View Filing Data

1,167

Issuance of units, net of offering costs (in shares)

$ 2,272

$ 3,808,836

$ 2,272

$ 3,806,564

$ 3,808,836

3,806,564

$ 8,823,242

$ 3,808,836

227,216

1,000,000

227,216

1,000,000

227,216

$ 60

$ (60)

(60)

6,025

Legal settlement in common stock

911,398

$ 911,398

$ 158

109,841

109,999

Legal settlement in common stock (in shares)

15,843

Vendor payment in common stock

$ 29

23,216

23,245

Vendor payment in common stock (in shares)

2,898

(32,076)

(15,419,308)

$ 22,653

^[1]

150,114,671

(25,900)

(148,710,427)

1,400,997

2,265,320

^[1]

Issuance of units, net of offering costs (in shares)

$ 151,000,000

^[1]

1,071,989,000,000

$ 1,072,140,000,000

^[1]

150,962

$ 3

^[1]

(3)

^[1]

270

Stock/Share cancellation (in shares)

238,190

^[1]

(2)

(12,579)

(3,048,084)

$ 2,646

^[1]

161,094,268

(38,479)

(151,758,511)

9,299,924

^[1]

264,496

$ 22,653

^[1]

150,114,671

(25,900)

(148,710,427)

1,400,997

2,265,320

^[1]

(9,635,722)

$ 3,214

^[1]

162,391,324

(18,838)

(158,346,149)

4,029,551

^[1]

321,274

$ 22,653

^[1]

150,114,671

(25,900)

(148,710,427)

$ 1,400,997

2,265,320

^[1]

Issuance of units, net of offering costs (in shares)

$ 3,182

$ 597,743

$ 3,182

$ 594,561

$ 597,743

594,561

$ 13,530,401

$ 597,743

318,236

15,912

318,236

5,912,307

318,236

5,912,307

318,236

$ 57

$ (57)

(57)

5,650

862,281

$ 862,281

Interest settlement in common stock (in shares)

$ 1,442

271,168

272,610

144,238

Stock/Share cancellation (in shares)

(31)

12,807

(13,368,098)

$ 86,457

^[1]

165,313,902

(13,093)

(162,078,525)

3,308,741

8,645,720

^[1]

$ 2,646

^[1]

161,094,268

(38,479)

(151,758,511)

9,299,924

^[1]

264,496

Issuance of units, net of offering costs (in shares)

$ 33,700,000

^[1]

$ 5,200,000

^[1]

639,400,000

19,226,800,000

$ 673,100,000

$ 19,232,000,000

^[1]

33,654

5,202

213,890

18,113

Balance (in shares) at Jun. 30, 2018

(3,332,213)

Balance at Jun. 30, 2018

$ 3,035

^[1]

161,506,820

(20,366)

(155,090,724)

6,398,765

^[1]

303,352

Issuance of units, net of offering costs (in shares)

$ 10,700,000

^[1]

40,531,600,000

$ 40,542,300,000

^[1]

10,710

206,651

Interest settlement in common stock (in shares)

$ 72

^[1]

272,537

272,609

^[1]

7,212

1,528

(3,255,425)

$ 3,214

^[1]

162,391,324

(18,838)

(158,346,149)

4,029,551

^[1]

321,274

$ 86,457

^[1]

165,313,902

(13,093)

(162,078,525)

3,308,741

8,645,720

^[1]

Issuance of units, net of offering costs (in shares)

$ 450,000,000

^[1]

477,800,900,000

$ 478,250,900,000

^[1]

450,000

98,033

2,826

(3,853,116)

$ 8,823

^[1]

170,272,078

(10,267)

(165,931,641)

4,338,993

^[1]

882,286

$ 86,457

^[1]

$ 165,313,902

165,313,902

(13,093)

(162,078,525)

3,308,741

8,645,720

^[1]

(9,928,565)

(1,556,970)

$ 8,823

^[1]

$ 170,272,078

$ (10,267)

$ (165,931,641)

4,338,993

^[1]

882,286

(2,593,011)

Balance at Jun. 30, 2019

1,827,003

(3,482,438)

Organization, Consolidation and Presentation of Financial Statements [Abstract]

$ (1,556,970)

[1]	Reflects the 1 for 20 reverse stock split that became effective on August 29, 2019. Refer to Note 8 Stockholders equity for further information.

Stockholders' Equity - Summary of Status of Options Granted (Details) - USD ($)	3 Months Ended		6 Months Ended	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Jun. 30, 2019	Jun. 30, 2019	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Stockholders' Equity Note [Abstract]
Number of Options, Outstanding Balance	210,834		211,559	211,559	139,395	119,106
Number of Options, Granted	0	0	0	0	95,800	58,324
Number of Options, Exercised					0	(1,167)
Number of Options, Forfeited	(107)	(720)	(720)	(143)	(18,812)	(24,538)
Number of Options, Expired	(499)	0	(5)	(499)	(4,824)	(12,330)
Number of Options, Outstanding Balance	9,936	210,834	210,834	9,936	211,559	139,395	119,106
Number of Options, Vested and expected to vest					211,559
Number of Options, Exercisable					10,445
Weighted Average Exercise Price, Outstanding Balance			$ 20.58	$ 20.58	$ 31.16	$ 44.00
Weighted Average Exercise Price, Granted					3.84	17.58
Weighted Average Exercise Price, Exercised					0	7.01
Weighted Average Exercise Price, Forfeited					11.98	36.31
Weighted Average Exercise Price, Expired					56.12	83.49
Weighted Average Exercise Price, Outstanding Balance					20.58	$ 31.16	$ 44.00
Weighted Average Exercise Price, Vested and expected to vest					20.58
Weighted Average Exercise Price, Exercisable					$ 1.25
Weighted-Average Remaining Contractual Life, Outstanding (in years)					7 years 7 months 6 days	8 years 3 months 18 days	8 years 7 months 6 days
Weighted-Average Remaining Contractual Life, Vested and expected to vest (in years)					7 years 7 months 6 days
Weighted-Average Remaining Contractual Life, Exercisable (in years)					5 years 3 months 18 days
Aggregate Intrinsic Value, Outstanding			$ 52,200	$ 52,200	$ 3,733,900	$ 66,329,800
Aggregate Intrinsic Value, Exercised					0	1,125,600
Aggregate Intrinsic Value, Outstanding					52,200	$ 3,733,900	$ 66,329,800
Aggregate Intrinsic Value, Vested and expected to vest					52,200
Aggregate Intrinsic Value, Exercisable					$ 52,200

Organization

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Organization

Note 1 – Organization

OpGen, Inc. (“OpGen” or the “Company”) was incorporated in Delaware in 2001. References in this report to the “Company” include OpGen and its wholly-owned subsidiaries. The Company’s headquarters and its principal operations are in Gaithersburg, Maryland. The Company also has operations in Copenhagen, Denmark, and Bogota, Colombia. The Company operates in one business segment.

OpGen is a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. The Company is 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. Its proprietary DNA tests and informatics address the rising threat of antibiotic resistance by helping physicians and other healthcare providers optimize care decisions for patients with acute infections.

The Company’s molecular diagnostics and informatics products, product candidates and services combine its Acuitas molecular diagnostics and Acuitas Lighthouse informatics platform for use with its proprietary, curated MDRO knowledgebase. The Company is working to deliver products and services, some in development, to a global network of customers and partners.

•

The Company’s Acuitas molecular diagnostic tests provide rapid microbial identification and antibiotic resistance gene information. These products include its Acuitas antimicrobial resistance, or AMR, Gene Panel Urine test in development for patients at risk for complicated urinary tract infection, or cUTI, and its Acuitas AMR Gene Panel test for use with bacterial isolates in development for testing bacterial isolates, and its QuickFISH and PNA FISH FDA-cleared and CE-marked diagnostics used to rapidly detect pathogens in positive blood cultures. Each of the Acuitas AMR Gene Panel tests is available for sale for research use only, or RUO and is not for use in diagnostic procedures.

•

The Company’s Acuitas Lighthouse informatics systems are cloud-based HIPAA compliant informatics offerings that combine clinical lab test results with patient and hospital information to provide analytics and actionable insights to help manage MDROs in the hospital and patient care environment. Components of the informatics systems include the Acuitas Lighthouse Knowledgebase and the Acuitas Lighthouse Software. The Acuitas Lighthouse Knowledgebase is a relational database management system and a proprietary data warehouse of genomic data matched with antibiotic susceptibility information for bacterial pathogens. The Acuitas Lighthouse Software system includes the Acuitas Lighthouse Portal, a suite of web applications and dashboards, the Acuitas Lighthouse Prediction Engine, which is a data analysis software, and other supporting software components. The Acuitas Lighthouse Software can be customized and made specific to a healthcare facility or collaborator, such as a pharmaceutical company. The Acuitas Lighthouse Software is not distributed commercially for antibiotic resistance prediction and is not for use in diagnostic procedures.

The Company’s operations are subject to certain risks and uncertainties. The risks include the risk that the Company will not receive 510(k) clearance for its Acuitas AMR Gene Panel test for use with bacterial isolates on a timely basis, or at all, the timing and ultimate success of future 510(k) clearance submissions for additional Acuitas AMR Gene Panel tests and Acuitas Lighthouse Software, rapid technology changes, the need to retain key personnel, the need to protect intellectual property and the need to raise additional capital financing on terms acceptable to the Company. The Company’s success depends, in part, on its ability to develop, obtain regulatory approval for and commercialize its proprietary technology as well as raise additional capital.

Implementation Agreement with Curetis N.V.

As announced on September 4, 2019, OpGen has entered into an Implementation Agreement with Curetis N.V., a Dutch publicly-listed company on Euronext under ticker CURE, or the Implementation Agreement. Under the Implementation Agreement, OpGen has agreed to purchase, through Crystal GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany and a wholly-owned subsidiary of OpGen, all of the outstanding shares and acquire all of the related business assets of Curetis GmbH, or Curetis, a private limited liability company organized under the laws of the Federal Republic of Germany and a wholly-owned subsidiary of Curetis N.V., to create a combined business within OpGen, which we refer to as “Newco” herein.

Pursuant to the Implementation Agreement, we have agreed to acquire (i) all of the issued and outstanding capital stock of Curetis, or the Transferred Shares, and (ii) all of the assets of Curetis N.V. that are solely and exclusively related to the business of Curetis, or the Transferred Assets. The Company has also agreed to assume (1) the Curetis N.V. 2016 Stock Option Plan, as amended, or the 2016 Stock Option Plan, and the outstanding awards thereunder, (2) the obligation to issue equity to the holders of awards under the Curetis AG Phantom Stock Option Incentive Plan of 2010, as amended, or the PSOP, and (3) the outstanding indebtedness of Curetis N.V. under certain convertible notes, or the Curetis Convertible Notes, including providing for conversion of such notes into shares of the Company’s common stock. We will also assume all of the liabilities of Curetis N.V. that are solely and exclusively related to the business being acquired.

Under the Implementation Agreement, the Company has agreed to issue, as the sole consideration, 2,662,564 shares of common stock, less the number of shares of common stock the issuance of which shall be reserved by the Company in connection with (a) its assumption of the 2016 Stock Option Plan, (b) any future issuance of shares of common stock under the PSOP, and (c) shares of common stock reserved for future issuance upon the conversion, if any, of the Curetis Convertible Notes, or together, the Consideration. The number of shares of common stock to be reserved for the deductions described above are based on a conversion ratio of 0.0959, which is the ratio of the Consideration as contrasted with the number of ordinary shares of Curetis N.V. on a fully diluted basis. The number of shares of OpGen common stock to be issued to Curetis N.V. is fixed, therefore, the percentage ownership of the Company owned by Curetis will not be known until the closing occurs.

On November 12, 2019 the Company filed a Registration Statement on Form S-4 to register the Consideration. The transactions under the Implementation Agreement are subject to approval by the stockholders of the Company and the shareholders and debt holders of Curetis N.V and Curetis GmbH. The Company plans to call a special meeting of its stockholders as soon as practicable and deliver a proxy statement to its stockholders in advance of such special meeting.

The Implementation Agreement contains customary representations and warranties of the parties and the parties have agreed to use their commercially reasonable efforts to take all actions necessary to consummate the closing of the transactions contemplated by the Implementation Agreement. Pursuant to the Implementation Agreement, the Company committed to raise at least $10,000,000 of gross interim equity financing to support the continuing operations of both the Company and the Curetis Group, and to lend funds to the Curetis Group following such offering (See Note 13 – Subsequent Events).

Note 1 - Organization

OpGen, Inc. (“OpGen” or the “Company”) was incorporated in Delaware in 2001. References in this report to the “Company” include OpGen and its wholly-owned subsidiaries. The Company’s headquarters are in Gaithersburg, Maryland, and its principal operations are in Gaithersburg, Maryland. The Company also has operations in Woburn, Massachusetts, Copenhagen, Denmark, and Bogota, Colombia. The Company operates in one business segment.

OpGen, Inc. is a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. The Company is 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. Its proprietary DNA tests and informatics address the rising threat of antibiotic resistance by helping physicians and other healthcare providers optimize care decisions for patients with acute infections.

•

The Company’s Acuitas molecular diagnostic tests provide rapid microbial identification and antibiotic resistance gene information. These products include its Acuitas antimicrobial resistance, or AMR, Gene Panel (Urine) test in development for patients at risk for complicated urinary tract infection, or cUTI, and its Acuitas AMR Gene Panel (Isolates) test in development for testing bacterial isolates, and its QuickFISH and PNA FISH FDA-cleared and CE-marked diagnostics used to rapidly detect pathogens in positive blood cultures. Each of the Acuitas AMR Gene Panel tests is available for sale for research use only, or RUO.

•

The Company’s operations are subject to certain risks and uncertainties. The risks include the risk that the Company will not receive 510(k) clearance for its Acuitas AMR Gene Panel tests and Acuitas Lighthouse Software on a timely basis, or at all, rapid technology changes, the need to retain key personnel, the need to protect intellectual property and the need to raise additional capital financing on terms acceptable to the Company. The Company’s success depends, in part, on its ability to develop, obtain regulatory approval for and commercialize its proprietary technology as well as raise additional capital.

License Agreements, Research Collaborations and Development Agreements - Additional Information (Details)	1 Months Ended	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2017 USD ($)	Sep. 30, 2019 USD ($) Agreement	Sep. 30, 2018 USD ($)	Sep. 30, 2019 USD ($) Agreement	Sep. 30, 2018 USD ($)	Dec. 31, 2018 USD ($)	Dec. 31, 2017 USD ($) Segment
Revenue from contract		$ 648,220	$ 552,221	$ 2,677,940	$ 2,187,348	$ 294,630,700,000	$ 321,100,700,000
Royalty expense		62,500	62,500	187,500	187,500	25,000,000,000	25,718,600,000
Annual future minimum royalty payments due		250,000		250,000		25,000,000,000
New York State Department Of Health And I L U M Health Solutions L L C [Member]
Collaboration revenue receivable over 12 months of the project		1,600,000		$ 1,600,000
Contractual agreement period				15 months
Collaborations Revenue [Member]
Revenue from contract		75,000	0	$ 1,075,000	359,316	51,601,600,000	39,717,800,000
Collaborations Revenue [Member] \| New York State Department Of Health And I L U M Health Solutions L L C [Member]
Revenue from contract		75,000		1,100,000
Product [Member]
Revenue from contract		573,035	539,856	1,597,505	1,805,877	239,562,600,000	277,186,900,000
Laboratory Service Revenue [Member]
Revenue from contract		$ 185	$ 12,365	$ 5,435	$ 22,155	$ 3,466,500,000	$ 4,196,000,000
F I S H Product Line [Member]
Number of license agreements		1		1			1
Centers For Disease Control And Prevention
Number of contract awarded year	1 year
Centers For Disease Control And Prevention \| Cloud Based Mobile Software
Contract awarded value for funds development and evaluation of software	$ 86,000,000,000

Stockholders' Equity (Deficit) - Additional Information (Details 1) - USD ($)

3 Months Ended

6 Months Ended

9 Months Ended

12 Months Ended

28 Months Ended

Mar. 29, 2019

Oct. 22, 2018

Apr. 19, 2018

Feb. 06, 2018

Sep. 13, 2016

Sep. 30, 2019

Jun. 30, 2019

Mar. 31, 2019

Sep. 30, 2018

Jun. 30, 2018

Mar. 31, 2018

Jun. 30, 2019

Jun. 30, 2018

Sep. 30, 2019

Sep. 30, 2018

Dec. 31, 2018

Dec. 31, 2017

Dec. 31, 2018

Jan. 17, 2018

Jan. 16, 2018

Dec. 31, 2016

Common stock, shares authorized

50,000,000

200,000,000

Common stock, shares issued

882,268

17,645,720

882,268

432,286

2,265,320

432,286

Common stock, shares outstanding

882,268

17,645,720

882,268

432,286

2,265,320

432,286

Preferred stock, shares authorized

10,000,000

Preferred stock, shares issued

Preferred stock, shares outstanding

Proceeds from issuance of common stock, net of issuance costs

$ 478,250,900,000

$ 19,232,000,000

$ 4,782,509

$ 597,743

$ 3,808,836

Net proceeds from sale of common stock and warrants

$ 1,072,813,100,000

$ 10,728,132

$ 13,530,401

$ 8,754,882

Stock-based compensation, tax benefit from compensation expense

$ 0

Stock options, granted

95,800

58,324

Stock options, granted, weighted average exercise price

$ 3.84

$ 17.58

Stock options, forfeited

107

720

143

18,812

24,538

Stock options, outstanding

9,936

210,834

9,936

211,559

139,395

211,559

119,106

Stock options, expired

499

4,824

12,330

Share-based compensation arrangement by share-based payment award, equity instruments other than options, grants in period

11,175

Share-based compensation arrangement by share-based payment award, equity instruments other than options, vested in period

5,650

6,025

Share-based compensation arrangement by share-based payment award, equity instruments other than options, forfeited in period

Share-based compensation arrangement by share-based payment award, equity instruments other than options, non-vested, outstanding

250

5,900

250

750

Two Thousand Fifteen Plan [Member]

Share-based compensation arrangement by share-based payment award, number of shares authorized

2,710

54,200

2,710

Share-based compensation arrangement by share-based payment award, description

the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors.

Share-based compensation arrangement by share-based payment award, number of shares available for grant

3,827

84,412

3,827

Share-based compensation arrangement by share-based payment award, common stock percentage

4.00%

Restricted Stock Units R S U [Member]

Share-based compensation arrangement by share-based payment award, equity instruments other than options, grants in period

313,000

17,150

Share-based compensation arrangement by share-based payment award, equity instruments other than options, vested in period

Share-based compensation arrangement by share-based payment award, equity instruments other than options, forfeited in period

500

Share-based compensation arrangement by share-based payment award, equity instruments other than options, non-vested, outstanding

16,663

313,250

16,663

$ 115

$ 40,542,300,000

$ 19,232,000,000

$ 597,743

$ 3,808,836

At The Market Offering [Member] | Sales Agreement [Member] | Cowen And Company Limited Liability Company [Member]

318,236

227,216

690,247

Aggregate gross proceeds from issuance of common stock

$ 9,400,000

$ 11,500,000

11,500,000

$ 597,743

$ 3,808,836

Proceeds from issuance of common stock, net of issuance costs

318,236

227,216

690,247

$ 600,000

At The Market Offering [Member] | Maximum [Member] | Sales Agreement [Member] | Cowen And Company Limited Liability Company [Member]

600,000

Aggregate gross proceeds from issuance of common stock

$ 2,500,000,000,000

2,500,000,000,000

115

$ 597,743

$ 3,808,836

February Two Thousand Eighteen Public Offering [Member]

318,236

227,216

690,247

2,841,152

Gross proceeds from sale of common stock and warrants

$ 3.25

$ 120,000,000,000

Net proceeds from sale of common stock and warrants

$ 10,700,000

Class of warrant or right, number of securities called by each warrant or right

Each unit included one share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share.

Each unit included one twentieth of a share of common stock and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one twentieth of a share of common stock for an exercise price of $0.20 per share, and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share.

0.025

Class of warrant or right, exercise price of warrants or rights

$ 65.00

February Two Thousand Eighteen Public Offering [Member] | Placement Agent [Member]

5 years

Class of warrant or right, exercise price of warrants or rights

$ 81.25

5 years

$ 478,250,900,000

673,100,000

$ 1,072,140,000,000

$ 13,530,401

$ 8,823,242

5,912,307

1,000,000

$ 3,182

$ 2,272

Common Stock [Member] | October Two Thousand Eighteen Public Offering [Member]

318,236

227,216

690,247

$ 3,182

$ 2,272

Proceeds from issuance of common stock, net of issuance costs

111,000

318,236

227,216

690,247

$ 2,800,000

$ 3,200,000

Common Stock [Member] | At The Market Offering [Member]

$ 29.00

115

$ 10,700,000

^[1]

$ 5,200,000

^[1]

$ 597,743

$ 3,808,836

Common Stock [Member] | At The Market Offering [Member] | Sales Agreement [Member] | Cowen And Company Limited Liability Company [Member]

10,710

^[1]

5,202

^[1]

318,236

227,216

690,247

Common Stock [Member] | March Two Thousand Nineteen Public Offering [Member]

15,912

690,247

Proceeds from issuance of common stock, net of issuance costs

450,000

$ 4,800,000

$ 5,400,000

Common Stock [Member] | February Two Thousand Eighteen Public Offering [Member] | Placement Agent [Member]

$ 12.00

9,231

$ 450,000,000

^[1]

$ 33,700,000

^[1]

$ 151,000,000

^[1]

$ 3,182

$ 2,272

Prefunded Units [Member] | February Two Thousand Eighteen Public Offering [Member]

450,000

^[1]

33,654

^[1]

150,962

^[1]

318,236

227,216

690,247

851,155

$ 3.24

Additional Paid In Capital [Member] | At The Market Offering [Member]

$ 594,561

$ 3,806,564

$ 115

$ 40,531,600,000

$ 19,226,800,000

$ 597,743

$ 3,808,836

Additional Paid In Capital [Member] | Public Placement [Member]

318,236

227,216

690,247

$ 477,800,900,000

$ 639,400,000

$ 1,071,989,000,000

$ 594,561

$ 3,806,564

Pre Funded Warrant [Member] | February Two Thousand Eighteen Public Offering [Member]

5,912,307

1,000,000

Class of warrant or right, exercise price of warrants or rights

$ 0.20

Stockholders' Equity Note [Abstract]

851,155

[1]	Reflects the 1 for 20 reverse stock split that became effective on August 29, 2019. Refer to Note 8 Stockholders equity for further information.

Stockholders' equity (deficit)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Stockholders' equity

Note 8 – Stockholders’ equity (deficit)

As of September 30, 2019, the Company has 50,000,000 authorized shares of common stock and 882,268 shares issued and outstanding, and 10,000,000 authorized shares of preferred stock, of which none were issued or outstanding.

In September 2016, the Company entered into the Sales Agreement with Cowen pursuant to which the Company could offer and sell from time to time, up to an aggregate of $25 million of shares of its common stock through Cowen, as sales agent, with initial sales limited to an aggregate of $11.5 million. During the year ended December 31, 2018, the Company sold 15,912 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $0.6 million, and gross proceeds of $0.6 million. In connection with the October 2018 Public Offering, the Company terminated the at the market offering.

In the February 2018 Public Offering, the Company issued 2,841,152 units at $3.25 per unit, and 851,155 pre-funded units at $3.24 per pre-funded unit, raising gross proceeds of approximately $12 million and net proceeds of approximately $10.7 million. Each unit included one twentieth of a share of common stock and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one twentieth of a share of common stock for an exercise price of $0.20 per share, and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. The common warrants were exercisable immediately and have a five-year term from the date of issuance. The 851,155 pre-funded warrants issued in the February 2018 Public Offering were exercised during the year ended December 31, 2018.

In connection with the February 2018 Public Offering, the Company issued to its placement agent warrants to purchase 9,231 shares of common stock. The warrants issued to the placement agent have an exercise price of $81.25 per share and are exercisable for five years.

On October 22, 2018, the Company closed the October 2018 Public Offering of 111,000 shares of its common stock at a public offering price of $29.00 per share. The offering raised gross proceeds of approximately $3.2 million and net proceeds of approximately $2.8 million.

On March 29, 2019, the Company closed the March 2019 Public Offering of 450,000 shares of its common stock at a public offering price of $12.00 per share. The offering raised gross proceeds of $5.4 million and net proceeds of approximately $4.8 million.

Following receipt of approval from stockholders at a special meeting of stockholders held on August 22, 2019, the Company filed an amendment to its Amended and Restated Certificate of Incorporation to affect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty shares. All share amounts and per share prices in this Quarterly Report have been adjusted to reflect the reverse stock split.

Stock options

In 2008, the Company adopted the 2008 Stock Option and Restricted Stock Plan (the “2008 Plan”), pursuant to which the Company’s Board of Directors could grant either incentive or non-qualified stock options or shares of restricted stock to directors, key employees, consultants and advisors.

In April 2015, the Company adopted, and the Company’s stockholders approved, the 2015 Equity Incentive Plan (the “2015 Plan”); the 2015 Plan became effective upon the execution and delivery of the underwriting agreement for the Company’s initial public offering in May 2015. Following the effectiveness of the 2015 Plan, no further grants will be made under the 2008 Plan. The 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of the Code to employees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides for the grants of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors and consultants.

Under the 2015 Plan, the aggregate number of shares of the common stock authorized for issuance may not exceed (1) 2,710 plus (2) the sum of the number of shares subject to outstanding awards under the 2008 Plan as of the 2015 Plan’s effective date, that are subsequently forfeited or terminated for any reason before being exercised or settled, plus (3) the number of shares subject to vesting restrictions under the 2008 Plan as of the 2015 Plan’s effective date that are subsequently forfeited. In addition, the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. Shares subject to awards granted under the 2015 Plan that are forfeited or terminated before being exercised or settled or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2015 Plan. However, shares that have actually been issued shall not again become available unless forfeited. As of September 30, 2019, 3,827 shares remain available for issuance under the 2015 Plan, which includes 17,291 shares automatically added to the 2015 Plan on January 1, 2019.

For the three and nine months ended September 30, 2019 and 2018, the Company recognized stock-based compensation expense as follows:

	Three Months Ended September 30,					Nine Months Ended September 30,
	2019		2018			2019		2018
Cost of services	$	584	$	(2,807	)	$	1,146	$	924
Research and development		20,175		56,961			55,635		187,512
General and administrative		65,318		141,974			202,696		434,314
Sales and marketing		5,090		10,523			15,694		35,981
	$	91,167	$	206,651		$	275,171	$	658,731

No income tax benefit for stock-based compensation arrangements was recognized in the condensed consolidated statements of operations and comprehensive loss due to the Company’s net loss position.

The Company did not grant any stock options during the three months ended September 30, 2019. During the three months ended September 30, 2019, 107 options were forfeited and 499 options expired. The Company did not grant any stock options during the nine months ended September 30, 2019. During the nine months ended September 30, 2019, 143 options were forfeited and 499 options expired. The Company had total stock options to acquire 9,936 shares of common stock outstanding at September 30, 2019.

Restricted stock units

During the nine months ended September 30, 2019, 17,150 restricted stock units were granted, no restricted stock units vested and 500 restricted stock units were forfeited. The Company had 16,663 total restricted stock units outstanding at September 30, 2019.

Stock purchase warrants

At September 30, 2019 and December 31, 2018, the following warrants to purchase shares of common stock were outstanding:

				Outstanding at
Issuance	Exercise Price		Expiration	September 30, 2019 (1)		December 31, 2018 (1)
November 2009	$	3,955.00	November 2019		17		17
January 2010	$	3,955.00	January 2020		17		17
March 2010	$	3,955.00	March 2020		7		7
November 2011	$	3,955.00	November 2021		15		15
December 2011	$	3,955.00	December 2021		2		2
March 2012	$	54,950.00	March 2019		—		8
February 2015	$	3,300.00	February 2025		451		451
May 2015	$	3,300.00	May 2020		6,555		6,555
May 2016	$	656.00	May 2021		9,483		9,483
June 2016	$	656.00	May 2021		4,102		4,102
June 2017	$	390.00	June 2022		938		938
July 2017	$	345.00	July 2022		318		318
July 2017	$	250.00	July 2022		2,501		2,501
July 2017	$	212.60	July 2022		50,006		50,006
February 2018	$	81.20	February 2023		9,232		9,232
February 2018	$	65.00	February 2023		92,338		92,338
					175,982		175,990

The warrants listed above were issued in connection with various debt, equity or development contract agreements.

(1)

Warrants to purchase fractional shares of common stock resulting from the reverse stock split on August 29, 2019 were rounded up to the next whole share of common stock on a holder by holder basis.

Note 7 - Stockholders’ Equity

As of December 31, 2018, the Company has 50,000,000 shares of authorized common shares and 8,645,720 shares issued and outstanding, and 10,000,000 of authorized preferred shares, of which none were issued or outstanding.

In September 2016, the Company entered into the Sales Agreement with Cowen pursuant to which the Company may offer and sell from time to time, up to an aggregate of $25 million of shares of its common stock through Cowen, as sales agent, with initial sales limited to an aggregate of $11.5 million. Pursuant to the Sales Agreement, Cowen may sell the shares of common stock by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act, including, without limitation, sales made by means of ordinary brokers’ transactions on The Nasdaq Capital Market or otherwise at market prices prevailing at the time of sale, in block transactions, or as otherwise directed by the Company. The Company pays Cowen compensation equal to 3.0% of the gross proceeds from the sales of common stock pursuant to the terms of the Sales Agreement. As of December 31, 2018, the Company has sold an aggregate of 690,247 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $8.8 million, and gross proceeds of $9.4 million. During the year ended December 31, 2018, the Company sold 318,236 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $0.6 million, and gross proceeds of $0.6 million. In connection with the October 2018 Public Offering, the Company terminated the at the market offering.

In the July 2017 Public Offering, the Company issued 18,164,195 units at $0.40 per unit, and 6,835,805 pre-funded units at $0.39 per pre-funded unit, raising gross proceeds of approximately $10 million and net proceeds of approximately $8.8 million. jVen Capital was one of the investors participating in the offering. Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. At closing, the outstanding Bridge Financing Notes issued to jVen Capital, were repaid in the principal amount of $1 million plus accrued interest of $6,438. All pre-funded warrants issued in the July 2017 Public Offering were exercised during the year ended December 31, 2017.

In connection with the July 2017 Public Offering, the Company issued to its placement agent warrants to purchase 50,000 shares of common stock. The warrants issued to the Placement Agent have an exercise price of $12.50 per share and are exercisable for five years.

In September 2017, the Company issued 15,843 shares of its common stock with an aggregate value of $110,000 to settle a dispute related to pre-Merger AdvanDx activities. In October 2017, the Company issued 2,898 shares of its common stock with an aggregate value of $23,245 to a vendor in exchange for consulting services.

Following receipt of approval from stockholders at a special meeting of stockholders held on January 17, 2018, the Company filed an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty-five shares, and to reduce the authorized shares of common stock from 200,000,000 to 50,000,000 shares. All share amounts and per share prices in this Annual Report have been adjusted to reflect the reverse stock split.

In the February 2018 Public Offering, the Company issued 2,841,152 units at $3.25 per unit, and 851,155 pre-funded units at $3.24 per pre-funded unit, raising gross proceeds of approximately $12 million and net proceeds of approximately $10.7 million. Each unit included one share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. All 851,155 pre-funded warrants issued in the February 2018 Public Offering were exercised during the year ended December 31, 2018.

In connection with the February 2018 Public Offering, the Company issued to its placement agent warrants to purchase 184,615 shares of common stock. The warrants issued to the Placement Agent have an exercise price of $4.0625 per share and are exercisable for five years.

On October 22, 2018, the Company closed the October 2018 Public Offering of 2,220,000 shares of its common stock at a public offering price of $1.45 per share. The offering raised gross proceeds of approximately $3.2 million and net proceeds of approximately $2.8 million.

Stock options

In 2008, the Board adopted, and the stockholders approved, the 2008 Stock Option and Restricted Stock Plan (the “2008 Plan”), pursuant to which the Company’s Board of Directors may grant either incentive or non-qualified stock options or shares of restricted stock to directors, key employees, consultants and advisors.

In April 2015, the Board adopted, and the Company’s stockholders approved, the 2015 Equity Incentive Plan (the “2015 Plan”); the 2015 Plan became effective upon the execution and delivery of the underwriting agreement for the Company’s IPO. Following the effectiveness of the 2015 Plan, no further grants have been made under the 2008 Plan. The 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of the Code to employees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides for the grants of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors and consultants.

Under the 2015 Plan, the aggregate number of shares of the common stock authorized for issuance may not exceed (1) 54,200 plus (2) the sum of the number of shares subject to outstanding awards under the 2008 Plan as of the 2015 Plan’s effective date, that are subsequently forfeited or terminated for any reason before being exercised or settled, plus (3) the number of shares subject to vesting restrictions under the 2008 Plan as of the 2015 Plan’s effective date that are subsequently forfeited. In addition, the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. Shares subject to awards granted under the 2015 Plan that are forfeited or terminated before being exercised or settled, or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2015 Plan. However, shares that have actually been issued shall not again become available unless forfeited. As of December 31, 2018, 50,863 shares remain available for issuance under the 2015 Plan.

For the years ended December 31, 2018 and 2017, the Company recognized stock compensation expense as follows:

	Year Ended December 31,
	2018		2017
Cost of services	$	964	$	13,776
Research and development		241,122		237,103
General and administrative		574,244		603,787
Sales and marketing		45,951		56,732
	$	862,281	$	911,398

No income tax benefit for stock-based compensation arrangements was recognized in the consolidated statements of operations due to the Company’s net loss position.

As of December 31, 2018, the Company had unrecognized expense related to its stock options of $0.5 million, which will be recognized over a weighted average period of 7.6 years.

A summary of the status of options granted is presented below as of and for the years ended December 31, 2018 and 2017:

	Number of Options			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Life (in years)		Aggregate Intrinsic Value
Outstanding at January 1, 2017		119,106		$	44.00		8.6	$	663,298
Granted		58,324		$	17.58
Exercised		(1,167	)	$	7.01			$	11,256
Forfeited		(24,538	)	$	36.31
Expired		(12,330	)	$	83.49
Outstanding at December 31, 2017		139,395		$	31.16		8.3	$	37,339
Granted		95,800		$	3.84
Exercised		—			—
Forfeited		(18,812	)	$	11.98
Expired		(4,824	)	$	56.12
Outstanding at December 31, 2018		211,559		$	20.58		7.6	$	522
Vested and expected to vest		211,559		$	20.58		7.6	$	522
Exercisable at December 31, 2018		10,445		$	1.25		5.3	$	522

The total fair value of options vested in the years ended December 31, 2018 and 2017 was $930,921 and $2,086,843, respectively. The fair value of each option grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below:

	Year Ended December 31,
	2018		2017
Annual dividend		—		—
Expected life (in years)	5.25 - 6.25		5.25 - 6.25
Risk free interest rate	2.5 - 2.9%		1.8 - 2.3%
Expected volatility	46.0 - 49.6%		44.2 - 53.0%

Restricted stock units

A summary of the status of restricted stock units granted is presented below as of and for the years ended December 31, 2018 and 2017:

	Number of Options			Weighted- Average Grant Date Fair Value
Unvested at January 1, 2017		750		$	42.50
Granted		11,175		$	6.93
Vested		(6,025	)	$	8.01
Forfeited		—			—
Unvested at December 31, 2017		5,900		$	31.16
Granted		—			—
Vested		(5,650	)	$	8.93
Forfeited		—			—
Unvested at December 31, 2018		250		$	42.50

As of December 31, 2018, there was approximately $9,000 of unrecognized compensation cost related to restricted stock units, which is expected to be recognized over a weighted average period of 0.92 years.

Stock purchase warrants

At December 31, 2018 and 2017, the following warrants to purchase shares of common stock were outstanding:

				Outstanding at December 31,
Issuance	Exercise Price		Expiration	2018 (1)		2017 (1)
March 2008	$	19,763.50	March 2018		—		2
November 2009	$	197.75	November 2019		270		270
January 2010	$	197.75	January 2020		270		270
March 2010	$	197.75	March 2020		55		55
November 2011	$	197.75	November 2021		212		212
December 2011	$	197.75	December 2021		27		27
March 2012	$	2,747.50	March 2019		165		165
February 2015	$	165.00	February 2025		9,001		9,001
May 2015	$	165.00	May 2020		138,310		138,310
May 2016	$	32.81	May 2021		189,577		189,577
June 2016	$	32.81	May 2021		82,035		82,035
June 2017	$	19.50	June 2022		18,754		18,754
July 2017	$	17.25	July 2022		6,350		6,350
July 2017	$	12.50	July 2022		50,000		50,000
July 2017	$	10.625	July 2022		1,000,003		1,000,003
February 2018	$	4.06	February 2023		184,615		—
February 2018	$	3.25	February 2023		1,846,153		—
					3,525,797		1,495,031

The warrants listed above were issued in connection with various equity, debt, preferred stock or development contract agreements.

(1)	Warrants to purchase fractional shares of common stock resulting from the reverse stock split on January 17, 2018 were rounded up to the next whole share of common stock on a holder by holder basis.

Leases - Schedule of Supplemental Cash Flow Information (Details) - USD ($)	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Cash used in operating activities
Operating leases	$ 655,963
Finance leases	60,482
Cash used in financing activities
Finance leases	389,501	$ 177,092
ROU assets obtained in exchange for lease obligations
Finance leases	$ 592,014

Stockholders' Equity - Schedule of Fair Value of Option Grant Estimated Using Black-Scholes Option Pricing Model (Details)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Annual dividend	0.00%	0.00%
Risk free interest rate, minimum	2.50%	1.80%
Risk free interest rate, maximum	2.90%	2.30%
Expected volatility, minimum	46.00%	44.20%
Expected volatility, maximum	49.60%	53.00%
Maximum [Member]
Expected life (in years)	6 years 3 months	6 years 3 months
Minimum [Member]
Expected life (in years)	5 years 3 months	5 years 3 months

Subsequent Events - Additional Information (Details) - USD ($)

1 Months Ended

3 Months Ended

6 Months Ended

9 Months Ended

12 Months Ended

28 Months Ended

Oct. 28, 2019

Mar. 29, 2019

Oct. 22, 2018

Feb. 06, 2018

Jul. 31, 2015

Mar. 31, 2019

^[1]

Sep. 30, 2018

^[1]

Jun. 30, 2018

^[1]

Mar. 31, 2018

^[1]

Jun. 30, 2019

Jun. 30, 2018

Sep. 30, 2019

Sep. 30, 2018

Dec. 31, 2018

Dec. 31, 2017

Dec. 31, 2018

Nov. 12, 2019

Jun. 28, 2017

Net proceeds from sale of common stock and warrants

$ 0

$ 1,072,813,100,000

$ 0

$ 10,728,132

$ 13,530,401

$ 8,754,882

M G H I F Financing Agreement [Member]

45,454

Amended And Restated M G H I F Financing Agreement [Member]

$ 110.00

Subsequent Event [Member] | Interim Facility Agreement [Member] | Curetis Gmb H [Member]

13,120

Maximum committed capital lending capacity

$ 4,000,000

Subsequent Event [Member] | Interim Facility Agreement [Member] | Curetis Gmb H [Member] | Minimum [Member]

Closing condition to raise maximum capital

$ 10,000,000

October Two Thousand Nineteen Public Offering [Member] | Subsequent Event [Member]

318,236

227,216

690,247

2,590,170

Gross proceeds from sale of common stock and warrants

$ 2.00

$ 9,400,000

Net proceeds from sale of common stock and warrants

$ 8,300,000

October Two Thousand Nineteen Public Offering [Member] | Prefunded Units [Member] | Subsequent Event [Member]

2,109,830

Over Allotment Option [Member] | Common Stock [Member] | Subsequent Event [Member]

$ 1.99

Period option granted to underwriters to purchase additional shares

30 days

Additional shares issued

705,000

October Two Thousand Eighteen Public Offering [Member] | Common Stock [Member]

705,000

111,000

318,236

227,216

690,247

March Two Thousand Nineteen Public Offering [Member] | Common Stock [Member]

$ 29.00

450,000

February Two Thousand Eighteen Public Offering [Member]

$ 12.00

2,841,152

Gross proceeds from sale of common stock and warrants

$ 3.25

$ 120,000,000,000

Net proceeds from sale of common stock and warrants

$ 10,700,000

February Two Thousand Eighteen Public Offering [Member] | Prefunded Units [Member]

851,155

$ 3.24

Public Placement [Member] | Common Stock [Member]

5,912,307

1,000,000

450,000

33,654

150,962

318,236

227,216

690,247

At The Market Offering [Member] | Common Stock [Member]

318,236

227,216

690,247

Revenue from Contract with Customer [Abstract]

10,710

5,202

318,236

227,216

690,247

[1]	Reflects the 1 for 20 reverse stock split that became effective on August 29, 2019. Refer to Note 8 Stockholders equity for further information.

Revenue from Contracts with Customers (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Schedule of Revenues by Type of Service

The Company provides diagnostic test products, laboratory services to hospitals, clinical laboratories and other healthcare provider customers, and enters into collaboration agreements with government agencies and healthcare providers. The revenues by type of service consist of the following:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2019		2018		2019		2018
Product sales	$	573,035	$	539,856	$	1,597,505	$	1,805,877
Laboratory services		185		12,365		5,435		22,155
Collaboration revenue		75,000		—		1,075,000		359,316
Total revenue	$	648,220	$	552,221	$	2,677,940	$	2,187,348

	December 31,
	2018		2017
Product sales	$	2,395,626	$	2,771,869
Laboratory services		34,665		41,960
Collaboration revenue		516,016		397,178
Total revenue	$	2,946,307	$	3,211,007

Summary of Changes in Deferred Revenue

Changes in deferred revenue for the period were as follows:

Balance at December 31, 2018	$	15,824
Revenue recognized in the current period from the amounts in the beginning balance		(6,016	)
New deferrals, net of amounts recognized in the current period		—
Balance at September 30, 2019	$	9,808

Changes in deferred revenue for the period were as follows:

Balance at December 31, 2017	$	24,442
Revenue recognized in the current period from the amounts in the beginning balance		(14,450	)
New deferrals, net of amounts recognized in the current period		5,832
Balance at December 31, 2018	$	15,824

Fair value measurements - Additional Information (Details) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018
Assets transferred between fair value measurement levels			$ 0
Fair Value Measurements Nonrecurring [Member]
Financial assets measured at fair value	$ 0		0		$ 0
Financial liabilities measured at fair value	0		0		0
Impairment of non-financial assets and liabilities at fair value	0	$ 0	0	$ 0	0
Fair Value Measurements Recurring [Member]
Non-financial assets measured at fair value	0		0		0
Non-financial liabilities measured at fair value	$ 0		$ 0		$ 0

Leases - Schedule of Future Minimum Lease Payments (Details)	Dec. 31, 2018 USD ($)
Leases [Abstract]
2019	$ 1,615,679
2020	1,534,204
2021	639,829
2022	40,080
Total	$ 3,829,792

Summary of Significant Accounting Policies (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Accounting Policies [Abstract]

Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the statements of cash flows:

	September 30, 2019		December 31, 2018		September 30, 2018		December 31, 2017
Cash and cash equivalents	$	626,420	$	4,572,487	$	4,735,506	$	1,847,171
Restricted cash		185,380		164,720		185,380		243,380
Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows	$	811,800	$	4,737,207	$	4,920,886	$	2,090,551

	December 31, 2018		December 31, 2017		December 31, 2016
Cash and cash equivalents	$	4,572,487	$	1,847,171	$	4,117,324
Restricted cash		164,720		243,380		243,380
Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows	$	4,737,207	$	2,090,551	$	4,360,704

Schedule of Inventories

Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following:

	September 30, 2019		December 31, 2018
Raw materials and supplies	$	292,271	$	368,438
Work-in-process		14,676		58,402
Finished goods		161,427		116,907
Total	$	468,374	$	543,747

Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following:

	December 31,
	2018		2017
Raw materials and supplies	$	368,438	$	360,134
Work-in process		58,402		51,233
Finished goods		116,907		122,058
Total	$	543,747	$	533,425

Schedule of Finite-Lived Intangible Assets

Finite-lived intangible assets include trademarks, developed technology and customer relationships and consisted of the following as of September 30, 2019 and December 31, 2018

			September 30, 2019					December 31, 2018
	Cost		Accumulated Amortization			Net Balance		Accumulated Amortization			Net Balance
Trademarks and trade names	$	461,000	$	(194,361	)	$	266,639	$	(159,783	)	$	301,217
Developed technology		458,000		(275,814	)		182,186		(226,746	)		231,254
Customer relationships		1,094,000		(658,321	)		435,679		(541,105	)		552,895
	$	2,013,000	$	(1,128,496	)	$	884,504	$	(927,634	)	$	1,085,366

Finite-lived intangible assets include trademarks, developed technology and customer relationships, and consisted of the following as of December 31, 2018 and 2017:

			December 31, 2018					December 31, 2017
	Cost		Accumulated Amortization			Net Balance		Accumulated Amortization			Net Balance
Trademarks and tradenames	$	461,000	$	(159,783	)	$	301,217	$	(113,679	)	$	347,321
Developed technology		458,000		(226,746	)		231,254		(161,322	)		296,678
Customer relationships		1,094,000		(541,105	)		552,895		(384,817	)		709,183
	$	2,013,000	$	(927,634	)	$	1,085,366	$	(659,818	)	$	1,353,182

Schedule of Expected Amortization of Intangible Assets

Expected amortization of intangible assets for each of the next five fiscal years is as follows.

Year Ending December 31,
2019	$	267,816
2020		267,816
2021		267,816
2022		165,117
2023		46,104
Thereafter		70,697
Total	$	1,085,366

Property, Plant and Equipment

Property and equipment consisted of the following at December 31, 2018 and 2017:

	December 31,
	2018			2017
Laboratory and manufacturing equipment	$	4,829,323		$	4,109,367
Office furniture and equipment		700,299			700,299
Computers and network equipment		1,520,713			1,505,651
Leasehold improvements		745,800			729,504
		7,796,135			7,044,821
Less accumulated depreciation		(6,574,308	)		(6,209,284	)
Property and equipment, net	$	1,221,827		$	835,537

Stockholders' Equity (Deficit) - Company Recognized Stock-Based Compensation Expense (Details) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Dec. 31, 2017
Allocated share-based compensation expense	$ 91,167	$ 206,651	$ 275,171	$ 658,731	$ 862,281	$ 911,398
General And Administrative Expense [Member]
Allocated share-based compensation expense	65,318	141,974	202,696	434,314	574,244	603,787
Cost Of Sales [Member]
Allocated share-based compensation expense	584	(2,807)	1,146	924	964	13,776
Selling And Marketing Expense [Member]
Allocated share-based compensation expense	5,090	10,523	15,694	35,981	45,951	56,732
Research And Development Expense [Member]
Allocated share-based compensation expense	$ 20,175	$ 56,961	$ 55,635	$ 187,512	$ 241,122	$ 237,103

Income Taxes - Additional Information (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Deferred tax assets, net of valuation allowance, total		$ 52,348,036	$ 49,251,408
Deferred tax assets, valuation allowance		$ 52,348,036	$ 49,251,408
Maximum percentage of taxable income in which NOLs permitted to deduct		80.00%
U.S. federal corporate tax rate		21.00%	34.00%
Toll tax liability			$ 0
Reduction of deferred tax assets			$ 146
Maximum [Member]
U.S. federal corporate tax rate			35.00%
Domestic Country [Member]
Operating loss carryforwards		$ 178,163,456	$ 165,981,195
Operating loss carryforwards incurred prior to 2018, expiration terms	begin to expire in 2022	begin to expire in 2022

Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Income Tax Disclosure [Abstract]
NOL carryforward	$ 49,480,731	$ 46,326,407
R&E credit carryforward	2,559,479	2,559,479
Share-based compensation	329,796	345,088
Inventory reserve	19,068	45,338
Depreciation	0	71,756
Interest expense	51,152	0
Accruals and other	284,662	247,093
Total deferred tax assets	52,724,888	49,595,161
Valuation allowance	(52,348,036)	(49,251,408)
Deferred tax liabilities:
Intangible assets	(256,011)	(343,753)
Depreciation	(120,841)	0
Net	$ 0	$ 0

Debt - Additional Information (Details)	3 Months Ended		9 Months Ended		12 Months Ended
Debt - Additional Information (Details)	Sep. 30, 2019 USD ($)	Sep. 30, 2018 USD ($)	Sep. 30, 2019 USD ($)	Sep. 30, 2018 USD ($)	Dec. 31, 2018 USD ($) Product	Dec. 31, 2017 USD ($)
Short-term debt	$ 508,292		$ 508,292		$ 398,595	$ 1,010,961
Interest expense, debt	49,099	$ 28,074	142,672	$ 140,453	191,195	233,505
M G H I F Financing Agreement [Member]
Short-term debt	333,000		333,000		333,000	10
Long-term debt, outstanding	329,000		329,000		660,000
Notes Payable Other Payables [Member]
Short-term debt	175,000		175,000		$ 65,000	$ 56,000
Bridge Financing Notes
Number of notes \| Product					3
Number of notes drew down \| Product					2
Due In Two Thousand Twenty [Member]
Debt instrument, annual principal payment	333,000		333,000		$ 333
Due In Two Thousand Twenty One [Member]
Debt instrument, annual principal payment	$ 333,000		$ 333,000		333,000
Due In Two Thousand Nineteen [Member]
Debt instrument, annual principal payment					$ 333

Leases - Schedule of Maturities of Lease Liabilities (Details)	Sep. 30, 2019 USD ($)
Operating
2019	$ 279,055
2020	1,128,294
2021	536,819
2022	40,080
Total lease payments	1,984,248
Less: Interest	(183,614)
Present value of lease liabilities	1,800,634
Finance
2019	180,753
2020	633,130
2021	270,043
2022	41,961
2023	3,364
Thereafter	280
Total lease payments	1,129,531
Less: Interest	(90,808)
Present value of lease liabilities	1,038,723
Total
2019	459,808
2020	1,761,424
2021	806,862
2022	82,041
2023	3,364
Thereafter	280
Total lease payments	3,113,779
Less: Interest	(274,422)
Present value of lease liabilities	$ 2,839,357

Leases

9 Months Ended

Sep. 30, 2019

Leases [Abstract]

Leases

Note 10 – Leases

The following table presents the Company’s ROU assets and lease liabilities as of September 30, 2019:

Lease Classification	September 30, 2019
ROU Assets:
Operating	$	1,214,482
Financing		1,096,472
Total ROU assets	$	2,310,954
Liabilities
Current:
Operating	$	987,833
Finance		627,620
Noncurrent:
Operating		812,801
Finance		411,103
Total lease liabilities	$	2,839,357

Maturities of lease liabilities as of September 30, 2019 by fiscal year are as follows:

Maturity of Lease Liabilities	Operating			Finance			Total
2019	$	279,055		$	180,753		$	459,808
2020		1,128,294			633,130			1,761,424
2021		536,819			270,043			806,862
2022		40,080			41,961			82,041
2023		—			3,364			3,364
Thereafter		—			280			280
Total lease payments		1,984,248			1,129,531			3,113,779
Less: Interest		(183,614	)		(90,808	)		(274,422	)
Present value of lease liabilities	$	1,800,634		$	1,038,723		$	2,839,357

Statement of operations classification of lease costs are as follows:

		September 30, 2019
Lease Cost	Classification	Three months ended		Nine months ended
Operating	Operating expenses	$	216,368	$	655,963
Finance:
Amortization	Operating expenses		124,749		329,438
Interest expense	Other expenses		18,704		60,482
Total lease costs		$	359,821	$	1,045,883

Other Information	Total
Weighted average remaining lease term (in years)
Operating leases		1.9
Finance leases		1.8
Weighted average discount rate:
Operating leases		10.0	%
Finance leases		9.2	%

Supplemental Cash Flow Information	Total
Cash paid for amounts included in the measurement of lease liabilities
Cash used in operating activities
Operating leases	$	655,963
Finance leases	$	60,482
Cash used in financing activities
Finance leases	$	389,501
ROU assets obtained in exchange for lease obligations:
Finance leases	$	592,014

Lease Commitments as of December 31, 2018

Minimum lease payments for future years as of December 31, 2018 were as follows:

Year ending December 31,	Total
2019	$	1,615,679
2020		1,534,204
2021		639,829
2022		40,080
2023 and thereafter		—
Total	$	3,829,792

Stockholders' Equity (Deficit) - Additional Information (Details) - USD ($)

3 Months Ended

6 Months Ended

9 Months Ended

12 Months Ended

28 Months Ended

Mar. 29, 2019

Oct. 22, 2018

Apr. 19, 2018

Feb. 06, 2018

Sep. 13, 2016

Sep. 30, 2019

Jun. 30, 2019

Mar. 31, 2019

Sep. 30, 2018

Jun. 30, 2018

Mar. 31, 2018

Jun. 30, 2019

Jun. 30, 2018

Sep. 30, 2019

Sep. 30, 2018

Dec. 31, 2018

Dec. 31, 2017

Dec. 31, 2018

Jan. 17, 2018

Jan. 16, 2018

Dec. 31, 2016

Common stock, shares authorized

50,000,000

200,000,000

Common stock, shares issued

882,268

17,645,720

882,268

432,286

2,265,320

432,286

Common stock, shares outstanding

882,268

17,645,720

882,268

432,286

2,265,320

432,286

Preferred stock, shares authorized

10,000,000

Preferred stock, shares issued

Preferred stock, shares outstanding

Proceeds from issuance of common stock, net of issuance costs

$ 478,250,900,000

$ 19,232,000,000

$ 4,782,509

$ 597,743

$ 3,808,836

Net proceeds from sale of common stock and warrants

$ 1,072,813,100,000

$ 0

$ 10,728,132

$ 13,530,401

$ 8,754,882

Stock split

on August 22, 2019, the Company filed an amendment to its Amended and Restated Certificate of Incorporation to affect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty shares. All share amounts and per share prices in this Quarterly Report have been adjusted to reflect the reverse stock split.

Stock-based compensation, tax benefit from compensation expense

$ 0

Stock options, granted

95,800

58,324

Stock options, granted, weighted average exercise price

$ 3.84

$ 17.58

Stock options, forfeited

107

720

143

18,812

24,538

Stock options, outstanding

9,936

210,834

9,936

211,559

139,395

211,559

119,106

Stock options, expired

499

4,824

12,330

Share-based compensation arrangement by share-based payment award, equity instruments other than options, grants in period

11,175

Share-based compensation arrangement by share-based payment award, equity instruments other than options, vested in period

5,650

6,025

Share-based compensation arrangement by share-based payment award, equity instruments other than options, forfeited in period

Share-based compensation arrangement by share-based payment award, equity instruments other than options, non-vested, outstanding

250

5,900

250

750

Restricted Stock Units R S U [Member]

Share-based compensation arrangement by share-based payment award, equity instruments other than options, grants in period

313,000

17,150

Share-based compensation arrangement by share-based payment award, equity instruments other than options, vested in period

Share-based compensation arrangement by share-based payment award, equity instruments other than options, forfeited in period

500

Share-based compensation arrangement by share-based payment award, equity instruments other than options, non-vested, outstanding

16,663

313,250

16,663

Two Thousand Fifteen Plan [Member]

Share-based compensation arrangement by share-based payment award, number of shares authorized

2,710

54,200

2,710

Share-based compensation arrangement by share-based payment award, description

Share-based compensation arrangement by share-based payment award, number of shares available for grant

3,827

84,412

3,827

Share-based compensation arrangement by share-based payment award, common stock percentage

4.00%

$ 115

$ 40,542,300,000

$ 19,232,000,000

$ 597,743

$ 3,808,836

At The Market Offering [Member] | Sales Agreement [Member] | Cowen And Company Limited Liability Company [Member]

318,236

227,216

690,247

Aggregate gross proceeds from issuance of common stock

$ 9,400,000

$ 11,500,000

11,500,000

$ 597,743

$ 3,808,836

Proceeds from issuance of common stock, net of issuance costs

318,236

227,216

690,247

$ 600,000

At The Market Offering [Member] | Sales Agreement [Member] | Cowen And Company Limited Liability Company [Member] | Maximum [Member]

600,000

Aggregate gross proceeds from issuance of common stock

$ 2,500,000,000,000

2,500,000,000,000

115

$ 597,743

$ 3,808,836

February Two Thousand Eighteen Public Offering [Member]

318,236

227,216

690,247

2,841,152

Gross proceeds from sale of common stock and warrants

$ 3.25

$ 120,000,000,000

Net proceeds from sale of common stock and warrants

$ 10,700,000

Class of warrant or right, number of securities called by each warrant or right

0.025

Class of warrant or right, exercise price of warrants or rights

$ 65.00

February Two Thousand Eighteen Public Offering [Member] | Placement Agent [Member]

5 years

Class of warrant or right, exercise price of warrants or rights

$ 81.25

5 years

$ 478,250,900,000

673,100,000

$ 1,072,140,000,000

$ 13,530,401

$ 8,823,242

5,912,307

1,000,000

$ 3,182

$ 2,272

Common Stock [Member] | October Two Thousand Eighteen Public Offering [Member]

318,236

227,216

690,247

$ 3,182

$ 2,272

Proceeds from issuance of common stock, net of issuance costs

111,000

318,236

227,216

690,247

$ 2,800,000

$ 3,200,000

Common Stock [Member] | At The Market Offering [Member]

$ 29.00

115

$ 10,700,000

^[1]

$ 5,200,000

^[1]

$ 597,743

$ 3,808,836

Common Stock [Member] | At The Market Offering [Member] | Sales Agreement [Member] | Cowen And Company Limited Liability Company [Member]

10,710

^[1]

5,202

^[1]

318,236

227,216

690,247

Common Stock [Member] | March Two Thousand Nineteen Public Offering [Member]

15,912

690,247

Proceeds from issuance of common stock, net of issuance costs

450,000

$ 4,800,000

$ 5,400,000

Common Stock [Member] | February Two Thousand Eighteen Public Offering [Member] | Placement Agent [Member]

$ 12.00

9,231

$ 450,000,000

^[1]

$ 33,700,000

^[1]

$ 151,000,000

^[1]

$ 3,182

$ 2,272

Prefunded Units [Member] | February Two Thousand Eighteen Public Offering [Member]

450,000

^[1]

33,654

^[1]

150,962

^[1]

318,236

227,216

690,247

851,155

$ 3.24

Additional Paid In Capital [Member] | At The Market Offering [Member]

$ 594,561

$ 3,806,564

$ 115

$ 40,531,600,000

$ 19,226,800,000

$ 597,743

$ 3,808,836

Additional Paid In Capital [Member] | Public Placement [Member]

318,236

227,216

690,247

$ 477,800,900,000

$ 639,400,000

$ 1,071,989,000,000

$ 594,561

$ 3,806,564

Pre Funded Warrant [Member] | February Two Thousand Eighteen Public Offering [Member]

5,912,307

1,000,000

Class of warrant or right, exercise price of warrants or rights

$ 0.20

Proceeds from issuance of common stock, net of issuance costs

851,155

[1]	Reflects the 1 for 20 reverse stock split that became effective on August 29, 2019. Refer to Note 8 Stockholders equity for further information.

Fair value measurements

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Fair Value Disclosures [Abstract]

Fair value measurements

Note 6 – Fair value measurements

The Company classifies its financial instruments using a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include:

•

Level 1 - defined as observable inputs such as quoted prices in active markets;

•

Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and

•

Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions such as expected revenue growth and discount factors applied to cash flow projections.

For the nine months ended September 30, 2019, the Company has not transferred any assets between fair value measurement levels.

Financial assets and liabilities measured at fair value on a recurring basis

The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the hierarchy.

As part of the Company’s bridge financing and amendment to the MGHIF Note, the Company issued stock purchase warrants that the Company considers to be mark-to-market liabilities due to certain put features that allow the holder to put the warrant back to the Company for cash equal to the Black-Scholes value of the warrant upon a change of control or fundamental transaction. The Company determines the fair value of the warrant liabilities using the Black-Scholes option pricing model. Using this model, level 3 unobservable inputs include the estimated volatility of the Company’s common stock, estimated terms of the instruments, and estimated risk-free interest rates.

The following table sets forth a summary of changes in the fair value of level 3 liabilities measured at fair value on a recurring basis for the nine months ended September 30, 2019:

Description

Balance at

December 31,

2018

Change in

Fair Value

Balance at

September 30, 2019

Warrant liability

(67

)

—

Financial assets and liabilities carried at fair value on a non-recurring basis

The Company does not have any financial assets and liabilities measured at fair value on a non-recurring basis.

Non-financial assets and liabilities carried at fair value on a recurring basis

The Company does not have any non-financial assets and liabilities measured at fair value on a recurring basis.

Non-financial assets and liabilities carried at fair value on a non-recurring basis

The Company measures its long-lived assets, including property and equipment and intangible assets (including goodwill), at fair value on a non-recurring basis when they are deemed to be impaired. No such fair value impairment was recognized in the three and nine months ended September 30, 2019 and 2018.

Note 12 - Fair Value Measurements

The Company classifies its financial instruments using a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include:

•

Level 1 - defined as observable inputs such as quoted prices in active markets;

•

Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and

•

Financial assets and liabilities measured at fair value on a recurring basis

The Company originally accounted for the conversion option embedded in the Bridge Financing Notes as a mark-to-market derivative financial instrument. The Company determined the fair value of the embedded conversion option liability using a probability-weighted expected return method. Using this method, level 3 unobservable inputs include the probability of default, the probability of a qualified financing, the probability of conversion, the estimated volatility of the Company’s common stock, estimated terms of the instruments, and estimated risk-free interest rates, among other inputs. The fair value of the conversion option was expensed at the time of repayment of the Bridge Financing Notes.

The following table sets forth a summary of changes in the fair value of level 3 liabilities measured at fair value on a recurring basis for the year ended December 31, 2018:

Description

Balance at

December 31,

2017

Change in

Fair Value

Balance at

December 31,

2018

Warrant liability

8,453

(8,386

)

Financial assets and liabilities carried at fair value on a non-recurring basis

The Company does not have any financial assets and liabilities measured at fair value on a non-recurring basis.

Non-financial assets and liabilities carried at fair value on a recurring basis

The Company does not have any non-financial assets and liabilities measured at fair value on a recurring basis.

Non-financial assets and liabilities carried at fair value on a non-recurring basis

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Subsequent Events

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Subsequent Events [Abstract]

Subsequent Events

Note 13 – Subsequent events

On October 28, 2019, the Company closed the October 2019 Public Offering of 2,590,170 units at $2.00 per unit and 2,109,830 pre-funded units at $1.99 per pre-funded unit. The Company also granted the underwriter a 30-day option to purchase up to an additional 705,000 shares of common stock and/or common warrants to purchase up to 705,000 shares of common stock. The offering raised gross proceeds of approximately $9.4 million and net proceeds of approximately $8.3 million.

On October 31, 2019, the Company filed a Form 8-K to report that, following the October 2019 Public Offering, it believed it had regained compliance with the Nasdaq continuing listing requirement for stockholders’ equity. Nasdaq confirmed the Company’s compliance with all continuing listing requirements in November 2019.

On November 12, 2019, Crystal GmbH, OpGen’s subsidiary, as lender, and Curetis GmbH, as borrower, entered into an Interim Facility Agreement, or the Interim Facility. Under the Interim Facility, the lender shall lend to the Borrower, for the benefit of the Curetis Group, committed capital, up to $4 million, between November 18, 2019 and the closing of the transaction contemplated by the Implementation Agreement. Under the Interim Facility, OpGen and Curetis N.V. have confirmed that the October 2019 Public Offering satisfies the closing condition for OpGen to raise at least $10 million, and that the entry into the Interim Facility satisfies an additional closing condition.

On November 12, 2019, the Company filed a Registration Statement on Form S-4 to register the Consideration to be issued under the Implementation Agreement. Such filing was a requirement to closing the transactions contemplated by the Implementation Agreement.

Debt

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Debt Disclosure [Abstract]

Debt

Note 7 – Debt

As of September 30, 2019, the Company’s outstanding short-term debt consisted of approximately $333,000 due under the MGHIF Note, as well as the financing arrangements for the Company’s insurance with note balances of approximately $175,000 with a final payment scheduled for May 2020. The Company’s outstanding long-term debt as of September 30, 2019 consisted of approximately $329,000 due under the MGHIF Note (see Note 5 “MGHIF financing”). As of December 31, 2018, the Company’s outstanding short-term debt consisted of $333,000 due under the MGHIF Note, net of discounts and financing costs, as well as the financing arrangements for the Company’s insurance with note balances of approximately $65,000. The Company’s outstanding long-term debt as of December 31, 2018 consisted of approximately $660,000 due under the MGHIF Note, net of discounts and financing costs. Total principal payments of approximately $333,000 are due annually in 2020 and 2021.

Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $49,099 and $28,074 for the three months ended September 30, 2019 and 2018, respectively. Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $142,672 and $140,453 for the nine months ended September 30, 2019 and 2018, respectively.

Note 6 - Debt

As of December 31, 2018, the Company’s outstanding short-term debt consisted of approximately $333,000 due under the MGHIF Note, as well as, the financing arrangements for the Company’s insurance with note balances of approximately $65,000 with a final payment scheduled for April 2019. The Company’s outstanding long-term debt as of December 31, 2018 consisted of approximately $660,000 due under the MGHIF Note, net of discounts and financing costs (see Note 5 “MGHIF Financing”). As of December 31, 2017, the Company’s outstanding short-term debt consisted of the $1.0 million MGHIF Note, net of discounts and financing costs, as well as the financing arrangements for the Company’s insurance with note balances of approximately $56,000. The Company did not have any long-term debt as of December 31, 2017. Total principal payments of approximately $333,000 are due annually in 2019, 2020, and 2021.

The Company drew down on two of three Bridge Financing Notes (see discussion in Note 2 "Going Concern and Management’s Plans”) during June and July of 2017. The outstanding Bridge Financing Notes were repaid in full subsequent to the closing of the July 2017 Public Offering.

The Company accounted for the embedded conversion option granted to jVen Capital in the Bridge Financing Notes as a mark-to-market derivative financial instrument carried at fair value. Changes in fair value of the embedded conversion option were reflected in earnings during the period of change. The embedded conversion option was expensed along with the remaining unamortized discount at the date of the Bridge Financing Notes repayment. The warrants issued to jVen Capital and MGHIF are classified as mark-to-market liabilities under ASC 480 due to certain put features that allow the holder to put the warrant back to the Company for cash equal to the Black-Scholes value of the warrant upon a change of control or fundamental transaction.

Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $191,195 and $233,505 for the years ended December 31, 2018 and 2017, respectively.

Stockholders' Equity - Summary of Status of Restricted Stock Unit Granted (Details) - $ / shares	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Stockholders' Equity Note [Abstract]
Number of Options, Outstanding Balance	5,900	750
Number of Options, Granted	0	11,175
Number of Options, Vested	(5,650)	(6,025)
Number of Options, Forfeited	0	0
Number of Options, Outstanding Balance	250	5,900
Weighted Average Grant Date Fair Value, Outstanding Balance	$ 31.16	$ 42.50
Weighted Average Grant Date Fair Value, Granted	0	6.93
Weighted Average Grant Date Fair Value, Vested	8.93	8.01
Weighted Average Grant Date Fair Value, Forfeited	0	0
Weighted Average Grant Date Fair Value, Outstanding Balance	$ 42.50	$ 31.16

Revenue from Contracts with Customers - Schedule of Revenues by Type of Service (Details) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Dec. 31, 2017
Total revenue	$ 648,220	$ 552,221	$ 2,677,940	$ 2,187,348	$ 294,630,700,000	$ 321,100,700,000
Product [Member]
Total revenue	573,035	539,856	1,597,505	1,805,877	239,562,600,000	277,186,900,000
Collaborations Revenue [Member]
Total revenue	75,000	0	1,075,000	359,316	51,601,600,000	39,717,800,000
Laboratory Service Revenue [Member]
Total revenue	$ 185	$ 12,365	$ 5,435	$ 22,155	$ 3,466,500,000	$ 4,196,000,000

Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash Cash Equivalents and Restricted Cash (Details) - USD ($)	Sep. 30, 2019	Dec. 31, 2018	Sep. 30, 2018	Dec. 31, 2017	Dec. 31, 2016
Accounting Policies [Abstract]
Cash and cash equivalents	$ 626,420	$ 4,572,487	$ 4,735,506	$ 1,847,171	$ 4,117,324
Restricted cash	185,380	164,720	185,380	243,380	243,380
Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows	$ 811,800	$ 4,737,207	$ 4,920,886	$ 2,090,551	$ 4,360,704

Revenue from Contracts with Customers - Additional Information (Details) - USD ($)	Sep. 30, 2019	Dec. 31, 2018
Revenue from Contract with Customer [Abstract]
Contract with customers, asset	$ 0	$ 0
Unsatisfied performance obligations related to contracts with customers	$ 500,000	$ 0

Document And Entity Information	9 Months Ended
Document And Entity Information	Sep. 30, 2019
Document And Entity Information
Document Type	S-4/A
Amendment Flag	true
Amendment Description	To update financials
Document Period End Date	Sep. 30, 2019
Entity Registrant Name	OPGEN INC
Entity Central Index Key	0001293818
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false

Liquidity and Management's Plans - Additional Information (Details) - USD ($)

1 Months Ended

3 Months Ended

6 Months Ended

9 Months Ended

12 Months Ended

28 Months Ended

Mar. 29, 2019

Oct. 22, 2018

Jul. 30, 2018

Jul. 14, 2018

Jun. 11, 2018

Apr. 19, 2018

Feb. 06, 2018

Sep. 13, 2016

Jul. 31, 2015

Mar. 31, 2019

Sep. 30, 2018

Jun. 30, 2018

Mar. 31, 2018

Jun. 30, 2019

Jun. 30, 2018

Sep. 30, 2019

Sep. 30, 2018

Dec. 31, 2018

Dec. 31, 2017

Dec. 31, 2018

$ 478,250,900,000

$ 19,232,000,000

$ 4,782,509

$ 597,743

$ 3,808,836

Net proceeds from sale of common stock and warrants

$ 0

$ 1,072,813,100,000

$ 0

$ 10,728,132

$ 13,530,401

$ 8,754,882

M G H I F Financing Agreement [Member]

45,454

Proceeds from issuance of common stock, net of issuance costs

$ 110.00

$ 5,000,000

M G H I F Financing Agreement [Member] | Second Amended And Restated Senior Secured Promissory Note [Member]

$ 1,000,000

$ 1,000,000

Revised and extended maturity date for payment, terms

$ 285,512

Six semi-annual payments

Principal payments includes accrued and unpaid interest

$ 166,667

Beginning date of debt maturity

Jan. 02, 2019

Ending date of debt maturity

Jul. 01, 2021

318,236

227,216

690,247

At The Market Offering [Member] | Sales Agreement [Member] | Cowen And Company Limited Liability Company [Member]

$ 115

$ 40,542,300,000

$ 19,232,000,000

$ 597,743

$ 3,808,836

318,236

227,216

690,247

Proceeds from issuance of common stock, net of issuance costs

$ 600,000

600,000

Aggregate gross proceeds from issuance of common stock

9,400,000

$ 9,400,000

Aggregate net proceeds from sale of common stock

$ 11,500,000

11,500,000

597,743

$ 3,808,836

$ 8,800,000

At The Market Offering [Member] | Maximum [Member] | Sales Agreement [Member] | Cowen And Company Limited Liability Company [Member]

Aggregate gross proceeds from issuance of common stock

318,236

227,216

690,247

$ 2,500,000,000,000

2,500,000,000,000

February Two Thousand Eighteen Public Offering [Member]

115

$ 597,743

$ 3,808,836

2,841,152

Gross proceeds from sale of common stock and warrants

$ 3.25

$ 120,000,000,000

Net proceeds from sale of common stock and warrants

$ 10,700,000

Class of warrant or right, number of securities called by each warrant or right

0.025

Class of warrant or right, exercise price of warrants or rights

$ 65.00

5 years

5,912,307

1,000,000

$ 478,250,900,000

$ 673,100,000

$ 1,072,140,000,000

$ 13,530,401

$ 8,823,242

318,236

227,216

690,247

Common Stock [Member] | October Two Thousand Eighteen Public Offering [Member]

$ 3,182

$ 2,272

111,000

318,236

227,216

690,247

$ 29.00

Proceeds from issuance of common stock, net of issuance costs

$ 3,200,000

$ 2,800,000

Common Stock [Member] | Private Placement [Member] | M G H I F Financing Agreement [Member] | Second Amended And Restated Senior Secured Promissory Note [Member]

$ 3,182

$ 2,272

144,238

Accrued and unpaid interest due date

$ 285,512

Jul. 14, 2018

Common Stock [Member] | At The Market Offering [Member]

10,710

^[1]

5,202

^[1]

318,236

227,216

690,247

Common Stock [Member] | At The Market Offering [Member] | Sales Agreement [Member] | Cowen And Company Limited Liability Company [Member]

115

$ 10,700,000

^[1]

$ 5,200,000

^[1]

$ 597,743

$ 3,808,836

Common Stock [Member] | March Two Thousand Nineteen Public Offering [Member]

15,912

690,247

450,000

$ 12.00

Proceeds from issuance of common stock, net of issuance costs

$ 5,400,000

$ 4,800,000

450,000

^[1]

33,654

^[1]

150,962

^[1]

318,236

227,216

690,247

Prefunded Units [Member] | February Two Thousand Eighteen Public Offering [Member]

$ 450,000,000

^[1]

$ 33,700,000

^[1]

$ 151,000,000

^[1]

$ 3,182

$ 2,272

851,155

$ 3.24

Additional Paid In Capital [Member] | At The Market Offering [Member]

$ 594,561

$ 3,806,564

318,236

227,216

690,247

Additional Paid In Capital [Member] | Public Placement [Member]

$ 115

$ 40,531,600,000

19,226,800,000

$ 597,743

$ 3,808,836

5,912,307

1,000,000

Pre Funded Warrant [Member] | February Two Thousand Eighteen Public Offering [Member]

$ 477,800,900,000

$ 639,400,000

$ 1,071,989,000,000

$ 594,561

$ 3,806,564

Class of warrant or right, exercise price of warrants or rights

$ 0.20

Related Party Transactions

851,155

[1]	Reflects the 1 for 20 reverse stock split that became effective on August 29, 2019. Refer to Note 8 Stockholders equity for further information.

Related Party Transactions

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Note 12 – Related party transactions

In October 2016, the Company entered into an agreement with Merck Sharp & Dohme Corp. (“MSD”), a wholly-owned subsidiary of Merck, and an affiliate of MGHIF, a principal stockholder of the Company and a related party to the Company. Under the agreement, MSD provided access to its archive of over 200,000 bacterial pathogens. The Company is initially performing molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse informatics, and to speed development of its rapid diagnostic products. MSD gains access to the high-resolution genotype data for the isolates as well as access to the Acuitas Lighthouse informatics to support internal research and development programs. The Company is required to expend up to $175,000 for the procurement of materials related to the activities contemplated by the agreement. Contract life-to-date, the Company has incurred $171,646 of procurement costs which have been recognized as research and development expense. The Company did not recognize any research and development expense related to the agreement in the three months ended September 30, 2019 and 2018. The Company recognized research and development expense of $0 and $22,604 related to the agreement in the nine months ended September 30, 2019 and 2018, respectively.

In December 2017, the Company entered into a subcontractor agreement with ILÚM, whereby ILÚM will provide services to the Company in the performance of the Company’s CDC contract to deploy ILÚM’s commercially-available cloud- and mobile-based software platform for infectious disease management in up to three medical sites in Colombia with the aim of improving antibiotic use in resource-limited settings. The Company did not incur any cost of services expense related to the contract in the three months ended September 30, 2019 and 2018. The Company recognized $0 and $198,665 of cost of services expense related to the contract in the nine months ended September 30, 2019 and 2018, respectively.

Note 11 - Related Party Transactions

In October 2016, the Company entered into an agreement with Merck Sharp & Dohme, a wholly-owned subsidiary of Merck Co. & Inc. (“Merck”), an affiliate of MGHIF, a principal stockholder of the Company and a related party to the Company. Under the agreement, Merck provided access to its archive of over 200,000 bacterial pathogens. The Company is initially performing molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse, and to speed development of its rapid diagnostic products. Merck gains access to the high-resolution genotype data for the isolates as well as access to the Acuitas Lighthouse informatics to support internal research and development programs. The Company is required to expend up to $175,000 for the procurement of materials related to the activities contemplated by the agreement. Contract life-to-date, the Company has incurred $171,646 of procurement costs which have been recognized as research and development expense, including $22,603 and $146,177 during the years ended December 31, 2018 and 2017.

In December 2017, we entered into a subcontractor agreement with ILÚM Health Solutions, LLC, an entity created by Merck’s Healthcare Services and Solutions division, whereby ILÚM Health Solutions provided services to the Company in the performance of the Company’s CDC contract to deploy ILÚM’s commercially-available cloud- and mobile-based software platform for infectious disease management in up to three medical sites in Colombia with the aim of improving antibiotic use in resource-limited settings. During the years ended December 31, 2018 and 2017, the Company recognized $329,162 and $210,180 of cost of services expense related to the contract, respectively.

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Statement of Financial Position [Abstract]
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01	$ 0.01
Common stock, shares authorized	50,000,000	50,000,000	50,000,000
Common stock, shares issued	882,268	432,286	2,265,320
Common stock, shares outstanding	882,268	432,286	2,265,320
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01	$ 0.01
Preferred stock, shares authorized	10,000,000	10,000,000	10,000,000
Preferred stock, shares issued	0	0	0
Preferred stock, shares outstanding	0	0	0

Condensed Consolidated Statements of Cash Flows - USD ($)	9 Months Ended		12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Dec. 31, 2017
Cash flows from operating activities
Net loss	$ (9,928,565)	$ (9,635,722)	$ (13,368,098)
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization	687,107	508,162	730,884
Noncash interest expense	2,659	108,011	133,802
Stock compensation expense	275,171	658,731	862,281
Loss (gain) on sale of equipment	9,904	(5,253)	(5,253)
Change in fair value of warrant liability	(67)	(8,070)	(8,386)
Impairment of right-of-use asset	520,759	0	0
Changes in operating assets and liabilities:
Accounts receivable	(5,173)	492,444	432,814	$ (260,471)
Inventory	74,449	3,179	(11,273)	161,027
Other assets	55,122	(164,346)	486	(315,688)
Accounts payable	314,559	(493,971)	89,493	(563,357)
Accrued compensation and other liabilities	(55,871)	174,560	77,871	399,224
Deferred revenue	(6,016)	(14,119)	(8,618)	(12,955)
Net cash used in operating activities	(8,055,962)	(8,376,394)	(11,073,997)	(14,303,880)
Cash flows from investing activities
Purchases of property and equipment	(72,607)	(41,910)	(147,767)	(276,950)
Proceeds from sale of equipment	29,250	10,440	10,440	0
Net cash used in investing activities	(43,357)	(31,470)	(137,327)	(276,950)
Cash flows from financing activities
Proceeds from issuance of common stock, net of issuance costs	4,782,509	597,743	597,743	3,808,836
Proceeds from issuance of units, net of selling costs	0	10,728,132	13,530,401	8,754,882
Proceeds from debt, net of issuance costs	470,519	381,253	381,253	1,168,222
Proceeds from exercise of stock options			0	76,537
Payments on debt	(694,156)	(299,256)	(371,573)	(1,255,198)
Payments on finance leases	(389,501)	(177,092)
Payments on capital lease obligations			(292,722)	(205,085)
Net cash provided by financing activities	4,169,371	11,230,780	13,845,102	12,348,194
Effects of exchange rates on cash	4,541	7,419	12,878	(37,517)
Net (decrease) increase in cash, cash equivalents and restricted cash	(3,925,407)	2,830,335	2,646,656	(2,270,153)
Cash, cash equivalents and restricted cash at beginning of period	4,737,207	2,090,551	2,090,551	4,360,704
Cash, cash equivalents and restricted cash at end of period	811,800	4,920,886	4,737,207	2,090,551
Supplemental disclosure of cash flow information
Cash paid for interest	170,608	32,442	57,393	48,211
Supplemental disclosures of noncash investing and financing activities:
Right-of-use assets acquired through finance leases	528,413	585,278
Property and equipment acquired through capital lease			706,778
Shares issued to settle obligations	0	272,610	272,610	133,245
Conversion of accounts payable to finance lease	$ 63,600	$ 156,775	156,775	0
Unpaid deferred offering costs			$ 0	$ 48,398

Summary of Significant Accounting Policies - Schedule of Expected Amortization of Intangible Assets (Details) - USD ($)	Sep. 30, 2019	Dec. 31, 2018	Dec. 31, 2017
Accounting Policies [Abstract]
2019		$ 267,816
2020		267,816
2021		267,816
2022		165,117
2023		46,104
Thereafter		70,697
Net Balance	$ 884,504	$ 1,085,366	$ 1,353,182

Fair value measurements (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Fair Value Disclosures [Abstract]

Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis

The following table sets forth a summary of changes in the fair value of level 3 liabilities measured at fair value on a recurring basis for the nine months ended September 30, 2019:

Description

Balance at

December 31,

2018

Change in

Fair Value

Balance at

September 30, 2019

Warrant liability

(67

)

—

The following table sets forth a summary of changes in the fair value of level 3 liabilities measured at fair value on a recurring basis for the year ended December 31, 2018:

Description

Balance at

December 31,

2017

Change in

Fair Value

Balance at

December 31,

2018

Warrant liability

8,453

(8,386

)

Summary of Significant Accounting Policies - Additional Information (Details)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2019 USD ($) Customer	Sep. 30, 2018 USD ($)	Sep. 30, 2019 USD ($) Customer shares	Sep. 30, 2018 USD ($) shares	Dec. 31, 2018 USD ($) Customer shares	Dec. 31, 2017 USD ($) Customer shares
FDIC limit of insurable cash	$ 250,000		$ 250,000		$ 250,000
Letters of credit outstanding, amount	185,380		185,380		164,720	$ 243,380
Allowance for doubtful accounts receivable	$ 18,309		$ 18,309		$ 18,332	$ 31,278
Number of individual customers accounting for more than 10% of revenue \| Customer					1	1
Number of individual customers accounting for more than 10% of accounts receivable \| Customer	1		1		1	1
Inventory valuation reserves	$ 129,345		$ 129,345		$ 71,270	$ 155,507
Depreciation expense					463,068	401,272
Amortization of intangible assets	66,954	$ 66,954	200,862	$ 200,862	267,816	267,816
Impairment of finite-lived intangible assets	0	0	0	0	0	0
Goodwill	600,814		600,814		$ 600,814	$ 600,814
Impairment of goodwill	0	$ 0	$ 0	$ 0
Share-based compensation arrangement by share-based payment award, award vesting period					4 years
Antidilutive securities excluded from computation of earnings per share, amount \| shares			200,000	200,000	37	16
Undiscounted future minimum operating lease commitments	1,984,248		$ 1,984,248
Operating lease right of use asset	1,214,482		1,214,482		$ 0
Operating lease liability	$ 1,800,634		1,800,634
Accounting Standards Update201602 [Member]
Impairment charge			$ 520,759
Undiscounted future minimum operating lease commitments					$ 28
Maximum [Member]
Accounts receivable period due			60 days		60 days
Estimated useful lives of related assets					5 years
Fair value assumptions, expected term					6 years 3 months	6 years 3 months
Maximum [Member] \| Employee Stock Option [Member]
Fair value assumptions, expected term					10 years
Minimum [Member]
Accounts receivable period due			30 days		30 days
Estimated useful lives of related assets					3 years
Fair value assumptions, expected term					5 years 3 months	5 years 3 months
Minimum [Member] \| Employee Stock Option [Member]
Fair value assumptions, expected term					6 years 3 months
Domestic Country [Member]
Operating loss carryforwards					$ 178,163,456	$ 165,981,195
Operating loss carryforwards, expiration terms			begin to expire in 2022		begin to expire in 2022
Customer Relationships [Member]
Finite-lived intangible asset, useful life			7 years		7 years
Developed Technology Rights [Member]
Finite-lived intangible asset, useful life			7 years		7 years
Trademarks And Trade Names [Member]
Finite-lived intangible asset, useful life			10 years		10 years
Customer One [Member] \| Sales Revenue Net [Member] \| Customer Concentration Risk [Member]
Concentration risk, percentage	12.00%	10.00%			17.00%	11.00%
Customer One [Member] \| Accounts Receivable [Member] \| Customer Concentration Risk [Member]
Concentration risk, percentage			20.00%		12.00%	41.00%
Customer Two [Member] \| Sales Revenue Net [Member] \| Customer Concentration Risk [Member]
Concentration risk, percentage			40.00%	16.00%

Commitments

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Commitments and Contingencies Disclosure [Abstract]

Commitments

Note 9 – Commitments

Registration and other stockholder rights

In connection with the various investment transactions, the Company entered into registration rights agreements with stockholders, pursuant to which the investors were granted certain demand registration rights and/or piggyback and/or resale registration rights in connection with subsequent registered offerings of the Company’s common stock.

Supply agreements

In June 2017, the Company entered into an agreement with Life Technologies Corporation (“LTC”) to supply the Company with QuantStudio 5 Real-Time PCR Systems (“QuantStudio 5”) to be used to run OpGen’s Acuitas AMR Gene Panel tests. Under the terms of the agreement, the Company must notify LTC of the number of QuantStudio 5s that it commits to purchase in the following quarter. As of September 30, 2019, the Company has acquired twenty-four QuantStudio 5s including nine in the nine months ended September 30, 2019. As of September 30, 2019, the Company has not committed to acquiring additional QuantStudio 5s in the next three months.

Note 9 - Commitments

Operating leases

The Company leases a facility in Gaithersburg, Maryland under an operating lease that expires January 31, 2021, with one additional five-year renewal at the Company’s election. The Company also leases a facility in Woburn, Massachusetts under an operating lease that expires January 30, 2022. Additionally, the Company leases office space in Denmark; this lease is currently on a month-to-month basis.

Rent expense under the Company’s facility operating leases for the year ended December 31, 2018 and 2017 was $984,639 and $949,244, respectively.

Capital leases

The Company leases lab equipment, office furniture, and computer equipment under various capital leases. The leases expire at various dates through 2021. The leases require monthly principal and interest payments. Following is a schedule by year of the estimated future minimum payments under all operating and capital leases as of December 31, 2018:

Year ending December 31,	Capital Leases			Operating Leases		Total
2019	$	508,114		$	1,107,565	$	1,615,679
2020		408,264			1,125,940		1,534,204
2021		104,579			535,250		639,829
2022		—			40,080		40,080
2023 and thereafter		—			—		—
Total		1,020,957		$	2,808,835	$	3,829,792
Less: amount representing interest		(96,251	)
Less: amount representing service costs		(88,172	)
Net present value of future minimum lease payments		836,534
Current maturities		(399,345	)
Long-term maturities	$	437,189

Assets under capital leases were included in the following balance sheet categories as of December 31:

	2018			2017
Laboratory and manufacturing equipment	$	1,563,346		$	850,792
Office furniture and equipment		64,790			64,790
Computers and network equipment		24,350			24,350
Less accumulated amortization		(749,480	)		(454,471	)
Capital lease assets, net	$	903,006		$	485,461

Amortization expense associated with equipment under capital leases for the years ended December 31, 2018 and 2017 was $295,009 and $161,606, respectively, and is included within depreciation and amortization expense in the consolidated statements of operations.

Registration and other stockholder rights

Restructuring

In early June 2017, the Company commenced a restructuring of its operations to improve efficiency and reduce its cost structure. The restructuring plans anticipate that the Company will consolidate operations for FDA-cleared and CE marked products and research and development activities for the Acuitas Rapid Test in Gaithersburg, Maryland, and reduce the size of its commercial organization while the Company works to complete the development of its Acuitas Rapid Test and Acuitas Lighthouse Knowledgebase products and services in development.

There were approximately $121,000 of one-time termination benefits that were recognized during the year ended December 31, 2017 related to the restructuring. The Company does not anticipate any further one-time termination benefits related to the restructuring plan. Retention agreements were issued to certain employees in which retention bonuses are earned and paid upon the completion of a designated service period. The service periods ended in December 2017. The Company incurred total retention expense of approximately $68,000 during the year ended December 31, 2017. The future minimum lease payments for the Woburn facility were approximately $1.4 million as of December 31, 2018. A liability for costs that will continue to be incurred under a contract for its remaining term without economic benefit to the entity shall be recognized at the cease-use date. If the contract is an operating lease the fair value of the liability at the cease-use date shall be determined based on the remaining lease rentals, adjusted for the effects of any prepaid or deferred items recognized under the lease, and reduced by estimated sublease rentals that could be reasonably obtained for the property. The Company expects the cease-use date for the Woburn facility to be in the first quarter of 2019. We do not believe there will be significant additional costs related to restructuring outside of what is described herein.

Supply Agreements

In June 2017, the Company entered into an agreement with Life Technologies Corporation, a subsidiary of Thermo Fisher Scientific (“LTC”) to supply the Company with Thermo Fisher Scientific’s QuantStudio 5 Real-Time PCR Systems (“QuantStudio 5”) to be used to run OpGen’s Acuitas AMR Gene Panel tests. Under the terms of the agreement the Company must notify LTC of the number of QuantStudio 5s that it commits to purchase in the following quarter. As of December 31, 2018 the Company has acquired fifteen QuantStudio 5s including eleven in the twelve months ended December 31, 2018. As of December 31, 2018 the Company has committed to acquiring an additional three QuantStudio 5s at a total cost of approximately $135,000 in the next three months.

Stockholders' equity (deficit) (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Stockholders' Equity Note [Abstract]

Schedule of Company Recognized Stock-Based Compensation Expense

For the three and nine months ended September 30, 2019 and 2018, the Company recognized stock-based compensation expense as follows:

	Three Months Ended September 30,					Nine Months Ended September 30,
	2019		2018			2019		2018
Cost of services	$	584	$	(2,807	)	$	1,146	$	924
Research and development		20,175		56,961			55,635		187,512
General and administrative		65,318		141,974			202,696		434,314
Sales and marketing		5,090		10,523			15,694		35,981
	$	91,167	$	206,651		$	275,171	$	658,731

For the years ended December 31, 2018 and 2017, the Company recognized stock compensation expense as follows:

	Year Ended December 31,
	2018		2017
Cost of services	$	964	$	13,776
Research and development		241,122		237,103
General and administrative		574,244		603,787
Sales and marketing		45,951		56,732
	$	862,281	$	911,398

Schedule of Warrants to Purchase Shares of Common Stock

At September 30, 2019 and December 31, 2018, the following warrants to purchase shares of common stock were outstanding:

							Outstanding at
Issuance			Exercise Price		Expiration		September 30, 2019 (1)		December 31, 2018 (1)
	November 2009		$	3,955.00		November 2019		17		17
	January 2010		$	3,955.00		January 2020		17		17
	March 2010		$	3,955.00		March 2020		7		7
	November 2011		$	3,955.00		November 2021		15		15
	December 2011		$	3,955.00		December 2021		2		2
	March 2012		$	54,950.00		March 2019		—		8
	February 2015		$	3,300.00		February 2025		451		451
	May 2015		$	3,300.00		May 2020		6,555		6,555
	May 2016		$	656.00		May 2021		9,483		9,483
	June 2016		$	656.00		May 2021		4,102		4,102
	June 2017		$	390.00		June 2022		938		938
	July 2017		$	345.00		July 2022		318		318
	July 2017		$	250.00		July 2022		2,501		2,501
	July 2017		$	212.60		July 2022		50,006		50,006
	February 2018		$	81.20		February 2023		9,232		9,232
	February 2018		$	65.00		February 2023		92,338		92,338
								175,982		175,990
	(1)	Warrants to purchase fractional shares of common stock resulting from the reverse stock split on August 29, 2019 were rounded up to the next whole share of common stock on a holder by holder basis.

At December 31, 2018 and 2017, the following warrants to purchase shares of common stock were outstanding:

				Outstanding at December 31,
Issuance	Exercise Price		Expiration	2018 (1)		2017 (1)
March 2008	$	19,763.50	March 2018		—		2
November 2009	$	197.75	November 2019		270		270
January 2010	$	197.75	January 2020		270		270
March 2010	$	197.75	March 2020		55		55
November 2011	$	197.75	November 2021		212		212
December 2011	$	197.75	December 2021		27		27
March 2012	$	2,747.50	March 2019		165		165
February 2015	$	165.00	February 2025		9,001		9,001
May 2015	$	165.00	May 2020		138,310		138,310
May 2016	$	32.81	May 2021		189,577		189,577
June 2016	$	32.81	May 2021		82,035		82,035
June 2017	$	19.50	June 2022		18,754		18,754
July 2017	$	17.25	July 2022		6,350		6,350
July 2017	$	12.50	July 2022		50,000		50,000
July 2017	$	10.625	July 2022		1,000,003		1,000,003
February 2018	$	4.06	February 2023		184,615		—
February 2018	$	3.25	February 2023		1,846,153		—
					3,525,797		1,495,031

Summary of Status of Options Granted

A summary of the status of options granted is presented below as of and for the years ended December 31, 2018 and 2017:

	Number of Options			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Life (in years)		Aggregate Intrinsic Value
Outstanding at January 1, 2017		119,106		$	44.00		8.6	$	663,298
Granted		58,324		$	17.58
Exercised		(1,167	)	$	7.01			$	11,256
Forfeited		(24,538	)	$	36.31
Expired		(12,330	)	$	83.49
Outstanding at December 31, 2017		139,395		$	31.16		8.3	$	37,339
Granted		95,800		$	3.84
Exercised		—			—
Forfeited		(18,812	)	$	11.98
Expired		(4,824	)	$	56.12
Outstanding at December 31, 2018		211,559		$	20.58		7.6	$	522
Vested and expected to vest		211,559		$	20.58		7.6	$	522
Exercisable at December 31, 2018		10,445		$	1.25		5.3	$	522

Schedule of Fair Value of Option Grant Estimated Using Black-Scholes Option Pricing Model

The fair value of each option grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below:

	Year Ended December 31,
	2018		2017
Annual dividend		—		—
Expected life (in years)	5.25 - 6.25		5.25 - 6.25
Risk free interest rate	2.5 - 2.9%		1.8 - 2.3%
Expected volatility	46.0 - 49.6%		44.2 - 53.0%

Summary of Status of Restricted Stock Unit Granted

A summary of the status of restricted stock units granted is presented below as of and for the years ended December 31, 2018 and 2017:

	Number of Options			Weighted- Average Grant Date Fair Value
Unvested at January 1, 2017		750		$	42.50
Granted		11,175		$	6.93
Vested		(6,025	)	$	8.01
Forfeited		—			—
Unvested at December 31, 2017		5,900		$	31.16
Granted		—			—
Vested		(5,650	)	$	8.93
Forfeited		—			—
Unvested at December 31, 2018		250		$	42.50

Income taxes

12 Months Ended

Dec. 31, 2018

Income Tax Disclosure [Abstract]

Income Taxes

Note 8 - Income Taxes

At December 31, 2018 and 2017, the Company had net deferred tax assets of $52,348,036 and $49,251,408, respectively, primarily consisting of NOL carryforwards, research and experimental (“R&E”) credits, and differences between depreciation and amortization recorded for financial statement and tax purposes. The Company’s net deferred tax assets at December 31, 2018 and 2017 have been offset by a valuation allowance of $52,348,036 and $49,251,408, respectively. The valuation allowance has been recorded due to the uncertainty of realization of the deferred tax assets. The Company’s deferred tax assets and liabilities as of December 31, 2018 and 2017 are as follows:

	December 31,
	2018			2017
Deferred tax assets:
NOL carryforward	$	49,480,731		$	46,326,407
R&E credit carryforward		2,559,479			2,559,479
Share-based compensation		329,796			345,088
Inventory reserve		19,068			45,338
Depreciation		—			71,756
Interest expense		51,152			—
Accruals and other		284,662			247,093
Total deferred tax assets		52,724,888			49,595,161
Valuation allowance		(52,348,036	)		(49,251,408	)
Deferred tax liabilities:
Intangible assets		(256,011	)		(343,753	)
Depreciation		(120,841	)		—
Net	$	—		$	—

The difference between the Company’s expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual income tax provision (benefit) relates to the effect of the following:

	2018			2017
Federal income tax benefit at statutory rates		21.0	%		34.0	%
Permanent adjustment		(1.4	)%		—
Provision to return adjustment		(0.2	)%		—
State income tax benefit, net of Federal benefit		(6.4	)%		6.8	%
Tax reform impact		—			(134.5	)%
Change in valuation allowance		(13.0	)%		93.0	%
Change in state tax rates and other		—			0.7	%
		0.0	%		0.0	%

The Company has federal NOL carryforwards of $178,163,456 and $165,981,195 at December 31, 2018 and 2017, respectively. The NOL carryforwards incurred prior to 2018 begin to expire in 2022. Under the Tax Cuts and Jobs Act (the Tax Act), the amount of post 2017 NOLs that we are permitted to deduct in any taxable year is limited to 80% of our taxable income in such year, where taxable income is determined without regard to the NOL deduction itself. In addition, the Tax Act generally eliminates the ability to carry back any NOL to prior taxable years, while allowing post 2017 unused NOLs to be carried forward indefinitely. Utilization of the NOL carryforward may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code. There can be no assurance that the NOL carryforward will ever be fully utilized. To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Internal Revenue Code of 1986, as amended. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized.

In December 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the "Tax Act"), most of the provisions of which took effect starting in 2018. The Tax Act made broad and complex changes to the U.S. tax code, including, but not limited to: (i) reducing the U.S. federal corporate tax rate from 35 percent to 21 percent; (ii) eliminating the corporate alternative minimum tax (AMT) and changing how existing AMT credits can be realized; (iii) creating a new limitation on deductible interest expense; and (iv) changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017; and (v) changing the U.S. federal taxation of earnings of foreign subsidiaries. The U.S. change in federal taxation for foreign subsidiary earnings included a one-time toll charge on deemed repatriated earnings of foreign subsidiaries as of December 31, 2017. As a result of the accumulated losses in the Company’s foreign subsidiary, the Company had no toll tax liability for the tax year ended December 31, 2017. For 2018, the Company considered in its estimated annual effective tax rate additional provisions of Tax Reform including changes to the deduction for interest expense pursuant to IRC Section 163(j) interest limitation.

As a result, the most significant impact on the Company’s consolidated financial statements was the reduction of approximately $14.6 million of the deferred tax assets related to net operating losses and other deferred tax assets. Such reduction is offset by a change in the Company’s valuation allowance. Additionally, the Company has foreign subsidiaries. At December 31, 2017 and November 2, 2017, the cumulative earnings and profits of these entities were negative. Accordingly, the Company was not liable for the transition tax on foreign earnings enacted under the Tax Act.

Summary of significant accounting policies (Policies)

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Accounting Policies [Abstract]

Basis of presentation and consolidation

The Company has prepared the accompanying unaudited condensed consolidated financial statements pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) and the standards of accounting measurement set forth in the Interim Reporting Topic of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”). Certain information and note disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the information not misleading. The Company recommends that the unaudited condensed consolidated financial statements be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Company’s 2018 Annual Report on Form 10-K. In the opinion of management, all adjustments that are necessary for a fair presentation of the Company’s financial position for the periods presented have been reflected. All adjustments are of a normal, recurring nature, unless otherwise stated. The interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2018 consolidated balance sheet included herein was derived from the audited consolidated financial statements but does not include all disclosures including notes required by GAAP for complete financial statements.

The accompanying unaudited condensed consolidated financial statements include the accounts of OpGen and its wholly-owned subsidiaries; all intercompany transactions and balances have been eliminated.

Basis of Presentation

The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The consolidated financial statements consolidate the operations of all controlled subsidiaries; all intercompany activity is eliminated.

Foreign currency

The Company has subsidiaries located in Copenhagen, Denmark, and Bogota, Colombia, both of which use currencies other than the U.S dollar as their functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive loss, a component of stockholders’ equity (deficit). Foreign currency translation adjustments are the sole component of accumulated other comprehensive loss at September 30, 2019 and December 31, 2018.

Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the U.S. dollar.

Foreign Currency

The Company has subsidiaries located in Copenhagen, Denmark, and Bogota, Colombia, both of which use currencies other than the U.S. dollar as their functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive (loss)/income, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive (loss)/income at December 31, 2018 and 2017.

Use of estimates

In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying unaudited condensed consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, stock-based compensation, allowances for doubtful accounts and inventory obsolescence, discount rates used to discount unpaid lease payments to present values, valuation of derivative financial instruments measured at fair value on a recurring basis, deferred tax assets and liabilities and related valuation allowance, the estimated useful lives of long-lived assets, and the recoverability of long-lived assets. Actual results could differ from those estimates.

Use of Estimates

In preparing financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, share-based compensation, allowances for doubtful accounts and inventory obsolescence, and valuation of derivative financial instruments measured at fair value on a recurring basis, deferred tax assets and liabilities and related valuation allowance, depreciation and amortization and estimated useful lives of long-lived assets. Actual results could differ from those estimates.

Fair value of financial instruments

Financial instruments classified as current assets and liabilities (including cash and cash equivalent, receivables, accounts payable, deferred revenue and short-term notes) are carried at cost, which approximates fair value, because of the short-term maturities of those instruments.

Fair value of financial instruments

For additional fair value disclosures, see Note 12.

Cash, cash equivalents and restricted cash

Cash, cash equivalents and restricted cash

The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (“FDIC”) insured limit of $250,000. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk.

At September 30, 2019, the Company has funds totaling $185,380, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. At December 31, 2018, the Company had funds totaling $164,720, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying unaudited condensed consolidated balance sheets.

	September 30, 2019		December 31, 2018		September 30, 2018		December 31, 2017
Cash and cash equivalents	$	626,420	$	4,572,487	$	4,735,506	$	1,847,171
Restricted cash		185,380		164,720		185,380		243,380
Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows	$	811,800	$	4,737,207	$	4,920,886	$	2,090,551

Cash and cash equivalents and restricted cash

The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (FDIC) insured limits of $250,000. The Company has not experienced any losses in such accounts, and management believes it is not exposed to any significant credit risk.

As of December 31, 2018 and 2017, the Company had funds totaling $164,720 and $243,380, respectively, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying consolidated balance sheets.

Accounts receivable

The Company’s accounts receivable result from revenues earned but not yet collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $18,309 and $18,332 as of September 30, 2019 and December 31, 2018, respectively.

One individual customer represented 12% of revenues for the three months ended September 30, 2019. No individual customer represented in excess of 10% of revenues for the three months ended September 30, 2018. One individual customer represented 40% and 16% of revenues for the nine months ended September 30, 2019 and 2018, respectively. At September 30, 2019, one individual customer represented 20% of total accounts receivable. At December 31, 2018, one individual customer represented 12% of total accounts receivable.

Accounts Receivable

The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $18,332 and $31,278 as of December 31, 2018 and 2017, respectively.

At December 31, 2018, the Company had accounts receivable from one customer which individually represented 12% of total accounts receivable. At December 31, 2017, the Company had accounts receivable from one customer which individually represented 41% of total accounts receivable. For the year ended December 31, 2018, revenue earned from one customer represented 17% of total revenues. For the year ended December 31, 2017, revenue earned from one customer represented 11% of total revenues.

Inventory

Inventory

Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following:

	September 30, 2019		December 31, 2018
Raw materials and supplies	$	292,271	$	368,438
Work-in-process		14,676		58,402
Finished goods		161,427		116,907
Total	$	468,374	$	543,747

Inventory includes reagents and components for QuickFISH and PNA FISH kit products, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations were $129,345 and $71,270 at September 30, 2019 and December 31, 2018, respectively.

Inventory

Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following:

	December 31,
	2018		2017
Raw materials and supplies	$	368,438	$	360,134
Work-in process		58,402		51,233
Finished goods		116,907		122,058
Total	$	543,747	$	533,425

Inventory includes reagents and components for QuickFISH and PNA FISH kit products, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations were $71,270 and $155,507 at December 31, 2018 and 2017, respectively.

Property and equipment

Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the three and nine months ended September 30, 2019 and 2018, the Company determined that its property and equipment was not impaired.

Property and equipment

Property and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated service lives approximate three to five years. Depreciation expense was $463,068 and $401,272 for the years ended December 31, 2018 and 2017, respectively. Property and equipment consisted of the following at December 31, 2018 and 2017:

	December 31,
	2018			2017
Laboratory and manufacturing equipment	$	4,829,323		$	4,109,367
Office furniture and equipment		700,299			700,299
Computers and network equipment		1,520,713			1,505,651
Leasehold improvements		745,800			729,504
		7,796,135			7,044,821
Less accumulated depreciation		(6,574,308	)		(6,209,284	)
Property and equipment, net	$	1,221,827		$	835,537

Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the years ended December 31, 2018 and 2017, the Company determined that its property and equipment was not impaired.

Leases

The Company determines if an arrangement is a lease at inception. For leases where the Company is the lessee, right-of-use (“ROU”) assets represent the Company’s right to use the underlying asset for the term of the lease and the lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date of the underlying lease arrangement to determine the present value of lease payments. The ROU asset also includes any prepaid lease payments and any lease incentives received. The lease term to calculate the ROU asset and related lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The Company’s lease agreements generally do not contain any material variable lease payments, residual value guarantees or restrictive covenants.

Lease expense for operating leases is recognized on a straight-line basis over the lease term as an operating expense while expense for financing leases is recognized as depreciation expense and interest expense using the accelerated interest method of recognition. The Company has made certain accounting policy elections whereby the Company (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12 months or less) and (ii) combines lease and non-lease elements of our operating leases.

ROU assets

ROU assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which the Company can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. In conjunction with adoption of Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842) (“ASC 842”), the Company determined that the ROU asset associated with its Woburn, Massachusetts office lease may not be recoverable. As a result, the Company recorded an impairment charge of $520,759 during the nine months ended September 30, 2019.

Deferred rent

Deferred rent is recorded and amortized to the extent the total minimum rental payments allocated to the current period on a straight-line basis exceed or are less than the cash payments required.

Intangible assets and goodwill

Intangible assets and goodwill as of September 30, 2019 consist of finite-lived intangible assets and goodwill.

Finite-lived intangible assets

Finite-lived intangible assets include trademarks, developed technology and customer relationships and consisted of the following as of September 30, 2019 and December 31, 2018:

			September 30, 2019					December 31, 2018
	Cost		Accumulated Amortization			Net Balance		Accumulated Amortization			Net Balance
Trademarks and trade names	$	461,000	$	(194,361	)	$	266,639	$	(159,783	)	$	301,217
Developed technology		458,000		(275,814	)		182,186		(226,746	)		231,254
Customer relationships		1,094,000		(658,321	)		435,679		(541,105	)		552,895
	$	2,013,000	$	(1,128,496	)	$	884,504	$	(927,634	)	$	1,085,366

Finite-lived intangible assets are amortized over their estimated useful lives. The estimated useful life of trademarks is 10 years, developed technology is 7 years, and customer relationships is 7 years. The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets.

Total amortization expense of intangible assets was $66,954 for each of the three months ended September 30, 2019 and 2018. Total amortization expense of intangible assets was $200,862 for each of the nine months ended September 30, 2019 and 2018.

Finite-lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. During the three and nine months ended September 30, 2019 and 2018, the Company determined that its finite-lived intangible assets were not impaired.

In accordance with ASC 360-10, Property, Plant and Equipment, the Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that long-lived assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets. During the fourth quarter of 2018, events and circumstances indicated the Company’s intangible assets might be impaired. However, management’s estimate of undiscounted cash flows indicated that such carrying amounts were expected to be recovered. Nonetheless, it is reasonably possible that the estimate of undiscounted cash flows may change in the near term resulting in the need to write down those assets to fair value. Management’s estimate of cash flows might change if there is an unfavorable development of sales trends.

Goodwill

Goodwill represents the excess of the purchase price paid in a July 2015 merger transaction in which the Company acquired AdvanDx, Inc. and its subsidiary (the “Merger”) over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company’s goodwill balance as of September 30, 2019 and December 31, 2018 was $600,814.

The Company conducts an impairment test of goodwill on an annual basis as of October 1 of each year, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. During the three and nine months ended September 30, 2019 and 2018, the Company determined that its goodwill was not impaired.

Intangible assets and goodwill

Intangible assets and goodwill as of December 31, 2018 and 2017 were acquired as part of a July 2015 merger transaction in which the Company acquired AdvanDx, Inc. and its subsidiary (the “Merger”) and consist of finite-lived intangible assets and goodwill.

Finite-lived intangible assets

Finite-lived intangible assets include trademarks, developed technology and customer relationships, and consisted of the following as of December 31, 2018 and 2017:

			December 31, 2018					December 31, 2017
	Cost		Accumulated Amortization			Net Balance		Accumulated Amortization			Net Balance
Trademarks and tradenames	$	461,000	$	(159,783	)	$	301,217	$	(113,679	)	$	347,321
Developed technology		458,000		(226,746	)		231,254		(161,322	)		296,678
Customer relationships		1,094,000		(541,105	)		552,895		(384,817	)		709,183
	$	2,013,000	$	(927,634	)	$	1,085,366	$	(659,818	)	$	1,353,182

Total amortization expense of intangible assets was $267,816 and $267,816 for the years ended December 31, 2018 and 2017, respectively. Expected amortization of intangible assets for each of the next five fiscal years is as follows.

Year Ending December 31,
2019	$	267,816
2020		267,816
2021		267,816
2022		165,117
2023		46,104
Thereafter		70,697
Total	$	1,085,366

Finite-lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. During the years ended December 31, 2018 and 2017, the Company determined that its finite-lived intangible assets were not impaired.

In accordance with ASC 360-10, the Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that long-lived assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets. During 2018, events and circumstances indicated the Company’s intangible assets might be impaired. However, management’s estimate of undiscounted cash flows indicated that such carrying amounts were expected to be recovered. Nonetheless, it is reasonably possible that the estimate of undiscounted cash flows may change in the near term, resulting in the need to write down those assets to fair value.

Goodwill

Goodwill represents the excess of the purchase price for AdvanDx, Inc. and subsidiary (collectively, “AdvanDx”) over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions.

The Company conducts an impairment test of goodwill on an annual basis as of October 1 of each year, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. As of December 31, 2018, the Company determined that its goodwill was not impaired.

Deferred rent

Leases

ROU assets

Deferred rent

Deferred rent is recorded and amortized to the extent the total minimum rental payments allocated to the current period on a straight-line basis exceed or are less than the cash payments required.

Revenue recognition

Revenue recognition

The Company derives revenues from (i) the sale of QuickFISH and PNA FISH diagnostic test products and Acuitas AMR Gene Panel RUO test products, (ii) providing laboratory services, and (iii) providing collaboration services including funded software arrangements, and license arrangements.

The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers, (ii) identification of distinct performance obligations in the contract, (iii) determination of contract transaction price, (iv) allocation of contract transaction price to the performance obligations and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation.

The Company recognizes revenues upon the satisfaction of its performance obligation (upon transfer of control of promised goods or services to our customers) in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services.

The Company defers incremental costs of obtaining a customer contract and amortizes the deferred costs over the period that the goods and services are transferred to the customer. The Company had no material incremental costs to obtain customer contracts in any period presented.

Deferred revenue results from amounts billed in advance to customers or cash received from customers in advance of services being provided.

Revenue recognition

Subsequent to the Adoption of Accounting Standards Codification Revenue from Contracts with Customers (“ASC 606”) on January 1, 2018

The Company derives revenues from (i) the sale of QuickFISH and PNA FISH diagnostic test products and Acuitas AMR Gene Panel (RUO) test products, (ii) providing laboratory services, and (iii) providing collaboration services including funded software arrangements, and license arrangements.

Deferred revenue results from amounts billed in advance to customers or cash received from customers in advance of services being provided.

For details about the Company’s revenue recognition policy prior to the adoption of ASC 606, refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2017.

Research and development costs

Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, and fees paid to consultants and outside service partners.

Research and development costs

Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, fees paid to consultants and outside service partners.

Transaction Costs

Transaction costs

Transaction costs include expenses associated with legal, accounting, and regulatory services rendered in connection with business combinations. Transaction costs are expensed as incurred in support of the business combination.

Stock-based compensation

Stock-based compensation expense is recognized at fair value. The fair value of stock-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur.

Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award.

Share-based compensation

Share-based compensation expense is recognized at fair value. The fair value of share-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur.

Fair value of common stock

For periods prior to the Company’s IPO in May 2015, given the lack of an active public market for the common stock, the Company’s board of directors determined the fair value of the common stock. In the absence of a public market, and as an emerging company with no significant revenues, the Company believed that it was appropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. The factors included: (1) the achievement of clinical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with the Company’s stage of development; (4) capital market conditions for life science and medical diagnostic companies, particularly similarly situated, privately held, early stage companies; (5) the Company’s available cash, financial condition and results of operations; (6) the most recent sales of the Company’s preferred stock; and (7) the preferential rights of the outstanding preferred stock. Since the IPO, the Company uses the quoted market price of its common stock as its fair value.

Expected volatility

Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Until a significant trading history for its common stock develops, the Company has identified several public entities of similar size, complexity and stage of development; accordingly, historical volatility has been calculated using the volatility of this peer group.

Expected dividend yield

The Company has never declared or paid dividends on its common stock and has no plans to do so in the foreseeable future.

Risk-free interest rate

This is the U.S. Treasury rate for the day of each option grant during the year, having a term that most closely resembles the expected term of the option.

Expected term

This is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Company estimates the expected term of the option to be 6.25 years for options with a standard four-year vesting period, using the simplified method. Over time, management will track actual terms of the options and adjust their estimate accordingly so that estimates will approximate actual behavior for similar options.

Income taxes

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized.

Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts.

The Company had federal net operating loss (“NOL”) carryforwards of $178.2 million at December 31, 2018. Despite the NOL carryforwards, which begin to expire in 2022, the Company may have future tax liability due to alternative minimum tax or state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized.

Income taxes

The Company had federal net operating loss (“NOL”) carryforwards of $178,163,456 and $165,981,195 at December 31, 2018 and 2017, respectively. Despite the NOL carryforwards, which begin to expire in 2022, the Company may have future tax liability due to alternative minimum tax or state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized.

Loss per share

Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period.

For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method.

For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 0.2 million shares and 0.2 million shares as of September 30, 2019 and 2018, respectively.

Loss per share

Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period.

For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method.

For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 3.7 million shares and 1.6 million shares as of December 31, 2018 and 2017, respectively.

Accounting pronouncements adopted and not yet adopted

Adopted accounting pronouncements

There have been no developments to the Recent Accounting Pronouncements discussion included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, including the expected dates of adoption and estimated effects on the Company’s condensed consolidated financial statements, except for the following:

In February 2016, the FASB issued ASC 842, which amends the existing accounting standards for leases. The guidance requires lessees to recognize assets and liabilities related to long-term leases on the balance sheet and expands disclosure requirements regarding leasing arrangements. The Company adopted this guidance effective January 1, 2019 using the modified retrospective transition method and the following practical expedients:

•

The Company did not reassess if any expired or existing contracts are or contain leases.

•

The Company did not reassess the classification of any expired or existing leases.

Additionally, the Company made ongoing accounting policy elections whereby the Company (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12 months or less) and (ii) combines lease and non-lease elements of our operating leases.

Upon adoption of the new guidance on January 1, 2019, the Company recorded an operating lease right of use asset of approximately $2.2 million (net of existing deferred rent) and recognized a lease liability of approximately $2.5 million.

In June 2018, the FASB issued ASU 2018-07: Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees, and as a result, the accounting for share-based payments to non-employees will be substantially aligned. ASU 2018-07 is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year, early adoption is permitted but no earlier than an entity’s adoption date of ASC 606. The adoption of this new guidance did not have a material impact on the Company’s condensed consolidated financial statements.

In August 2018, the SEC issued a final rule that amends certain disclosure requirements that were duplicative, outdated or superseded. In addition, the final rule expanded the financial reporting requirements for changes in stockholders’ equity for interim reporting periods. The Company adopted the new guidance on January 1, 2019 with no material impact to the condensed consolidated financial statements.

The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows.

Adopted accounting pronouncements

In May 2014, the Financial Accounting Standards Board (“FASB”) and International Accounting Standards Board (“IASB”) jointly issued a new revenue recognition standard, Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (“ASC 606”) that is designed to improve financial reporting by creating common recognition guidance for U.S. GAAP and International Financial Reporting Standards (“IFRS”). This guidance provides a robust framework for addressing revenue issues, improves the comparability of revenue recognition practices across industries, provides useful information to users of financial statements through improved disclosure requirements and simplifies the presentation of financial statements. The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. From March to December 2016, amendments to the new revenue recognition standard were issued to clarify numerous accounting topics, including, but not limited to (i) the implementation guidance on principal versus agent considerations, (ii) the identification of performance obligations, (iii) the licensing implementation guidance, (iv) the objective of the collectability criterion, (v) the application of the variable consideration guidance and modified retrospective transition method, (vi) the way in which impairment testing is performed and (vii) the disclosure requirements for revenue recognized from performance obligations. This guidance permits the use of either a full retrospective method or a modified retrospective approach. The modified retrospective approach is applied only to the most current period presented along with a cumulative-effect adjustment at the date of adoption. This guidance became effective for annual reporting periods beginning after December 15, 2017.

On January 1, 2018, the Company adopted ASC 606, using the modified retrospective method. Results for reporting periods beginning subsequent to December 31, 2017 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historical accounting policies prior to adoption. In adopting the guidance, the Company applied the guidance to all contracts and used available practical expedients including assessing contracts with similar terms and conditions on a “portfolio” basis. The adoption of this new guidance did not have a material impact on the Company’s condensed consolidated financial statements.

In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows: Restricted Cash, which addresses classification and presentation of changes in restricted cash on the statement of cash flows. The standard requires that restricted cash and restricted cash equivalents be included as components of total cash and cash equivalents as presented on the statement of cash flows. The Company adopted ASU 2016-18 using a retrospective transition method effective January 1, 2018 and applied to the periods presented on the condensed consolidated statements of cash flows. Restricted cash includes cash and cash equivalents that is restricted through legal contracts, regulations or the Company’s intention to use the cash for a specific purpose. The Company’s restricted cash primarily related to funds held as collateral for letters of credit.

	December 31, 2018		December 31, 2017		December 31, 2016
Cash and cash equivalents	$	4,572,487	$	1,847,171	$	4,117,324
Restricted cash		164,720		243,380		243,380
Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows	$	4,737,207	$	2,090,551	$	4,360,704

Accounting pronouncements not yet adopted

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (“ASC 842”), which amends the existing accounting standards for leases. The new standard requires lessees to record a right-of-use (“ROU”) asset and a corresponding lease liability on the balance sheet (with the exception of short-term leases), whereas under current accounting standards, the Company’s lease portfolio consists of operating leases and is not recognized on its consolidated balance sheets. The new standard also requires expanded disclosures regarding leasing arrangements. The new standard is effective for the Company beginning January 1, 2019. In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842): Targeted Improvements, which provides an alternative modified transition method. Under this method, the cumulative-effect adjustment to the opening balance of retained earnings is recognized on the date of adoption with prior periods not restated.

The new standard provides a number of optional practical expedients in transition. The Company expects to elect: (1) the ‘package of practical expedients’, which permits it not to reassess under the new standard its prior conclusions about lease identification, lease classification, and initial direct costs; (2) the use-of-hindsight; and (3) the practical expedient pertaining to land easements. In addition, the new standard provides practical expedients for an entity’s ongoing accounting that the Company anticipates making, such as the (1) the election for certain classes of underlying asset to not separate non-lease components from lease components and (2) the election for short-term lease recognition exemption for all leases that qualify.

The Company will adopt ASC 842 as of January 1, 2019, using the alternative modified transition method. In preparation of adopting ASC 842, the Company is implementing additional internal controls to enable future preparation of financial information in accordance with ASC 842. The Company has also substantially completed its evaluation of the impact on the Company’s lease portfolio. The Company believes the largest impact will be on the consolidated balance sheets for the accounting of facilities-related leases, which represents a majority of its operating leases it has entered into as a lessee. These leases will be recognized under the new standard as ROU assets and operating lease liabilities. The Company will also be required to provide expanded disclosures for its leasing arrangements. As of December 31, 2018, the Company had $2.8 million of undiscounted future minimum operating lease commitments that are not recognized on its consolidated balance sheets as determined under the current standard. For a lessor, the results of operations are not expected to significantly change after adoption of the new standard.

While substantially complete, the Company is still in the process of finalizing its evaluation of the effect of ASC 842 on the Company’s consolidated financial statements and disclosures. The Company will finalize its accounting assessment and quantitative impact of the adoption during the first quarter of fiscal year 2019. As the Company completes its evaluation of this new standard, new information may arise that could change the Company’s current understanding of the impact to leases. Additionally, the Company will continue to monitor industry activities and any additional guidance provided by regulators, standards setters, or the accounting profession, and adjust the Company’s assessment and implementation plans accordingly.

In June 2018, the FASB issued ASU 2018-07: Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees, and as a result, the accounting for share-based payments to non-employees will be substantially aligned. ASU 2018-07 is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year, and early adoption is permitted but no earlier than an entity’s adoption date of ASC 606. The Company does not expect this new guidance will have a material impact on its financial statements and related disclosures.

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($)

3 Months Ended

9 Months Ended

12 Months Ended

Sep. 30, 2019

Sep. 30, 2018

Sep. 30, 2019

Sep. 30, 2018

Dec. 31, 2018

Dec. 31, 2017

Revenue

General and administrative

$ 648,220

$ 552,221

$ 2,677,940

$ 2,187,348

$ 294,630,700,000

$ 321,100,700,000

Operating expenses

Research and development

1,139,369

1,286,300

4,069,335

3,821,117

5,677,243

6,883,293

1,560,706

1,743,636

4,901,136

5,365,221

7,069,315

6,692,659

Sales and marketing

376,955

361,310

1,142,755

1,117,380

1,531,556

2,767,670

Transaction costs

538,061

Impairment of right-of-use asset

520,759

Total operating expenses

4,073,648

3,782,419

12,446,261

11,689,341

16,126,549

18,476,798

Operating loss

(3,425,428)

(3,230,198)

(9,768,321)

(9,501,993)

Other (expense) income

Other income (expense)

1,043

(93)

(8,213)

5,210

5,384

(87,255)

Interest expense

(49,099)

(28,074)

(142,672)

(140,453)

(191,195)

(233,505)

Foreign currency transaction gains (losses)

(8,954)

3,025

(9,426)

(6,556)

(10,431)

23,179

Change in fair value of derivative financial instruments

(85)

8,070

8,386

144,064

Total other expense

(57,010)

(25,227)

(160,244)

(133,729)

(187,856)

(153,517)

Loss before income taxes

(3,482,438)

(3,255,425)

(9,928,565)

(9,635,722)

(13,368,098)

(15,419,308)

Provision for income taxes

Net loss available to common stockholders

(3,482,438)

(3,255,425)

(9,928,565)

(9,635,722)

$ (13,368,098)

$ (15,419,308)

^[1]

$ (3,482,438)

$ (3,255,425)

$ (9,928,565)

$ (9,635,722)

Net loss per common share - basic and diluted

$ (3.95)

^[1]

$ (10.67)

^[1]

$ (13.32)

^[1]

$ (36.09)

^[1]

$ (2.22)

$ (9.80)

Weighted average shares outstanding - basic and diluted

882,280

^[1]

305,187

^[1]

745,471

^[1]

266,997

^[1]

6,009,065

1,573,769

Other comprehensive gain foreign currency translation adjustment

$ (3,482,438)

$ (3,255,425)

$ (9,928,565)

$ (9,635,722)

$ (13,368,098)

$ (15,419,308)

7,298

1,528

5,174

7,062

12,807

(32,076)

Comprehensive loss

(3,475,140)

(3,253,897)

(9,923,391)

(9,628,660)

(13,355,291)

(15,451,384)

Laboratory Service Revenue [Member]

Revenue

Collaborations Revenue [Member]

185

12,365

5,435

22,155

3,466,500,000

4,196,000,000

Revenue

Cost of products and services

75,000

1,075,000

359,316

51,601,600,000

39,717,800,000

Service [Member]

Operating expenses

196,184

98,189

592,647

446,144

625,516

520,338

Product [Member]

Revenue

Cost of products and services

573,035

539,856

1,597,505

1,805,877

239,562,600,000

277,186,900,000

Operating expenses

$ 262,373

$ 292,984

$ 681,568

$ 939,479

$ 1,222,919

$ 1,612,838

[1]	Reflects the 1 for 20 reverse stock split that became effective on August 29, 2019. Refer to Note 8 Stockholders equity for further information.

Commitments - Additional Information (Details)			9 Months Ended	12 Months Ended
Commitments - Additional Information (Details)	Sep. 30, 2019 Product	Dec. 31, 2018 USD ($)	Sep. 30, 2019 Product	Dec. 31, 2018 USD ($)	Dec. 31, 2017 USD ($)
Operating lease description				The Company leases a facility in Gaithersburg, Maryland under an operating lease that expires January 31, 2021, with one additional five-year renewal at the Company’s election. The Company also leases a facility in Woburn, Massachusetts under an operating lease that expires January 30, 2022. Additionally, the Company leases office space in Denmark; this lease is currently on a month-to-month basis.
Operating leases, rent expense, net, total				$ 984,639	$ 949,244
Capital leases description				The Company leases lab equipment, office furniture, and computer equipment under various capital leases. The leases expire at various dates through 2021. The leases require monthly principal and interest payments.
Capital leases expiration date description				The leases expire at various dates through 2021.
Restructuring benefits recognized					121,000
Retention expense incurred					68,000
Future minimum operating lease payments		$ 2,808,835		$ 2,808,835
Designated service period of employees, description				The service periods ended in December 2017
Capital Lease Obligations
Capital leases, income statement, amortization expense				$ 295,009	$ 161,606
MA
Operating leases expiration date				Jan. 31, 2021
Operating leases additional term		5 years		5 years
Advandx \| MA
Operating leases expiration date				Jan. 30, 2022
Future minimum operating lease payments		$ 14		$ 14
Life Technologies Corporation Supply Agreement [Member] \| Quant Studio Five Real Time P C R Systems [Member]
Number of products acquired	24	15		11
Committed to acquire total cost of additional products in next three months		$ 135,000		$ 135,000
Number of products committed to be acquired				3
Number of products acquired during period \| Product			9

License Agreements, Research Collaborations and Development Agreements

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

License Agreements Research Collaborations And Development Agreements [Abstract]

License Agreements, Research Collaborations and Development Agreements

Note 11 – License agreements, research collaborations and development agreements

In 2018, the Company announced a 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 division, to develop a state-of-the-art research program to detect, track, and manage antimicrobial-resistant infections at healthcare institutions statewide. The Company is working together with DOH’s Wadsworth Center and ILÚM to develop an infectious disease digital health and precision medicine platform that connects healthcare institutions to DOH and uses genomic microbiology for statewide surveillance and control of antimicrobial resistance. As part of the collaboration, the Company will receive $1.6 million over the 15 month demonstration portion of the project. The demonstration project began in early 2019. During the three and nine months ended September 30, 2019, the Company recognized $75,000 and $1.1 million of revenue related to the contract, respectively.

The Company is a party to one license agreement to acquire certain patent rights and technologies related to its FISH product line. Royalties are incurred upon the sale of a product or service which utilizes the licensed technology. The Company recognized net royalty expense of $62,500 for each of the three months ended September 30, 2019 and 2018. The Company recognized net royalty expense of $187,500 for each of the nine months ended September 30, 2019 and 2018. Annual future minimum royalty fees are $250,000 under this agreement.

Note 10 - License Agreements, Research Collaborations and Development Agreements

The Company is a party to one license agreement to acquire certain patent rights and technologies related to its FISH product line. Royalties are incurred upon the sale of a product or service which utilizes the licensed technology. Certain of the agreements require the Company to pay minimum royalties or license maintenance fees. The Company recognized net royalty expense of $250,000 and $257,186 for the years ended December 31, 2018 and 2017, respectively. Annual future minimum royalty fees are $250,000 under these agreements.

In September 2017, the Company was awarded a contract from the Centers for Disease Control and Prevention (“CDC”) to develop smartphone-based clinical decision support solutions for antimicrobial stewardship, or AMS, and infection control in low- and middle-income countries. The one-year $860,000 award began September 30, 2017 and funds development and evaluation of cloud-based mobile software. The Company worked with subcontractors Ilúm, LLC, an affiliate of Merck, and Universidad El Bosque (“UEB”) of Bogota, Colombia under this CDC contract. During the years ended December 31, 2018 and 2017, the Company recognized $503,881 and $357,178 of revenue related to the contract, respectively.

In June 2016, the Company entered into a license agreement with Hitachi, pursuant to which it resolved various matters with respect to previously delivered milestones under the technology development agreement and provided a development license and commercial products license to certain technology. The license agreement contains non-contingent multiple elements (the licenses) that the Company determined did not have stand alone value, and a contingent substantive milestone. The licenses are treated as a single unit of accounting and the Company will recognize the revenue associated with that unit of accounting over the applicable license period. During the years ended December 31, 2018 and 2017, the Company recognized $12,397 and $25,000 of revenue related to the license agreement, respectively.

Commitments - Schedule of Capital Leased Assets (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Less accumulated amortization	$ (749,480)	$ (454,471)
Capital lease assets, net	903,006	485,461
Furniture and Fixtures [Member]
Capital leased assets gross	64,790	64,790
Equipment [Member]
Capital leased assets gross	1,563,346	850,792
Computer Equipment [Member]
Capital leased assets gross	$ 24,350	$ 24,350

Leases (Tables)

9 Months Ended

Sep. 30, 2019

Leases [Abstract]

Schedule of ROU Assets and Lease Liabilities

The following table presents the Company’s ROU assets and lease liabilities as of September 30, 2019:

Lease Classification	September 30, 2019
ROU Assets:
Operating	$	1,214,482
Financing		1,096,472
Total ROU assets	$	2,310,954
Liabilities
Current:
Operating	$	987,833
Finance		627,620
Noncurrent:
Operating		812,801
Finance		411,103
Total lease liabilities	$	2,839,357

Schedule of Maturities of Lease Liabilities

Maturities of lease liabilities as of September 30, 2019 by fiscal year are as follows:

Maturity of Lease Liabilities	Operating			Finance			Total
2019	$	279,055		$	180,753		$	459,808
2020		1,128,294			633,130			1,761,424
2021		536,819			270,043			806,862
2022		40,080			41,961			82,041
2023		—			3,364			3,364
Thereafter		—			280			280
Total lease payments		1,984,248			1,129,531			3,113,779
Less: Interest		(183,614	)		(90,808	)		(274,422	)
Present value of lease liabilities	$	1,800,634		$	1,038,723		$	2,839,357

Schedule of Statement of Operations Classification of Lease Costs and Other Information

Statement of operations classification of lease costs are as follows:

		September 30, 2019
Lease Cost	Classification	Three months ended		Nine months ended
Operating	Operating expenses	$	216,368	$	655,963
Finance:
Amortization	Operating expenses		124,749		329,438
Interest expense	Other expenses		18,704		60,482
Total lease costs		$	359,821	$	1,045,883

Other Information	Total
Weighted average remaining lease term (in years)
Operating leases		1.9
Finance leases		1.8
Weighted average discount rate:
Operating leases		10.0	%
Finance leases		9.2	%

Schedule of Supplemental Cash Flow Information

Supplemental Cash Flow Information	Total
Cash paid for amounts included in the measurement of lease liabilities
Cash used in operating activities
Operating leases	$	655,963
Finance leases	$	60,482
Cash used in financing activities
Finance leases	$	389,501
ROU assets obtained in exchange for lease obligations:
Finance leases	$	592,014

Schedule of Future Minimum Lease Payments

Minimum lease payments for future years as of December 31, 2018 were as follows:

Year ending December 31,	Total
2019	$	1,615,679
2020		1,534,204
2021		639,829
2022		40,080
2023 and thereafter		—
Total	$	3,829,792

Liquidity and management's plans

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Liquidation Basis Of Accounting Abstract [Abstract]

Liquidity and management's plans

Note 2 – Liquidity and management’s plans

The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred, and continues to incur, significant losses from operations. The Company has funded its operations primarily through external investor financing transactions, including the following in 2018 and 2019 to date:

•

On March 29, 2019, the Company closed a public offering (the “March 2019 Public Offering”) of 450,000 shares of its common stock at a public offering price of $12.00 per share. The offering raised gross proceeds of $5.4 million and net proceeds of approximately $4.8 million.

•

On October 22, 2018, the Company closed a public offering (the “October 2018 Public Offering”) of 111,000 shares of its common stock at a public offering price of $29.00 per share. The offering raised gross proceeds of approximately $3.2 million and net proceeds of approximately $2.8 million.

•

On June 11, 2018, the Company executed an Allonge (the “Allonge”) to its Second Amended and Restated Senior Secured Promissory Note, dated June 28, 2017, with a principal amount of $1,000,000 issued to Merck Global Health Innovation Fund, LLC (“MGHIF”). The Allonge provided that accrued and unpaid interest of $285,512 due as of July 14, 2018, the original maturity date, be paid through the issuance of shares of OpGen’s common stock in a private placement transaction. In addition, the Allonge revised and extended the maturity date for payment of the Promissory Note to six semi-annual payments of $166,667 plus accrued and unpaid interest beginning on January 2, 2019 and ending on July 1, 2021. On July 30, 2018, the Company issued 7,212 shares of common stock to MGHIF in a private placement transaction for $285,512 of accrued and unpaid interest due as of July 14, 2018 under the MGHIF Note.

•

On February 6, 2018, the Company closed a public offering (the “February 2018 Public Offering”) of 2,841,152 units at $3.25 per unit, and 851,155 pre-funded units at $3.24 per pre-funded unit, raising gross proceeds of approximately $12 million and net proceeds of approximately $10.7 million. Each unit included one twentieth of a share of common stock and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one twentieth of a share of common stock for an exercise price of $0.20 per share, and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. The 851,155 pre-funded warrants issued in the February 2018 Public Offering were exercised during the year ended December 31, 2018.

•

On September 13, 2016, the Company entered into the Sales Agreement (the “Sales Agreement”) with Cowen and Company LLC (“Cowen”) pursuant to which the Company could offer and sell from time to time, up to an aggregate of $25 million of shares of its common stock through Cowen, as sales agent, with initial sales limited to an aggregate of $11.5 million. During the year ended December 31, 2018, the Company sold 15,912 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $0.6 million, and gross proceeds of $0.6 million. The at the market offering was terminated in connection with the October 2018 Public Offering.

To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, strategic financings or other transactions, additional equity financings, debt financings and other funding transactions, licensing and/or partnering arrangements and business combination transactions. There can be no assurance that the Company will be able to complete any such transaction on acceptable terms or otherwise. The Company believes that current cash plus the cash generated from the October 2019 Public Offering (See Note 13 – Subsequent Events) will be sufficient to fund operations into the first quarter of 2020 and to meet the Company’s obligations under the Interim Facility. This has led management to conclude that substantial doubt about the Company’s ability to continue as a going concern exists. In the event the Company is unable to successfully raise additional capital during or before the end of the first quarter of 2020, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated. Accordingly, in such circumstances the Company would be compelled to immediately reduce general and administrative expenses and delay research and development projects, including the purchase of scientific equipment and supplies, until it is able to obtain sufficient financing. If such sufficient financing is not received on a timely basis, the Company would then need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection.

Note 2 - Going Concern and Management’s Plans

The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred, and continues to incur, significant losses from operations. The Company has funded its operations primarily through external investor financing arrangements and significant actions taken by the Company to reduce costs, including:

•

On October 22, 2018, the Company closed a public offering (the “October 2018 Public Offering”) of 2,220,000 shares of its common stock at a public offering price of $1.45 per share. The offering raised gross proceeds of approximately $3.2 million and net proceeds of approximately $2.8 million.

•

On June 11, 2018, the Company executed an Allonge (the “Allonge”) to its Second Amended and Restated Senior Secured Promissory Note, dated June 28, 2017, with a principal amount of $1,000,000 issued to Merck Global Health Innovation Fund, LLC (“MGHIF”). The Allonge provided that accrued and unpaid interest of $285,512 due as of July 14, 2018, the original maturity date, be paid through the issuance of shares of OpGen’s common stock in a private placement transaction. In addition, the Allonge revised and extended the maturity date for payment of the Note to six semi-annual payments of $166,667 plus accrued and unpaid interest beginning on January 2, 2019 and ending on July 1, 2021. On July 30, 2018, the Company issued 144,238 shares of common stock to MGHIF in a private placement transaction for $285,512 of accrued and unpaid interest due as of July 14, 2018 under the MGHIF Note.

•

On February 6, 2018, the Company closed a public offering (the “February 2018 Public Offering”) of 2,841,152 units at $3.25 per unit, and 851,155 pre-funded units at $3.24 per pre-funded unit, raising gross proceeds of approximately $12 million and net proceeds of approximately $10.7 million. Each unit included one share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. As of April 19, 2018, all 851,155 pre-funded warrants issued in the February 2018 Public Offering have been exercised.

•

On July 18, 2017, the Company closed a public offering (the “July 2017 Public Offering”) of 18,164,195 units at $0.40 per unit, and 6,835,805 pre-funded units at $0.39 per pre-funded unit, raising gross proceeds of approximately $10 million and net proceeds of approximately $8.8 million. jVen Capital, LLC (“jVen Capital”) was one of the investors participating in the offering. jVen Capital is an affiliate of Evan Jones, the Company’s Chairman of the Board and Chief Executive Officer. Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. Approximately $1 million of the gross proceeds was used to repay the outstanding Bridge Financing Notes to jVen Capital in July 2017.

•

In early June 2017, the Company commenced a restructuring of its operations to improve efficiency and reduce its cost structure. Under the restructuring plan the Company is consolidating its operations, including manufacturing, for its FDA-cleared and CE marked QuickFISH and PNA FISH families of products and research and development activities for the Acuitas AMR Gene Panel products and services, in Gaithersburg, Maryland, and reducing the size of its commercial organization while the Company works to complete the development of its Acuitas AMR Gene Panel and Acuitas Lighthouse Knowledgebase products and services in development.

•

On May 31, 2017, the Company entered into a Note Purchase Agreement with jVen Capital, under which jVen Capital agreed to provide bridge financing in an aggregate principal amount of up to $1,500,000 to the Company in up to three separate tranches of $500,000 (each, a “Bridge Financing Note” and collectively, the “Bridge Financing Notes”). In connection with the issuance of Bridge Financing Notes, in June and July 2017, the Company issued jVen Capital stock purchase warrants to acquire 5,634 shares with an exercise price of $19.50 per share, and warrants to acquire 6,350 shares with an exercise price of $17.25 per share. The Company drew down on two of three Bridge Financing Notes during June and July 2017, and repaid such outstanding Bridge Financing Notes in full upon the closing of the July 2017 Public Offering.

•

On September 13, 2016, the Company entered into the Sales Agreement (the “Sales Agreement”) with Cowen and Company LLC (“Cowen”) pursuant to which the Company may offer and sell from time to time, up to an aggregate of $25 million of shares of its common stock through Cowen, as sales agent, with initial sales limited to an aggregate of $11.5 million. As of December 31, 2018, the Company sold an aggregate of 690,247 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $8.8 million, and gross proceeds of $9.4 million. During the year ended December 31, 2018, the Company has sold 318,236 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $0.6 million, and gross proceeds of $0.6 million. In connection with the October 2018 Public Offering, the Company terminated the at the market offering.

To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, strategic financings or other transactions, additional equity financings, debt financings and other funding transactions, licensing and/or partnering arrangements and business combination transactions. There can be no assurance that the Company will be able to complete any such transaction on acceptable terms or otherwise. The Company believes that current cash will be sufficient to fund operations into the second quarter of 2019. This has led management to conclude that substantial doubt about the Company’s ability to continue as a going concern exists. In the event the Company is unable to successfully raise additional capital during or before the second quarter of 2019, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated. Accordingly, in such circumstances the Company would be compelled to immediately reduce general and administrative expenses and delay research and development projects, including the purchase of scientific equipment and supplies, until it is able to obtain sufficient financing. If such sufficient financing is not received on a timely basis, the Company would then need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection.

Revenue from contracts with customers

9 Months Ended

12 Months Ended

Sep. 30, 2019

Dec. 31, 2018

Revenue from Contract with Customer [Abstract]

Revenue from contracts with customers

Note 4 – Revenue from contracts with customers

Disaggregated revenue

	Three Months Ended September 30,				Nine Months Ended September 30,
	2019		2018		2019		2018
Product sales	$	573,035	$	539,856	$	1,597,505	$	1,805,877
Laboratory services		185		12,365		5,435		22,155
Collaboration revenue		75,000		—		1,075,000		359,316
Total revenue	$	648,220	$	552,221	$	2,677,940	$	2,187,348

Deferred revenue

Changes in deferred revenue for the period were as follows:

Balance at December 31, 2018	$	15,824
Revenue recognized in the current period from the amounts in the beginning balance		(6,016	)
New deferrals, net of amounts recognized in the current period		—
Balance at September 30, 2019	$	9,808

Contract assets

The Company had no contract assets as of September 30, 2019, which are generated when contractual billing schedules differ from revenue recognition timing. Contract assets represent a conditional right to consideration for satisfied performance obligations that becomes a billed receivable when the conditions are satisfied.

Unsatisfied performance obligations

Remaining contract consideration for which revenue has not been recognized due to unsatisfied performance obligations was $500,000 at September 30, 2019, which the Company expects to recognize over the next six months.

Note 4 - Revenue from Contracts with Customers

Disaggregated Revenue

	December 31,
	2018		2017
Product sales	$	2,395,626	$	2,771,869
Laboratory services		34,665		41,960
Collaboration revenue		516,016		397,178
Total revenue	$	2,946,307	$	3,211,007

Deferred Revenue

Changes in deferred revenue for the period were as follows:

Balance at December 31, 2017	$	24,442
Revenue recognized in the current period from the amounts in the beginning balance		(14,450	)
New deferrals, net of amounts recognized in the current period		5,832
Balance at December 31, 2018	$	15,824

Contract Assets

The Company had no contract assets as of December 31, 2018, which are generated when contractual billing schedules differ from revenue recognition timing. Contract assets represent a conditional right to consideration for satisfied performance obligations that becomes a billed receivable when the conditions are satisfied.

Unsatisfied Performance Obligations

The Company had no unsatisfied performance obligations related to its contracts with customers at December 31, 2018.

Commitments - Schedule of Future Minimum Lease Payments For Capital Leases (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Capital Leases
2019	$ 508,114
2020	408,264
2021	104,579
Total	1,020,957
Less: amount representing interest	(96,251)
Less: amount representing service costs	(88,172)
Net present value of future minimum lease payments	836,534
Current maturities	(399,345)	$ (154,839)
Long-term maturities	437,189
Operating Leases
2019	1,107,565
2020	1,125,940
2021	535,250
2022	40,080
Total	2,808,835
Total
2019	1,615,679
2020	1,534,204
2021	639,829
2022	40,080
Total	$ 3,829,792

Fair value measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis
Balance at the beginning of the period	$ 67	$ 8,453
Change in Fair Value		(8,386)
Balance at the end of the period		67
Warrant [Member]
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis
Balance at the beginning of the period	67
Change in Fair Value	(67)
Balance at the end of the period	$ 0	$ 67

Commitments (Tables)

12 Months Ended

Dec. 31, 2018

Commitments and Contingencies Disclosure [Abstract]

Schedule of Future Minimum Lease Payments For Capital Leases

Following is a schedule by year of the estimated future minimum payments under all operating and capital leases as of December 31, 2018:

Year ending December 31,	Capital Leases			Operating Leases		Total
2019	$	508,114		$	1,107,565	$	1,615,679
2020		408,264			1,125,940		1,534,204
2021		104,579			535,250		639,829
2022		—			40,080		40,080
2023 and thereafter		—			—		—
Total		1,020,957		$	2,808,835	$	3,829,792
Less: amount representing interest		(96,251	)
Less: amount representing service costs		(88,172	)
Net present value of future minimum lease payments		836,534
Current maturities		(399,345	)
Long-term maturities	$	437,189

Schedule of Capital Leased Assets

Assets under capital leases were included in the following balance sheet categories as of December 31:

	2018			2017
Laboratory and manufacturing equipment	$	1,563,346		$	850,792
Office furniture and equipment		64,790			64,790
Computers and network equipment		24,350			24,350
Less accumulated amortization		(749,480	)		(454,471	)
Capital lease assets, net	$	903,006		$	485,461

Income Taxes - Expected Income Tax Provision (Details)	12 Months Ended
Income Taxes - Expected Income Tax Provision (Details)	Dec. 31, 2018	Dec. 31, 2017
Income Tax Disclosure [Abstract]
Federal income tax benefit at statutory rates	21.00%	34.00%
Permanent adjustment	(1.40%)
Provision to return adjustment	(0.20%)
State income tax benefit, net of Federal benefit	(6.40%)	6.80%
Tax reform impact		(134.50%)
Change in valuation allowance	(13.00%)	93.00%
Change in state tax rates and other		0.70%
Total	0.00%	0.00%

Income taxes (Tables)

12 Months Ended

Dec. 31, 2018

Income Tax Disclosure [Abstract]

Deferred Tax Assets and Liabilities

The Company’s deferred tax assets and liabilities as of December 31, 2018 and 2017 are as follows:

	December 31,
	2018			2017
Deferred tax assets:
NOL carryforward	$	49,480,731		$	46,326,407
R&E credit carryforward		2,559,479			2,559,479
Share-based compensation		329,796			345,088
Inventory reserve		19,068			45,338
Depreciation		—			71,756
Interest expense		51,152			—
Accruals and other		284,662			247,093
Total deferred tax assets		52,724,888			49,595,161
Valuation allowance		(52,348,036	)		(49,251,408	)
Deferred tax liabilities:
Intangible assets		(256,011	)		(343,753	)
Depreciation		(120,841	)		—
Net	$	—		$	—

Expected Income Tax Provision (Benefit) from Applying Federal Statutory Tax Rates to the Pre-Tax Loss and Actual Income Tax Provision (Benefit)

	2018			2017
Federal income tax benefit at statutory rates		21.0	%		34.0	%
Permanent adjustment		(1.4	)%		—
Provision to return adjustment		(0.2	)%		—
State income tax benefit, net of Federal benefit		(6.4	)%		6.8	%
Tax reform impact		—			(134.5	)%
Change in valuation allowance		(13.0	)%		93.0	%
Change in state tax rates and other		—			0.7	%
		0.0	%		0.0	%

Condensed Consolidated Statements of Stockholders' Equity (10-K) - USD ($)

Common Stock [Member]

Public Placement [Member]

Common Stock [Member]

At The Market Offering [Member]

Sales Agreement [Member]

Cowen And Company Limited Liability Company [Member]

Common Stock [Member]

At The Market Offering [Member]

Common Stock [Member]

October Two Thousand Eighteen Public Offering [Member]

Common Stock [Member]

Additional Paid In Capital [Member]

Public Placement [Member]

Additional Paid In Capital [Member]

At The Market Offering [Member]

Additional Paid In Capital [Member]

Accumulated Other Comprehensive Income [Member]

Retained Earnings [Member]

Public Placement [Member]

At The Market Offering [Member]

Sales Agreement [Member]

Cowen And Company Limited Liability Company [Member]

Maximum [Member]

At The Market Offering [Member]

Sales Agreement [Member]

Cowen And Company Limited Liability Company [Member]

At The Market Offering [Member]

Total

Balance at Dec. 31, 2016

$ 10,122

$ 136,442,302

$ 6,176

$ (133,291,119)

$ 3,167,481

Balance (in shares) at Dec. 31, 2016

1,012,171

Stock option exercises

$ 12

8,168

$ 8,180

1,167

Issuance of units, net of offering costs (in shares)

$ 2,272

$ 3,808,836

$ 2,272

$ 3,806,564

$ 3,808,836

3,806,564

$ 8,823,242

$ 3,808,836

227,216

1,000,000

227,216

1,000,000

227,216

$ 60

$ (60)

(60)

6,025

Legal settlement in common stock

911,398

$ 911,398

$ 158

109,841

109,999

Legal settlement in common stock (in shares)

15,843

Vendor payment in common stock

$ 29

23,216

23,245

Vendor payment in common stock (in shares)

2,898

(32,076)

(15,419,308)

$ 22,653

^[1]

150,114,671

(25,900)

(148,710,427)

1,400,997

2,265,320

^[1]

Issuance of units, net of offering costs (in shares)

$ 151,000,000

^[1]

1,071,989,000,000

$ 1,072,140,000,000

^[1]

150,962

$ 3

^[1]

(3)

^[1]

270

Share cancellation (in shares)

238,190

^[1]

(2)

(12,579)

(3,048,084)

$ 2,646

^[1]

161,094,268

(38,479)

(151,758,511)

9,299,924

^[1]

264,496

$ 22,653

^[1]

150,114,671

(25,900)

(148,710,427)

1,400,997

2,265,320

^[1]

(9,635,722)

$ 3,214

^[1]

162,391,324

(18,838)

(158,346,149)

4,029,551

^[1]

321,274

$ 22,653

^[1]

150,114,671

(25,900)

(148,710,427)

$ 1,400,997

2,265,320

^[1]

Issuance of units, net of offering costs (in shares)

$ 3,182

$ 597,743

$ 3,182

$ 594,561

$ 597,743

594,561

$ 13,530,401

$ 597,743

318,236

15,912

318,236

5,912,307

318,236

5,912,307

318,236

$ 57

$ (57)

(57)

5,650

Share cancellation (in shares)

862,281

$ 862,281

(31)

Interest settlement in common stock, (in shares)

$ 1,442

271,168

272,610

144,238

12,807

(13,368,098)

$ 86,457

^[1]

165,313,902

(13,093)

(162,078,525)

3,308,741

8,645,720

^[1]

$ 2,646

^[1]

161,094,268

(38,479)

(151,758,511)

9,299,924

^[1]

264,496

Issuance of units, net of offering costs (in shares)

$ 33,700,000

^[1]

$ 5,200,000

^[1]

639,400,000

19,226,800,000

$ 673,100,000

$ 19,232,000,000

^[1]

33,654

5,202

213,890

18,113

Balance (in shares) at Jun. 30, 2018

(3,332,213)

Balance at Jun. 30, 2018

$ 3,035

^[1]

161,506,820

(20,366)

(155,090,724)

6,398,765

^[1]

303,352

Issuance of units, net of offering costs (in shares)

$ 10,700,000

^[1]

40,531,600,000

$ 40,542,300,000

^[1]

10,710

206,651

Interest settlement in common stock, (in shares)

$ 72

^[1]

272,537

272,609

^[1]

7,212

1,528

(3,255,425)

$ 3,214

^[1]

162,391,324

(18,838)

(158,346,149)

4,029,551

^[1]

321,274

$ 86,457

^[1]

165,313,902

(13,093)

(162,078,525)

3,308,741

8,645,720

^[1]

Issuance of units, net of offering costs (in shares)

$ 450,000,000

^[1]

477,800,900,000

$ 478,250,900,000

^[1]

450,000

98,033

2,826

(3,853,116)

$ 8,823

^[1]

170,272,078

(10,267)

(165,931,641)

4,338,993

^[1]

882,286

$ 86,457

^[1]

$ 165,313,902

165,313,902

(13,093)

(162,078,525)

3,308,741

8,645,720

^[1]

(9,928,565)

(1,556,970)

$ 8,823

^[1]

$ 170,272,078

$ (10,267)

$ (165,931,641)

4,338,993

^[1]

882,286

(2,593,011)

Balance at Jun. 30, 2019

1,827,003

(3,482,438)

Proceeds from issuance of common stock, net of issuance costs

$ (1,556,970)

[1]	Reflects the 1 for 20 reverse stock split that became effective on August 29, 2019. Refer to Note 8 Stockholders equity for further information.

Revenue from Contracts with Customers - Summary of Changes in Deferred Revenue (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018
Revenue Recognition and Deferred Revenue [Abstract]
Balance at December 31, 2017	$ 15,824	$ 24,422
Revenue recognized in the current period from the amounts in the beginning balance		(14,450)
New deferrals, net of amounts recognized in the current period		5,832
Balance at December 31, 2018	15,824	15,824
Revenue recognized in the current period from the amounts in the beginning balance	(6,016)
Balance at September 30, 2019	$ 9,808	$ 15,824

Liquidity and Management's Plans - Additional Information (Details 1) - USD ($)

1 Months Ended

3 Months Ended

6 Months Ended

9 Months Ended

12 Months Ended

28 Months Ended

Oct. 22, 2018

Jul. 30, 2018

Jul. 14, 2018

Jun. 11, 2018

Apr. 19, 2018

Feb. 06, 2018

Jul. 18, 2017

Sep. 13, 2016

Oct. 31, 2017

Jul. 31, 2017

Jul. 31, 2015

Mar. 31, 2019

Sep. 30, 2018

Jun. 30, 2018

Mar. 31, 2018

Jun. 30, 2019

Jun. 30, 2018

Sep. 30, 2019

Sep. 30, 2018

Dec. 31, 2018

Dec. 31, 2017

Dec. 31, 2018

Jun. 30, 2017

Jun. 28, 2017

May 31, 2017

$ 478,250,900,000

$ 19,232,000,000

$ 4,782,509

$ 597,743

$ 3,808,836

Net proceeds from sale of common stock and warrants

$ 0

$ 1,072,813,100,000

$ 0

$ 10,728,132

$ 13,530,401

$ 8,754,882

Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | Maximum [Member]

Bridge Financing Note Two [Member] | Note Purchase Agreement [Member]

$ 150,000,000,000

Bridge Financing Note One [Member] | Note Purchase Agreement [Member]

50,000,000,000

Bridge Financing Note Three [Member] | Note Purchase Agreement [Member]

50,000,000,000

M G H I F Financing Agreement [Member]

$ 50,000,000,000

45,454

Proceeds from issuance of common stock, net of issuance costs

$ 110.00

$ 5,000,000

M G H I F Financing Agreement [Member] | Second Amended And Restated Senior Secured Promissory Note [Member]

$ 1,000,000

$ 1,000,000

Revised and extended maturity date for payment, terms

$ 285,512

Six semi-annual payments

Principal payments includes accrued and unpaid interest

$ 166,667

Beginning date of debt maturity

Jan. 02, 2019

Ending date of debt maturity

Jul. 01, 2021

Amended And Restated M G H I F Financing Agreement [Member]

Class of warrant or right, number of securities called by warrants or rights

13,120

February Two Thousand Eighteen Public Offering [Member]

2,841,152

Gross proceeds from sale of common stock and warrants

$ 3.25

$ 120,000,000,000

Net proceeds from sale of common stock and warrants

$ 10,700,000

Class of warrant or right, number of securities called by each warrant or right

0.025

Class of warrant or right, exercise price of warrants or rights

$ 65.00

July Two Thousand Seventeen Public Offering [Member]

5 years

18,164,195

Gross proceeds from sale of common stock and warrants

$ 0.40

$ 1,000,000

Net proceeds from sale of common stock and warrants

$ 8,800,000

Class of warrant or right, number of securities called by each warrant or right

Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share.

0.04

Class of warrant or right, exercise price of warrants or rights

$ 10.625

July Two Thousand Seventeen Public Offering [Member] | Bridge Financing Notes [Member]

5 years

Repayment of outstanding debt

$ 100,000

318,236

227,216

690,247

At The Market Offering [Member] | Sales Agreement [Member] | Cowen And Company Limited Liability Company [Member]

$ 115

$ 40,542,300,000

$ 19,232,000,000

$ 597,743

$ 3,808,836

318,236

227,216

690,247

Proceeds from issuance of common stock, net of issuance costs

$ 600,000

600,000

Aggregate gross proceeds from issuance of common stock

9,400,000

$ 9,400,000

Aggregate net proceeds from sale of common stock

$ 11,500,000

11,500,000

597,743

$ 3,808,836

$ 8,800,000

At The Market Offering [Member] | Sales Agreement [Member] | Cowen And Company Limited Liability Company [Member] | Maximum [Member]

Aggregate gross proceeds from issuance of common stock

318,236

227,216

690,247

$ 2,500,000,000,000

2,500,000,000,000

115

$ 597,743

$ 3,808,836

5,912,307

1,000,000

$ 478,250,900,000

$ 673,100,000

$ 1,072,140,000,000

$ 13,530,401

$ 8,823,242

318,236

227,216

690,247

Common Stock [Member] | Vendor Consulting Services [Member]

$ 3,182

$ 2,272

2,898

Common Stock [Member] | October Two Thousand Eighteen Public Offering [Member]

$ 2,324,500,000

111,000

318,236

227,216

690,247

$ 29.00

Proceeds from issuance of common stock, net of issuance costs

$ 3,200,000

$ 2,800,000

Common Stock [Member] | Private Placement [Member] | M G H I F Financing Agreement [Member] | Second Amended And Restated Senior Secured Promissory Note [Member]

$ 3,182

$ 2,272

144,238

Accrued and unpaid interest due date

$ 285,512

Jul. 14, 2018

Common Stock [Member] | At The Market Offering [Member]

10,710

^[1]

5,202

^[1]

318,236

227,216

690,247

Common Stock [Member] | At The Market Offering [Member] | Sales Agreement [Member] | Cowen And Company Limited Liability Company [Member]

115

$ 10,700,000

^[1]

$ 5,200,000

^[1]

$ 597,743

$ 3,808,836

15,912

690,247

450,000

^[1]

33,654

^[1]

150,962

^[1]

318,236

227,216

690,247

Pre Funded Warrant [Member] | February Two Thousand Eighteen Public Offering [Member]

$ 450,000,000

^[1]

$ 33,700,000

^[1]

$ 151,000,000

^[1]

$ 3,182

$ 2,272

Class of warrant or right, exercise price of warrants or rights

$ 0.20

Pre Funded Warrant [Member] | July Two Thousand Seventeen Public Offering [Member]

851,155

Class of warrant or right, number of securities called by each warrant or right

0.04

Class of warrant or right, exercise price of warrants or rights

$ 0.25

Prefunded Units [Member] | February Two Thousand Eighteen Public Offering [Member]

851,155

Prefunded Units [Member] | July Two Thousand Seventeen Public Offering [Member]

$ 3.24

6,835,805

$ 0.39

Additional Paid In Capital [Member] | At The Market Offering [Member]

$ 594,561

$ 3,806,564

318,236

227,216

690,247

Additional Paid In Capital [Member] | Public Placement [Member]

$ 115

$ 40,531,600,000

19,226,800,000

$ 597,743

$ 3,808,836

5,912,307

1,000,000