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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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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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March 31,
2017 |
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December 31,
2016 |
||||
ASSETS
|
|
|
|
||||
CURRENT ASSETS
|
|
|
|
||||
Cash and cash equivalents
|
$
|
9,664
|
|
|
$
|
9,502
|
|
Accounts receivable, net of allowance for doubtful accounts
|
12,675
|
|
|
11,748
|
|
||
Other current assets
|
2,018
|
|
|
2,174
|
|
||
Total current assets
|
24,357
|
|
|
23,424
|
|
||
FIXED ASSETS, net of accumulated depreciation
|
4,778
|
|
|
4,738
|
|
||
OTHER ASSETS
|
|
|
|
||||
Restricted cash
|
300
|
|
|
300
|
|
||
Patents and other intangible assets, net of accumulated amortization
|
1,451
|
|
|
1,503
|
|
||
Investment in joint venture
|
256
|
|
|
268
|
|
||
Goodwill
|
12,029
|
|
|
12,029
|
|
||
Other
|
194
|
|
|
172
|
|
||
Total other assets
|
14,230
|
|
|
14,272
|
|
||
Total Assets
|
$
|
43,365
|
|
|
$
|
42,434
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
CURRENT LIABILITIES
|
|
|
|
||||
Accounts payable and accrued expenses
|
$
|
8,099
|
|
|
$
|
8,148
|
|
Obligations under capital leases, current portion
|
229
|
|
|
109
|
|
||
Deferred revenue
|
432
|
|
|
789
|
|
||
Term note, current portion
|
—
|
|
|
2,000
|
|
||
Total current liabilities
|
8,760
|
|
|
11,046
|
|
||
Term note
|
4,779
|
|
|
2,654
|
|
||
Obligations under capital leases
|
616
|
|
|
374
|
|
||
Deferred rent payable and other
|
229
|
|
|
290
|
|
||
Warrant liability
|
7,620
|
|
|
2,018
|
|
||
Deferred revenue, long-term
|
436
|
|
|
428
|
|
||
Total Liabilities
|
22,440
|
|
|
16,810
|
|
||
STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Preferred stock, authorized 9,764 shares, $0.0001 par value, none issued
|
—
|
|
|
—
|
|
||
Common stock, authorized 100,000 shares, $0.0001 par value, 19,756 and 18,936 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively
|
2
|
|
|
2
|
|
||
Additional paid-in capital
|
144,457
|
|
|
139,576
|
|
||
Accumulated (deficit)
|
(123,534
|
)
|
|
(113,954
|
)
|
||
Total Stockholders’ Equity
|
20,925
|
|
|
25,624
|
|
||
Total Liabilities and Stockholders’ Equity
|
$
|
43,365
|
|
|
$
|
42,434
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
Revenue
|
|
$
|
6,966
|
|
|
$
|
6,068
|
|
Cost of revenues
|
|
4,209
|
|
|
4,103
|
|
||
Gross profit
|
|
2,757
|
|
|
1,965
|
|
||
Operating expenses:
|
|
|
|
|
||||
Research and development
|
|
1,110
|
|
|
1,532
|
|
||
General and administrative
|
|
3,477
|
|
|
4,318
|
|
||
Sales and marketing
|
|
971
|
|
|
1,298
|
|
||
Total operating expenses
|
|
5,558
|
|
|
7,148
|
|
||
Loss from operations
|
|
(2,801
|
)
|
|
(5,183
|
)
|
||
Other income (expense):
|
|
|
|
|
||||
Interest expense
|
|
(194
|
)
|
|
(126
|
)
|
||
Interest income
|
|
17
|
|
|
4
|
|
||
Change in fair value of acquisition note payable
|
|
(232
|
)
|
|
34
|
|
||
Change in fair value of warrant liability
|
|
(7,294
|
)
|
|
17
|
|
||
Other expense
|
|
(46
|
)
|
|
—
|
|
||
Total other (expense)
|
|
(7,749
|
)
|
|
(71
|
)
|
||
Loss before income taxes
|
|
(10,550
|
)
|
|
(5,254
|
)
|
||
Income tax (benefit)
|
|
(970
|
)
|
|
—
|
|
||
Net (loss)
|
|
$
|
(9,580
|
)
|
|
$
|
(5,254
|
)
|
Basic and diluted net (loss) per share
|
|
$
|
(0.51
|
)
|
|
$
|
(0.39
|
)
|
Basic and diluted weighted-average shares outstanding
|
|
18,904
|
|
|
13,547
|
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
||||
Net (loss)
|
$
|
(9,580
|
)
|
|
$
|
(5,254
|
)
|
Adjustments to reconcile net (loss) to net cash (used in) operating activities:
|
|
|
|
||||
Depreciation
|
534
|
|
|
518
|
|
||
Amortization
|
83
|
|
|
87
|
|
||
Provision for bad debts (recoveries)
|
(21
|
)
|
|
—
|
|
||
Stock-based compensation
|
435
|
|
|
534
|
|
||
Change in fair value of acquisition note payable
|
232
|
|
|
(34
|
)
|
||
Change in fair value of warrant liability
|
7,294
|
|
|
(17
|
)
|
||
Amortization of debt issuance costs
|
7
|
|
|
4
|
|
||
Amortization of discount on debt
|
7
|
|
|
—
|
|
||
Loss in equity method investment
|
12
|
|
|
12
|
|
||
Loss on extinguishment of debt
|
78
|
|
|
—
|
|
||
Changes in:
|
|
|
|
||||
Accounts receivable
|
(901
|
)
|
|
(1,828
|
)
|
||
Other current assets
|
156
|
|
|
295
|
|
||
Other non-current assets
|
28
|
|
|
3
|
|
||
Accounts payable, accrued expenses and deferred revenue
|
(694
|
)
|
|
(101
|
)
|
||
Deferred rent payable and other
|
(61
|
)
|
|
(6
|
)
|
||
Net cash (used in) operating activities
|
(2,391
|
)
|
|
(5,787
|
)
|
||
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
||||
Purchase of fixed assets
|
(178
|
)
|
|
(319
|
)
|
||
Patent costs
|
(31
|
)
|
|
(39
|
)
|
||
Net cash (used in) investing activities
|
(209
|
)
|
|
(358
|
)
|
||
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
||||
Principal payments on capital lease obligations
|
(34
|
)
|
|
(41
|
)
|
||
Proceeds from warrant exercises
|
1,750
|
|
|
—
|
|
||
Proceeds from Partners for Growth IV, L.P. term note
|
6,000
|
|
|
—
|
|
||
Principal payments on Silicon Valley Bank term note
|
(4,667
|
)
|
|
—
|
|
||
Payment of debt issuance costs and loan fees
|
(287
|
)
|
|
—
|
|
||
Net cash provided by (used in) financing activities
|
2,762
|
|
|
(41
|
)
|
||
Net increase (decrease) in cash and cash equivalents
|
162
|
|
|
(6,186
|
)
|
||
CASH AND CASH EQUIVALENTS
|
|
|
|
||||
Beginning
|
9,502
|
|
|
19,459
|
|
||
Ending
|
$
|
9,664
|
|
|
$
|
13,273
|
|
SUPPLEMENTAL CASH FLOW DISCLOSURE
|
|
|
|
||||
Cash paid for interest
|
$
|
269
|
|
|
$
|
97
|
|
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING ACTIVITIES
|
|
|
|
||||
Fixed assets acquired through capital lease arrangements
|
$
|
396
|
|
|
$
|
—
|
|
Derivative warrants issued with debt
|
1,004
|
|
|
—
|
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Biopharma Services
|
$
|
3,719
|
|
|
$
|
3,350
|
|
Clinical Services
|
2,954
|
|
|
2,456
|
|
||
Discovery Services
|
293
|
|
|
262
|
|
||
|
$
|
6,966
|
|
|
$
|
6,068
|
|
|
March 31,
2017 |
|
December 31,
2016 |
||||
Biopharma Services
|
$
|
3,315
|
|
|
$
|
3,683
|
|
Clinical Services
|
10,310
|
|
|
8,972
|
|
||
Discovery Services
|
416
|
|
|
480
|
|
||
Allowance for doubtful accounts
|
(1,366
|
)
|
|
(1,387
|
)
|
||
|
$
|
12,675
|
|
|
$
|
11,748
|
|
|
Three Months Ended March 31,
|
||
|
2017
|
|
2016
|
Medicare
|
14%
|
|
15%
|
Other insurers
|
23%
|
|
22%
|
Other healthcare facilities
|
6%
|
|
4%
|
|
43%
|
|
41%
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Numerator:
|
|
|
|
||||
Net (loss) for basic earnings per share
|
$
|
(9,580
|
)
|
|
$
|
(5,254
|
)
|
Change in fair value of warrant liability
|
—
|
|
|
17
|
|
||
Net (loss) for diluted earnings per share
|
$
|
(9,580
|
)
|
|
$
|
(5,271
|
)
|
Denominator:
|
|
|
|
||||
Weighted-average basic common shares outstanding
|
18,904
|
|
|
13,547
|
|
||
Assumed conversion of dilutive securities:
|
|
|
|
||||
Common stock purchase warrants
|
—
|
|
|
—
|
|
||
Potentially dilutive common shares
|
—
|
|
|
—
|
|
||
Denominator for diluted earnings per share – adjusted weighted-average shares
|
18,904
|
|
|
13,547
|
|
||
Basic net (loss) per share
|
$
|
(0.51
|
)
|
|
$
|
(0.39
|
)
|
Diluted net (loss) per share
|
$
|
(0.51
|
)
|
|
$
|
(0.39
|
)
|
|
|
|
|
|
Three Months Ended March 31,
|
||||
|
2017
|
|
2016
|
||
Common stock purchase warrants
|
6,608
|
|
|
4,362
|
|
Stock options
|
2,520
|
|
|
1,928
|
|
Restricted shares of common stock
|
68
|
|
|
98
|
|
|
9,196
|
|
|
6,388
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||
SVB Term Note, repaid in 2017
|
$
|
—
|
|
|
$
|
4,667
|
|
PFG Term Note, net of discount of $992
|
5,008
|
|
|
—
|
|
||
Less unamortized debt issuance costs
|
229
|
|
|
13
|
|
||
Term notes, net
|
4,779
|
|
|
4,654
|
|
||
Less current maturities
|
—
|
|
|
2,000
|
|
||
Long-term portion
|
$
|
4,779
|
|
|
$
|
2,654
|
|
|
|
|
|
|
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, 2017
|
2,198
|
|
|
$
|
9.09
|
|
|
7.04
|
|
$
|
—
|
|
Granted
|
468
|
|
|
2.49
|
|
|
|
|
|
|||
Cancelled or expired
|
(146
|
)
|
|
9.49
|
|
|
|
|
|
|||
Outstanding March 31, 2017
|
2,520
|
|
|
$
|
7.84
|
|
|
7.10
|
|
$
|
1,558
|
|
Exercisable March 31, 2017
|
1,381
|
|
|
$
|
10.17
|
|
|
5.56
|
|
$
|
161
|
|
|
Three Months Ended March 31,
|
|
|
2017
|
|
Volatility
|
73.57
|
%
|
Risk free interest rate
|
2.03
|
%
|
Dividend yield
|
0.00
|
%
|
Term (years)
|
6.00
|
|
Weighted-average fair value of options granted during the period
|
1.63
|
|
|
Three Months Ended March 31,
|
||||
|
2017
|
|
2016
|
||
Volatility
|
77.41
|
%
|
|
75.92
|
%
|
Risk free interest rate
|
2.22
|
%
|
|
1.56
|
%
|
Dividend yield
|
0.00
|
%
|
|
0.00
|
%
|
Term (years)
|
7.14
|
|
|
8.14
|
|
|
Non-vested Restricted Stock Awards
|
|||||
|
Number of
Shares (in thousands) |
|
Weighted-Average Grant Date Fair Value
|
|||
Non-vested at January 1, 2017
|
80
|
|
|
$
|
6.30
|
|
Vested
|
(10
|
)
|
|
8.38
|
|
|
Cancelled
|
(2
|
)
|
|
$
|
11.36
|
|
Non-vested at March 31, 2017
|
68
|
|
|
$
|
5.85
|
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Cost of revenues
|
$
|
59
|
|
|
$
|
69
|
|
Research and development
|
50
|
|
|
50
|
|
||
General and administrative
|
300
|
|
|
387
|
|
||
Sales and marketing
|
26
|
|
|
28
|
|
||
Total stock-based compensation
|
$
|
435
|
|
|
$
|
534
|
|
Issued With / For
|
Exercise
Price |
|
Warrants
Outstanding January 1, 2017 |
|
2017 Warrants Issued
|
|
2017 Warrants Exercised
|
|
Warrants Outstanding March 31, 2017
|
||||||
Non-Derivative Warrants:
|
|
|
|
|
|
|
|
|
|
||||||
Financing
|
$
|
10.00
|
|
|
243
|
|
|
—
|
|
|
—
|
|
|
243
|
|
Financing
|
15.00
|
|
|
361
|
|
|
—
|
|
|
—
|
|
|
361
|
|
|
Debt guarantee
|
15.00
|
|
|
109
|
|
|
—
|
|
|
—
|
|
|
109
|
|
|
2015 Offering
|
5.00
|
|
|
3,450
|
|
|
—
|
|
|
—
|
|
|
3,450
|
|
|
Total non-derivative warrants
|
$
|
6.42
|
|
C
|
4,163
|
|
|
—
|
|
|
—
|
|
|
4,163
|
|
Derivative Warrants:
|
|
|
|
|
|
|
|
|
|
||||||
2016 Offerings
|
2.25
|
|
A
|
2,870
|
|
|
—
|
|
|
(868
|
)
|
|
2,002
|
|
|
2017 Debt
|
2.82
|
|
B
|
—
|
|
|
443
|
|
|
—
|
|
|
443
|
|
|
Total derivative warrants
|
2.35
|
|
C
|
2,870
|
|
|
443
|
|
|
(868
|
)
|
|
2,445
|
|
|
Total
|
$
|
4.92
|
|
C
|
7,033
|
|
|
443
|
|
|
(868
|
)
|
|
6,608
|
|
A
|
These warrants are subject to fair value accounting and contain a contingent net cash settlement feature.
|
B
|
These warrants are subject to fair value accounting and contain a net settlement provision that uses the
90
-trading day price of our common stock. These warrants are subject to a
20%
reduction if certain financial milestones are met.
|
C
|
Weighted-average exercise prices are as of
March 31, 2017
.
|
Issued with/for
|
Fair value of
warrants outstanding as of December 31, 2016 |
|
Fair value
of warrants issued |
|
Fair value
of warrants exercised |
|
Change in
fair value of warrants |
|
Fair value of
warrants outstanding as of March 31, 2017 |
||||||||||
2016 Offerings
|
$
|
2,018
|
|
|
$
|
—
|
|
|
$
|
(2,696
|
)
|
|
$
|
6,758
|
|
|
$
|
6,080
|
|
2017 Debt
|
—
|
|
|
1,004
|
|
|
—
|
|
|
536
|
|
|
1,540
|
|
|||||
|
$
|
2,018
|
|
|
$
|
1,004
|
|
|
$
|
(2,696
|
)
|
|
$
|
7,294
|
|
|
$
|
7,620
|
|
2016 Offerings
|
Exercised During the Three Months Ended March 31, 2017
|
|
As of March 31, 2017
|
|
As of December 31, 2016
|
||||||
Exercise price
|
$
|
2.25
|
|
|
$
|
2.25
|
|
|
$
|
2.25
|
|
Expected life (years)
|
4.79
|
|
|
4.82
|
|
|
5.06
|
|
|||
Expected volatility
|
76.29
|
%
|
|
77.41
|
%
|
|
72.82
|
%
|
|||
Risk-free interest rate
|
1.94
|
%
|
|
1.93
|
%
|
|
1.93
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
2017 Debt
|
Issued During the Three Months Ended March 31, 2017
|
|
As of March 31, 2017
|
||||
Exercise price
|
$
|
2.82
|
|
|
$
|
2.82
|
|
Expected life (years)
|
7.00
|
|
|
6.98
|
|
||
Expected volatility
|
74.61
|
%
|
|
77.41
|
%
|
||
Risk-free interest rate
|
2.22
|
%
|
|
2.22
|
%
|
||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
March 31, 2017
|
||||||||||||||
|
Total
|
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
||||||||
Warrant liability
|
$
|
7,620
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,620
|
|
Note payable
|
346
|
|
|
—
|
|
|
—
|
|
|
346
|
|
||||
|
$
|
7,966
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,966
|
|
|
|
|
|
|
|
|
|
|
December 31, 2016
|
||||||||||||||
|
Total
|
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
||||||||
Warrant liability
|
$
|
2,018
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,018
|
|
Note payable
|
114
|
|
|
—
|
|
|
—
|
|
|
114
|
|
||||
|
$
|
2,132
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,132
|
|
|
|
|
|
|
|
|
|
|
Note Payable
|
||
|
to VenturEast
|
||
Fair value at December 31, 2016
|
$
|
114
|
|
Change in fair value
|
232
|
|
|
Fair value at March 31, 2017
|
$
|
346
|
|
|
Three Months Ended March 31,
|
|
Change
|
|||||||||||
(dollars in thousands)
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
Revenue
|
$
|
6,966
|
|
|
$
|
6,068
|
|
|
$
|
898
|
|
|
15
|
%
|
Cost of revenues
|
4,209
|
|
|
4,103
|
|
|
106
|
|
|
3
|
%
|
|||
Research and development expenses
|
1,110
|
|
|
1,532
|
|
|
(422
|
)
|
|
(28
|
)%
|
|||
General and administrative expenses
|
3,477
|
|
|
4,318
|
|
|
(841
|
)
|
|
(19
|
)%
|
|||
Sales and marketing expenses
|
971
|
|
|
1,298
|
|
|
(327
|
)
|
|
(25
|
)%
|
|||
Loss from operations
|
(2,801
|
)
|
|
(5,183
|
)
|
|
2,382
|
|
|
(46
|
)%
|
|||
Interest income (expense)
|
(177
|
)
|
|
(122
|
)
|
|
(55
|
)
|
|
45
|
%
|
|||
Change in fair value of acquisition note payable
|
(232
|
)
|
|
34
|
|
|
(266
|
)
|
|
(782
|
)%
|
|||
Change in fair value of warrant liability
|
(7,294
|
)
|
|
17
|
|
|
(7,311
|
)
|
|
(43,006
|
)%
|
|||
Other expense
|
(46
|
)
|
|
—
|
|
|
(46
|
)
|
|
n/a
|
|
|||
Loss before income taxes
|
(10,550
|
)
|
|
(5,254
|
)
|
|
(5,296
|
)
|
|
101
|
%
|
|||
Income tax (benefit)
|
(970
|
)
|
|
—
|
|
|
(970
|
)
|
|
n/a
|
|
|||
Net (loss)
|
$
|
(9,580
|
)
|
|
$
|
(5,254
|
)
|
|
$
|
(4,326
|
)
|
|
82
|
%
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
Reconciliation of net (loss):
|
|
|
|
|
||||
Net (loss)
|
|
$
|
(9,580
|
)
|
|
$
|
(5,254
|
)
|
ADD:
|
|
|
|
|
||||
Change in fair value of acquisition note payable
|
|
232
|
|
|
(34
|
)
|
||
Change in fair value of warrant liability
|
|
7,294
|
|
|
(17
|
)
|
||
Adjusted net (loss)
|
|
$
|
(2,054
|
)
|
|
$
|
(5,305
|
)
|
Reconciliation of net (loss) per share, basic and diluted:
|
|
|
|
|
||||
Basic and diluted net (loss) per share
|
|
$
|
(0.51
|
)
|
|
$
|
(0.39
|
)
|
Adjustments to net (loss)
|
|
0.40
|
|
|
—
|
|
||
Adjusted basic and diluted net (loss) per share
|
|
$
|
(0.11
|
)
|
|
$
|
(0.39
|
)
|
Basic and diluted weighted-average shares outstanding
|
|
18,904
|
|
|
13,547
|
|
||
|
|
|
|
|
|
Three Months Ended March 31,
|
|
Change
|
|||||||||||||||||
|
2017
|
|
2016
|
|
|
|
|
|||||||||||||
(dollars in thousands)
|
$
|
|
%
|
|
$
|
|
%
|
|
$
|
|
%
|
|||||||||
Biopharma Services
|
$
|
3,719
|
|
|
53
|
%
|
|
$
|
3,350
|
|
|
55
|
%
|
|
$
|
369
|
|
|
11
|
%
|
Clinical Services
|
2,954
|
|
|
43
|
%
|
|
2,456
|
|
|
41
|
%
|
|
498
|
|
|
20
|
%
|
|||
Discovery Services
|
293
|
|
|
4
|
%
|
|
262
|
|
|
4
|
%
|
|
31
|
|
|
12
|
%
|
|||
Total Revenue
|
$
|
6,966
|
|
|
100
|
%
|
|
$
|
6,068
|
|
|
100
|
%
|
|
$
|
898
|
|
|
15
|
%
|
|
Three Months Ended
March 31, |
||||||
(in thousands)
|
2017
|
|
2016
|
||||
Cash provided by (used in):
|
|
|
|
||||
Operating activities
|
$
|
(2,391
|
)
|
|
$
|
(5,787
|
)
|
Investing activities
|
(209
|
)
|
|
(358
|
)
|
||
Financing activities
|
2,762
|
|
|
(41
|
)
|
||
Net increase (decrease) in cash and cash equivalents
|
$
|
162
|
|
|
$
|
(6,186
|
)
|
•
|
our ability to achieve revenue growth and profitability;
|
•
|
the costs for funding the operations we recently acquired;
|
•
|
our ability to improve efficiency of billing and collection processes;
|
•
|
our ability to obtain approvals for our new diagnostic tests;
|
•
|
our ability to execute on our marketing and sales strategy for our 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 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, products 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, 2016 and other reports, as applicable, we file with the Securities and Exchange Commission.
|
•
|
Revenue recognition;
|
•
|
Accounts receivable and bad debts;
|
•
|
Stock-based compensation; and
|
•
|
Warrant liability.
|
•
|
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;
|
•
|
our ability to improve efficiency of billing and collection processes;
|
•
|
our ability to obtain reimbursement from governmental and other third-party payors for our tests and services;
|
•
|
our ability clinically validate our pipeline of tests currently in development;
|
•
|
our ability to execute on our marketing and sales strategy for our 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;
|
•
|
ability to raise additional capital to meet our liquidity needs;
|
•
|
competition from clinical laboratory services companies, 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 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, 2016, as updated in other reports, as applicable, that we file with the Securities and Exchange Commission.
|
|
|
|
|
|
|
Cancer Genetics, Inc.
|
|
|
|
|
|
|
(Registrant)
|
|
|
|
|
|||
Date: May 12, 2017
|
|
|
|
|
|
/s/ Panna L. Sharma
|
|
|
|
|
|
|
Panna L. Sharma
|
|
|
|
|
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|||
Date: May 12, 2017
|
|
|
|
|
|
/s/ John A. Roberts
|
|
|
|
|
|
|
John A. Roberts
|
|
|
|
|
|
|
Chief Operating Officer
(Principal Financial Officer)
|
|
|
|
|
|
|
|
Date: May 12, 2017
|
|
|
|
|
|
/s/ Igor Gitelman
|
|
|
|
|
|
|
Igor Gitelman
|
|
|
|
|
|
|
Chief Accounting Officer
(Principal Accounting Officer)
|
Exhibit
No.
|
|
Description
|
|
|
|
10.1
|
|
Employment Agreement, dated as of May 11, 2017 by and between the Company and Rita Shaknovich * +
|
|
|
|
31.1
|
|
Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under The Securities Exchange Act of 1934, as amended *
|
|
|
|
31.2
|
|
Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under The Securities Exchange Act of 1934, as amended *
|
|
|
|
32.1
|
|
Certifications of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of The Sarbanes-Oxley Act of 2002 **
|
|
|
|
32.2
|
|
Certifications of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of The Sarbanes-Oxley Act of 2002 **
|
|
|
|
101
|
|
The following materials from the Registrant’s quarterly report on Form 10-Q for the quarter ended March 31, 2017, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Balance Sheet at March 31, 2017 (unaudited) and December 31, 2016, (ii) Consolidated Statements of Operations for the three month periods ended March 31, 2017 and 2016 (unaudited), (iii) Consolidated Statements of Cash Flows for the three month periods ended March 31, 2017 and 2016 (unaudited) and (iv) Notes to Consolidated Financial Statements (unaudited)
|
|
|
|
*
|
|
Filed herewith.
|
**
|
|
Furnished herewith.
|
+
|
|
Indicates a management contract or compensatory plan in which directors and/or executive officers are eligible to participate.
|
1.
|
Employment.
The Company hereby employs Employee in the capacity of the Chief Medical Officer (“CMO”) and Chair of the Clinical Advisory Board of the Company, reporting directly to the President and Chief Executive Officer of the Company (the "CEO"). Employee accepts such employment and agrees to perform such roles and provide such management and other services for the Company as are customary to such office and such additional responsibilities, consistent with the position as the Company's Chief Medical Officer and Chair of the Clinical Advisory Board, as may be assigned from time to time by the CEO. Medical directors, both employees and consultants, will report to Employee and Employee will share the responsibility of managing the activity, workflow and quality of the clinical laboratory directors and their teams, and will be responsible for designing and implementing a plan for strategic unified clinical laboratory oversight and portfolio development.
|
2.
|
Term.
The employment hereunder shall be for a period commencing on May 28, 2017 (the "Commencement Date") and ending on the two (2)-year anniversary of the Commencement Date (the "Initial Term"), unless earlier terminated as provided in Section 4 or 5. This Agreement shall be automatically renewed for successive one (1)-year periods thereafter, commencing upon the expiration of the Initial Term, unless earlier terminated as provided in Section 4 or 5. Employee's employment following the Commencement Date will be on a full-time business basis requiring the devotion of substantially all of Employee’s productive business time for the efficient and successful operation of the business of the Company.
|
3.
|
Compensation and Benefits.
|
3.1
|
Cash Compensation.
|
3.2
|
Bonus Plan.
|
3.5
|
Reimbursement of Expenses.
Employee shall be entitled to be reimbursed for all reasonable expenses including the cost of travel for business; home office operation; business meals and entertainment, incurred by Employee in performing her tasks, duties and responsibilities under Section 2 or otherwise in connection with and reasonably related to the furtherance of the Company's business. Employee shall submit expense reports and receipts documenting the expenses incurred in accordance with Company policy, and will comply with using the Company's electronic travel and expense software and travel planning systems.
|
3.6
|
Mobile Device & Phones.
The Company shall provide a mobile phone that is compliant with the company policy
and is HIPAA compliant. The Employee is welcome to use Employee’s own device or phone, but it must be registered with the Information Technology department and must follow the Company's "BYOD" (Bring Your Own Device) policies, including but not limited to setting up of passwords, backups of information and compliance with email and communication policies.
|
4.
|
Change of Control.
|
5.
|
Termination
|
(i)
|
Employee's final and unappealed conviction of (or pleading guilty or "nolo contendere" to) any felony or a major misdemeanor involving dishonesty or moral turpitude; provided, however, that prior to discharging Employee for Cause, the Company shall give a written statement of findings to Employee setting forth specifically the grounds on which Cause is based, and Employee shall have a period often (10) days thereafter to respond in writing to the Company's findings; or
|
(ii)
|
The Employee's (1) unreasonable failure to perform her duties, as determined by the Board of Directors, or (2) substantial and material breach of, or default under, this Agreement or the Proprietary Information and Invention Assignment Agreement (as defined herein), (3) The unreasonable failure of the Company, as determined by the Board of Directors, to meet reasonable benchmarks that are in control of the Employee, as may be agreed to from time to time by the
|
5.2
|
Effects of Termination.
|
6.
|
Conflicts of Interest
|
|
|
|
|
|
Date: May 12, 2017
|
|
|
|
/s/ Panna L. Sharma
|
|
|
|
|
Panna L. Sharma
|
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
Date: May 12, 2017
|
|
|
|
/s/ John A. Roberts
|
|
|
|
|
John A. Roberts
|
|
|
|
|
Chief Operating Officer
|
|
|
|
|
(Principal Financial Officer)
|
|
/s/ Panna L. Sharma
|
Panna L. Sharma
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
/s/ John A. Roberts
|
John A. Roberts.
|
Chief Operating Officer
(Principal Financial Officer)
|