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 2019 and
2020 to date:
· On February 11, 2020, the Company entered into an At the Market Common Offering
(the "ATM Agreement") with H.C. Wainwright & Co., LLC ("Wainwright"), which we
amended and restated on November 13, 2020 to add BTIG, LLC ("BTIG"), pursuant
to which the Company may offer and sell from time to time in an "at the market
offering," at its option, up to an aggregate of $22.1 million of shares of the
Company's common stock through the sales agents, (the "2020 ATM Offering").
During the three months ended September 30, 2020, the Company sold 1,523,663
shares of its common stock under the 2020 ATM Offering resulting in aggregate
net proceeds to the Company of approximately $3.6 million, and gross proceeds
of $3.8 million. During the nine months ended September 30, 2020, the Company
sold 7,078,039 shares of its common stock under the 2020 ATM Offering resulting
in aggregate net proceeds to the Company of approximately $15.0 million, and
gross proceeds of $15.7 million.
· On October 28, 2019, the Company closed a public offering (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, raising gross proceeds of approximately
$9.4 million and net proceeds of approximately $8.3 million. Each unit included
one share of common stock and one common warrant to purchase one share of
common stock at an exercise price of $2.00 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 one share
of common stock at an exercise price of $2.00 per share. The common warrants
are exercisable immediately and have a five-year term from the date of
issuance. As of September 30, 2020, all 2,109,830 pre-funded warrants issued in
the October 2019 Public Offering have been exercised. Additionally, during the
nine months ended September 30, 2020, 4,341,000 common warrants issued in the
October 2019 Public Offering were exercised for net proceeds of approximately
$8.7 million. As of September 30, 2020, 359,000 common warrants issued in the
October 2019 Public Offering remain outstanding.
· 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.
8
To meet our 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. 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 first quarter of 2021. 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 2021, 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 we are able to obtain
sufficient financing. If 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 3 - Summary of significant accounting policies
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 following unaudited condensed consolidated
financial statements be read in conjunction with the audited consolidated
financial statements and the notes thereto included in the Company's latest
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, 2019 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 as of September 30, 2020
including Curetis GmbH and subsidiaries acquired on April 1, 2020; all
intercompany transactions and balances have been eliminated.
Foreign currency
The Company has subsidiaries located in Holzgerlingen, Germany; Vienna, Austria;
Copenhagen, Denmark; and Bogota, Colombia, each 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 income (loss), a component of
stockholders' equity. Foreign currency translation adjustments are the sole
component of accumulated other comprehensive income (loss) at September 30, 2020
and 2019.
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 United States
dollar.
9
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, determining the fair
value of assets acquired and liabilities assumed in business combinations, the
estimated useful lives of long-lived assets, and the recoverability 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 equivalents, 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.
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 Deposit Insurance Corporation ("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, 2020 and December 31, 2019, the Company had funds totaling
$293,972 and $185,380, 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 unaudited
condensed consolidated balance sheets.
The following table provides a reconciliation of cash, cash equivalents and
restricted cash reported within the condensed consolidated balance sheets that
sum to the total of the same amounts shown in the statements of cash flows:
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