As used herein, the "Company" refers toCancer Genetics, Inc. and its wholly owned subsidiaries: Cancer Genetics Italia, S.r.l.,Gentris, LLC , and vivoPharmPty, Ltd. , except as expressly indicated or unless the context otherwise requires. The following Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") is intended to help facilitate an understanding of the Company's financial condition and its historical results of operations for the periods presented. This MD&A should be read in conjunction with the audited consolidated financial statements and notes thereto included in this annual report on Form 10-K. This MD&A may contain forward-looking statements that involve risks and uncertainties. For a discussion on forward-looking statements, see the information set forth in the Introductory Note to this Annual Report under the caption "Forward Looking Statements", which information is incorporated herein by reference. The share numbers in the following discussion reflect a 1-for-30 reverse stock split that the Company effectedOctober 24, 2019 . Overview The Company is focused on supporting the efforts of the biotechnology and pharmaceutical industries to develop innovative new drug therapies. Until the closing of the Business Disposals (as defined below) inJuly 2019 , the Company was an emerging leader in enabling precision medicine in oncology by providing multi-disciplinary diagnostic and data solutions, facilitating individualized therapies through the Company's diagnostic tests, services and molecular markers. Following the Business Disposals, the Company currently has an extensive set of anti-tumor referenced data based on predictive xenograft and syngeneic tumor models from the acquisition of vivoPharm,Pty Ltd. ("vivoPharm") in 2017, to provide Discovery Services such as contract research services, focused primarily on unique specialized studies to guide drug discovery and development programs in the oncology and immuno-oncology fields. The Company offers preclinical services such as predictive tumor models, human orthotopic xenografts and syngeneic immuno-oncology relevant tumor models in itsU.S. operations, and is a leader in the field of immuno-oncology preclinical services for its global customers. This service is supplemented with GLP toxicology and extended bioanalytical services in the Company'sAustralia -based operations. Net cash used in operating activities from continuing operations was$3.2 million and$3.2 million for the years endedDecember 31, 2019 and 2018, respectively, and the Company had unrestricted cash and cash equivalents of$3.9 million atDecember 31, 2019 , an increase of$3.7 million fromDecember 31, 2018 . The Company has working capital from continuing operations atDecember 31, 2019 of$1.4 million . In addition, the Company has$1.2 million of liabilities associated with its discontinuing operations that will be funded primarily from its continuing operations. The Company does not project that cash atDecember 31, 2019 will be sufficient to fund normal operations for the twelve months from the issuance of these financial statements in the Annual Report on Form 10-K. The Company's ability to continue as a going concern is dependent on reduced losses and improved future cash flows. Alternatively, the Company may be required to raise additional equity or debt capital, or consummate other strategic transactions. These factors raise substantial doubt about the Company's ability to continue as a going concern. The Company can provide no assurance that these actions will be successful or that additional sources of financing will be available on favorable terms, if at all. Business Disposals - Discontinuing Operations
BioServe Biotechnologies
On
siParadigm, Inc.
OnJuly 5, 2019 , the Company entered into an asset purchase agreement (the "Clinical Agreement") by and among the Company and siParadigm, LLC ("siParadigm"), pursuant to which the Company sold to siParadigm certain assets associated with the Company's clinical laboratory business (the "Clinical Business," and such assets, the "Designated Assets") and agreed to cease operating the Clinical Business. The Designated Assets include intellectual property, equipment and customer lists associated with the Clinical Business, and for a period the Company was providing certain transitional services to siParadigm pursuant to the Clinical Agreement. The cash consideration paid by siParadigm at closing was$747 thousand , which includes$45 thousand for certain equipment plus a$1.0 million advance payment of the Earn-Out (as defined below), less$177 thousand of supplier invoices paid directly by siParadigm, an adjustment of$11 thousand and transaction costs of$110 thousand . The Earn-Out, to be paid over 30
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the 24 months post-closing, is based on fees for all tests performed by
siParadigm for the Company's clinical customers during the 12-month period
following the closing (the "Earn-Out"). The Clinical Business sale (together
with the BioPharma Disposal defined below, the "Business Disposals") was
completed on
Interpace Biosciences, Inc.
OnJuly 15, 2019 , the Company entered into a secured creditor asset purchase agreement (the "BioPharma Agreement") by and among the Company,Gentris, LLC , a wholly owned subsidiary of the Company, Partners forGrowth IV, L.P. ("PFG"), Interpace Biosciences, Inc. ("IDXG") and a newly-formed subsidiary of IDXG,Interpace BioPharma, Inc. ("Buyer"). The BioPharma Agreement provided for a consensual private foreclosure sale by PFG of all assets relating to the Company's BioPharma Business (as defined in the BioPharma Agreement) to Buyer (the "BioPharma Disposal"). The BioPharma Disposal was consummated onJuly 15, 2019 . Pursuant to the BioPharma Agreement, Buyer purchased from PFG certain assets and assumed certain liabilities of the Company relating to the BioPharma Business, providing as gross consideration$23.5 million , less certain closing adjustments totaling$2.0 million , of which$7.7 million was settled in the form of a promissory note issued by Buyer to the Company (the "Excess Consideration Note") and the remainder was paid to PFG in cash. PFG utilized the cash proceeds to satisfy the outstanding balances of theSilicon Valley Bank ("SVB") asset-based revolving line of credit ("ABL") and the$6.0 million term note to PFG ("PFG Term Note"), and to satisfy certain transaction expenses. The balance of$2.3 million was delivered to the Company in addition to the Excess Consideration Note. The Excess Consideration Note which required interest-only quarterly payments at a rate of 6% per year, was settled onOctober 24, 2019 for$6.0 million , including interest of$24 thousand . The Buyer withheld from the settlement of the Excess Consideration Note$775 thousand for a net worth adjustment (assets less liabilities) of the BioPharma business ("Net Worth"),$153 thousand to secure collection of certain older accounts receivable of the Company purchased by Buyer ("AR Holdback") and an additional$735 thousand as security for indemnification obligations of the Company for any breaches of certain limited warranties and covenants of the Company and other specified items, subject to agreed-upon caps, baskets and survival periods as set forth in the BioPharma Agreement ("Indemnification Holdback"). The Company received the full amounts of the AR Holdback and the Indemnification Holdback in April andMay 2020 , respectively. The Company and Buyer also entered into a transition services agreement (the "TSA") pursuant to which the Company and Buyer are providing certain services to each other to accommodate the transition of the BioPharma Business to Buyer. In particular, the Company agreed to provide to Buyer, among other things, certain personnel services, payroll processing, administration services and benefit administration services (collectively, the "Payroll and Benefits Services"), for a period not to exceed six months fromJuly 15, 2019 , subject to the terms and conditions of theTSA , in exchange for payment or reimbursement, as applicable, by Buyer for the costs related thereto, including salaries and benefits for certain of the Company's BioPharma employees during the transition period. The Company continues to provide the Payroll and Benefits Services under theTSA with respect to a limited number of employees. In addition, the Buyer is reimbursing the Company, in part, for the salaries and benefits ofJohn A. Roberts , the Company's Chief Executive Officer, andGlenn Miles , the Company's Chief Financial Officer. The above business disposals have been classified as discontinuing operations in conformity with accounting principles generally accepted inthe United States of America . Accordingly, the operations and balances of BioServe and the Company's BioPharma and Clinical operations have been reported as discontinuing operations. Unless otherwise indicated, information in the MD&A relates to continuing operations.
2019 Offerings
InJanuary 2019 , the Company closed two public offerings and issued an aggregate of 952 thousand shares of common stock for$5.4 million , net of expenses and discounts of$1.1 million . The Company also issued 67 thousand warrants to its underwriters in conjunction with these offerings.
Note Payable to
OnOctober 21, 2019 , the Company issued an unsecured promissory note toAtlas Sciences, LLC ("Atlas Sciences"), an affiliate ofIliad Research and Trading, L.P. ("Iliad"), for$1.3 million ("Note Payable"). The Company received consideration of$1.3 million , reflecting an original issue discount of$88 thousand and expenses payable by the Company of$10 thousand . The Note Payable has a 12-month term and bears interest at 10% per annum. The proceeds from the Note Payable were utilized to partially repay the Convertible Note (see Note 8 to the audited consolidated financial statements included in Part II Item 8 of this Annual Report on Form 10-K).
Key Factors Affecting the Company's Results of Operations and Financial Condition
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The Company's wholly-owned subsidiary, vivoPharm, provides proprietary preclinical oncology and immuno-oncology services, offering integrated services in different disease areas to the biotechnology and pharmaceutical industries. vivoPharm is a leader in orthotopic and metastases tumor models. The Company provides all services including toxicology testing and bioanalytical analysis to GLP. vivoPharm specializes in conducting studies tailored to guide drug development, starting from compound libraries and ending with a comprehensive set of in vitro and in vivo data and reports, as needed for Investigational New Drug (IND) filing. The Company's ability to complete such studies is dependent upon its ability to leverage its collaborative relationships with pharmaceutical and biotechnology companies and leading institutions to facilitate its research and obtain data for its quality assurance and test validation efforts. The Company believes that the factors discussed in the following paragraphs have had and are expected to continue to have a material impact on its results of operations and financial condition.
Revenues from Continuing Operations
Revenue from the Company's Discovery Services comes from preclinical oncology and immuno-oncology services offered to its biotechnology and pharmaceutical customers. The Company is a leader in orthotopic and metastases tumor models and offer whole body imaging, in addition to toxicology testing and bioanalytical analysis. Discovery Services are designed to specialize in conducting studies tailored to guide drug development, starting from compound libraries and ending with a comprehensive set of in vitro and in vivo data and reports, as needed for Investigational New Drug (IND) filing. During the year endedDecember 31, 2019 , three customers accounted for approximately 61% of the consolidated revenue from continuing operations. During the year endedDecember 31, 2018 , three customers accounted for approximately 53% of the consolidated revenue from continuing operations.
Cost of Revenues from Continuing Operations
The Company's cost of revenues consists principally of internal personnel costs, including non-cash stock-based compensation, laboratory consumables, shipping costs, overhead and other direct expenses, such as specimen procurement and third-party validation studies. The Company continues to pursue various strategies to control its cost of revenues, including automating the Company's processes through more efficient technology and attempting to negotiate improved terms with its suppliers.
Operating Expenses from Continuing Operations
The Company classifies its operating expenses into five categories: research and development, sales and marketing, general and administrative, impairment of goodwill and merger costs. The Company's operating expenses principally consist of personnel costs, including non-cash stock-based compensation, outside services, laboratory consumables and overhead, development costs, marketing program costs and legal and accounting fees.
Research and Development Expenses. Research and development expenses from
continuing operations relate to the Company's allocation of losses from its
joint venture with
General and Administrative Expenses. General and administrative expenses consist principally of personnel-related expenses, professional fees, such as legal, accounting and business consultants, occupancy costs, bad debt and other general expenses. Sales and Marketing Expenses. The Company's sales and marketing expenses consist principally of personnel and related overhead costs for its business development team and their support personnel, travel and entertainment expenses, and other selling costs including sales collaterals and trade shows. The Company expects its sales and marketing expenses to remain relatively flat as it continues to operate and grow its Discovery Services business. Impairment ofGoodwill : During 2019, the Company recorded a goodwill impairment charge of$2.9 million after considering the effects of the Business Disposals and declines in its stock price. If the Company is not successful in executing its strategic business plans, there may be further impairments in the future.
Merger Costs. In the pursuit of various strategic options for the Company, legal and other professional costs are incurred while evaluating, negotiating, executing and implementing merger and acquisition alternatives.
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Coronavirus (COVID-19) Pandemic. OnMarch 11, 2020 theWorld Health Organization declared the novel strain of coronavirus ("COVID-19") a global pandemic and recommended containment and mitigation measures worldwide. In addition, as the Company is located inNew Jersey , the Company is currently under a shelter-in-place mandate and many of its customers worldwide are similarly impacted. The global outbreak of COVID-19 continues to rapidly evolve, and the extent to which COVID-19 may impact the Company's business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and social distancing inthe United States and other countries, business closures or business disruptions, and the effectiveness of actions taken inthe United States and other countries to contain and treat the disease. As a healthcare provider, the Company is still providing Discovery Services and has yet to experience a slowdown in its project work, however, the future of many projects may be delayed. The Company continues to vigilantly monitor the situation with its primary focus on the health and safety of its employees and clients.
Results of Operations
Years Ended
The following table sets forth certain information concerning the Company's results of continuing operations for the periods shown (in thousands):
Year Ended December 31, Change 2019 2018 $ % Revenue$ 7,305 $ 4,932 $ 2,373 48 % Cost of revenues 3,701 3,090 611 20 % Research and development - 154 (154 ) -100 % General and administrative 5,171 6,716 (1,545 ) -23 % Sales and marketing 1,146 1,197 (51 ) -4 % Impairment of goodwill 2,873 - 2,873 N/A Merger costs 117 1,464 (1,347 ) -92 % Loss from continuing operations (5,703 ) (7,689 ) 1,986 -26 % Interest expense, net (1,329 ) (298 ) (1,031 ) 346 % Change in fair value of acquisition note payable 4 136 (132 ) -97 % Change in fair value of other derivatives 86 (86 ) 172 -200 % Change in fair value of warrant liability 70 3,732 (3,662 ) -98 % Change in fair value of siParadigm Earn-Out (935 ) - (935 ) N/A Change in fair value of Excess Consideration Note 93 - 93 N/A Gain on troubled debt restructuring 258 - 258 N/A Other expense 59 - 59 N/A Loss before income taxes (7,397 ) (4,205 ) (3,192 ) 76 % Income tax benefit 512 - 512 N/A
Net loss from continuing operations
Non-GAAP Financial Information
In addition to disclosing financial results in accordance withUnited States generally accepted accounting principles ("GAAP"), the table below contains non-GAAP financial measures that the Company believes are helpful in understanding and comparing its past financial performance and its future results, and are reflected as "Adjusted EBITDA." The Company uses Adjusted EBITDA to normalize its operations. The Company defined adjusted EBITDA as earnings before (1) net interest expense, (2) taxes, (3) depreciation and amortization, (4) non-cash stock-based compensation, (5) goodwill impairment, (7) gain on troubled debt restructuring and (6) changes in fair value of various assets and liabilities that are remeasured on a recurring basis. These non-GAAP financial measures should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP, and the financial results calculated in accordance with GAAP and reconciliations from these results should be carefully evaluated. Management believes that these non-GAAP measures provide useful information about the Company's core operating results and cash flow performance and thus are appropriate to enhance the overall understanding of the Company's past financial performance and its prospects for the future. The non-GAAP financial measures are included in the table below. 33
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Reconciliation from GAAP to Non-GAAP Results (in thousands):
Year Ended
2019
2018
Reconciliation of net loss from continuing operations: Net loss from continuing operations
$ (6,885 ) $ (4,205 ) Adjustments: Interest expense, net 1,329 298 Depreciation 159 310 Amortization 454 491 Stock-based compensation 263 530 Impairment of goodwill 2,873 - Merger costs 117 1,464 Change in fair value of acquisition note payable (4 ) (136 ) Change in fair value of other derivatives (86 )
86
Change in fair value of warrant liability (70 ) (3,732 ) Change in fair value of siParadigm Earn-Out 935
-
Change in fair value of Excess Consideration Note (93 )
-
Gain on troubled debt restructuring (258 )
-
Income tax benefit (512 )
-
Adjusted EBITDA (loss) from continuing operations
Adjusted EBITDA loss from continuing operations decreased 64% to$1.8 million during the year endedDecember 31, 2019 , from an Adjusted EBITDA loss of$4.9 million during the year endedDecember 31, 2018 .
Revenue from Continuing Operations
Revenue from continuing operations increased 48%, or$2.4 million , to$7.3 million for the year endedDecember 31, 2019 , from$4.9 million for the year endedDecember 31, 2018 , principally due to an increase in the number of clinical studies conducted in the Company'sU.S. operations from sponsors based in theU.S. andEurope , which resulted in a higher volume of active projects as the demand for its CRO services continued to increase throughout the year.
Cost of Revenues from Continuing Operations
Cost of revenues from continuing operations increased 20%, or$611 thousand , to$3.7 million for the year endedDecember 31, 2019 , from$3.1 million for the year endedDecember 31, 2018 , principally due to increased usage of lab supplies of$431 thousand , outsourced labor of$124 thousand and payroll costs and benefits of$110 thousand required to support the increase in revenue. Gross margin increased from 37% to 49% during the year endedDecember 31, 2019 . The increase in gross margin was caused by gaining operating leverage over the Company's fixed costs associated with its laboratory operations and personnel as its revenue increased incrementally higher than its related costs.
Operating Expenses from Continuing Operations
Research and Development Expenses. Research and development expenses from
continuing operations decreased
General and Administrative Expenses. General and administrative expenses from continuing operations decreased 23%, or$1.5 million to$5.2 million for the year endedDecember 31, 2019 , from$6.7 million for the year endedDecember 31, 2018 primarily due to decreased legal costs of$1.2 million and decreased costs of other professional services of$557 thousand as a result of negotiating fee arrangements with certain vendors. The Company also had a$207 thousand reduction in director fees primarily as a result of the directors waiving past due compensation of$263 thousand in exchange for stock options valued at$54 thousand . Other causes for the decline include reduced stock-based compensation expense of$251 thousand and a$237 thousand decrease in NASDAQ and transfer agent fees during the year endedDecember 31, 2019 . These reductions were offset, in part, by an increase 34
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in salaries and bonuses of
Impairment ofGoodwill . During the year endedDecember 31, 2019 , the Company recorded impairment of goodwill of$2.9 million after considering the effects of the Business Disposals and declines in its stock price. Merger Costs. During the year endedDecember 31, 2019 , the Company recognized$117 thousand of merger costs associated with the Business Disposals, as compared to$1.5 million during the year endedDecember 31, 2018 related to its failed merger withNovellusDx, Ltd. ("NDX").
Interest Expense, Net
Net interest expense from continuing operations increased by$1.0 million during the year endedDecember 31, 2019 primarily due to two financing agreements that were only in place for a portion of the year endedDecember 31, 2018 . The Company incurred$571 thousand of interest on the Convertible Note and the Advance from NDX (defined below) during the year endedDecember 31, 2019 , compared to$175 thousand during the year endedDecember 31, 2018 . The Company also amortized$1.1 million of debt discounts on these two agreements during the year endedDecember 31, 2019 compared to$517 thousand during the year endedDecember 31, 2018 . The Company entered into a standstill agreement with Iliad during the first quarter of 2019, which resulted in$202 thousand of additional fees. Later the Company entered into a second standstill agreement that reduced the conversion price on a portion of the Convertible Note, resulting in$547 thousand of additional interest. InJune 2019 , the Company defaulted on the Convertible Note, creating a 15% increase in the outstanding balance at the date of default, which totaled$409 thousand . The Company allocated$1.5 million and$389 thousand of this interest to discontinuing operations during the years endedDecember 31, 2019 and 2018, respectively. The interest expense was partially offset by interest income received from the Excess Consideration Note of$107 thousand during the year endedDecember 31, 2019 .
Change in Fair Value of Warrant Liability
Changes in fair value of some of the Company's common stock warrants may impact its results. Accounting rules require the Company to record certain of its warrants as a liability, measure the fair value of these warrants each quarter and record changes in that value in earnings. The Company recognized non-cash income of$70 thousand for the year endedDecember 31, 2019 , as compared to non-cash income of$3.7 million for the year endedDecember 31, 2018 , as a result of fluctuations in its stock price. In the future, if the its stock price increases, the Company would record a non-cash charge as a result of changes in the fair value of its common stock warrants. Consequently, the Company may be exposed to non-cash charges, or it may record non-cash income, as a result of this warrant exposure in future periods.
Change in Fair Value of siParadigm Earn-Out
The siParadigm Earn-Out relates to the disposal of the Company's Clinical
Business in
Change in Fair Value of Excess Consideration Note
The Excess Consideration Note relates to the disposal of its Biopharma Business inJuly 2019 . During the year endedDecember 31, 2019 , the Company recognized a$93 thousand gain due to the increase in fair value of the Excess Consideration Note due to changes in the expected settlement of the AR Holdback and the Indemnification Holdback.
Gain on Troubled Debt Restructuring
During the year endedDecember 31, 2019 , the Company recognized a$258 thousand gain on troubled debt restructuring related to a settlement agreement reached with NDX ("NDX Settlement Agreement") covering$1.5 million in funds advanced to the Company prior to the failed merger in 2018 ("Advance from NDX"). The NDX Settlement Agreement required the Company to repay$1.1 million of principal and interest on the Advance from NDX. Upon receipt of these payments, the Advance from NDX was reduced to$450 thousand . The remaining amount due is interest-free and payable in monthly installments of$50 thousand , which began inNovember 2019 . Income Tax Benefit 35
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OnApril 4, 2019 , the Company sold$11.6 million of grossState of New Jersey NOLs relating to the 2017 tax year as well as$72 thousand of state research and development tax credits. The sale resulted in the net receipt by the Company of$512 thousand . The Company did not sell any NOLs during 2018. The Company's effective rate for the years endedDecember 31, 2019 and 2018 was 7.1% and 0.0%, respectively.
Liquidity and Capital Resources
Sources and Uses of Liquidity
The primary sources of the Company's liquidity have been cash collections from customers, funds generated from debt financings and equity financings, and cash received from the Business Disposals. The Company expects to continue generating additional cash from its customers in the future and from its Business Disposals for a limited time until the Earn-Out is paid as discussed below. DuringJanuary 2019 , the Company closed two public offerings and issued an aggregate of 952 thousand shares of common stock for$5.4 million , net of expenses and discounts of$1.1 million . InOctober 2019 , the Company issued the Note Payable to Atlas Sciences for$1.3 million , net of discounts, which was remitted directly to Iliad to satisfy a portion of the Convertible Note balance. The Company also sold$11.6 million of gross State of New Jersey NOL's relating to the 2017 tax year as well as$72 thousand of state research and development tax credits inApril 2019 . The sale resulted in the net receipt by the Company of$512 thousand . InJuly 2019 , the Company completed two business disposals, resulting in an aggregate of$9.0 million of net cash proceeds at the time of closing; however,$1.0 million of the funds received is an advance from siParadigm that is being deducted from the Earn-Out amounts due during the period. AtDecember 31, 2019 . the estimated future Earn-Out payments from siParadigm, net of the remaining balance of the advance, were$285 thousand , which are expected to be collected in variable monthly payments throughJuly 2021 ; the monthly payment amount is based on the number of tests performed by siParadigm for the Company's former Clinical Services' customers. AtDecember 31, 2019 , the Company also holds a note receivable from IDXG (the Excess Consideration Note) for$888 thousand . The balance atDecember 31, 2019 represents the AR Holdback of$153 thousand and the Indemnification Holdback of$735 thousand , which were due to the Company onJanuary 15, 2020 and were received in full in April andMay 2020 , respectively. The primary uses of the Company's liquidity have been cash used to fund the Company's operations, as detailed in the cash flows section below, as well as cash used to repay the Company's lenders. During 2019, the Company settled the Convertible Note owed to Iliad and significantly reduced the amount of its Advance from NDX. The Note Payable to Atlas Sciences matures inOctober 2020 ; furthermore, Atlas Sciences is entitled to demand monthly redemptions of up to$300 thousand beginning inApril 2020 . The Company is also required to remit monthly installments of$50 thousand to NDX until the Advance from NDX is repaid. Subsequent to year-end, an additional$250 thousand was repaid on the Advance from NDX. AtDecember 31, 2019 , the Company does not project that cash atDecember 31, 2019 will be sufficient to fund normal operations for the twelve months from the issuance of these financial statements in the Annual Report on Form 10-K. The Company's ability to continue as a going concern is dependent on reduced losses and improved future cash flows. Alternatively, the Company may be required to raise additional equity or debt capital, or consummate other strategic transactions. These factors raise substantial doubt about the Company's ability to continue as a going concern for the next twelve months from the issuance of these financial statements in the Annual Report on Form 10-K. The Company can provide no assurance that these actions will be successful or that additional sources of financing will be available on favorable terms, if at all.
Cash Flows from Continuing Operations
The Company's net cash flow from operating, investing and financing activities from continuing operations for the periods below were as follows (in thousands):
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Table of Contents Year Ended December 31, 2019 2018 Cash provided by (used in) continuing operations: Operating activities$ (3,239 ) $ (3,201 ) Investing activities (28 ) (17 ) Financing activities
3,420 3,957 Effect of foreign currency exchange rates on cash and cash equivalents and restricted cash
(17 ) (59 ) Net increase in cash and cash equivalents and restricted cash from continuing operations
$ 136 $ 680
The Company had cash and cash equivalents and restricted cash of
The$136 thousand increase in cash and cash equivalents and restricted cash from continuing operations was principally the result of$5.4 million received in the 2019 Offerings, net of expenses. These receipts were offset, in part, by$3.2 million of net cash used to fund operations,$1.0 million used to settle the remainder of the Convertible Note with Iliad, and$892 thousand of payments on the Advance from NDX. The$680 thousand increase in cash and cash equivalents and restricted cash from continuing operations for the year endedDecember 31, 2018 , principally resulted from proceeds of$2.5 million and$1.5 million from the Convertible Note and Advance from NDX, respectively, offset, in part, by net cash used in operations of$3.2 million .
Cash Used in Operating Activities from Continuing Operations
During the year endedDecember 31, 2019 , cash used in operating activities from continuing operations was$3.2 million , consisting of net loss from continuing operations of$6.9 million , positive non-cash adjustments of$5.4 million and additional uses of cash relating to changes in working capital items of$1.7 million . Changes in cash flows from working capital items were primarily driven by a net increase in other current assets of$279 thousand , a net decrease in accounts payable, accrued expenses and deferred revenue of$1.3 million , and a decrease in obligations under operating leases of$189 thousand . These uses of cash were partially offset by a net decrease in accounts receivable of$81 thousand . During the year endedDecember 31, 2018 , cash used in operating activities from continuing operations was$3.2 million , consisting of net loss from continuing operations of$4.2 million , negative non-cash adjustments of$2.0 million and additional cash provided relating to changes in working capital items of$3.0 million . Cash flows from changes in working capital items were primarily driven by a net increase in accounts payable, accrued expenses and deferred revenue of$2.9 million and a net reduction in accounts receivable of$296 thousand . These cash flows were offset by an increase in other current assets of$87 thousand and other non-current assets of$49 thousand .
Cash Provided by Investing Activities from Continuing Operations
Net cash used in continuing investing activities was
Net cash used in continuing investing activities was
Cash Provided by Financing Activities from Continuing Operations
Net cash provided by continuing financing activities was$3.4 million for the year endedDecember 31, 2019 and principally resulted from net proceeds received from the 2019 Offerings of$5.4 million , offset, in part, by principal payments of$1.0 million and$892 thousand on the Convertible Note and the Advance from NDX, respectively, as well as$72 thousand of payments on finance leases. Net cash provided by continuing financing activities was$4.0 million for the year endedDecember 31, 2018 and resulted from proceeds of$2.5 million and$1.5 million from the Convertible Note and Advance from NDX, respectively. 37
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Capital Resources and Expenditure Requirements
The Company expects to continue to incur operating losses in the future, as the costs of being public have significant effect on losses that keep the Company from being profitable. The Company expects losses to continue, only to the extent that the business does not outpace the public company-related expenses, such as legal and audit fees and director's and officer's liability insurance. These losses have had, and will continue to have, an adverse effect on the Company's working capital, total assets and stockholders' equity. Because of the numerous risks and uncertainties associated with its revenue growth and costs associated with being a public company, the Company is unable to predict when it will become profitable, and it may never become profitable. Even if the Company does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis. The Company's inability to achieve and then maintain profitability would negatively affect its business, financial condition, results of operations and cash flows. As a result, it may need to raise additional capital to fund its current operations, to repay certain outstanding indebtedness and to fund its business to meet its long-term business objectives through public or private equity offerings, debt financings, borrowings or strategic partnerships coupled with an investment in the Company or a combination thereof. If the Company raises additional funds through the issuance of convertible debt securities, or other debt securities, these securities could be secured and could have rights senior to those of its common stock. In addition, any new debt incurred by the Company could impose covenants that restrict its operations and increase its interest expense. The issuance of any new equity securities will also dilute the interest of current stockholders. InOctober 2019 , the Company settled the Convertible Note owed to Iliad and now owes$1.3 million in principal amount to Atlas Sciences under a new unsecured note due inOctober 2020 . The Company also owes an aggregate of$350 thousand to NDX as ofDecember 31, 2019 pursuant to the NDX Settlement Agreement, which is payable in monthly installments of$50 thousand . The Company has no material capital commitments outside of its existing debt arrangements. Even after the Business Disposals, the Company does not project that cash atDecember 31, 2019 will be sufficient to fund normal operations for the twelve months from the issuance of these financial statements in the Annual Report on Form 10-K. The Company's ability to continue as a going concern is dependent on reduced losses and improved future cash flows. Alternatively, the Company may be required to raise additional equity or debt capital, or consummate other strategic transactions. These factors raise substantial doubt about the Company's ability to continue as a going concern for the next twelve months from the issuance of these financial statements in the Annual Report on Form 10-K.The Company can provide no assurance that these actions will be successful or that additional sources of financing will be available on favorable terms, if at all. The Company made this assessment in light of the expected impact of COVID 19. The Company's forecast of the period of time through which its current financial resources will be adequate to support its operations and its expected operating expenses are forward-looking statements and involve risks and uncertainties. Actual results could vary materially and negatively as a result of a number of factors, including:
• the Company's ability to adapt its business for future developments in
light of the global outbreak of the novel coronavirus, which
continues
to rapidly evolve;
• the Company's ability to achieve profitability by increasing sales of
the Company's preclinical CRO services focused on oncology and immuno-oncology; • the Company's ability to raise additional capital to repay its indebtedness and meet its liquidity needs;
• the Company's ability to execute on its marketing and sales strategy
for its preclinical research services and gain acceptance of its services in the market;
• the Company's ability to keep pace with rapidly advancing market and
scientific developments; • the Company's ability to satisfyU.S. (including FDA) and international regulatory requirements with respect to its
services; • the Company's ability to maintain its present customer base and obtain new customers;
• competition from preclinical CRO services companies, many of which are
much larger than the Company in terms of employee base, revenues and overall number of customers and related market share;
• the Company's ability to maintain the Company's clinical and research
collaborations and enter into new collaboration agreements with highly regarded organizations in the field of oncology so that, among other things, the Company has access to thought leaders in advanced preclinical and translational science; • potential product liability or intellectual property infringement claims; • the Company's dependency on third-party manufacturers to supply it with instruments and specialized supplies; • the Company's ability to attract and retain a sufficient number of scientists, clinicians, sales personnel and other key personnel with extensive experience in oncology and immuno-oncology, who are in short supply; • the Company's ability to obtain or maintain patents or other appropriate protection for the intellectual property in its proprietary tests and services; 38
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• the Company's ability to effectively manage its international
businesses inAustralia ,Europe andChina , including the
expansion of
its customer base and volume of new contracts in these markets;
• the Company's dependency on the intellectual property licensed to the
Company or possessed by third parties; and
• the Company's ability to adequately support future growth; and
• other risks discussed in the section entitled "Risk Factors."
The consolidated financial statements for the year endedDecember 31, 2019 were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. Accordingly, they do not give effect to adjustments that would be necessary should the Company be required to liquidate its assets. The ability of the Company to meet its obligations, and to continue as a going concern is dependent upon the availability of future funding and the continued growth in revenues. The consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.
Future Contractual Obligations
The following table reflects a summary of the Company's estimates of future contractual obligations as ofDecember 31, 2019 . The information in the table reflects future unconditional payments and is based on the terms of the relevant agreements, appropriate classification of items underU.S. GAAP as currently in effect and certain assumptions, such as the interest rate on the Company's variable debt that was in effect as ofDecember 31, 2019 . Future events could cause actual payments to differ from these amounts. Payments Due
by Period
Less than 1 More than 5 Contractual Obligations Total Year 1-3 Years 3-5 Years years (dollars in thousands) Principal and interest on unsecured debt$ 1,789 $ 1,789 $ - $ - $ - Finance lease obligations, including interest, for equipment 209 84 80 45 - Operating lease obligations relating to administrative offices and laboratories 220 209 11 - - Total$ 2,218 $ 2,082 $ 91 $ 45 $ - Income Taxes Over the past several years the Company has generated operating losses in all jurisdictions in which it may be subject to income taxes. As a result, the Company has accumulated significant net operating losses and other deferred tax assets. Because of the Company's history of losses and the uncertainty as to the realization of those deferred tax assets, a full valuation allowance has been recognized. The Company does not expect to report a benefit related to the deferred tax assets until it has a history of earnings, if ever, that would support the realization of its deferred tax assets.
Off-Balance Sheet Arrangements
Since inception, the Company has not engaged in any off-balance sheet activities as defined in Item 303(a)(4) of Regulation S-K.
Critical Accounting Policies and Significant Judgment and Estimates
The Company's management's discussion and analysis of financial condition and results of operations is based on its consolidated financial statements, which have been prepared in accordance withU.S. GAAP. The preparation of consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates based on historical experience and makes various assumptions, which management believes to be reasonable under the circumstances, which form the basis for judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The notes to the Company's audited consolidated financial statements contain a summary of its significant accounting policies. Management considers the following accounting policies critical to the understanding of the results of the Company's operations: • Revenue recognition;
• Accounts receivable and bad debts;
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• Warrant liabilities and other derivatives;
• Stock-based compensation;
• Income taxes; and
• Impairment of intangibles and long-lived assets.
Recent Accounting Pronouncements
The notes to the Company's audited consolidated financial statements contain a summary of recent accounting pronouncements.
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