Exhibit Number
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Description
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99.1
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Press Release, dated February 27, 2019, entitled "
NewLink Genetics Reports Fourth Quarter, Year-End 2018 Financial Results and Provides Update for Clinical Programs
"
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99.2
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NewLink Genetics Corporation
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By:
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/s/ Carl W. Langren
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Carl W. Langren
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Its:
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Chief Financial Officer
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•
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Updated results on the cohort of patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG), from the efficacy portion of a Phase 1b study of indoximod for the treatment of pediatric patients with recurrent malignant brain tumors, are anticipated in 2019
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•
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Results from a Phase 2 study of NLG207 (formerly CRLX101), a nanoparticle formulation of the topoisomerase 1 inhibitor, camptothecin, conducted by the Gynecological Oncology Group (GOG) for patients with recurrent ovarian cancer, has been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2019, at the Georgia World Conference Center, in Atlanta, March 29 - April 3, 2019
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•
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Updated results from a Phase 1 study of NLG802, a prodrug of indoximod with enhanced pharmacokinetic properties, are anticipated in 2019
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•
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Updated results from a Phase 1b study of indoximod for pediatric patients with recurrent malignant brain tumors are anticipated in 2019
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•
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Completion by Merck of the rolling Biologics License Application (BLA) filing for V920 (rVSV∆G-ZEBOV-GP), our partnered Ebola vaccine candidate, is expected in 2019
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•
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Presented Phase 1 results of indoximod plus front-line radiation and maintenance chemotherapy for the treatment of pediatric patients with newly diagnosed DIPG at the American Association of Clinical Research (AACR) Annual Meeting, April 2018, and updated Phase 1 results at the International Symposium of Pediatric Neuro-Oncology (ISPNO) Annual Meeting, July 2018, showing
symptomatic improvement and marked radiographic improvement in DIPG patients.
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•
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Presented updated Phase 1 results for indoximod plus standard of care chemotherapy for younger, healthy patients with newly diagnosed acute myeloid leukemia (AML) in an oral session at the 60
th
American Society of Hematology (ASH) Annual Meeting, December 2018
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•
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Presented final results from two Phase 2 studies of indoximod at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting with results for indoximod plus checkpoint inhibition in advanced melanoma which we believe showed encouraging overall and complete response rates which compared favorably to historical PD-1 monotherapy results and results for indoximod plus gemcitabine / nab-paclitaxel in metastatic pancreatic cancer demonstrating potentially promising activity that correlated with a measurable immune response
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•
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At the Society for Immunotherapy of Cancer (SITC) 2018 Annual Meeting, we presented correlative immunologic assay results from biopsies obtained during both the advanced melanoma and the metastatic pancreatic cancer trials previously presented at ASCO 2018, illustrating indoximod’s impact on the tumor microenvironment as well as first-in-human results showing significantly enhanced pharmacokinetic properties of our indoximod prodrug, NLG802
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•
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November 13, 2018, our partner, Merck, announced that it had begun the rolling submission of licensure application for Ebola vaccine, V920 (rVSV∆G-ZEBOV-GP), to the FDA
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NewLink Genetics Corporation
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|||||||||||||||
Consolidated Statements of Operations
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(unaudited)
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(In thousands, except share and per share amounts)
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Three Months Ended December 31,
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Year Ended December 31,
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2018
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2017
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2018
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2017
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||||||||
Grant revenue
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$
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—
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$
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10,042
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$
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11,268
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$
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28,321
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Licensing and collaboration revenue
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202
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56
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1,206
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390
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Total operating revenues
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202
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10,098
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12,474
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28,711
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Operating expenses:
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Research and development
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5,721
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17,461
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45,694
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69,866
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General and administrative
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5,427
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6,688
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29,218
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31,726
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Total operating expenses
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11,148
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24,149
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74,912
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101,592
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Loss from operations
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(10,946
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)
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(14,051
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)
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(62,438
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)
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(72,881
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)
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Other income and expense:
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Miscellaneous expense
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(118
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)
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(24
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)
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(102
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)
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(126
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)
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Interest income
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519
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263
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2,029
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616
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Interest expense
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(2
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)
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(4
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)
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(52
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)
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(119
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)
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Other income, net
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399
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235
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1,875
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371
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Net loss before taxes
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(10,547
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)
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(13,816
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)
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(60,563
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)
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(72,510
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)
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Income tax (expense) benefit
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(22
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)
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130
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6,968
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559
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Net loss
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$
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(10,569
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)
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$
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(13,686
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)
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$
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(53,595
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)
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$
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(71,951
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)
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Basic and diluted loss per share
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$
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(0.28
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)
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$
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(0.37
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)
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$
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(1.44
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)
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$
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(2.30
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)
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Basic and diluted average shares outstanding
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37,229,006
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36,770,490
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37,191,262
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31,304,309
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NewLink Genetics Corporation
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Condensed Consolidated Balance Sheets
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(unaudited)
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(In thousands)
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Year Ended
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December 31,
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December 31,
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2018
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2017
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Assets
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Current assets:
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Cash and cash equivalents
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$
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120,738
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$
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158,708
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Prepaid expenses and other current assets
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5,536
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6,226
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Income tax receivable
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339
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356
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Other receivables
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459
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10,176
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Total current assets
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127,072
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175,466
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Property and equipment, net
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3,727
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5,091
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Income tax receivable
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140
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$
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140
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Total non-current assets
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3,867
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$
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5,231
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Total assets
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$
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130,939
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$
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180,697
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Liabilities and Stockholders' Equity
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Current liabilities:
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Accounts payable
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$
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555
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$
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9,256
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Accrued expenses
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8,139
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12,467
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Current portion of unearned revenue
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—
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56
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Current portion of deferred rent
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92
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92
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Current portion of notes payable and obligations under capital leases
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61
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160
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Total current liabilities
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8,847
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22,031
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Long-term liabilities:
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Royalty obligation payable to Iowa Economic Development Authority
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6,000
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6,000
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Notes payable and obligations under capital leases
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43
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111
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Deferred rent
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906
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998
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Total long-term liabilities
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6,949
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7,109
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Total liabilities
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15,796
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29,140
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Stockholders' equity:
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Blank check preferred stock, $0.01 par value: Authorized shares - 5,000,000 at December 31, 2018 and 2017; issued and outstanding shares - 0 at December 31, 2018 and 2017
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—
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—
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Common stock, $0.01 par value: Authorized shares - 75,000,000 at December 31, 2018 and 2017; issued 37,343,547 and 37,168,122 at December 31, 2018 and 2017, respectively, and outstanding 37,251,220 and 37,109,556 at December 31, 2018 and 2017, respectively
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373
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|
|
372
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Additional paid-in capital
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407,199
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389,786
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Treasury stock, at cost: 92,327 and 58,566 shares at December 31, 2018 and 2017, respectively
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(1,417
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)
|
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(1,142
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)
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Accumulated deficit
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(291,012
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)
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(237,459
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)
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Total stockholders' equity
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115,143
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151,557
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Total liabilities and stockholders' equity
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$
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130,939
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$
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180,697
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