000-51863
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03-0491827
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(Commission
File No.)
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(IRS
Employer Identification No.)
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Not
Applicable
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(Former
Name or Former Address, if Changed Since Last
Report)
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR 240.13e-4(c))
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Exhibit No.
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Description
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99.1
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Press
release of Vanda Pharmaceuticals Inc. dated May 1,
2007.
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VANDA
PHARMACEUTICALS INC.
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By:
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/s/
STEVEN
A. SHALLCROSS
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Name:
Steven A. Shallcross
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Title:
Senior Vice President, Chief Financial Officer and
Treasurer
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·
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Operating
Expenses.
First quarter 2007 R&D expenses, primarily consisting of salaries and
related costs of R&D personnel, stock-based compensation, and the
costs of consultants, materials and supplies associated with the
company’s
clinical trials and research initiatives, were $10.6 million, up
from $7.9
million in the previous quarter and down from $15.5 million in the
first
quarter of 2006. The increase in R&D expenses in the first quarter of
2007 relative to the fourth quarter of 2006 was primarily due to
higher
costs related to the preparation of the NDA for iloperidone, clinical
supply manufacturing costs for VEC-162, and Phase II trial initiation
expenses for VSF-173. The decrease in R&D expenses in the first
quarter of 2007 relative to the first quarter of 2006 was primarily
due to
lower clinical trial expenses for the company’s iloperidone and VEC-162
Phase III trials that were completed in
2006.
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·
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Net
loss applicable to common stockholders
for the first quarter of 2007 was $15.4 million. This compares to
a net
loss of $11.9 million in the fourth quarter of 2006, and $18.1 million
in
the first quarter of 2006.
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·
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Net
loss per share applicable to common stockholders
for the first quarter of 2007 was $0.61, compared to $0.54 in the
fourth
quarter of 2006 and $385.61 in the first quarter of 2006.
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·
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Cash
and marketable securities
increased by $98.1 million during the first quarter. Changes included
net
cash proceeds of $111.3 million from the issuance of common stock
in the
company’s follow-on public offering, $15.4 million of operating losses,
decreases in accrued R&D expenses and accounts payable of $2.2
million, and $0.1 million in fixed asset additions; offset by $4.3
million
of non-cash depreciation, amortization, and stock-based compensation
expenses and other items of $0.2
million.
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·
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The
balance sheet
at
the end of the first quarter of 2007 reflected $130.0 million of
unrestricted cash, cash equivalents and marketable securities, compared
to
$31.9 million as of December 31, 2006, and $20.1 million as of March
31,
2006.
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Three
Months Ended
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|||||||
March
31,2007
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March
31, 2006
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||||||
Revenues
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$
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-
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$
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-
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|||
Operating
expenses:
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|||||||
Research
and development
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10,592,059
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15,488,554
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|||||
General
and administrative
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6,233,549
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2,924,948
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|||||
Total
operating expenses
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16,825,608
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18,413,502
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Loss
from operations
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(16,825,608
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)
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(18,413,502
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)
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|||
Interest
income
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1,433,654
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293,861
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|||||
Interest
expense
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-
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(2,809
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)
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||||
Total
other income, net
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1,433,654
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291,052
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|||||
Net
loss before tax provision
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(15,391,954
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)
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(18,122,450
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)
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Tax
provision
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806
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-
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|||||
Net
loss applicable to common stockholders
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$
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(15,392,760
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)
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$
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(18,122,450
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)
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Basic
and diluted net loss per share applicable to common stockholders
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$
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(0.61
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)
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$
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(385.61
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)
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Shares
used in calculation of basic and diluted net loss per
share
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25,340,455
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46,997
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March
31,
2007
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December
31,
2006
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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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64,221,338
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$
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30,928,895
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Marketable
securities
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62,698,169
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941,981
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|||||
Prepaid
expenses, deposits and other current assets
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1,838,638
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1,949,466
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|||||
Total
current assets
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128,758,145
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33,820,342
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|||||
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|||||||
Marketable
securities, long-term
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3,000,181
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-
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|||||
Property
and equipment, net
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1,829,893
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1,859,704
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Deposits
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150,000
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150,000
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|||||
Restricted
cash
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430,230
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430,230
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Total
assets
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$
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134,168,449
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$
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36,260,276
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|||||||
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|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
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|||||||
Current
liabilities:
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|||||||
Accounts
payable
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$
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2,010,347
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$
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2,783,249
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Accrued
expenses
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4,904,128
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6,322,808
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|||||
Total
current liabilities
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6,914,475
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9,106,057
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|||||
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|||||||
Long-term
liabilities:
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|||||||
Deferred
rent
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246,075
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238,413
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Deferred
grant revenue
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142,411
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129,950
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Other
long-term liabilities
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59,683
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28,984
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Total
liabilities
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7,362,644
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9,503,404
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|||||
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|||||||
Stockholders'
equity:
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|||||||
Common
stock
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26,562
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22,129
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Additional
paid-in capital
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242,029,862
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126,578,588
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Accumulated
other comprehensive loss
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(17,283
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)
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(3,269
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)
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Deficit
accumulated during the development stage
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(115,233,336
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)
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(99,840,576
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)
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Total
stockholders' equity
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126,805,805
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26,756,872
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|||||
Total
liabilities and stockholders' equity
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$
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134,168,449
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$
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36,260,276
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Three
Months Ended
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|||||||
March
31,
2007
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March
31,
2006
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||||||
Cash
flows from operating activities:
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|||||||
Net
loss
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$
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(15,392,760
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)
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$
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(18,122,450
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)
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Adjustments
to reconcile net income to net cash used
in
operating activities:
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|||||||
Depreciation
and amortization
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148,671
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120,235
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Employee
and non-employee stock-based compensation
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4,107,972
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1,520,317
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Loss
on disposal of assets
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-
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29,528
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|||||
Accretion
of discount on investments
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(230,268
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)
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(92,261
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)
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Changes
in assets and liabilities:
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|||||||
Prepaid
expenses and other current assets
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109,921
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(252,666
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)
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Deposits
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-
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-
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|||||
Accounts
payable
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(767,846
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)
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1,122,758
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Accrued
expenses
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(1,419,185
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)
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4,627,273
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Deferred
grant revenue
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-
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-
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|||||
Other
liabilities
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38,361
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328,546
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|||||
Net
cash used in operating activities
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(13,405,134
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)
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(10,718,720
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)
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Cash
flows from investing activities:
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|||||||
Purchases
of property and equipment
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(118,678
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)
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(358,048
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)
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Purchases
of marketable securities
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(65,477,330
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)
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(1,639,702
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)
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Proceeds
from sales of marketable securities
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-
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-
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|||||
Maturities
of marketable securities
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950,000
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4,270,000
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|||||
Investment
in restricted cash
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-
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-
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|||||
Net
cash provided by (used in) investing activities
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(64,646,008
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)
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2,272,250
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||||
Cash
flows from financing activities:
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|||||||
Principal
payments on obligations under capital lease
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-
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(344
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)
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Principal
payments on note payable
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-
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(45,873
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)
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||||
Proceeds
from exercise of stock options and warrants
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56,516
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294
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|||||
Proceeds
from issuance of common stock, net of
issuance
costs
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111,291,219
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-
|
|||||
Net
cash provided by (used in) financing activities
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111,347,735
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(45,923
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)
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||||
Effect
of foreign currency translation
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(4,150
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)
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(458
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)
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Net
increase (decrease) in cash and cash equivalents
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33,292,443
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(8,492,851
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)
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||||
Cash
and cash equivalents, beginning of period
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30,928,895
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21,012,815
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|||||
Cash
and cash equivalents, end of period
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$
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64,221,338
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$
|
12,519,964
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