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Delaware
|
52-0845822
|
|
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
|
|
incorporation
or organization)
|
Identification
No.)
|
|
¨
Large
accelerated filer
|
x
Accelerated
filer
|
|
¨
Non-accelerated
filer
|
¨
Smaller reporting
company
|
|
December
31, 2009
|
June 30,
2010
|
|||||||
|
|
(Unaudited)
|
|||||||
| ASSETS | ||||||||
|
Current
assets:
|
||||||||
|
Cash
and cash equivalents (Note 11)
|
$ | 58,072 | $ | 5,331 | ||||
|
Marketable
securities maturing in less than one year (Note 5)
|
- | 30,433 | ||||||
|
Inventories
(Note 4)
|
- | 934 | ||||||
|
Prepaid
expenses and other current assets
|
332 | 120 | ||||||
|
Total
current assets
|
58,404 | 36,818 | ||||||
|
Property
and equipment, net
|
4,704 | 4,675 | ||||||
|
Marketable
securities maturing in one year or
greater
(Note 5)
|
- | 14,783 | ||||||
|
Patent
and trademark rights, net
|
830 | 836 | ||||||
|
Investment
|
35 | 35 | ||||||
|
Construction
in progress (Note 8)
|
135 | 405 | ||||||
|
Other
assets (Note 4)
|
886 | 35 | ||||||
|
Total
assets
|
$ | 64,994 | $ | 57,587 | ||||
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
|
Current
liabilities:
|
||||||||
|
Accounts
payable
|
$ | 1,294 | $ | 1,335 | ||||
|
Accrued
expenses (Note 6)
|
1,321 | 509 | ||||||
|
Current
portion of capital lease (Note 7)
|
- | 35 | ||||||
|
Total
current liabilities
|
2,615 | 1,879 | ||||||
|
Long-term
liabilities
|
||||||||
|
Long-term
portion of capital lease (Note 7)
|
- | 21 | ||||||
|
Commitments
and contingencies
|
||||||||
|
Stockholders’
equity (Note 9):
|
||||||||
|
Preferred
stock, par value $0.01 per share, authorized 5,000,000; issued and
outstanding; none
|
- | - | ||||||
|
Common
stock, par value $0.001 per share, authorized 200,000,000 shares; issued
and outstanding 132,787,447 and 134,368,677, respectively
|
133 | 135 | ||||||
|
Additional
paid-in capital
|
273,093 | 274,121 | ||||||
|
Accumulated
other comprehensive loss
|
- | (2 | ) | |||||
|
Accumulated
deficit
|
(210,847 | ) | (218,567 | ) | ||||
|
Total
stockholders’ equity
|
62,379 | 55,687 | ||||||
|
Total
liabilities and stockholders’ equity
|
$ | 64,994 | $ | 57,587 | ||||
|
Three months ended June 30,
|
||||||||
|
2009
|
2010
|
|||||||
|
Revenues:
|
||||||||
|
Clinical
treatment programs
|
$ | 17 | $ | 41 | ||||
|
Total
revenues
|
17 | 41 | ||||||
|
Costs
and expenses:
|
||||||||
|
Production/cost
of goods sold
|
152 | 328 | ||||||
|
Research
and development
|
1,982 | 1,694 | ||||||
|
General
and administrative
|
1,862 | 1,788 | ||||||
|
Total
costs and expenses
|
3,996 | 3,810 | ||||||
|
Operating
loss
|
(3,979 | ) | (3,769 | ) | ||||
|
Interest
and other income
|
109 | 93 | ||||||
|
Net
loss
|
$ | (3,870 | ) | $ | (3,676 | ) | ||
|
Basic
and diluted loss per share (Note 2)
|
$ | (.04 | ) | $ | (.03 | ) | ||
|
Weighted
average shares outstanding, basic and diluted
|
100,077,267 | 133,107,607 | ||||||
|
Six months ended June 30,
|
||||||||
|
2009
|
2010
|
|||||||
|
Revenues:
|
||||||||
|
Clinical
treatment programs
|
$ | 46 | $ | 73 | ||||
|
Total
revenues
|
46 | 73 | ||||||
|
Costs
and expenses:
|
||||||||
|
Production/cost
of goods sold
|
273 | 468 | ||||||
|
Research
and development
|
3,577 | 3,690 | ||||||
|
General
and administrative
|
3,028 | 3,757 | ||||||
|
Total
costs and expenses
|
6,878 | 7,915 | ||||||
|
Operating
loss
|
(6,832 | ) | (7,842 | ) | ||||
|
Financing
costs
|
(241 | ) | - | |||||
|
Interest
and other income
|
116 | 122 | ||||||
|
Net
loss
|
$ | (6,957 | ) | $ | (7,720 | ) | ||
|
Basic
and diluted loss per share (Note 2)
|
$ | (.08 | ) | $ | (.06 | ) | ||
|
Weighted
average shares outstanding, basic and diluted
|
89,110,201 | 132,963,622 | ||||||
|
Common
Stock
Share
s
|
Common
Stock
$.001
Par
Value
|
Additional
Paid-In
Capital
|
Accumulated
Other
Compre-hensive
Loss
|
Accumulated
Deficit
|
Total
Stockholders’
Equity
|
Compre-
hensive
Loss
|
||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||
|
Balance
at December 31, 2009
|
132,787,447 | $ | 133 | $ | 273,093 | $ | - | $ | (210,847 | ) | $ | 62,379 | $ | - | ||||||||||||||
|
Stock
issued for settlement of accounts payable
|
446,761 | - | 302 | - | - | 302 | - | |||||||||||||||||||||
|
Equity
based compensation
|
614,469 | 1 | 434 | - | - | 435 | - | |||||||||||||||||||||
|
Shares
sold at the market
|
520,000 | 1 | 292 | - | - | 293 | ||||||||||||||||||||||
|
Unrealized
loss in investment securities
|
- | - | - |
(2
|
) | - | (2 | ) | (2 | ) | ||||||||||||||||||
|
|
||||||||||||||||||||||||||||
|
Net
loss
|
- | - | - | - | (7,720 | ) | (7,720 | ) | (7,720 | ) | ||||||||||||||||||
|
|
||||||||||||||||||||||||||||
|
Balance
at June 30, 2010
|
134,368,677 | $ | 135 | $ | 274,121 | $ | (2 | ) | $ | (218,567 | ) | $ | 55,687 | $ | (7,722 | ) | ||||||||||||
|
2009
|
2010
|
|||||||
|
Cash
flows from operating activities:
|
||||||||
|
Net
loss
|
$ | (6,957 | ) | $ | (7,720 | ) | ||
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
|
Depreciation
of property and
equipment
|
177 | 192 | ||||||
|
Amortization
of patent and trademark rights,
and
royalty interest
|
186 | 39 | ||||||
|
Financing
cost related to Standby Financing
|
241 | - | ||||||
|
Equity
based compensation
|
141 | 435 | ||||||
|
Gain
on disposal of equipment
|
(83 | ) | (77 | ) | ||||
|
Change
in assets and liabilities:
|
||||||||
|
Accounts
and other receivables
|
(9 | ) | - | |||||
|
Prepaid
expenses and other
current
assets
|
171 | 212 | ||||||
|
Accounts
payable
|
1,017 | 343 | ||||||
|
Accrued
expenses
|
987 | (812 | ) | |||||
|
Net
cash used in operating
activities
|
$ | (4,129 | ) | $ | (7,388 | ) | ||
|
Cash
flows from investing activities:
|
||||||||
|
Purchase
of property plant and
equipment
|
$ | (5 | ) | $ | (362 | ) | ||
|
Additions
to patent and trademark
rights
|
(130 | ) | (45 | ) | ||||
|
Capital
lease deposit
|
- | (6 | ) | |||||
|
Purchase
of short-term
investments
|
(1,000 | ) | (45,218 | ) | ||||
|
Net
cash used in investing activities
|
$ | (1,135 | ) | $ | (45,631 | ) | ||
|
2009
|
2010
|
|||||||
|
Cash
flows from financing activities:
|
||||||||
|
Payments
on capital lease
|
$ | - | $ | (15 | ) | |||
|
Warrants
and options converted
|
5,683 | - | ||||||
|
Proceeds
from sale of stock, net of issuance costs
|
34,119 | 293 | ||||||
|
Net
cash provided by financing activities
|
$ | 39,802 | $ | 278 | ||||
|
Net
increase (decrease) in cash and cash equivalents
|
34,538 | (52,741 | ) | |||||
|
Cash
and cash equivalents at beginning of period
|
6,119 | 58,072 | ||||||
|
Cash
and cash equivalents at end of period
|
$ | 40,657 | $ | 5,331 | ||||
|
Supplemental
disclosures of non-cash investing
and
financing cash flow information:
|
||||||||
|
Issuance
of common stock for accounts payable and accrued expenses
|
$ | 1,137 | $ | 302 | ||||
|
Equipment
acquired by capital lease
|
$ | - | $ | 70 | ||||
|
Unrealized
loss on investments
|
$ | - | $ | (2 | ) | |||
|
Six Months Ended June 30,
|
||||||||
|
2009
|
2010
|
|||||||
|
Risk-free
interest rate
|
1.76%
- 2.54%
|
1.02%-2.03%
|
||||||
|
Expected
dividend yield
|
-
|
-
|
||||||
|
Expected
lives
|
2.5
– 5.0 yrs.
|
5.0
years
|
||||||
|
Expected
volatility
|
86.78%
- 110.57%
|
109.72%-110.01%
|
||||||
|
Weighted
average grant date fair value of options and warrants
issued
|
$ | 113,814 | $ | 402,771 | ||||
|
Number
of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
|
Outstanding
December 31, 2008
|
6,258,608 | $ | 2.60 | 7.92 | $ | - | ||||||||||
|
Options
granted
|
- | - | - | - | ||||||||||||
|
Options
forfeited
|
(29,856 | ) | 2.24 | 5.75 | - | |||||||||||
|
Outstanding
December 31, 2009
|
6,228,752 | $ | 2.60 | 6.95 | - | |||||||||||
|
Options
granted
|
820,000 | .66 | 10.00 | - | ||||||||||||
|
Options
forfeited
|
- | - | - | - | ||||||||||||
|
Outstanding
June 30, 2010
|
7,048,752 | $ | 2.37 | 6.64 | $ | - | ||||||||||
|
Exercisable
June 30, 2010
|
6,991,530 | $ | 2.38 | 6.64 | $ | - | ||||||||||
|
Number
of
Options
|
Weighted
Average
Exercise
Price
|
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
|
Outstanding
December 31, 2008
|
76,944 | $ | 1.41 | 8.89 | $ | - | ||||||||||
|
Options
granted
|
- | - | - | - | ||||||||||||
|
Options
vested
|
(38,611 | ) | 1.28 | 7.92 | - | |||||||||||
|
Options
forfeited
|
- | - | - | - | ||||||||||||
|
Outstanding
December 31, 2009
|
38,333 | $ | 1.54 | 8.00 | - | |||||||||||
|
Options
granted
|
18,889 | .66 | 10.00 | - | ||||||||||||
|
Options
vested
|
- | - | - | - | ||||||||||||
|
Options
forfeited
|
- | - | - | - | ||||||||||||
|
Outstanding
June 30, 2010
|
57,222 | $ | 1.25 | 8.33 | $ | - | ||||||||||
|
Number of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
|
Outstanding
December 31, 2008
|
2,417,482 | $ | 2.35 | 6.98 | - | |||||||||||
|
Options
granted
|
361,250 | 2.12 | 7.00 | - | ||||||||||||
|
Options
exercised
|
(293,831 | ) | 1.56 | 7.93 | - | |||||||||||
|
Options
forfeited
|
(251,469 | ) | 2.14 | 7.43 | - | |||||||||||
|
Outstanding
December 31, 2009
|
2,233,432 | $ | 2.44 | 5.73 | - | |||||||||||
|
Options
granted
|
40,000 | .71 | 9.88 | - | ||||||||||||
|
Options
exercised
|
- | - | - | - | ||||||||||||
|
Options
forfeited
|
- | - | - | - | ||||||||||||
|
Outstanding
June 30, 2010
|
2,273,432 | $ | 2.41 | 5.31 | - | |||||||||||
|
Exercisable
June 30, 2010
|
2,152,598 | $ | 2.39 | 5.61 | - | |||||||||||
|
Number of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
|
Outstanding
December 31, 2008
|
26,667 | $ | 1.43 | 9.00 | $ | - | ||||||||||
|
Options
granted
|
131,250 | 2.81 | 3.42 | - | ||||||||||||
|
Options
vested
|
(18,333 | ) | 1.79 | 7.45 | - | |||||||||||
|
Options
forfeited
|
- | - | - | - | ||||||||||||
|
Outstanding
December 31, 2009
|
139,584 | $ | 2.68 | 3.76 | - | |||||||||||
|
Options
granted
|
- | - | - | - | ||||||||||||
|
Options
vested
|
(18,750 | ) | 2.81 | 3.00 | - | |||||||||||
|
Options
forfeited
|
- | - | - | - | ||||||||||||
|
Outstanding
June 30, 2010
|
120,834 | $ | 2.66 | 3.88 | $ | - | ||||||||||
|
Inventories consist of the following:
|
(in thousands)
|
|||||||
|
December 31,
|
June 30,
|
|||||||
|
2009
|
2010
|
|||||||
|
Inventory
work in process
|
$ | - | $ | 934 | ||||
|
Finished
goods, net of reserves of $282,000 at December 31, 2009
and $250,000 at June 30, 2010.
|
- | - | ||||||
| $ | - | $ | 934 | |||||
|
Other assets consist of the following:
|
(in thousands)
|
|||||||
|
December 31,
|
June 30,
|
|||||||
|
2009
|
2010
|
|||||||
|
Inventory
work in process
|
$ | 864 | $ | - | ||||
|
Security
deposit
|
15 | 16 | ||||||
|
Internet
Domain Names
|
7 | 7 | ||||||
|
Deposit
on new telephone system
|
- | 6 | ||||||
|
Security
deposit on Capital Lease (see Note 7)
|
- | 6 | ||||||
| $ | 886 | $ | 35 | |||||
|
June 30, 2010
(in thousands)
|
|||||||||||||
|
Name Of Security
|
Cost
|
Market
Value
|
Unrealized
Gain
(Loss)
|
Maturity
Date
|
|||||||||
|
Marketable
Securities with maturity periods less than one year:
|
|||||||||||||
|
Protective
Life
|
523 | 502 | (21 | ) |
8/16/2010
|
||||||||
|
GE
Money Bank
|
250 | 250 | - |
10/15/2010
|
|||||||||
|
Discover
Bank
|
500 | 500 | - |
10/29/2010
|
|||||||||
|
Toyota
Motor Credit
|
1,020 | 1.017 | (3 | ) |
12/15/2010
|
||||||||
|
GE
Money Bank
|
250 | 249 | (1 | ) |
1/14/2011
|
||||||||
|
World
Financial Capital
|
300 | 299 | (1 | ) |
1/28/2011
|
||||||||
|
Bank
of America
|
500 | 499 | (1 | ) |
4/21/2011
|
||||||||
|
Merrick
Bank
|
250 | 250 | - |
4/21/2011
|
|||||||||
|
American
Express Bank FSB
|
250 | 250 | - |
9/30/2010
|
|||||||||
|
Beal
Bank
|
250 | 250 | - |
12/8/2010
|
|||||||||
|
Safra
National Bank
|
250 | 250 | - |
1/1/2011
|
|||||||||
|
Goldman
Sachs
|
1,062 | 1,026 | (36 | ) |
1/15/2011
|
||||||||
|
Discover
Bank
|
250 | 249 | (1 | ) |
6/23/2011
|
||||||||
|
PIMCO
|
22,200 | 22,531 | 331 |
NA
|
|||||||||
|
Cisco
Systems
|
786 | 771 | (15 | ) |
2/22/2011
|
||||||||
|
IBM
Corp.
|
784 | 772 | (12 | ) |
3/22/2011
|
||||||||
|
Oracle
Corp.
|
785 | 768 | (17 | ) |
1/15/2011
|
||||||||
|
Total
Marketable Securities with maturity periods less than one
year:
|
$ | 30,210 | $ | 30,433 | $ | 223 | |||||||
|
Marketable
Securities with maturity periods greater than one year:
|
|||||||||||||
|
PlainsCapital
Bank
|
250 | 249 | (1 | ) |
10/31/2011
|
||||||||
|
Citibank
N.A.
|
250 | 250 | - |
4/30/2012
|
|||||||||
|
Wright
Express Financial Services
|
250 | 250 | - |
4/26/2012
|
|||||||||
|
Bank
of Northern Miami
|
250 | 250 | - |
7/30/2012
|
|||||||||
|
Park
Sterling Bank
|
250 | 250 | - |
10/16/2012
|
|||||||||
|
Columbus
Bank & Trust Co.
|
250 | 251 | 1 |
10/22/2012
|
|||||||||
|
World's
Foremost Bank
|
100 | 103 | 3 |
1/28/2013
|
|||||||||
|
Medallion
Bank
|
242 | 244 | 2 |
4/30/2013
|
|||||||||
|
Wells
Fargo
|
1,081 | 1,052 | (29 | ) |
8/1/2011
|
||||||||
|
Bank
of America
|
1,066 | 1,042 | (24 | ) |
8/15/2011
|
||||||||
|
Wachovia
Bank
|
274 | 271 | (3 | ) |
9/28/2011
|
||||||||
|
Bank
One Corp.
|
1,070 | 1,062 | (8 | ) |
11/15/2011
|
||||||||
|
Morgan
Stanley
|
1,077 | 1,045 | (32 | ) |
1/9/2012
|
||||||||
|
Goldman
Sachs
|
1,035 | 1,018 | (17 | ) |
8/1/2012
|
||||||||
|
Merrill
Lynch
|
1,088 | 1,059 | (29 | ) |
8/15/2012
|
||||||||
|
Morgan
Stanley
|
1,071 | 1,053 | (18 | ) |
8/31/2012
|
||||||||
|
Wells
Fargo
|
1,083 | 1,066 | (17 | ) |
9/1/2012
|
||||||||
|
GE
Capital
|
104 | 102 | (2 | ) |
5/29/2012
|
||||||||
|
Sallie
Mae Bank
|
104 | 102 | (2 | ) |
5/29/2012
|
||||||||
|
Israel
Disc Bank
|
250 | 249 | (1 | ) |
9/11/2012
|
||||||||
|
Allstate
|
115 | 112 | (3 | ) |
9/16/2012
|
||||||||
|
World's
Foremost Bank
|
104 | 103 | (1 | ) |
3/4/2013
|
||||||||
|
BWW
Bank North America
|
251 | 252 | 1 |
6/4/2013
|
|||||||||
|
Goldman
Sachs
|
250 | 251 | 1 |
6/17/2013
|
|||||||||
|
General
Dynamics
|
763 | 758 | (5 | ) |
7/15/2011
|
||||||||
|
Merck
& Co.
|
817 | 796 | (21 | ) |
11/15/2011
|
||||||||
|
Shell
International
|
755 | 754 | (1 | ) |
9/22/2011
|
||||||||
|
3M
Company
|
808 | 789 | (19 | ) |
11/1/2011
|
||||||||
|
Total
Marketable Securities with maturity periods greater than one
year:
|
$ | 15,008 | $ | 14,783 | $ | (225 | ) | ||||||
|
Total
Marketable Securities
|
$ | 45,218 | $ | 45,216 | (2 | ) | |||||||
|
(in thousands)
|
||||||||
|
December 31,
|
June 30,
|
|||||||
|
2009
|
2010
|
|||||||
|
Compensation
|
$ | 716 | $ | 205 | ||||
|
Professional
fees
|
421 | 154 | ||||||
|
Other
expenses
|
71 | 37 | ||||||
|
Other
liability
|
113 | 113 | ||||||
| $ | 1,321 | $ | 509 | |||||
|
(in
thousands)
|
||||
|
Asset
|
||||
|
Balance at
|
||||
|
June 30,
2010
|
||||
|
Leased
Equipment included with property and equipment
|
$ | 70 | ||
|
Less:
accumulated depreciation
|
(4 | ) | ||
| $ | 66 | |||
|
2010
|
$ | 18 | ||
|
2011
|
35 | |||
|
2012
|
4 | |||
|
Total
lease payments remaining
|
57 | |||
|
Less:
amount representing interest
|
(1 | ) | ||
|
Present
value of remaining minimum lease payments
|
56 | |||
|
Less:
current obligations under lease obligations
|
(35 | ) | ||
|
Long-term
capital lease obligations
|
$ | 21 |
|
|
·
|
Level
1 – Quoted prices are available in active markets for identical assets or
liabilities at the reporting date.
|
|
|
·
|
Level
2 – Observable inputs other than Level 1 prices such as quote prices for
similar assets or liabilities; quoted prices in markets that are not
active; or other inputs that are observable or can be corroborated by
observable market data for substantially the full term of the assets or
liabilities.
|
|
|
·
|
Level
3 – Unobservable inputs that are supported by little or no market activity
and that are significant to the fair value of the assets or
liabilities. Level 3 assets and liabilities include financial
instruments whose value is determined using pricing models, discounted
cash flow methodologies, or other valuation techniques, as well as
instruments for which the determination of fair value requires significant
management judgment or estimation. As of December 31, 2009, the
Company has classified the warrants with cash settlement features as Level
3. Management evaluates a variety of inputs and then estimates
fair value based on those inputs. The primary inputs evaluated
by management to determine the likelihood of a change in control to a
non-public company (thereby triggering the cash settlement feature) were
the Company’s FDA approval status including the additional requirements
including required cash outflows prior to resubmission to the FDA
(observable), the industry and market conditions (unobservable),
litigation matters against the Company (observable) and statistics
regarding the number of company’s going private
(observable).
|
|
Total
|
Level
1
|
Level
2
|
Level
3
|
|||||||||||||
|
Assets:
|
||||||||||||||||
|
Marketable
Securities
|
$ | 45,216 | $ | 45,216 | $ | - | $ | - | ||||||||
|
Liabilities:
|
||||||||||||||||
|
Warrants
|
- | - | - | - | ||||||||||||
|
Total
|
$ | 45,21 6 | $ | 45,21 6 | $ | - | $ | - | ||||||||
|
|
·
|
The
June 11, 2010 employment agreements with William A. Carter, Chairman of
the Board and Chief Executive Officer, and Thomas K. Equels, Vice Chairman
of the Board, Secretary and General Counsel, were amended to make certain
terminology revisions that did not impact or alter the terms of these
executives’ compensation. These amendments were reviewed and
approved by the Compensation Committee on July 14, 2010 with unanimous
recommendation to the Board for approval. On July 15, 2010, the
Board of Directors unanimously approved the amendments. As a
result, these amended employment agreements were signed on July 15, 2010
with an effective date of June 11,
2010.
|
|
|
·
|
The
existing employment agreement with Robert Dickey IV, Senior Vice
President, was set to expire on September 1, 2010. Upon
discussion and review on July 14, 2010, the Compensation Committee
unanimously recommendation to the Board that an agreement be authorized
for renewal on a month-to-month basis at the same general terms and level
of compensation as established in the employment agreement of February 1,
2010. On July 15, 2010, the Board of Directors unanimously
authorized the renewal of this extension within the terms recommended by
the Compensation Committee. As a result, this agreement renewal
was signed on August 3, 2010 with an effective date of September 1,
2010.
|
|
|
·
|
The
adviser’s agreement with SAGE was scheduled to expire on November 13,
2010. Upon discussion and review on July 15, 2010, the Company
entered into an amended adviser’s agreement for an initial term of 18
months.
|
|
|
1)
|
a
decrease in Research and Development costs of approximately $288,000 or
15%;
|
|
|
2)
|
a
decrease in General and Administrative expenses of approximately $74,000
or 4%; offset by
|
|
|
3)
|
an
increase in Production/Cost of Goods Sold of approximately $176,000 or
116%; and
|
|
|
4)
|
an
increase in interest income of $16,000 from invested
funds.
|
|
|
1)
|
an
increase in Production/Cost of Goods Sold of approximately $195,000 or
71%; and
|
|
|
2)
|
an
increase in Research and Development costs of approximately $113,000 or
3%;
|
|
|
3)
|
An
increase in General and Administrative expenses of approximately $729,000
or 24%; offset by
|
|
|
4)
|
a
decrease in finance costs of $241,000, or 100% from a Standby Finance
Agreement executed in February
2009.
|
|
1.
|
preserve,
secure and control capital;
|
|
2.
|
maintain
liquidity to meet our operating cash flow requirements;
and
|
|
3.
|
maximize
return subject to policies and procedures that manage risks with respect
to a conservative to moderate investment exposure at high credit quality
institutions.
|
|
1.
|
U.S.
Treasury and Government
Obligations;
|
|
2.
|
Federal
Agency securities sponsored by enterprises and
instrumentalities;
|
|
3.
|
Certificates
of Deposit;
|
|
4.
|
Money
market funds with assets of greater than $1
Billion;
|
|
5.
|
PIMCO
Total Return Fund A;
|
|
6.
|
Corporate
debt obligations or commercial paper issued by corporations, commercial
banks, investment banks and bank holding companies, rated A2/A or better
by Moody’s or Standard & Poor’s or P-1 by Moody’s or A-1 or better by
Standard & Poor’s; and
|
|
7.
|
Asset-backed
securities rated AAA/Aaa, P-1 or A-1+ by Moody’s or Standard &
Poor’s.
|
|
(a)
|
Hemispherx
Biopharma, Inc. v. Johannesburg Consolidated Investments, et al.,U.S.
District Court for the Southern District of Florida, Case No.
04-10129-CIV.
|
|
(b)
|
Hemispherx
Biopharma, Inc. v. MidSouth Capital, Inc., Adam Cabibi, And Robert L.
Rosenstein v. Hemispherx Biopharma, Inc. and The Sage Group,
Inc.,
Civil Action
No. 1:09-CV-03110-CAP.
|
|
(c)
|
Cato
Capital, LLC v. Hemispherx Biopharma, Inc., U.S. District Court for the
District of Delaware, Case No.
09-549-GMS.
|
|
(d)
|
In re
Hemispherx Biopharma, Inc. Litigation, U. S. District Court for the
Eastern District of Pennsylvania, Civil Action No.
09-5262.
|
|
(e)
|
Summation.
|
|
|
·
|
announcements
of the results of clinical trials by us or our
competitors;
|
|
|
·
|
announcement
of legal actions against us and/or settlements or verdicts adverse to
us;
|
|
|
·
|
adverse
reactions to products;
|
|
|
·
|
governmental
approvals, delays in expected governmental approvals or withdrawals
of any prior governmental approvals or public or regulatory
agency comments regarding the safety or effectiveness of our products, or
the adequacy of the procedures, facilities or controls employed in the
manufacture of our products;
|
|
|
·
|
changes
in U.S. or foreign regulatory policy during the period of product
development;
|
|
|
·
|
developments
in patent or other proprietary rights, including any third party
challenges of our intellectual property
rights;
|
|
|
·
|
announcements
of technological innovations by us or our
competitors;
|
|
|
·
|
announcements
of new products or new contracts by us or our
competitors;
|
|
|
·
|
actual
or anticipated variations in our operating results due to the level of
development expenses and other
factors;
|
|
|
·
|
changes
in financial estimates by securities analysts and whether our earnings
meet or exceed the
estimates;
|
|
|
·
|
conditions
and trends in the pharmaceutical and other
industries;
|
|
|
·
|
new
accounting standards;
|
|
|
·
|
overall
investment market fluctuation; and
|
|
|
·
|
occurrence
of any of the risks described in these "Risk
Factors".
|
|
(a)
|
Exhibits
|
|
10.1
|
Amended
and Restated Employment Agreement with Dr. William A. Carter dated July 15
2010.
|
|
10.2
|
Amended
and Restated Employment Agreement with Thomas K. Equels dated July 15
,
2010.
|
|
10.3
|
Amended
and Restated Employment Agreement with Robert Dickey dated August 3,
2010.
|
|
10.4
|
Amended
Advisors Agreement with The Sage Group, Inc. dated July 15
2010.
|
|
31.1
|
Certification
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the
Company's Chief Executive Officer.
|
|
31.2
|
Certification
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the
Company's Chief Financial Officer.
|
|
32.1
|
Certification
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the
Company's Chief Executive Officer.
|
|
32.2
|
Certification
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the
Company's Chief Financial
Officer.
|
|
HEMISPHERx
BIOPHARMA, INC.
|
|
|
/s/ William A. Carter
|
|
|
William
A. Carter, M.D.
|
|
|
Chief
Executive Officer
|
|
|
&
President
|
|
|
/s/
Charles T. Bernhardt
|
|
|
Charles
T. Bernhardt, CPA
|
|
|
Chief
Financial Officer
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|