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x
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QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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27-2004382
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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11055 Flintkote Avenue, Suite B, San Diego, California
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92121
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(Address of principal executive offices)
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(Zip Code)
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(858) 952-7570
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(Registrant’s telephone number, including area code)
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Large accelerated filer
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o
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Accelerated filer
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o
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Non-accelerated filer
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o
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(Do not check if a smaller reporting company)
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Smaller reporting company
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x
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Emerging growth company
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o
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September 30, 2017
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December 31, 2016
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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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7,434,298
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$
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13,915,094
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Short-term investments
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—
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23,978,022
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Accounts receivable
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178,127
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100,460
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Prepaid expenses and other current assets
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939,200
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956,616
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Total current assets
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8,551,625
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38,950,192
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Property and equipment, net
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3,126,969
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3,826,915
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Other assets
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539,309
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1,173,304
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Total Assets
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$
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12,217,903
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$
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43,950,411
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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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675,499
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$
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1,130,536
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Accrued expenses
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2,620,250
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4,021,365
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Deferred rent
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298,213
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285,246
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Current portion of long-term debt (in default)
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1,488,041
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2,360,109
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Total current liabilities
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5,082,003
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7,797,256
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Long-term debt, less current portion
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—
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14,176,359
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Derivative financial instruments—warrants
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2,037,712
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834,940
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Deferred rent, net of current portion
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1,153,316
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1,373,717
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Total Liabilities
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8,273,031
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24,182,272
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Commitments and contingencies (Note 9)
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Stockholders’ equity
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Preferred stock, $0.001 par value, 20,000,000 shares authorized; 60,600 shares outstanding at September 30, 2017 and December 31, 2016; designated as Series A Convertible Preferred Stock with liquidation preference of $606,000 at September 30, 2017 and December 31, 2016
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60
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60
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Common stock, $0.0001 par value, 150,000,000 shares authorized; 38,105,251 and 30,696,791 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively
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3,811
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3,070
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Additional paid-in capital
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174,426,891
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167,890,984
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Accumulated other comprehensive loss
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(15,194
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)
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(10,773
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)
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Accumulated deficit
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(170,470,696
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)
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(148,115,202
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)
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Total stockholders’ equity
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3,944,872
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19,768,139
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Total liabilities and stockholders’ equity
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$
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12,217,903
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$
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43,950,411
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Three Months Ended September 30,
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Nine Months Ended September 30,
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||||||||||||
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2017
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2016
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2017
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2016
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Revenues:
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Royalties
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$
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58,779
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$
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47,236
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$
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169,415
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$
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207,869
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Diagnostic services
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58,119
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37,978
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142,482
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69,558
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Clinical research services
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6,431
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3,900
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8,481
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35,573
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Total revenues
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123,329
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89,114
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320,378
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313,000
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Costs and expenses:
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Cost of revenues
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473,202
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424,559
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1,427,831
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1,143,293
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Research and development
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1,414,706
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3,937,398
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6,676,251
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11,221,876
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Selling and marketing
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419,927
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2,940,862
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2,442,931
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9,127,450
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General and administrative
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3,659,587
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2,710,782
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9,915,359
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9,183,761
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Restructuring (benefit) charges
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(46,472
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)
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—
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1,669,526
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—
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Total operating expenses
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5,920,950
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10,013,601
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22,131,898
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30,676,380
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Loss from operations
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(5,797,621
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)
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(9,924,487
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)
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(21,811,520
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)
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(30,363,380
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)
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Net interest expense
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(16,473
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)
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(354,993
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)
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(877,741
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)
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(967,522
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)
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Gain from change in fair value of derivative financial instruments—warrants
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1,528,669
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88,208
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2,012,747
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674,834
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Loss on extinguishment of debt
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—
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—
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(1,655,825
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)
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—
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Other loss, net
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(6,541
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)
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—
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(4,975
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)
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—
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Net loss
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(4,291,966
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)
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(10,191,272
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)
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(22,337,314
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)
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(30,656,068
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)
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Preferred stock dividend
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(6,060
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)
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(6,060
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)
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(18,180
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)
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(18,180
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)
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Net loss attributable to common stockholders
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$
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(4,298,026
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)
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$
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(10,197,332
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)
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$
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(22,355,494
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)
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$
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(30,674,248
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)
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||||||||
Net loss per common share — basic
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$
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(0.12
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)
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$
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(0.34
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)
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$
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(0.68
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)
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$
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(1.02
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)
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Net loss per common share — diluted
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$
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(0.12
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)
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$
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(0.34
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)
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$
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(0.68
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)
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$
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(1.04
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)
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Weighted-average shares outstanding — basic
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36,465,672
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30,339,774
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32,826,306
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30,018,841
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Weighted-average shares outstanding — diluted
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36,465,672
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30,339,774
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32,826,306
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30,136,572
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Three Months Ended September 30,
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Nine Months Ended September 30,
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||||||||||||
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2017
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2016
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2017
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2016
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||||||||
Net loss
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$
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(4,291,966
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)
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$
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(10,191,272
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)
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$
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(22,337,314
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)
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$
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(30,656,068
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)
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Other comprehensive income (loss):
|
|
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Foreign currency translation loss
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(1,544
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)
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(81
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)
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(13,486
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)
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(1,877
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)
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Unrealized gain or reversal of previous losses on securities available-for-sale
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—
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(7,997
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)
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9,065
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(2,865
|
)
|
||||
Total other comprehensive income (loss)
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(1,544
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)
|
|
(8,078
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)
|
|
(4,421
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)
|
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(4,742
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Total comprehensive loss
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(4,293,510
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)
|
|
(10,199,350
|
)
|
|
(22,341,735
|
)
|
|
(30,660,810
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Preferred stock dividend
|
(6,060
|
)
|
|
(6,060
|
)
|
|
(18,180
|
)
|
|
(18,180
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Comprehensive loss attributable to common stockholders
|
$
|
(4,299,570
|
)
|
|
$
|
(10,205,410
|
)
|
|
$
|
(22,359,915
|
)
|
|
$
|
(30,678,990
|
)
|
|
Nine Months Ended
September 30, |
||||||
|
2017
|
|
2016
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(22,337,314
|
)
|
|
$
|
(30,656,068
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Loss on disposal of assets
|
28,199
|
|
|
—
|
|
||
Impairment loss
|
485,000
|
|
|
—
|
|
||
Depreciation and amortization
|
956,995
|
|
|
693,485
|
|
||
Stock based compensation expense
|
3,117,364
|
|
|
5,942,392
|
|
||
Loss on extinguishment of debt
|
1,655,825
|
|
|
—
|
|
||
Accretion of final fee premium
|
293,614
|
|
|
266,423
|
|
||
Amortization of discount on debt
|
113,780
|
|
|
105,710
|
|
||
Net realized loss on short-term investments
|
6,400
|
|
|
—
|
|
||
Amortization of premiums on short-term investments
|
9,230
|
|
|
61,719
|
|
||
Deferred rent
|
(207,435
|
)
|
|
(133,378
|
)
|
||
Interest income accrued on short-term investments
|
(90,330
|
)
|
|
10,122
|
|
||
Change in fair value of derivative financial instruments—warrants
|
(2,012,747
|
)
|
|
(674,834
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Decrease in other assets
|
—
|
|
|
2,761
|
|
||
(Increase) decrease in accounts receivable
|
(77,667
|
)
|
|
13,584
|
|
||
Decrease (increase) in prepaid expenses and other current assets
|
18,230
|
|
|
(157,051
|
)
|
||
(Decrease) increase in accounts payable and accrued expenses
|
(1,908,796
|
)
|
|
2,490,137
|
|
||
Net cash used in operating activities
|
(19,949,652
|
)
|
|
(22,034,998
|
)
|
||
|
|
|
|
||||
Investing activities:
|
|
|
|
||||
Capital expenditures, net
|
(136,251
|
)
|
|
(797,781
|
)
|
||
Maturities of short-term investments
|
16,431,837
|
|
|
—
|
|
||
Purchases of short-term investments
|
(8,804,604
|
)
|
|
(24,451,611
|
)
|
||
Sales of short-term investments
|
16,434,553
|
|
|
—
|
|
||
Net cash provided by (used in) investing activities
|
23,925,535
|
|
|
(25,249,392
|
)
|
||
|
|
|
|
||||
Financing activities:
|
|
|
|
||||
Proceeds from sales of common stock and warrants, net of expenses
|
6,634,803
|
|
|
2,293,857
|
|
||
Proceeds from exercise of options
|
—
|
|
|
366,966
|
|
||
Borrowings under equipment line of credit
|
—
|
|
|
792,251
|
|
||
Borrowings under long-term debt, net of costs
|
—
|
|
|
7,805,086
|
|
||
Payment upon debt extinguishment
|
(1,613,067
|
)
|
|
—
|
|
||
Repayments of long-term debt
|
(15,000,000
|
)
|
|
(8,896,166
|
)
|
||
Repayments of equipment line of credit
|
(469,578
|
)
|
|
—
|
|
||
Net cash (used in) provided by financing activities
|
(10,447,842
|
)
|
|
2,361,994
|
|
||
Effect of exchange rate changes on cash and cash equivalents
|
(8,837
|
)
|
|
(1,544
|
)
|
||
Net change in cash and equivalents
|
(6,480,796
|
)
|
|
(44,923,940
|
)
|
||
Cash and cash equivalents—Beginning of period
|
13,915,094
|
|
|
67,493,047
|
|
||
Cash and cash equivalents—End of period
|
$
|
7,434,298
|
|
|
$
|
22,569,107
|
|
|
|
|
|
||||
Supplementary disclosure of cash flow activity:
|
|
|
|
||||
Cash paid for taxes
|
$
|
800
|
|
|
$
|
4,560
|
|
Cash paid for interest
|
$
|
650,331
|
|
|
$
|
806,228
|
|
Supplemental disclosure of non-cash investing and financing activities:
|
|
|
|
||||
Preferred stock dividends accrued
|
$
|
18,180
|
|
|
$
|
18,180
|
|
Leasehold improvements paid for by lessor
|
$
|
—
|
|
|
$
|
1,860,000
|
|
•
|
Seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; and
|
•
|
Relinquish licenses or otherwise dispose of rights to technologies, product candidates or products that the Company would otherwise seek to develop or commercialize themselves, on unfavorable terms.
|
•
|
Raising capital through public and private equity offerings;
|
•
|
Adding capital through short-term and long-term borrowings;
|
•
|
Introducing operation and business development initiatives to bring in new revenue streams by leveraging capabilities within our CLIA lab, as well as monetizing our proprietary NextCollect™ DNA collection and preservation cup;
|
•
|
Reducing operating costs by identifying internal synergies;
|
•
|
Engaging in strategic partnerships; and
|
•
|
Taking actions to reduce or delay capital expenditures.
|
|
Three Months
Ended September 30, |
|
Nine Months
Ended September 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Numerator: Net loss attributable to common shareholders
|
$
|
(4,298,026
|
)
|
|
$
|
(10,197,332
|
)
|
|
$
|
(22,355,494
|
)
|
|
$
|
(30,674,248
|
)
|
Adjustment for gain from change in fair value of derivative financial instruments
—
warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
(533,750
|
)
|
||||
Net loss used for diluted loss per share
|
$
|
(4,298,026
|
)
|
|
$
|
(10,197,332
|
)
|
|
$
|
(22,355,494
|
)
|
|
$
|
(31,207,998
|
)
|
Denominator for basic and diluted net loss per share:
|
|
|
|
|
|
|
|
||||||||
Weighted-average shares used to compute basic loss per share
|
36,465,672
|
|
|
30,339,774
|
|
|
32,826,306
|
|
|
30,018,841
|
|
||||
Adjustments to reflect assumed exercise of warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
117,731
|
|
||||
Weighted-average shares used to compute diluted net loss per share
|
36,465,672
|
|
|
30,339,774
|
|
|
32,826,306
|
|
|
30,136,572
|
|
||||
Net loss per share attributable to common stockholders:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(0.12
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.68
|
)
|
|
$
|
(1.02
|
)
|
Diluted
|
$
|
(0.12
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.68
|
)
|
|
$
|
(1.04
|
)
|
|
September 30,
|
||||
|
2017
|
|
2016
|
||
Options to purchase Common Stock
|
4,257,031
|
|
|
6,051,186
|
|
Warrants to purchase Common Stock
|
8,972,503
|
|
|
4,546,939
|
|
Restricted Stock Units
|
1,277,302
|
|
|
392,000
|
|
Series A Convertible Preferred Stock
|
63,125
|
|
|
63,125
|
|
|
14,569,961
|
|
|
11,053,250
|
|
|
Fair Value Measurements at
September 30, 2017 |
||||||||||||||
|
Quoted Prices in Active Markets for Identical Assets and Liabilities
(Level 1)
|
|
Significant Other Observable Inputs
(Level 2)
|
|
Significant Unobservable Inputs
(Level 3)
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market fund (1)
|
$
|
6,510,214
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,510,214
|
|
Total Assets
|
$
|
6,510,214
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,510,214
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Derivative financial instruments
—
warrants
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,037,712
|
|
|
$
|
2,037,712
|
|
Total Liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
2,037,712
|
|
|
$
|
2,037,712
|
|
|
Fair Value Measurements at
December 31, 2016 |
||||||||||||||
|
Quoted Prices in Active Markets for Identical Assets and Liabilities
(Level 1)
|
|
Significant Other Observable Inputs
(Level 2)
|
|
Significant Unobservable Inputs
(Level 3)
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market fund (1)
|
$
|
12,095,620
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
12,095,620
|
|
Corporate debt securities (2)
|
—
|
|
|
14,160,686
|
|
|
—
|
|
|
14,160,686
|
|
||||
Commercial paper (3)
|
—
|
|
|
2,393,948
|
|
|
—
|
|
|
2,393,948
|
|
||||
U.S. treasury securities (2)
|
—
|
|
|
8,621,892
|
|
|
—
|
|
|
8,621,892
|
|
||||
Total Assets
|
$
|
12,095,620
|
|
|
$
|
25,176,526
|
|
|
$
|
—
|
|
|
$
|
37,272,146
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Derivative financial instruments
—
warrants
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
834,940
|
|
|
$
|
834,940
|
|
Total Liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
834,940
|
|
|
$
|
834,940
|
|
|
Description
|
|
Balance at
December 31, 2016 |
|
Issuance of Derivative Financial Instruments
|
|
Realized
Gain
|
|
Balance at
September 30, 2017 |
|||||||
Derivative financial instruments
—
warrants
|
|
$
|
834,940
|
|
|
3,215,519
|
|
|
$
|
(2,012,747
|
)
|
|
$
|
2,037,712
|
|
|
December 31, 2016
|
||||||||||||||||
|
|
|
|
|
Unrealized
|
|
|
||||||||||
|
Maturity in Years
|
|
Cost
|
|
Gains
|
|
Losses
|
|
Fair Value
|
||||||||
Corporate debt securities
|
Less than 1 year
|
|
$
|
14,165,915
|
|
|
$
|
44
|
|
|
$
|
(5,273
|
)
|
|
$
|
14,160,686
|
|
Commercial paper
|
Less than 1 year
|
|
1,195,444
|
|
|
—
|
|
|
—
|
|
|
1,195,444
|
|
||||
U.S. treasury securities
|
Less than 1 year
|
|
8,625,728
|
|
|
330
|
|
|
(4,166
|
)
|
|
8,621,892
|
|
||||
Total Investment
|
|
|
$
|
23,987,087
|
|
|
$
|
374
|
|
|
$
|
(9,439
|
)
|
|
$
|
23,978,022
|
|
|
As of September 30,
2017 |
|
As of December 31,
2016 |
||||
Furniture and office equipment
|
$
|
1,076,709
|
|
|
$
|
1,144,741
|
|
Leasehold improvements
|
1,994,514
|
|
|
1,994,514
|
|
||
Laboratory equipment
|
2,584,363
|
|
|
2,449,645
|
|
||
|
5,655,586
|
|
|
5,588,900
|
|
||
Less—accumulated depreciation and amortization
|
(2,528,617
|
)
|
|
(1,761,985
|
)
|
||
Property and equipment, net
|
$
|
3,126,969
|
|
|
$
|
3,826,915
|
|
|
Nine Months Ended September 30,
|
||||
|
2017
|
|
2016
|
||
Estimated fair value of Trovagene common stock
|
0.73-1.26
|
|
|
4.49-4.65
|
|
Expected warrant term
|
1.3-5.5 years
|
|
|
2.3-2.8 years
|
|
Risk-free interest rate
|
1.27-1.95%
|
|
|
0.71-0.87%
|
|
Expected volatility
|
86-109%
|
|
|
82-89%
|
|
Dividend yield
|
0
|
%
|
|
0
|
%
|
Date
|
|
Description
|
|
Number of Warrants
|
|
Derivative
Instrument
Liability
|
|||
December 31, 2016
|
|
Balance of derivative financial instruments
—
warrants liability
|
|
967,295
|
|
|
$
|
834,940
|
|
|
|
Issuance of derivative financial instruments
|
|
4,643,626
|
|
|
3,215,519
|
|
|
|
|
Change in fair value of derivative financial instruments
—
warrants during the period recognized as a gain in the condensed consolidated statements of operations
|
|
—
|
|
|
(2,012,747
|
)
|
|
September 30, 2017
|
|
Balance of derivative financial instruments
—
warrants liability
|
|
5,610,921
|
|
|
$
|
2,037,712
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Included in research and development expense
|
$
|
219,480
|
|
|
$
|
872,792
|
|
|
$
|
798,143
|
|
|
$
|
1,862,069
|
|
Included in cost of revenue
|
15,633
|
|
|
42,639
|
|
|
56,998
|
|
|
99,164
|
|
||||
Included in selling and marketing expense
|
118,434
|
|
|
476,865
|
|
|
550,317
|
|
|
1,493,744
|
|
||||
Included in general and administrative expense
|
1,067,633
|
|
|
437,075
|
|
|
1,837,128
|
|
|
2,487,415
|
|
||||
Benefit from restructuring
|
—
|
|
|
—
|
|
|
(125,222
|
)
|
|
—
|
|
||||
Total stock-based compensation expense
|
$
|
1,421,180
|
|
|
$
|
1,829,371
|
|
|
$
|
3,117,364
|
|
|
$
|
5,942,392
|
|
|
Nine Months Ended
September 30, |
||||
|
2017
|
|
2016
|
||
Risk-free interest rate
|
1.82
|
%
|
|
1.48
|
%
|
Dividend yield
|
0
|
%
|
|
0
|
%
|
Expected volatility
|
87
|
%
|
|
103
|
%
|
Expected term
|
5.2 years
|
|
|
5.5 years
|
|
|
Total Options
|
|
Weighted-Average
Exercise Price
Per Share
|
|
Intrinsic
Value
|
|||||
Balance outstanding, December 31, 2016
|
5,528,628
|
|
|
$
|
5.49
|
|
|
$
|
—
|
|
Granted
|
823,106
|
|
|
$
|
0.84
|
|
|
|
|
|
Canceled / Forfeited
|
(2,077,246
|
)
|
|
$
|
6.24
|
|
|
|
|
|
Expired
|
(17,457
|
)
|
|
$
|
4.74
|
|
|
|
|
|
Balance outstanding, September 30, 2017
|
4,257,031
|
|
|
$
|
4.23
|
|
|
$
|
381
|
|
Exercisable at September 30, 2017
|
2,492,242
|
|
|
$
|
4.79
|
|
|
$
|
—
|
|
|
Number of Shares
|
|
Weighted-Average
Grant Date Fair Value
Per Share
|
|
Intrinsic Value
|
|||||
Non-vested RSU outstanding, December 31, 2016
|
272,000
|
|
|
$
|
3.99
|
|
|
$
|
571,200
|
|
Granted
|
2,249,242
|
|
|
$
|
1.59
|
|
|
|
||
Vested
|
(369,487
|
)
|
|
$
|
3.48
|
|
|
$
|
645,775
|
|
Forfeited
|
(874,453
|
)
|
|
$
|
1.75
|
|
|
|
||
Non-vested RSU outstanding, September 30, 2017
|
1,277,302
|
|
|
$
|
1.44
|
|
|
$
|
932,430
|
|
|
Total Warrants
|
|
Weighted-Average
Exercise Price
Per Share
|
|
Weighted-Average
Remaining Contractual
Term
|
|||
Balance outstanding, December 31, 2016
|
5,505,901
|
|
|
$
|
3.83
|
|
|
1.6
|
Granted
|
4,643,626
|
|
|
$
|
1.41
|
|
|
|
Expired
|
(1,177,024
|
)
|
|
$
|
5.32
|
|
|
|
Balance outstanding, September 30, 2017
|
8,972,503
|
|
|
$
|
2.38
|
|
|
3.3
|
•
|
Announced preclinical research demonstrating synergy of PCM-075 with Zytiga® (abiraterone acetate) in Castration-Resistant Prostate Cancer tumor cells.
|
•
|
Announced that the FDA granted Orphan Drug Designation to PCM-075 for the treatment of patients with AML.
|
•
|
Announced the expansion and strengthening of its Board of Directors with the appointment of Athena Countouriotis, M.D. Dr. Countouriotis brings significant experience in oncology clinical development and orphan indications
|
•
|
Announced PCM-075 synergy with a HDAC Inhibitor in Non-Hodgkin Lymphoma Cell Lines. Additionally, PCM-075 demonstrates synergy in combination with more than ten chemotherapeutic and targeted therapies across a broad range of solid tumor and hematologic cancers.
|
•
|
Announced preclinical AML data shows PCM-075 significantly enhances the efficacy of a FLT3 inhibitor in combination therapy.
|
•
|
Announced FDA approval of IND for Phase 1b/2 trial of PCM-075 in patients with AML.
|
•
|
Announced peer-reviewed publication of first-in-human Phase 1 trial results with PCM-075 in the journal Investigational New Drugs. The data from the trial demonstrated PCM-075’s potential as safe and effective treatment for solid tumor and hematological malignancies.
|
•
|
Completed a registered direct offering of 6,191,500 shares of common stock and a concurrent private placement issuing warrants to purchase up to 4,643,626 shares of common stock. The net proceeds from the registered direct offering and concurrent private placement were approximately $6.5 million in July 2017.
|
•
|
Entered into an agreement with Novogene Co. Ltd. (“Novogene”), a leading global provider of genomic services and solutions and the largest sequencing capacity in the world, whereby Novogene will purchase NextCollect™, our proprietary urine collection and nucleic acid preservation device for validation in the Chinese market.
|
•
|
Engaged PRA Health Sciences, a leading, global contract research organization, to conduct our Phase 1b/2 clinical trial of PCM-075.
|
•
|
Executed a supplier agreement with NerPharMa, S.r.l., a pharmaceutical manufacturing company and a subsidiary of Nerviano Medical Sciences S.r.l., to manufacture drug product for PCM-075.
|
•
|
Submitted an IND application to FDA to conduct a Phase 1b/2 clinical trial of PCM-075 in AML.
|
•
|
Announced expansion of key claims for our NPM1 patent portfolio for AML.
|
•
|
Entered into an agreement with a global biopharmaceutical company to utilize Trovera® ctDNA tests and services in cancer clinical trials.
|
•
|
Entered into an agreement with AstraZeneca to utilize Trovera® ctDNA test and services in prospective biomarker study.
|
•
|
Announced phase 1 safety study conducted by Nerviano Medical Sciences supports planned development of PCM-075 in AML.
|
•
|
Established a Clinical Advisory Board, appointing Dr. Jorge Cortes, of MD Anderson, Dr. Sandra Silberman, a leading clinical researcher in hematology/oncology, and practicing physician at the Duke VAMC, Dr. Filip Janku, of City of Hope Cancer Center, and Dr. David Berz, of the Beverly Hills Cancer Center. Dr. Cortes and Dr. Silberman have extensive experience in the development of novel therapies for the treatment of hematologic cancers. Dr. Cortes will serve as the Principal Investigator for the Phase 1b/2 clinical trial in AML.
|
•
|
Entered into a license agreement with Nerviano that grants us exclusive global development and commercialization rights to NMS-1286937, which we refers to as PCM-075. PCM-075 is an oral, investigative drug and a highly-selective PLK 1 inhibitor for the treatment of AML.
|
|
Three Months Ended September 30,
|
||||||||||
|
2017
|
|
2016
|
|
Increase (Decrease)
|
||||||
Royalties
|
$
|
58,779
|
|
|
$
|
47,236
|
|
|
$
|
11,543
|
|
Diagnostic services
|
58,119
|
|
|
37,978
|
|
|
20,141
|
|
|||
Clinical research services
|
6,431
|
|
|
3,900
|
|
|
2,531
|
|
|||
Total revenues
|
$
|
123,329
|
|
|
$
|
89,114
|
|
|
$
|
34,215
|
|
|
Three Months Ended September 30,
|
||||||||||
|
2017
|
|
2016
|
|
Increase (Decrease)
|
||||||
Salaries and staff costs
|
$
|
301,919
|
|
|
$
|
1,407,529
|
|
|
$
|
(1,105,610
|
)
|
Stock-based compensation
|
219,480
|
|
|
872,792
|
|
|
(653,312
|
)
|
|||
Outside services, consultants and lab supplies
|
604,140
|
|
|
1,215,889
|
|
|
(611,749
|
)
|
|||
Facilities
|
254,681
|
|
|
372,891
|
|
|
(118,210
|
)
|
|||
Travel and scientific conferences
|
28,000
|
|
|
51,203
|
|
|
(23,203
|
)
|
|||
Other
|
6,486
|
|
|
17,094
|
|
|
(10,608
|
)
|
|||
Total research and development
|
$
|
1,414,706
|
|
|
$
|
3,937,398
|
|
|
$
|
(2,522,692
|
)
|
|
Three Months Ended September 30,
|
||||||||||
|
2017
|
|
2016
|
|
Increase (Decrease)
|
||||||
Salaries and staff costs
|
$
|
158,097
|
|
|
$
|
1,427,254
|
|
|
$
|
(1,269,157
|
)
|
Stock-based compensation
|
118,434
|
|
|
476,865
|
|
|
(358,431
|
)
|
|||
Outside services and consultants
|
51,717
|
|
|
441,699
|
|
|
(389,982
|
)
|
|||
Facilities
|
51,388
|
|
|
112,573
|
|
|
(61,185
|
)
|
|||
Trade shows, conferences and marketing
|
31,017
|
|
|
243,692
|
|
|
(212,675
|
)
|
|||
Travel
|
54
|
|
|
212,375
|
|
|
(212,321
|
)
|
|||
Other
|
9,220
|
|
|
26,404
|
|
|
(17,184
|
)
|
|||
Total sales and marketing
|
$
|
419,927
|
|
|
$
|
2,940,862
|
|
|
$
|
(2,520,935
|
)
|
|
Three Months Ended September 30,
|
||||||||||
|
2017
|
|
2016
|
|
Increase (Decrease)
|
||||||
Personnel and outside services costs
|
$
|
1,450,261
|
|
|
$
|
1,136,266
|
|
|
$
|
313,995
|
|
Board of Directors’ fees
|
120,085
|
|
|
122,187
|
|
|
(2,102
|
)
|
|||
Stock-based compensation
|
1,067,633
|
|
|
437,075
|
|
|
630,558
|
|
|||
Legal and accounting fees
|
595,194
|
|
|
695,061
|
|
|
(99,867
|
)
|
|||
Facilities and insurance
|
291,547
|
|
|
149,921
|
|
|
141,626
|
|
|||
Travel
|
14,185
|
|
|
47,769
|
|
|
(33,584
|
)
|
|||
Fees, licenses, taxes and other
|
120,682
|
|
|
122,503
|
|
|
(1,821
|
)
|
|||
Total general and administrative
|
$
|
3,659,587
|
|
|
$
|
2,710,782
|
|
|
$
|
948,805
|
|
|
Three Months Ended September 30,
|
||||||||||
|
2017
|
|
2016
|
|
Increase (Decrease)
|
||||||
Net loss attributable to common shareholders
|
$
|
(4,298,026
|
)
|
|
$
|
(10,197,332
|
)
|
|
$
|
(5,899,306
|
)
|
Net loss per common share — basic
|
$
|
(0.12
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.22
|
)
|
Net loss per common share — diluted
|
$
|
(0.12
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.22
|
)
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding — basic
|
36,465,672
|
|
|
30,339,774
|
|
|
6,125,898
|
|
|||
Weighted average shares outstanding — diluted
|
36,465,672
|
|
|
30,339,774
|
|
|
6,125,898
|
|
|
Nine Months Ended September 30,
|
||||||||||
|
2017
|
|
2016
|
|
Increase (Decrease)
|
||||||
Royalties
|
$
|
169,415
|
|
|
$
|
207,869
|
|
|
$
|
(38,454
|
)
|
Diagnostic services
|
142,482
|
|
|
69,558
|
|
|
72,924
|
|
|||
Clinical research services
|
8,481
|
|
|
35,573
|
|
|
(27,092
|
)
|
|||
Total revenues
|
$
|
320,378
|
|
|
$
|
313,000
|
|
|
$
|
7,378
|
|
|
Nine Months Ended September 30,
|
||||||||||
|
2017
|
|
2016
|
|
Increase (Decrease)
|
||||||
Salaries and staff costs
|
$
|
1,468,491
|
|
|
$
|
4,263,595
|
|
|
$
|
(2,795,104
|
)
|
Stock-based compensation
|
798,143
|
|
|
1,862,069
|
|
|
(1,063,926
|
)
|
|||
Outside services, consultants and lab supplies
|
1,456,504
|
|
|
3,837,485
|
|
|
(2,380,981
|
)
|
|||
Facilities
|
842,196
|
|
|
1,042,682
|
|
|
(200,486
|
)
|
|||
Travel and scientific conferences
|
72,901
|
|
|
157,445
|
|
|
(84,544
|
)
|
|||
Fees, licenses and other
|
2,038,016
|
|
|
58,600
|
|
|
1,979,416
|
|
|||
Total research and development
|
$
|
6,676,251
|
|
|
$
|
11,221,876
|
|
|
$
|
(4,545,625
|
)
|
|
Nine Months Ended September 30,
|
||||||||||
|
2017
|
|
2016
|
|
Increase (Decrease)
|
||||||
Salaries and staff costs
|
$
|
977,040
|
|
|
$
|
4,266,029
|
|
|
$
|
(3,288,989
|
)
|
Stock-based compensation
|
550,317
|
|
|
1,493,744
|
|
|
(943,427
|
)
|
|||
Outside services and consultants
|
219,800
|
|
|
1,117,368
|
|
|
(897,568
|
)
|
|||
Facilities
|
220,860
|
|
|
362,339
|
|
|
(141,479
|
)
|
|||
Trade shows, conferences and marketing
|
357,233
|
|
|
1,082,883
|
|
|
(725,650
|
)
|
|||
Travel
|
71,865
|
|
|
716,473
|
|
|
(644,608
|
)
|
|||
Other
|
45,816
|
|
|
88,614
|
|
|
(42,798
|
)
|
|||
Total sales and marketing
|
$
|
2,442,931
|
|
|
$
|
9,127,450
|
|
|
$
|
(6,684,519
|
)
|
|
Nine Months Ended September 30,
|
||||||||||
|
2017
|
|
2016
|
|
Increase (Decrease)
|
||||||
Personnel and outside services costs
|
$
|
3,270,134
|
|
|
$
|
3,279,860
|
|
|
$
|
(9,726
|
)
|
Board of Directors’ fees
|
347,205
|
|
|
345,240
|
|
|
1,965
|
|
|||
Stock-based compensation
|
1,837,128
|
|
|
2,487,415
|
|
|
(650,287
|
)
|
|||
Legal and accounting fees
|
3,358,411
|
|
|
2,077,585
|
|
|
1,280,826
|
|
|||
Facilities and insurance
|
742,405
|
|
|
551,382
|
|
|
191,023
|
|
|||
Travel
|
81,106
|
|
|
151,355
|
|
|
(70,249
|
)
|
|||
Fees, licenses, taxes and other
|
278,970
|
|
|
290,924
|
|
|
(11,954
|
)
|
|||
Total general and administrative
|
$
|
9,915,359
|
|
|
$
|
9,183,761
|
|
|
$
|
731,598
|
|
|
Nine Months Ended September 30,
|
||||||||||
|
2017
|
|
2016
|
|
Increase (Decrease)
|
||||||
Net loss attributable to common shareholders
|
$
|
(22,355,494
|
)
|
|
$
|
(30,674,248
|
)
|
|
$
|
(8,318,754
|
)
|
Net loss per common share — basic
|
$
|
(0.68
|
)
|
|
$
|
(1.02
|
)
|
|
$
|
(0.34
|
)
|
Net loss per common share — diluted
|
$
|
(0.68
|
)
|
|
$
|
(1.04
|
)
|
|
$
|
(0.36
|
)
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding — basic
|
32,826,306
|
|
|
30,018,841
|
|
|
2,807,465
|
|
|||
Weighted average shares outstanding — diluted
|
32,826,306
|
|
|
30,136,572
|
|
|
2,689,734
|
|
Exhibit
Number
|
|
Description of Exhibit
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
|
TROVAGENE, INC.
|
|
|
|
|
November 9, 2017
|
By:
|
/s/ William J. Welch
|
|
|
William J. Welch
|
|
|
Chief Executive Officer (Principal Executive Officer and Principal Financial Officer)
|
1.
|
Award of Shares
.
|
2.
|
|
(a)
|
Subject to the terms and conditions of this Agreement and the Plan, on the Date of Grant the Company hereby grants to the Participant 745,392 shares of Common Stock (the “
Award Shares
”), which award shall be subject to adjustment as set forth in
Section 3
hereof and
Section 7
of the Plan. The grant of Award Shares on the Date of Grant is hereafter referred to as “
Grant #1
.”
|
(b)
|
In addition to Grant #1, the Company agrees to make additional grants (the “
Additional Grants
”) of Award Shares on the grant dates indicated below (“Grant Dates”), if Participant continues to be employed on such Grant Dates, which shall be subject to the same terms and conditions specified in this Agreement for Grant #1, including without limitation the Tax Payment provided in
Section 14
hereof. It is intended that, in the aggregate, the Additional Grants will increase Participant’s ownership to five percent (5%) of the shares of Common Stock issued and outstanding and the number of shares indicated below for Grants #2 through #9 will be adjusted in accordance with
Section 3
hereof as necessary to achieve this intent. The Additional Grants will be made at least as rapidly as provided in the following schedule, but the Compensation Committee of the Board in its discretion may decide to make such Additional Grants at an earlier date or dates, subject to Participant’s continued employment on such Grant Dates:
|
Grant #
|
Grant Date
|
Number of Shares
|
Percentage of Shares Outstanding
|
Grant #2
|
January 15, 2018
|
152,021
|
0.375%
|
Grant #3
|
April 15, 2018
|
152,021
|
0.375%
|
Grant #4
|
July _15, 2018
|
152,021
|
0.375%
|
Grant #5
|
October 15, 2018
|
152,021
|
0.375%
|
Grant #6
|
January 15, 2019
|
152,021
|
0.375%
|
Grant #7
|
April _15, 2019
|
152,021
|
0.375%
|
Grant #8
|
July 15, 2019
|
152,021
|
0.375%
|
Grant #9
|
October 15, 2019
|
152,018
|
0.375%
|
3.
|
Vesting of Award Shares
. The Award Shares shall be 100% vested on the Date of Grant and each subsequent Grant Date. The right to the additional Grants will be subject to the Participant’s continued employment with the Company on each applicable Grant Date. Each of the Additional Grants shall be 100% vested on the Date of Grant.
|
4.
|
Anti-Dilution Protection
. To the extent any event occurs that would cause the Restricted Shares (including Grant #1 and the Additional Grants) to constitute less than five percent (5%) of the aggregate Common Stock issued and outstanding through the period that includes the last Grant, the Company shall adjust the Additional Grants that have not been awarded to award to the Participant such additional number of shares of Common Stock as are necessary to maintain such percentage to reflect such dilution, which adjusted Additional Grants shall be subject to the same vesting and other terms and conditions specified in this Agreement, including without limitation the Tax Payment provided in
Section 14
hereof.
|
5.
|
Termination of Service and Forfeiture of Award Shares
. If the Participant ceases to serve as an employee of the Company (for any or no reason), all Award Shares which the Participant has received shall be subject to the applicable repurchase provisions set forth herein and, except as otherwise provided in
Section 15
hereof, the Participant shall not be entitled to any Additional Grants after such termination of employment date.
|
6.
|
Rights as Holder of Award Shares
. The Participant shall be the record owner of the Award Shares granted pursuant to this Agreement unless and until such Award Shares are (a) repurchased in connection with termination of the Participant’s employment pursuant to, and in accordance with,
Section 7
hereof, or (b) transferred in accordance with
Section 6
hereof. As a record owner of the Award Shares, the Participant shall be entitled to all rights of a holder of Award Shares as provided in this Agreement and the Plan; provided, however, that the Participant shall not be (i) eligible to receive dividends or other distributions with respect to the Award Shares until such Award Shares become vested, or (ii) entitled to vote at meetings of the Company’s shareholders with respect to the Award Shares until such Award Shares become vested. Dividends or other distributions with respect to the Award Shares that are unvested will be paid to the Participant at the time such Award Shares become vested and if such Award Shares fail to vest any dividends or other distributions with respect thereto shall be forfeited. The Participant is obligated to become a party to any agreement approved by the Board with respect to a Change in Control.
|
7.
|
Transferability
. The Participant may transfer, directly or indirectly, any Award Shares only in accordance with the Plan and this Agreement. Any purported assignment, transfer or grant by the Participant, directly or indirectly, of any Award Shares in contravention of the Plan and this Agreement shall be entirely null and void.
|
8.
|
Call Rights
.
|
(a)
|
Upon the date the Participant ceases to serve as an employee of the Company for any reason (a “
Call Event Date
”), the Company may elect (the “
Call Right
”) to repurchase all or any portion of the vested Award Shares held by the Participant on the Call Event Date, in accordance with the terms and
|
(b)
|
The purchase price to be paid by the Company to the Participant for each vested Restricted Share repurchased as a result of the Company’s exercise of the Call Right will be the Fair Market Value of such Restricted Share as of the date of the Company’s written notice of exercise to the Participant. The Company will pay for the vested Award Shares to be purchased by it pursuant to the Company’s exercise of the Call Right, at its option, after offset of bona fide debts owed by the Participant, by a check or wire transfer of immediately available funds. The Company will be entitled to receive customary representations and warranties from the Participant regarding such sale, including, without limitation, with respect to title and freedom from encumbrances. The closing of the purchase of the Award Shares pursuant to the Company’s exercise of the Call Right shall take place on the date designated by the Company, which date shall not be more than thirty (30) days nor less than five (5) days after the date of the written notice of exercise to the Participant. If the Company elects to defer the closing date to more than fifteen (15) days after the date of the written notice of exercise to the Participant, then (a) any portion of the applicable payment that shall not have been made as of fifteen (15) days after the date of the written notice of exercise to the Participant shall accrue interest at a rate of fifteen percent (15%) per annum, from and including the date that is fifteen (15) days after the date of the written notice of exercise, through and including the payment date. For purposes of determining the Fair Market Value purchase price, Fair Market Value will be based on the average closing price of a share of Common Stock as reported in the
Wall Street Journal
for the five trading days immediately preceding the date of the written notice of exercise to the Participant.
|
9.
|
Award Shares Subject to the Plan
. By entering into this Agreement the Participant agrees and acknowledges that (a) the Participant has received and read a copy of the Plan and (b) the Award Shares are subject to the Plan, the terms and provisions of which are hereby incorporated herein by reference. Except as otherwise explicitly stated in this Agreement, in the event of a conflict between any term or provision contained herein and a term or provision of the Plan, the applicable terms and provisions of the Plan will govern and prevail. The grant of Award Shares pursuant to this Agreement shall not restrict in any way the adoption of any amendment to the
Plan.
|
10.
|
Lock-Up of Award Shares
. With respect to each grant of Award Shares, during the period beginning on the date of each grant of Award Shares until one year after such date of grant, the Participant agrees not to directly or indirectly, (i) offer, sell, offer to sell, contract to sell, hedge, pledge, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase or sell (or announce any offer, sale, offer of sale, contract of sale, hedge, pledge, sale of any option or contract to purchase, purchase of any option or contract of sale, grant of any option, right or warrant to purchase or other sale or disposition), or otherwise transfer or dispose of (or enter into any transaction or device that is designed to, or could be expected to, result in the disposition by any person at any time in the future), the Award Shares subject to such grant, that are beneficially owned, within the meaning of Rule 13d-3 under the Securities Exchange Act of 1934, as amended.
|
11.
|
No Reliance on the Company
. In making the Participant’s investment decision with respect to the receipt of the Award Shares, the Participant represents and warrants that he has not relied upon the Company, any of its affiliates, counsel to the Company, or any representative of any of the foregoing for any advice of any sort, including, but not limited to, tax or securities law advice.
|
12.
|
No Right to Continued Service
. This Agreement shall not be construed as giving the Participant the right to be retained in the employ of, or in any other continuing relationship with, the Company or any of its affiliates.
|
13.
|
Amendment; Waiver
. Subject to Sections 8.6.4 and 8.6.5 of the Plan, no amendment or modification of any provision of this Award Agreement shall be effective unless signed in writing by or on behalf of the Company
|
14.
|
Governing Law
. All issues and questions concerning the construction, validity, interpretation and enforceability of this Agreement and the exhibit hereto, and their negotiation, execution, performance or nonperformance, interpretation, termination, construction and all matters based upon, arising out of or related to any of the foregoing, whether arising in law or equity, shall be governed by, and construed in accordance with, the laws of the State of Delaware, without giving effect to any choice of law or conflict of law rules or provisions that would cause the application of the laws of any jurisdiction other than the State of Delaware.
|
15.
|
WAIVER OF JURY TRIAL
. EACH PARTY HERETO IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL ACTION OR PROCEEDING (INCLUDING COUNTERCLAIMS) RELATING TO OR ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ANY OF THE TRANSACTIONS OR RELATIONSHIPS HEREBY CONTEMPLATED OR OTHERWISE IN CONNECTION WITH THE ENFORCEMENT OF ANY RIGHTS OR OBLIGATIONS HEREUNDER.
|
16.
|
Withholding
. No later than the date the Company is required to deposit the required withholding taxes after the date or dates Participant receives any Award Shares, including Award Shares awarded pursuant to the anti-dilution provisions of
Section 3
hereof, the Company shall pay to or on behalf of the Participant an amount, determined by Participant’s tax accountant on an estimated basis to be the actual amount necessary to satisfy the full amount of Participant’s federal, state, and local taxes required by law or regulation (collectively, “
Taxes
”) to be paid by the Participant as a result of the receipt of the Award Shares (the “
Tax Payment
”), together with an amount equal to any Taxes incurred by the Participant as a result of the Participant’s actual or constructive receipt of the Tax Payment and shall withhold and deposit such amount with the Internal Revenue Service on Participant’s behalf. In the event of any difference between the estimated Taxes and the actual Taxes paid, the parties agree to reconcile and remit any such difference within 60 days after the latest of the date or dates Participant files his annual federal and state income tax returns for the tax year in which the Tax Payment is paid or withheld. The Tax Payment provisions of this
Section 15
shall not apply with respect to any Taxes arising in connection with a Realization Bonus that in the sole discretion of the Company is paid in the form of cash in the event of the Participant’s termination without Cause or resignation for Good Reason pursuant to
Section 16
hereof.
|
17.
|
Realization Bonus
. Upon the consummation of a Sale of the Company, a termination by the Company without Cause (as defined in Participant’s employment agreement with the Company signed on May 6, 2016 (the “
Employment Agreement
”)), or Participant’s resignation for Good Reason (as defined in the Employment Agreement) prior to the date that all of the Additional Grants under
Section 1
have been granted, Participant will be entitled to receive either: (a) a cash bonus in an amount equal to the difference between the fair market value of the Award Shares then held by Participant and the fair market value of the Award Shares Participant would have received if he held five percent (5%) of the issued and outstanding shares of Common Stock of the Company (disregarding the fair market value attributable to shares disposed of by Participant prior to the Sale of the Company, termination without Cause or resignation for Good Reason), or (b) such Additional Grants as are necessary to increase the Participant’s total Award Shares granted hereunder to equal five percent (5%) of the shares of Common Stock issued and outstanding (clauses (a) or (b) hereof collectively, the “
Realization Bonus
”). The form of payment of the Realization Bonus in cash or in Common Stock shall be within the sole discretion of the Company. As used herein, “
Sale of the Company
” means: (i) a sale or other disposition of all or substantially all (more than 50% of the total gross fair market value of all of the assets of the Company immediately before such sale, determined without regard to any liabilities associated with such assets) of the Company to a person or persons acting as a group within the 12 month period ending on the date of the most recent sale to such person or group; (ii) a sale or other disposition of more than 50% of the combined voting power of the equity interests in the Company to a person or persons acting as a group within the 12 month period ending on the date of the most recent sale of equity interests to such person or group; or (iii) a merger or consolidation of the Company with or into another entity whereby the equity holders of the Company immediately prior to such merger or consolidation do not own 50% or more of the voting securities of the
|
18.
|
Counterparts
. This Agreement may be executed in counterparts (including by electronic transmission), each one of which shall be deemed an original and all of which together shall constitute one and the same Agreement.
|
19.
|
Headings
. The headings and captions herein are inserted for convenience of reference only and are not intended to govern, limit or aid in the construction of any term or provision hereof.
|
20.
|
Severability
. If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction or other authority to be invalid, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions of this Agreement shall remain in full force and effect and shall in no way be affected, impaired or invalidated.
|
21.
|
Entire Agreement
. This Agreement and the Employment Agreement between the Company and the Participant dated May 6, 2016, together with all agreements referenced herein and the exhibit hereto, constitute the entire agreement and understanding among the parties hereto in respect of the subject matter hereof and thereof and supersede all prior and contemporaneous arrangements, agreements and understandings, both oral and written, whether in term sheets, presentations or otherwise among the parties hereto, or between any of them, with respect to the subject matter hereof and thereof.
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Trovagene, Inc. (the “Registrant”);
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions);
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
November 9, 2017
|
/s/ William J. Welch
|
|
William J. Welch
|
|
Chief Executive Officer (Principal Executive Officer and Principal Financial Officer)
|
November 9, 2017
|
/s/ William J. Welch
|
|
William J. Welch
|
|
Chief Executive Officer (Principal Executive Officer and Principal Financial Officer)
|