Conference call to be held at 4:30 p.m. Eastern Time today

GAITHERSBURG, Md., Nov. 11, 2020 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, reported today its financial and operating results for the three and nine months ended September 30, 2020 and provided a business update. Total OpGen revenue for the third quarter of 2020 was approximately $1.1 million, up from $0.6 million in the third quarter of 2019. The financial results for the three months ended September 30, 2020 reflect the consummation of our business combination with Curetis GmbH on April 1, 2020. OpGen’s cash as of September 30, 2020 was approximately $10.5 million. The company has access to an additional $6.4 million under its expanded ATM program and has 594,000 warrants outstanding at an average exercise price of $2.16. In addition, the Company continues to have access to an additional €5.0 million tranche of non-dilutive debt financing for COVID-19 related R&D programs from the European Investment Bank.

As previously reported, OpGen announced details regarding a strategic reprioritization of its product portfolio, platform pipeline and priorities going forward. This reprioritization was based on feedback from extensive market research, a customer survey of 150 stakeholders in the decision making on new diagnostic platforms, and key-opinion-leader interviews conducted by an independent market research firm over the past two quarters. Following a review of this research, OpGen and its board decided to consolidate the company’s product portfolio on its proprietary Unyvero platform and unique bioinformatics capabilities. As a result of this change in priority, the company anticipates the following key impacts:

Oliver Schacht, President and CEO of OpGen commented, “Reprioritization efforts including the consolidation of our product portfolio highlights our focus on rapid, molecular diagnostic offerings and bioinformatics as we look to 2021 and beyond. Additionally, the discontinuation of the Acuitas AMR Gene Panel (urine) clinical trial and the Legacy FISH products business will result in significant operational synergies and cost savings for OpGen. We believe this shift will create meaningful, long term shareholder value for our investors, partners and healthcare provides alike as we continue to establish ourselves as industry leaders in molecular diagnostics and bioinformatics space.”

Third Quarter and Nine Month 2020 Financial Results

The company also announced accomplishment of the following key milestones in the third quarter of 2020 and year to date:

Mr. Schacht commented, “I am pleased with our third quarter financial results and am encouraged by the exciting business updates that were issued this quarter including the CE mark certification for our SARS-CoV-2 Kit, notable awards and grants, peer-reviewed publications and the submission of our formal response letter to the FDA, which upon continued positive interactions with the FDA, makes us believe there should be a near-term clearance decision once the COVID-19 related FDA delays allow the agency to respond. In addition to the business and pipeline progress achieved this quarter, we are excited to provide further details about our reprioritization strategy aimed at creating both near-term and long-term growth potential for the company. As we wrap up 2020 OpGen is in a strong position to achieve pipeline and growth targets in the years ahead and I look forward to the company’s continued successes.”

Conference Call Information

OpGen’s management will host a conference call today, November 11 at 4:30 p.m. ET to discuss the third quarter financial results and other business activities, as well as answer questions. Dial-in information is below:

Dial-in Information
U.S. Dial-in Number: +1 (877) 705 6003
International Dial-in Number: +1 (201) 493 6725
Webcast: http://public.viavid.com/index.php?id=142176
Conference ID: 13712431

Following the conclusion of the conference call, a replay will be available through November 25, 2020. 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 Information
U.S. Dial-in Number: +1 (844) 512 2921
International Dial-in Number: +1 (412) 317 6671
Replay PIN: 13712431

About OpGen, Inc.

OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with 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 product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas® Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.

For more information, please visit www.opgen.com.

Forward-Looking Statements

This press release includes statements regarding OpGen’s third quarter 2020 results, the company’s strategic portfolio and product pipeline priorities, the ongoing integration of OpGen with its acquired subsidiaries, Curetis GmbH and Ares Genetics GmbH, and the impact of COVID-19 on the company and general market conditions. 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, 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 realization of expected benefits of our business combination transaction with Curetis GmbH, the success of our commercialization efforts, the impact of COVID-19 on the Company’s operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, 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:
Oliver Schacht
President and CEO
InvestorRelations@opgen.com

OpGen Press Contact:
Matthew Bretzius 
FischTank Marketing and PR
matt@fischtankpr.com

OpGen Investor Contact:
Megan Paul
Edison Group 
mpaul@edisongroup.com


OpGen, Inc.
Consolidated Balance Sheets
(unaudited)
    
 September 30, 2020 December 31, 2019
Assets   
Current assets   
Cash and cash equivalents$10,488,072  $2,708,223 
Accounts receivable, net 423,432   567,811 
Inventory, net 2,975,060   473,030 
Note receivable —   2,521,479 
Prepaid expenses and other current assets 1,072,364   396,760 
Total current assets 14,958,928   6,667,303 
Property and equipment, net 3,370,847   130,759 
Finance lease right-of-use assets, net 571,329   958,590 
Operating lease right-of-use assets 1,373,418   1,043,537 
Goodwill 8,057,894   600,814 
Intangible assets, net 16,071,680   817,550 
Other noncurrent assets 300,744   203,271 
Total assets$ 44,704,840  $ 10,421,824 
Liabilities and Stockholders’ Equity   
Current liabilities   
Accounts payable$1,240,351  $1,056,035 
Accrued compensation and benefits 2,003,002   855,994 
Accrued liabilities 2,664,581   1,046,661 
Deferred revenue 51,622   9,808 
Short-term notes payable 1,156,517   373,599 
Short-term finance lease liabilities 348,000   579,030 
Short-term operating lease liabilities 1,142,435   1,017,414 
Total current liabilities 8,606,508   4,938,541 
Note payable 18,159,433   329,456 
Deriviative liabilities 74,239   — 
Long-term finance lease liabilities 76,701   313,263 
Long-term operating lease liabilities 554,295   547,225 
Other long term liabilites 154,716   - 
Total liabilities 27,625,892   6,128,485 
Commitments   
Stockholders' equity   
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at September 30, 2020 and December 31, 2019, respectively —   — 
Common stock, $0.01 par value; 50,000,000 shares authorized; 19,799,348 and 5,582,280 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively 197,993   55,823 
Additional paid-in capital 208,892,463   178,779,814 
Accumulated deficit (193,625,510)  (174,524,983)
Accumulated other comprehensive income/(loss) 1,614,002   (17,315)
Total stockholders’ equity 17,078,948   4,293,339 
Total liabilities and stockholders’ equity$ 44,704,840  $ 10,421,824 
    



OpGen, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
        
 Three Months Ended September 30, Nine Months Ended September 30,
 2020 2019 2020 2019
Revenue       
Product sales$601,562  $573,035  $1,569,799  $1,597,505 
Laboratory services 112,892   185   138,884  $5,435 
Collaboration revenue 342,311   75,000   1,153,400   1,075,000 
Total revenue 1,056,765   648,220   2,862,083   2,677,940 
Operating expenses       
Cost of products sold 1,350,296   262,373   2,340,766   681,568 
Cost of services 159,794   196,184   550,115   592,647 
Research and development 2,433,553   1,139,369   6,630,134   4,069,335 
General and administrative 2,356,413   1,560,706   6,549,432   4,901,136 
Sales and marketing 932,671   376,955   2,258,980   1,142,755 
Transaction costs —   538,061   470,322   538,061 
Impairment of intangible assets —   —   750,596   — 
Impairment of right-of-use asset —   —   —   520,759 
Total operating expenses 7,232,727   4,073,648   19,550,345   12,446,261 
Operating loss (6,175,962)  (3,425,428)  (16,688,262)  (9,768,321)
Other (expense) income       
Interest and other income/(expense) 19,965   1,043   101,644   (8,213)
Interest expense (1,183,927)  (49,099)  (2,267,085)  (142,672)
Foreign currency transaction losses (501,168)  (8,954)  (794,832)  (9,426)
Change in fair value of derivative financial instruments 165,497   —   548,008   67 
Total other expense (1,499,633)  (57,010)  (2,412,265)  (160,244)
Loss before income taxes (7,675,595)  (3,482,438)  (19,100,527)  (9,928,565)
Provision for income taxes —   —   —   — 
Net loss$ (7,675,595) $ (3,482,438) $ (19,100,527) $ (9,928,565)
        
Net loss per common share - basic and diluted$ (0.40) $ (3.95) $ (1.36) $ (13.32)
Weighted average shares outstanding - basic and diluted 19,116,864   882,280   14,016,896   745,471 
Net loss$(7,675,595) $(3,482,438) $(19,100,527) $(9,928,565)
Other comprehensive income - foreign currency translation 1,266,901   7,298   1,631,317   5,174 
Comprehensive loss$ (6,408,694) $ (3,475,140) $ (17,469,210) $ (9,923,391)