• OpGen takes strategic steps to develop the Unyvero platform and product pipeline, to give attention to the pending Acuitas AMR Gene Panel (isolates) FDA clearance and expects to take a position considerably in bioinformatics
  • OpGen subsidiary Ares Genetics obtained notification of train of possibility to barter for a possible future license by its IVD Accomplice
  • OpGen has discontinued Acuitas AMR Gene Panel (urine) medical trial and will discontinue FISH product line globally by mid-2021
  • Whole Income for Q3 2020 was roughly $1.1 million {dollars}
  • Maintained sturdy stability sheet with $10.5 million money as of September 30, 2020

Convention name to be held at 4:30 p.m. Japanese Time right this moment

GAITHERSBURG, Md., Nov. 11, 2020 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision drugs firm harnessing the facility of molecular diagnostics and bioinformatics to assist fight infectious illness, reported right this moment its monetary and working outcomes for the three and 9 months ended September 30, 2020 and supplied a enterprise replace. Whole OpGen income for the third quarter of 2020 was roughly $1.1 million, up from $0.6 million within the third quarter of 2019. The monetary outcomes for the three months ended September 30, 2020 mirror the consummation of our enterprise mixture with Curetis GmbH on April 1, 2020. OpGen’s money as of September 30, 2020 was roughly $10.5 million. The corporate has entry to an extra $6.4 million beneath its expanded ATM program and has 594,000 warrants excellent at a median train worth of $2.16. As well as, the Firm continues to have entry to an extra €5.0 million tranche of non-dilutive debt financing for COVID-19 associated R&D packages from the European Funding Financial institution.

As beforehand reported, OpGen introduced particulars relating to a strategic reprioritization of its product portfolio, platform pipeline and priorities going ahead. This reprioritization was based mostly on suggestions from in depth market analysis, a buyer survey of 150 stakeholders within the resolution making on new diagnostic platforms, and key-opinion-leader interviews carried out by an unbiased market analysis agency over the previous two quarters. Following a overview of this analysis, OpGen and its board determined to consolidate the corporate’s product portfolio on its proprietary Unyvero platform and distinctive bioinformatics capabilities. Because of this variation in precedence, the corporate anticipates the next key impacts:

  • Product portfolio going ahead is centered round fast, molecular diagnostic platform choices and elevated give attention to worth added bioinformatics options, together with Ares Genetics’ subsequent technology sequencing-based and synthetic intelligence powered AMR and AST prediction capabilities.
  • Following the profitable completion of the three phases of the partnered R&D program as introduced within the throughout our second quarter 2020 earnings name, Ares Genetics has just lately obtained formal notification from its undisclosed international main IVD company associate that they’ve exercised their choice to solely negotiate with Ares Genetics the scope and phrases of a possible unique license or different association with Ares to Ares Genetics’ know-how within the subject of human medical diagnostics within the coming months.
  • Platform consolidation to appreciate important operational synergies and price financial savings over time as fewer merchandise and platforms would should be maintained from a regulatory, high quality administration and logistics and repair standpoint.
  • Unyvero platform and product portfolio to be expanded past decrease respiratory tract infections corresponding to pneumonia (LRT / LRT BAL) to incorporate sophisticated urinary tract infections (cUTI) and invasive joint infections (IJI) within the U.S. with medical trials for future FDA submission and clearance anticipated to start out in 2021. Related merchandise in each medical indication areas utilizing the identical pattern varieties have already been efficiently developed and CE-IVD marked and are commercially out there in Europe and different markets.
  • Current notification from the FDA has indicated that the company plans to proceed prioritizing emergency use authorization (EUA) requests for diagnostic merchandise supposed to deal with the COVID-19 pandemic for at the least the rest of the yr, which can affect the statutory overview intervals for ongoing submissions. Throughout this time, the FDA plans to supply month-to-month updates relating to the continued affect of such prioritization of EUAs on our Acuitas AMR Gene Panel for Isolates submission. Regardless of such affect, OpGen has remained in open and ongoing dialogue with the FDA relating to the standing of the Acuitas AMR Gene Panel for Isolates submission since our October 2020 formal response to the FDA’s Further Data (AI) requests. If the Acuitas AMR Gene Panel for Isolates is cleared by the FDA, OpGen anticipates swift business launch within the U.S. within the following months.
  • Legacy FISH merchandise enterprise together with Fast FISH® and PNA FISH® to be discontinued by mid-2021 in Europe, the U.S. and remainder of world with final manufacturing tons to be manufactured in early 2021. All clients within the U.S. and distributors in Europe have been knowledgeable of the discontinuation and OpGen expects final stocking orders to return in by year-end with a number of orders already obtained.
  • Acuitas AMR Gene Panel (urine) medical trial has been discontinued and all medical trial websites have been notified as focus shifts to Unyvero platform for sophisticated UTI indication in addition to further future functions.

Oliver Schacht, President and CEO of OpGen commented, “Reprioritization efforts together with the consolidation of our product portfolio highlights our give attention to fast, molecular diagnostic choices and bioinformatics as we glance to 2021 and past. Moreover, the discontinuation of the Acuitas AMR Gene Panel (urine) medical trial and the Legacy FISH merchandise enterprise will lead to important operational synergies and price financial savings for OpGen. We consider this shift will create significant, long run shareholder worth for our traders, companions and healthcare gives alike as we proceed to ascertain ourselves as business leaders in molecular diagnostics and bioinformatics house.”

Third Quarter and 9 Month 2020 Financial Outcomes

  • Whole income for the third quarter of 2020 was roughly $1.1 million, up from $0.6 million within the third quarter of 2019. Whole income for the 9 months ended September 30, 2020 was $2.9 million, in contrast with $2.7 million for the 9 months ended September 30, 2019;
  • Working bills for the third quarter of 2020 have been $7.2 million, in contrast with $4.1 million within the third quarter of 2019. Working bills for the 9 months ended September 30, 2020 have been $19.6 million, in contrast with $12.4 million for the 9 months ended September 30, 2019;
  • The online loss for the third quarter of 2020 was $7.7 million or $0.40 per share, in contrast with $3.5 million or $3.95 per share within the third quarter of 2019. The online loss for the 9 months ended September 30, 2020 was $19.1 million or $1.36 per share, in contrast with a internet lack of $9.9 million or $13.32 per share for the 9 months ended September 30, 2019; and
  • Money and money equivalents have been $10.5 million as of September 30, 2020.

The corporate additionally introduced accomplishment of the next key milestones within the third quarter of 2020 and yr up to now:

  • OpGen’s subsidiary Curetis GmbH obtained CE mark certification within the European Union for its personal SARS-CoV-2 Equipment with PULB for the detection of SARS-CoV-2, the virus that causes COVID-19.
  • OpGen introduced that subsidiary Ares Genetics GmbH gained the Austrian nationwide digitization award and was additionally nominated for the 40th Austrian Innovation Award for its synthetic intelligence powered, next-generation sequencing based mostly molecular antibiotic susceptibility take a look at marketed beneath the model identify ARESupa – Common Pathogenome Assay.
  • OpGen’s subsidiary Curetis GmbH was awarded EUR 350 thousand in non-dilutive grant funding in a collaboration mission with InfectoGnostics campus at Jena College Hospital.
  • OpGen introduced the award of a German Federal Authorities grant to its subsidiary, Curetis GmbH, and collaborators Carpegen GmbH and the Clinic for Small Animal Inner Medication of the LMU Ludwig-Maximilians College to collaborate on a mission targeted on journey associated and enteric illnesses in small animals.
  • OpGen’s subsidiary Ares Genetics GmbH in collaboration with researchers from the Johns Hopkins College College of Medication, introduced the publishing of a peer-reviewed examine on modifiable danger components for the emergence of ceftolozane-tazobactam resistance in P. aeruginosa within the journal Scientific Infectious Illnesses.
  • OpGen introduced the discharge of a brand new peer-reviewed publication that demonstrates the medical utility of the Unyvero LRT panel and its potential affect on antibiotic use in hospitalized sufferers with suspected pneumonia in comparison with therapy directed based mostly on microbiological tradition outcomes.
  • OpGen efficiently accomplished its examine collaboration with Karolinska Institutet on bacterial co-infections in COVID-19 pneumonia sufferers and knowledge on the Unyvero HPN Panel was introduced by the Karolinska investigators at ECCVID 2020.
  • OpGen considerably improved its working capital place within the third quarter of 2020 by means of the sale of roughly 1.8 million shares of widespread inventory beneath the corporate’s ATM program and the train of warrants from the October 2019 financing for gross proceeds of $4.3 million throughout the third quarter. Through the 9 months ended September 30, 2020, the Firm bought roughly 11.4 million shares of widespread inventory beneath the corporate’s ATM program and upon train of warrants from the October 2019 providing for gross proceeds of $24.4 million.
  • The German Federal Ministry for Financial Affairs and Power (BMWi) concluded its investigation of the OpGen enterprise mixture with Curetis close to its affect on the general public order and safety of the Federal Republic of Germany in addition to nationwide healthcare pursuits within the gentle of the present COVID-19 pandemic. No additional motion is predicted from the Federal authorities on this matter.

Mr. Schacht commented, “I’m happy with our third quarter monetary outcomes and am inspired by the thrilling enterprise updates that have been issued this quarter together with the CE mark certification for our SARS-CoV-2 Equipment, notable awards and grants, peer-reviewed publications and the submission of our formal response letter to the FDA, which upon continued optimistic interactions with the FDA, makes us consider there ought to be a near-term clearance resolution as soon as the COVID-19 associated FDA delays permit the company to reply. Along with the enterprise and pipeline progress achieved this quarter, we’re excited to supply additional particulars about our reprioritization technique geared toward creating each near-term and long-term development potential for the corporate. As we wrap up 2020 OpGen is in a powerful place to attain pipeline and development targets within the years forward and I stay up for the corporate’s continued successes.”

Convention Name Data

OpGen’s administration will host a convention name right this moment, November 11 at 4:30 p.m. ET to debate the third quarter monetary outcomes and different enterprise actions, in addition to reply questions. Dial-in data is under:

Dial-in Data
U.S. Dial-in Quantity: +1 (877) 705 6003
Worldwide Dial-in Quantity: +1 (201) 493 6725
Webcast: http://public.viavid.com/index.php?id=142176
Convention ID: 13712431

Following the conclusion of the convention name, a replay shall be out there by means of November 25, 2020. The reside, listen-only webcast of the convention name can also be accessed by visiting the Traders part of the Firm’s web site at www.opgen.com. A replay of the webcast shall be out there following the conclusion of the decision and shall be archived on the Firm’s web site for 90 days. Replay entry data is under:

Replay Data
U.S. Dial-in Quantity: +1 (844) 512 2921
Worldwide Dial-in Quantity: +1 (412) 317 6671
Replay PIN: 13712431

About OpGen, Inc.

OpGen, Inc. (Gaithersburg, MD, USA) is a precision drugs firm harnessing the facility of molecular diagnostics and bioinformatics to assist fight infectious illness. Together with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we’re creating and commercializing molecular microbiology options serving to to information clinicians with extra fast and actionable details about life threatening infections to enhance affected person outcomes, and reduce the unfold of infections attributable to multidrug-resistant microorganisms, or MDROs. OpGen’s product portfolio contains Unyvero, Acuitas AMR Gene Panel and Acuitas® Lighthouse, and the ARES Expertise Platform together with ARESdb, utilizing NGS know-how and AI-powered bioinformatics options for antibiotic response prediction.

For extra data, please go to www.opgen.com.

Ahead-Wanting Statements

This press launch contains statements relating to OpGen’s third quarter 2020 outcomes, the corporate’s strategic portfolio and product pipeline priorities, the continued integration of OpGen with its acquired subsidiaries, Curetis GmbH and Ares Genetics GmbH, and the affect of COVID-19 on the corporate and common market circumstances. These statements and different statements relating to OpGen’s future plans and objectives represent “forward-looking statements” throughout the that means of Part 27A of the Securities Act of 1933 and Part 21E of the Securities Trade Act of 1934 and are supposed to qualify for the secure harbor from legal responsibility established by the Personal Securities Litigation Reform Act of 1995. Such statements are topic to dangers and uncertainties which are typically troublesome to foretell, are past our management, and which can trigger outcomes to vary materially from expectations. Components that would trigger our outcomes to vary materially from these described embody, however usually are not restricted to, our capacity to efficiently, well timed and cost-effectively develop, search and procure regulatory clearance for and commercialize our product and companies choices, the speed of adoption of our services by hospitals and different healthcare suppliers, the belief of anticipated advantages of our enterprise mixture transaction with Curetis GmbH, the success of our commercialization efforts, the affect of COVID-19 on the Firm’s operations, monetary outcomes, and commercialization efforts in addition to on capital markets and common financial circumstances, the impact on our enterprise of present and new regulatory necessities, and different financial and aggressive components. For a dialogue of probably the most important dangers and uncertainties related to OpGen’s enterprise, please overview our filings with the Securities and Trade Fee. You might be cautioned to not place undue reliance on these forward-looking statements, that are based mostly on our expectations as of the date of this press launch and communicate solely as of the date of this press launch. We undertake no obligation to publicly replace or revise any forward-looking assertion, whether or not because of new data, future occasions or in any other case.

OpGen:
Oliver Schacht
President and CEO
InvestorRelations@opgen.com

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

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

OpGen, Inc.
Consolidated Steadiness Sheets
(unaudited)
       
  September 30, 2020   December 31, 2019
Property      
Present belongings      
Money and money equivalents $ 10,488,072     $ 2,708,223  
Accounts receivable, internet   423,432       567,811  
Stock, internet   2,975,060       473,030  
Word receivable         2,521,479  
Pay as you go bills and different present belongings   1,072,364       396,760  
Whole present belongings   14,958,928       6,667,303  
Property and gear, internet   3,370,847       130,759  
Finance lease right-of-use belongings, internet   571,329       958,590  
Working lease right-of-use belongings   1,373,418       1,043,537  
Goodwill   8,057,894       600,814  
Intangible belongings, internet   16,071,680       817,550  
Different noncurrent belongings   300,744       203,271  
Whole belongings $ 44,704,840     $ 10,421,824  
Liabilities and Stockholders’ Fairness      
Present liabilities      
Accounts payable $ 1,240,351     $ 1,056,035  
Accrued compensation and advantages   2,003,002       855,994  
Accrued liabilities   2,664,581       1,046,661  
Deferred income   51,622       9,808  
Brief-term notes payable   1,156,517       373,599  
Brief-term finance lease liabilities   348,000       579,030  
Brief-term working lease liabilities   1,142,435       1,017,414  
Whole present liabilities   8,606,508       4,938,541  
Word payable   18,159,433       329,456  
Deriviative liabilities   74,239        
Lengthy-term finance lease liabilities   76,701       313,263  
Lengthy-term working lease liabilities   554,295       547,225  
Different long run liabilites   154,716        
Whole liabilities   27,625,892       6,128,485  
Commitments      
Stockholders’ fairness      
Most well-liked inventory, $0.01 par worth; 10,000,000 shares licensed; none issued and excellent at September 30, 2020 and December 31, 2019, respectively          
Frequent inventory, $0.01 par worth; 50,000,000 shares licensed; 19,799,348 and 5,582,280 shares issued and excellent at September 30, 2020 and December 31, 2019, respectively   197,993       55,823  
Further paid-in capital   208,892,463       178,779,814  
Collected deficit   (193,625,510 )     (174,524,983 )
Collected different complete earnings/(loss)   1,614,002       (17,315 )
Whole stockholders’ fairness   17,078,948       4,293,339  
Whole liabilities and stockholders’ fairness $ 44,704,840     $ 10,421,824  
       
OpGen, Inc.
Consolidated Statements of Operations and Complete Loss
(unaudited)
               
  Three Months Ended September 30,   9 Months Ended September 30,
  2020   2019   2020   2019
Income              
Product gross sales $ 601,562     $ 573,035     $ 1,569,799     $ 1,597,505  
Laboratory companies   112,892       185       138,884     $ 5,435  
Collaboration income   342,311       75,000       1,153,400       1,075,000  
Whole income   1,056,765       648,220       2,862,083       2,677,940  
Working bills              
Price of merchandise bought   1,350,296       262,373       2,340,766       681,568  
Price of companies   159,794       196,184       550,115       592,647  
Analysis and improvement   2,433,553       1,139,369       6,630,134       4,069,335  
Normal and administrative   2,356,413       1,560,706       6,549,432       4,901,136  
Gross sales and advertising and marketing   932,671       376,955       2,258,980       1,142,755  
Transaction prices         538,061       470,322       538,061  
Impairment of intangible belongings               750,596        
Impairment of right-of-use asset                     520,759  
Whole working bills   7,232,727       4,073,648       19,550,345       12,446,261  
Working loss   (6,175,962 )     (3,425,428 )     (16,688,262 )     (9,768,321 )
Different (expense) earnings              
Curiosity and different earnings/(expense)   19,965       1,043       101,644       (8,213 )
Curiosity expense   (1,183,927 )     (49,099 )     (2,267,085 )     (142,672 )
Overseas foreign money transaction losses   (501,168 )     (8,954 )     (794,832 )     (9,426 )
Change in truthful worth of spinoff monetary devices   165,497             548,008       67  
Whole different expense   (1,499,633 )     (57,010 )     (2,412,265 )     (160,244 )
Loss earlier than earnings taxes   (7,675,595 )     (3,482,438 )     (19,100,527 )     (9,928,565 )
Provision for earnings taxes                      
Web loss $ (7,675,595 )   $ (3,482,438 )   $ (19,100,527 )   $ (9,928,565 )
               
Web loss per widespread share – fundamental and diluted $ (0.40 )   $ (3.95 )   $ (1.36 )   $ (13.32 )
Weighted common shares excellent – fundamental and diluted   19,116,864       882,280       14,016,896       745,471  
Web loss $ (7,675,595 )   $ (3,482,438 )   $ (19,100,527 )   $ (9,928,565 )
Different complete earnings – overseas foreign money translation   1,266,901       7,298       1,631,317       5,174  
Complete loss $ (6,408,694 )   $ (3,475,140 )   $ (17,469,210 )   $ (9,923,391 )



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