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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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|
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DELAWARE
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26-2025616
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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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245 First Street, Suite 1800
Cambridge, MA
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02142
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(Address of principal executive offices)
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(Zip 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
(Do not check if a smaller reporting company)
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Smaller reporting company
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x
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|
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Emerging growth company
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x
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Page
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Item 1.
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||
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Item 2.
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Item 3.
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Item 4.
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||
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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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•
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our expected future loss and accumulated deficit levels;
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•
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our projected financial position and estimated cash burn rate;
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•
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our estimates regarding expenses, future revenues, capital requirements and needs for, and ability to obtain, additional financing;
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•
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our ability to continue as a going concern;
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•
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our need to raise substantial additional capital to fund our operations;
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•
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the success, cost and timing of our pre-clinical studies and clinical trials in the United States, Canada and in other foreign jurisdictions;
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•
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the potential enrollment challenges to our Phase 3 clinical trial of Vicinium due to anticipated shortages of Bacillus Calmette-Guérin, or BCG;
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•
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the potential that results of pre-clinical studies and clinical trials indicate our product candidates are unsafe or ineffective;
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•
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our dependence on third parties, including contract research organizations, or CROs, in the conduct of our pre-clinical studies and clinical trials;
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•
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the difficulties and expenses associated with obtaining and maintaining regulatory approval of our product candidates and companion diagnostics, if any, in the United States, Canada and in other foreign jurisdictions, and the labeling under any approval we may obtain;
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•
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our plans and ability to develop and commercialize our product candidates;
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•
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our ability to achieve certain future regulatory, development and commercialization milestones under our license agreement, which we refer to as the License Agreement, with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., or collectively, Roche;
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•
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market acceptance of our product candidates, the size and growth of the potential markets for our product candidates, and our ability to serve those markets;
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•
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obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology;
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•
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the successful development of our commercialization capabilities, including sales and marketing capabilities; and
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•
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the success of competing therapies and products that are or become available.
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June 30,
2017 |
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December 31, 2016
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
15,751
|
|
|
$
|
25,342
|
|
Prepaid expenses and other current assets
|
707
|
|
|
585
|
|
||
Total current assets
|
16,458
|
|
|
25,927
|
|
||
Property and equipment, net
|
632
|
|
|
796
|
|
||
Restricted cash
|
10
|
|
|
10
|
|
||
Intangible assets
|
60,500
|
|
|
60,500
|
|
||
Goodwill
|
17,371
|
|
|
16,864
|
|
||
Other assets
|
77
|
|
|
—
|
|
||
Total assets
|
$
|
95,048
|
|
|
$
|
104,097
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
1,245
|
|
|
$
|
1,667
|
|
Accrued expenses
|
2,492
|
|
|
1,774
|
|
||
Deferred revenue
|
—
|
|
|
425
|
|
||
Due to related party
|
118
|
|
|
114
|
|
||
Total current liabilities
|
3,855
|
|
|
3,980
|
|
||
Other liabilities
|
148
|
|
|
—
|
|
||
Warrant liability
|
—
|
|
|
5
|
|
||
Deferred tax liability
|
16,335
|
|
|
16,335
|
|
||
Contingent consideration
|
48,800
|
|
|
45,100
|
|
||
Commitments and contingencies
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized at June 30, 2017 and December 31, 2016 and no shares issued and outstanding at June 30, 2017 and December 31, 2016
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value per share; 200,000,000 shares authorized at June 30, 2017 and December 31, 2016 and 24,687,456 and 24,531,964 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively
|
25
|
|
|
25
|
|
||
Additional paid-in capital
|
162,564
|
|
|
161,963
|
|
||
Accumulated deficit
|
(136,679
|
)
|
|
(123,311
|
)
|
||
Total stockholders’ equity
|
25,910
|
|
|
38,677
|
|
||
Total liabilities and stockholders’ equity
|
$
|
95,048
|
|
|
$
|
104,097
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Revenue:
|
|
|
|
|
|
|
|
||||||||
Collaboration revenue
|
$
|
—
|
|
|
$
|
277
|
|
|
$
|
—
|
|
|
$
|
506
|
|
License revenue
|
—
|
|
|
—
|
|
|
425
|
|
|
—
|
|
||||
Total revenue
|
—
|
|
|
277
|
|
|
425
|
|
|
506
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
2,909
|
|
|
3,298
|
|
|
5,783
|
|
|
7,930
|
|
||||
General and administrative
|
2,241
|
|
|
3,471
|
|
|
4,454
|
|
|
5,618
|
|
||||
Loss from change in fair value of contingent consideration
|
2,200
|
|
|
—
|
|
|
3,700
|
|
|
—
|
|
||||
Total operating expenses
|
7,350
|
|
|
6,769
|
|
|
13,937
|
|
|
13,548
|
|
||||
Loss from operations
|
(7,350
|
)
|
|
(6,492
|
)
|
|
(13,512
|
)
|
|
(13,042
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
||||||||
Other income, net
|
34
|
|
|
1
|
|
|
135
|
|
|
139
|
|
||||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
(915
|
)
|
||||
Interest expense
|
—
|
|
|
—
|
|
|
—
|
|
|
(247
|
)
|
||||
Total other income (expense), net
|
34
|
|
|
1
|
|
|
135
|
|
|
(1,023
|
)
|
||||
Net loss and comprehensive loss
|
$
|
(7,316
|
)
|
|
$
|
(6,491
|
)
|
|
$
|
(13,377
|
)
|
|
$
|
(14,065
|
)
|
Net loss per share — basic and diluted
|
$
|
(0.30
|
)
|
|
$
|
(0.33
|
)
|
|
$
|
(0.54
|
)
|
|
$
|
(0.71
|
)
|
Weighted-average number of common shares used in net loss per share — basic and diluted
|
24,685
|
|
|
19,874
|
|
|
24,648
|
|
|
19,756
|
|
|
Six Months Ended
June 30, |
||||||
|
2017
|
|
2016
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(13,377
|
)
|
|
$
|
(14,065
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
174
|
|
|
93
|
|
||
Non-cash interest expense
|
—
|
|
|
26
|
|
||
Stock-based compensation expense
|
566
|
|
|
1,207
|
|
||
Change in fair value of warrant liability
|
(5
|
)
|
|
(102
|
)
|
||
Loss from change in fair value of contingent consideration
|
3,700
|
|
|
—
|
|
||
Loss on extinguishment of debt
|
—
|
|
|
221
|
|
||
Gain on sale of equipment
|
(79
|
)
|
|
—
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Prepaid expenses and other assets
|
(200
|
)
|
|
(126
|
)
|
||
Restricted cash
|
—
|
|
|
(25
|
)
|
||
Accounts payable
|
(422
|
)
|
|
609
|
|
||
Accrued expenses and other liabilities
|
359
|
|
|
(991
|
)
|
||
Deferred revenue
|
(425
|
)
|
|
(406
|
)
|
||
Due to related party
|
4
|
|
|
—
|
|
||
Net cash used in operating activities
|
(9,705
|
)
|
|
(13,559
|
)
|
||
Investing activities
|
|
|
|
||||
Sales of equipment
|
69
|
|
|
—
|
|
||
Net cash provided by investing activities
|
69
|
|
|
—
|
|
||
Financing activities
|
|
|
|
||||
Payments on notes payable
|
—
|
|
|
(14,124
|
)
|
||
Proceeds from exercise of common stock options
|
40
|
|
|
88
|
|
||
Proceeds from sale of common stock pursuant to ESPP
|
5
|
|
|
—
|
|
||
Net cash provided by (used in) financing activities
|
45
|
|
|
(14,036
|
)
|
||
Net decrease in cash and cash equivalents
|
(9,591
|
)
|
|
(27,595
|
)
|
||
Cash and cash equivalents at beginning of period
|
25,342
|
|
|
36,079
|
|
||
Cash and cash equivalents at end of period
|
$
|
15,751
|
|
|
$
|
8,484
|
|
Supplemental cash flow information
|
|
|
|
||||
Cash paid for interest
|
$
|
—
|
|
|
$
|
663
|
|
Description
|
June 30,
2017 |
|
Active
Markets
(Level 1)
|
|
Observable
Inputs
(Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
15,751
|
|
|
$
|
15,751
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Restricted cash
|
10
|
|
|
10
|
|
|
—
|
|
|
—
|
|
||||
Total assets
|
$
|
15,761
|
|
|
$
|
15,761
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Contingent consideration
|
48,800
|
|
|
—
|
|
|
—
|
|
|
48,800
|
|
||||
Total liabilities
|
$
|
48,800
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
48,800
|
|
Description
|
December 31, 2016
|
|
Active
Markets
(Level 1)
|
|
Observable
Inputs
(Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
25,342
|
|
|
$
|
25,342
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Restricted cash
|
10
|
|
|
10
|
|
|
—
|
|
|
—
|
|
||||
Total assets
|
$
|
25,352
|
|
|
$
|
25,352
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
5
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5
|
|
Contingent consideration
|
45,100
|
|
|
—
|
|
|
—
|
|
|
45,100
|
|
||||
Total liabilities
|
$
|
45,105
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
45,105
|
|
|
June 30,
2017 |
|
December 31, 2016
|
||
Risk-free interest rate
|
1.14
|
%
|
|
0.85
|
%
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
Expected term (in years)
|
0.42
|
|
|
0.92
|
|
Expected volatility
|
73.45
|
%
|
|
83.39
|
%
|
Beginning balance, January 1, 2017
|
$
|
5
|
|
Change in fair value
|
(5
|
)
|
|
Ending balance, June 30, 2017
|
$
|
—
|
|
Beginning balance, January 1, 2017
|
45,100
|
|
|
Loss from change in fair value of contingent consideration
|
3,700
|
|
|
Ending balance, June 30, 2017
|
$
|
48,800
|
|
|
Previously Reported
|
|
Currently Reported
|
||||
Cash and cash equivalents
|
$
|
136
|
|
|
$
|
136
|
|
Prepaid expenses and other assets
|
1,162
|
|
|
1,162
|
|
||
Property and equipment
|
867
|
|
|
867
|
|
||
In-process research and development - U.S. Vicinium
|
12,200
|
|
|
12,200
|
|
||
In-process research and development - E.U. Vicinium
|
41,100
|
|
|
41,100
|
|
||
In-process research and development - R.O.W. Vicinium
|
7,200
|
|
|
7,200
|
|
||
Goodwill
|
16,864
|
|
|
17,371
|
|
||
Accounts payable
|
(1,163
|
)
|
|
(1,163
|
)
|
||
Accrued expenses
|
(1,494
|
)
|
|
(2,001
|
)
|
||
Other liabilities
|
(812
|
)
|
|
(812
|
)
|
||
Deferred tax liability
|
(16,335
|
)
|
|
(16,335
|
)
|
||
|
$
|
59,725
|
|
|
$
|
59,725
|
|
|
June 30,
2017 |
|
December 31, 2016
|
||||
Development costs
|
$
|
1,757
|
|
|
$
|
852
|
|
Employee compensation
|
476
|
|
|
352
|
|
||
Professional fees
|
206
|
|
|
413
|
|
||
Other
|
53
|
|
|
157
|
|
||
|
$
|
2,492
|
|
|
$
|
1,774
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Stock options
|
$
|
268
|
|
|
$
|
444
|
|
|
$
|
455
|
|
|
$
|
879
|
|
Restricted stock
|
51
|
|
|
51
|
|
|
102
|
|
|
105
|
|
||||
Restricted stock units
|
—
|
|
|
106
|
|
|
3
|
|
|
198
|
|
||||
Performance stock options
|
—
|
|
|
14
|
|
|
—
|
|
|
14
|
|
||||
Employee stock purchase plan
|
3
|
|
|
6
|
|
|
6
|
|
|
11
|
|
||||
|
$
|
322
|
|
|
$
|
621
|
|
|
$
|
566
|
|
|
$
|
1,207
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Research and development expense
|
$
|
83
|
|
|
$
|
226
|
|
|
$
|
123
|
|
|
$
|
447
|
|
General and administrative expense
|
239
|
|
|
395
|
|
|
$
|
443
|
|
|
760
|
|
|||
|
$
|
322
|
|
|
$
|
621
|
|
|
$
|
566
|
|
|
$
|
1,207
|
|
|
Shares
|
|
Weighted-Average
Exercise Price
|
|||
Outstanding at December 31, 2016
|
2,024,468
|
|
|
$
|
4.41
|
|
Granted
|
248,025
|
|
|
1.85
|
|
|
Exercised
|
(140,400
|
)
|
|
0.28
|
|
|
Cancelled or forfeited
|
(166,887
|
)
|
|
9.85
|
|
|
Outstanding at June 30, 2017
|
1,965,206
|
|
|
$
|
3.92
|
|
Exercisable at June 30, 2017
|
942,661
|
|
|
$
|
4.76
|
|
Vested and expected to vest at June 30, 2017
(1)
|
1,965,206
|
|
|
$
|
3.92
|
|
(1)
|
Represents the number of vested options, plus the number of unvested options expected to vest. The Company adopted ASU 2016-09 as of January 1, 2017 and elected an accounting policy to record forfeitures as they occur.
|
|
Restricted
Stock
|
|
Weighted-Average
Grant Date
Fair Value
|
|||
Unvested at December 31, 2016
|
22,150
|
|
|
$
|
11.43
|
|
Vested
|
(8,860
|
)
|
|
11.43
|
|
|
Unvested at June 30, 2017
|
13,290
|
|
|
$
|
11.43
|
|
|
Restricted
Stock Units
|
|
Weighted-Average
Grant Date
Fair Value
|
|||
Unvested at December 31, 2016
|
3,333
|
|
|
$
|
4.09
|
|
Vested
|
(3,333
|
)
|
|
4.09
|
|
|
Unvested at June 30, 2017
|
—
|
|
|
$
|
—
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended
June 30, |
||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||
Stock options
|
1,965,206
|
|
|
2,205,774
|
|
|
1,965,206
|
|
|
2,205,774
|
|
Unvested restricted stock
|
13,290
|
|
|
31,010
|
|
|
13,290
|
|
|
31,010
|
|
Restricted stock units
|
—
|
|
|
77,133
|
|
|
—
|
|
|
77,133
|
|
Common stock warrants
|
926,840
|
|
|
926,840
|
|
|
926,840
|
|
|
926,840
|
|
|
2,905,336
|
|
|
3,240,757
|
|
|
2,905,336
|
|
|
3,240,757
|
|
•
|
the scope, initiation, progress, timing, costs and results of pre-clinical development and laboratory testing and clinical trials for our product candidates;
|
•
|
our ability to establish collaborations on favorable terms, if at all, particularly manufacturing, marketing and distribution arrangements for our product candidates;
|
•
|
the costs and timing of the implementation of commercial-scale manufacturing activities;
|
•
|
the costs and timing of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval;
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
|
•
|
our obligation to make milestone, royalty and other payments to third party licensors under our licensing agreements;
|
•
|
the extent to which we in-license or acquire rights to other products, product candidates or technologies;
|
•
|
the outcome, timing and cost of regulatory review by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities, including Health Canada, to require that we perform more studies or clinical trials than those that we currently expect;
|
•
|
our ability to achieve certain future regulatory, development and commercialization milestones under the License Agreement with Roche;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the revenue, if any, received from commercial sales of any product candidates for which we receive regulatory approval.
|
•
|
employee-related expenses, including salaries, benefits, travel and stock-based compensation expense;
|
•
|
expenses incurred under agreements with contract research organizations, or CROs, and investigative sites that conduct our clinical trials;
|
•
|
expenses associated with developing manufacturing capabilities and manufacturing clinical study materials;
|
•
|
facilities, depreciation, and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance, and other supplies; and
|
•
|
expenses associated with pre-clinical and regulatory activities.
|
•
|
the scope, progress, outcome and costs of our clinical trials and other research and development activities;
|
•
|
the efficacy and potential advantages of our product candidates compared to alternative treatments, including any standard of care;
|
•
|
the market acceptance of our product candidates;
|
•
|
the cost and timing of the implementation of commercial-scale manufacturing of our product candidates;
|
•
|
obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
|
•
|
significant and changing government regulation; and
|
•
|
the timing, receipt and terms of any marketing approvals.
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
(in thousands)
|
||||||||||||||
Programs:
|
|
|
|
|
|
|
|
||||||||
Vicinium (1)
|
$
|
1,600
|
|
|
$
|
—
|
|
|
$
|
3,119
|
|
|
$
|
—
|
|
Proxinium
|
—
|
|
|
—
|
|
|
27
|
|
|
—
|
|
||||
VB6-845d
|
16
|
|
|
—
|
|
|
88
|
|
|
—
|
|
||||
EBI-031 (2)
|
—
|
|
|
1,013
|
|
|
—
|
|
|
2,752
|
|
||||
Isunakinra/EBI-005 (3)
|
—
|
|
|
208
|
|
|
—
|
|
|
1,530
|
|
||||
Total direct program expenses
|
1,616
|
|
|
1,221
|
|
|
3,234
|
|
|
4,282
|
|
||||
Personnel and other expenses:
|
|
|
|
|
|
|
|
||||||||
Employee and contractor-related expenses
|
961
|
|
|
1,716
|
|
|
1,816
|
|
|
2,900
|
|
||||
Platform-related lab expenses
|
164
|
|
|
102
|
|
|
291
|
|
|
239
|
|
||||
Facility expenses
|
103
|
|
|
163
|
|
|
194
|
|
|
310
|
|
||||
Other expenses
|
65
|
|
|
96
|
|
|
248
|
|
|
199
|
|
||||
Total personnel and other expenses
|
1,293
|
|
|
2,077
|
|
|
2,549
|
|
|
3,648
|
|
||||
Total research and development expenses
|
$
|
2,909
|
|
|
$
|
3,298
|
|
|
$
|
5,783
|
|
|
$
|
7,930
|
|
|
Three Months Ended
June 30, |
|
|
||||||||
|
2017
|
|
2016
|
|
Change
|
||||||
|
(in thousands)
|
||||||||||
Revenue:
|
|
|
|
|
|
||||||
Collaboration revenue
|
$
|
—
|
|
|
$
|
277
|
|
|
$
|
(277
|
)
|
License revenue
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total revenue
|
—
|
|
|
277
|
|
|
(277
|
)
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
2,909
|
|
|
3,298
|
|
|
(389
|
)
|
|||
General and administrative
|
2,241
|
|
|
3,471
|
|
|
(1,230
|
)
|
|||
Loss from change in fair value of contingent consideration
|
2,200
|
|
|
—
|
|
|
2,200
|
|
|||
Total operating expenses
|
7,350
|
|
|
6,769
|
|
|
581
|
|
|||
Loss from operations
|
(7,350
|
)
|
|
(6,492
|
)
|
|
(858
|
)
|
|||
Other income
|
34
|
|
|
1
|
|
|
33
|
|
|||
Net loss and comprehensive loss
|
$
|
(7,316
|
)
|
|
$
|
(6,491
|
)
|
|
$
|
(825
|
)
|
|
Six Months Ended
June 30, |
|
|
||||||||
|
2017
|
|
2016
|
|
Change
|
||||||
|
(in thousands)
|
||||||||||
Revenue:
|
|
|
|
|
|
||||||
Collaboration revenue
|
$
|
—
|
|
|
$
|
506
|
|
|
$
|
(506
|
)
|
License revenue
|
425
|
|
|
—
|
|
|
425
|
|
|||
Total revenue
|
425
|
|
|
506
|
|
|
(81
|
)
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
5,783
|
|
|
7,930
|
|
|
(2,147
|
)
|
|||
General and administrative
|
4,454
|
|
|
5,618
|
|
|
(1,164
|
)
|
|||
Loss from change in fair value of contingent consideration
|
3,700
|
|
|
—
|
|
|
3,700
|
|
|||
Total operating expenses
|
13,937
|
|
|
13,548
|
|
|
389
|
|
|||
Loss from operations
|
(13,512
|
)
|
|
(13,042
|
)
|
|
(470
|
)
|
|||
Other income (expense), net
|
135
|
|
|
(1,023
|
)
|
|
1,158
|
|
|||
Net loss and comprehensive loss
|
$
|
(13,377
|
)
|
|
$
|
(14,065
|
)
|
|
$
|
688
|
|
|
Six Months Ended
June 30, |
||||||
|
2017
|
|
2016
|
||||
|
(in thousands)
|
||||||
Net cash (used in) provided by :
|
|
|
|
||||
Operating activities
|
$
|
(9,705
|
)
|
|
$
|
(13,559
|
)
|
Investing activities
|
69
|
|
|
—
|
|
||
Financing activities
|
45
|
|
|
(14,036
|
)
|
||
Net decrease in cash and cash equivalents
|
$
|
(9,591
|
)
|
|
$
|
(27,595
|
)
|
•
|
continue our Phase 3 clinical trial for Vicinium and initiate our Phase 1/2a clinical trial for Proxinium;
|
•
|
continue the research and pre-clinical and clinical development of our other product candidates;
|
•
|
seek to discover and develop additional product candidates;
|
•
|
in-license or acquire the rights to other products, product candidates or technologies;
|
•
|
seek marketing approvals for any product candidates that successfully complete clinical trials;
|
•
|
establish sales, marketing and distribution capabilities and scale up and validate external manufacturing capabilities to commercialize any products for which we may obtain marketing approval;
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
•
|
add equipment and physical infrastructure to support our research and development;
|
•
|
hire additional clinical, quality control, scientific and management personnel; and
|
•
|
expand our operational, financial and management systems and personnel.
|
•
|
the scope, initiation, progress, timing, costs and results of pre-clinical development and laboratory testing of our pre-clinical product candidates;
|
•
|
our ability to establish collaborations on favorable terms, if at all, particularly manufacturing, marketing and distribution arrangements for our product candidates;
|
•
|
the costs and timing of the implementation of commercial-scale manufacturing activities;
|
•
|
the costs and timing of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval;
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
|
•
|
our obligation to make milestone, royalty and other payments to third party licensors under our licensing agreements;
|
•
|
the extent to which we in-license or acquire rights to other products, product candidates or technologies;
|
•
|
the outcome, timing and cost of regulatory review by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities, including Health Canada, to require that we perform more studies than those that we currently expect;
|
•
|
our ability to achieve certain future regulatory, development and commercialization milestones under the License Agreement with Roche;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the revenue, if any, received from commercial sales of any product candidates for which we receive regulatory approval.
|
Item 1A.
|
Risk Factors
|
ELEVEN BIOTHERAPEUTICS, INC.
|
||
|
|
|
By:
|
|
/s/ John J. McCabe
|
|
|
John J. McCabe
|
|
|
Chief Financial Officer (Principal Financial and Accounting Officer)
|
Exhibit
No.
|
|
Description
|
10.1*+
|
|
Amendment to Employment Agreement dated June 8, 2017 between Eleven Biotherapeutics, Inc. and Arthur P. DeCillis.
|
31.1
|
|
Rule 13a-14(a) Certification of Principal Executive Officer
|
31.2
|
|
Rule 13a-14(a) Certification of Principal Financial Officer
|
32.1
|
|
Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. §1350
|
101.INS*
|
|
XBRL Instance Document
|
101.SCH*
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL*
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF*
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB*
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE*
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
*
|
Filed herewith.
|
+
|
This exhibit is a compensatory plan or arrangement in which our executive officers or directors participate.
|
|
245 First Street
Suite 1800
Cambridge, MA 02142
|
|
245 First Street
Suite 1800
Cambridge, MA 02142
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Eleven Biotherapeutics, Inc.;
|
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 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 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; and
|
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.
|
/s/ Stephen A. Hurly
|
Stephen A. Hurly
|
President and Chief Executive Officer
|
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Eleven Biotherapeutics, Inc.;
|
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 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 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; and
|
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.
|
/s/ John J. McCabe
|
John J. McCabe
|
Chief Financial Officer
|
(Principal Financial Officer)
|
(1)
|
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(2)
|
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Stephen A. Hurly
|
Stephen A. Hurly
|
President and Chief Executive Officer
|
(Principal Executive Officer)
|
/s/ John J. McCabe
|
John J. McCabe
|
Chief Financial Officer
|
(Principal Financial Officer)
|