UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C.
20549
___________________________________
FORM
10-Q
(Mark
One)
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the
quarterly period ended June 30, 2008
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the
transition period from _____________ to ___________
Commission
file number
0-29222
AVAX
TECHNOLOGIES, INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
13-3575874
|
(State
or other jurisdiction of incorporation or organization
)
|
(I.R.S.
Employer Identification No.)
|
2000
Hamilton Street, Suite 204, Philadelphia,
Pennsylvania
|
19130
|
(Address
of principal executive offices)
|
(Zip
Code)
|
(215)
241-9760
(Registrant’s
telephone number, including area code)
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. Yes
x
No
¨
Indicate
by check mark whether the Registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting company.
See
definition of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
Accelerated filer
o
|
Accelerated
filer
o
|
Non-accelerated
filer
o
(do
not check if a smaller reporting company)
|
Smaller
reporting company
x
|
Indicate
by check mark whether the Registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes
¨
No
x
On
August
14, 2008, there were 142,605,753 shares of the Registrant’s common stock, par
value $.004 per share, issued and outstanding
.
AVAX
TECHNOLOGIES, INC.
Table
of Contents
|
|
|
Page
|
PART
I - FINANCIAL INFORMATION
|
|
|
Item
1.
|
Financial
Statements
|
|
3
|
|
Consolidated
Balance Sheet - As of June 30, 2008 (Unaudited) and December 31,
2007
|
|
3
|
|
Consolidated
Statements of Operations and Comprehensive Loss (Unaudited) For the
Three
Months and Six Months Ended June 30, 2008 and 2007 and for the Period
from
January 12, 1990 (Incorporation) to June 30, 2008
|
|
4
|
|
Consolidated
Statements of Cash Flows (Unaudited) For the Six Months Ended June
30,
2008 and 2007 and for the Period from January 12, 1990
(Incorporation) to June 30, 2008
|
|
5
|
|
Notes
to Consolidated Financial Statements
|
|
7
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
13
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
|
17
|
Item
4T.
|
Controls
and Procedures
|
|
17
|
PART
II - OTHER INFORMATION
|
|
|
Item
1.
|
Legal
Proceedings
|
|
19
|
Item 1A.
|
Risk
Factors
|
|
19
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
19
|
Item
3.
|
Defaults
Upon Senior Securities
|
|
19
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
|
19
|
Item
5.
|
Other
Information
|
|
19
|
Item
6.
|
Exhibits
|
|
19
|
Signatures
|
|
20
|
PART
I - FINANCIAL INFORMATION
Item
1.
Financial
Statements.
AVAX
Technologies, Inc. and Subsidiaries
(a
development stage company)
|
|
June 30,
2008
(unaudited)
|
|
December 31,
2007
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
1,346,161
|
|
$
|
5,903,207
|
|
Accounts
receivable
|
|
|
5,543
|
|
|
131,387
|
|
Inventory
|
|
|
5,775
|
|
|
11,520
|
|
VAT
receivable
|
|
|
65,794
|
|
|
82,896
|
|
Prepaid
expenses and other current assets
|
|
|
468,517
|
|
|
317,105
|
|
Total
current assets
|
|
|
1,891,790
|
|
|
6,446,115
|
|
Property,
plant and equipment, at cost
|
|
|
4,438,187
|
|
|
4,247,706
|
|
Less
accumulated depreciation
|
|
|
3,735,755
|
|
|
3,505,051
|
|
Net
property, plant and equipment
|
|
|
702,432
|
|
|
742,655
|
|
Goodwill
|
|
|
188,387
|
|
|
188,387
|
|
Total
assets
|
|
$
|
2,782,609
|
|
$
|
7,377,157
|
|
|
|
|
|
|
|
|
|
Liabilities
and stockholders’ equity (deficit)
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,399,647
|
|
$
|
2,091,674
|
|
Accrued
expenses
|
|
|
513,480
|
|
|
551,777
|
|
Accrued
and withheld payroll taxes and liabilities
|
|
|
429,631
|
|
|
699,603
|
|
Deferred
revenue
|
|
|
257,321
|
|
|
250,000
|
|
ANVAR
advances
|
|
|
432,138
|
|
|
400,691
|
|
Total
current liabilities
|
|
|
3,032,217
|
|
|
3,993,745
|
|
Stockholders’
equity
:
|
|
|
|
|
|
|
|
Preferred
stock, $.01 par value:
|
|
|
|
|
|
|
|
Authorized
shares – 5,000,000, including Series C – 120,000 shares
|
|
|
|
|
|
|
|
Series
C convertible preferred stock:
|
|
|
|
|
|
|
|
Issued
and outstanding shares – 33,500 at June 30, 2008 and December 31, 2007
(liquidation preference - $3,350,000)
|
|
|
335
|
|
|
335
|
|
Common
stock, $.004 par value:
|
|
|
|
|
|
|
|
Authorized
shares 500,000,000 at June 30, 2008 and December 31, 2007
Issued
and outstanding shares –141,574,997 at June 30, 2008 and December 31, 2007
|
|
|
566,300
|
|
|
566,300
|
|
Additional
paid-in capital
|
|
|
86,909,550
|
|
|
86,657,058
|
|
Subscription
receivable
|
|
|
(422
|
)
|
|
(422
|
)
|
Accumulated
other comprehensive income
|
|
|
336,094
|
|
|
414,971
|
|
Deficit
accumulated during the development stage
|
|
|
(88,061,465
|
)
|
|
(84,254,830
|
)
|
Total
stockholders’ equity (deficit)
|
|
|
(249,608
|
)
|
|
3,383,412
|
|
Total
liabilities and stockholders’ equity (deficit)
|
|
$
|
2,782,609
|
|
$
|
7,377,157
|
|
See
accompanying notes.
AVAX
Technologies, Inc. and Subsidiaries
(a
development stage company)
Consolidated
Statements of Operations and Comprehensive Loss
(Unaudited)
|
|
Three months ended
June 30,
|
|
Six months ended
June 30,
|
|
Period from
January 12, 1990
(Incorporation) to
June 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
2008
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain
from sale of the Product
|
|
$
|
–
|
|
$
|
–
|
|
$
|
–
|
|
$
|
–
|
|
$
|
1,951,000
|
|
Product
and contract service revenue
|
|
|
91,135
|
|
|
58,769
|
|
|
206,775
|
|
|
203,316
|
|
|
7,022,869
|
|
Grant
revenue
|
|
|
5,295
|
|
|
–
|
|
|
9,773
|
|
|
–
|
|
|
215,885
|
|
Total
revenue
|
|
|
96,430
|
|
|
58,769
|
|
|
216,548
|
|
|
203,316
|
|
|
9,189,754
|
|
Costs
and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
1,228,394
|
|
|
1,041,708
|
|
|
2,360,238
|
|
|
2,051,497
|
|
|
54,607,978
|
|
Acquired
in process research and development
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
4,420,824
|
|
Write
down of acquired intellectual property and other
intangibles
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
3,416,091
|
|
Amortization
of acquired intangibles
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
715,872
|
|
Selling,
general and administrative
|
|
|
754,335
|
|
|
623,274
|
|
|
1,718,072
|
|
|
1,094,193
|
|
|
39,677,453
|
|
Total
operating loss
|
|
|
(1,886,299
|
)
|
|
(1,606,213
|
)
|
|
(3,861,762
|
)
|
|
(2,942,374
|
)
|
|
(93,648,464
|
)
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
11,204
|
|
|
84,565
|
|
|
52,849
|
|
|
94,878
|
|
|
6,257,440
|
|
Interest
expense
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
(812,067
|
)
|
Other,
net
|
|
|
1,885
|
|
|
–
|
|
|
2,278
|
|
|
–
|
|
|
145,471
|
|
Total
other income , net
|
|
|
13,089
|
|
|
84,565
|
|
|
55,127
|
|
|
94,878
|
|
|
5,590,844
|
|
Loss
before income taxes
|
|
|
(1,873,210
|
)
|
|
(1,521,648
|
)
|
|
(3,806,635
|
)
|
|
(2,847,496
|
)
|
|
(88,057,620
|
)
|
Income
taxes
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
Loss
from continuing operations
|
|
|
(1,873,210
|
)
|
|
(1,521,648
|
)
|
|
(3,806,635
|
)
|
|
(2,847,496
|
)
|
|
(88,057,620
|
)
|
Loss
from discontinued operations
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
(3,845
|
)
|
Net
loss
|
|
|
(1,873,210
|
)
|
|
(1,521,648
|
)
|
|
(3,806,635
|
)
|
|
(2,847,496
|
)
|
|
(88,061,465
|
)
|
Amount
payable for liquidation preference
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
(1,870,033
|
)
|
Net
loss attributable to common stockholders
|
|
$
|
(1,873,210
|
)
|
$
|
(1,521,648
|
)
|
$
|
(3,806,635
|
)
|
$
|
(2,847,496
|
)
|
$
|
(89,931,498
|
)
|
Loss
per common share – basic and diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from continuing operations
|
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
|
|
|
Loss
from discontinued operations
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
|
|
Net
loss
|
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
|
|
|
Weighted-average
number of common shares outstanding
|
|
|
141,530,614
|
|
|
130,037,855
|
|
|
141,555,545
|
|
|
95,915,992
|
|
|
|
|
Net
loss
|
|
$
|
(1,873,210
|
)
|
$
|
(1,521,648
|
)
|
$
|
(3,806,635
|
)
|
$
|
(2,847,496
|
)
|
|
|
|
Foreign
currency translation adjustment
|
|
|
16,961
|
|
|
(5,963
|
)
|
|
16,961
|
|
|
(40,200
|
)
|
|
|
|
Comprehensive
loss
|
|
$
|
(1,856,249
|
)
|
$
|
(1,527,611
|
)
|
$
|
(3,789,674
|
)
|
$
|
(2,887,696
|
)
|
|
|
|
See
accompanying notes.
AVAX
Technologies, Inc. and Subsidiaries
(a
development stage company)
Consolidated
Statements of Cash Flows
(Unaudited)
|
|
Six months ended June 30,
|
|
Period from
January 12, 1990
(Incorporation) to
June 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
Operating
activities
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(3,806,635
|
)
|
$
|
(2,847,496
|
)
|
$
|
(88,061,465
|
)
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
131,257
|
|
|
146,731
|
|
|
5,215,984
|
|
Amortization
of discount on convertible notes payable
|
|
|
–
|
|
|
–
|
|
|
142,500
|
|
Extraordinary
gain related to negative goodwill on consolidated
subsidiary
|
|
|
–
|
|
|
–
|
|
|
(902,900
|
)
|
Cumulative
effect of change in accounting
|
|
|
–
|
|
|
–
|
|
|
(186,295
|
)
|
Amortization
of deferred gain on joint venture
|
|
|
–
|
|
|
–
|
|
|
(1,805,800
|
)
|
Equity
in net loss of joint venture
|
|
|
–
|
|
|
–
|
|
|
1,703,763
|
|
Employee
Stock Option Expense
|
|
|
252,492
|
|
|
63,810
|
|
|
600,188
|
|
Minority
interest in net loss of consolidated subsidiary
|
|
|
–
|
|
|
–
|
|
|
(80,427
|
)
|
Acquired
in-process research and development charge
|
|
|
–
|
|
|
–
|
|
|
4,420,824
|
|
Write
down of acquired intellectual property and other
intangibles
|
|
|
–
|
|
|
–
|
|
|
3,416,091
|
|
Compensatory
stock issue
|
|
|
–
|
|
|
–
|
|
|
25,000
|
|
Gain
on sale of the Product
|
|
|
–
|
|
|
–
|
|
|
(1,951,000
|
)
|
Gain
on sale of intellectual property
|
|
|
–
|
|
|
–
|
|
|
(787
|
)
|
Accretion
of interest on common stock receivable
|
|
|
–
|
|
|
–
|
|
|
(449,000
|
)
|
Accretion
of interest on amount payable to preferred stockholders and Former
Officer
|
|
|
–
|
|
|
–
|
|
|
449,000
|
|
Loss
on sale of furniture and equipment
|
|
|
–
|
|
|
–
|
|
|
246,254
|
|
Issuance
of common stock or warrants for services
|
|
|
–
|
|
|
–
|
|
|
423,289
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
126,247
|
|
|
142,136
|
|
|
143,475
|
|
Inventory
|
|
|
6,165
|
|
|
(1,210
|
)
|
|
36,929
|
|
Prepaid
expenses and other current assets
|
|
|
(119,211
|
)
|
|
(820
|
)
|
|
(275,242
|
)
|
Research
and development tax credit receivable
|
|
|
–
|
|
|
–
|
|
|
320,488
|
|
Accounts
payable and accrued liabilities
|
|
|
(1,040,646
|
)
|
|
359,732
|
|
|
1,162,421
|
|
Deferred
revenue
|
|
|
6,788
|
|
|
287,835
|
|
|
217,080
|
|
Amount
payable to Former Officer
|
|
|
–
|
|
|
–
|
|
|
80,522
|
|
Net
cash used in operating activities
|
|
$
|
(4,443,543
|
)
|
$
|
(1,849,282
|
)
|
$
|
(75,109,108
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Investing
activities
|
|
|
|
|
|
|
|
|
|
|
Purchases
of marketable securities
|
|
|
–
|
|
|
–
|
|
|
(351,973,210
|
)
|
Proceeds
from sale of marketable securities
|
|
|
–
|
|
|
–
|
|
|
344,856,738
|
|
Proceeds
from sale of short-term investments
|
|
|
–
|
|
|
–
|
|
|
7,116,472
|
|
Purchases
of furniture and equipment
|
|
|
(64,895
|
)
|
|
(29,175
|
)
|
|
(3,794,960
|
)
|
Proceeds
from sale of furniture and equipment
|
|
|
–
|
|
|
–
|
|
|
51,119
|
|
Cash
acquired in acquisition of control of joint venture
|
|
|
–
|
|
|
–
|
|
|
991,634
|
|
Organization
costs incurred
|
|
|
–
|
|
|
–
|
|
|
(622,755
|
)
|
Net
cash used in investing activities
|
|
$
|
(64,895
|
)
|
$
|
(29,175
|
)
|
$
|
(3,374,962
|
)
|
AVAX
Technologies, Inc. and Subsidiaries
(a
development stage company)
Consolidated
Statements of Cash Flows (continued)
(Unaudited)
|
|
Six months ended June 30,
|
|
Period from
January 12, 1990
(Incorporation)
to
June
30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
Financing
activities
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of notes payable
to
related party
|
|
$
|
–
|
|
$
|
–
|
|
$
|
957,557
|
|
Principal
payments on notes payable to related party
|
|
|
–
|
|
|
–
|
|
|
(802,000
|
)
|
Proceeds
from loans payable and the related issuance of warrants
|
|
|
–
|
|
|
–
|
|
|
2,314,000
|
|
Principal
payments on loans payable
|
|
|
–
|
|
|
–
|
|
|
(1,389,000
|
)
|
Payments
for fractional shares from reverse splits and preferred stock
conversions
|
|
|
–
|
|
|
–
|
|
|
(76
|
)
|
Financing
costs incurred
|
|
|
–
|
|
|
–
|
|
|
(90,000
|
)
|
Shareholder
capital contribution
|
|
|
–
|
|
|
–
|
|
|
93,637
|
|
Payments
received on subscription receivable
|
|
|
–
|
|
|
–
|
|
|
4,542
|
|
Proceeds
received from exercise of stock warrants
|
|
|
–
|
|
|
–
|
|
|
76,892
|
|
Elimination
of consolidated accounting treatment for joint venture
|
|
|
–
|
|
|
–
|
|
|
(2,511,701
|
)
|
Capital
contribution through sale of interest in consolidated
subsidiary
|
|
|
–
|
|
|
–
|
|
|
2,624,000
|
|
Net
proceeds received from issuance of preferred and common
stock
|
|
|
–
|
|
|
9,318,359
|
|
|
78,170,851
|
|
Net
cash provided by financing activities
|
|
|
–
|
|
|
9,318,359
|
|
|
79,448,702
|
|
Effect
of exchange rate changes on cash
|
|
|
(48,608
|
)
|
|
(39,380
|
)
|
|
381,529
|
|
Net
increase (decrease) in cash
|
|
|
(4,557,046
|
)
|
|
7,400,522
|
|
|
1,346,161
|
|
Cash
at beginning of period
|
|
|
5,903,207
|
|
|
1,484,570
|
|
|
–
|
|
Cash
at end of period
|
|
$
|
1,346,161
|
|
$
|
8,885,092
|
|
$
|
1,346,161
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information
|
|
|
|
|
|
|
|
|
|
|
Interest
Paid
|
|
$
|
–
|
|
$
|
–
|
|
$
|
197,072
|
|
Non-cash
activity:
|
|
|
|
|
|
|
|
|
|
|
Issuance
of restricted stock compensation
|
|
$
|
–
|
|
$
|
–
|
|
$
|
25,000
|
|
Common
stock warrants issued with convertible notes
|
|
$
|
–
|
|
$
|
–
|
|
$
|
142,500
|
|
Conversion
of bridge loan into common stock
|
|
$
|
–
|
|
$
|
–
|
|
$
|
950,000
|
|
Payment
of interest with common stock
|
|
$
|
–
|
|
$
|
–
|
|
$
|
23,275
|
|
See
accompanying notes.
AVAX
Technologies, Inc. and Subsidiaries
(a
development stage company)
Notes
to
Consolidated Financial Statements
(Unaudited)
1.
Description of Business
AVAX
Technologies, Inc. and its subsidiaries (the “Company” or “AVAX”) is a
development stage biopharmaceutical company.
In
November 1995, the Company sold its leading product under development, an
over-the-counter nutritional, dietary, medicinal and/or elixorative food
supplement or drug and all of the related patents and other intellectual
property. The agreement was for $2.4 million in shares of common stock of
Interneuron Pharmaceuticals, Inc. (“IPI”), a public company, the parent of the
purchaser of the product (the “Stock”). Certain common stockholders of the
Company were also common stockholders of IPI. Pursuant to the terms of the
agreement, the purchase price, payable in two equal installments in December
1996 and 1997, was fixed, and the number of shares of the Stock would vary
depending on the quoted market price of the Stock at such time. Because the
Stock was receivable in two equal annual installments, the gain from the sale
of
the product, $1,951,000, was calculated by discounting the value of the Stock
receivable using a discount rate of 15%.
Also
in
November 1995, the Company entered into a license agreement with Thomas
Jefferson University (“TJU”) to develop, commercially manufacture and sell
products embodying immunotherapeutic vaccines for the treatment of malignant
melanoma and other cancers (the “Invention”)
(see
Note 4
).
In
December 1996, the Company entered into a license agreement with Rutgers
University (“Rutgers”) to develop, commercially manufacture and sell products
embodying a series of compounds for the treatment of cancer and infectious
diseases. During September 2004, the Company and Rutgers agreed to cancel the
license agreement and all of the Company’s obligations associated with the
license agreement.
In
February 1997, the Company entered into a license agreement with Texas A&M
University to develop, commercially manufacture and sell products embodying
a
series of compounds for the treatment of cancer (the “Texas A&M Compounds”)
(see
Note 4
).
In
November 1999, the Company entered into a definitive joint venture agreement
with Australia Vaccine Technologies (“AVT”) (formerly Neptunus International
Holdings Limited), a pharmaceutical group in Australia, under the subsidiary
name, AVAX Holdings Australia Pty Limited (“AVAX Holdings”). Under the joint
venture agreement, AVAX Holdings, through its affiliated entities, AVAX
Australia Pty Limited and AVAX Australia Manufacturing Pty Limited (the “Joint
Venture Companies”), was organized for the purpose of manufacturing and
marketing M-Vax, an immunotherapy for the post-surgical treatment of Stage
3 and
4 melanoma (“M-Vax”), in Australia and New Zealand. In January 2002, the Joint
Venture Companies repurchased 90% of AVT’s interest in the two joint venture
companies, resulting in AVAX owning a 95% interest in the net equity of both
joint venture companies. The Company was seeking but was unable to obtain a
timely governmental reimbursement for the costs of treatment with the M-Vax
in
Australia, and determined to discontinue operations in Australia in order to
focus the cash resources of the Company on its U.S. and European operations.
In
September 2002, the Company announced that it would be discontinuing its
operations in Australia, and, in December 2002, the Company completed the
liquidation of its Australian subsidiary.
In
August
2000, the Company completed its acquisition of GPH, S.A. (“Holdings”) and
Genopoietic S.A. (“Genopoietic”), each a French societe anonyme based in Paris,
France with its principal operating facility in Lyon, France. Holdings and
Genopoietic were organized in 1993 to develop gene therapy applications and
market gene therapy treatments for cancer. The Company has designated the Lyon,
France operations facility as its primary source facility for the production
of
vaccines to be used in clinical trials. In addition, the Company currently
performs contract manufacturing and research activities at its facilities
located in Lyon. The Company’s June 30, 2008 consolidated balance sheet includes
approximately $516,707 in net assets related to these subsidiaries.
The
Company’s business is subject to significant risks consistent with biotechnology
companies that are developing products for human therapeutic use. These risks
include, but are not limited to, uncertainties regarding research and
development, access to capital, obtaining and enforcing patents, receiving
regulatory approval, and competition with other biotechnology and pharmaceutical
companies. The Company is seeking to continue to finance its operations with
a
combination of equity and debt financing and, in the longer term, revenues
from
product sales, if any. However, there can be no assurance that it will
successfully develop any product or, if it does, that the product will generate
any sufficient revenues or that the Company will continue to have the finances
available to support its operations.
2.
Basis of Presentation
The
financial information for the three-month and six-month periods ended June
30,
2008 and 2007, contained herein, is unaudited.
The
Company believes this information has been prepared in accordance with
accounting principles generally accepted in the United States for interim
financial information and Article 8 of Regulation S-X. The Company also believes
this information includes all adjustments (consisting only of normal recurring
adjustments) necessary to present fairly the financial position, results of
operations and cash flows for the periods then ended. The results of operations
for the three-month and six-month periods ended June 30, 2008 are not
necessarily indicative of the results of operations that may be expected for
the
entire year.
The
accompanying financial statements and the related notes should be read in
conjunction with the Company’s audited financial statements for the year ended
December 31, 2007 included in the Company’s Annual Report on Form
10-K.
The
consolidated financial statements have been prepared assuming that the Company
will continue as a going concern. For the year ended December 31, 2007, the
Company incurred a net loss of $6,413,648 and a use of cash in operating
activities of $4,731,897. For the six months ended June 30, 2008, the Company
incurred a net loss of $3,806,635 and a use of cash in operating activities
of
$4,443,543. The Company’s cash requirements were satisfied through a private
placement of common stock in April 2007, maintaining balances in accounts
payable and accrued expenses on terms in excess of those afforded in commercial
practice and customer agreements and through the use of available cash. However,
the Company does not have sufficient resources to maintain its existing plan
of
operations throughout 2008. These conditions raise substantial doubt about
the
Company’s ability to continue as a going concern. Management anticipates that
additional debt or equity financing will be required to fund ongoing operations
in 2008. The Company is currently negotiating to raise additional capital or
secure revenue sources to fund current operations. However, there is no
assurance that the Company will successfully obtain the required capital or
revenues or, if obtained, the amounts will be sufficient to fund ongoing
operations in 2008. The inability to secure additional capital could have a
material adverse effect on the Company, including the possibility that the
Company could have to cease operations. Management has considered the impact
of
the going concern status in its evaluation of the recoverability and
classification of its assets and liabilities.
3.
Significant Accounting Policies
Principles
of Consolidation
The
accompanying consolidated financial statements include the accounts of AVAX
Technologies, Inc. and its subsidiaries. All significant intercompany balances
and transactions have been eliminated.
Foreign
Currency Translation
Holdings
and Genopoietic use the Euro as their functional currency as required by the
European Union. In accordance with Statement of Financial Accounting Standards
(SFAS) No. 52, “Foreign Currency Translation,” the financial statements of these
entities have been translated into U.S. dollars, the functional currency of
the
Company and its other wholly-owned subsidiaries and the reporting currency
herein, for purposes of consolidation.
Use
of Estimates
The
preparation of consolidated financial statements in conformity with accounting
principles generally accepted in the United States requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date
of
the financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those
estimates.
Revenue
Recognition
The
Company’s revenues are related to the provision of contract services and the
sale of its product, the AC Vaccine Technology, for the treatment of melanoma.
Contract service revenue is recognized in installments based upon the
contractual agreement entered into with clients. Product revenues represent
fees
received or payable to the Company related to the manufacture and sale of the
vaccine. Product revenue is recognized when the vaccine is received by the
hospital administering the vaccine.
The
Company records as deferred revenue amounts received in advance of the provision
of services in accordance with contracts or grants. Deferred revenue primarily
consisted of $250,000 received pursuant to a clinical development and
manufacturing agreement for which activities needed to be completed by May
31,
2008 which had been extended to early August, 2008 in order to earn the half
the
funds. Pursuant to the agreement, if the Company’s manufacturing facility in
Philadelphia, PA is not able to produce products pursuant to the agreement,
then
$125,000 of the funds received will default to the collaboration
partner.
The
due
date for the obligation has passed but the other party has not demanded
repayment of the obligation. If the facilities are not able to produce products
pursuant to the agreement by August 31, 2008, then the remaining $125,000 will
default and be payable back to the collaboration partner.
Accounts
Receivable
Accounts
receivable are stated at the amount management expects to collect from
outstanding balances. Management provides for probable uncollectible accounts
through a charge to earnings and a credit to a valuation allowance based on
its
assessment of the current status of individual accounts. Balances that are
still
outstanding after management has used reasonable collection efforts are written
off through a charge to the valuation allowance and a credit to accounts
receivable. There was no valuation allowance at June 30, 2008. The Company
generally does not charge interest on accounts receivable.
Concentrations
of Credit Risk
Financial
instruments that potentially subject the Company to credit risk are principally
cash and accounts receivable. Cash consists of checking accounts, money market
accounts and a certificate of deposit. The Company places its cash with its
principal bank that is a high credit quality financial institution. Cash
deposits generally are in excess of the FDIC insurance limits. Credit limits,
ongoing credit evaluations, and account monitoring procedures are utilized
to
minimize the risk of loss from accounts receivable. Collateral is generally
not
required.
Fair
Value of Financial Instruments
The
carrying amount of accounts receivable, accounts payable and accrued liabilities
are considered to be representative of their respective fair values due to
their
short-term nature.
Inventories
Inventories
are stated at the lower of cost, determined using the first-in, first-out
method, or market. The Company’s inventories include raw materials and supplies
used in research and development activities.
Accrued
Expenses
The
Company provides for accrued expenses based upon its contractual obligation,
as
calculated by the Company, for all claims made for payment to the Company.
Depreciation
Depreciation
is computed using the straight-line method over the estimated useful lives
of
furniture and equipment, which range from three to ten years. Depreciation
for
the Company’s manufacturing facility and related equipment are computed using
the straight-line method over estimated useful lives of 5 to 10 years. Leasehold
improvements related to the building are being amortized using the straight-line
method over the actual life of the lease.
Goodwill
The
Company adopted SFAS No. 142, “Goodwill and Other Intangible Assets”, on
January 1, 2002. This accounting standard requires that goodwill and
indefinite lived assets no longer be amortized but instead be tested at least
annually for impairment, and expensed against earnings when the implied fair
value of a reporting unit, including goodwill, is less than its carrying amount.
The Company performed its annual goodwill impairment test in accordance with
SFAS No. 142 and determined that the carrying amount of goodwill was
reasonable.
Prior
to
the adoption of SFAS No. 142, the Company had recorded cumulative amortization
of $113,032. If SFAS No. 142 had been applied to earlier periods, the adjusted
loss from continuing operations would be $87,944,588 and the adjusted net loss
would be $87,948,433.
Research
and Development Costs
Research
and development costs, including payments related to research and license
agreements, are expensed when incurred. Contractual research expenses are
recorded pursuant to the provisions of the contract under which the obligations
originate. Research and development costs include all costs incurred related
to
the research and development, including manufacturing costs incurred, related
to
the Company’s research programs. The Company is required to produce its products
in compliance with current Good Manufacturing Practices (“cGMP”), which requires
a minimum level of staffing, personnel and facilities testing and maintenance.
Based upon its current staffing level required to be in compliance with cGMP,
the Company has excess capacity. Utilizing this excess capacity, revenue is
generated through contract manufacturing engagements. Costs for production
of
products will be capitalized and charged to cost of goods sold only after the
Company has received approval to market the drug by a regulatory
authority.
Stock-Based
Compensation
Effective
January 1, 2006, the Company has adopted SFAS 123R, “Share-Based Payment.”
SFAS 123R establishes standards for the accounting for transactions in
which an entity exchanges its equity instruments for goods or services and
requires that the compensation cost relating to share-based payment transactions
be recognized in financial statements, measured by the fair value of the equity
or liability instruments issued, adjusted for estimated forfeitures. The Company
transitioned to SFAS 123R using the modified-prospective methods, under which
prior periods have not been revised for comparative purposes. The valuation
provisions of SFAS 123R apply to new grants and to grants that were outstanding
as of the effective date and are subsequently modified. Estimated compensation
for grants that were outstanding as of the effective date will be recognized
over the remaining service period using the compensation cost previously
estimated for our SFAS 123 pro forma disclosures. Recognized stock-based
compensation expense for the three and six months ended June 30, 2008 includes
compensation expense for share-based payment awards granted prior to, but not
yet vested as of December 31, 2005, based on the grant date fair value
estimated in accordance with the pro forma provisions of SFAS 123 and
compensation expense for the share-based payment awards granted subsequent
to
December 31, 2005 based on the grant date fair value estimated in
accordance with the provisions of SFAS 123R.
Prior
to
the adoption of SFAS 123R, the Company applied the intrinsic-value-based method
of accounting prescribed by Accounting Principles Board Opinion (“APB”) 25,
“Accounting for Stock Issued to Employees,” and related interpretations, to
account for its fixed-plan stock options to employees. Under this method,
compensation cost was recorded only if the market price of the underlying stock
on the date of grant exceeded the exercise price. SFAS 123, “Accounting for
Stock-Based Compensation,” established accounting and disclosure requirements
using a fair-value-based method of accounting for stock-based employee
compensation plans. As permitted by SFAS 123, the Company elected to continue
to
apply the intrinsic-value-based method of accounting described above, and
adopted only the disclosure requirements of SFAS 123, as amended by SFAS No.
148, “Accounting for Stock-Based Compensation, Transition and Disclosure.” The
fair-value-based method used to determine historical pro forma amounts under
SFAS 123 was similar in most respects to the method used to determine
stock-based compensation expense under SFAS 123R. However, in its pro forma
disclosures, the Company accounted for option forfeitures as they occurred,
rather than based on estimates of future forfeitures.
The
Company maintains three employee stock option plans and a director stock option
plan, and has issued non-qualified stock options to an executive officer and
a
director outside of the existing stock option plans, which non-plan option
grants have been approved by the Board of Directors and the stockholders of
the
Company. These plans are more fully discussed in our Annual Report on Form
10-K
filed for the year ended December 31, 2007. In addition, the Company issues
warrants to consultants at the discretion of the Board of Directors of the
Company. The Company accounts for warrants granted to consultants in accordance
with Emerging Issues Task Force Issue 96-18, “Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services.” The Company determines the value of stock warrants
utilizing the Black-Scholes option-pricing model.
Compensation
costs for fixed awards with pro rata vesting are allocated to periods on the
straight-line basis. For the three and six month periods ended June 30, 2007,
no
options or warrants were issued. The estimated weighted average fair value
of
warrants granted as of June 30, 2008 was calculated based on the following
assumptions:
|
|
Three Months Ended
June 30, 2008
|
|
Six Months Ended
June 30, 2008
|
|
Expected
term (in years)
|
|
|
5.00
|
|
|
5.00
|
|
Volatility
|
|
|
71.5
|
%
|
|
73.5
|
%
|
Risk-free
interest rate
|
|
|
3.18
|
%
|
|
2.86
|
%
|
Expected
dividends
|
|
|
0
|
|
|
0
|
|
Compensation
expense of $191,619 and $35,076 was charged to administrative expenses for
the
six months ended June 30, 2008 and 2007, respectively, while $60,873 and $28,734
was charged to research and development expenses related to stock options
outstanding and not vested for the same periods, respectively.
As of
June 30, 2008, total compensation cost related to non-vested stock options
not
yet recognized is $542,685 and is expected to be allocated to expenses over
a
weighted-average period of 18 months.
Options
and Warrants Outstanding
In
addition to options and warrants granted for compensatory purposes, the Company
also issues warrants from time to time in conjunction with financing
transactions. A summary of applicable stock option and warrant activity and
related information for the six months ended June 30, 2008, is as
follows:
|
|
Options
and
Warrants
|
|
Weighted-Average
Exercise Price
|
|
Outstanding
at beginning of period
|
|
|
122,331,693
|
|
$
|
0.19
|
|
Granted
|
|
|
850,000
|
|
$
|
0.11
|
|
Exercised
|
|
|
—
|
|
|
—
|
|
Forfeited
|
|
|
50,000
|
|
$
|
0.91
|
|
Outstanding
at end of period
|
|
|
123,131,693
|
|
$
|
0.19
|
|
Exercisable
at end of period
|
|
|
114,228,471
|
|
$
|
0.19
|
|
The
fair
value of option grants is estimated at the date of grant using the Black-Scholes
model. The options and warrants expire at various times through July 2017.
The
weighted-average exercise price of warrants granted during the first six months
of 2008 was $0.11.
The
fair
value of option grants is estimated at the date of grant using the Black-Scholes
model. The following table shows the options and warrants outstanding by strike
price with the average expected remaining term of the instruments, in years,
as
of June 30, 2008.
Exercise
Price Range
|
|
Options & Warrants
Outstanding
|
|
Weighted-Average
Remaining Term
|
|
Vested Options &
Warrants
|
|
Weighted-Average
Remaining Term
|
|
$0.090
- $0.143
|
|
|
15,988,178
|
|
|
3.50
|
|
|
8,042,425
|
|
|
0.57
|
|
$0.150
- $0.190
|
|
|
90,915,400
|
|
|
3.93
|
|
|
90,252,900
|
|
|
3.91
|
|
$0.285
- $0.330
|
|
|
2,347,792
|
|
|
3.39
|
|
|
2,052,823
|
|
|
3.31
|
|
$0.340
- $0.390
|
|
|
5,682,293
|
|
|
1.34
|
|
|
5,682,293
|
|
|
1.34
|
|
$0.410
- $0.470
|
|
|
7,603,030
|
|
|
1.76
|
|
|
7,603,030
|
|
|
1.76
|
|
$0.890
- $0.906
|
|
|
230,000
|
|
|
0.34
|
|
|
230,000
|
|
|
0.34
|
|
$2.940
|
|
|
240,000
|
|
|
0.34
|
|
|
240,000
|
|
|
0.34
|
|
$8.240
|
|
|
125,000
|
|
|
3.34
|
|
|
125,000
|
|
|
3.34
|
|
|
|
|
123,131,693
|
|
|
|
|
|
114,228,471
|
|
|
|
|
Earnings
Per Share
Net
loss
per share is based on net loss divided by the weighted average number of shares
of common stock outstanding during the respective periods. Diluted earnings
per
share information is not presented, as the effects of stock options, warrants
and other convertible securities would be anti-dilutive for the periods
presented.
4.
License
and Research Agreements
In
November 1995, the Company entered into an agreement with TJU for the exclusive
worldwide license to develop, manufacture and sell the Invention
(see
Note 1)
.
In
consideration for the license agreement, the Company paid cash of $10,000 and
issued an aggregate of 458,243 shares of common stock to TJU and the scientific
founder (the “Scientist”).
Under
the
terms of the license agreement, the Company is obligated to (i) pay certain
milestone payments as follows: $10,000 upon initiation of the first clinical
trial that is approved by the Food and Drug Administration (“FDA”) or comparable
international agency, $10,000 upon the first filing of a New Drug Application
(“NDA”) with the FDA or comparable international agency, and $25,000 upon
receipt by the Company of approval from the FDA or comparable international
agency to market products, (ii) enter into a research agreement to fund a study
to be performed by TJU for the development of the technology related to the
Invention (the “Study”) at approximately $220,000 per annum for the first three
years, and (iii) following the third year, spend an aggregate of $500,000 per
year (which includes costs incurred pursuant to the research agreement plus
other internal and external costs) on the development of the Invention until
commercialized in the United States. If following the third year, the Company
files for United States marketing approval through a Company sponsored NDA,
the
Company may elect to spend less than $500,000 per year on the development of
the
Invention during the period of time the NDA is under review by the FDA. During
2000, a payment of $25,000 was made to TJU pursuant to the license agreement.
In
addition, the Company is obligated to pay royalties on its worldwide net revenue
derived from the Invention and a percentage of all revenues received from
sub-licensees of the Invention
.
The
research agreement with TJU mentioned above was to continue until completion
of
the study, although it is terminable, upon notice by either party to the other,
at any time. The Company has maintained the appropriate level of spending on
the
development of the Invention in accordance with the license
agreement.
In
February 1997, the Company licensed from Texas A&M University (“Texas
A&M”) an issued U.S. patent and certain U.S. and foreign patent applications
relating to a series of novel cancer-fighting anti-estrogen compounds that
may
be
especially
effective against hormone-dependent tumors. The development of the anti-estrogen
compounds is no longer a part of the Company‘s plan of operation. The Company
has been notified by Texas A&M that Texas A&M considers the Company to
be in violation of the license agreement and that the Company’s rights under the
license agreement have been revoked. The Company disputes the contention by
Texas A&M and the Company is attempting to return the technology to the
University. Texas A&M has filed a lawsuit against the Company seeking
reimbursement from the Company for certain patent expenses incurred by the
university from the Company. Although the disputed amount is fully accrued
in the attached financial statements, the Company continues to dispute certain
amounts that are claimed by the university.
5.
ANVAR
Advances
Genopoietic
receives financial support from a French governmental agency (“ANVAR”). These
advances are subject to conditions specifying that non-compliance with such
conditions could result in the forfeiture of all or a portion of the future
amounts to be received, as well as the repayment of all or a portion of amounts
received to date. If certain products are commercialized, the June 30, 2008
balance of $432,138 is repayable based on an annual royalty equal to 47% of
the
revenue related to the project. As such, the total amount of advances received
was recorded as a liability in the accompanying consolidated balance sheet.
In
case of failure or partial success, as defined in the agreement, $96,378 is
payable. The due date for the obligation has passed but the grantor agency
has
not demanded repayment of the obligation. Due to the uncertainty regarding
the
amount that to will be required to be repaid to ANVAR, the Company maintains
the
full amount of the obligation as a current liability.
Item
2.
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
Cautionary
Statement Regarding Forward-Looking Statements
In
this
report, in other filings with the Securities and Exchange Commission (“SEC”) and
in press releases and other public communications throughout the year, AVAX
Technologies, Inc. (“AVAX,” the “Company,” “we” or “us”) makes, or will make
statements that plan for or anticipate the future. These forward-looking
statements involve risks and uncertainties, including, among other things:
statements about the future of biotechnology products and the biopharmaceutical
industry, statements about our future business plans and strategies, and other
statements that are not historical in nature. These forward-looking statements
are based on our current expectations. Many of these statements are found in
this “Management’s Discussion and Analysis of Financial Condition and Results of
Operations.”
Forward-looking
statements may be identified by words or phrases such as “believe,” “expect,”
“anticipate,” “should,” “planned,” “may,” “estimated” and “potential.” The
Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for
forward-looking statements. In order to comply with the terms of the safe
harbor, and because forward-looking statements involve future risks and
uncertainties, listed below are a variety of factors that could cause actual
results and experience to differ materially from the anticipated results or
other expectations expressed in our forward-looking statements. These factors
include:
|
·
|
Our
history of operating losses, our continuing cash requirements, our
immediate need to raise capital in the third quarter of 2008 and
substantial capital thereafter, and the uncertainty of our prospects
of
reaching a meaningful level of
revenues.
|
|
·
|
The
business uncertainties arising from our decision to conduct all AC
Vaccine
manufacturing activities at our Lyon, France facility and the logistical
issues and risks relating to shipping biologics from the U.S. and
other
countries to France and the vaccine from France to patients in the
U.S.
and other countries.
|
|
·
|
Uncertainty
about whether our products will successfully complete the long, complex
and expensive clinical trial and regulatory approval process for
approval
of new drugs in the U.S. and certain European countries.
|
|
·
|
Uncertainty
about whether our AC Vaccine technology can be developed to produce
safe
and effective products and, if so, whether our AC Vaccine products
will be
commercially accepted and
profitable.
|
|
·
|
Difficulties
arising from our competition with other companies conducting clinical
trials and treatment regimens for patients and clinical sites for
our
clinical trials.
|
|
·
|
The
expenses, delays, uncertainties and complications typically encountered
by
development stage biopharmaceutical businesses, many of which are
beyond
our control.
|
|
·
|
Our
financial and development obligations and our responsibility to meet
requisite research funding levels under our license agreements in
order to
protect our rights to our products and
technologies.
|
|
·
|
Each
of the other factors discussed in our Annual Report on Form 10-K
for the
year ended December 31, 2007, under Item 1A – “Risk
Factors.”
|
GENERAL
Since
our
inception, we have primarily concentrated our efforts and resources on the
development and commercialization of individualized vaccine therapies and other
technologies for the treatment of cancer. These efforts require that we expend
money in the development and clinical testing of our products.
We
have
been unprofitable since our founding and we fund our losses primarily through
equity offerings of equity and debt. We incurred net losses of $6,413,648 and
$5,355,500 for the 12 months ended December 31, 2007 and 2006, respectively,
and
$3,806,635 for the six months ended June 30, 2008. We have a cumulative net
loss
of $89,931,498 as of June 30, 2008. We expect to continue to incur operating
losses, primarily due to the expenses associated with our product development
efforts, and the cost of maintaining our manufacturing facilities in Europe
and
the U.S.
Our
ability to continue as an operating company depends upon our immediate need
to
raise capital. We are in discussions with investors for a proposed bridge
financing (the “Bridge Financing”) for the purpose of raising funds for working
capital for the next few months, but there can be no assurance that we will
complete the Bridge Financing or that the terms of such financing will be
favorable to us or our existing stockholders. To the extent that we issue
securities that are not registered under the Securities Act of 1933, as amended
(the “Act”) in connection with the proposed Bridge Financing, the securities may
not be offered or sold in the United States absent registration or an applicable
exemption from registration. Even if we complete a Bridge Financing, we will
need to raise additional funds immediately if we are to continue as a going
concern. If we are successful in raising sufficient additional capital, it
should allow us to develop products, obtain regulatory approval for our proposed
products, and enter into agreements for product development, manufacturing
and
commercialization.
There is
no assurance that additional capital can be raised in an amount which is
sufficient for all such purposes, or on terms favorable to us or to our
stockholders.
In
the
event that we do not complete the Bridge Financing or raise additional
financing,
it
will
be difficult for the Company to continue operations as they exist. We may be
forced to shut down our operations or seek bankruptcy relief. If we
discontinue our operations, we may not have sufficient funds to pay
any
amounts to our stockholders.
Our
M-Vax
product does not currently generate any material revenue, and we may never
achieve significant revenues or profitable operations from the sale of M-Vax
or
any other products that we may develop.
The
major
challenges for others and us in the biopharmaceutical industry are the
significant costs, time and uncertainties related to efforts to obtain
regulatory approval to market drug products in the U.S. and foreign countries.
We have encountered a number of these challenges in our efforts to develop
the
AC Vaccine into marketable products including the following:
|
·
|
the
FDA clinical hold of our AC Vaccine clinical trials in 2001 and the
resultant substantial expenses and delays in resolving the FDA concerns
and refiling new INDs for a revised AC
Vaccine;
|
|
·
|
manufacturing
challenges relating to the production of a vaccine from the patient’s own
cancer cells, such as the sterility issues we previously experienced
at
our Philadelphia facility;
|
|
·
|
our
failure to develop a market for the AC Vaccine in Australia
notwithstanding substantial expenditures of time and money to do
so;
|
|
·
|
our
past inability to agree with the FDA on an acceptable potency assay
(which
is a biological measure of the drug’s active ingredients) of our product
prior to administration of the vaccine, which was required before
we could
commence our Phase III registration trial for
M-Vax;
|
|
·
|
our
inability to generate any meaningful revenues from any other products
or
services while we work to develop our lead products and technologies;
and
|
|
·
|
the
periodic cutbacks in our development plans and programs due to the
limited
cash resources from time to time in recent years and in particular,
currently.
|
As
a
result of the FDA clinical hold, we concluded that (1) it would no longer be
feasible to continue the clinical development of the original AC Vaccine using
the established manufacturing format (referred to as the “fresh” vaccine product
format), and (2) a revised product format needed to be established, tested
and
reviewed by the FDA. Through these research and development activities we
re-engineered the manufacturing steps for the production and distribution of
the
AC Vaccine, referred to as the “frozen” vaccine technology, which we believe has
substantial advantages over the former “fresh” product.
Results
of Operations for the Three and Six Months Ended June 30, 2008 compared with
the
comparable periods ended June 30, 2007
Revenue
Revenue
recognized for the three and six months ended June 30, 2008 were $96,430 and
$216,548, respectively, compared with revenue of $58,769 and $203,316,
respectively, for the same periods in 2007. The increase in revenues for the
three months ended June 30, 2008 was due to higher manufacturing
reimbursements related to compassionate use treatments and higher revenues
realized from contract manufacturing. The increase in revenues for the six
months ended June 30, 2008 was due to a higher exchange rate in the current
year.
Research
and Development Expenses
Our
research and development activities focus primarily on clinical development
and
trials of our AC Vaccine technology for the treatment of melanoma, ovarian
cancer, lung cancer and other cancers. Our clinical development program includes
the development of techniques, procedures and tests that need to be developed
as
part of the manufacturing of our biological product so that the product can
be
evaluated and potentially approved by regulatory authorities.
Our
research and development expenses consist primarily of costs associated with
the
clinical trials of our product candidates, compensation and other expenses
for
research personnel, payments to collaborators under contract research
agreements, costs for our consultants and compensation, materials, maintenance
and supplies for the operation and maintenance of our biological clean room
facilities, which are necessary for the production of materials to be used
in
clinical trials. All of these costs qualify as research and development expenses
in accordance with the guidance included in Statement of Financial Accounting
Standards No. 2 “Accounting for Research and Development Costs.”
Manufacturing
costs included in this category relate to the costs of developing, supporting
and maintaining facilities and personnel that produce clinical samples in
compliance with cGMP. Our facilities and the personnel maintained for
manufacturing are currently at what we feel are the minimum required for
compliance with cGMP. Based upon the current capacity of our facilities, our
personnel and our current and future planned clinical trials, we have excess
capacity for the production and testing of biological products. We use this
excess capacity to generate cash in the form of contract manufacturing
alliances. Because the incremental costs incurred to provide these services
are
not material or quantifiable, they are not presented separately.
Contract
manufacturing encompasses services we provide to other biotechnology or
pharmaceutical companies that are pursuing the clinical development of
biological products. The engagements generally consist of two components. The
first component is process validation in which the contracting company provides
information on its product and the processes and techniques used to produce
the
product. Procedures are developed, documented and catalogued for the cGMP
production of the product using known and acceptable techniques, tests and
materials. Small-scale lots are produced, and techniques, feasibility of the
production processes and tests validated. The end product of the first phase
of
an engagement is a pilot batch of product and the necessary production
formulation and techniques to be used to file an IND with regulatory authorities
for human clinical trials. The second phase of an engagement consists of the
production of batches of product to be used in human clinical trials. The
typical engagement results in production of small batches of product to be
used
in early stage (Phase I and II) clinical trials.
Research
and development costs incurred through June 30, 2008 were $54,607,978. The
majority of these costs relate to clinical research and development of our
AC
Vaccine technology. Our management estimates that greater than 90% of the
periodic and cumulative research and development expenses incurred relate to
our
one major program, the AC Vaccine. At this time, due to the risks inherent
in
the clinical trial process, risks associated with the product and product
characterization, risks associated with regulatory review and approval of
clinical product candidates and the limited funds available, we are unable
to
estimate with any certainty the costs we will incur in the continued development
of our product candidates for commercialization.
During
the three months ended June 30, 2008, research and development expenses
increased 17.9% from $1,041,708 as of June 30, 2007 to $1,228,394 as of June
30,
2008. For the six-month period ended June 30, 2008, expenses increased 15.0%
from $2,051,497 as of June 30, 2007 to $2,360,238 as of June 30, 2008. Expenses
for the periods are broken out by region as follows:
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
United
States
|
|
$
|
583,693
|
|
$
|
584,380
|
|
$
|
1,071,558
|
|
$
|
1,052,191
|
|
France
|
|
|
644,701
|
|
|
457,328
|
|
|
1,288,680
|
|
|
999,306
|
|
|
|
$
|
1,228,394
|
|
$
|
1,041,708
|
|
$
|
2,360,238
|
|
$
|
2,051,497
|
|
In
the
U.S., the expense increase in 2008 is the result of the launch of the Phase
III
registration study, MAVALDI, for M-Vax in the U.S., Europe and Israel. The
increased research costs related to new site initiation
fees
plus
costs incurred for the contract research organization. These increased expenses
were partially offset by a decline in expenses for the Phase I/II study in
M-Vax, which was completed during 2007. The increase in costs in France was
due
to higher salaries and taxes for new employees plus higher facility costs
related to an increase in the amount of space.
Selling,
General and Administrative Expenses
During
the three months ended June 30, 2008, selling, general and administrative
expenses increased approximately 21.0%, from $623,374 as of June 30, 2007 to
$754,335, and for the six month period ended June 30, 2008, expenses increased
approximately 57.0% from $1,094,193 as of June 30, 2007 to $1,718,073. Expenses
for the periods are broken out by region as follows:
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
United
States
|
|
$
|
702,600
|
|
$
|
489,498
|
|
$
|
1,616,126
|
|
$
|
864,775
|
|
France
|
|
|
51,735
|
|
|
133,776
|
|
|
101,946
|
|
|
229,418
|
|
|
|
$
|
754,335
|
|
$
|
623,274
|
|
$
|
1,718,072
|
|
$
|
1,094,193
|
|
In
the
U.S., the expense increase in 2008 is the result of higher salary costs and
related expense for the Company’s new executive officer, salary increases for
existing administrative staff and higher consulting costs to improving existing
accounting and financial processes necessary for Sarbanes-Oxley 404 compliance
by year end. In addition, there were increased legal costs including for
securities and employment matters, financing efforts and patent counsel in
connection with the filing and execution of ongoing patent expenses. Also,
there
were increased costs for travel, investor relations and public relations
activities related to on-going financing activities. The decrease in
administrative costs in France is due to one less administrative person in
2008
and less spending on marketing and logistics activities for Phase III Mvax
clinical trials.
Other
income, net decreased from $84,565 and $94,878 earned in the three and six
months ended June 30, 2007, to $11,204 and $52,849 for the comparable periods
in
2008. The decrease is the function of lower interest rates with a lower average
invested balance of cash.
Assuming
we are successful in raising additional capital, we anticipate our spending
over
the next 12 months for research and development and selling, general and
administrative expenses will increase as compared with 2008, as we continue
to
implement and accelerate the plan of operation described above.
Liquidity
and Capital Resources
Our
ability to continue as an operating company depends upon our immediate need
to
raise capital. We are in discussions with investors for a proposed Bridge
Financing for the purpose of raising funds for working capital for the next
few
months, but there can be no assurance that we will complete the Bridge Financing
or that the terms of such financing will be favorable to us or our existing
stockholders. To the extent that we issue securities that are not registered
under the Act in connection with the proposed Bridge Financing, the securities
may not be offered or sold in the United States absent registration or an
applicable exemption from registration. Even if we complete a Bridge Financing,
we will need to raise additional funds immediately if we are to continue as
a
going concern. If we are successful in raising sufficient additional capital,
it
should allow us to develop products, obtain regulatory approval for our proposed
products, and enter into agreements for product development, manufacturing
and
commercialization.
There
is
no assurance that additional capital can be raised in an amount which is
sufficient for all such purposes, or on terms favorable to us or to our
stockholders.
Our
current extremely limited cash resources require that we significantly curtail
our efforts to enlist new clinical sites for the Phase III registration trial
for M-Vax and to significantly slow the patient enrollment in that trial until
we are successful in raising additional capital. We will use the proceeds of
any
offering primarily to fund the additional costs associated with enlisting
clinical sites for and patient enrollment in the Phase III trial for M-Vax
and
to initiate the Phase II clinical trial for O-Vax (“O-Vax”),, the Company’s AC
Vaccine for ovarian cancer, in the United States. To implement the current
plan
of operation described above for the balance of 2008 and into the first quarter
of 2009, we need to raise substantial additional capital. If we are able to
raise this additional capital, the key components of our plan of operation
for
the balance of 2008 and the first quarter of 2009 will include:
|
·
|
Enrolling
patients in our Phase III registration trial U.S. for M-Vax for the
treatment of Stage 3 and 4 melanoma patients, which trial will proceed
under the Special Protocol Assessment that we received from the U.S.
FDA
in October 2006.
|
|
·
|
Continuing
the treatment of melanoma patients outside the U.S. on a compassionate
use
basis with M-Vax.
|
|
·
|
Initiating
the launch of the O-Vax study with Cancer Treatment Centers of
America.
|
|
·
|
Continuing
our discussions with the European Medical Evaluations Agency and
AFSSAPs,
the FDA equivalent regulatory bodies for the European Union and France,
respectively, regarding the regulatory requirements for the AC Vaccine
and
its continued development in Europe and
France.
|
|
·
|
Initiating
discussion with Japanese regulatory authorities regarding the regulatory
approval process for autologous products like our AC Vaccines and
the
requirements for making M-Vax available for compassionate use in
Japan.
|
We
continually evaluate our plan of operation discussed above to determine the
manner in which we can most effectively utilize our limited cash resources.
The
timing of completion of any aspect of our plan of operations is highly dependent
upon the availability of cash to implement that aspect of the plan and other
factors beyond our control.
Even
if
we raise substantial additional capital in the near future, if our current
and
planned clinical trials for the AC Vaccine in the U.S. and Europe do not
demonstrate continuing progress toward taking one or more products to market,
our ability to raise additional capital in the future to fund our product
development efforts would likely be seriously impaired. The ability of a
biotechnology company, such as AVAX, to raise additional capital in the
marketplace to fund its continuing development operations is conditioned upon
the Company continuing to move its development products toward ultimate
regulatory approval and commercialization. If in the future we are not able
to
demonstrate adequate progress in the development of one or more products, we
will not be able to raise the capital we need to continue our then-current
business operations and business activities, and we will likely not have
sufficient liquidity or cash resources to continue operating.
We
conduct our capital raising efforts in U.S. dollars, while a significant portion
of our revenues and expenses are generated and incurred in currencies other
than
U.S. dollars, mainly Euros. To the extent that we are unable to match revenues
received in foreign currencies with costs paid in the same currency, exchange
rate fluctuations in any such currency could have an adverse effect on our
results of operations and cash flows.
Because
our working capital requirements depend upon numerous factors, including
progress of our research and development programs, pre-clinical and clinical
testing, timing and cost of obtaining regulatory approvals, changes in levels
of
resources that we devote to the development of manufacturing and marketing
capabilities, competitive and technological advances, status of competitors,
and
our ability to establish collaborative arrangements with other organizations,
there can be no assurance that our current cash resources will be sufficient
to
fund our operations beyond August 2008. Because we have no committed external
sources of capital, and expect no significant product revenues for the
foreseeable future, we will require additional financing to fund future
operations or will need to enter into contract manufacturing relationships
on
terms favorable to us. There can be no assurance, however, that we will be
able
to obtain the additional funds sought in this offering or attract
contract-manufacturing relationships on acceptable terms, if at all and we
may
have to cease operations. We have begun to curtail certain initiatives and
projects, including the deferral of senior management salaries, due to the
fact
we have not raised additional capital as of the date of this
report.
In
the
event that we do not complete the Bridge Financing or raise additional
financing, it will be difficult for the Company to continue operations as they
exist. We may be forced to shut down our operations or seek bankruptcy
relief. If we discontinue our operations, we may not have sufficient funds
to pay any amounts to our stockholders.
Item
3.
Quantitative
and Qualitative Disclosures About Market Risk.
Not
applicable as we are a smaller reporting company.
Item
4T. Controls and Procedures.
Conclusion
Regarding the Effectiveness of Disclosure Controls and
Procedures
We
maintain disclosure controls and procedures that are designed to ensure that
information required to be disclosed in our reports filed or submitted pursuant
to the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is
recorded, processed, summarized and reported within the time periods specified
in the SEC’s rules and forms, and that information required to be disclosed by
us is accumulated and communicated to management, including our President and
Chief Executive Officer and our Executive Chairman to allow timely decisions
regarding required disclosure.
Under
the
supervision and with the participation of our management, including our
President and Chief Executive Officer and our Executive Chairman, we carried
out
an evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures pursuant to Exchange Act Rule 13a-15(e) and 15d-15(e)
as
of June 30, 2008. Based upon that evaluation, our President and Chief Executive
Officer and our Executive Chairman concluded that our disclosure controls and
procedures were not effective as of June 30, 2008, due to the material weakness
described in our Management’s Report on Internal Control Over Financial
Reporting previously reported in our Form 10-K for the year ended December
31,
2007. These included:
|
o
|
Our
lack of sufficient personnel at the U.S. headquarters in the accounting,
treasury and financial reporting functions affected our ability to
have
adequate segregation of duties over financial transactions and adequate
monitoring controls over the annual and quarterly financial close
processes.
|
|
o
|
The
lack of segregation of duties often results in the same individual
performing two or more of the following functions: initiation and
authorization of financial transactions, recording of transactions,
and
custody of financial assets. The lack of segregation of duties also
prevented us from satisfying important monitoring control objectives,
such
as authorization, completeness and accuracy, and reconciliation of
accounting transactions and information.
|
In
light
of the material weaknesses, in preparing our consolidated financial statements
as of and for the quarter ended June 30, 2008, we performed additional analyses
and other post-closing procedures to ensure our consolidated financial
statements included in this quarterly report fairly present, in all material
respects, our financial condition, results of operations and cash flows for
the
fiscal years covered thereby in conformity with generally accepted accounting
principles.
Changes
in Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting, as such term
is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during
the
three months ended June 30, 2008, that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
We
plan
to take corrective actions to remediate the material weaknesses noted above.
Specifically, assuming we are successful in raising additional capital, we
plan
to hire additional qualified personnel to assist with various accounting and
finance functions within the organization. We believe this new personnel will
reduce the risk associated with our lack of segregation of duties and thus
enhance our system of internal controls over financial reporting.
Management
believes that the actions described above, when fully implemented, will be
effective in remediation of the specific material weakness discussed
above.
Limitations
of Effectiveness of Controls
As
of the
date of this filing, we are satisfied that actions implemented to date and
the
planned actions described above will remediate the material weaknesses and
deficiencies in the internal controls and information systems that have been
identified. We note that, like other companies, any system of internal controls,
however well designed and operated, can provide only reasonable assurance,
and
not absolute assurance, that the objectives of the internal control system
will
be met. The design of any control system is based, in part, upon the benefits
of
the control system relative to its costs. Because of the inherent limitations
in
all control systems, no evaluation of controls can provide absolute assurance
that all control issues and instances of fraud, if any, within the Company
have
been detected. These inherent limitations include the realities that judgments
in decision-making can be faulty, and that controls can be circumvented by
the
individual acts of some persons, by collusion of two or more people or by
management override of control. In addition, over time, controls may become
inadequate because of changes in conditions, or the degree of compliance with
the policies or procedures may deteriorate. In addition, the design of any
control system is based in part upon certain assumptions about the likelihood
of
future events. Because of the limitations inherent in a cost-effective control
system, misstatements due to error or fraud may occur and may not be
detected.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings.
On
February 1, 2008, a suit was filed against us by Texas A&M University in the
United States District Court of Brazos County, Texas as previously disclosed
in
our Form 10-K, filed with the SEC on April 15, 2008.
Discovery
efforts have begun and the Company is considering alternatives to resolve the
suit.
On
July
16, 2008, a suit was filed against us by the University of Colorado in the
Adams
County, Colorado District Court. The lawsuit by the University of
Colorado alleges that the Company is in breach of a clinical research
contract by failing to reimburse the University of Colorado for approximately
$84,000 in patient enrollment and treatment expenses. The Company has previously
responded that it disputes the amount billed based on milestones and other
treatment criteria per the terms and conditions of the agreement. No discovery
has begun in this matter.
The
Company is subject to various legal proceedings and claims that arise in the
ordinary course of its business. We believe that the ultimate liability with
respect to these actions will not have a material adverse effect on the
Company’s financial position.
Item
1A. Risk Factors.
Not
applicable as we are a smaller reporting company.
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds.
None.
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Submission of Matters to a Vote of Security Holders.
None.
Item
5. Other Information.
None.
Item
6.
Exhibits.
31.1
|
Certification
of Principal Executive Officer and Principal Financial Officer of
the
Company under Rule 13a-14(a), as adopted pursuant to Section 302
of the
Sarbanes-Oxley Act of 2002. *
|
|
|
32.1
|
Certification
of Principal Executive Officer and Principal Financial Officer pursuant
to
18 U.S.C. Section 1350. *
|
*
Filed
herewith
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.
|
AVAX
Technologies, Inc.
|
|
|
|
Date:
August
15, 2008
|
|
|
|
|
|
|
By:
|
/s/
Francois Martelet
|
|
|
Francois
Martelet
|
|
|
President
and Chief Executive Officer
|
|
|
(Principal
Executive Officer and
|
|
|
Principal
Financial Officer)
|
AVAX Technologies (CE) (USOTC:AVXT)
Gráfico Histórico do Ativo
De Nov 2024 até Dez 2024
AVAX Technologies (CE) (USOTC:AVXT)
Gráfico Histórico do Ativo
De Dez 2023 até Dez 2024