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Delaware
(State or other jurisdiction of
incorporation or organization)
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2836
(Primary Standard Industrial
Classification Code Number)
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27-0072226
(I.R.S. Employer
Identification Number)
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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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x
(Do not check if a smaller reporting company)
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Smaller reporting company
|
o
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June 30, 2014
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December 31, 2013
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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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204,250
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$
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113,163
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Collaboration receivables (includes related party amounts of $3,731 and $3,616 at June 30, 2014 and December 31, 2013, respectively)
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3,731
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3,616
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Prepaid expenses and other current assets
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2,180
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2,243
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Total current assets
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210,161
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119,022
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||
Property and equipment, net
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3,581
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3,705
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Restricted cash
|
902
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913
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Other assets
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—
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92
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||
Total assets
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$
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214,644
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$
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123,732
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Liabilities and stockholders’ equity
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|
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Current liabilities:
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Accounts payable
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$
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2,614
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|
$
|
885
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|
Accrued expenses
|
6,475
|
|
|
6,927
|
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||
Accrued litigation settlement
|
5,000
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|
|
—
|
|
||
Deferred revenue
|
1,505
|
|
|
2,031
|
|
||
Deferred rent
|
499
|
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|
499
|
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Notes payable, net of discount
|
—
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16,868
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||
Total current liabilities
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16,093
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27,210
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Deferred revenue, net of current portion
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5,124
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5,620
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Deferred rent, net of current portion
|
2,088
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2,337
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Warrants to purchase common stock
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21,512
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30,753
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||
Total liabilities
|
44,817
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65,920
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Commitments and contingencies (Note 13)
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|
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Stockholders’ equity:
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Undesignated preferred stock, $0.001 par value: 25,000,000 shares authorized and no shares issued or outstanding
|
—
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—
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Common stock, $0.001 par value: 175,000,000 shares authorized; 31,722,496, and 28,348,630 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively
|
32
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|
|
29
|
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Additional paid-in capital
|
387,790
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250,107
|
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Accumulated deficit
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(217,995
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)
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(192,324
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)
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Total stockholders’ equity
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169,827
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57,812
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Total liabilities and stockholders’ equity
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$
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214,644
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$
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123,732
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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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2014
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2013
|
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2014
|
|
2013
|
||||||||
Revenue:
|
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|
|
|
|
|
|
|
||||
Collaboration revenue:
|
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License and milestone
|
$
|
347
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|
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$
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22,891
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$
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1,021
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$
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35,406
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Cost-sharing, net
|
3,731
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3,536
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6,364
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6,034
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||||
Total revenue(1)
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4,078
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26,427
|
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|
7,385
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41,440
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Costs and expenses:
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Research and development
|
12,677
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8,911
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24,442
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17,691
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||||
Litigation settlement
|
5,000
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|
—
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5,000
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|
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—
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||||
General and administrative
|
3,712
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3,365
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7,462
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6,461
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||||
Total costs and expenses
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21,389
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12,276
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36,904
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24,152
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(Loss) income from operations
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(17,311
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)
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14,151
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(29,519
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)
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17,288
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||||
Other income (expense):
|
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Other income (expense), net
|
740
|
|
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(355
|
)
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4,737
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|
|
(1,422
|
)
|
||||
Interest income
|
21
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|
|
8
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|
|
34
|
|
|
20
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|
||||
Interest expense
|
—
|
|
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(726
|
)
|
|
(922
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)
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(1,161
|
)
|
||||
Total other income (expense), net
|
761
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(1,073
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)
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3,849
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(2,563
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)
|
||||
Net (loss) income
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$
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(16,550
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)
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$
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13,078
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$
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(25,670
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)
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$
|
14,725
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Comprehensive (loss) income
|
$
|
(16,550
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)
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$
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13,078
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$
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(25,670
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)
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$
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14,725
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Reconciliation of net loss to net loss applicable to common stockholders:
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Net (loss) income
|
$
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(16,550
|
)
|
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$
|
13,078
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$
|
(25,670
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)
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$
|
14,725
|
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Accretion of dividends, interest, redemption value and issuance costs on redeemable convertible preferred stock
|
—
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(6,843
|
)
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—
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(13,599
|
)
|
||||
Gain on extinguishment of redeemable convertible preferred stock
|
—
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—
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—
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2,765
|
|
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Net income (loss) applicable to participating securities
|
—
|
|
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(5,492
|
)
|
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—
|
|
|
(3,428
|
)
|
||||
Net (loss) income applicable to common stockholders—basic and diluted
|
$
|
(16,550
|
)
|
|
$
|
743
|
|
|
$
|
(25,670
|
)
|
|
$
|
463
|
|
|
|
|
|
|
|
|
|
||||||||
Net (loss) income
|
$
|
(16,550
|
)
|
|
$
|
13,078
|
|
|
$
|
(25,670
|
)
|
|
$
|
14,725
|
|
Accretion of dividends, interest, redemption value and issuance costs on redeemable convertible preferred stock
|
—
|
|
|
(6,843
|
)
|
|
—
|
|
|
(13,599
|
)
|
||||
Gain on extinguishment of redeemable convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
2,765
|
|
||||
Net income (loss) applicable to participating securities
|
—
|
|
|
(5,000
|
)
|
|
—
|
|
|
(3,125
|
)
|
||||
Net (loss) income applicable to common stockholders—basic and diluted
|
$
|
(16,550
|
)
|
|
$
|
1,235
|
|
|
$
|
(25,670
|
)
|
|
$
|
766
|
|
Net (loss) income per share applicable to common stockholders— basic and diluted: (Note 8)
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(0.52
|
)
|
|
$
|
0.30
|
|
|
$
|
(0.83
|
)
|
|
$
|
0.19
|
|
Diluted
|
$
|
(0.52
|
)
|
|
$
|
0.28
|
|
|
$
|
(0.83
|
)
|
|
$
|
0.17
|
|
Weighted-average number of common shares used in computing net income (loss) per share applicable to common stockholders:
|
|
|
|
|
|
|
|
||||||||
Basic
|
31,552
|
|
|
2,438
|
|
|
30,939
|
|
|
2,437
|
|
||||
Diluted
|
31,552
|
|
|
4,457
|
|
|
30,939
|
|
|
4,434
|
|
|
|
|
|
|
|
|
|
|
||||||||
(1) Includes related party revenue (Note 19)
|
|
$
|
4,078
|
|
|
$
|
3,614
|
|
|
$
|
7,385
|
|
|
$
|
16,413
|
|
|
Six Months Ended
June 30, |
||||||
|
2014
|
|
2013
|
||||
Operating Activities
|
|
|
|
|
|
||
Net loss
|
$
|
(25,670
|
)
|
|
$
|
14,725
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||
Depreciation and amortization
|
542
|
|
|
449
|
|
||
Stock-based compensation
|
2,132
|
|
|
948
|
|
||
(Payment) / accretion of deferred interest
|
(536
|
)
|
|
171
|
|
||
Amortization of deferred debt issuance costs
|
36
|
|
|
177
|
|
||
Change in fair value of warrants
|
(4,730
|
)
|
|
1,500
|
|
||
Gain on retirement of warrants
|
—
|
|
|
(76
|
)
|
||
Forgiveness of related party receivable
|
—
|
|
|
237
|
|
||
Changes in assets and liabilities:
|
|
|
|
|
|
||
Prepaid expenses and other current assets
|
44
|
|
|
38
|
|
||
Collaboration receivables
|
(115
|
)
|
|
(1,564
|
)
|
||
Related party receivable
|
—
|
|
|
(4
|
)
|
||
Accounts payable
|
1,729
|
|
|
314
|
|
||
Accrued expenses
|
(418
|
)
|
|
(2,006
|
)
|
||
Accrued litigation settlement
|
5,000
|
|
|
—
|
|
||
Deferred revenue
|
(1,021
|
)
|
|
(25,406
|
)
|
||
Deferred rent
|
(250
|
)
|
|
(250
|
)
|
||
Restricted cash
|
12
|
|
|
—
|
|
||
Net cash used in operating activities
|
(23,245
|
)
|
|
(10,747
|
)
|
||
Investing Activities
|
|
|
|
|
|
||
Purchases of property and equipment
|
(379
|
)
|
|
(125
|
)
|
||
Net cash used in investing activities
|
(379
|
)
|
|
(125
|
)
|
||
Financing Activities
|
|
|
|
|
|
||
Proceeds from issuance of common stock from public offering, net issuance costs
|
129,166
|
|
|
—
|
|
||
Payments of long-term debt
|
(16,332
|
)
|
|
—
|
|
||
Payments made to repurchase redeemable convertible preferred stock, common stock and warrants to purchase common stock
|
—
|
|
|
(300
|
)
|
||
Proceeds from exercise of stock options and warrants to purchase common stock
|
1,877
|
|
|
26
|
|
||
Net cash provided by financing activities
|
114,711
|
|
|
(274
|
)
|
||
Net increase (decrease) in cash and cash equivalents
|
91,087
|
|
|
(11,146
|
)
|
||
Cash and cash equivalents at beginning of period
|
113,163
|
|
|
39,611
|
|
||
Cash and cash equivalents at end of period
|
$
|
204,250
|
|
|
$
|
28,465
|
|
Supplemental Disclosure of Cash Flow Information:
|
|
|
|
|
|
||
Cash paid for interest
|
$
|
1,574
|
|
|
$
|
850
|
|
Supplemental Disclosure of Non-Cash Investing and Financing Activities:
|
|
|
|
|
|
||
Accretion of dividends, interest, redemption value, and issuance costs on preferred stock
|
$
|
—
|
|
|
$
|
13,599
|
|
Follow-on offering costs included in accounts payable and accrued expense
|
$
|
8
|
|
|
$
|
—
|
|
Reclassification of warrant liability to additional paid-in capital
|
$
|
4,511
|
|
|
$
|
678
|
|
Purchase of property and equipment included in accounts payable and accrued expenses
|
$
|
39
|
|
|
$
|
—
|
|
|
June 30, 2014
|
||||||||||||||
|
Quoted Prices
in Active Markets
for Identical Items
(Level 1)
|
|
Significant Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds
|
$
|
199,639
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
199,639
|
|
Restricted cash
|
902
|
|
|
—
|
|
|
—
|
|
|
902
|
|
||||
Total assets
|
$
|
200,541
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
200,541
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrants to purchase redeemable convertible preferred stock
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Warrants to purchase common stock
|
—
|
|
|
—
|
|
|
21,512
|
|
|
21,512
|
|
||||
Total liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
21,512
|
|
|
21,512
|
|
|
December 31, 2013
|
||||||||||||||
|
Quoted Prices
in Active Markets
for Identical Items
(Level 1)
|
|
Significant other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds
|
$
|
101,394
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
101,394
|
|
Restricted cash
|
913
|
|
|
—
|
|
|
—
|
|
|
913
|
|
||||
Total assets
|
$
|
102,307
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
102,307
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrants to purchase redeemable convertible preferred stock
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Warrants to purchase common stock
|
—
|
|
|
—
|
|
|
30,753
|
|
|
30,753
|
|
||||
Total liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
30,753
|
|
|
$
|
30,753
|
|
|
Six Months Ended June 30,
|
||||||
|
2014
|
|
2013
|
||||
Beginning balance
|
$
|
30,753
|
|
|
$
|
6,651
|
|
Change in fair value
|
(4,730
|
)
|
|
1,500
|
|
||
Exercises
|
(4,511
|
)
|
|
(678
|
)
|
||
Repurchases
|
—
|
|
|
(83
|
)
|
||
Ending balance
|
$
|
21,512
|
|
|
$
|
7,390
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||
Outstanding stock options
|
3,585
|
|
|
—
|
|
|
3,585
|
|
|
—
|
|
Common stock warrants
|
748
|
|
|
—
|
|
|
748
|
|
|
—
|
|
Preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Preferred stock warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,333
|
|
|
—
|
|
|
4,333
|
|
|
—
|
|
|
Warrants as of
|
|
|
|
|
|
|
||||||||
|
|
|
|
|
Weighted-
Average
Exercise
|
|
|
|
Balance Sheet
Classification
|
||||||
|
June 30, 2014
|
|
December 31, 2013
|
|
Price Per
Share
|
|
Expiration
|
|
June 30, 2014
|
|
December 31, 2013
|
||||
Warrants to purchase common stock
|
14
|
|
|
46
|
|
|
$
|
10.92
|
|
|
June 25, 2019
|
|
Equity(1)
|
|
Equity(1)
|
Warrants to purchase common stock
|
19
|
|
|
64
|
|
|
12.56
|
|
|
March 18, 2020
|
|
Equity(2) (3)
|
|
Equity(2) (3)
|
|
Warrants to purchase common stock
|
702
|
|
|
857
|
|
|
5.88
|
|
|
June 10, 2020 - July 9, 2020
|
|
Liability(4) (5) (6) (7)
|
|
Liability(4) (5) (6) (7)
|
|
Warrants to purchase common stock
|
13
|
|
|
13
|
|
|
4.00 - 7.40
|
|
|
March 31, 2015 - December 31, 2017
|
|
Equity(8)
|
|
Equity(8)
|
|
All warrants
|
748
|
|
|
980
|
|
|
$
|
6.12
|
|
|
|
|
|
|
|
|
(1)
|
In March 2014, the warrant holders exercised warrants to purchase
32,050
shares of Common Stock on a net basis, resulting in the issuance of
22,955
shares of Common Stock.
|
(2)
|
In March 2014, the warrant holders exercised warrants to purchase
12,738
shares of Common Stock on a net basis, resulting in the issuance of
9,202
shares of Common Stock.
|
(3)
|
In April 2014, the warrant holders exercised warrants to purchase
31,847
shares of common stock on a net basis, resulting in the issuance of
21,082
shares of Common Stock.
|
(4)
|
In March 2014, the warrant holders exercised warrants to purchase
543
shares of Common Stock on a net basis, resulting in the issuance of
456
shares of Common Stock.
|
(5)
|
In March 2014, the warrant holders exercised warrants to purchase
23,445
shares of Common Stock on a cash basis, resulting in the issuance of
23,445
shares of Common Stock.
|
(6)
|
In May and June 2014, the warrant holders exercised warrants to purchase
114,103
shares of common stock on a net basis, resulting in the issuance of
92,173
shares of Common Stock.
|
(7)
|
In April 2014, the warrant holders exercised warrants to purchase
16,956
shares of common stock on a cash basis, resulting in the issuance of
16,956
shares of Common Stock.
|
(8)
|
Warrants to purchase common stock were issued in connection with various debt financing transactions that were consummated in periods prior to December 31, 2012. See discussion below for further details.
|
•
|
$18.8 million
for research and development services
|
•
|
$2.9 million
for the sotatercept joint development committee
|
•
|
$3.7 million
for the ACE 536 joint development committee
|
•
|
$2.8 million
for the manufacturing services
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Research and development
|
$
|
453
|
|
|
$
|
160
|
|
|
$
|
852
|
|
|
$
|
311
|
|
General and administrative
|
661
|
|
|
360
|
|
|
1,280
|
|
|
637
|
|
||||
|
$
|
1,114
|
|
|
$
|
520
|
|
|
$
|
2,132
|
|
|
$
|
948
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||
Expected volatility
|
71.1
|
%
|
|
70.3
|
%
|
|
71.5
|
%
|
|
70.3
|
%
|
Expected term (in years)
|
6.0
|
|
|
6.0
|
|
|
6.0
|
|
|
6.0
|
|
Risk-free interest rate
|
1.9
|
%
|
|
1.4
|
%
|
|
1.8
|
%
|
|
1.4
|
%
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Number
of Grants
|
|
Weighted-
Average
Exercise
Price
Per Share
|
|
Weighted-
Average
Contractual
Life (in years)
|
|
Aggregate
Intrinsic
Value(1)
|
|||||
Outstanding at December 31, 2013
|
3,942
|
|
|
$
|
7.05
|
|
|
6.43
|
|
|
|
|
Granted
|
115
|
|
|
$
|
45.17
|
|
|
|
|
|
|
|
Exercised
|
(428
|
)
|
|
$
|
3.83
|
|
|
|
|
|
|
|
Canceled or forfeited
|
(44
|
)
|
|
$
|
20.18
|
|
|
|
|
|
|
|
Outstanding at June 30, 2014
|
3,585
|
|
|
$
|
8.49
|
|
|
6.23
|
|
$
|
92,624
|
|
Exercisable at June 30, 2014
|
2,414
|
|
|
$
|
4.86
|
|
|
5.08
|
|
$
|
70,341
|
|
Vested and expected to vest at June 30, 2014(2)
|
3,522
|
|
|
$
|
8.31
|
|
|
6.18
|
|
$
|
91,561
|
|
|
(1)
|
The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the estimated fair value of the common stock for the options that were in the money at
June 30, 2014
.
|
(2)
|
This represents the number of vested options at
June 30, 2014
, plus the number of unvested options expected to vest at
June 30, 2014
, based on the unvested options outstanding at
June 30, 2014
, adjusted for the estimated forfeiture rate.
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
License and milestone
|
$
|
347
|
|
|
$
|
452
|
|
|
$
|
1,021
|
|
|
$
|
11,084
|
|
Cost sharing, net
|
3,731
|
|
|
3,162
|
|
|
6,364
|
|
|
5,329
|
|
||||
|
$
|
4,078
|
|
|
$
|
3,614
|
|
|
$
|
7,385
|
|
|
$
|
16,413
|
|
•
|
conduct clinical trials for dalantercept;
|
•
|
continue our preclinical studies and potential clinical development efforts of our existing preclinical protein therapeutic candidates;
|
•
|
continue research activities for the discovery of new protein therapeutics;
|
•
|
manufacture protein therapeutics for our preclinical studies and clinical trials;
|
•
|
seek regulatory approval for our protein therapeutics; and
|
•
|
operate as a public company.
|
•
|
direct employee-related expenses, including salaries, benefits, travel and stock-based compensation expense of our research and development personnel;
|
•
|
expenses incurred under agreements with clinical research organizations, or CROs, and investigative sites that will conduct our clinical trials;
|
•
|
the cost of acquiring and manufacturing preclinical and clinical study materials and developing manufacturing processes;
|
•
|
allocated facilities, depreciation, and other expenses, which include rent and maintenance of facilities, insurance and other supplies;
|
•
|
expenses associated with obtaining and maintaining patents; and
|
•
|
costs associated with preclinical activities and regulatory compliance.
|
•
|
the scope, rate of progress, and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;
|
•
|
future clinical trial results;
|
•
|
potential changes in government regulation; and
|
•
|
the timing and receipt of any regulatory approvals.
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||
(in thousands)
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||
Sotatercept(1)
|
|
$0
|
|
$1
|
|
$0
|
|
$1
|
||||
ACE-536(1)
|
|
2,630
|
|
|
1,047
|
|
|
4,148
|
|
|
1,750
|
|
Dalantercept
|
|
1,557
|
|
|
1,076
|
|
|
2,985
|
|
|
2,152
|
|
ACE-031(2)
|
|
8
|
|
|
499
|
|
|
15
|
|
|
1,001
|
|
ACE-083
|
|
1,195
|
|
|
—
|
|
|
2,551
|
|
|
—
|
|
Total direct research and development expenses
|
|
5,390
|
|
|
2,623
|
|
|
9,699
|
|
|
4,904
|
|
Other expenses(3)
|
|
7,287
|
|
|
6,288
|
|
|
14,743
|
|
|
12,787
|
|
Total research and development expenses
|
|
$12,677
|
|
$8,911
|
|
$24,442
|
|
$17,691
|
|
|
|
Three Months Ended
June 30, |
|
Increase
|
||||||||
(in thousands)
|
|
2014
|
|
2013
|
|
(Decrease)
|
||||||
Revenue:
|
|
|
|
|
|
|
|
|
|
|||
Collaboration revenue:
|
|
|
|
|
|
|
|
|
|
|||
License and milestone
|
|
$
|
347
|
|
|
$
|
22,891
|
|
|
$
|
(22,544
|
)
|
Cost-sharing, net
|
|
3,731
|
|
|
3,536
|
|
|
195
|
|
|||
Total revenue
|
|
4,078
|
|
|
26,427
|
|
|
(22,349
|
)
|
|||
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
|
12,677
|
|
|
8,911
|
|
|
3,766
|
|
|||
Litigation settlement
|
|
5,000
|
|
|
—
|
|
|
5,000
|
|
|||
General and administrative
|
|
3,712
|
|
|
3,365
|
|
|
347
|
|
|||
Total costs and expenses
|
|
21,389
|
|
|
12,276
|
|
|
9,113
|
|
|||
Loss from operations
|
|
(17,311
|
)
|
|
14,151
|
|
|
(31,462
|
)
|
|||
Other income (expense), net
|
|
761
|
|
|
(1,073
|
)
|
|
1,834
|
|
|||
Net (loss) income
|
|
$
|
(16,550
|
)
|
|
$
|
13,078
|
|
|
$
|
(29,628
|
)
|
|
|
Three Months Ended
June 30, |
|
Increase
|
||||||||
(in thousands)
|
|
2014
|
|
2013
|
|
(Decrease)
|
||||||
Collaboration revenue:
|
|
|
|
|
|
|
|
|
|
|||
Celgene:
|
|
|
|
|
|
|
|
|
|
|||
License and milestone
|
|
$
|
347
|
|
|
$
|
452
|
|
|
$
|
(105
|
)
|
Cost-sharing, net
|
|
3,731
|
|
|
3,162
|
|
|
569
|
|
|||
Total Celgene
|
|
4,078
|
|
|
3,614
|
|
|
464
|
|
|||
Shire:
|
|
|
|
|
|
|
|
|
|
|||
License and milestone
|
|
—
|
|
|
22,439
|
|
|
(22,439
|
)
|
|||
Cost-sharing, net
|
|
—
|
|
|
374
|
|
|
(374
|
)
|
|||
Total Shire
|
|
—
|
|
|
22,813
|
|
|
(22,813
|
)
|
|||
Total collaboration revenue
|
|
4,078
|
|
|
26,427
|
|
|
(22,349
|
)
|
|||
Total revenue
|
|
$
|
4,078
|
|
|
$
|
26,427
|
|
|
$
|
(22,349
|
)
|
|
|
Six Months Ended
June 30, |
|
Increase
|
||||||||
(in thousands)
|
|
2014
|
|
2013
|
|
(Decrease)
|
||||||
Revenue:
|
|
|
|
|
|
|
|
|
|
|||
Collaboration revenue:
|
|
|
|
|
|
|
|
|
|
|||
License and milestone
|
|
$
|
1,021
|
|
|
$
|
35,406
|
|
|
$
|
(34,385
|
)
|
Cost-sharing, net
|
|
6,364
|
|
|
6,034
|
|
|
330
|
|
|||
Total revenue
|
|
7,385
|
|
|
41,440
|
|
|
(34,055
|
)
|
|||
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
|
24,442
|
|
|
17,691
|
|
|
6,751
|
|
|||
Litigation settlement
|
|
5,000
|
|
|
—
|
|
|
5,000
|
|
|||
General and administrative
|
|
7,462
|
|
|
6,461
|
|
|
1,001
|
|
|||
Total costs and expenses
|
|
36,904
|
|
|
24,152
|
|
|
12,752
|
|
|||
Loss from operations
|
|
(29,519
|
)
|
|
17,288
|
|
|
(46,807
|
)
|
|||
Other income (expense), net
|
|
3,849
|
|
|
(2,563
|
)
|
|
6,412
|
|
|||
Net (loss) income
|
|
$
|
(25,670
|
)
|
|
$
|
14,725
|
|
|
$
|
(40,395
|
)
|
|
|
Six Months Ended
June 30, |
|
Increase
|
||||||||
(in thousands)
|
|
2014
|
|
2013
|
|
(Decrease)
|
||||||
Collaboration revenue:
|
|
|
|
|
|
|
|
|
|
|||
Celgene:
|
|
|
|
|
|
|
|
|
|
|||
License and milestone
|
|
$
|
1,021
|
|
|
$
|
11,084
|
|
|
$
|
(10,063
|
)
|
Cost-sharing, net
|
|
6,364
|
|
|
5,329
|
|
|
1,035
|
|
|||
Total Celgene
|
|
7,385
|
|
|
16,413
|
|
|
(9,028
|
)
|
|||
Shire:
|
|
|
|
|
|
|
|
|
|
|||
License and milestone
|
|
—
|
|
|
24,322
|
|
|
(24,322
|
)
|
|||
Cost-sharing, net
|
|
—
|
|
|
705
|
|
|
(705
|
)
|
|||
Total Shire
|
|
—
|
|
|
25,027
|
|
|
(25,027
|
)
|
|||
Total collaboration revenue
|
|
7,385
|
|
|
41,440
|
|
|
(34,055
|
)
|
|||
Total revenue
|
|
$
|
7,385
|
|
|
$
|
41,440
|
|
|
$
|
(34,055
|
)
|
|
|
Six Months Ended
June 30, |
||||||
(in thousands)
|
|
2014
|
|
2013
|
||||
Net cash provided by (used in):
|
|
|
|
|
|
|
||
Operating activities
|
|
$
|
(23,245
|
)
|
|
$
|
(10,747
|
)
|
Investing activities
|
|
(379
|
)
|
|
(125
|
)
|
||
Financing activities
|
|
114,711
|
|
|
(274
|
)
|
||
Net increase (decrease) in cash and cash equivalents
|
|
$
|
91,087
|
|
|
$
|
(11,146
|
)
|
•
|
the achievement of milestones under our agreement with Celgene;
|
•
|
the terms and timing of any other collaborative, licensing and other arrangements that we may establish;
|
•
|
the initiation, progress, timing and completion of preclinical studies and clinical trials for our protein therapeutic candidates and potential protein therapeutic candidates;
|
•
|
the number and characteristics of protein therapeutic candidates that we pursue;
|
•
|
the progress, costs and results of our clinical trials;
|
•
|
the outcome, timing and cost of regulatory approvals;
|
•
|
delays that may be caused by changing regulatory requirements;
|
•
|
the cost and timing of hiring new employees to support our continued growth;
|
•
|
the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;
|
•
|
the costs and timing of procuring clinical and commercial supplies of our protein therapeutic candidates;
|
•
|
the extent to which we acquire or invest in businesses, products or technologies; and
|
•
|
the costs involved in defending and prosecuting litigation regarding in-licensed intellectual property.
|
|
ACCELERON PHARMA INC.
|
|
|
|
|
Date: August 12, 2014
|
By:
|
/s/ JOHN L. KNOPF, PH.D.
|
|
|
John L. Knopf, Ph.D.
|
|
|
Chief Executive Officer and President
|
|
|
|
Date: August 12, 2014
|
By:
|
/s/ KEVIN F. MCLAUGHLIN
|
|
|
Kevin F. McLaughlin
|
|
|
Chief Financial Officer
|
Exhibit
number
|
|
Description of exhibit
|
|
10.1
|
|
|
Amendment, dated as of July 25, 2014, to Amended and Restated License Agreement between Salk Institute for Biological Studies and Acceleron Pharma Inc. dated as of August 11, 2010.
|
31.1
|
|
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
31.2
|
|
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
32.1
|
|
|
Certification of Principal Executive Officer and 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.INS*
|
|
|
XBRL Instance Document
|
|
|
|
|
101.SCH*
|
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
101.CAL*
|
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
101.LAB*
|
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
|
101.PRE*
|
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
101.DEF*
|
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
THE SALK INSTITUTE FOR BIOLOGICAL STUDIES
By:
/s/ William R. Brody
Name:
William R. Brody
Title:
President
Date:
7/18/2014
|
|
|
|
|
|
|
|
|
|
|
|
ACCELERON PHARMA, INC.
By:
/s/ John Knopf
Name:
John Knopf
Title:
CEO
Date:
7/25/2014
|
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;
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August 12, 2014
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/s/ John L. Knopf
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Date
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John L. Knopf, Ph D.
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|
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Chief Executive Officer and President
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b)
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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;
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August 12, 2014
|
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/s/ Kevin F. McLaughlin
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Date
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Kevin F. McLaughlin
|
|
|
Chief Financial Officer
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Date: August 12, 2014
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By:
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/s/ John L. Knopf
|
|
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John L. Knopf PhD
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|
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President and Chief Executive Officer
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|
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(Principal Executive Officer)
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|
|
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Date: August 12, 2014
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By:
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/s/ Kevin F. McLaughlin
|
|
|
Kevin F. McLaughlin
|
|
|
Chief Financial Officer
|
|
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(Principal Financial Officer)
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