UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q/A

(Amendment No. 1)

(Mark one)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2024

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________ to __________

Commission File Number 001-37367

OPGEN, INC.

(Exact name of registrant as specified in its charter)

Delaware		06-1614015
(State or other jurisdiction of incorporation or organization)		(I.R.S. employer identification no.)

23219 Stringtown Road, Suite 300, Clarksburg, MD		20871
(Address of principal executive offices)		(Zip code)

Registrant’s telephone number, including area code: (240) 813-1260

Securities registered or to be registered pursuant to Section 12(b) of the Act.

Title of each class		Trading Symbols		Name of each exchange on which registered
Common Stock		OPGN		Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐ No ☒

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☐ No ☒

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

8,355,496 shares of the Company’s common stock, par value $0.01 per share, were outstanding as of August 16, 2024.

EXPLANATORY NOTE

OpGen, Inc. (the “Company”) is filing this Amendment No. 1 on Form 10-Q/A (the “Amended 10-Q”) to amend the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024 (the “Original 10-Q”), originally filed with the Securities and Exchange Commission (the “SEC”) on July 8, 2024, to amend and restate the original filing in its entirety in response to certain matters described in this explanatory note.

Subsequent to the filing of the Company’s Original 10-Q for the three months ended March 31, 2024, the Company identified an error relating to the accounting treatment of an indemnification asset in the Company’s previously issued unaudited condensed consolidated financial statements included in the Company’s Original 10-Q for the quarter ended March 31, 2024 (the “Affected Period”).

During the three months ended December 31, 2023, the Company recorded impairments to the Company’s operating lease right-of-use asset and leasehold improvement property and equipment relating to the Company’s lease in Rockville, Maryland, since the Company did not initially foresee ongoing benefits from the lease given the Company’s financial position and its inability to identify a subtenant for such space. During the three months ended March 31, 2024, the Company identified a subtenant, and as a result, recorded an indemnification asset and associated gain on lease indemnification to reflect the new subtenant’s agreement to indemnify the Company from any claims, obligations, or liabilities that may arise during their tenancy beginning on April 1, 2024. The Company subsequently determined that this accounting was incorrect and that it should continue to account for the headlease as a continuing operating lease and the lease assignment as a sublease. As a result, the Company is filing this Amended 10-Q to correct the error in the Affected Period by adjusting the following information for the three months ended March 31, 2024: (i) removing the previously recorded indemnification asset and gain on lease indemnification; and (ii) changing the accounting estimates related to the Company’s operating lease right-of-use asset and leasehold improvement property and equipment and recording a gain on impairment adjustment associated with the Rockville, Maryland office due to the identification of a subtenant in the three months ended March 31, 2024. In total, the restatement and associated change in accounting estimates resulted in an incremental loss of approximately $0.1 million.

As a result of this error, the Company determined that the previously issued unaudited condensed consolidated financial statements for the Affected Period should no longer be relied upon. All material restatement information is included in this Amended 10-Q, and we do not intend to separately amend other filings that we have previously filed with the SEC. Accordingly, investors and other readers should rely only on the financial information and other disclosures regarding the Affected Period in this Amended 10-Q and in any other future filings with the SEC, as applicable, and should not rely on any previously issued or filed reports, press releases, corporate presentations or similar communications relating to the Affected Period.

As a result of the error described above and the related restatement, the Company has identified a material weakness in its internal control over financial reporting, as described in more detail in the revised Part I – Item 4. Controls and Procedures of this Amended 10-Q. Due to the identification of a material weakness, the Company concluded that its disclosure controls and procedures and internal control over financial reporting were not effective as of March 31, 2024. A discussion of the Company’s plans to remediate this material weakness is set forth in the revised Part I – Item 4. Controls and Procedures of this Amended 10-Q.

Except as described above and the items set forth below, no other amendments are being made to the Original 10-Q. This Amended 10-Q does not reflect events occurring after the filing of the Original 10-Q or modify or update the disclosure contained therein in any way other than as required to reflect the amendments discussed above.

The Company has included in this Amended 10-Q updated certifications executed as of the date of this Amended 10-Q by the Company’s principal executive officer and principal financial officer as required by Sections 302 and 906 of the Sarbanes Oxley Act of 2002. The updated certifications are included as Exhibits 31.1, 31.2, and 32.1 to this Amended 10-Q.

Items restated in this Form 10-Q/A

The following items have been revised in this Amended 10-Q, solely as a result of, and to reflect, the restatement described above:

●

Part I – Item 1. Unaudited Condensed Consolidated Financial Statements

●

Part I – Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

●

Part I – Item 4. Controls and Procedures

●

Part II – Item 6. Exhibits

For the convenience of the reader, this Amended 10-Q sets forth the information in the original filing in its entirety, as such information is modified and superseded where necessary to reflect the restatement.

OPGEN, INC.

TABLE OF CONTENTS FOR FORM 10-Q/A

INFORMATION REGARDING FORWARD-LOOKING STATEMENTS		iv

PART I.	FINANCIAL INFORMATION	1

Item 1.	Unaudited Condensed Consolidated Financial Statements	1
	Condensed Consolidated Balance Sheets at March 31, 2024 and December 31, 2023	1
	Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three months ended March 31, 2024 and 2023	2
	Condensed Consolidated Statements of Stockholders’ (Deficit) Equity for the three months ended March 31, 2024 and 2023	3
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2024 and 2023	4
	Notes to Unaudited Condensed Consolidated Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	34
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	42
Item 4.	Controls and Procedures	42

PART II.	OTHER INFORMATION	43

Item 1.	Legal Proceedings	43
Item 1A.	Risk Factors	43
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	43
Item 3.	Defaults Upon Senior Securities	43
Item 4.	Mine Safety Disclosures	43
Item 5.	Other Information	43
Item 6.	Exhibits	44

SIGNATURES		45

iii

INFORMATION REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q/A of OpGen, Inc. contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In this quarterly report, we refer to OpGen, Inc. as the “Company,” “we,” “our” or “us.” All statements other than statements of historical facts contained herein, including statements regarding our future results of operations and financial position, strategy and plans, and our expectations for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect” or the negative version of these words and similar expressions are intended to identify forward-looking statements.

We have based these forward-looking statements on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, strategy, short- and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in Part I Item 1A “Risk Factors” of our most recent annual report on Form 10-K and any risk factors included in Part II Item 1A “Risk Factors” of this quarterly report on Form 10-Q/A. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances included herein may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Forward-looking statements include, but are not limited to, statements about:

●

our liquidity and working capital requirements, including our cash requirements over the next 12 months;

●

our ability to maintain compliance with the ongoing listing requirements for the Nasdaq Capital Market;

●

our ability to execute upon and achieve the benefits of the strategic direction under the Company’s new leadership and Board;

●

our ability to identify and realize the benefits of potential strategic transactions;

●

adverse effects on our business condition and results of operations from general economic and market conditions and overall fluctuations in the United States and international markets, including deteriorating market conditions due to investor concerns regarding inflation;

●

our use of proceeds from capital financing transactions;

●

compliance with the U.S. regulations applicable to our business; and

●

our expectations regarding future revenue and expenses.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. In addition, neither we nor any other person assumes responsibility for the accuracy and completeness of any of these forward-looking statements. These risks should not be construed as exhaustive and should be read in conjunction with our other disclosures, including but not limited to the risk factors described in Part I Item 1A “Risk Factors” of our most recent annual report on Form 10-K and any risk factors included in Part II, Item 1A of this quarterly report. Other risks may be described from time to time in our filings made under the securities laws. New risks emerge from time to time. It is not possible for our management to predict all risks. All forward-looking statements in this quarterly report speak only as of the date made and are based on our current beliefs and expectations. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

NOTE REGARDING TRADEMARKS

We own various U.S. federal trademark registrations and applications and unregistered trademarks and servicemarks, including but not limited to OpGen^® and Acuitas^®. All other trademarks, servicemarks or trade names referred to in this quarterly report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this quarterly report are sometimes referred to without the^® and™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies, products or services.

Part I. FINANCIAL INFORMATION

Item 1. Unaudited Condensed Consolidated Financial Statements

OpGen, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(unaudited)


	March 31, 2024			December 31, 2023
	(As Restated)
Assets
Current assets
Cash and cash equivalents	$	267,493		$	1,151,823
Accounts receivable, net		37,968			103,316
Prepaid expenses and other current assets		227,112			324,735
Total current assets		532,573			1,579,874
Property and equipment, net		1,192,774			-
Operating lease right-of-use assets		844,705			-
Finance lease right-of-use assets, net		-			138
Other noncurrent assets		302,262			302,262
Total assets	$	2,872,314		$	1,882,274

Liabilities and Stockholders’ Deficit
Current liabilities
Accounts payable	$	191,575		$	111,149
Accrued compensation and benefits		47,828			127,601
Accrued liabilities		378,586			135,476
Deferred revenue		8,571			25,926
EIB loan guaranty		10,920,451			10,873,867
Short-term finance lease liabilities		-			280
Short-term operating lease liabilities		154,117			147,943
Total current liabilities		11,701,128			11,422,242
Long-term operating lease liabilities, net of short-term amount		1,981,428			2,021,616
Total liabilities		13,682,556			13,443,858

Commitments and contingencies (Note 8)

Stockholders’ deficit
Series D convertible preferred stock, $0.01 par value; 1,000 shares authorized; 250 shares issued and outstanding at March 31, 2024 and December 31, 2023		2			2,500
Series E convertible preferred stock, $0.01 par value; 3,000,000 shares authorized; 200,000 and 0 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively		2,000			-
Common stock, $0.01 par value; 100,000,000 shares authorized; 1,303,739 and 1,282,686 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively		13,037			12,827
Additional paid-in capital		294,380,054			293,991,529
Accumulated deficit		(305,205,335	)		(305,493,302	)
Accumulated other comprehensive loss		-			(75,138	)
Total stockholders’ deficit		(10,810,242	)		(11,561,584	)
Total liabilities and stockholders’ deficit	$	2,872,314		$	1,882,274

See accompanying notes to unaudited condensed consolidated financial statements.

OpGen, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(unaudited)


	Three months ended March 31,
	2024			2023
	(As Restated)
Revenue
Product sales	$	141,373		$	410,897
Laboratory services		26,776			21,673
Collaboration revenue		-			480,874
Total revenue		168,149			913,444

Operating expenses
Cost of products sold		73,236			592,378
Cost of services		1,575			128,306
Research and development, net		25,856			1,812,831
General and administrative		1,684,151			2,423,953
Sales and marketing		128,646			1,026,087
Total operating expenses		1,913,464			5,983,555

Operating loss		(1,745,315	)		(5,070,111	)

Other income (expense)
Interest and other income		10			30,106
Gain on impairment adjustment		2,079,575			-
Interest expense		-			(617,298	)
Foreign currency transaction gains (losses)		281			(91,994	)
Change in fair value of derivative financial instruments		-			12,694
Change in fair value of EIB loan guaranty		(46,584	)		-
Total other income (expense)		2,033,282			(666,492	)

Income (loss) before income taxes		287,967			(5,736,603	)
Provision for income taxes		-			-
Net income (loss)	$	287,967		$	(5,736,603	)
Net income (loss) allocated to preferred stockholders		(84,462	)		-
Net income (loss) available to common stockholders	$	203,505		$	(5,736,603	)

Earnings (loss) per share attributable to common stockholders
Basic	$	0.158		$	(12.53	)
Diluted	$	0.154		$	(12.53	)

Weighted average shares outstanding
Basic		1,284,305			457,727
Diluted		1,331,578			457,727

Net income (loss)	$	287,967		$	(5,736,603	)
Other comprehensive income - foreign currency translation		-			153,067
Comprehensive income (loss)	$	287,967		$	(5,583,536	)

See accompanying notes to unaudited condensed consolidated financial statements.

OpGen, Inc. and Subsidiaries

Condensed Consolidated Statements of Stockholders’ (Deficit) Equity

(unaudited)


	Common Stock				Preferred Stock				Additional			Accumulated Other Comprehensive
	Number of Shares		Amount		Number of Shares		Amount		Paid-in Capital			Income (Loss)			Accumulated Deficit			Total
Balances at December 31, 2022		289,992	$	2,900		-	$	-	$	281,193,260		$	(795,840	)	$	(272,824,772	)	$	7,575,548
Issuance of RSUs		1,163		12		-		-		(12	)		-			-			-
Stock compensation expense		-		-		-		-		211,122

Amendment: SEC Form 10-Q/A filed by OpGen Inc.