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ý
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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04-3462475
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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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Large accelerated filer
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¨
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Accelerated filer
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¨
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Non-accelerated filer
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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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Item 1.
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Item 2.
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Item 3.
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Item 4.
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Item 1.
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Item 1A.
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Item 2.
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Item 3.
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Item 4.
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Item 5.
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Item 6.
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June 30,
2016 |
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December 31,
2015 |
||||
ASSETS
|
|
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|
||||
CURRENT ASSETS
|
|
|
|
||||
Cash and cash equivalents
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$
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10,552
|
|
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$
|
19,459
|
|
Accounts receivable, net of allowance for doubtful accounts
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11,944
|
|
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6,621
|
|
||
Other current assets
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1,970
|
|
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2,118
|
|
||
Total current assets
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24,466
|
|
|
28,198
|
|
||
FIXED ASSETS, net of accumulated depreciation
|
5,372
|
|
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6,069
|
|
||
OTHER ASSETS
|
|
|
|
||||
Restricted cash
|
300
|
|
|
300
|
|
||
Patents and other intangible assets, net of accumulated amortization
|
1,639
|
|
|
1,727
|
|
||
Investment in joint venture
|
314
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|
|
341
|
|
||
Goodwill
|
12,029
|
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12,029
|
|
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Other
|
115
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|
|
220
|
|
||
Total other assets
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14,397
|
|
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14,617
|
|
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Total Assets
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$
|
44,235
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$
|
48,884
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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|
|
|
||||
CURRENT LIABILITIES
|
|
|
|
||||
Accounts payable and accrued expenses
|
$
|
7,632
|
|
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$
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7,579
|
|
Obligations under capital leases, current portion
|
72
|
|
|
122
|
|
||
Deferred revenue
|
423
|
|
|
831
|
|
||
Bank term note, current portion
|
2,000
|
|
|
1,333
|
|
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Total current liabilities
|
10,127
|
|
|
9,865
|
|
||
Obligations under capital leases
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242
|
|
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276
|
|
||
Deferred rent payable and other
|
306
|
|
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315
|
|
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Warrant liability
|
—
|
|
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17
|
|
||
Deferred revenue, long-term
|
753
|
|
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752
|
|
||
Bank term note
|
3,648
|
|
|
4,642
|
|
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Total Liabilities
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15,076
|
|
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15,867
|
|
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STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Preferred stock, authorized 9,764 shares, $0.0001 par value, none issued
|
—
|
|
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—
|
|
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Common stock, authorized 100,000 shares, $0.0001 par value, 16,120 and 13,652 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively
|
2
|
|
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1
|
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Additional paid-in capital
|
136,590
|
|
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131,167
|
|
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Accumulated (deficit)
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(107,433
|
)
|
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(98,151
|
)
|
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Total Stockholders’ Equity
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29,159
|
|
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33,017
|
|
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Total Liabilities and Stockholders’ Equity
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$
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44,235
|
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$
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48,884
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Three Months Ended June 30,
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|
Six Months Ended June 30,
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||||||||||||
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2016
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2015
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2016
|
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2015
|
||||||||
Revenue
|
$
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7,001
|
|
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$
|
4,185
|
|
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$
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13,069
|
|
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$
|
8,555
|
|
Cost of revenues
|
4,285
|
|
|
3,097
|
|
|
8,388
|
|
|
6,239
|
|
||||
Gross profit
|
2,716
|
|
|
1,088
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|
|
4,681
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|
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2,316
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
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1,680
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1,256
|
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3,212
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|
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2,533
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|
||||
General and administrative
|
3,658
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3,062
|
|
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7,976
|
|
|
6,049
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|
||||
Sales and marketing
|
1,379
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|
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1,184
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|
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2,677
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|
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2,300
|
|
||||
Total operating expenses
|
6,717
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|
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5,502
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|
|
13,865
|
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|
10,882
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|
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Loss from operations
|
(4,001
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)
|
|
(4,414
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)
|
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(9,184
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)
|
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(8,566
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
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||||||||
Interest expense
|
(107
|
)
|
|
(82
|
)
|
|
(233
|
)
|
|
(115
|
)
|
||||
Interest income
|
13
|
|
|
13
|
|
|
17
|
|
|
25
|
|
||||
Change in fair value of acquisition note payable
|
67
|
|
|
(316
|
)
|
|
101
|
|
|
(406
|
)
|
||||
Change in fair value of warrant liability
|
—
|
|
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(181
|
)
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|
17
|
|
|
(196
|
)
|
||||
Total other (expense)
|
(27
|
)
|
|
(566
|
)
|
|
(98
|
)
|
|
(692
|
)
|
||||
Net (loss)
|
$
|
(4,028
|
)
|
|
$
|
(4,980
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)
|
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$
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(9,282
|
)
|
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$
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(9,258
|
)
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Basic and Diluted Net (Loss) Per Share
|
$
|
(0.28
|
)
|
|
$
|
(0.51
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)
|
|
$
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(0.66
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)
|
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$
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(0.95
|
)
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Basic and Diluted Weighted-Average Shares Outstanding
|
14,538
|
|
|
9,715
|
|
|
14,042
|
|
|
9,709
|
|
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Six Months Ended June 30,
|
||||||
|
2016
|
|
2015
|
||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
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|
||||
Net (loss)
|
$
|
(9,282
|
)
|
|
$
|
(9,258
|
)
|
Adjustments to reconcile net (loss) to net cash (used in) operating activities:
|
|
|
|
||||
Depreciation
|
1,016
|
|
|
680
|
|
||
Amortization
|
174
|
|
|
17
|
|
||
Provision for bad debts
|
—
|
|
|
216
|
|
||
Stock-based compensation
|
1,024
|
|
|
1,454
|
|
||
Change in fair value of acquisition note payable
|
(101
|
)
|
|
406
|
|
||
Change in fair value of Gentris contingent consideration
|
—
|
|
|
(162
|
)
|
||
Change in fair value of warrant liability
|
(17
|
)
|
|
196
|
|
||
Amortization of debt issuance costs
|
6
|
|
|
2
|
|
||
Loss in equity method investment
|
27
|
|
|
405
|
|
||
Changes in:
|
|
|
|
||||
Accounts receivable
|
(5,323
|
)
|
|
(910
|
)
|
||
Other current assets
|
148
|
|
|
(457
|
)
|
||
Other non-current assets
|
(12
|
)
|
|
(73
|
)
|
||
Accounts payable, accrued expenses and deferred revenue
|
(253
|
)
|
|
162
|
|
||
Deferred rent payable and other
|
(9
|
)
|
|
(38
|
)
|
||
Net cash (used in) operating activities
|
(12,602
|
)
|
|
(7,360
|
)
|
||
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
||||
Purchase of fixed assets
|
(319
|
)
|
|
(257
|
)
|
||
Decrease in restricted cash
|
—
|
|
|
6,000
|
|
||
Patent costs
|
(86
|
)
|
|
(68
|
)
|
||
Net cash provided by (used in) investing activities
|
(405
|
)
|
|
5,675
|
|
||
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
||||
Principal payments on capital lease obligations
|
(84
|
)
|
|
(29
|
)
|
||
Payments for deferred equity offering costs
|
—
|
|
|
(86
|
)
|
||
Proceeds from option exercises
|
—
|
|
|
23
|
|
||
Proceeds from offering of common stock, net of offering costs
|
4,517
|
|
|
—
|
|
||
Principal payments on bank term note
|
(333
|
)
|
|
—
|
|
||
Payment of debt issuance costs
|
—
|
|
|
(33
|
)
|
||
Net cash provided by (used in) financing activities
|
4,100
|
|
|
(125
|
)
|
||
Net (decrease) in cash and cash equivalents
|
(8,907
|
)
|
|
(1,810
|
)
|
||
CASH AND CASH EQUIVALENTS
|
|
|
|
||||
Beginning
|
19,459
|
|
|
25,554
|
|
||
Ending
|
$
|
10,552
|
|
|
$
|
23,744
|
|
SUPPLEMENTAL CASH FLOW DISCLOSURE
|
|
|
|
||||
Cash paid for interest
|
$
|
202
|
|
|
$
|
72
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Biopharma Services
|
$
|
4,219
|
|
|
$
|
2,675
|
|
|
7,569
|
|
|
$
|
6,006
|
|
|
Clinical Services
|
2,542
|
|
|
1,251
|
|
|
4,998
|
|
|
2,124
|
|
||||
Discovery Services
|
240
|
|
|
259
|
|
|
502
|
|
|
425
|
|
||||
|
$
|
7,001
|
|
|
$
|
4,185
|
|
|
$
|
13,069
|
|
|
$
|
8,555
|
|
|
June 30,
2016 |
|
December 31,
2015 |
||||
Biopharma Services
|
$
|
5,144
|
|
|
$
|
3,238
|
|
Clinical Services
|
7,119
|
|
|
3,733
|
|
||
Discovery Services
|
345
|
|
|
314
|
|
||
Allowance for doubtful accounts
|
(664
|
)
|
|
(664
|
)
|
||
|
$
|
11,944
|
|
|
$
|
6,621
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Medicare
|
12%
|
|
7%
|
|
13%
|
|
7%
|
Other insurers
|
17%
|
|
6%
|
|
19%
|
|
6%
|
Other healthcare facilities
|
7%
|
|
9%
|
|
6%
|
|
8%
|
|
36%
|
|
22%
|
|
38%
|
|
21%
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||
Common stock purchase warrants
|
5,632
|
|
|
1,117
|
|
|
5,632
|
|
|
1,117
|
|
Stock options
|
1,892
|
|
|
1,933
|
|
|
1,892
|
|
|
1,933
|
|
Restricted shares of common stock
|
84
|
|
|
123
|
|
|
84
|
|
|
123
|
|
|
7,608
|
|
|
3,173
|
|
|
7,608
|
|
|
3,173
|
|
|
|
|
Capital
Leases |
|
Operating
Leases |
|
Total
|
||||||
2016 (remaining 6 months)
|
|
|
$
|
48
|
|
|
$
|
792
|
|
|
$
|
840
|
|
2017
|
|
|
78
|
|
|
1,589
|
|
|
$
|
1,667
|
|
||
2018
|
|
|
75
|
|
|
397
|
|
|
$
|
472
|
|
||
2019
|
|
|
70
|
|
|
342
|
|
|
$
|
412
|
|
||
2020
|
|
|
59
|
|
|
135
|
|
|
$
|
194
|
|
||
Thereafter
|
|
|
24
|
|
|
—
|
|
|
$
|
24
|
|
||
Total minimum lease payments
|
|
|
354
|
|
|
$
|
3,255
|
|
|
$
|
3,609
|
|
|
Less amount representing interest
|
|
|
40
|
|
|
|
|
|
|||||
Present value of net minimum obligations
|
|
|
314
|
|
|
|
|
|
|||||
Less current obligation under capital lease
|
|
|
72
|
|
|
|
|
|
|||||
Long-term obligation under capital lease
|
|
|
$
|
242
|
|
|
|
|
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Term Note, principal balance
|
$
|
5,667
|
|
|
$
|
6,000
|
|
Less unamortized debt issuance costs
|
19
|
|
|
25
|
|
||
Term Note, net
|
5,648
|
|
|
5,975
|
|
||
Less current maturities
|
2,000
|
|
|
1,333
|
|
||
Long-term portion
|
$
|
3,648
|
|
|
$
|
4,642
|
|
|
|
|
|
|
Options Outstanding
|
|
Weighted-
Average
Remaining
Contractual
Term (in years)
|
|
Aggregate
Intrinsic
Value
(in thousands)
|
|||||||
|
Number of
Shares
(in thousands)
|
|
Weighted-
Average
Exercise
Price
|
|
||||||||
Outstanding January 1, 2016
|
1,961
|
|
|
$
|
10.55
|
|
|
7.68
|
|
$
|
—
|
|
Canceled or expired
|
(69
|
)
|
|
9.78
|
|
|
|
|
|
|||
Outstanding June 30, 2016
|
1,892
|
|
|
$
|
10.57
|
|
|
7.13
|
|
$
|
—
|
|
Exercisable June 30, 2016
|
1,173
|
|
|
$
|
10.43
|
|
|
6.46
|
|
$
|
—
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||
|
2015
|
|
2015
|
||
Volatility
|
58.83
|
%
|
|
63.89
|
%
|
Risk free interest rate
|
1.61
|
%
|
|
1.65
|
%
|
Dividend yield
|
0.00
|
%
|
|
0.00
|
%
|
Term (years)
|
5.99
|
|
|
6.15
|
|
Weighted-average fair value of options granted during the period
|
5.71
|
|
|
5.77
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||
Volatility
|
74.61
|
%
|
|
69.85
|
%
|
|
75.26
|
%
|
|
70.18
|
%
|
Risk free interest rate
|
1.27
|
%
|
|
2.42
|
%
|
|
1.42
|
%
|
|
2.15
|
%
|
Dividend yield
|
0.00
|
%
|
|
0.00
|
%
|
|
0.00
|
%
|
|
0.00
|
%
|
Term (years)
|
7.89
|
|
|
8.84
|
|
|
8.02
|
|
|
8.96
|
|
|
Non-vested Restricted Stock Awards
|
|||||
|
Number of
Shares (in thousands) |
|
Weighted-Average Grant Date Fair Value
|
|||
Non-vested at January 1, 2016
|
121
|
|
|
$
|
8.25
|
|
Vested
|
(37
|
)
|
|
9.84
|
|
|
Non-vested at June 30, 2016
|
84
|
|
|
$
|
7.55
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Cost of revenues
|
$
|
67
|
|
|
$
|
55
|
|
|
$
|
136
|
|
|
$
|
104
|
|
Research and development
|
45
|
|
|
128
|
|
|
95
|
|
|
223
|
|
||||
General and administrative
|
352
|
|
|
535
|
|
|
739
|
|
|
1,056
|
|
||||
Sales and marketing
|
26
|
|
|
39
|
|
|
54
|
|
|
71
|
|
||||
Total stock-based compensation
|
$
|
490
|
|
|
$
|
757
|
|
|
$
|
1,024
|
|
|
$
|
1,454
|
|
Issued With / For
|
Exercise
Price |
|
Warrants
Outstanding January 1, 2016 |
|
2016 Warrants Issued
|
|
2016 Warrants Expired
|
|
Warrants Outstanding June 30, 2016
|
||||||
Non-Derivative Warrants:
|
|
|
|
|
|
|
|
|
|
||||||
Financing
|
$
|
10.00
|
|
|
243
|
|
|
—
|
|
|
—
|
|
|
243
|
|
Financing
|
15.00
|
|
|
436
|
|
|
—
|
|
|
—
|
|
|
436
|
|
|
Debt guarantee
|
15.00
|
|
|
233
|
|
|
—
|
|
|
(87
|
)
|
|
146
|
|
|
Consulting
|
10.00
|
|
|
10
|
|
|
—
|
|
|
(10
|
)
|
|
—
|
|
|
2015 Offering
|
5.00
|
|
|
3,450
|
|
|
—
|
|
|
—
|
|
|
3,450
|
|
|
2016 Offering
|
2.25
|
|
|
—
|
|
|
1,357
|
|
|
—
|
|
|
1,357
|
|
|
Total non-derivative warrants
|
$
|
5.59
|
|
B
|
4,372
|
|
|
1,357
|
|
|
(97
|
)
|
|
5,632
|
|
Derivative Warrants:
|
|
|
|
|
|
|
|
|
|
||||||
Financing
|
4.00
|
|
A
|
60
|
|
|
—
|
|
|
(60
|
)
|
|
—
|
|
|
Total derivative warrants
|
—
|
|
B
|
60
|
|
|
—
|
|
|
(60
|
)
|
|
—
|
|
|
Total
|
$
|
5.59
|
|
B
|
4,432
|
|
|
1,357
|
|
|
(157
|
)
|
|
5,632
|
|
A
|
These warrants were subject to fair value accounting and contained an exercise price adjustment feature.
|
B
|
Weighted-average exercise prices are as of
June 30, 2016
.
|
|
June 30, 2016
|
||||||||||||||
|
Total
|
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
||||||||
Notes payable
|
$
|
165
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
165
|
|
|
|
|
|
|
|
|
|
|
December 31, 2015
|
||||||||||||||
|
Total
|
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
||||||||
Warrant liability
|
$
|
17
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
17
|
|
Notes payable
|
266
|
|
|
—
|
|
|
—
|
|
|
266
|
|
||||
|
$
|
283
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
283
|
|
|
|
|
|
|
|
|
|
|
Note Payable
|
|
Warrant
|
||||
|
to VenturEast
|
|
Liability
|
||||
Fair value at December 31, 2015
|
$
|
266
|
|
|
$
|
17
|
|
Change in fair value
|
(101
|
)
|
|
(17
|
)
|
||
Fair value at June 30, 2016
|
$
|
165
|
|
|
$
|
—
|
|
|
Three Months Ended June 30,
|
|
Change
|
|||||||||||
(dollars in thousands)
|
2016
|
|
2015
|
|
$
|
|
%
|
|||||||
Revenue
|
$
|
7,001
|
|
|
$
|
4,185
|
|
|
$
|
2,816
|
|
|
67
|
%
|
Cost of revenues
|
4,285
|
|
|
3,097
|
|
|
1,188
|
|
|
38
|
%
|
|||
Research and development expenses
|
1,680
|
|
|
1,256
|
|
|
424
|
|
|
34
|
%
|
|||
General and administrative expenses
|
3,658
|
|
|
3,062
|
|
|
596
|
|
|
19
|
%
|
|||
Sales and marketing expenses
|
1,379
|
|
|
1,184
|
|
|
195
|
|
|
16
|
%
|
|||
Loss from operations
|
(4,001
|
)
|
|
(4,414
|
)
|
|
413
|
|
|
(9
|
)%
|
|||
Interest income (expense)
|
(94
|
)
|
|
(69
|
)
|
|
(25
|
)
|
|
36
|
%
|
|||
Change in fair value of acquisition note payable
|
67
|
|
|
(316
|
)
|
|
383
|
|
|
(121
|
)%
|
|||
Change in fair value of warrant liability
|
—
|
|
|
(181
|
)
|
|
181
|
|
|
(100
|
)%
|
|||
Net (loss)
|
$
|
(4,028
|
)
|
|
$
|
(4,980
|
)
|
|
$
|
952
|
|
|
(19
|
)%
|
|
Three Months Ended June 30,
|
|
Change
|
|||||||||||||||||
|
2016
|
|
2015
|
|
|
|
|
|||||||||||||
(dollars in thousands)
|
$
|
|
%
|
|
$
|
|
%
|
|
$
|
|
%
|
|||||||||
Biopharma Services
|
$
|
4,219
|
|
|
60
|
%
|
|
$
|
2,675
|
|
|
64
|
%
|
|
$
|
1,544
|
|
|
58
|
%
|
Clinical Services
|
2,542
|
|
|
36
|
%
|
|
1,251
|
|
|
30
|
%
|
|
1,291
|
|
|
103
|
%
|
|||
Discovery Services
|
240
|
|
|
4
|
%
|
|
259
|
|
|
6
|
%
|
|
(19
|
)
|
|
(7
|
)%
|
|||
Total Revenue
|
$
|
7,001
|
|
|
100
|
%
|
|
$
|
4,185
|
|
|
100
|
%
|
|
$
|
2,816
|
|
|
67
|
%
|
|
Six Months Ended June 30,
|
|
Change
|
|||||||||||
(dollars in thousands)
|
2016
|
|
2015
|
|
$
|
|
%
|
|||||||
Revenue
|
$
|
13,069
|
|
|
$
|
8,555
|
|
|
$
|
4,514
|
|
|
53
|
%
|
Cost of revenues
|
8,388
|
|
|
6,239
|
|
|
2,149
|
|
|
34
|
%
|
|||
Research and development expenses
|
3,212
|
|
|
2,533
|
|
|
679
|
|
|
27
|
%
|
|||
General and administrative expenses
|
7,976
|
|
|
6,049
|
|
|
1,927
|
|
|
32
|
%
|
|||
Sales and marketing expenses
|
2,677
|
|
|
2,300
|
|
|
377
|
|
|
16
|
%
|
|||
Loss from operations
|
(9,184
|
)
|
|
(8,566
|
)
|
|
(618
|
)
|
|
7
|
%
|
|||
Interest income (expense)
|
(216
|
)
|
|
(90
|
)
|
|
(126
|
)
|
|
140
|
%
|
|||
Change in fair value of acquisition note payable
|
101
|
|
|
(406
|
)
|
|
507
|
|
|
100
|
%
|
|||
Change in fair value of warrant liability
|
17
|
|
|
(196
|
)
|
|
213
|
|
|
(109
|
)%
|
|||
Net (loss)
|
$
|
(9,282
|
)
|
|
$
|
(9,258
|
)
|
|
$
|
(24
|
)
|
|
—
|
%
|
|
Six Months Ended June 30,
|
|
Change
|
|||||||||||||||||
|
2016
|
|
2015
|
|
|
|
|
|||||||||||||
(dollars in thousands)
|
$
|
|
%
|
|
$
|
|
%
|
|
$
|
|
%
|
|||||||||
Biopharma Services
|
$
|
7,569
|
|
|
58
|
%
|
|
$
|
6,006
|
|
|
70
|
%
|
|
$
|
1,563
|
|
|
26
|
%
|
Clinical Services
|
4,998
|
|
|
38
|
%
|
|
2,124
|
|
|
25
|
%
|
|
2,874
|
|
|
135
|
%
|
|||
Discovery Services
|
502
|
|
|
4
|
%
|
|
425
|
|
|
5
|
%
|
|
77
|
|
|
18
|
%
|
|||
Total Revenue
|
$
|
13,069
|
|
|
100
|
%
|
|
$
|
8,555
|
|
|
100
|
%
|
|
$
|
4,514
|
|
|
53
|
%
|
|
Six Months Ended
June 30, |
||||||
(in thousands)
|
2016
|
|
2015
|
||||
Cash provided by (used in):
|
|
|
|
||||
Operating activities
|
$
|
(12,602
|
)
|
|
$
|
(7,360
|
)
|
Investing activities
|
(405
|
)
|
|
5,675
|
|
||
Financing activities
|
4,100
|
|
|
(125
|
)
|
||
Net (decrease) in cash and cash equivalents
|
$
|
(8,907
|
)
|
|
$
|
(1,810
|
)
|
•
|
our ability to achieve revenue growth and profitability;
|
•
|
the costs for funding the operations we recently acquired and our ability to successfully integrate those operations with and into our own;
|
•
|
our ability to obtain approvals for our new diagnostic tests;
|
•
|
our ability to execute on our marketing and sales strategy for our genomic tests and gain acceptance of our tests in the market;
|
•
|
our ability to obtain adequate reimbursement from governmental and other third-party payors for our tests and services;
|
•
|
the costs, scope, progress, results, timing and outcomes of the clinical trials of our diagnostic tests;
|
•
|
the costs of operating and enhancing our laboratory facilities;
|
•
|
our ability to succeed with our cost control initiative;
|
•
|
the timing of and the costs involved in regulatory compliance, particularly if the regulations change;
|
•
|
the costs of maintaining, expanding and protecting our intellectual property portfolio, including potential litigation costs and liabilities;
|
•
|
our ability to manage the costs of manufacturing our tests;
|
•
|
our rate of progress in, and cost of research and development activities associated with, tests in research and early development;
|
•
|
the effect of competing technological and market developments;
|
•
|
costs related to expansion;
|
•
|
our ability to secure financing and the amount thereof; and
|
•
|
other risks and uncertainties discussed in our annual report on Form 10-K for the year ended December 31, 2015 and other reports, as applicable, we file with the Securities and Exchange Commission.
|
•
|
Revenue recognition;
|
•
|
Accounts receivable and bad debts; and
|
•
|
Stock-based compensation.
|
•
|
our ability to achieve profitability by increasing sales of our laboratory tests and services and to continually develop and commercialize novel and innovative diagnostic tests and services for cancer patients;
|
•
|
ability to raise additional capital to meet our liquidity needs;
|
•
|
our ability clinically validate our pipeline of genomic microarray tests currently in development;
|
•
|
our ability to execute on our marketing and sales strategy for our genomic tests and gain acceptance of our tests in the market;
|
•
|
our ability to keep pace with rapidly advancing market and scientific developments;
|
•
|
our ability to satisfy U.S. (including FDA) and international regulatory requirements with respect to our tests and services, many of which are new and still evolving;
|
•
|
our ability to obtain reimbursement from governmental and other third-party payors for our tests and services;
|
•
|
competition from clinical laboratory services companies, diagnostic tests currently available or new tests that may emerge;
|
•
|
our ability to maintain our clinical collaborations and enter into new collaboration agreements with highly regarded organizations in the cancer field so that, among other things, we have access to thought leaders in the field and to a robust number of samples to validate our genomic tests;
|
•
|
our ability to maintain our present customer base and obtain new customers;
|
•
|
potential product liability or intellectual property infringement claims;
|
•
|
our dependency on third-party manufacturers to supply or manufacture our products;
|
•
|
our ability to attract and retain a sufficient number of scientists, clinicians, sales personnel and other key personnel with extensive experience in oncology, who are in short supply;
|
•
|
our ability to obtain or maintain patents or other appropriate protection for the intellectual property in our proprietary tests and services;
|
•
|
our dependency on the intellectual property licensed to us or possessed by third parties;
|
•
|
our ability to expand internationally and launch our tests in emerging markets, such as India and Brazil;
|
•
|
our ability to adequately support future growth; and
|
•
|
the risk factors discussed in our annual report on Form 10-K for the year ended December 31, 2015, as updated in other reports, as applicable, that we file with the Securities and Exchange Commission.
|
|
|
|
|
|
|
Cancer Genetics, Inc.
|
|
|
|
|
|
|
(Registrant)
|
|
|
|
|
|||
Date: August 9, 2016
|
|
|
|
|
|
/s/ Panna L. Sharma
|
|
|
|
|
|
|
Panna L. Sharma
|
|
|
|
|
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|||
Date: August 9, 2016
|
|
|
|
|
|
/s/ Edward J. Sitar
|
|
|
|
|
|
|
Edward J. Sitar
|
|
|
|
|
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
Date: August 9, 2016
|
|
|
|
/s/ Panna L. Sharma
|
|
|
|
|
Panna L. Sharma
|
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
Date: August 9, 2016
|
|
|
|
/s/ Edward J. Sitar
|
|
|
|
|
Edward J. Sitar
|
|
|
|
|
Chief Financial Officer
|
|
|
|
|
(Principal Financial Officer)
|
|
/s/ Panna L. Sharma
|
Panna L. Sharma
|
President and Chief Executive Officer
|
|
/s/ Edward J. Sitar
|
Edward J. Sitar
|
Chief Financial Officer
|