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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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Delaware
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2836
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20-1450200
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(State or other jurisdiction of
incorporation or organization)
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(Primary Standard Industrial
Classification Code Number)
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(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
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(Do not check if a smaller reporting company)
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Smaller reporting company
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o
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Page
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March 31, 2015
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December 31, 2014
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(Unaudited)
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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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183,638
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$
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191,602
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Accounts receivable
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94
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|
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298
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Prepaid expenses and other current assets
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1,279
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|
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1,322
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Total current assets
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185,011
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|
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193,222
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Property and equipment, net of accumulated depreciation
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3,164
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2,427
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Other assets
|
97
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|
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145
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TOTAL ASSETS
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$
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188,272
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$
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195,794
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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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$
|
1,115
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|
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$
|
1,209
|
|
Accrued expenses
|
1,079
|
|
|
2,163
|
|
||
Deferred revenue
|
—
|
|
|
13
|
|
||
Current portion of deferred rent
|
26
|
|
|
97
|
|
||
Current portion of deferred manufacturing costs
|
428
|
|
|
154
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|
||
Total current liabilities
|
2,648
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|
|
3,636
|
|
||
Long-term liabilities:
|
|
|
|
||||
Deferred rent
|
263
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|
|
209
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|
||
Deferred manufacturing costs
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—
|
|
|
313
|
|
||
Total long-term liabilities
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263
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|
|
522
|
|
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TOTAL LIABILITIES
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2,911
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|
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4,158
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Commitments and contingencies: (Note: 8)
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|
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Stockholders’ equity:
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Common stock, $0.01 par value; 200,000,000 shares authorized at March 31, 2015 and December 31, 2014; 27,055,937 shares issued and 26,378,474 shares issued and outstanding; at March 31, 2015; 27,050,055 issued and 26,372,592 issued and outstanding at December 31, 2014
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271
|
|
|
271
|
|
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Treasury stock: 677,463 shares held at March 31, 2015 and December 31, 2014
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(5,056
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)
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|
(5,056
|
)
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||
Additional paid-in capital
|
310,848
|
|
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309,365
|
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||
Accumulated deficit
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(120,702
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)
|
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(112,944
|
)
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Total stockholders’ equity
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185,361
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|
|
191,636
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|
||
Total liabilities and stockholders’ equity
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$
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188,272
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|
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$
|
195,794
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|
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Three Months Ended March 31,
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||||||
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2015
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2014
|
||||
REVENUES
|
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Grants
|
$
|
107
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|
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$
|
552
|
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Total revenues
|
107
|
|
|
552
|
|
||
OPERATING EXPENSES
|
|
|
|
||||
Research and development
|
5,718
|
|
|
2,389
|
|
||
General and administrative
|
2,197
|
|
|
440
|
|
||
Total operating expenses
|
7,915
|
|
|
2,829
|
|
||
Loss from operations
|
(7,808
|
)
|
|
(2,277
|
)
|
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OTHER INCOME (EXPENSE):
|
|
|
|
||||
Interest income
|
50
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|
|
3
|
|
||
Interest expense
|
—
|
|
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(16
|
)
|
||
Total other income (expense)
|
50
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|
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(13
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)
|
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NET LOSS
|
(7,758
|
)
|
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$
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(2,290
|
)
|
|
Preferred stock dividends
|
—
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|
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(540
|
)
|
||
Net loss attributable to common shareholders, basic and diluted
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$
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(7,758
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)
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$
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(2,830
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)
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Net loss per common share attributable to common shareholders, basic and diluted
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$
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(0.30
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)
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$
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(1.52
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)
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Weighted-average shares outstanding, basic and diluted
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26,259,392
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1,863,350
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Three Months Ended March 31,
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||||||
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2015
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2014
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CASH FLOWS FROM OPERATING ACTIVITIES
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Net loss
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$
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(7,758
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)
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$
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(2,290
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)
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Adjustments to reconcile net loss to net cash used in operating activities:
|
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||||
Depreciation expense
|
196
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|
|
159
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|
||
Share-based compensation
|
1,489
|
|
|
76
|
|
||
Amortization of lease liability
|
(17
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)
|
|
(28
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)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
204
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|
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(527
|
)
|
||
Prepaid expenses and other assets
|
91
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|
|
17
|
|
||
Accounts payable
|
(94
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)
|
|
(106
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)
|
||
Accrued liabilities
|
(1,176
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)
|
|
(581
|
)
|
||
Deferred costs
|
(52
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)
|
|
62
|
|
||
Other liabilities
|
92
|
|
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—
|
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NET CASH USED IN OPERATING ACTIVITIES
|
(7,025
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)
|
|
(3,218
|
)
|
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CASH FLOWS FROM INVESTING ACTIVITIES:
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|
|
|
||||
Purchases of property and equipment
|
(933
|
)
|
|
(22
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)
|
||
CASH USED IN INVESTING ACTIVITIES
|
(933
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)
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(22
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)
|
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CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
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||||
Proceeds from exercise of stock options
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2
|
|
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—
|
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Proceeds from issuance of Series B preferred stock
|
—
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7,320
|
|
||
Payment of issuance costs of common stock
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(8
|
)
|
|
—
|
|
||
Proceeds from exercise of common warrants
|
—
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|
|
201
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|
||
Payments on line of credit
|
—
|
|
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(100
|
)
|
||
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES
|
(6
|
)
|
|
7,421
|
|
||
NET CHANGE IN CASH AND CASH EQUIVALENTS
|
(7,964
|
)
|
|
4,181
|
|
||
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
191,602
|
|
|
11,168
|
|
||
CASH AND CASH EQUIVALENTS AT END OF PERIOD
|
$
|
183,638
|
|
|
$
|
15,349
|
|
NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
|
|
|
||||
Dividends accrued on preferred stock
|
$
|
—
|
|
|
540
|
|
•
|
its stage of development;
|
•
|
its operational and financial performance;
|
•
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the nature of its services and its competitive position in the marketplace;
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•
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the value of companies that it considers peers based on a number of factors, including similarity to the Company with respect to industry and business model;
|
•
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the likelihood of achieving a liquidity event, such as an initial public offering and the nature and history of its business;
|
•
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issuances of preferred stock and the rights, preferences, and privileges of its preferred stock relative to those of its common stock;
|
•
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business conditions and projections;
|
•
|
the history of the Company and progress of its research and development efforts and clinical trials; and
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•
|
the lack of marketability of its common stock.
|
Common Stock Equivalents:
|
March 31, 2015
|
|
March 31, 2014
|
||
Series A Preferred Stock Convertible Preferred Stock - as converted to common stock
|
—
|
|
|
1,496,782
|
|
Series B Preferred Stock Convertible Preferred Stock - as converted to common stock
|
—
|
|
|
4,791,740
|
|
Warrants to purchase common stock
|
355,392
|
|
|
473,031
|
|
Options to purchase common stock
|
3,443,011
|
|
|
1,584,692
|
|
|
3,798,403
|
|
|
8,346,245
|
|
|
Balance at
March 31, 2015 |
|
Quoted prices in active
markets for identical
assets (Level 1)
|
|
Significant other
observable inputs
(Level 2)
|
|
Significant unobservable
inputs (Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
181,636
|
|
|
$
|
181,636
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
$
|
181,636
|
|
|
$
|
181,636
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Balance at
December 31, 2014 |
|
Quoted prices in active
markets for identical
assets (Level 1)
|
|
Significant other
observable inputs
(Level 2)
|
|
Significant unobservable
inputs (Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
43,587
|
|
|
$
|
43,587
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
$
|
43,587
|
|
|
$
|
43,587
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
March 31, 2015
|
|
December 31, 2014
|
||||
Accrued payroll
|
$
|
—
|
|
|
$
|
731
|
|
Commission on exercise of warrants
|
—
|
|
|
731
|
|
||
Medical facility fees
|
559
|
|
|
201
|
|
||
Patient treatment costs
|
125
|
|
|
128
|
|
||
License costs
|
52
|
|
|
50
|
|
||
Other
|
343
|
|
|
322
|
|
||
Total accrued expenses
|
$
|
1,079
|
|
|
$
|
2,163
|
|
|
Three Months Ended
March 31, |
||||||
|
2015
|
|
2014
|
||||
Research and development
|
$
|
599
|
|
|
$
|
66
|
|
General and administrative
|
890
|
|
|
10
|
|
||
Total share-based compensation
|
$
|
1,489
|
|
|
$
|
76
|
|
|
Three Months Ended
March 31, |
||||
|
2015
|
|
2014
|
||
Expected volatility
|
91.2
|
%
|
|
101.0
|
%
|
Expected term (in years)
|
6.08
|
|
|
6.25
|
|
Risk-free interest rate
|
1.6
|
%
|
|
2.7
|
%
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
Options
|
|
Weighted-
Average Exercise Price Per Share |
|
(in years)
Weighted-
Average Contractual Life |
|
(in thousands)
Aggregate
Intrinsic
Value
(1)
|
|||||
Outstanding at December 31, 2014
|
2,733,793
|
|
|
$
|
5.09
|
|
|
8.39
|
|
$
|
49,076
|
|
Granted
|
715,100
|
|
|
$
|
23.70
|
|
|
|
|
|
||
Exercised
|
(5,882
|
)
|
|
$
|
0.34
|
|
|
|
|
|
||
Canceled or forfeited
|
—
|
|
|
$
|
—
|
|
|
|
|
|
||
Outstanding at March 31, 2015
|
3,443,011
|
|
|
$
|
8.96
|
|
|
8.53
|
|
$
|
49,297
|
|
Exercisable at March 31, 2015
|
1,294,072
|
|
|
$
|
2.30
|
|
|
6.91
|
|
$
|
26,299
|
|
•
|
BPX-501.
We are developing a CaspaCIDe product candidate, BPX-501, as an adjunct T-cell therapy administered after allogeneic HSCT, using donor stem cells. BPX-501 is designed to decrease the risk of including T cells with the transplant by enabling the elimination of donor T cells through the triggering of the CaspaCIDe safety switch upon emergence of graft-versus-host-disease, or
|
•
|
BPX-201.
We are developing a DeCIDe product candidate, BPX-201, as a dendritic cell cancer vaccine made from the patient’s own white blood cells, designed to treat metastatic castrate-resistant prostate cancer, or mCRPC. It targets the prostate specific membrane antigen, or PSMA, and uses our DeCIDe activation switch technology. BPX-201 is currently being evaluated in an 18-patient Phase 1 clinical trial for mCRPC. We are evaluating opportunities for BPX-201 in combination with other cancer immunotherapies, such as checkpoint inhibitors.
|
•
|
BPX-401.
We are developing a CIDeCAR product candidate, BPX-401, as a next-generation CAR T cell therapy for hematological cancers that express the CD19 antigen.
|
•
|
BPX-601.
We are developing a GoCAR-T product candidate, BPX-601, for solid tumors overexpressing prostate stem cell antigen, or PSCA, such as some prostate, pancreatic, bladder, esophageal and gastric cancers.
|
•
|
BPX-701.
We are developing a CaspaCIDe TCR product candidate, BPX-701, in collaboration with Leiden University Medical Center, initially for the treatment of PRAME-expressing melanoma, sarcomas and neuroblastoma.
|
•
|
per patient clinical trial costs;
|
•
|
the number of patients that participate in the clinical trials;
|
•
|
the number of sites included in the clinical trials;
|
•
|
the process of collection, differentiation, selection and expansion of immune cells for our cellular immuno-therapies;
|
•
|
the countries in which the clinical trials are conducted;
|
•
|
the length of time required to enroll eligible patients;
|
•
|
the number of doses that patients receive;
|
•
|
the drop-out or discontinuation rates of patients;
|
•
|
potential additional safety monitoring or other studies requested by regulatory agencies;
|
•
|
the duration of patient follow-up; and
|
•
|
the efficacy and safety profile of the product candidates.
|
|
THREE MONTHS ENDED
MARCH 31,
|
|
|
||||||||
|
2015
|
|
2014
|
|
CHANGE
|
||||||
(in thousands)
|
|
|
|
|
|
||||||
Grant revenues
|
$
|
107
|
|
|
$
|
552
|
|
|
$
|
(445
|
)
|
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
5,718
|
|
|
2,389
|
|
|
3,329
|
|
|||
General and administrative
|
2,197
|
|
|
440
|
|
|
1,757
|
|
|||
Total operating expenses
|
7,915
|
|
|
2,829
|
|
|
5,086
|
|
|||
Loss from operations
|
(7,808
|
)
|
|
(2,277
|
)
|
|
(5,531
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Interest income
|
50
|
|
|
3
|
|
|
47
|
|
|||
Interest expense
|
—
|
|
|
(16
|
)
|
|
16
|
|
|||
Total other income (expense)
|
50
|
|
|
(13
|
)
|
|
63
|
|
|||
Net loss
|
$
|
(7,758
|
)
|
|
$
|
(2,290
|
)
|
|
$
|
(5,468
|
)
|
|
THREE MONTHS ENDED
MARCH 31,
|
|
|
||||||||
Program
|
2015
|
|
2014
|
|
CHANGE
|
||||||
(in thousands)
|
|
|
|
|
|
||||||
BPX-201
|
$
|
689
|
|
|
$
|
515
|
|
|
$
|
174
|
|
BPX-501
|
2,745
|
|
|
615
|
|
|
2,130
|
|
|||
General
|
2,284
|
|
|
1,259
|
|
|
1,025
|
|
|||
Total
|
$
|
5,718
|
|
|
$
|
2,389
|
|
|
$
|
3,329
|
|
|
THREE MONTHS ENDED
MARCH 31,
|
|
|
||||||||
|
2015
|
|
2014
|
|
CHANGE
|
||||||
(in thousands)
|
|
|
|
|
|
||||||
Net cash used in operating activities
|
$
|
(7,025
|
)
|
|
$
|
(3,218
|
)
|
|
$
|
(3,807
|
)
|
Net cash used in investing activities:
|
(933
|
)
|
|
(22
|
)
|
|
(911
|
)
|
|||
Net cash (used in) provided by financing activities
|
(6
|
)
|
|
7,421
|
|
|
(7,427
|
)
|
|||
Net cash (used in) provided by cash and cash equivalents
|
$
|
(7,964
|
)
|
|
$
|
4,181
|
|
|
$
|
(12,145
|
)
|
•
|
successful enrollment in, and completion of, clinical trials;
|
•
|
receipt of marketing approvals from applicable regulatory authorities;
|
•
|
making arrangements with third-party manufacturers;
|
•
|
obtaining and maintaining patent and trade secret protection and regulatory exclusivity; and
|
•
|
launching commercial sales of our products, if and when approved, whether alone or in collaboration with others.
|
•
|
initiate or continue clinical trials of BPX-501 and any other product candidates;
|
•
|
continue the research and development of our product candidates; seek to discover additional product candidates; seek regulatory approvals for our product candidates if they successfully complete clinical trials;
|
•
|
establish a sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any products that may receive regulatory approval; enhance operational, financial and information management systems and hire additional personnel, including personnel to support development of our product candidates and, if a product candidate is approved, our commercialization efforts; and
|
•
|
incur additional costs associated with becoming a public company.
|
|
|
Commitment
|
|
Less Than 1 year
|
|
1 to 3 Years
|
|
3 to 5 Years
|
|
More Than 5 Years
|
||||||||||
Operating lease agreements (1)
|
|
$
|
9,454
|
|
|
$
|
1,435
|
|
|
$
|
3,849
|
|
|
$
|
4,170
|
|
|
—
|
|
|
Contract manufacturing arrangements (2)
|
|
4,288
|
|
|
3,742
|
|
|
546
|
|
|
—
|
|
|
—
|
|
|||||
Facility lease agreements (3)
|
|
384
|
|
|
192
|
|
|
192
|
|
|
—
|
|
|
—
|
|
|||||
License agreements (4)
|
|
3,336
|
|
|
1,359
|
|
|
1,701
|
|
|
153
|
|
|
123
|
|
|||||
Total contractual obligations
|
|
$
|
17,462
|
|
|
$
|
6,728
|
|
|
$
|
6,288
|
|
|
$
|
4,323
|
|
|
$
|
123
|
|
(1)
|
Operating lease agreements - The amounts above are comprised of two five-year lease agreements. The first lease will expire on January 31, 2020. See Note 13 to the audited financial statements included in our Annual Report for more information about the first lease. We entered into an additional five-year lease in May 2015, which will become effective on September 1, 2015. Under this new lease, we will be responsible for monthly base rental payments, which escalate on September 1 of each year until the lease expires on August 31, 2020. For more information about this second lease, see Note 9 to the financial statements included in this quarterly report.
|
(2)
|
Contract manufacturing arrangements - We have entered into several manufacturing service arrangements with various terms. The obligations listed in the table above represent estimates of when certain services will be performed.
|
(3)
|
Facility lease agreements - In March 2013 we entered into a two-year manufacturing facility agreement for cell processing for a clinical trial. In February 2015, the agreement was extended for an additional two years.
|
(4)
|
License agreements - We have entered into several license agreements under which we obtained rights to certain intellectual property. Under the agreements, we could be obligated for payments upon successful completion of clinical and regulatory milestones regarding the products covered by this license. The obligations listed in the table above represent estimates of when the milestones will be achieved. We cannot assure that the timing of the milestones will be completed when estimated or at all.
|
|
Bellicum Pharmaceuticals, Inc.
|
|
|
|
|
Date: May 12, 2015
|
By:
|
/s/ THOMAS J. FARRELL
|
|
|
Thomas J. Farrell
|
|
|
President and Chief Executive Officer
|
|
|
|
Date: May 12, 2015
|
By:
|
/s/ ALAN A. MUSSO
|
|
|
Alan A. Musso
|
|
|
Chief Financial Officer and Treasurer
Principal Financial and Accounting Officer
|
|
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;
|
|
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
|
|
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.
|
Date: May 12, 2015
|
By:
|
/s/ Thomas J. Farrell
|
|
|
Thomas J. Farrell
|
|
|
President and Chief Executive Officer
|
|
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;
|
|
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
|
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal controls 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.
|
Date: May 12
, 2015
|
By:
|
/s/ Alan A. Musso
|
|
|
Alan A. Musso
|
|
|
Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
|
|
/s/ Thomas J. Farrell
|
|
|
Thomas J. Farrell
|
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
May 12, 2015
|
|
|
|
|
|
|
|
|
/s/ Alan A. Musso
|
|
|
Alan A. Musso
|
|
|
Chief Financial Officer and Treasurer
|
|
|
(Principal Financial and Accounting Officer)
|
|
|
May 12, 2015
|
|