AIM ImmunoTech Inc. - Quarter Report: 2007 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
Quarterly
Report Pursuant to Section 13 or 15(d)
of
the
Securities Exchange Act of 1934
For
the
Quarterly Period Ended March 31, 2007
Commission
File Number: 0-27072
HEMISPHERx
BIOPHARMA, INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
52-0845822
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
incorporation
or organization)
|
Identification
No.)
|
1617
JFK Boulevard, Suite 660, Philadelphia, PA 19103
(Address
of principal executive offices) (Zip Code)
(215)
988-0080
(Registrant's
telephone number, including area code)
Not
Applicable
(Former
name, former address and former fiscal year, if changed since last
report)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days. x
Yes o No
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of accelerated
filer and large accelerated filer in Rule 12b-2 of the Exchange Act. (Check
one):
o Large
accelerated filer x
Accelerated filer o
Non-accelerated filer
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
o
Yes x No
71,989,622
shares of common stock were issued and outstanding as of April 30, 2007.
PART
I -
FINANCIAL INFORMATION
ITEM
1:
Financial Statements
HEMISPHERx
BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated
Balance Sheets
(in
thousands)
December
31,
|
March
31,
|
||||||
2006
|
2007
|
||||||
(unaudited)
|
|||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
3,646
|
$
|
4,179
|
|||
Short
term investments (Note 4)
|
18,375
|
20,421
|
|||||
Inventory,
net
|
957
|
843
|
|||||
Accounts
and other receivables, net of reserves of $1 and $1, respectively
|
93
|
559
|
|||||
Prepaid
expenses and other current assets
|
168
|
195
|
|||||
Total
current assets
|
23,239
|
26,197
|
|||||
Property
and equipment, net
|
4,720
|
4,667
|
|||||
Patent
and trademark rights, net
|
857
|
878
|
|||||
Investment
|
35
|
35
|
|||||
Construction
in Progress
|
601
|
635
|
|||||
Royalty
Interest
|
624
|
587
|
|||||
Deferred
financing costs
|
38
|
19
|
|||||
Advance
receivable (Note 5)
|
1,300
|
1,300
|
|||||
Other
assets
|
17
|
17
|
|||||
Total
assets
|
$
|
31,431
|
$
|
34,335
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,548
|
$
|
1,594
|
|||
Accrued
expenses
|
1,261
|
1,330
|
|||||
Current
portion of long-term debt (Note 5)
|
3,871
|
3,987
|
|||||
Total
current liabilities
|
6,680
|
6,911
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders'
equity:
|
|||||||
Preferred
stock, par value $0.01 per share, authorized
5,000,000; issued and outstanding; none
|
-
|
-
|
|||||
Common
stock, par value $0.01 per share, authorized
200,000,000 shares; issued and outstanding
66,816,764 and 70,676,490
respectively
|
67
|
71
|
|||||
Additional
paid-in capital
|
191,689
|
199,239
|
|||||
Accumulated
other comprehensive income
|
46
|
265
|
|||||
Accumulated
deficit
|
(167,051
|
)
|
(172,151
|
)
|
|||
Total
stockholders' equity
|
24,751
|
27,424
|
|||||
Total
liabilities and stockholders' equity
|
$
|
31,431
|
$
|
34,335
|
See
accompanying notes to condensed consolidated financial statements.
2
HEMISPHERX
BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated
Statements of Operations
(in
thousands, except share and per share data)
(Unaudited)
Three
months ended March 31,
|
|||||||
2006
|
2007
|
||||||
Revenues:
|
|||||||
Sales
of product net
|
$
|
183
|
$
|
220
|
|||
Clinical
treatment programs
|
53
|
35
|
|||||
Total
revenues
|
236
|
255
|
|||||
Costs
and expenses:
|
|||||||
Production/cost
of goods sold
|
299
|
236
|
|||||
Research
and development
|
2,430
|
3,176
|
|||||
General
and administrative
|
3,093
|
1,783
|
|||||
Total
costs and expenses
|
5,822
|
5,195
|
|||||
Other
(expense) and interest and other income
|
(45
|
)
|
49
|
||||
Interest
expense
|
(84
|
)
|
(71
|
)
|
|||
Financing
costs (Note 5)
|
(205
|
)
|
(138
|
)
|
|||
Net
loss
|
$
|
(5,920
|
)
|
$
|
(5,100
|
)
|
|
Basic
and diluted loss per share (Note 2)
|
$
|
(.10
|
)
|
$
|
(.07
|
)
|
|
Weighted
average shares outstanding, basic and diluted
|
58,235,839
|
68,825,344
|
See
accompanying notes to consolidated financial statements.
3
HEMISPHERx
BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated
Statements of Changes in Stockholders' Equity and Comprehensive loss
(in
thousands except share data)
(Unaudited)
Common
Stock
Shares
|
Common
Stock $.001 Par
Value
|
Additional
paid-in
capital
|
Accumulated
other comprehensive
income
|
Accumulated
deficit
|
Total
stockholders’ equity
|
||||||||||||||
Balance
at December 31, 2006
|
66,816,764
|
$
|
67
|
$
|
191,689
|
$
|
46
|
$
|
(167,051
|
)
|
$
|
24,751
|
|||||||
Interest
Payments
|
33,203
|
-
|
76
|
-
|
-
|
76
|
|||||||||||||
Private
placement, net of issuance costs
|
3,798,113
|
4
|
7,266
|
-
|
-
|
7,270
|
|||||||||||||
Stock
issued for settlement of accounts payable
|
28,410
|
-
|
63
|
-
|
-
|
63
|
|||||||||||||
Equity
based compensation
|
-
|
-
|
145
|
-
|
-
|
145
|
|||||||||||||
Net
comprehensive income (loss)
|
-
|
-
|
-
|
219
|
(5,100
|
)
|
(4,881
|
)
|
|||||||||||
Balance
at March 31, 2007
|
70,676,490
|
$
|
71
|
$
|
199,239
|
$
|
265
|
$
|
(172,151
|
)
|
$
|
27,424
|
See
accompanying notes to consolidated financial statements.
4
HEMISPHERx
BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated
Statements of Cash Flows
For
the
Three Months Ended March 31, 2006 and 2007
(in
thousands)
(Unaudited)
2006
|
2007
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(5,920
|
)
|
$
|
(5,100
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
of property and equipment
|
30
|
61
|
|||||
Amortization
of patent and trademark
rights, and royalty interest
|
28
|
44
|
|||||
Financing
cost related to debt discounts
|
205
|
138
|
|||||
Equity
based compensation
|
1,953
|
145
|
|||||
Common
stock issued in payment of interest expense
|
101
|
73
|
|||||
Changes
in assets and liabilities:
|
|||||||
Inventory
|
138
|
114
|
|||||
Accounts
and other receivables
|
34
|
(466
|
)
|
||||
Prepaid
expenses and other current
assets
|
(48
|
)
|
(27
|
)
|
|||
Accounts
payable
|
807
|
109
|
|||||
Accrued
expenses
|
(224
|
)
|
69
|
||||
Net
cash used in operating activities
|
$
|
(2,896
|
)
|
$
|
(4,840
|
)
|
|
Cash
flows from investing activities:
|
|||||||
Purchase
of property plant and equipment
|
$
|
(6
|
)
|
$
|
(19
|
)
|
|
Additions
to patent and trademark rights
|
(22
|
)
|
(51
|
)
|
|||
Maturity
of short term investments
|
12,548
|
18,329
|
|||||
Purchase
of short term investments
|
(13,344
|
)
|
(20,156
|
)
|
|||
Construction
in Progress
|
(860
|
)
|
-
|
||||
Net
cash used in investing activities
|
$
|
(1,684
|
)
|
$
|
(1,897
|
)
|
5
HEMISPHERX
BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated
Statements of Cash Flows (Continued)
For
the
Three Months Ended March 31, 2006 and 2007
(in
thousands)
(Unaudited)
2006
|
2007
|
||||||
Cash
flows from financing activities:
|
|||||||
Proceeds
from exercise of stock warrants
|
$
|
672
|
$
|
-
|
|||
Proceeds
from sale of stock, net of issuance costs
|
10,600
|
7,270
|
|||||
Net
cash provided by financing activities
|
$
|
11,272
|
$
|
7,270
|
|||
Net
increase in cash and cash equivalents
|
6,692
|
533
|
|||||
|
|||||||
Cash
and cash equivalents at beginning of period
|
3,827
|
3,646
|
|||||
Cash
and cash equivalents at end of period
|
$
|
10,519
|
$
|
4,179
|
|||
Supplemental
disclosures of non-cash investing and financing cash flow
information:
|
|||||||
Issuance
of common stock for accounts
payable and accrued expenses
|
$
|
84
|
$
|
63
|
|||
Issuance
of common stock for debt
conversion and debt payments
|
$
|
333
|
$
|
-
|
|||
Unrealized
gains on investments
|
$
|
220
|
$
|
219
|
See
accompanying notes to consolidated financial statements.
6
HEMISPHERx
BIOPHARMA, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1: BASIS OF PRESENTATION
The
consolidated financial statements include the financial statements of Hemispherx
Biopharma, Inc. and its wholly-owned subsidiaries. The Company has three
domestic subsidiaries BioPro Corp., BioAegean Corp. and Core Biotech Corp.,
all
of which are incorporated in Delaware and are dormant. The Company’s foreign
subsidiary, Hemispherx Biopharma Europe N.V./S.A., established in Belgium in
1998, has limited or no activity. All significant intercompany balances and
transactions have been eliminated in consolidation.
In
the
opinion of management, all adjustments necessary for a fair presentation of
such
consolidated financial statements have been included. Such adjustments consist
of normal recurring items. Interim results are not necessarily indicative of
results for a full year.
The
interim consolidated financial statements and notes thereto are presented as
permitted by the Securities and Exchange Commission (SEC), and do not contain
certain information which will be included in our annual consolidated financial
statements and notes thereto.
These
consolidated financial statements should be read in conjunction with our
consolidated financial statements included in our annual report on Form 10-K
for the
year
ended December 31, 2006, as filed with the SEC on March
19, 2007.
NOTE
2: NET
LOSS PER SHARE
Basic
and diluted net loss per share is computed using the weighted average number
of
shares of common stock outstanding during the period. Equivalent common shares,
consisting of stock options and warrants including the Company’s convertible
debentures, which amounted to 18,416,587 and 22,294,987 shares, are excluded
from the calculation of diluted net loss per share for the three months ended
March 31, 2006 and 2007, respectively, since their effect is antidilutive.
NOTE
3: EQUITY BASED COMPENSATION
The
fair
value of each option award is estimated on the date of grant using a
Black-Scholes option valuation model. Expected volatility is based on the
historical volatility of the price of the Company’s stock. The risk-free
interest rate is based on U.S. Treasury issues with a term equal to the expected
life of the option. The Company uses historical data to estimate expected
dividend yield, expected life and forfeiture rates. The fair values of the
options granted, were estimated based on the following weighted average
assumptions:
Three
Months Ended March 31,
|
|||||||
2006
|
2007
|
||||||
Risk-free
interest rate
|
4.3%
- 4.6
|
%
|
4.46
- 4.77
|
%
|
|||
Expected
dividend yield
|
-
|
-
|
|||||
Expected
lives
|
2.5-5
yrs
|
5
yrs
|
|||||
Expected
volatility
|
72.1%-79.3
|
%
|
77.06
- 77.57
|
%
|
|||
Weighted
average grant date fair value of options and warrants issued
|
$
|
2,503,000
|
$
|
135,712
|
7
Stock
option activity during the three months ended March 31, 2007, is as
follows:
Stock
option activity for employees:
Number
of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
December 31, 2006
|
2,001,969
|
$
|
2.51
|
8.01
|
|||||||||
Options
granted
|
64,120
|
2.14
|
9.75
|
||||||||||
Options
forfeited
|
-
|
-
|
-
|
||||||||||
Outstanding
March 31, 2007
|
2,066,089
|
2.50
|
8.10
|
-
|
|||||||||
Exercisable
March 31, 2007
|
1,952,103
|
2.52
|
8.70
|
-
|
The
weighted-average grant-date fair value of options granted during the three
months ended March 31, 2007 was $80,716.
Unvested
stock option activity for employees:
Number
of
Options
|
Weighted
Average
Exercise
Price
|
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
December 31, 2006
|
113,986
|
$
|
2.26
|
9.05
|
|||||||||
Options
granted
|
-
|
-
|
-
|
||||||||||
Options
forfeited
|
-
|
-
|
-
|
-
|
|||||||||
Outstanding
March 31, 2007
|
113,986
|
$
|
2.26
|
9.05
|
-
|
Stock
option activity for non-employees:
Number
of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
December 31, 2006
|
1,326,732
|
$
|
2.63
|
8.18
|
|||||||||
Options
granted
|
33,750
|
$
|
2.37
|
9.75
|
|||||||||
Options
forfeited
|
-
|
-
|
-
|
||||||||||
Outstanding
March 31, 2007
|
1,360,482
|
$
|
2.63
|
8.20
|
-
|
||||||||
Exercisable
March 31, 2007
|
1,323,382
|
$
|
2.63
|
8.60
|
-
|
The
weighted-average grant-date fair value of options granted during the three
months ended March 31, 2007 was $42,486.
8
Unvested
stock option activity for non-employees during the year:
Number
of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
December 31, 2006
|
37,100
|
$
|
2.28
|
9.81
|
|
||||||||
Options
granted
|
-
|
-
|
-
|
|
|||||||||
Options
forfeited
|
-
|
-
|
-
|
-
|
|||||||||
Outstanding
March 31, 2007
|
37,100
|
$
|
2.28
|
9.81
|
-
|
The
impact on the Company’s results of operations of recording equity based
compensation for the three months ended March 31, 2007 was to increase general
and administrative expenses by approximately $123,000 and reduce earnings per
share by $0.00 per basic and diluted share.
As
of
March 31, 2007, there was $94,000 of unrecognized equity based compensation
cost
related to options granted under the Equity Incentive Plan.
Note
4: SHORT TERM INVESTMENTS
Securities
classified as available for sale consisted of:
March
31, 2007
|
Unrealized
|
||||||||||||
Name
of security
|
Cost
|
Market
value
|
gain
(loss)
|
Maturity
date
|
|||||||||
Natexis
Banques Popolare
|
$
|
969,000
|
$
|
992,000
|
$
|
23,000
|
May,
2007
|
||||||
AIG
FDG Disc Com Paper
|
972,000
|
997,000
|
25,000
|
April,
2007
|
|||||||||
General
Electric Cap Corp
|
965,000
|
988,000
|
23,000
|
June,
2007
|
|||||||||
American
General Fin Corp
|
965,000
|
987,000
|
22,000
|
June,
2007
|
|||||||||
Daimlechrysler
|
965,000
|
987,000
|
22,000
|
June,
2007
|
|||||||||
LaSalle
Bank
|
965,000
|
987,000
|
22,000
|
June,
2007
|
|||||||||
General
Electric Cap Corp
|
1,240,000
|
1,258,000
|
18,000
|
July,
2007
|
|||||||||
General
Electric Cap Serv
|
1,202,000
|
1,216,000
|
14,000
|
September,
2007
|
|||||||||
HSBC
Finance
|
1,000,000
|
1,014,000
|
14,000
|
August,
2007
|
|||||||||
FHLMC
|
1,051,000
|
1,065,000
|
14,000
|
November,
2007
|
|||||||||
FHLMC
|
960,000
|
973,000
|
13,000
|
October,
2007
|
|||||||||
FNMA
|
800,000
|
806,000
|
6,000
|
December,
2007
|
|||||||||
FNMA
|
3,000,000
|
3,029,000
|
29,000
|
November,
2007
|
|||||||||
FHLMC
|
3,099,000
|
3,125,000
|
26,000
|
December,
2007
|
|||||||||
HSBC
Finance
|
1,004,000
|
1,002,000
|
(2,000
|
)
|
December,
2007
|
||||||||
General
Electric
|
999,000
|
995,000
|
(4,000
|
)
|
December,
2007
|
||||||||
$
|
20,156,000
|
$
|
20,421,000
|
$
|
265,000
|
9
December
31, 2006
|
|
|
|||||||||||
Name
of security
|
Cost
|
Market
value
|
Unrealized
gain (loss)
|
Maturity
date
|
|||||||||
AIG
Discount Commercial
|
$
|
972,000
|
$
|
983,000
|
$
|
11,000
|
April,
2007
|
||||||
Natexis
Banques Popolare
|
969,000
|
979,000
|
10,000
|
May,
2007
|
|||||||||
American
General Finance
|
965,000
|
974,000
|
9,000
|
June,
2007
|
|||||||||
Daimler
Chrysler
|
965,000
|
974,000
|
9,000
|
June,
2007
|
|||||||||
LaSalle
Bank
|
965,000
|
974,000
|
9,000
|
June,
2007
|
|||||||||
General
Electric
|
1,240,000
|
1,242,000
|
2,000
|
July,
2007
|
|||||||||
HSBC
Finance
|
1,000,000
|
1,000,000
|
-
|
August,
2007
|
|||||||||
American
General Finance
|
976,000
|
987,000
|
11,000
|
September,
2007
|
|||||||||
General
Electric
|
965,000
|
974,000
|
9,000
|
September,
2007
|
|||||||||
General
Electric
|
1,202,000
|
1,200,000
|
(2,000
|
)
|
September,
2007
|
||||||||
FHLMC
|
960,000
|
960,000
|
-
|
October,
2007
|
|||||||||
FHLMC
|
1,051,000
|
1,051,000
|
-
|
November,
2007
|
|||||||||
FNMA
|
3,000,000
|
2,991,000
|
(9,000
|
)
|
November,
2007
|
||||||||
FHLMC
|
3,099,000
|
3,086,000
|
(13,000
|
)
|
December,
2007
|
||||||||
$
|
18,329,000
|
$
|
18,375,000
|
$
|
46,000
|
No
investment securities were pledged to secure public funds at March 31, 2007
and
December 31, 2006, respectively.
The
table
below indicates the length of time individual securities have been in a
continuous unrealized loss position at March 31, 2007 and December 31,
2006.
March
31, 2007
|
||||||||||||||||||||||
Number
|
Less
than 12 Months
|
12
months or longer
|
Total
|
|||||||||||||||||||
Name
of security
|
of
Securities
|
Fair
value
|
Unrealized
loss
|
Fair
value
|
Unrealized
loss
|
Fair
value
|
Unrealized
loss
|
|||||||||||||||
Natexis
Banques Popolare
|
1
|
$
|
992,000
|
-
|
-
|
-
|
$
|
992,000
|
-
|
|||||||||||||
AIG
FDG Disc Com Paper
|
1
|
997,000
|
-
|
-
|
-
|
997,000
|
-
|
|||||||||||||||
General
Electric Cap Corp
|
1
|
988,000
|
-
|
-
|
-
|
988,000
|
-
|
|||||||||||||||
American
General Fin Corp
|
1
|
987,000
|
-
|
-
|
-
|
987,000
|
-
|
|||||||||||||||
Daimlechrysler
|
1
|
987,000
|
-
|
-
|
-
|
987,000
|
-
|
|||||||||||||||
LaSalle
Bank
|
1
|
987,000
|
-
|
-
|
-
|
987,000
|
-
|
|||||||||||||||
General
Electric Cap Corp
|
1
|
1,258,000
|
-
|
-
|
-
|
1,258,000
|
-
|
|||||||||||||||
General
Electric Cap Serv
|
1
|
1,216,000
|
-
|
-
|
-
|
1,216,000
|
-
|
|||||||||||||||
HSBC
Finance
|
1
|
1,014,000
|
-
|
-
|
-
|
1,014,000
|
-
|
|||||||||||||||
FHLMC
|
1
|
1,065,000
|
-
|
-
|
-
|
1,065,000
|
-
|
|||||||||||||||
FHLMC
|
1
|
973,000
|
-
|
-
|
-
|
973,000
|
-
|
|||||||||||||||
FNMA
|
1
|
806,000
|
-
|
-
|
-
|
806,000
|
-
|
|||||||||||||||
FNMA
|
1
|
3,029,000
|
-
|
-
|
-
|
3,029,000
|
-
|
|||||||||||||||
FHLMC
|
1
|
3,125,000
|
-
|
-
|
-
|
3,125,000
|
-
|
|||||||||||||||
HSBC
Finance
|
1
|
1,002,000
|
(2,000.00
|
)
|
-
|
-
|
1,002,000
|
(2,000.00
|
)
|
|||||||||||||
General
Electric
|
1
|
995,000
|
(4,000.00
|
)
|
-
|
-
|
995,000
|
(4,000.00
|
)
|
|||||||||||||
Total
Temporary Impairment Securities
|
16
|
$
|
20,421,000
|
($6,000
|
)
|
$
|
-
|
$
|
-
|
$
|
20,421,000
|
($6,000
|
)
|
10
December
31, 2006
|
||||||||||||||||||||||
Number
|
Less
than 12 months
|
12
months or longer
|
Total
|
|||||||||||||||||||
Name
of security
|
of
Securities
|
Fair
value
|
Unrealized
loss
|
Fair
value
|
Unrealized
loss
|
Fair
value
|
Unrealized
loss
|
|||||||||||||||
AIG
Discount Commercial
|
1
|
$
|
983,000
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
983,000
|
$
|
-
|
|||||||||
Natexis
Banques Popolare
|
1
|
979,000
|
-
|
-
|
-
|
979,000
|
-
|
|||||||||||||||
American
General Finance
|
1
|
974,000
|
-
|
-
|
-
|
974,000
|
-
|
|||||||||||||||
Daimler
Chrysler
|
1
|
974,000
|
-
|
-
|
-
|
974,000
|
-
|
|||||||||||||||
LaSalle
Bank
|
1
|
974,000
|
-
|
-
|
-
|
974,000
|
-
|
|||||||||||||||
General
Electric
|
1
|
1,242,000
|
-
|
-
|
-
|
1,242,000
|
-
|
|||||||||||||||
HSBC
Finance
|
1
|
1,000,000
|
-
|
-
|
-
|
1,000,000
|
-
|
|||||||||||||||
American
General Finance
|
1
|
987,000
|
-
|
-
|
-
|
987,000
|
-
|
|||||||||||||||
General
Electric
|
1
|
974,000
|
-
|
-
|
-
|
974,000
|
-
|
|||||||||||||||
General
Electric
|
1
|
1,200,000
|
(2,000
|
)
|
-
|
-
|
1,200,000
|
(2,000
|
)
|
|||||||||||||
FHLMC
|
1
|
960,000
|
-
|
-
|
-
|
960,000
|
-
|
|||||||||||||||
FHLMC
|
1
|
1,051,000
|
-
|
-
|
-
|
1,051,000
|
-
|
|||||||||||||||
FNMA
|
1
|
2,991,000
|
(9,000
|
)
|
-
|
-
|
2,991,000
|
(9,000
|
)
|
|||||||||||||
FHLMC
|
1
|
3,086,000
|
(13,000
|
)
|
-
|
-
|
3,086,000
|
(13,000
|
)
|
|||||||||||||
Total
Temporary Impairment Securities
|
14
|
$
|
18,375,000
|
$
|
(24,000
|
)
|
$
|
-
|
$
|
-
|
$
|
18,375,000
|
$
|
(24,000
|
)
|
In
management's opinion, the unrealized losses reflect changes in interest rates
subsequent to the acquisition of specific securities. The Company has the
ability to hold these securities until maturity or market price recovery.
Management believes that the unrealized losses represent temporary impairment
of
the securities.
Comprehensive
Income
The
Company reports comprehensive income, which includes net loss, as well as
certain other items, which result in a charge to equity during the period.
Three
months ended March 31
(in
thousands)
|
|||||||
2006
|
2007
|
||||||
Unrealized
gains during the period
|
$
|
131
|
$
|
243
|
|||
Realized
loss (gains) during the period
|
89
|
(24
|
)
|
||||
Other
comprehensive income
|
$
|
220
|
$
|
219
|
There
are
no income tax effects allocated to comprehensive income as the Company has
no
tax liabilities due to net operating losses.
11
Note
5: DEBENTURE FINANCING
Long
term debt consists of the following:
|
(in
thousands)
|
|||||||
December
31, 2006
|
March
31, 2007
|
||||||
October
2003
|
$
|
2,071
|
$
|
2,071
|
|||
January
2004
|
1,031
|
1,031
|
|||||
July
2004
|
1,000
|
1,000
|
|||||
Total
|
4,102
|
4,102
|
|||||
Less
Discounts
|
(231
|
)
|
(115
|
)
|
|||
Total
|
3,871
|
3,987
|
|||||
Less
current portion
|
3,871
|
3,987
|
|||||
Long
term debt
|
$
|
-
|
$
|
-
|
October
2003 Debentures
As
of
March 31, 2007, the investors had converted approximately $2,071,000 principal
amount of the October 2003 Debenture into 1,025,336 shares of Common Stock.
The
remaining balance of $2,071,000 is convertible into 1,025,336 shares of common
stock.
The
Company recorded financing costs for the three months ended March 31, 2006
and
2007, with regard to the October 2003 Debentures of $0 and $0, respectively.
Interest expense for the three months ended March 31, 2006 and 2007, with regard
to the October 2003 Debentures was approximately $36,000 and $36,000,
respectively.
January
2004 Debentures
As
of
March 31, 2007, the Company has made aggregate installment payments of
$1,889,000 and the investors have converted an aggregate of $1,080,000 of
principal amount of the January 2004 Debentures into 1,094,149 and 507,257
shares of common stock, respectively. The remaining principal on these
Debentures was approximately $1,031,000 as of March 31, 2007.
The
Company recorded financing costs for the three months ended March 31, 2006
and
2007, with regard to the January 2004 Debentures of $49,000 and $0,
respectively. Interest expense for the three months ended March 31, 2006 and
2007, with regard to the January 2004 Debentures was approximately $22,000
and
$18,000, respectively.
July
2004 Debentures
As
of
March 31, 2007, the Company has made aggregate installment payments of $500,000
and the investors have converted an aggregate of $500,000 of principal amount
of
the July 2004 Debenture into 331,669 and 240,385 shares of common stock,
respectively. The remaining principal amount on these debentures was $1,000,000
as of March 31, 2007.
The
Company recorded financing costs for the three months ended March 31, 2006
and
2007, with regard to the July 2004 Debentures of $137,000 and $116,000,
respectively. Interest expense for the three months ended March 31, 2006 and
2007, with regard to the July 2004 Debentures was approximately $26,000 and
$17,000, respectively.
12
Conversion
of Convertible Debt
The
maximum number of shares issuable upon debt conversion, including interest
as
well as 135% of the shares issuable upon conversion and interest payments were
2,951,354 and 2,809,974 shares at March 31, 2006 and 2007,
respectively.
Collateral
and Financial Covenants
Pursuant
to the terms and conditions of all of the outstanding Debentures, the Company
has pledged all of the Company’s assets, other than the Company’s intellectual
property, as collateral, and the Company is subject to comply with certain
financial covenants. As of March 31, 2007, the Company was fully compliant
with
its financial covenants. In connection with the debenture agreements, the
Company is required to have outstanding Letters of Credit of $1,000,000 as
additional collateral.
NOTE
6: EQUITY FINANCING
As
of
March 31, 2007, Fusion Capital has purchased from the Company 7,856,649 shares
for aggregate gross proceeds of approximately $15,389,129 pursuant to the April
2006 common stock purchase agreement between the Company and Fusion Capital.
In
addition, the Company issued to Fusion Capital 99,058 shares towards the
remaining commitment fee.
NOTE
7: RECENT
ACCOUNTING PRONOUNCEMENTS
The
Company adopted the provisions of FASB Interpretation No. 48, "Accounting for
Uncertainty in Income Taxes" ("FIN 48") effective January 1, 2007. The purpose
of FIN 48 is to clarify and set forth consistent rules for accounting for
uncertain tax positions in accordance with Statement of Financial Accounting
Standards No. 109, "Accounting for Income Taxes". The cumulative effect of
applying the provisions of this interpretation are required to be reported
separately as an adjustment to the opening balance of retained earnings in
the
year of adoption. The adoption of this standard did not have an impact on the
financial condition or the results of our operations.
On
February 15, 2007, the FASB issued FASB Statement No. 159, The Fair Value Option
for Financial Assets and Financial Liabilities - Including an Amendment of
FASB
Statement No. 115. This standard permits an entity to choose to measure many
financial instruments and certain other items at fair value. This option is
available to all entities, including not-for-profit organizations. Most of
the
provisions in Statement 159 are elective; however, the amendment to FASB
Statement No. 115, Accounting for Certain Investments in Debt and Equity
Securities, applies to all entities with available-for-sale and trading
securities. Some requirements apply differently to entities that do not report
net income. The FASB's stated objective in issuing this standard is as follows:
"to improve financial reporting by providing entities with the opportunity
to
mitigate volatility in reported earnings caused by measuring related assets
and
liabilities differently without having to apply complex hedge accounting
provisions".
The
fair
value option established by Statement 159 permits all entities to choose to
measure eligible items at fair value at specified election dates. A business
entity will report unrealized gains and losses on items for which the fair
value
option has been elected in earnings (or another performance indicator if the
business entity does not report earnings) at each subsequent reporting date.
A
not-for-profit organization will report unrealized gains and losses in its
statement of activities or similar statement. The fair value option: (a) may
be
applied instrument by instrument, with a few exceptions, such as investments
otherwise accounted for by the equity method; (b) is irrevocable (unless a
new
election date occurs); and (c) is applied only to entire instruments and not
to
portions of instruments.
13
Statement
159 is effective as of the beginning of an entity's first fiscal year that
begins after November 15, 2007. Early adoption is permitted as of the
beginning of the previous fiscal year provided that the entity makes that choice
in the first 120 days of that fiscal year and also elects to apply the
provisions of FASB Statement No. 157, Fair Value Measurements.
ITEM
2: Management's
Discussion and Analysis of Financial Condition and Results of
Operations.
Special
Note Regarding Forward-Looking Statements
Certain
statements in this document constitute "forwarding-looking statements" within
the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities and Exchange Act of 1995 (collectively, the
"Reform Act"). Certain, but not necessarily all, of such forward-looking
statements can be identified by the use of forward-looking terminology such
as
"believes," "expects," "may," "will," "should," or "anticipates" or the negative
thereof or other variations thereon or comparable terminology, or by discussions
of strategy that involve risks and uncertainties. All statements other than
statements of historical fact, included in this report regarding our financial
position, business strategy and plans or objectives for future operations are
forward-looking statements. Without limiting the broader description of
forward-looking statements above, we specifically note that statements regarding
potential drugs, their potential therapeutic effect, the possibility of
obtaining regulatory approval, our ability to manufacture and sell any products,
market acceptance or our ability to earn a profit from sales or licenses of
any
drugs or our ability to discover new drugs in the future are all forward-looking
in nature.
Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors, including but not limited to, the risk factors discussed below,
which may cause the actual results, performance or achievements of Hemispherx
and its subsidiaries to be materially different from any future results,
performance or achievements expressed or implied by such forward-looking
statements and other factors referenced in this report. We do not undertake
and
specifically decline any obligation to publicly release the results of any
revisions which may be made to any forward-looking statement to reflect events
or circumstances after the date of such statements or to reflect the occurrence
of anticipated or unanticipated events.
Overview
General
We
are a
biopharmaceutical company engaged in the clinical development, manufacture
and
marketing of new drug entities based on natural immune system enhancing
technologies for the treatment of viral and immune based acute and chronic
disorders. We were founded in the early 1970s, as a contract researcher for
the
National Institutes of Health. Since that time, we have established a strong
foundation of laboratory, pre-clinical, and clinical data with respect to the
development of nucleic acids to enhance the natural antiviral defense system
of
the human body and to aid the development of therapeutic products for the
treatment of acute and chronic diseases. We own a U.S. Food and Drug
Administration (“FDA”) approved GMP (good manufacturing practice) manufacturing
facility in New Jersey. Our flagship products include Ampligen® and Alferon N
Injection®.
14
Ampligen®
is an experimental drug currently undergoing clinical development for the
treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS” or
“CFS”) and HIV, and clinical testing for treatment/prevention of avian and
seasonal influenza. We have completed Phase III clinical trials using Ampligen®
to treat ME/CFS patients and are currently in the process of preparing and
filing a New Drug Application (“NDA”) with the FDA.
Alferon
N
Injection® is the registered trademark for our injectable formulation of natural
alpha interferon, which is approved by the FDA for the treatment of genital
warts. Alferon N Injection® is also in clinical development for treating
Multiple Sclerosis and West Nile Virus (“WNV”).
New
Accounting Pronouncements
We
adopted the provisions of FASB Interpretation No. 48, "Accounting for
Uncertainty in Income Taxes" ("FIN 48") effective January 1, 2007. The purpose
of FIN 48 is to clarify and set forth consistent rules for accounting for
uncertain tax positions in accordance with Statement of Financial Accounting
Standards No. 109, "Accounting for Income Taxes". The cumulative effect of
applying the provisions of this interpretation are required to be reported
separately as an adjustment to the opening balance of retained earnings in
the
year of adoption. The adoption of this standard did not have an impact on our
financial condition or the results of our operations.
On
February 15, 2007, the FASB issued FASB Statement No. 159, The Fair Value Option
for Financial Assets and Financial Liabilities - Including an Amendment of
FASB
Statement No. 115. This standard permits an entity to choose to measure many
financial instruments and certain other items at fair value. This option is
available to all entities, including not-for-profit organizations. Most of
the
provisions in Statement 159 are elective; however, the amendment to FASB
Statement No. 115, Accounting for Certain Investments in Debt and Equity
Securities, applies to all entities with available-for-sale and trading
securities. Some requirements apply differently to entities that do not report
net income. The FASB's stated objective in issuing this standard is as follows:
"to improve financial reporting by providing entities with the opportunity
to
mitigate volatility in reported earnings caused by measuring related assets
and
liabilities differently without having to apply complex hedge accounting
provisions".
The
fair
value option established by Statement 159 permits all entities to choose to
measure eligible items at fair value at specified election dates. A business
entity will report unrealized gains and losses on items for which the fair
value
option has been elected in earnings (or another performance indicator if the
business entity does not report earnings) at each subsequent reporting date.
A
not-for-profit organization will report unrealized gains and losses in its
statement of activities or similar statement. The fair value option: (a) may
be
applied instrument by instrument, with a few exceptions, such as investments
otherwise accounted for by the equity method; (b) is irrevocable (unless a
new
election date occurs); and (c) is applied only to entire instruments and not
to
portions of instruments.
15
Statement
159 is effective as of the beginning of an entity's first fiscal year that
begins after November 15, 2007. Early adoption is permitted as of the
beginning of the previous fiscal year provided that the entity makes that choice
in the first 120 days of that fiscal year and also elects to apply the
provisions of FASB Statement No. 157, Fair Value Measurements.
Disclosure
About Off-Balance
Sheet Arrangements
None.
Critical
Accounting Policies
There
have been no material changes in our critical accounting policies and estimates
from those disclosed in Item 7 of our Annual Report on Form 10-K for the year
ended December 31, 2006.
RESULTS
OF OPERATIONS
Three
months ended March 31, 2006 versus Three months ended March 31,
2007
Net
loss
Our
net
loss of approximately $5,100,000 for the three months ended March 31, 2007
was
14% lower when compared to the same period in 2006. This $820,000 reduction
in
loss was primarily due to:
1) |
Lower
General & Administrative expenses of $1,310,000 principally related to
a reduction in non-cash equity based
compensation,
|
2) |
An
increase of $94,000 in interest and other income due to the timing
of the
maturities of our short term investments in marketable
securities,
|
3) |
Lower
interest expense and non-cash financing costs of $80,000 relating
to the
amortization of debt discounts on our convertible debentures as they
get
closer to maturity,
|
4) |
An
increase in Research and Development of $746,000 associated with
our
Ampligen® NDA preparation and the production of Ampligen® raw materials
(polymers) at our New Brunswick
facility.
|
Net
loss
per share was $0.07 for the current period versus $0.10 for the same period
in
2006.
Revenues
Revenues
for the three months ended March 31, 2007 were $255,000 as compared to revenues
of $236,000 for the same period in 2006. Ampligen®
sold
under the cost recovery clinical program was down $18,000 or 34% and Alferon
N
Injection®
sales
were up $37,000 or 20%. The increase in Alferon N Injection® sales can be
attributed to a sales price increase during the current quarter. Ampligen® sold
under the cost recovery clinical program is a product of physicians and ME/CFS
patients applying to us to enroll in the program. This program has been in
effect for several years and is offered as a treatment option to patients
severely affected by CFS. As the name “cost recovery” implies, we have no gain
or profit on these sales. The benefits to us include 1) physicians and patients
becoming familiar with Ampligen® and 2) collection of clinical data relating to
the patients’ treatment and results. We are altering our marketing strategy for
Alferon N Injection®
by
relaunching the product via a collaborative marketing initiative between
Hemispherx and a national Specialty Pharmacy network encompassing specialty
pharmacists, pharmacies and targeted physician specialists. Such an effort
is intended to focus our efforts in the most appropriate and productive market
segment for the product. It is anticipated that such an initiative may
generate a positive impact on Alferon® revenues in an efficient, cost effective
manner.
16
Production
costs/cost of goods sold
Production/cost
of goods sold decreased approximately $63,000 or 21% for the three months ended
March 31, 2007 compared to the same period in 2006. This decrease was primarily
due to lower production costs relating to excess production capacity during
the
prior period as more production was directed toward Ampligen® research and
development. Cost of goods sold for the year ended March 31, 2006 and 2007
were
$96,000 and $93,000, respectively.
Hyaluron,
Inc. (“Hyaluron”) of Burlington, Massachusetts formulates, packages and labels
our Alferon N Injection® product. Hyaluron has recently completed three lots of
Alferon N Injection® to be used for stability testing. These tests are necessary
as Hyaluron is our new provider of this process. We continue to work with them
in preparing the facility for FDA approval as our contract manufacturer for
Alferon N Injection®.
We
outsource certain components of our overall research and development,
manufacturing, marketing and distribution while maintaining control over the
entire process through our quality assurance group and our clinical monitoring
group.
Research
and Development costs
Overall
research and development costs for the three months ended March 31, 2007 were
$3,176,000 as compared to $2,430,000 for the same period a year ago representing
an increase of $746,000 or 31%.
The
higher costs reflect an increase in the direct costs associated with our effort
to develop our lead product, Ampligen®, as a therapy in treating acute and
chronic diseases and on-going clinical trials involving patients with HIV and
pre-clinical and clinical testing for possible treatment for avian and seasonal
influenza viruses. Also, incremental costs were incurred for development of
alternative delivery routes for Alferon N more suitable for various biodefense
treatment indications.
Much
of
this increase in R&D cost is related to the production of raw materials at
our new production lines recently installed at our New Brunswick facility.
The
New Brunswick facility successfully produced three lots of Poly I and three
lots
of Poly C12U,
which
have been used by Hollister-Stier (our contract manufacturer) in the manufacture
of three process validation and scale up batches of Ampligen® doses.
Historically,
we have outsourced the manufacturing of Ampligen® to certain contractor
facilities in the United States and South Africa while maintaining full quality
control and supervision of the process. We
completed the set up of a Poly I and Poly C12U
material manufacturing operation in 2006 in our New Brunswick, NJ facility.
The
transfer of Ampligen® raw materials production to our own facilities has obvious
advantages with respect to overall control of the manufacturing process, keeping
costs down, controlling regulatory compliance issues and allows us to obtain
Ampligen® raw materials on a more consistent manufacturing basis. A sufficient
number of lots of Ampligen® was produced in 2006 to produce the three validation
batches of Ampligen® discussed above. We continue to produce Ampligen® raw
material for the purpose of manufacturing process validation. We
have
identified three contract manufacturers to expand polymer manufacture and
obtained preliminary proposals from two and initiated discussions with the
third. This would provide a backup to our New Jersey facility and additional
production capacity, if necessary. This transfer of polymer manufacturing to
our
own facilities, and/or to another contract manufacturer may delay certain steps
in commercialization process, specifically, our Ampligen NDA Registration
process now underway.
17
Hollister-Stier
has completed three (3) pilot manufacturing runs of Ampligen® for stability
testing and three (3) commercial size runs of Ampligen® for process validation
and clinical supply. The first three pilot runs were completed during the period
December 2005 through January 2006 utilizing polymer/raw material from Ribotech
(our previous supplier of raw material). The six month accelerated stability
data, along with twelve (12) months of real time data, on these three lots
support a two year expiration period with additional test results forthcoming.
The three lots were run in January, February and March 2007 utilizing Poly
I and
PolyC12U
raw
material from our NJ facility. We anticipate placing these three process
validation lots in stability studies to monitor and confirm the product quality
and stability.
We
continue our efforts with respect to completing the registration process for
an
NDA with the Food and Drug Administration (“FDA”) for using Ampligen® to treat
patients afflicted with Chronic Fatigue Syndrome (“CFS”).
We
started the NDA process on December 29, 2006 with the filing of one of the
three
major required sections. Subsequently, we have filed various other portions
of
the application with the FDA for comment and suggestions. As is customary,
the
FDA reviewers have asked for various clarifications in certain areas and
additional information in various other areas including preclinical sections,
chemistry/manufacturing sections and medical sections. Our staff and two
retained Clinical Research Organizations (CROs) have been actively working
to
respond to the various queries, including conducting additional clinical exams
and lab testing. While this process may delay the finalization and completion
of
the NDA, we feel that in the long run it may accelerate an effective review
process. The application is also being expanded in certain sections such that
it
may be simultaneously suitable for filing in certain other countries. Finally,
as a result of the lengthy regulatory history of Ampligen®,
certain
early non-CFS studies (such as those in HIV/AIDS, hepatitis and thermal injury)
are requiring extensive reprogramming of archival data for inclusion in the
application to meet current FDA requirements. In contrast, the CFS medical
reports are substantially complete and the company plans to submit the CFS
medical reports at the same time that the archived studies have been
reprogrammed.
The
NDA
is being filed electronically to facilitate the ease of review by the FDA.
We
cannot
yet provide guidance as to the tentative date at which the compilation and
filing of the NDA will be complete, as significant factors are outside our
control including, without limitation, the ability and willingness of the
independent clinical investigators to complete the requisite reports at an
acceptable regulatory standard and the ability to collect overseas generated
data.
The
timing of the FDA review process of the NDA is subject to the control of the
FDA
and could result in one of the following events; 1) approval to market Ampligen®
for use in treating ME/CFS patients, 2) require more research, development,
and
clinical work, 3) approval to market as well as conduct more testing, or 4)
reject our NDA application. Given these variables, we are unable to project
when
material net cash inflows are expected to commence from the sale of
Ampligen®.
18
We
are
actively engaged in broad-based ongoing experimental studies assessing the
efficacy of our products Ampligen®, Alferon N Injection® and Alferon® LDO
against influenza viruses as an adjuvant and/or single agent antiviral with
the
Defence R&D Canada, the National Institute of Infectious Diseases in Tokyo
and various research affiliates of the National Institutes of Health in the
United States.
On
April
12, 2007, we announced that Japan's Ministry of Health, Labor and Welfare (MHLW)
issued authorization to its National Institute of Infectious Diseases (NIID)
approving their budget to advance studies indicating that an H5N1 influenza
vaccine co-administered intranasally with Hemispherx's experimental therapeutic
double stranded RNA (dsRNA) Ampligen® (Poly I: Poly C12U)
protected against mutated strains of the virus and, further that, the seasonal
trivalent influenza vaccine co-administered intranasally with Ampligen®
maintained efficacy even when challenged with the H5N1 influenza virus.
The
studies are to be lead by Dr. Hideki Hasegawa of the National Institute of
Infectious Diseases with whom Hemispherx has been collaborating on the earlier
animal studies. Enlarged studies, scheduled over three years, will focus
initially on efficacy and stability as it pertains to the formulation of the
vaccine and Ampligen®. Subsequent studies will focus on GLP (Good Laboratory
Practices) including studies required for regulatory submission including
pharmacology, safety, toxicology, reproduction and carcinogenicity.
Dr.
Hasegawa initially presented the results of his studies at the Second
International Conference on Influenza Vaccines for the World in Vienna, Austria
in October 2006. In this presentation, he examined the protective efficacy
of
intranasal co-administration of inactivated whole-virion H5N1 vaccine with
Ampligen® in mice and non-human primates. Intranasal administration of a
candidate influenza vaccine with Ampligen® resulted in dramatically increased
secretion of IgA (also known as immunoglobulin A) which formed the basis of
mucosal immunity. The induced mucosal immunity thereafter protected subjects
when challenged with Vietnam, Hong Kong and Indonesian strains of the H5N1
viruses.
Dr.
Hasegawa's presentation concluded: 1) that the intranasal administration of
Ampligen® combined with H5N1 vaccine induced cross-protective mucosal immunity
against heterologous H5N1 influenza virus infection in mice; 2) intranasal
administration of Ampligen® combined with H5N1 vaccine provided protection in
the macaque monkey, a non-human primate which has a complex immune system
,similar to that of humans, from H5N1 infection; and 3) Ampligen® is the only
human-applicable dsRNA which has a well-documented safety profile in humans.
Dr.
Hasegawa conveyed his desire to commence the studies as soon as
possible.
Further
studies are planned with Defence R&D Canada, Suffield (“DRDC Suffield”), an
agency of the Canadian Department of National Defence. DRDC Suffield, is
evaluating the antiviral efficacy of our experimental therapeutic Ampligen® and
Alferon N Injection® for protection against human respiratory influenza virus
infection in well validated animal models. DRDC Suffield is conducting research
and development of new drugs that could potentially become part of the arsenal
of existing antiviral weapons to combat the bird flu. The initial study focused
on the testing of potential drugs against the respiratory influenza virus
infection on a mouse-adapted strain of human influenza. DRDC Suffield had
previously conducted extensive research in the use of liposome delivery
technology to enhance the antiviral activity of a closely-allied Ampligen®
analogue, Poly ICLC (an immunomodulating dsRNA) which is very similar to
Ampligen®. Results suggest that ribo nucleic acid-based drugs have the ability
to elicit protective broad-spectrum antiviral immunity against various
pathogenic viruses. Hence, there is the potential for efficacy to be maintained
against mutating strains of an influenza virus. Liposomes, a carrier system
for
nucleic acid-based drugs, have shown an ability to protect these drugs against
in vivo degradation, delivering them to intracellular sites of infection,
thereby reducing any toxicity and prolonging their therapeutic effectiveness.
Protection can be afforded for 21 days with two doses of dsRNA. Initial studies
reported by DRDC Suffield indicated that Ampligen® was effective in a mouse
model of avian H5N1 infection by decreasing death rates.
19
A
more
definitive protocol is being developed to further validate the results of a
clinical study conducted at the Princess Margaret Hospital in Hong Kong. This
study evaluated the use of Alferon® LDO (Low Dose Oral Interferon Alfa-N3, Human
Leukocyte Derived) to determine the affect on genes associated with anti-viral
and immunological functions in normal volunteers. This
study completed the dosing of ten patients. The initial results, conducted
in
collaboration with the Cleveland Clinic, did indicate that the Alferon® LDO
stimulated gene banks associated with an antiviral immune response in these
otherwise healthy volunteers.
A
clinical study to evaluate the use of Alferon® LDO in HIV infected volunteers is
being conducted in Philadelphia, PA. The study is being conducted at two sites,
Drexel University and Philadelphia FIGHT, a comprehensive AIDS service
organization providing primary care, consumer education, advocacy and research
on potential treatments and vaccines. The study is designed to determine whether
Alferon® LDO can resuscitate the broad-spectrum antiviral and immunostimulatory
genes. As of April 2007, twenty-two (22) patients have enrolled and completed
dosing. We are currently receiving data from this study and we are in the
process of analyzing the results along with the results from the Alferon® LDO
study conducted in Hong Kong. This methodology may have implications for
treating other emerging viruses such as avian influenza (bird flu). The
Philadelphia results collaborated the findings of the Hong Kong study. Present
production methods for vaccines involve the use of millions of chicken eggs
and
would be slow to respond to an outbreak according to various World Health
Organization expert panels. Health officials are also concerned that bird flu
could mutate to cause the next
pandemic and render present vaccines under development ineffective. We have
initiated a collaboration with a research organization in the Netherlands
(ViroClinics) to study the activity of Alferon® LDO against avian influenza in a
primate model. The initial findings from this primate study indicate that
Alferon® LDO mitigated the development of the atypical pneumonia caused by H5N1
influenza in a dose related manner. This study is ongoing.
Two
toxicology studies were completed at the Lovelace clinic in Albuquerque, New
Mexico to support new methods of Ampligen® administration. These studies
involved the use of Ampligen as a vaccine immunostimulant and indicated that
Ampligen® can be safely administered intranasally and intramucosally as well as
intravenously. Based
on
the results of the two toxicology studies we have initiated a clinical trial
to
be conducted in Australia. The clinical trial in Australia is to study the
immunostimulant effect of Ampligen® in influenza in the elderly by vaccination.
We expect to start enrolling patients in the 2nd
Quarter
2007.
20
General
and Administrative Expenses
General
and Administrative (“G&A”) expenses for the three months ended March 31,
2006 and 2007 were approximately $3,093,000 and $1,783,000, respectively,
reflecting a decrease of $1,310,000 or 42%. This
decrease related primarily to a reduction in non-cash equity based compensation
of $1,808,000 compared to the same period in 2006. Fewer stock options were
granted to employees in the current period. This decrease in non-cash equity
based compensation was partially offset by increases in other expenses including
legal and professional fees, mainly due to the Bioclones litigation, Director
fees, resulting from an increase in their fee base, accounting fees, primarily
due to an increase in year end close out activities in the current period,
and
lastly temporary help.
Interest
and Other Income and Expense
Interest
and other income for the three months ended March 31, 2006 and 2007 increased
approximately $94,000 as compared to the same period a year earlier. The
increase in interest and other income during the current period can primarily
be
attributed to the timing of the maturities of our marketable securities during
the same period a year earlier. All funds in excess of our immediate need are
invested in short-term securities.
Interest
Expense and Financing Costs
Interest
expense and non-cash financing costs were approximately $209,000 for the three
months ended March 31, 2007 versus $289,000 for the same period a year
ago.
The main
reason for the decrease in interest expense and financing costs of $80,000
can
be attributed to decreased amortization charges on debt discounts during the
current period versus the same period a year earlier as our convertible
debentures have come closer to maturity (Please see Note 5 in the consolidated
financial statements contained herein for more details on these
transactions).
Liquidity
and Capital Resources
Cash
used
in operating activities for the three months ended March 31, 2007 was
$4,840,000. Cash used in investing activities for the three months ending March
31, 2007, amounted to $1,897,000, primarily from the maturity and purchase
of
short-term investments during the current quarter. Cash provided by financing
activities for the three months ended March 31, 2007 amounted to $7,270,000,
primarily from the sale of common stock. As of April 30, 2007 we had
approximately $24,900,000 in cash and cash equivalents and short-term
investments, or an increase of approximately 13% from December 31, 2006. These
funds should be sufficient to meet our operating cash requirements for the
next
18 months. Our notes payable balances, which come due in June 2007, may be
converted or extended which will require no cash outlay. If not extended or
converted, the payment to debenture holders would be approximately $2,700,000
leaving cash sufficient for operations for the next 15 months.
Debentures
As
of
April 30, 2007, the Company made aggregate installment payments of $2,389,000
and the investors converted an aggregate $3,651,000 principal amount of debt
from the debentures as noted below (in thousands):
Debenture
|
Original
Principal Amount
|
Debt
Conversion to Common Shares
|
Installment
payments in Common Shares
|
Remaining
Principal Amount
|
Common
Shares issued for Conversion
|
Common
Shares issued in installments
|
|||||||||||||
October
2003
|
$
|
4,142
|
$
|
2,071
|
$
|
-
|
$
|
2,071
|
1,025,336
|
-
|
|||||||||
January
2004
|
4,000
|
1,080
|
1,889
|
1,031
|
507,257
|
1,094,149
|
|||||||||||||
July
2004
|
2,000
|
500
|
500
|
1,000
|
240,385
|
331,669
|
|||||||||||||
Totals
|
$
|
10,142
|
$
|
3,651
|
$
|
2,389
|
$
|
4,102
|
1,772,978
|
1,425,818
|
21
Pursuant
to the terms and conditions of all of the outstanding Debentures, we have
pledged all of our assets, other than our intellectual property, as collateral,
and we are subject to comply with certain financial covenants.
In
connection with the debenture agreements, we are required to have outstanding
Letters of Credit of $1,000,000 as additional collateral.
See
Note
5 of the consolidated financial statements for a full description of all
Debentures.
Equity
Financing
On
April
12, 2006, we entered into a common stock purchase agreement (the “2006 Purchase
Agreement”) with Fusion Capital Fund II, LLC (“Fusion Capital”), pursuant to
which Fusion Capital has agreed, under certain conditions, to purchase on each
trading day $100,000 of our common stock up to an aggregate of $50.0 million
over a period of approximately 25 months. Pursuant to the terms of the
Registration Rights Agreement, dated as of April 12, 2006, we registered
12,386,723 shares issuable to or issued to Fusion Capital under the Purchase
Agreement. Through May 7, 2007, the Company has sold to Fusion Capital an
aggregate of 9,375,390 shares under the common stock purchase agreement for
aggregate gross proceeds of $17,789,128 and issued 436,264 Commitment Shares.
Under
the
rules of the American Stock Exchange, in the event that we elect to sell more
than 12,386,723 shares to Fusion Capital, we were required to seek stockholder
approval. This approval was obtained on September 20, 2006. We also will be
required to file a new registration statement and have it declared effective
by
the SEC in the event we elect to sell to Fusion Capital more than the 12,386,723
shares previously registered.
We
are
using the proceeds from this financing for general corporate purposes.
Because
of our long-term capital requirements, we may seek to access the public equity
market whenever conditions are favorable, even if we do not have an immediate
need for additional capital at that time. Any additional funding may result
in
significant dilution and could involve the issuance of securities with rights,
which are senior to those of existing stockholders. We may also need additional
funding earlier than anticipated, and our cash requirements, in general, may
vary materially from those now planned, for reasons including, but not limited
to, changes in our research and development programs, clinical trials,
competitive and technological advances, the regulatory processes, including
the
commercializing of Ampligen products.
22
There
can
be no assurances that we will raise adequate funds from these or other sources,
which may have a material adverse effect on our ability to develop our products.
Also,
we
have the ability to curtail discretionary spending, including some research
and
development activities, if required to conserve cash.
ITEM
3: Quantitative and Qualitative Disclosures About Market
Risk
We
had
approximately $24,600,000 in cash and cash equivalents and short-term
investments at March 31, 2007. To the extent that our cash and cash equivalents
and short term investments exceed our near term funding needs, we generally
invest the excess cash in three to twelve month interest bearing financial
instruments. We employ established conservative policies and procedures to
manage any risks with respect to investment exposure.
Our
financial instruments that are exposed to concentrations of credit risk consist
primarily of cash and cash equivalents. We place our cash and cash equivalents
with what management believes to be high credit quality institutions. At times
such investments may be in excess of the FDIC insurance limit.
We
have
not entered into, and do not expect to enter into, financial instruments for
trading or hedging purposes.
Item
4: Controls and Procedures
Our
Chairman of the Board (serving as the principal executive officer) and the
Chief
Financial Officer performed an evaluation of our disclosure controls and
procedures, which have been designed to permit us to effectively identify and
timely disclose important information. They concluded that the controls and
procedures were effective as of March 31, 2007 to ensure that material
information was accumulated and communicated to our management, including our
Chief Executive Officer and Chief Financial Officer, as appropriate to allow
timely decisions regarding required disclosure. During the quarter ended March
31, 2007, we have made no change in our internal controls over financial
reporting that has materially affected, or is reasonably likely to materially
affect, our internal controls over financial reporting.
Part
II - OTHER INFORMATION
Item
1. Legal Proceedings
On
September 30, 1998, we filed a multi-count complaint against Manuel P. Asensio,
Asensio & Company, Inc. (“Asensio”). The action included claims of
defamation, disparagement, tortuous interference with existing and prospective
business relations and conspiracy, arising out of Asensio’s false and defamatory
statements. The complaint further alleged that Asensio defamed and disparaged
us
in furtherance of a manipulative, deceptive and unlawful short-selling scheme
in
August and September, 1998. In 1999, Asensio filed an answer and counterclaim
alleging that in response to Asensio’s strong sell recommendation and other
press releases, we made defamatory statements about Asensio. We denied the
material allegations of the counterclaim. In July 2000, following dismissal
in
federal court for lack of subject matter jurisdiction, we transferred the action
to the Pennsylvania State Court. In March 2001, the defendants responded to
the
complaints as amended and a trial commenced on January 30, 2002. A jury verdict
disallowed the claims against the defendants for defamation and disparagement
and the court granted us a directed verdict on the counterclaim. On July 2,
2002
the Court entered an order granting us a new trial against Asensio for
defamation and disparagement. Thereafter, Asensio appealed the granting of
a new
trial to the Superior Court of Pennsylvania. The Superior Court of Pennsylvania
has denied Asensio’s appeal. Asensio petitioned the Supreme Court of
Pennsylvania for allowance of an appeal, which was denied. We now anticipate
the
scheduling of a new trial against Asensio for defamation and disparagement
in
the Philadelphia Common Pleas Court.
23
In
June
2002, a former ME/CFS clinical trial patient in Belgium filed a claim in
Belgium, against Hemispherx Biopharma Europe, NV/SA, our Belgian subsidiary,
and
one of its clinical trial investigators alleging that she was harmed in the
Belgium ME/CFS clinical trial as a result of negligence and breach of
warranties. We believe the claim is without merit and we are defending the
claim
against us through our product liability insurance carrier.
In
December 2004, we filed a multicount complaint in federal court (Southern
District of Florida) against a conspiratorial group seeking to illegally
manipulate our stock for purposes of bringing about a hostile takeover of
Hemispherx. The lawsuit alleges that the conspiratorial group commenced with
a
plan to seize control of our cash and proprietary assets by an illegal campaign
to drive down our stock price and publish disparaging reports on our management
and current fiduciaries. The lawsuit seeks monetary damages from each member
of
the conspiratorial group as well as injunctions preventing further recurrences
of their misconduct. The conspiratorial group includes Bioclones, a privately
held South African Biopharmaceutical company that collaborated with us, and
Johannesburg Consolidated Investments, a South African corporation, Cyril
Donninger, R. B. Kebble, H. C. Buitendag, Bart Goemaere, and John Doe(s).
Bioclones, Johannesburg Consolidated Investments, Cyril Donninger, R. B. Kebble
and H.C. Buitendag filed a motion to dismiss the complaint, which was granted
by
the court. The Company is in the process of appealing this decision to the
11th
federal
circuit court of appeals.
On
January 10, 2005, we initiated a multicount lawsuit in the United States
District Court for the Eastern District of Pennsylvania seeking injunctive
relief and damages against a conspiratorial group, many of whom are foreign
nationals or companies located outside the United States alleging that the
conspiratorial group has engaged in secret meetings, market manipulations,
fraudulent misrepresentations, utilization of foreign accounts and foreign
secrecy laws all in furtherance of an illegal scheme to take over Hemispherx
and
enrich themselves at the expense of our public stockholders. On February 18,
2005, we filed an amended complaint in the same lawsuit joining Redlabs, USA,
Inc. as a defendant with the existing defendants R.E.D. Laboratories, N.V./S.A.,
Bart Goemaere, Jan Goemaere, Dr. Kenny De Meirleir, Kenneth Schepmans, Johan
Goossens, Lieven Vansacker and John Does. Pursuant to an agreement in which
R.E.D. Laboratories, N.V./S.A. and Dr. Kenny De Meirleir agreed not to
participate in a hostile takeover of Hemispherx for a period of five years,
R.E.D. Laboratories, N.V./S.A. and Dr. Kenny De Meirleir have been dismissed
as
defendants in the litigation. The Company dismissed without prejudice the
litigation against the remaining defendants.
In
October 2006, litigation was initiated against us in the Court of Common Pleas,
Philadelphia County, Pennsylvania between us and Hospira Worldwide, Inc. with
regard to a dispute with respect to fees for services charged by Hospira
Worldwide, Inc. to us. The dispute was promptly settled and the litigation
dismissed.
In
January 2007, arbitration proceedings were initiated by Bioclones (Proprietary),
Ltd., (“Bioclones”) and are pending in South Africa to determine damages arising
out of the termination of a marketing agreement we had with Bioclones. We had
deemed the marketing agreement void due to numerous and long standing failures
of performance by Bioclones and will present claims for damages against
Bioclones in the arbitration. Bioclones has now confirmed that the marketing
agreement has been terminated.
24
In
January 2007, we filed an application in South Africa for the dissolution of
Ribotech (PTY) Ltd. (“Ribotech”) on the grounds that the purpose for the
existence of Ribotech, the marketing agreement between us and Bioclones, had
been terminated. The application for termination is now pending.
In
March
2007, Cedric Philipp (“Philipp”) initiated an arbitration proceeding in
Philadelphia, Pennsylvania with the American Arbitration Association alleging
that, under a 1994 agreement between us and Philipp (“1994 Agreement”), we owed
him commissions on product, or services he alleges we have purchased from
Hollister-Stier. We are defending this claim on, among other claims, the ground
that the 1994 Agreement has been terminated. In April 2007, we filed a
declaratory judgment action in the Court of Common Please of Philadelphia asking
the court to declare that the 1994 agreement between us and Cedric Philipp
has
been terminated. This declaratory judgment action is now pending.
ITEM
1A. Risk Factors.
The
following cautionary statements identify important factors that could cause
our
actual result to differ materially from those projected in the forward-looking
statements made in this Form 10-Q. Among the key factors that have a direct
bearing on our results of operations are:
Risks
Associated With Our Business
No
assurance of successful product development
Ampligen®
and
related products. The development of Ampligen®
and
our
other related products is subject to a number of significant risks.
Ampligen®
may
be
found to be ineffective or to have adverse side effects, fail to receive
necessary regulatory clearances, be difficult to manufacture on a commercial
scale, be uneconomical to market or be precluded from commercialization by
proprietary right of third parties. Our products are in various stages of
clinical and pre-clinical development and, require further clinical studies
and
appropriate regulatory approval processes before any such products can be
marketed. We do not know when, if ever, Ampligen®
or
our
other products will be generally available for commercial sale for any
indication. Generally, only a small percentage of potential therapeutic products
are eventually approved by the FDA for commercial sale.
We
are in
the registration process for an NDA with the FDA for approval to use Ampligen
in
the treatment of Chronic Fatigue Syndrome. We can provide no guidance as to
the
tentative date at which the compilation and filing of the NDA will be complete,
as significant factors are outside our control including, without limitation,
the ability and willingness of the independent clinical investigators to
complete the requisite reports at an acceptable regulatory standard, the ability
to collect overseas generated data, and the time required for our New Brunswick
staff/facilities to interface with Hollister-Stier to assure compliance with
manufacturing regulatory standards. Also, the timing of the FDA review process
of the NDA is subject to the control of the FDA and could result in one of
the
following events; 1) approval to market Ampligen® for use in treating ME/CFS
patients 2) require more research, development, and clinical work, 3) approval
to market as well as conduct more testing, or 4) reject our NDA application.
Given these variables, we are unable to project when material net cash inflows
are expected to commence from the sale of Ampligen®.
25
Alferon
N
Injection®. Although Alferon N Injection® is approved for marketing in the
United States for the intra-lesional treatment of refractory or recurring
external genital warts in patients 18 years of age or older; to date it has
not
been approved for other indications. We face many of the risks discussed above,
with regard to developing this product for use to treat other ailments such
as
multiple sclerosis and cancer.
Our
drug and related technologies are investigational and subject to regulatory
approval. If we are unable to obtain regulatory approval, our operations will
be
significantly affected.
All
of
our drugs and associated technologies, other than Alferon N Injection®, are
investigational and must receive prior regulatory approval by appropriate
regulatory authorities for general use and are currently legally available
only
through clinical trials with specified disorders. At present, Alferon N
Injection® is only approved for the intra-lesional treatment of refractory or
recurring external genital warts in patients 18 years of age or older. Use
of
Alferon N Injection® for other indications will require regulatory approval. In
this regard, ISI, the company from which we obtained our rights to Alferon
N
Injection®, conducted clinical trials related to use of Alferon N Injection® for
treatment of HIV and Hepatitis C. In both instances, the FDA determined that
additional studies were necessary in order to fully evaluate the efficacy of
Alferon N Injection® in the treatment of HIV and Hepatitis C diseases. We have
no immediate plans to conduct these additional studies at this time.
Our
products, including Ampligen®, are subject to extensive regulation by numerous
governmental authorities in the U.S. and other countries, including, but not
limited to, the FDA in the U.S., the Health Protection Branch (“HPB”) of Canada,
and the Agency for the Evaluation of Medicinal Products (“EMEA”) in Europe.
Obtaining regulatory approvals is a rigorous and lengthy process and requires
the expenditure of substantial resources. In order to obtain final regulatory
approval of a new drug, we must demonstrate to the satisfaction of the
regulatory agency that the product is safe and effective for its intended uses
and that we are capable of manufacturing the product to the applicable
regulatory standards. We require regulatory approval in order to market
Ampligen® or any other proposed product and receive product revenues or
royalties. We cannot assure you that Ampligen® will ultimately be demonstrated
to be safe or efficacious. In addition, while Ampligen® is authorized for use in
clinical trials in the United States, we cannot assure you that additional
clinical trial approvals will be authorized in the United States or in other
countries, in a timely fashion or at all, or that we will complete these
clinical trials. If Ampligen® or one of our other products does not receive
regulatory approval in the U.S. or elsewhere, our operations most likely will
be
materially adversely affected.
Although
preliminary in vitro testing indicates that Ampligen® enhances the effectiveness
of different drug combinations on avian influenza, preliminary testing in the
laboratory is not necessarily predictive of successful results in clinical
testing or human treatment.
Ampligen®
is undergoing pre-clinical testing for possible treatment of avian flu. Although
preliminary in vitro testing indicates that Ampligen® enhances the effectiveness
of different drug combinations on avian flu, preliminary testing in the
laboratory is not necessarily predictive of successful results in clinical
testing or human treatment. No assurance can be given that similar results
will
be observed in clinical trials. Use of Ampligen® in the treatment of avian flu
requires prior regulatory approval. Only the FDA can determine whether a drug
is
safe, effective or promising for treating a specific application. As discussed
in the prior risk factor, obtaining regulatory approvals is a rigorous and
lengthy process.
26
In
addition, Ampligen® is being tested on two strains of avian flu. There are a
number of strains and strains mutate. No assurance can be given that a Ampligen®
will be effective on any strains that might infect humans.
We
may continue to incur substantial losses and our future profitability is
uncertain.
We
began
operations in 1966 and last reported net profit from 1985 through 1987. Since
1987, we have incurred substantial operating losses, as we pursued our clinical
trial effort to get our experimental drug, Ampligen, approved. As of March
31,
2007, our accumulated deficit was approximately $172,151,000. We have not yet
generated significant revenues from our products and may incur substantial
and
increased losses in the future. We cannot assure that we will ever achieve
significant revenues from product sales or become profitable. We require, and
will continue to require, the commitment of substantial resources to develop
our
products. We cannot assure that our product development efforts will be
successfully completed or that required regulatory approvals will be obtained
or
that any products will be manufactured and marketed successfully, or be
profitable.
We
may require additional financing which may not be
available.
The
development of our products will require the commitment of substantial resources
to conduct the time-consuming research, preclinical development, and clinical
trials that are necessary to bring pharmaceutical products to market. As of
April 30, 2007, we had approximately $24,900,000 in cash and cash equivalents
and short-term investments. These
funds should be sufficient to meet our operating cash requirements for the
next
18 months. Our notes payable balances, which come due in June 2007, may be
converted or extended which will require no cash outlay. If not extended or
converted, the payment to debenture holders would be approximately $2,700,000
leaving cash sufficient for operations for the next 15 months.
On
April
12, 2006, we entered into a common stock purchase agreement with Fusion Capital
pursuant to which Fusion Capital has agreed, under certain conditions and with
certain limitations, to purchase on each trading day $100,000 of our common
stock up to an aggregate of $50,000,000 over a 25 month period (see Part I,
Item
2.
“Management's Discussion and Analysis of Financial Condition and Results of
Operations; Liquidity And Capital Resources”).
We
only
have the right to receive $100,000 per trading day under the agreement with
Fusion Capital unless our stock price exceeds $1.90 by at least $0.10, in which
case the daily amount may be increased under certain conditions as the price
of
our common stock increases. Fusion Capital shall not have the right nor the
obligation to purchase any shares of our common stock on any trading days that
the market price of our common stock is less than $1.00. We have registered
an
aggregate of 13,201,840 shares purchasable by Fusion Capital pursuant to the
common stock purchase agreement (inclusive of up to 643,502 additional
Commitment Shares) and, through May 7, 2007, we have sold to Fusion Capital
an
aggregate of 9,375,390 shares under the common stock purchase agreement for
aggregate gross proceeds of $17,789,128. Assuming a purchase price of $1.61
per
share (the closing sale price of the common stock on May 7, 2007) and the
purchase by Fusion Capital of the remaining 2,367,831 shares (after issuing
the
remaining 207,238 Commitment Shares), total gross proceeds to us from the
remaining shares would only be $3,812,208 ($21,601,336 in the aggregate under
the common stock purchase agreement). Accordingly, depending upon the future
market price of our common stock, we may realize less than the maximum
$50,000,000 proceeds from the sale of stock under the Purchase
Agreement.
27
In
the
event we elect to issue additional shares to Fusion Capital, we will be required
to file a new registration statement and have it declared effective by the
Securities and Exchange Commission. In addition, Fusion Capital cannot purchase
more than 27,386,723 shares, inclusive of Commitment Shares under the common
stock purchase agreement. Accordingly, depending upon the future market price
of
our common stock, we may realize less than the maximum $50,000,000 proceeds
from
the sale of stock under the Purchase Agreement.
The
extent to which we rely on Fusion Capital as a source of funding will depend
on
a number of factors including, the prevailing market price of our common stock
and the extent to which we are able to secure working capital from other
sources.
If
obtaining sufficient financing from Fusion Capital were to prove unavailable
or
prohibitively dilutive and if we are unable to commercialize and sell Ampligen®
and/or increase sales of Alferon N Injection® or our other products, we will
need to secure another source of funding in order to satisfy our working capital
needs. Even if we are able to access the full $50,000,000 under the common
stock
purchase agreement with Fusion Capital, we may need to raise additional funds
through additional equity or debt financing or from other sources in order
to
complete the necessary clinical trials and the regulatory approval processes
including the commercializing of Ampligen® products. There can be no assurances
that we will raise adequate funds which may have a material adverse effect
on
our ability to develop our products. Also, we have the ability to curtail
discretionary spending, including some research and development activities,
if
required to conserve cash.
We
may not be profitable unless we can protect our patents and/or receive approval
for additional pending patents.
We
need
to preserve and acquire enforceable patents covering the use of Ampligen® for a
particular disease in order to obtain exclusive rights for the commercial sale
of Ampligen® for such disease. We obtained all rights to Alferon N Injection®,
and we plan to preserve and acquire enforceable patents covering its use for
existing and potentially new diseases. Our success depends, in large part,
on
our ability to preserve and obtain patent protection for our products and to
obtain and preserve our trade secrets and expertise. Certain of our know-how
and
technology is not patentable, particularly the procedures for the manufacture
of
our drug product which are carried out according to standard operating procedure
manuals. We have been issued certain patents including those on the use of
Ampligen® and Ampligen® in combination with certain other drugs for the
treatment of HIV. We also have been issued patents on the use of Ampligen® in
combination with certain other drugs for the treatment of chronic Hepatitis
B
virus, chronic Hepatitis C virus, and a patent which affords protection on
the
use of Ampligen® in patients with Chronic Fatigue Syndrome. We have not yet been
issued any patents in the United States for the use of AmpligenÒ
as a
sole treatment for any of the cancers, which we have sought to target. With
regard to Alferon N Injection®, we have acquired from ISI its patents for
natural alpha interferon produced from human peripheral blood leukocytes and
its
production process and we have filed a patent application for the use of
Alferon® LDO in treating viral diseases including avian influenza. We cannot
assure that our competitors will not seek and obtain patents regarding the
use
of similar products in combination with various other agents, for a particular
target indication prior to our doing such. If we cannot protect our patents
covering the use of our products for a particular disease, or obtain additional
patents, we may not be able to successfully market our products.
28
The
patent position of biotechnology and pharmaceutical firms is highly uncertain
and involves complex legal and factual questions.
To
date,
no consistent policy has emerged regarding the breadth of protection afforded
by
pharmaceutical and biotechnology patents. There can be no assurance that new
patent applications relating to our products or technology will result in
patents being issued or that, if issued, such patents will afford meaningful
protection against competitors with similar technology. It is generally
anticipated that there may be significant litigation in the industry regarding
patent and intellectual property rights. Such litigation could require
substantial resources from us and we may not have the financial resources
necessary to enforce the patent rights that we hold. No assurance can be made
that our patents will provide competitive advantages for our products or will
not be successfully challenged by competitors. No assurance can be given that
patents do not exist or could not be filed which would have a materially adverse
effect on our ability to develop or market our products or to obtain or maintain
any competitive position that we may achieve with respect to our products.
Our
patents also may not prevent others from developing competitive products using
related technology.
There
can be no assurance that we will be able to obtain necessary licenses if we
cannot enforce patent rights we may hold. In addition, the failure of third
parties from whom we currently license certain proprietary information or from
whom we may be required to obtain such licenses in the future, to adequately
enforce their rights to such proprietary information, could adversely affect
the
value of such licenses to us.
If
we
cannot enforce the patent rights we currently hold we may be required to obtain
licenses from others to develop, manufacture or market our products. There
can
be no assurance that we would be able to obtain any such licenses on
commercially reasonable terms, if at all. We currently license certain
proprietary information from third parties, some of which may have been
developed with government grants under circumstances where the government
maintained certain rights with respect to the proprietary information developed.
No assurances can be given that such third parties will adequately enforce
any
rights they may have or that the rights, if any, retained by the government
will
not adversely affect the value of our license.
There
is
no guarantee that our trade secrets will not be disclosed or known by our
competitors.
To
protect our rights, we require certain employees and consultants to enter into
confidentiality agreements with us. There can be no assurance that these
agreements will not be breached, that we would have adequate and enforceable
remedies for any breach, or that any trade secrets of ours will not otherwise
become known or be independently developed by competitors.
29
If
our distributors do not market our products successfully, we may not generate
significant revenues or become profitable.
We
have
limited marketing and sales capability. We are dependent upon existing and,
possibly future, marketing agreements and third party distribution agreements
for our products in order to generate significant revenues and become
profitable. As a result, any revenues received by us will be dependent on the
efforts of third parties, and there is no assurance that these efforts will
be
successful. Our agreement with Accredo offers the potential to provide some
marketing and distribution capacity in the United States while agreements with
Biovail Corporation and Laboratorios Del Dr. Esteve S.A. may provide a sales
force in Canada, Spain and Portugal.
We
cannot
assure that our U.S. or foreign marketing partners will be able to successfully
distribute our products, or that we will be able to establish future marketing
or third party distribution agreements on terms acceptable to us, or that the
cost of establishing these arrangements will not exceed any product revenues.
The failure to continue these arrangements or to achieve other such arrangements
on satisfactory terms could have a materially adverse effect on us.
There
are
no long-term agreements with suppliers of required materials. If we are unable
to obtain the required raw materials, we may be required to scale back our
operations or stop manufacturing Alferon N Injection® and/or
Ampligen®.
A
number
of essential materials are used in the production of Alferon N Injection®,
including human white blood cells. We do not have long-term agreements for
the
supply of any of such materials. There can be no assurance we can enter into
long-term supply agreements covering essential materials on commercially
reasonable terms, if at all.
There
are
a limited number of manufacturers in the United States available to provide
the
polymers for use in manufacturing Ampligen®. At present, we do not have any
agreements with third parties for the supply of any of these polymers. We have
established relevant manufacturing operations within our New Brunswick, New
Jersey facility for the production of Ampligen® raw materials in order to obtain
polymers on a more consistent manufacturing basis. The establishment of an
Ampligen® raw materials production line within our own facilities, while having
obvious advantages with respect to regulatory compliance (other parts of our
43,000 sq. ft. wholly owned FDA approved facility are already in compliance
for
the manufacture of Alferon N Injection®), may delay certain steps in the
commercialization process, specifically, our Ampligen®
NDA
Registration process with the FDA.
If
we are
unable to obtain or manufacture the required raw materials, we may be required
to scale back our operations or stop manufacturing. The costs and availability
of products and materials we need for the production of Ampligen® and the
commercial production of Alferon N Injection® and other products which we may
commercially produce are subject to fluctuation depending on a variety of
factors beyond our control, including competitive factors, changes in
technology, and FDA and other governmental regulations and there can be no
assurance that we will be able to obtain such products and materials on terms
acceptable to us or at all.
30
There
is no assurance that successful manufacture of a drug on a limited scale basis
for investigational use will lead to a successful transition to commercial,
large-scale production.
Small
changes in methods of manufacturing, including commercial scale-up, may affect
the chemical structure of Ampligen® and other RNA drugs, as well as their safety
and efficacy, and can, among other things, require new clinical studies and
affect orphan drug status, particularly, market exclusivity rights, if any,
under the Orphan Drug Act. The transition from limited production of
pre-clinical and clinical research quantities to production of commercial
quantities of our products will involve distinct management and technical
challenges and will require additional management and technical personnel and
capital to the extent such manufacturing is not handled by third parties. There
can be no assurance that our manufacturing will be successful or that any given
product will be determined to be safe and effective, capable of being
manufactured economically in commercial quantities or successfully
marketed.
We
have limited manufacturing experience and capacity.
Ampligen®
has been only produced in limited quantities for use in our clinical trials
and
we are dependent upon third party suppliers for substantially all of the
production process. The failure to continue these arrangements or to achieve
other such arrangements on satisfactory terms could have a material adverse
affect on us. Also, to be successful, our products must be manufactured in
commercial quantities in compliance with regulatory requirements and at
acceptable costs. To the extent we are involved in the production process,
our
current facilities are not adequate for the production of our proposed products
for large-scale commercialization, and we currently do not have adequate
personnel to conduct commercial-scale manufacturing. We intend to utilize
third-party facilities if and when the need arises or, if we are unable to
do
so, to build or acquire commercial-scale manufacturing facilities. We will
need
to comply with regulatory requirements for such facilities, including those
of
the FDA pertaining to current Good Manufacturing Practices (“cGMP”) regulations.
There can be no assurance that such facilities can be used, built, or acquired
on commercially acceptable terms, or that such facilities, if used, built,
or
acquired, will be adequate for our long-term needs.
We
may not be profitable unless we can produce Ampligen® or other products in
commercial quantities at costs acceptable to us.
We
have
never produced Ampligen® or any other products in large commercial quantities.
We must manufacture our products in compliance with regulatory requirements
in
large commercial quantities and at acceptable costs in order for us to be
profitable. We intend to utilize third-party manufacturers and/or facilities
if
and when the need arises or, if we are unable to do so, to build or acquire
commercial-scale manufacturing facilities. If we cannot manufacture commercial
quantities of Ampligen® or enter into third party agreements for its manufacture
at costs acceptable to us, our operations will be significantly affected. Also,
each production lot of Alferon N Injection® is subject to FDA review and
approval prior to releasing the lots to be sold. This review and approval
process could take considerable time, which would delay our having product
in
inventory to sell.
31
Rapid
technological change may render our products obsolete or
non-competitive.
The
pharmaceutical and biotechnology industries are subject to rapid and substantial
technological change. Technological competition from pharmaceutical and
biotechnology companies, universities, governmental entities and others
diversifying into the field is intense and is expected to increase. Most of
these entities have significantly greater research and development capabilities
than us, as well as substantial marketing, financial and managerial resources,
and represent significant competition for us. There can be no assurance that
developments by others will not render our products or technologies obsolete
or
noncompetitive or that we will be able to keep pace with technological
developments.
Our
products may be subject to substantial competition.
Ampligen®.
Competitors may be developing technologies that are, or in the future may be,
the basis for competitive products. Some of these potential products may have
an
entirely different approach or means of accomplishing similar therapeutic
effects to products being developed by us. These competing products may be
more
effective and less costly than our products. In addition, conventional drug
therapy, surgery and other more familiar treatments may offer competition to
our
products. Furthermore, many of our competitors have significantly greater
experience than us in pre-clinical testing and human clinical trials of
pharmaceutical products and in obtaining FDA, HPB and other regulatory approvals
of products. Accordingly, our competitors may succeed in obtaining FDA, HPB
or
other regulatory product approvals more rapidly than us. There are no drugs
approved for commercial sale with respect to treating ME/CFS in the United
States. The dominant competitors with drugs to treat HIV diseases include Gilead
Pharmaceutical, Pfizer, Bristol-Myers, Abbott Labs, Glaxo Smith Kline, Merck
and
Schering-Plough Corp. These potential competitors are among the largest
pharmaceutical companies in the world, are well known to the public and the
medical community, and have substantially greater financial resources, product
development, and manufacturing and marketing capabilities than we have. Although
we believe our principal advantage is the unique mechanism of action of
Ampligen® on the immune system, we cannot assure that we will be able to
compete.
ALFERON
N
Injection®. Many competitors are among the largest pharmaceutical companies in
the world, are well known to the public and the medical community, and have
substantially greater financial resources, product development, and
manufacturing and marketing capabilities than we have. Alferon N Injection®
currently competes with Schering’s injectable recombinant alpha interferon
product (INTRON® A) for the treatment of genital warts. 3M Pharmaceuticals also
received FDA approval for its immune-response modifier, Aldara®, a
self-administered topical cream, for the treatment of external genital and
perianal warts. In addition, Medigene recently received FDA approval for a
self-administered ointment, VeregenTM, which is indicated for the topical
treatment of external genital and perianal warts. Alferon N Injection® also
competes with surgical, chemical, and other methods of treating genital warts.
We cannot assess the impact products developed by our competitors, or advances
in other methods of the treatment of genital warts, will have on the commercial
viability of Alferon N Injection®. If and when we obtain additional approvals of
uses of this product, we expect to compete primarily on the basis of product
performance. Our competitors have developed or may develop products (containing
either alpha or beta interferon or other therapeutic compounds) or other
treatment modalities for those uses. In the United States, three recombinant
forms of beta interferon have been approved for the treatment of
relapsing-remitting multiple sclerosis. There can be no assurance that, if
we
are able to obtain regulatory approval of Alferon N Injection® for the treatment
of new indications, we will be able to achieve any significant penetration
into
those markets. In addition, because certain competitive products are not
dependent on a source of human blood cells, such products may be able to be
produced in greater volume and at a lower cost than Alferon N Injection®.
Currently, our wholesale price on a per unit basis of Alferon N Injection® is
higher than that of the competitive recombinant alpha and beta interferon
products.
32
General.
Other companies may succeed in developing products earlier than we do, obtaining
approvals for such products from the FDA more rapidly than we do, or developing
products that are more effective than those we may develop. While we will
attempt to expand our technological capabilities in order to remain competitive,
there can be no assurance that research and development by others or other
medical advances will not render our technology or products obsolete or
non-competitive or result in treatments or cures superior to any therapy we
develop.
Possible
side effects from the use of Ampligen® or Alferon N Injection® could adversely
affect potential revenues and physician/patient acceptability of our
product.
Ampligen®.
We believe that Ampligen® has been generally well tolerated with a low incidence
of clinical toxicity, particularly given the severely debilitating or life
threatening diseases that have been treated. A mild flushing reaction has been
observed in approximately 15% of patients treated in our various studies. This
reaction is occasionally accompanied by a rapid heart beat, a tightness of
the
chest, urticaria (swelling of the skin), anxiety, shortness of breath,
subjective reports of ''feeling hot,'' sweating and nausea. The reaction is
usually infusion-rate related and can generally be controlled by slowing the
infusion rate. Other adverse side effects include liver enzyme level elevations,
diarrhea, itching, asthma, low blood pressure, photophobia, rash, transient
visual disturbances, slow or irregular heart rate, decreases in platelets and
white blood cell counts, anemia, dizziness, confusion, elevation of kidney
function tests, occasional temporary hair loss and various flu-like symptoms,
including fever, chills, fatigue, muscular aches, joint pains, headaches, nausea
and vomiting. These flu-like side effects typically subside within several
months. One or more of the potential side effects might deter usage of Ampligen®
in certain clinical situations and therefore, could adversely affect potential
revenues and physician/patient acceptability of our product.
Alferon
N
Injection®. At present, Alferon N Injection® is only approved for the
intra-lesional (within the lesion) treatment of refractory or recurring external
genital warts in adults. In clinical trials conducted for the treatment of
genital warts with Alferon N Injection®, patients did not experience serious
side effects; however, there can be no assurance that unexpected or unacceptable
side effects will not be found in the future for this use or other potential
uses of Alferon N Injection® which could threaten or limit such product’s
usefulness.
We
may be subject to product liability claims from the use of Ampligen®, Alferon N
Injection®, or other of our products which could negatively affect our future
operations.
We
face
an inherent business risk of exposure to product liability claims in the event
that the use of Ampligen® or other of our products results in adverse effects.
This liability might result from claims made directly by patients, hospitals,
clinics or other consumers, or by pharmaceutical companies or others
manufacturing these products on our behalf. Our future operations may be
negatively affected from the litigation costs, settlement expenses and lost
product sales inherent to these claims. While we will continue to attempt to
take appropriate precautions, we cannot assure that we will avoid significant
product liability exposure. Although we currently maintain product liability
insurance coverage, there can be no assurance that this insurance will provide
adequate coverage against Ampligen® and/or Alferon N Injection® product
liability claims. A successful product liability claim against us in excess
of
Ampligen®’s $1,000,000 in insurance coverage; $3,000,000 in aggregate, or in
excess of Alferon N Injection®’s $5,000,000 in insurance coverage; $5,000,000 in
aggregate; or for which coverage is not provided could have a negative effect
on
our business and financial condition.
33
The
loss of Dr. William A. Carter’s services could hurt our chances for success.
Our
success is dependent on the continued efforts of Dr. William A. Carter because
of his position as a pioneer in the field of nucleic acid drugs, his being
the
co-inventor of Ampligen®, and his knowledge of our overall activities, including
patents and clinical trials. The loss of Dr. Carter’s services could have a
material adverse effect on our operations and chances for success. We have
secured key man life insurance in the amount of $2,000,000 on the life of Dr.
Carter and we have an employment agreement with Dr. Carter that, as amended,
runs until December 31, 2010. However, Dr. Carter has the right to terminate
his
employment upon not less than 30 days prior written notice. The loss of Dr.
Carter or other personnel, or the failure to recruit additional personnel as
needed could have a materially adverse effect on our ability to achieve our
objectives.
Uncertainty
of health care reimbursement for our products.
Our
ability to successfully commercialize our products will depend, in part, on
the
extent to which reimbursement for the cost of such products and related
treatment will be available from government health administration authorities,
private health coverage insurers and other organizations. Significant
uncertainty exists as to the reimbursement status of newly approved health
care
products, and from time to time legislation is proposed, which, if adopted,
could further restrict the prices charged by and/or amounts reimbursable to
manufacturers of pharmaceutical products. We cannot predict what, if any,
legislation will ultimately be adopted or the impact of such legislation on
us.
There can be no assurance that third party insurance companies will allow us
to
charge and receive payments for products sufficient to realize an appropriate
return on our investment in product development.
There
are risks of liabilities associated with handling and disposing of hazardous
materials.
Our
business involves the controlled use of hazardous materials, carcinogenic
chemicals, flammable solvents and various radioactive compounds. Although we
believe that our safety procedures for handling and disposing of such materials
comply in all material respects with the standards prescribed by applicable
regulations, the risk of accidental contamination or injury from these materials
cannot be completely eliminated. In the event of such an accident or the failure
to comply with applicable regulations, we could be held liable for any damages
that result, and any such liability could be significant. We do not maintain
insurance coverage against such liabilities.
34
Risks
Associated With an Investment in Our Common Stock
The
market price of our stock may be adversely affected by market
volatility.
The
market price of our common stock has been and is likely to be volatile. In
addition to general economic, political and market conditions, the price and
trading volume of our stock could fluctuate widely in response to many factors,
including:
· |
announcements
of the results of clinical trials by us or our
competitors;
|
· |
adverse
reactions to products;
|
· |
governmental
approvals, delays in expected governmental approvals or withdrawals
of any
prior governmental approvals or public or regulatory agency concerns
regarding the safety or effectiveness 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; and
|
· |
the
occurrence of any of the risks described in these "Risk
Factors."
|
Our
common stock is listed for quotation on the American Stock Exchange. For the
12-month period ended April 30, 2007, the price of our common stock has ranged
from $1.56 to $3.41 per share. We expect the price of our common stock to remain
volatile. The average daily trading volume of our common stock varies
significantly. Our relatively low average volume and low average number of
transactions per day may affect the ability of our stockholders to sell their
shares in the public market at prevailing prices and a more active market may
never develop.
In
the
past, following periods of volatility in the market price of the securities
of
companies in our industry, securities class action litigation has often been
instituted against companies in our industry. If we face securities litigation
in the future, even if without merit or unsuccessful, it would result in
substantial costs and a diversion of management attention and resources, which
would negatively impact our business.
Our
stock price may be adversely affected if a significant amount of shares, are
sold in the public market.
We
have
registered 13,201,840 for sale by Fusion Capital and 143,658 shares by others,
and may, in the future, register an additional 15,000,000 shares for sale by
Fusion Capital under the common stock purchase agreement. As of April 30, 2007,
approximately 1,121,953 shares of our common stock, constituted "restricted
securities" as defined in Rule 144 under the Securities Act, 396,669 of which
have been registered. Also, we have registered 9,669,238 shares issuable (i)
upon conversion of approximately 135% of Debentures that we issued in 2003
and
2004; (ii) as payment of 135% of the interest on all of the Debentures; (iii)
upon exercise of 135% of certain Warrants; and (iv) upon exercise of certain
other warrants. Registration of the shares permits the sale of the shares in
the
open market or in privately negotiated transactions without compliance with
the
requirements of Rule 144. To the extent the exercise price of the warrants
is
less than the market price of the common stock, the holders of the warrants
are
likely to exercise them and sell the underlying shares of common stock and
to
the extent that the conversion price and exercise price of these securities
are
adjusted pursuant to anti-dilution protection, the securities could be
exercisable or convertible for even more shares of common stock. We also may
issue shares to be used to meet our capital requirements or use shares to
compensate employees, consultants and/or directors. We are unable to estimate
the amount, timing or nature of future sales of outstanding common stock. Sales
of substantial amounts of our common stock in the public market could cause
the
market price for our common stock to decrease. Furthermore, a decline in the
price of our common stock would likely impede our ability to raise capital
through the issuance of additional shares of common stock or other equity
securities.
35
The
sale of our common stock to Fusion Capital may cause dilution and the sale
of
the shares of common stock acquired by Fusion Capital and other shares
registered for selling stockholders could cause the price of our common stock
to
decline.
The
sale
by Fusion Capital and other selling stockholders of our common stock will
increase the number of our publicly traded shares, which could depress the
market price of our common stock. Moreover, the mere prospect of sales by Fusion
Capital and other selling stockholders could depress the market price for our
common stock. The issuance of shares to Fusion Capital under the common stock
purchase agreement, will dilute the equity interest of existing stockholders
and
could have an adverse effect on the market price of our common
stock.
The
purchase price for the common stock to be sold to Fusion Capital pursuant to
the
common stock purchase agreement will fluctuate based on the price of our common
stock. All shares sold to Fusion Capital are to be freely tradable. Fusion
Capital may sell none, some or all of the shares of common stock purchased
from
us at any time. We expect that the shares offered by Fusion Capital will be
sold
over a period of in excess of two years. Depending upon market liquidity at
the
time, a sale of shares under this offering at any given time could cause the
trading price of our common stock to decline. The sale of a substantial number
of shares of our common stock to Fusion Capital pursuant to the purchase
agreement, or anticipation of such sales, could make it more difficult for
us to
sell equity or equity-related securities in the future at a time and at a price
that we might otherwise wish to effect sales.
Provisions
of our Certificate of Incorporation and Delaware law could defer a change of
our
management which could discourage or delay offers to acquire
us.
Provisions
of our Certificate of Incorporation and Delaware law may make it more difficult
for someone to acquire control of us or for our stockholders to remove existing
management, and might discourage a third party from offering to acquire us,
even
if a change in control or in management would be beneficial to our stockholders.
For example, our Certificate of Incorporation allows us to issue shares of
preferred stock without any vote or further action by our stockholders. Our
Board of Directors has the authority to fix and determine the relative rights
and preferences of preferred stock. Our Board of Directors also has the
authority to issue preferred stock without further stockholder approval. As
a
result, our Board of Directors could authorize the issuance of a series of
preferred stock that would grant to holders the preferred right to our assets
upon liquidation, the right to receive dividend payments before dividends are
distributed to the holders of common stock and the right to the redemption
of
the shares, together with a premium, prior to the redemption of our common
stock. In this regard, in November 2002, we adopted a stockholder rights plan
and, under the Plan, our Board of Directors declared a dividend distribution
of
one Right for each outstanding share of Common Stock to stockholders of record
at the close of business on November 29, 2002. Each Right initially entitles
holders to buy one unit of preferred stock for $30.00. The Rights generally
are
not transferable apart from the common stock and will not be exercisable unless
and until a person or group acquires or commences a tender or exchange offer
to
acquire, beneficial ownership of 15% or more of our common stock. However,
for
Dr. Carter, our chief executive officer, who already beneficially owns 8.0%
of
our common stock, the Plan’s threshold will be 20%, instead of 15%. The Rights
will expire on November 19, 2012, and may be redeemed prior thereto at $.01
per
Right under certain circumstances.
36
Because
the risk factors referred to above could cause actual results or outcomes to
differ materially from those expressed in any forward-looking statements made
by
us, you should not place undue reliance on any such forward-looking statements.
Further, any forward-looking statement speaks only as of the date on which
it is
made and we undertake no obligation to update any forward-looking statement
or
statements to reflect events or circumstances after the date on which such
statement is made or reflect the occurrence of unanticipated events. New factors
emerge from time to time, and it is not possible for us to predict which will
arise. In addition, we cannot assess the impact of each factor on our business
or the extent to which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any forward-looking
statements. Our research in clinical efforts may continue for the next several
years and we may continue to incur losses due to clinical costs incurred in
the
development of Ampligen® for commercial application. Possible losses may
fluctuate from quarter to quarter as a result of differences in the timing
of
significant expenses incurred and receipt of licensing fees and/or cost recovery
treatment revenues in Europe, Canada and in the United States.
ITEM
2: Unregistered Sales of Equity Securities and Use of Proceeds
During
the quarter ended March 31, 2007, we issued
1)
3,798,113 shares issued pursuant to the 2006 Purchase Agreement with Fusion
Capital, 2) an aggregate of 28,410 shares for services performed and an
aggregate of 33,203 shares for the payment of interest.
All
of
the foregoing transactions
were conducted pursuant
to the exemption from registration provided by Section 4(2) of the Securities
Act of 1933.
We
did
not repurchase any of our securities during the quarter ended March 31,
2007.
ITEM
3: Defaults upon Senior Securities
None.
ITEM
4: Submission
of Matters to a Vote of Security Holders
None
37
ITEM
5: Other Information
None.
ITEM
6: Exhibits
(a)
Exhibits
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
|
||
38
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
HEMISPHERx
BIOPHARMA, INC.
|
|||
/s/
William A. Carter
|
|||
William
A. Carter, M.D.
|
|||
Chief
Executive Officer & President
|
|||
/s/
Robert E. Peterson
|
|||
Robert E. Peterson |
|||
Chief
Financial Officer
|
|||
Date:
May 10, 2007
|
39