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UNITED STATES
 SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
_________________
FORM 8-K
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
 Securities Exchange Act of 1934
May 14, 2019
 Date of Report (date of earliest event reported)
_________________
OpGen, Inc.
(Exact name of Registrant as specified in its charter)
_________________
Delaware
(State or other jurisdiction of incorporation or organization)
  
001-37367
(Commission
File Number)
  
06-1614015
(I.R.S. Employer
 Identification Number)

708 Quince Orchard Road, Suite 205
Gaithersburg, MD 20878
(Address of principal executive offices)
(240) 813-1260
(Registrant’s telephone number, including area code)
Not Applicable
 (Former name or former address, if changed since last report)
_________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
[_]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[_]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[_]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[_]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [X]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [_]     
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock
OPGN
The Nasdaq Capital Market
Common Stock Warrants (IPO)
OPGNW
The Nasdaq Capital Market



Item 2.02   Results of Operations and Financial Condition.

On May 14, 2019, OpGen, Inc. issued a press release announcing its first quarter financial results for the quarter ended March 31, 2019.  The full text of such press release is furnished as Exhibit 99.1 to this report.
 
Item 9.01   Financial Statements and Exhibits.

(d)
Exhibits.

99.1

The information included herein and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (“Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
 
 
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
   
   
OpGen, Inc.
 
  
Date:  May 14, 2019
 
 /s/ Timothy C. Dec  
    Timothy C. Dec  
    Chief Financial Officer  
       
 



Exhibit 99.1
 
 


OpGen Reports First Quarter 2019 Financial Results and Provides Business Update

Submission of 510(k) application to the FDA for clearance of the Acuitas® AMR Gene Panel test for bacterial isolates

Revenue up 21% Quarter-over-Quarter

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

GAITHERSBURG, Md., May 14, 2019 -- OpGen, Inc. (NASDAQ: OPGN) today reported financial and operating results for the three months ended March 31, 2019 and provided a business update. Total revenue for the first quarter of 2019 was $1.0 million, compared with $0.85 million for the first quarter of 2018. Recent business highlights include:

·
Submission, on May 13, 2019, of 510(k) application to the U.S. Food and Drug Administration (“FDA”) for clearance of the Acuitas® AMR Gene Panel test for the detection of antimicrobial resistance genes in bacterial isolates;
·
Advancement of the collaboration with the New York State Department of Health (“DOH”) and ILÚM Health Solutions, LLC (“ILÚM”), a wholly owned subsidiary of Merck’s Healthcare Services and Solutions, LLC;
·
Achievement of first program milestone of $500,000 for New York State Infectious Disease Digital Health Initiative demonstration project, following installation of Acuitas systems at New York City metro area health systems and the Wadsworth Laboratories;
·
Publication of data supporting prediction of antibiotic resistance using the company’s Acuitas® AMR Gene Panel and Acuitas Lighthouse Software in the April issue of Antimicrobial Agents and Chemotherapy, a peer-reviewed scientific journal of the American Society for Microbiology;

·
Presentation of OpGen rapid diagnostic ID products to key opinion leaders during an event co-hosted with ILÚM at the VIII International Symposium on Hospital Acquired Infections and Antimicrobial Stewardship, held in Cali, Colombia;
·
Completion of public offering of common stock with gross proceeds of $5.4 million in March 2019.

“We have achieved several critical milestones to start the year, led by the submission of our first FDA 510(k) application for testing of antimicrobial resistance genes in bacterial isolates. We expect the process with the FDA to be completed in 2019 and have already started preparing for this key product launch,” said Evan Jones, Chairman and CEO of OpGen.
“Simultaneously, we are working to complete two additional 510(k) submissions for our lead rapid molecular diagnostic test, the Acuitas AMR Gene Panel (Urine) and the Acuitas Lighthouse Software. The clinical trials to support these submissions are anticipated to begin by the end of the second quarter. We plan to complete these trials in the third quarter of 2019 and will prepare the 510(k) submissions shortly thereafter.”
 
 
“To support the anticipated launch of these tests and informatics, we have established a robust network of hospitals and strategic industry players. We are particularly pleased with the advancement of the New York State Digital Health Initiative and continue to work closely with ILÚM and the New York State DOH to expand the impact of this important project. We are confident that we are well-positioned to execute on a successful commercial launch, as we aim to bring these products to more hospitals around the world,” Evan Jones concluded.
First Quarter 2019 Financial Results
·
Total revenue for the first quarter of 2019 was $1.0 million, compared with $0.85 million for the first quarter of 2018;
·
Operating expenses for the first quarter 2019 were $4.8 million, compared with $3.9 million for the first quarter of 2018. The increase was primarily due to an increase in research and development expense associated with the Acuitas AMR Gene Panel clinical trials and $0.5 million of non-cash impairment expense related to the Company’s Woburn, Massachusetts office right-of-use asset;
·
The net loss for the first quarter of 2019 was $3.9 million or $0.41 per share, compared with a net loss of $3.0 million or $0.75 per share for the first quarter of 2018;
·
Cash and cash equivalents were $6.0 million as of March 31, 2019.

Business and Operations Outlook

·
Complete clinical evaluations and file De Novo 510(k) applications with the FDA for the Acuitas AMR Gene Panel (Urine) and the Acuitas Lighthouse Software for rapid testing of urine specimens and prediction of antibiotic resistance to front-line antibiotics;
·
Continue to install Acuitas AMR Gene Panel systems in support of Research Use Only sales and full launch following first FDA clearance;
·
Expand commercial activities to support FDA clearance and launch of the Acuitas AMR Gene Panel products;
·
Present clinical verification study results for the Acuitas AMR Gene Panel (Urine) at the ASM Microbe conference in June 2019; and
·
Commercialize rapid testing products in South America, using Colombia as a springboard.
 
 

 
Conference Call Information

OpGen management will hold a conference call today, May 14, 2019 at 4:30 p.m. ET to discuss first quarter 2019 financial results and other business activities, and answer questions. 

Dial-in Information
U.S. Dial-In Number: (844)-420-8185           
International Dial-In Number: (216)-562-0481          
Conference ID: 6190299
Webcast URL: https://edge.media-server.com/m6/p/yxqz4fc4  

Replay Dial-in Information
U.S. Dial-In Number: (855)-859-2056
International Dial-In Number: (404)-537-3406
 Conference ID: 6190299

A live webcast of the conference call can be accessed by visiting the Investor Relations section of the company’s website at www.ir.opgen.com. A replay of the webcast will be available shortly after the conclusion of the call for 90 days.

About OpGen

OpGen, Inc. is a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. We are developing molecular information products and services for global healthcare settings, helping to guide clinicians with more rapid and actionable information about life threatening infections, improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs.  

Our molecular diagnostics and informatics products, product candidates and services combine our Acuitas molecular diagnostics and Acuitas Lighthouse informatics platform for use with our proprietary, curated MDRO knowledgebase. We are working to deliver our products and services, some in development, to a global network of customers and partners. The Acuitas AMR Gene Panel (RUO) is intended for Research Use Only and is not for use in diagnostic procedures. The Acuitas Lighthouse Software is not distributed commercially for antibiotic resistance prediction and is not for use in diagnostic procedures. For more information, please visit www.opgen.com.

OpGen, Acuitas, and Acuitas Lighthouse are registered trademarks of OpGen, Inc
Forward-Looking Statements
This press release includes statements relating to OpGen’s outlook for 2019. 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 timely and cost-effectively seek and obtain regulatory clearance for and commercialize our product and services offerings, our ability to successfully complete the demonstration project portion of the New York State Infectious Disease Digital Health Initiative, the rate of adoption of our products and services by hospitals and other healthcare providers, the success of our commercialization efforts, 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, including our Annual Report on Form 10-K for the year ended December 31, 2018, and subsequent filings. 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 Contact:
Michael Farmer
Vice President, Marketing
(240) 813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com
Press Contact:
Matthew Bretzius
FischTank Marketing and PR
matt@fischtankpr.com
Investor Contacts:
Joe Green
Edison Group
jgreen@edisongroup.com

OpGen, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
             
   
March 31, 2019
    
December 31, 2018
  
Assets
            
Current assets
            
Cash and cash equivalents
  
$
6,011,508
    
$
4,572,487
  
Accounts receivable, net
    
813,260
      
373,858
  
Inventory, net
    
498,852
      
543,747
  
Prepaid expenses and other current assets
    
162,178
      
292,918
  
Total current assets
    
7,485,798
      
5,783,010
  
Property and equipment, net 
    
248,167
      
1,221,827
  
Finance lease right-of-use assets, net
    
961,418
      
—
  
Operating lease right-of-use assets
    
1,546,155
      
—
  
Goodwill
    
600,814
      
600,814
  
Intangible assets, net
    
1,018,412
      
1,085,366
  
Other noncurrent assets
    
230,310
      
259,346
  
Total assets
  
$
12,091,074
    
$
8,950,363
  
Liabilities and Stockholders’ Equity
                
Current liabilities
                
Accounts payable
  
$
1,528,814
    
$
1,623,751
  
Accrued compensation and benefits
    
1,223,083
      
1,041,573
  
Accrued liabilities
    
950,156
      
902,019
  
Deferred revenue
    
9,993
      
15,824
  
Short-term notes payable
    
347,778
      
398,595
  
Short-term finance lease liabilities
    
492,300
      
399,345
  
Short-term operating lease liabilities
    
930,887
      
—
  
Total current liabilities
    
5,483,011
      
4,381,107
  
Deferred rent
    
—
      
162,919
  
Note payable
    
494,285
      
660,340
  
Warrant liability
    
—
      
67
  
Long-term finance lease liabilities
    
452,089
      
437,189
  
Long-term operating lease liabilities
    
1,322,696
      
—
  
Total liabilities
    
7,752,081
      
5,641,622
  
Commitments
                
Stockholders' equity
                
Common stock, $0.01 par value; 50,000,000 shares authorized; 17,645,720 and
   8,645,720 shares issued and outstanding at March 31, 2019 and
   December 31, 2018, respectively
    
176,457
      
86,457
  
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and
   outstanding at March 31, 2019 and December 31, 2018, respectively
    
—
      
—
  
Additional paid-in capital
    
170,104,444
      
165,313,902
  
Accumulated other comprehensive loss
    
(10,267
)
    
(13,093
)
Accumulated deficit
    
(165,931,641
)
    
(162,078,525
)
Total stockholders’ equity
    
4,338,993
      
3,308,741
  
Total liabilities and stockholders’ equity
  
$
12,091,074
    
$
8,950,363
  



OpGen, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)


             
   
Three Months Ended March 31,
  
   
2019
    
2018
  
Revenue
            
Product sales
  
$
520,177
    
$
633,496
  
Laboratory services
    
—
      
8,690
  
Collaboration revenue
    
500,000
      
204,040
  
Total revenue
    
1,020,177
      
846,226
  
Operating expenses
                
Cost of products sold
    
220,702
      
342,832
  
Cost of services
    
144,482
      
168,553
  
Research and development
    
1,776,382
      
1,230,429
  
General and administrative
    
1,747,585
      
1,790,522
  
Sales and marketing
    
372,233
      
329,773
  
Impairment of right-of-use asset
    
520,759
      
—
  
Total operating expenses
    
4,782,143
      
3,862,109
  
Operating loss
    
(3,761,966
)
    
(3,015,883
)
Other (expense) income
                
Other (expense) income
    
(24,422
)
    
5,298
  
Interest expense
    
(56,444
)
    
(57,846
)
Foreign currency transaction (losses) gains
    
(10,351
)
    
12,181
  
Change in fair value of derivative financial instruments
    
67
      
8,166
  
Total other expense
    
(91,150
)
    
(32,201
)
Loss before income taxes
    
(3,853,116
)
    
(3,048,084
)
Provision for income taxes
    
—
      
—
  
Net loss
    
(3,853,116
)
    
(3,048,084
)
Net loss available to common stockholders
  
$
(3,853,116
)
  
$
(3,048,084
)
Net loss per common share - basic and diluted
  
$
(0.41
)
  
$
(0.75
)
Weighted average shares outstanding - basic and diluted
    
9,345,720
      
4,055,715
  
Net loss
  
$
(3,853,116
)
  
$
(3,048,084
)
Other comprehensive gain (loss) - foreign currency translations
    
2,826
      
(12,579
)
Comprehensive loss
  
$
(3,850,290
)
  
$
(3,060,663
)