
| General and administrative | 2,020,452 | 2,088,226 | 6,779,773 | 7,444,138 | |||||||||||
| Sales and marketing | 1,031,496 | 1,003,577 | 3,252,277 | 2,705,378 | |||||||||||
| Impairment of right-of-use asset | — | — | — | 170,714 | |||||||||||
| Goodwill impairment charge | 6,975,520 | — | 6,975,520 | — | |||||||||||
| Total operating expenses | 13,962,011 | 6,325,718 | 26,516,907 | 20,366,778 | |||||||||||
| Operating loss | (13,513,298 | ) | (5,086,586 | ) | (24,631,244 | ) | (17,486,315 | ) | |||||||
| Other expense | |||||||||||||||
| Gain on extinguishment of debt | — | — | — | 259,353 | |||||||||||
| Warrant inducement expense | — | — | — | (7,755,541 | ) | ||||||||||
| Interest and other income, net | 11,174 | 31,844 | 28,147 | 41,471 | |||||||||||
| Interest expense | (569,306 | ) | (1,222,867 | ) | (2,618,799 | ) | (3,586,018 | ) | |||||||
| Foreign currency transaction gains | (51,547 | ) | 229,074 | 419,160 | 655,774 | ||||||||||
| Change in fair value of derivative financial instruments | 18,995 | (8,161 | ) | 54,623 | (122,572 | ) | |||||||||
| Total other expense | (590,684 | ) | (970,110 | ) | (2,116,869 | ) | (10,507,533 | ) | |||||||
| Loss before income taxes | (14,103,982 | ) | (6,056,696 | ) | (26,748,113 | ) | (27,993,848 | ) | |||||||
| Provision for income taxes | — | — | — | — | |||||||||||
| Net loss | $ | (14,103,982 | ) | $ | (6,056,696 | ) | $ | (26,748,113 | ) | $ | (27,993,848 | ) | |||
| Net loss available to common stockholders | $ | (14,103,982 | ) | $ | (6,056,696 | ) | $ | (26,748,113 | ) | $ | (27,993,848 | ) | |||
| Basic and diluted net loss per share attributable to common stockholders | $ | (0.30 | ) | $ | (0.16 | ) | $ | (0.57 | ) | $ | (0.79 | ) | |||
| Weighted average shares outstanding - basic and diluted | 47,656,972 | 38,270,250 | 46,915,880 | 35,373,397 | |||||||||||
| Net loss | $ | (14,103,982 | ) | $ | (6,056,696 | ) | $ | (26,748,113 | ) | $ | (27,993,848 | ) | |||
| Other comprehensive loss - foreign currency translation | (536,758 | ) | (597,527 | ) | (2,247,749 | ) | (1,146,355 | ) | |||||||
| Comprehensive loss | $ | (14,640,740 | ) | $ | (6,654,223 | ) | $ | (28,995,862 | ) | $ | (29,140,203 | ) | |||
OpGen:
Oliver Schacht
President and CEO
InvestorRelations@opgen.com
OpGen Press Contact:
Matthew Bretzius
FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact:
Alyssa Factor
Edison Group
afactor@edisongroup.com
