OpGen(OPGN) - 2021 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Unaudited Condensed Consolidated Financial Statements OpGen's Q1 2021 saw revenue increase and cash rise significantly from financing, despite a widened operating loss and substantial net loss Condensed Consolidated Balance Sheets Total assets increased to $75.2 million, driven by a significant rise in cash to $39.4 million, with stockholders' equity also growing substantially Condensed Consolidated Balance Sheet Highlights (unaudited) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $39,397,437 | $13,360,463 | | Total current assets | $42,773,526 | $16,887,643 | | Total assets | $75,155,598 | $49,751,045 | | Liabilities & Equity | | | | Total current liabilities | $6,573,201 | $7,372,030 | | Total liabilities | $29,124,317 | $28,559,790 | | Total stockholders' equity | $46,031,281 | $21,191,255 | Condensed Consolidated Statements of Operations and Comprehensive Loss Revenue increased to $0.83 million, but rising operating expenses and a $7.8 million warrant expense resulted in a $14.9 million net loss Condensed Consolidated Statements of Operations (unaudited) | Metric | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :--- | :--- | :--- | | Total revenue | $829,716 | $616,933 | | Total operating expenses | $7,090,934 | $4,611,419 | | Operating loss | $(6,261,218) | $(3,994,486) | | Warrant inducement expense | $(7,755,541) | $— | | Net loss | $(14,850,591) | $(3,949,294) | | Net loss per common share | $(0.50) | $(0.53) | Condensed Consolidated Statements of Stockholders' Equity Stockholders' equity increased to $46.0 million, primarily from stock offerings and warrant exercises, partially offset by a net loss - Raised $23.5 million net from an offering of common stock and warrants[21] - Received $9.1 million net from common stock warrant exercises[21] - Recognized a $7.8 million non-cash inducement expense related to a warrant repricing, which was added to additional paid-in capital[21] Condensed Consolidated Statements of Cash Flows Operating activities used $5.0 million, while financing activities provided $32.3 million, leading to a net cash increase of $25.9 million Cash Flow Summary (unaudited) | Cash Flow Activity | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,965,928) | $(2,344,742) | | Net cash used in investing activities | $(850,885) | $(2,201,057) | | Net cash provided by financing activities | $32,305,045 | $13,265,207 | | Net increase in cash | $25,859,234 | $8,761,232 | Notes to Unaudited Condensed Consolidated Financial Statements Notes detail the Curetis business combination, management's going concern doubt despite financing, and the discontinuation of the FISH product line - On April 1, 2020, OpGen completed its business combination with Curetis N.V., acquiring Curetis GmbH and other assets[27] - Management has concluded that substantial doubt exists about the Company's ability to continue as a going concern, as current cash is projected to fund operations only into the second quarter of 2022[32] - The company is discontinuing its QuickFISH and PNA FISH product portfolio, with the exit to be completed by June 30, 2021[29] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the Curetis acquisition and FISH exit, Q1 2021 revenue increase, rising expenses, significant capital raise, and ongoing going concern doubt - The company's focus is on its combined portfolio from the Curetis acquisition, including Unyvero, Acuitas, and ARES platforms, while exiting the FISH business by June 30, 2021[155] Q1 2021 vs Q1 2020 Revenue | Revenue Source | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Product sales | $613,918 | $366,933 | | Laboratory services | $97,726 | $— | | Collaboration revenue | $118,072 | $250,000 | | Total revenue | $829,716 | $616,933 | - Despite raising significant funds in early 2021, management concludes there is substantial doubt about the company's ability to continue as a going concern, with cash sufficient to fund operations only into Q2 2022[179] - The FDA review for the Acuitas AMR Gene Panel (Isolates) has been delayed due to the COVID-19 pandemic, with the FDA intending to complete its review by the end of August 2021, though this timeline is not guaranteed[164] Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, OpGen is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, OpGen is not required to provide quantitative and qualitative disclosures about market risk[189] Controls and Procedures Management concluded the company's disclosure controls were effective as of March 31, 2021, excluding the recently acquired Curetis business - Management concluded that as of March 31, 2021, the company's disclosure controls and procedures were effective[191] - The evaluation of controls excluded Curetis and its subsidiaries, which were acquired in April 2020, as an assessment of their internal controls has not yet been completed[191][192] PART II. OTHER INFORMATION Legal Proceedings The company reported no legal proceedings during the period - None[193] Risk Factors The report refers to the Risk Factors section of the Annual Report on Form 10-K for a discussion of potential risks - The company directs investors to the Risk Factors detailed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2020[194] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the period - None[195] Defaults Upon Senior Securities The company reported no defaults upon senior securities - None[196] Mine Safety Disclosures This item is not applicable to the company - Not applicable[197] Other Information The company reported no other information - None[198] Exhibits This section lists the exhibits filed with the Form 10-Q, including warrants, securities purchase agreements, and officer certifications