UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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|
For
the quarterly period ended June 30,
2009.
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¨
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TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT
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For
the transition period from ________ to
__________
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Commission
File Number: 000-50614
ORAGENICS,
INC.
(Exact
name of small business issuer as specified in its charter)
FLORIDA
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59-3410522
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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13700 Progress
Boulevard
Alachua,
Florida 32615
(Address
of principal executive offices)
(386)
418-4018
(Issuer's
telephone number)
Check
whether the issuer (1) filed all reports required to be filed by Section 13 or
15(d) of the Exchange Act during the past 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 has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit
and post such files). Yes o No o
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
the definitions of “large accelerated filer, “accelerated filer,”
“non-accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
Large accelerated
filer
|
¨
|
Accelerated
filer
|
¨
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Non-accelerated
filer
|
¨
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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
State the
number of shares outstanding of each of the issuer’s classes of common equity,
as of the latest practicable date:
As of
August 14, 2009, there were 90,366,898 shares of Common Stock, $.001 par value,
outstanding.
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Page
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PART
I – FINANCIAL INFORMATION
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Item
1.
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Financial
Statements
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3
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Balance
Sheets as of June 30, 2009 (unaudited) and December 31,
2008
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3
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Statements
of Operations for the Three and Six Months ended June 30, 2009 and 2008
(unaudited)
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4
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Statements
of Cash Flows for the Six Months ended June 30, 2009 and 2008
(unaudited)
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5
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Notes
to Financial Statements (unaudited)
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6
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Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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9
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Item
4T.
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20
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PART
II – OTHER INFORMATION
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Item
1.
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Legal
Proceedings
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21
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Item
1A.
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Risk
Factors
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21
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Item
2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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24
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Item
5.
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Other
Information
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25
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Item
6.
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Exhibits
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25
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PART
I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL
STATEMENTS
Oragenics,
Inc.
Balance
Sheets
|
|
June
30,
|
|
|
December
31,
|
|
Assets
|
|
2009
|
|
|
2008
|
|
|
|
(Unaudited)
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
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Cash
and cash equivalents
|
|
$ |
1,819,686 |
|
|
$ |
1,165,933 |
|
Accounts
receivables, trade net
|
|
|
20,248 |
|
|
|
6,286 |
|
Inventory
|
|
|
42,805 |
|
|
|
11,814 |
|
Prepaid
expenses and other current assets
|
|
|
69,731 |
|
|
|
86,666 |
|
|
|
|
|
|
|
|
|
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Total
current assets
|
|
|
1,952,470 |
|
|
|
1,270,699 |
|
|
|
|
|
|
|
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Property
and equipment, net
|
|
|
174,604 |
|
|
|
323,424 |
|
|
|
|
|
|
|
|
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Total
assets
|
|
$ |
2,127,074 |
|
|
$ |
1,594,123 |
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Liabilities
and Shareholders' Deficit
|
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Current
liabilities:
|
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|
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Accounts
payable and accrued expenses
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$ |
2,282,893 |
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$ |
1,743,684 |
|
Short
term notes payable
|
|
|
131,852 |
|
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|
27,687 |
|
|
|
|
|
|
|
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Total
current liabilities
|
|
|
2,414,745 |
|
|
|
1,771,371 |
|
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|
|
|
|
|
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Long
term note payable
|
|
|
1,000,000 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
3,414,745 |
|
|
|
1,771,371 |
|
|
|
|
|
|
|
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Shareholders'
deficit:
|
|
|
|
|
|
|
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Preferred
stock, no par value; 20,000,000 shares authorized; none issued and
outstanding
|
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|
- |
|
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|
- |
|
Common
stock, $0.001 par value; 100,000,000 shares authorized; 90,366,898
and
|
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|
|
|
|
|
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|
38,316,585
shares issued and outstanding at June 30, 2009 and December
31,
|
|
|
|
|
|
|
|
|
2008
respectively.
|
|
|
90,367 |
|
|
|
38,316 |
|
Additional
paid-in capital
|
|
|
23,963,895 |
|
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|
19,776,971 |
|
Stock
subscriptions receivable
|
|
|
(2,500,000 |
) |
|
|
- |
|
Accumulated
deficit
|
|
|
(22,841,933 |
) |
|
|
(19,992,535 |
) |
|
|
|
|
|
|
|
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Total
shareholders' deficit
|
|
|
(1,287,671 |
) |
|
|
(177,248 |
) |
|
|
|
|
|
|
|
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|
Total
liabilities and shareholders' deficit
|
|
$ |
2,127,074 |
|
|
$ |
1,594,123 |
|
See
accompanying notes.
Oragenics,
Inc.
Statements
of Operations
(Unaudited)
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Three
months ended
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Six
months ended
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June
30
|
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|
June
30
|
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|
2009
|
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|
2008
|
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|
2009
|
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|
2008
|
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|
|
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Revenues
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|
$ |
41,895 |
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|
$ |
- |
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$ |
166,167 |
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$ |
125,000 |
|
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|
|
|
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Cost
of sales
|
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|
23,604 |
|
|
|
- |
|
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|
35,384 |
|
|
|
- |
|
|
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Operating
expenses:
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Research
and development
|
|
|
394,311 |
|
|
|
492,667 |
|
|
|
979,975 |
|
|
|
971,040 |
|
Selling,
general and administrative
|
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|
1,211,017 |
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|
618,886 |
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2,718,172 |
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|
1,066,608 |
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|
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Total
operating expenses
|
|
|
1,605,328 |
|
|
|
1,111,553 |
|
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|
3,698,147 |
|
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|
2,037,648 |
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|
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Loss
from operations
|
|
|
(1,587,037 |
) |
|
|
(1,111,553 |
) |
|
|
(3,567,364 |
) |
|
|
(1,912,648 |
) |
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
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Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
- |
|
|
|
9,731 |
|
|
|
522 |
|
|
|
14,330 |
|
Interest
expense
|
|
|
(959 |
) |
|
|
- |
|
|
|
(1,504 |
) |
|
|
- |
|
Gain
on sale of property and equipment
|
|
|
11,274 |
|
|
|
- |
|
|
|
11,274 |
|
|
|
4,860 |
|
Gain
on extinguishment of payables
|
|
|
707,674 |
|
|
|
- |
|
|
|
707,674 |
|
|
|
- |
|
Sales
tax refund
|
|
|
- |
|
|
|
6,710 |
|
|
|
- |
|
|
|
6,710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
other income, net
|
|
|
717,989 |
|
|
|
16,441 |
|
|
|
717,966 |
|
|
|
25,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
before income taxes
|
|
|
(869,048 |
) |
|
|
(1,095,112 |
) |
|
|
(2,849,398 |
) |
|
|
(1,886,748 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(869,048 |
) |
|
$ |
(1,095,112 |
) |
|
$ |
(2,849,398 |
) |
|
$ |
(1,886,748 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share
|
|
$ |
(0.02 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
used to compute basic and diluted net loss per share
|
|
|
38,894,921 |
|
|
|
33,694,363 |
|
|
|
38,604,155 |
|
|
|
31,768,114 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes.
Oragenics,
Inc.
Statements
of Cash Flows
(Unaudited)
|
|
Six
months ended
|
|
|
|
June
30
|
|
|
|
2009
|
|
|
2008
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(2,849,398 |
) |
|
$ |
(1,886,748 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Non-cash
bonus paid in common stock
|
|
|
100,000 |
|
|
|
- |
|
Depreciation
and amortization
|
|
|
141,168 |
|
|
|
125,581 |
|
Stock-based
compensation expense
|
|
|
33,943 |
|
|
|
454,527 |
|
Gain
on extinguishment of payables
|
|
|
(707,674 |
) |
|
|
- |
|
Gain
on sale of property and equipment
|
|
|
(11,274 |
) |
|
|
(4,860 |
) |
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable, net
|
|
|
(13,962 |
) |
|
|
- |
|
Inventory
|
|
|
(30,991 |
) |
|
|
- |
|
Prepaid
expenses and other current assets
|
|
|
16,935 |
|
|
|
(84,479 |
) |
Accounts
payable and accrued expenses
|
|
|
1,107,632 |
|
|
|
8,401 |
|
Deferred
compensation
|
|
|
211,727 |
|
|
|
(43,750 |
) |
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(2,001,894 |
) |
|
|
(1,431,328 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchase
of property and equipment, net
|
|
|
(9,074 |
) |
|
|
(17,500 |
) |
Proceeds
from sale of property and equipment, net
|
|
|
28,000 |
|
|
|
27,250 |
|
|
|
|
|
|
|
|
|
|
Net
cash provided by investing activities
|
|
|
18,926 |
|
|
|
9,750 |
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Borrowings
under short term note payable
|
|
|
198,742 |
|
|
|
69,215 |
|
Borrowings
under long term note payable
|
|
|
1,000,000 |
|
|
|
- |
|
Payments
on short term note payable
|
|
|
(62,021 |
) |
|
|
- |
|
Net
proceeds from issuance of common stock
|
|
|
1,500,000 |
|
|
|
4,511,000 |
|
|
|
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
|
|
2,636,721 |
|
|
|
4,580,215 |
|
|
|
|
|
|
|
|
|
|
Net
increase in cash and cash equivalents
|
|
|
653,753 |
|
|
|
3,158,637 |
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at beginning of the period
|
|
|
1,165,933 |
|
|
|
475,508 |
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at end of the period
|
|
$ |
1,819,686 |
|
|
$ |
3,634,145 |
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
paid
|
|
$ |
1,503 |
|
|
$ |
- |
|
Non-cash
investing and financing activities:
|
|
|
|
|
|
|
|
|
Stock
subscription receivable
|
|
$ |
2,500,000 |
|
|
$ |
- |
|
Issuance
of common stock to employees as
|
|
|
|
|
|
|
|
|
settlement
of amounts owed
|
|
$ |
205,032 |
|
|
$ |
- |
|
See
accompanying notes.
Oragenics,
Inc.
Notes
to Financial Statements
(Unaudited)
1.
|
Organization
and Significant Accounting
Policies
|
Oragenics,
Inc. (the “Company”) was incorporated in November 1996; however, operating
activity did not commence until 1999. The Company is dedicated to developing
technologies associated with oral health, broad spectrum antibiotics and general
health benefits.
Basis of
Presentation
The
accompanying unaudited condensed financial statements as of June 30, 2009 and
December 31, 2008 and for the three and six months ended June 30, 2009 and 2008
have been prepared in accordance with accounting principles generally accepted
in the United States of America (GAAP) for interim financial information and
with the instructions to Form 10-Q and Article 10 of Regulation S-X.
Accordingly, they do not include all of the information and footnotes required
by GAAP for complete financial statements. In the opinion of management, the
accompanying financial statements include all adjustments, consisting of normal
recurring accruals, necessary for a fair presentation of the financial
condition, results of operations and cash flows for the periods presented. The
results of operations for the interim period June 30, 2009 are not necessarily
indicative of the results that may be expected for the year ended December 31,
2009 or any future period.
These
financial statements should be read in conjunction with the audited financial
statements and notes thereto for the year ended December 31, 2008, which are
included in our Annual Report on Form 10-K filed with the Securities and
Exchange Commission on April 1, 2009. In that report the Company disclosed that
it expects to incur substantial expenditures to further develop each of its
technologies and that it believes its working capital will be insufficient to
meet the business objectives as presently structured and that without sufficient
capital to fund its operations, the Company will be unable to continue as a
going concern. The accompanying financial statements do not include any
adjustments that might result from the outcome of this uncertainty. Although,
the Company currently believes that it will have sufficient resources to
commercialize selective products, it intends to seek additional funding to
further develop and commercialize other products.
Revenue
Recognition
The
Company recognizes revenue from the sales of product when title and risk of loss
pass to the customer, which is generally when product is
shipped. Grant revenues are recognized as the reimbursable expenses
are incurred over the life of the related grant.
Inventory
Inventories
are stated at the lower of cost or market. Cost, which includes
material, labor and overhead, is determined on a first-in, first-out
basis.
Net loss
per share is computed using the weighted average number of shares of common
stock outstanding. Common equivalent shares from stock options and warrants are
excluded as their effect is anti-dilutive.
Income
taxes are accounted for under the asset and liability method. Deferred tax
assets and liabilities are recognized for future tax consequences attributable
to differences between the financial statement carrying amounts of existing
assets and liabilities and their respective tax bases and operating loss and tax
credit carryforwards. Deferred tax assets and liabilities are measured using
enacted tax rates expected to apply to taxable income in the years in which
those temporary differences are expected to be recovered or settled. The effect
on deferred tax assets and liabilities of a change in tax rate is recognized in
operations in the period that includes the enactment date. Deferred tax assets
are reduced to estimated amounts expected to be realized by the use of a
valuation allowance.
In
September 2006, the FASB issued FASB Interpretation No. 48, “Accounting for Uncertainty in Income
Taxes, an interpretation of FASB Statements No. 109 ” (FIN 48). FIN
48 clarifies the accounting for uncertainty in income taxes by prescribing a
two-step method of first evaluating whether a tax position has met a more likely
than not recognition threshold and second, measuring that tax position to
determine the amount of benefit to be recognized in the financial statements.
FIN 48 provides guidance on the presentation of such positions within a
classified statement of financial position as well as on derecognition, interest
and penalties, accounting in interim periods, disclosure, and transition. FIN 48
was adopted by the Company effective January 1, 2007. As a
result of the implementation of Interpretation 48, the Company recognized a
$252,827 increase in the liability for unrecognized tax benefits that are
related to research and development credits, which was accounted for as a
reduction to the January 1, 2007 balance of the deferred tax asset
valuation allowance. The entire amount of this unrecognized tax benefit, if
recognized, would result in an increase to the deferred tax asset valuation
allowance, and would not have an impact on the effective tax rate.
The
Company files its income tax returns in the U.S. federal jurisdiction and in
Florida. With few exceptions, the Company is no longer subject to federal or
state income tax examinations by tax authorities for years before
2003.
4.
|
Fair
Value of Financial
Instruments
|
SFAS No.
157, Fair Value
Measurements (“SFAS 157”), defines fair value, establishes a framework
for measuring fair value in accordance with generally accepted accounting
principles, and expands disclosures about fair value measurements. SFAS 157
establishes a three-tier fair value hierarchy which prioritizes the inputs used
in measuring fair value as follows:
Level 1. Observable inputs
such as quoted prices in active markets;
Level 2. Inputs, other than
the quoted prices in active markets, that are observable either directly or
indirectly; and
Level 3. Unobservable inputs
in which there is little or no market data, which require the reporting entity
to develop its own assumptions.
The
Company does not have any assets or liabilities measured at fair value on a
recurring basis at June 30, 2009. The Company did not have any fair value
adjustments for assets and liabilities measured at fair value on a nonrecurring
basis during the six months ended June 30, 2009.
5.
|
Entry
into a Material Definitive
Agreement
|
On June
29, 2009, the Company entered into and consummated a private placement of equity
and debt financing pursuant to a Securities Purchase Agreement (the “Securities
Purchase Agreement”) with an accredited investor. Pursuant to the
terms of the Securities Purchase Agreement the Company issued 50,000,000 shares
of its Common Stock to the Koski Family Limited Partnership (“KFLP”) and
warrants to the KFLP to acquire 1,000,000 shares of Company common stock at an
exercise price of $0.10 per share in exchange for $4,000,000, the payment of
which consisted of the following: $1,500,000 in cash at closing and $2,500,000
pursuant to a non-interest bearing promissory note providing for five
consecutive monthly installment payments of $500,000 commencing July 31,
2009. The promissory note was recorded as a stock subscription
receivable and shown as a reduction to shareholders’ equity. KFLP
provided a secured loan of $1,000,000 to the Company. The
loan is secured by substantially all of the Company’s assets (excluding
receivables) and bears interest at the rate of Prime plus 4.0% which is payable
quarterly. The principal of the loan is due in five
years. The warrants expire in five years and are immediately
exercisable.
As a
result of the transaction the board of directors believes there was a change of
control of the Company with the KFLP acquiring a controlling interest of
approximately 56.6 % of our outstanding voting common stock. Two
Koski family members, Robert C. Koski and Christine L. Koski were appointed to
our Board of Directors. In addition, following the transaction, the
KFLP also has the ability to consent to the selection and appointment of two
outside directors.
The KFLP was also granted registration
rights in connection with any offerings by the Company of its
shares. Such registration rights require the Company to include a
certain amount of the KFLP shares in a Company offering determined based upon
15% of the shares to be publicly offered.
In connection with, and as a condition
to the Securities Purchase Agreement, the purchasers, including George Hawes our
largest shareholder prior to this transaction, under that certain securities
purchase agreement dated June 12, 2008, (the “Hawes Agreement”) entered into
waiver and release agreements with us. In addition, such individuals
waived and relinquished any special rights they possessed pursuant to agreements
with the Company, including, but not limited to, (i) rights of first refusal
(ii) antidilution regarding future equity sales and (iii) covenants regarding
secured lending. In connection with such waivers and releases,
warrants to acquire 3,220,000 shares of our common stock at an exercise price of
$1.30 per share that were previously issued under the Hawes Agreement were
subject to the right of exchange for new replacement warrants to acquire the
same number of shares under the same terms except for a change in the exercise
price from $1.30 to $0.75.
In
addition to the above, as a further condition to the consummation of the
transaction contemplated by the Securities Purchase Agreement the Company was
required to obtain satisfactory arrangements with three main creditors for
reductions in the amounts payable by the Company to such
creditors. The agreed upon reductions in accounts payable with such
creditors amounted to $707,674 in aggregate and the reductions were conditioned
upon prompt payment of the remaining balances owed to such creditors after
taking into account the reductions agreed to by such creditors. The
reduction was recorded as a gain on extinguishment of payables and reported as
Other Income.
6.
|
Stock
Options Issued During the 2nd Quarter,
2009
|
During
the quarter, the Company granted 100,000 stock options to each of Christine
Koski and Robert Koski, in connection with their commencement of service on our
board of directors. These stock options vested
immediately. There were no forfeitures recorded during the
period. From January, 1, 2009 to the date of this filing, 673,332
stock options previously granted have vested. Stock option compensation expense
of $33,943 was recorded and is a non-cash expense. This amount is
included in research and development and general and administrative expenses in
the accompanying statements of operations.
7.
|
Outstanding
Warrants and Stock Options
|
As of the
date of this filing there are approximately 6,877,778 warrants outstanding and
there are approximately 4,670,000 stock options have been granted that have not
been forfeited. The total number of outstanding warrants and
unexercised stock options is 11,547,778. If all warrants and stock options were
exercised, the total number of outstanding shares would be approximately
101,914,676. This share amount currently exceeds the number of shares
of common stock authorized in our Articles of Incorporation. We plan
to hold a shareholder meeting and submit a proposal to our shareholders to amend
our Articles of Incorporation to increase our authorized shares of common
stock. Because many of the aforementioned warrants and options are
currently out of the money and some of them may be cancelled without being
exercised we do not expect all of the shares covered by outstanding options and
warrants to ultimately be issued.
8.
|
Short
Term Note Payable
|
On April 15, 2009, we entered into
a loan agreement with an accredited investor for a short term note in
the amount of $100,000. The note matures on April 15,
2011 and bears interest at the rate of 15% per annum.
In connection with this borrowing we also issued warrants to
acquire 100,000 shares of our common stock at an exercise price of $.50 per
share and such warrants are exercisable for five years.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following information should be read in conjunction with the Financial
Statements, including the notes thereto, included elsewhere in this Form 10-Q.
This discussion contains certain forward-looking statements that involve risks
and uncertainties. Our actual results and the timing of certain events could
differ materially from those discussed in these forward-looking statements as a
result of certain factors, including, but not limited to, those set forth herein
and elsewhere in this Form 10-Q.
Overview
We are a
multi-faceted biopharmaceutical company focused on the discovery,
development and commercialization of a variety of products and
technologies. We are currently transitioning from a company
with a historic focus on research and development to a company with increased
focus on immediate and long term commercialization. We possess
a number of proprietary products and technologies some of which we have begun to
commercialize. We believe that each of our products and
platform technologies addresses potentially large market
opportunities.
We expect
to generate revenue through the sale of our consumer healthcare products.
We have currently received orders for our lead branded consumer products,
Probiora3 and EvoraPlus, which we have begun to fulfill. We are
optimistic about the ongoing level of interest we are experiencing with our
lead branded products at this time. As our Probiora3 and EvoraPlus
manufacturing, marketing and selling initiatives progress, we expect to
experience a higher level of overall expenses associated with such
efforts. We expect the current increases in our expenses to continue
into the near future as we fully implement the initiatives we have
underway.
Recent
Developments
Financing
Transaction
Our
ability to improve our operations during the quarter was limited due to the
significant lack of financial resources available to us. On April
30th, 2009,
to conserve capital, we terminated the employment of thirteen employees, leaving
us with five full-time employees who agreed to work for deferred compensation
and fringe benefits. Accordingly, during the quarter our primary focus was
directed towards raising additional capital.
As a
result of our efforts, on June 29, 2009, we successfully entered into and
consummated a private placement of equity and debt financing pursuant to a
Securities Purchase Agreement with an accredited investor. Pursuant
to the terms of the Securities Purchase Agreement the Company issued 50,000,000
shares of its Common Stock to the Koski Family Limited Partnership (“KFLP”) and
warrants to the KFLP to acquire 1,000,000 shares of Company common stock at an
exercise price of $0.10 per share in exchange for $4,000,000, the payment of
which consisted of the following: $1,500,000 in cash at closing and $2,500,000
pursuant to a non-interest bearing promissory note providing for five
consecutive monthly installment payments of $500,000 commencing July 31, 2009
and the KFLP provided a secured loan of $1,000,000 to the
Company. The loan is secured by substantially all of the Company’s
assets (excluding receivables) and bears interest at the rate of Prime plus 4.0%
which is payable quarterly. The principal of the loan is due in five
years. The warrants expire in five years and are immediately
exercisable. As a result of the financing transaction we believe a change
of control occurred with the KFLP acquiring a controlling interest of
approximately 56.6 % of our outstanding voting common stock.
In
addition to the above, as a further condition to the consummation of the
transaction contemplated by the Securities Purchase Agreement we were required
to obtain satisfactory arrangements with three main creditors for reductions in
the amounts payable by the Company to them. These reductions amounted
to $707,674 in aggregate and were conditioned upon prompt payment of the
remaining balances owed to such creditors after taking into account the agreed
upon reductions. These agreed upon reductions have been fully
reflected in our financial statements for the period and reported as Other
Income.
In
connection with, and as a closing condition to the Securities Purchase
Agreement, the purchasers, including George Hawes our largest shareholder prior
to this transaction, under that certain securities purchase agreement dated June
12, 2008, (the “Hawes Agreement”) entered into waiver and release agreements
with us. In addition, such individuals waived and relinquished any
special rights they possessed pursuant to agreements with the Company,
including, but not limited to, (i) rights of first refusal (ii) antidilution
regarding future equity sales and (iii) covenants regarding secured
lending. In connection with such waivers and releases, warrants to
acquire 3,220,000 shares of our common stock at an exercise price of $1.30 per
share that were previously issued under the Hawes Agreement were subject to the
right of exchange for new replacement warrants to acquire the same number of
shares under the same terms except for a change in the exercise price from $1.30
to $0.75.
Because
our financial position improved significantly as a result of the financing
transaction, we are now in a position to move forward operationally on several
fronts. In addition, due to our improved financial position we have
re-initiated normal operations and re-hired many of the employees we were forced
to terminate. However, our capital resources are still limited. As
such, our strategy will be to focus the bulk of our capital and human resources
on commercializing technologies that hold the most promise in producing revenue
in the near term.
Management & Board of Directors
Changes
Toward
the end of the first quarter and in the second quarter we also experienced
changes to our management team and the Board of Directors as
follows:
|
·
|
On
March 18, 2009 our President and Chief Executive Officer, Stanley Stein,
resigned and David Hirsch became our acting President and Chief Executive
Officer.
|
|
·
|
On
April 24, 2009, Dr. Zahradnik,
resigned as acting Chief Operating Officer and Vice President of Business
Development. Dr. Zahradnik, however, remains involved with us
as a consultant, and is active in assisting us in our efforts to
commercialize our ProBiora3
technology.
|
|
·
|
On
May 9, 2009, Dr. Marc Siegel, one of our independent directors,
resigned.
|
|
·
|
As
a result of, and after, the financing transaction, the following changes
occurred:
|
|
·
|
Christine
Koski, Robert Koski and David Hirsch were appointed to our Board of
Directors with Christine Koski elected as
Chairperson;
|
|
·
|
Independent
directors Welch, Hennecke and Sills resigned from our Board of
Directors;
|
|
·
|
Our
acting President and Chief Executive Officer, David Hirsch, was appointed
President and Chief Executive Officer;
and
|
|
·
|
Brian
Bohunicky was appointed Chief Financial
Officer.
|
In
addition to the foregoing, we expect to add additional outside directors in the
future and the KFLP has the ability to consent to such
appointments. Based upon these changes and the significant challenges
faced by us during the previous quarter, we believe that we are now positioned
to move forward to achieve operational stability, generate revenue and
eventually earn profits. As with any changes, however, we expect to
review and evaluate our strategies and initiatives with our new board of
directors as we proceed.
Financial
Strategy
Since our
inception, we have funded a significant portion of our operations from the
public and private sales of our securities. Furthermore, we have not earned
significant revenue from operations during the last two years. Most of our
revenue has been from sponsored research agreements and various governmental
grants. We will require substantial capital to fund our business operations and
will continue to seek substantial amounts of capital to effectuate our business
plans. The further development, testing and commercialization of our
technologies, individually and in the aggregate, are expected to be costly to
undertake and complete and will require additional capital over and above what
we currently have available to us. Our current available capital limits our
ability to fully develop our technologies. We expect to allocate our limited
capital resources to the development of our technologies while we continue to
explore additional capital raising opportunities. There can be no assurances
that such additional capital will be available to us or on favorable terms or at
all. The time periods for the expected continued development of our technologies
have been extended from those previously indicated by us due primarily to our
insufficient capital position. The time periods for expected
developments could also change in the future depending on the progress of our
ability to negotiate a partnering arrangement, as well as our efforts to raise
additional capital.
Although
we have started to earn revenue from the sales of our Consumer Healthcare
products and technologies, revenue to date has been modest. Our
objective is that the revenue from Consumer Healthcare products will be
sufficient and be able to fully support the continued operations of the Consumer
Healthcare Products Division. Due to our improved financial position,
we anticipate additional purchase orders and/or revenue from the sale of
EvoraPlusTM, our
oral probiotic for adults, during the remainder of the current calendar
year. Additionally, we are optimistic about the launch of Teddy’s
PrideTM, our
oral probiotic for the companion pet market, which will likely be introduced to
the marketplace during the same time period. We also anticipate that,
in the coming months, we will have opportunities to partner with or license some
of our technologies to larger global companies. We hope to be able to
negotiate upfront payments in connection with these potential partnerships
and/or licenses.
Operational
Strategy
We have a
number of products and platforms. These products and platforms are structured
and viewed by us as four distinct Divisions:
(1)
Consumer Healthcare, which consists of ProBiora3TM, the
EvoraPlusTM,
Teddy’s PrideTM and
EvoraKidsTM as well
as the LPT3-04TM weight
loss agent;
(2)
Diagnostics, which consists of the PIVIATTM and
PCMATTM
platforms;
(3)
Antibiotics, which consists of the DPOLTTM
lantibiotic synthesis platform; and
(4)
Replacement Therapy, which consists of our SMaRTTM
Replacement Therapy technology.
Because
we have limited capital and human resources, we cannot pursue commercialization
and further development of each and every technology that we own
simultaneously. As such, we have decided to pursue a strategic course
that focuses the majority of our resources towards those technologies that
present the best opportunity to generate revenue for the Company in the
short-term. The allocation of resources is determined by us on a
case-by-case basis and is subject to periodic review. Currently, we
are rolling out products in our Consumer Healthcare Division and most of our
resources are being deployed in support of that endeavor. However, we
still continue to commit resources to our other three divisions. As
the Consumer Healthcare Division matures and begins to generate meaningful
revenue and becomes self-sustaining, we anticipate being able to allocate
greater resources to the other divisions.
Technology
Descriptions and Objectives
Consumer
Healthcare
The
specific goal for our Consumer Healthcare division is to rapidly and effectively
commercialize ProBiora3TM and
LPT3-04TM.
ProBiora3TM
(Probiotics). ProBiora3TM
contains three naturally occurring, live microorganisms that help maintain
dental and oral health when administered to the host in adequate amounts. The
use of yogurt containing live
Lactobacillus cultures is an example of a probiotic
application. We will market ProBiora3TM under
self-proclaimed GRAS (“Generally Recognized As Safe”) status, which will
expedite our marketing efforts because it relieves us of the need for extensive
regulatory oversight. Two sets of subjects completed our ProBiora3TM human
study in 2006, and we believe the results confirmed that the product is safe for
human use and demonstrated a substantial effect of Probiora3 in reducing the
levels of specific bacteria in the mouths of young, healthy adult
subjects.
We have
developed a bifurcated strategy whereby we will establish two separate brands;
(1) where the actual technology, ProBiora3TM, will
be branded as an active ingredient for licensing and private labeling, and (2)
where we will market products under the three house brand names
below. Our house brands contain different ratios, or blends, of
the three natural strains contained in ProBiora3TM and
potentially different delivery mechanisms such that each product will be
tailored to the needs of specific markets. The products currently in production
or the product pipeline are:
|
·
|
EvoraPlusTM,
a product with equal weight of all three strains that is optimally
designed for the general consumer
market.
|
|
·
|
Teddy’s PrideTM,
a product that has a mixture which focuses exclusively on gum disease, a
problem endemic with
cats and dogs.
|
|
·
|
EvoraKidsTM,
a product that has a greater concentration of strains designed to reduce
dental caries, which
is more of an issue for children.
|
Other
house products with different formulations and delivery systems are also
planned. EvoraPlusTM was the
first product to market with Teddy’s Pride TM
expected to follow in the coming months. EvoraPlusTM is a
probiotic mint packaged in a 60 unit box with four 15 dose blister packs. The
intended usage is to take one mint twice a day after brushing. As such, one box
is designed to include a one-month’s supply of EvoraPlus TM. We
have completely outsourced the manufacturing and fulfillment
processes. Our manufacturer is a large, GMP certified manufacturer
with the ability to scale production to meet our expected needs.
Marketing
Progress. Anticipated sales of EvoraPlusTM have
been slow to materialize for a variety of reasons including primarily the lack
of appropriate funds available to drive our marketing efforts. In
addition, the weakening global economic environment, the timeliness of the
product’s launch, and delays in the adoption rates by mass retailers have also
hampered our progress.
Our
initial efforts to drive sales of our house products through the production of a
one-minute television spot have been delayed. Initial testing of our
spot ad was not satisfactory. However, we are re-formatting our spot
ad and we anticipate that the new version will be more successful in generating
demand for our products. However, our ability to purchase adequate
media time may be limited due to a lack of available capital
resources.
We have
made significant progress in our efforts to generate interest in the sale or
licensing of ProBiora3TM as an
active ingredient. We have had multiple, meaningful discussions with
several large, global consumer products companies who are interested in
incorporating the technology into products already in the stream of
commerce. Many of these products are well known and used by millions
of people on a daily basis. We anticipate that it is likely that we
will be able to sell or license ProBiora3TM to one
or more of these companies by the end of the year.
We have
made significant progress in our efforts to procure distributors to penetrate
global markets. We are in negotiations with a large, multi-billion
dollar Japanese company that has expressed an interest in obtaining exclusive
distribution right to Japan and the Pacific Rim. We are also in
discussions with a large distributor for the European markets. We
anticipate, assuming we are able to secure funding, that we will have
distributors in place to cover Asia, Europe and Latin America by the end of the
year. We are also hopeful that we will be able to secure upfront
payments for exclusivity in certain regions.
Despite
our efforts to sell our house products and commercialize ProBiora3TM, there
can be no assurances that we will meet our timeline for commercialization or
that the product will meet the sales projections we have
anticipated.
LPT3-04TM. LPT3-04TM is a
small molecule weight management agent for which we filed a U.S. patent
application on April 5, 2006 to protect our intellectual property rights to the
agent and its analogs. As a natural substance, LPT3-04TM is
orally available, and we believe it has an excellent safety and tolerability
profile. As with ProBiora3TM,
LPT3-04TM would
fall under the self-proclaimed GRAS status and we will be able to market
products containing the technology without the burden of substantial regulatory
oversight in most, if not all, of the markets in which we plan on introducing
products.
Our
strategy for our LPT3-04TM is
similar to that of our oral probiotic in that we plan on developing a bifurcated
strategy where we market the technology as an active ingredient for licensing or
private labeling and we develop a house brand to market to consumers directly
and through mass retail. We plan on developing several products under the house
brand that will vary by formulation and delivery mechanism. We will also develop
a product for the Pet Market since obesity is a problem that is present in the
animal markets as well. Design work for the house brand is in progress and we
anticipate having it completed by year’s end. We may also market directly to
Medical Professionals and Veterinary Offices.
We are
currently in the process of developing an adequate delivery system for
LPT3-04TM. Due
to capital constraints, this process has been delayed and we now anticipate that
this process will be complete by the end of the third quarter, 2009. Once this
has been accomplished, we plan on initiating subsequent and more comprehensive
human trials, which, once commenced, should last approximately four to five
months. If the results are satisfactory, we will initiate marketing
efforts immediately thereafter; however there can be no assurances that the
results of our contemplated clinical trials will prove successful.
Diagnostics
The goal
of our Diagnostics unit is to utilize the PIVIATTM and
PCMATTM
platforms to identify and secure intellectual property rights to gene targets
associated with the natural onset and progression of infections, cancers and
other diseases in humans, animals, and agricultural products. We believe these
platforms provide a number of profitable business models from which to realize
value.
PIVIATTM and
PCMATTM. Proteomics-based In Vivo Induced Antigen
Technology (PIVIATTM) is a
platform technology that enables rapid identification of novel targets for use
in the diagnosis and treatment of human infectious diseases. The method is
faster, more cost effective, and more sensitive than other methods currently in
use to identify such targets. As an example, a recent tuberculosis project has
yielded 44 novel targets for
Mycobacterium tuberculosis that are currently being analyzed for their
use in vaccine and diagnostic strategies.
We are
currently in discussions with various collaborators to look at specific
diagnostic markers and to develop vaccines utilizing our PIVIATTM gene
targets.
Proteomics-based
Change Mediated Antigen Technology (PCMATTM) is a
platform technology that was derived from and greatly extends the potential
applicability of PIVIATTM. This
technology rapidly identifies proteins (and their genes) that are expressed when
a cell undergoes any sort of change. PCMAT TM has
been used to identify proteins of plants that are expressed when it becomes
infected. Such genes are excellent targets for manipulation to increase the
resistance of the plant to infection. It has also been used to identify novel
proteins of human bowel cells that are expressed when the cell undergoes
transformation to a cancerous cell. Such proteins are excellent targets for new
diagnostics and therapeutic strategies. PCMATTM has
the potential to study an extraordinary range of medical and agricultural
applications.
The first
major commercial effort that we have undertaken utilizing the PCMATTM
platform has been to extract genetic targets from tissue samples containing
colorectal cancer. Colorectal cancer affects millions of people worldwide. The
current “Gold Standard” in the detection of colorectal cancer is the use of a
colonoscopy. Due to the invasive nature and cost of colonoscopies, patient
compliance is low. As such, many cases of bowel cancer go undetected until the
cancer has reached an advanced stage. Using the PCMATTM
diagnostic platform, we have discovered what we believe to be unique genetic
markers that appear during the earliest stages of colorectal cancer. As
announced last summer, we entered into a Collaboration Agreement with a major,
global diagnostics company regarding our gene targets for various stages of
colorectal cancer that we discovered using the PCMATTM
platform. Although we are highly optimistic about this Collaboration Agreement,
there can be no assurances that this Agreement will result in a diagnostic test
that will be marketed to appropriate health care professionals, nor can there be
any assurance that upon further examination, the diagnostic company will elect
to use these markers. We anticipate that the diagnostics company will
finish validation by the end of the third quarter, 2009, at which point they
will likely make a decision on whether to include our targets into a diagnostic
test. If they choose to do so, our agreement provides for the payment
of milestone fees upon the application of a 510K.
At
present, we are in discussions with major global diagnostics companies to
license our platforms and gene targets. We are optimistic about our
prospects. However, there can be no assurances that these discussions
will result in licensing or partnership agreements. We also are
further developing our strategy to include the subsequent validation of gene
targets after they are identified through our two platforms. This subsequent
validation will make discovered targets significantly more valuable. It will
also afford us with the ability to continue the development process in-house and
potentially design our own diagnostic tests. To that end, we have identified a
number of diseases that hold the greatest promise for future revenues from a
diagnostic test. We plan on utilizing our platforms to discover gene targets for
these diseases. However, these plans have been delayed due to capital
constraints. Once proper funding is secured, we will then proceed
accordingly.
If we are
able to secure adequate financing, we intend to use our Mexican Subsidiary in
conjunction with the Instituto de Biolotecnología, Universidad Nacional Autonoma
de Mexico (“IBUNAM”), the premier biotechnology institute in Mexico, for a
number of PIVIATTM and
PCMATTM
projects. Most of these projects will focus on diseases that are problematic to
Mexico and Latin America such as cholera and dengue fever. Projects will not
only include human diseases but also diseases present in agriculture. As well as
applicable problems that are present in the mining industry.
Antibiotics
The
cornerstone of our Antibiotics Division is the DPOLTTM
(Differentially Protected Orthogonal Lantionine Technology) Synthetic Chemistry
Platform, which affords us the ability to synthesize a unique class of
antibiotics known as lantibiotics.
DPOLTTM (Differentially
Protected Orthogonal Lantionine Technology). DPOLTTM is a
novel organic chemistry synthesis platform that will enable large scale, cost
effective production of clinical grade MU1140 and 50 other known lantibiotics.
Over the past 80 years, efforts to devise methods to investigate the usefulness
of this class of antibiotics have met with uniform failure. DPOLTTM is
anticipated to lead to 6-10 new antibiotics with novel mechanisms of action.
This represents a substantial potential pipeline of antibiotics to replace ones
that are currently failing due to the development of bacterial
resistance.
As
mentioned earlier, we announced the successful synthesis of an antibiotic using
our proprietary DPOLTTM
technology. The molecule belongs to a class of antibiotics called Lantibiotics
that were first discovered over 80 years ago. Although there are now over 50
different Lantibiotics known, this is the first report of a cost-effective
method for making one in sufficient amounts and with sufficient purity to enable
comprehensive testing and commercial viability.
This
initial antibiotic is very closely related to our lead antibiotic, MU 1140,
which has the potential to treat a wide variety of infections, including those
caused by MRSA and other drug resistant Gram positive bacteria. Domestically,
hospital borne infections alone have been on the rise, with an estimated
two-million patients contracting dangerous infection annually leading to
one-hundred-thousand deaths. Preliminary studies indicate that MU 1140 may be
the first new antibiotic in 35 years for the treatment of tuberculosis. In
addition to MU 1140, this technology will allow us to synthesize all 50 of the
known lantibiotics and to conveniently modify their structures in order to
improve their usefulness as antibiotics for the treatment of infectious
diseases. In effect, DPOLTTM will
provide a much needed pipeline of antibiotics at a time when drug resistant
bacteria are on the rise.
As a
first step in further development, the Company has retained a leading contract
manufacturer to refine and scale-up GMP production of the synthetic MU 1140
analog to achieve sufficient quantities for it to be fully tested for regulatory
approval. It is estimated that the regulatory process will take a minimum of
three years before this drug could become available. Other lantibiotics will
follow as they are developed and tested.
Last
fall, we announced that we were successful in using the DPOLTTM
platform to synthetically produce an analog of the MU 1140
molecule. We are now in the process of having the synthetic version
of MU 1140 scaled to production by Almac Sciences, one of Europe’s largest and
most reputable peptide manufacturers. This endeavor is more than half way
complete; however, due to capital constraints we have been forced to put the
project on hold. Once adequate financing is secured, we will complete
the process of scaling MU 1140, which we anticipate should take an additional
four to five months. This, in turn, should provide us with enough
synthetic MU 1140 to conduct preclinical testing. Once preclinical
testing is complete, we will seek partnership and/or licensing opportunities
with major pharmaceutical companies with the intent to fund subsequent phase I,
II & III FDA clinical trials.
Replacement
Therapy
Our
Replacement Therapy Division is centered on SMaRTTM
Replacement Therapy, our product for dental caries (tooth decay).
SMaRTTM Replacement
Therapy. SMaRTTM
Replacement Therapy™ is a professional/Rx product intended for the prevention of
dental caries (tooth decay). Dental caries remain a major health problem
afflicting a majority of the population in the United States and worldwide.
Lactic acid production by the oral bacterium Streptococcus mutans has long
been known to be integral to the pathogenic process for dental caries. Oragenics
Inc.’s replacement therapy technology replaces the indigenous, acid-producing
S. mutans with a
SMaRTTM
effector strain, which has been genetically modified so as not to produce the
acid associated with caries formation.
The
wild-type S mutans
originally used for construction of the SMaRT strain was isolated from a
human subject and was carefully selected based on its ability to produce the
antibiotic, MU1140. MU1140 has been shown to kill all other strains of S. mutans that it has been
tested against. The SMaRTTM
effector strain was generated by transforming this wild-type parent strain with
recombinant DNA that introduced a large deletion mutation in the gene for
lactate dehydrogenase (LDH) eliminating the strain’s ability to produce lactic
acid.
Our
SMaRTTM
effector strain for the replacement therapy of dental caries has the following
advantages over existing decay-prevention technologies: (1) a single treatment
regimen involving application of SMaRTTM cells
onto patients’ tooth surfaces using a cotton tipped swab for five minutes has
the potential to provide lifelong protection against most tooth decay; (2) the
possibility of deleterious side-effects are negligible since the effector strain
is essentially identical to the microorganism which is found universally on the
teeth of humans; (3) minimal patient education and compliance is
required.
SMaRTTM
Replacement Therapy offers the potential for lifelong protection against dental
caries following a single, painless application of a genetically modified
bacterial strain to the surfaces of the teeth. This technology is currently
approved for FDA phase 1b clinical trials. At present, our plans are to initiate
phase 1b trials once adequate financing has been achieved. We
anticipate the cost of conducting phase 1b to be under $1M. We also
anticipate that phase 1b trials will take less than six months to
complete. Once phase 1b trials have been completed and safety has
been established, we plan on seeking partnerships and/or licensing arrangements
with major pharmaceutical companies. It would be our intent to use
these partnerships and/or licensing arrangements to fund subsequent clinical
trials, which we anticipate will be costly and may take several years to
complete.
Global
Expansion
Although
we are domiciled in the United States, we feel that there are numerous
advantages in utilizing overseas talent and markets for a variety of our
products and technologies. At present, we have established a Mexican
Subsidiary and initiated limited operations in Mexico earlier this
year. Due to capital constraints, however, we have been unable to
advance our strategic initiatives in Mexico and we expect to evaluate our
ability to continue them on a go forward basis. Our common stock is
currently listed on the NYSE Paris Alternext Exchange and we have investigated
establishing operations in France; however, at present, we are reassessing our
overseas initiatives.
Critical
Accounting Estimates
Our
discussion and analysis of our financial condition and results of operations are
based upon our financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States of America. The
preparation of financial statements in accordance with accounting principles
generally accepted in the United States of America requires us to make estimates
and assumptions that affect reported amounts and related disclosures. We
consider an accounting estimate to be critical if it requires assumptions to be
made that were uncertain at the time the estimate was made; and changes in the
estimate or different estimates that could have been made could have a material
impact on our results of operations or financial condition. Our financial
statements do not include any significant estimates other than stock based
compensation that would have a material impact on our results of operations or
financial condition.
New
Accounting Pronouncements
In June
2009, the FASB issued SFAS No. 168, “The FASB Accounting Standards
CodificationTM and Hierarchy of Generally Accepted Accounting Principles, a
replacement of FASB Statement No. 162” (“SFAS 168”). SFAS 168 establishes
the FASB Standards Accounting Codification (“Codification”) as the source of
authoritative GAAP recognized by the FASB to be applied to nongovernmental
entities and rules and interpretive releases of the SEC as authoritative GAAP
for SEC registrants. The Codification will supersede all the existing non-SEC
accounting and reporting standards upon its effective date and subsequently, the
FASB will not issue new standards in the form of Statements, FASB Staff
Positions or Emerging Issues Task Force Abstracts. This Statement is effective
for financial statements issued for interim and annual periods ending after
September 15, 2009. The adoption of SFAS 168 is not expected to have a
material impact on the Company’s Financial Statements.
In June
2009, the FASB issued SFAS No. 167, “Amendments to FASB Interpretation
No. 46(R)” (“SFAS 167”). SFAS 167 amends FASB Interpretation
No. 46(R), “Consolidation of Variable Interest Entities” for determining
whether an entity is a variable interest entity and requires an enterprise to
perform an analysis to
determine whether the enterprise’s variable interest or interests give it a
controlling financial interest in a variable interest entity. SFAS 167 also
requires an enterprise to assess whether it has an implicit financial
responsibility to ensure that a variable interest entity operates as designed
when determining whether it has power to direct the activities of the variable
interest entity that most significantly impact the entity’s economic
performance. SFAS 167 also requires ongoing assessments of whether an enterprise
is the primary beneficiary of a variable interest entity, requires enhanced
disclosures and eliminates the scope exclusion for qualifying special-purpose
entities. SFAS 167 is effective for annual reporting periods beginning after
November 15, 2009. The Company is currently evaluating the impact the
adoption of SFAS 167 will have on its Financial Statements.
In June
2009, the FASB issued SFAS No. 166, “Accounting for Transfers of Financial
Assets — an amendment of FASB Statement No. 140” (“SFAS 166”). SFAS 166
seeks to improve the relevance, representational faithfulness, and comparability
of the information that a reporting entity provides in its financial statements
about a transfer of financial assets; the effects of a transfer on its financial
position, financial performance, and cash flows; and a transferor’s continuing
involvement, if any, in transferred financial assets. Additionally, on and after
the effective date, the concept of a qualifying special-purpose entity is no
longer relevant for accounting purposes. Therefore, formerly qualifying
special-purpose entities (as defined under previous accounting standards) should
be evaluated for consolidation by reporting entities on and after the effective
date in accordance with the applicable consolidation guidance. The disclosure
provisions of this Statement should be applied to transfers that occurred both
before and after the effective date of this Statement. SFAS 166 is effective for
annual reporting periods beginning after November 15, 2009. The adoption of
SFAS 166 is not expected to have a material impact on the Company’s Financial
Statements.
In May
2009, the FASB issued SFAS No. 165, “Subsequent Events” (“SFAS 165”), which
establishes general standards of accounting for and disclosure of events that
occur after the balance sheet date but before financial statements are issued or
are available to be issued. SFAS 165 is effective for interim or annual
financial periods ending after June 15, 2009. The adoption of SFAS 165 did
not have a material impact on the Company’s Financial Statements.
In April
2009, the FASB issued FSP Financial Accounting Standard 115-2 and FAS 124-2,
Recognition and Presentation of Other-Than-Temporary Impairments (“FSP FAS 115-2
and FAS 124-2”). FSP FAS 115-2 and FAS 124-2 amends the other-than-temporary
impairment guidance in U.S. GAAP for debt securities to make the guidance more
operational and to improve the presentation and disclosure of
other-than-temporary impairments on debt and equity securities in the financial
statements. FSP FAS 115-2 and FAS 124-2 is effective for fiscal years and
interim periods beginning after June 15, 2009. The adoption of FSP FAS
115-2 and FAS 124-2 is not expected to have a material impact on the Company’s
Financial Statements.
In April
2009, the FASB issued FSP FAS 157-4, Determining Fair Value When the Volume and
Level of Activity for the Asset or Liability Have Significantly Decreased and
Identifying Transactions That are Not Orderly (“FSP FAS 157-4”). FSP FAS 157-4
provides additional guidance for estimating fair value in accordance with SFAS
No. 157 when the volume and level of activity for both financial and
nonfinancial assets or liabilities have significantly decreased. FSP FAS 157-4
is effective for fiscal years and interim periods beginning after July 1,
2009 and shall be applied prospectively. The adoption of FSP FAS 157-4 on
July 15, 2009 did not have a material impact on the Company’s Financial
Statements.
Results
of Operations
Three
Months Ended June 30, 2009 and 2008
We had
$41,895 in revenues in the three months ended June 30, 2009 compared with no
revenues in the same period in 2008. The revenue was generated from EvoraPlus
product sales in the amount of $41,895 and there were no grant funds received
during the quarter. Cost of sales of $23,604 were recorded in the
three months ended June 30, 2009 compared with no cost of sales in the same
period in 2008. These costs were incurred in connection with the
production and manufacture of our Consumer Healthcare products. Our
second quarter operating expenses increased by 44.4% to $1,605,328 in the three
months ended June 30, 2009 from $1,111,553 in the same period in
2008. Research and development (R&D) expenses decreased 20.0% to
$394,311 in the three months ended June 30, 2009 from $492,667 in the same
period in 2008. This decrease in R&D was primarily due to the reduction in
options expense. Selling, general and administration (S,G&A)
expenses increased 95.7% to $1,211,017 in the three months ended June 30, 2009
from $618,886 in the same period in 2008. The increase over the prior period was
due to the addition of sales staff and associated marketing expenses, increases
in consulting fees associated with investor relations and legal fees and
compensation.
Other
income of $717,989 increased by $701, 548 for the three months ended June 30,
2009. Other income included the gain on extinguishment of payable of
$707,674 due to the reduction in expenses owed to three creditors that was
agreed to in connection with the June 29, 2009 financing
transaction. Gain on the sale of assets for the three months ended
June 30, 209 totaling $11,274 represents the sale of equipment no longer needed
to support on-going Mutacin research. Interest income decreased by
$9,731 in the three months ended June 30, 2009 compared to the same period in
2008. This decrease is primarily due to the Company’s reduced cash
position during the second quarter before the June 29, 2009 financing
transaction with the KFLP.
We
incurred net losses of $869,048 and $1,095,112 during the three months ended
June 30, 2009 and 2008, respectively. The decrease in our net loss was
principally caused by reduction in amounts owed to three creditors in connection
with the financing transaction and reduction in options expense.
Six
Months Ended June 30, 2009 and 2008
We had
$166,167 in revenues in the six months ended June 30, 2009 compared with
$125,000 in revenues in the same period in 2008. The revenue was generated from
the National Science Foundation (NSF) Phase II grant for work utilizing the
Company’s proprietary DPOLT TM
technology in the amount of $100,000 and EvoraPlus product sales in the amount
of $66,167. Cost of sales of $35,384 were recorded in the six months
ended June 30, 2009 compared with no cost of sales for the same period in
2008. Our cost of sales represents costs in connection with the
production and manufacture of our Consumer Healthcare products. Our
operating expenses increased by 81.5% to $3,698,147 in the six months ended June
30, 2009 from $2,037,648 in the same period in 2008. R&D expenses increased
slightly by .9% to $979,975 in the six months ended June 30, 2009 from $971,040
in the same period in 2008. S,G&A expenses increased 154.8% to
$2,718,172 in the six months ended June 30, 2009 from $1,066,608 in the same
period in 2008. The increase can be attributed to the Company’s
hiring of a new management and new sales team totaling $406,346 in salaries and
fringe benefits. Consulting fees for investor relations increased by
$577,605 due to the need for several investment firms to assist with our cash
raising activities. Legal fees increased by $551,647 to support
rights offering initiative, the Alternext Paris exchange and services to expand
our global business in Mexico and France. Other major S,G&A
increases include travel expenses to support global growth initiatives and
advertising expenses for our EvoraPlus product.
Other
income of $717,966 increased by $692,066 for the six months ended June 30,
2009. Other income included the gain on extinguishment of payable of
$707,674 due to the reduction in expenses owed to three creditors that was
agreed to in connection with the June 29, 2009 financing
transaction. Gain on the sale of assets for the six months ended June
30, 209 totaling $11,274 represents the sale of equipment no longer needed to
support on-going Mutacin research. Interest income decreased $13,808 in the six
months ended June 30, 2009 from $14,330 during the same period in 2008. This
decrease is primarily due to the Company’s reduced cash position before the
Koski Family investment.
We
incurred net losses of $2,849,398 and $1,886,748 during the six months ended
June 30, 2009 and 2008, respectively. The increase in our net loss was
principally caused by the increase in S,G&A expenses.
Liquidity
and Capital Resources
Since our
inception, we have funded our operations through the sale of equity securities
in private placement and our initial public offering, the sale of equity
securities and warrants in private placements, debt financing and
grants. For the first six months of 2009, we have received $100,000
of restricted funds as part of the $500,000 NSF Phase II grant to advance
development of its small peptide antibiotic synthesis program using our
proprietary DPOLTtm. This
federal grant will support studies focused on the synthesis and testing of our
lead antibiotic, MU 1140.
Our
operating activities used cash of $2,001,894 for the six months ended June 30,
2009 and $1,431,328 for the six months ended June 30, 2008. Our working capital
deficit was ($462,275) as of June 30, 2009. Cash used by operations in the six
months ended June 30, 2009 resulted primarily from our net loss from operations
of $2,849,398.
Our
investing activities provided an increase in cash of $18,926 during the six
month period ended June 30, 2009 as compared with a net increase in cash of
$9,750 for the same period ending June 30, 2008.
Our
financing activities for the six months ended June 30, 2009 provided net cash
increase of $2,636,721. This increase was attributable to the
purchase of $4,000,000, less stock subscription receivable of $2,500,000, of our
common stock by the KFLP; the loan from the KFLP in the amount of $1,000,000;
the loan from an accredited investor of $100,000; and net proceeds of a short
term note payable to finance our Product Liability
insurance. Additional details of our financing activities are
provided below:
Warrant Exercises – Q1 2008 –
On August 7, 2007, we closed on $1,171,591 in equity based
financing. We issued a total of 4,600,000 shares of restricted common stock and
warrants to acquire 4,600,000 shares of common stock in a private placement to
accredited investors. The shares were sold to accredited investors at $0.25 per
share, except that per AMEX requirements, our former CEO, Dr. Ronald Evens
acquired his shares at $0.44 per share, which was the closing share price on
August 7, 2007. Each warrant to purchase shares of common stock is
exercisable at the price of $0.58 per share. The unexercised warrants expired on
August 8, 2008 (the “August 2007 Warrants”). On January 31, 2008 we
amended the August 2007 Warrants, to reduce the exercise price to $0.44, which
was the fair market value on the date of the amendment for a designated period
of time (from January 28, 2008 to February 29, 2008). In
February 2008, amended Warrants, of 4,536,364 were issued upon exercise at the
amended exercise price resulting in additional working capital proceeds to us of
$1,996,000. The remaining unexercised August 2007 warrants expired unexercised
on August 8, 2008.
NSF SBIR Grants – On
February 15, 2008, we were awarded a two year NSF SBIR Phase II grant to
advance development of our small peptide antibiotic synthesis program using the
Company’s proprietary DPOLTtm. This
federal grant supports studies focused on the synthesis and testing of our lead
antibiotic, MU 1140. While the grant will total $500,000, to date we have
received $225,000 of these restricted funds and expect to receive $100, 000 in
the 3rd quarter
2009 with the balance to be issued during the remaining period of the grant. On
June 12, 2009 we received verbal grant approval with the University of Florida
under the prime grant with the Florida Department of Citrus in the amount of
$124, 570. The purpose of the University of Florida grant is to
identify disease-specific proteins expressed during citrus greening using our
proprietary PCMAT technology.
Private Placement, June 2008 –
On June 12, 2008, our Securities Purchase Agreement with accredited
investors became binding and we closed on $2,600,000 in equity based financing
with net proceeds of $2,515,000. We issued a total of 5,777,778 shares of
restricted common stock in the private placement. The shares were sold to
accredited investors at $0.45 per share. Each participating investor
also received warrants to purchase shares of common stock at the price of $1.30
per share. One warrant was issued for each share of common stock issued for a
total of 5,777,778 shares that may be acquired upon exercise of the warrants.
The warrants are exercisable and expire May 30, 2013. In connection
with, and as a condition to the June 29, 2009 financing transaction described
below, the purchasers, including George Hawes our largest shareholder prior to
this transaction, under that certain securities purchase agreement dated June
12, 2008, (the “Hawes Agreement”) entered into waiver and release agreements
with us. In addition, such individuals waived and relinquished any
special rights they possessed pursuant to agreements with the Company,
including, but not limited to, (i) rights of first refusal (ii) antidilution
regarding future equity sales and (iii) covenants regarding secured
lending. In connection with such waivers and releases, warrants to
acquire 3,220,000 shares of our common stock at an exercise price of $1.30 per
share that were previously issued under the Hawes Agreement were subject to the
right of exchange for new replacement warrants to acquire the same number of
shares under the same terms except for a change in the exercise price from $1.30
to $0.75. We intend to use the proceeds from the exercise of the
warrants, if any, for working capital and general corporate
purposes.
Line of Credit – On October
20, 2008, the Company obtained from Signature Bank of New York, a revolving line
of credit in the amount of up to $1,000,000, for the purpose of providing
working capital to the Company. We did not draw on this line and as
such on January 21, 2009, this line of credit was terminated by
us.
Short Term Notes Payable – In
March 2009, the
Company entered into a short term note payable for $53,087 with an interest rate
of 5.75% to finance product liability insurance. This note matures on
January 10, 2010. At June 30, 2009 the balance due was
$31,852. On April 15, 2009 we entered into a loan agreement with
an accredited investor for a short term note in the amount of
$100,000. The note matures on April 15, 2011 and
bears interest at the rate of 15% per annum. In connection
with this borrowing we also issued warrants to acquire 100,000 shares
of our common stock at an exercise price of $.50 per share and such warrants are
exercisable for five years.
Other Financings- On May 4,
2009 and June 10, 2009 we borrowed $32,556 and $13,100, respectively,
from Dr. Jeffery Hillman, our founder, Chief Science Officer and
director. These borrowings were to be repaid upon demand by Dr. Hillman,
were unsecured and did not bear interest. The proceeds from
these borrowings were used to purchase inventory for our Consumer
Health Care products division. On June 29, 2009 the aggregate amount
of these obligations of $45,656 were repaid by us in full through the issuance
of 456,564 shares of our common stock at a price of $.10 per share, which was
the closing price of our common stock on June 29, 2009.
Private Placement, June 2009 –
On June 29, 2009, we successfully entered into and consummated a private
placement of equity and debt financing pursuant to a Securities Purchase
Agreement with an accredited investor. Pursuant to the terms of the
Securities Purchase Agreement the Company issued 50,000,000 shares of its Common
Stock to the Koski Family Limited Partnership (“KFLP”) and issued warrants to
the KFLP to acquire 1,000,000 shares of Company common stock at an exercise
price of $0.10 per share in exchange for $4,000,000, the payment of which
consisted of the following: $1,500,000 in cash at closing and $2,500,000
pursuant to a non-interest bearing promissory note providing for five
consecutive monthly installment payments of $500,000 commencing July 31, 2009
and the KFLP provided a secured loan of $1,000,000 to the
Company. The loan is secured by substantially all of the Company’s
assets (excluding receivables) and bears interest at the rate of Prime plus 4.0%
which is payable quarterly. The principal of the loan is due in five
years. The warrants expire in five years and are immediately
exercisable.
Immediately
following the closing of the aforementioned June 29, 2009 financing transaction,
our Chief Executive Officer Mr. Hirsch was awarded a bonus of $100,000 which was
paid in 1,000,000 shares of our common stock at a price per share of
$0.10. In addition, we issued 250,000 shares of our common stock to our
newly appointed Chief Financial Officer for deferred compensation we owed to him
and we issued 343,750 shares of our common stock to another employee for
deferred compensation we owed to him.
As of
June 30, 2009, included in our accounts payable for the period were amounts that
we owed to (i) employees (excluding our Chief Financial Officer and the other
employee referenced above whose deferred compensation was paid in common stock)
for compensation incurred that we were not able to pay, (ii) former employees
(including some that were subsequently re-hired in July) for compensation
incurred that we were not able to pay, and (iii) former independent directors
for (a) fees in connection with their service on a special committee established
in connection with our strategic alternatives initiative, and (b) prior meeting
fees. The deferred aggregate amount owed to our employees and
directors as of June 30, 2009 was $395,935 and consisted of $227,050 to our
employees, $89,885 to our former employees and $79,000 to our former
directors. Following the financing transaction, in July,
approximately $227,685 of these deferred amounts were paid by us. The
remainder of the deferred amounts is expected to be settled by us in future
periods. The deferrals of payments to our officers, employees and former
employees and directors, did not reduce our expenses, but served to preserve our
limited cash resources at this time to the extent necessary to maintain our
operations.
Our business is based on
commercializing entirely new and unique technologies, and our current business
plan contains a variety of assumptions and expectations that are subject to
uncertainty, including assumptions and expectations about manufacturing
capabilities, clinical testing cost and pricing, continuing technological
improvements, strategic licensing relationships and other relevant matters.
These assumptions take into account recent financings, as well as expected but
currently unidentified additional financings. We have
experienced losses from operations during the last three fiscal years and have
an accumulated deficit of $22,841,933 as of June 30, 2009. The net
loss from operations for the first six months of 2009 was
$2,849,398. Cash used in operations for the six months ended June 30,
2009 was $2,001,894. As of June 30, 2009, our principal source of
liquidity was $1,819,686 of cash and cash equivalents. These
operating results occurred while developing and attempting to commercialize and
manufacture products from entirely new and unique technologies. Our business
plan requires significant spending related to clinical testing expenditures, as
well as conducting basic research. These factors place a significant
strain on our limited financial resources and adversely affect our ability to
continue as a going concern. Our ultimate success will likely depend
on our ability to continue to raise capital for our operations.
Our
capital requirements for the remainder of 2009 will depend on numerous factors,
including the initial success of our commercialization efforts and of our
research and development, the resources we devote to develop and support our
technologies and the success of pursuing strategic licensing and funded product
development relationships with external partners. Subject to our ability to
generate revenue and cash flow from our Consumer Healthcare products division
and our ability to raise additional capital including through possible joint
ventures and/or partnerships, we expect to need to incur substantial
expenditures to further commercialize or develop each of our technologies
including continued increases in costs related to research, preclinical testing
and clinical studies, as well as significant costs associated with being a
public company. We will require substantial funds to conduct research and
development and preclinical and Phase I clinical testing of our licensed,
patented technologies and to develop sublicensing relationships for the Phase II
and III clinical testing and manufacture and marketing of any products that are
approved for commercial sale. We must generate additional capital resources to
enable us to continue as a going concern. Our plans include seeking financing,
alliances or other partnership agreements with entities interested in our
technologies, or other business transactions that would generate sufficient
resources to assure continuation of our operations and research and development
programs as well as seeking equity financing.
Our
future success depends on our ability to continue to raise capital and
ultimately generate revenue and attain profitability. We cannot be certain that
additional capital, whether through selling additional debt or equity securities
or obtaining a line of credit or other loan, will be available to us or, if
available, will be on terms acceptable to us. If we issue additional securities
to raise funds, these securities may have rights, preferences, or privileges
senior to those of our common stock, and our current stockholders may experience
substantial dilution. Our issued and outstanding common stock when
coupled with outstanding options and warrants, currently exceeds our authorized
common stock. Accordingly, we will need to seek shareholder approval
to amend our Articles of Incorporation to increase our available authorized
shares of common stock. We expect to seek such an amendment in the
new future.
While we
continue to focus on our products and technologies, we may not have sufficient
capital resources to market our products and complete the development of our
technologies. We had a working capital deficit at June 30, 2009 of
($462,275). While we believe our currently available cash, cash
equivalents of $1,819,686 when combined with the stock subscription
receivable from KFLP of $2,500,000 (of which $2,000,000 remains owed as of
August 1, 2009) is sufficient to enable us to continue to operate during the
remainder of 2009. During this time, if additional capital is not
raised, we would need to adjust our currently anticipated operating plan of
operations until we are able to acquire the necessary funding. In
addition, we expect to continue to explore strategic alternatives that may be
available to us and our technologies.
ITEM
4T. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
We
maintain “disclosure controls and procedures,” as such term is defined in Rule
13a-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”), that
are designed to ensure that information required to be disclosed in our Exchange
Act reports is recorded, processed, summarized and reported within the time
periods specified in the Securities and Exchange Commission rules and forms, and
that such information is accumulated and communicated to our management,
including our Chief Executive Officer and Chief Financial Officer, as
appropriate, to allow timely decisions regarding required disclosure. We
conducted an evaluation (the “Evaluation”), under the supervision and with the
participation of our Chief Executive Officer (“CEO”) and Chief Financial Officer
(“CFO”), of the effectiveness of the design and operation of our disclosure
controls and procedures (“Disclosure Controls”) as of the end of the period
covered by this report pursuant to Rule 13a-15 of the Exchange Act. Based on
this Evaluation, our CEO and CFO concluded that our Disclosure Controls were not
effective as of the end of the period covered by this report due to the material
weaknesses described below.
As of
June 30, 2009, management assessed the effectiveness of our
internal control over financial reporting based on the criteria for
effective internal control over financial reporting established in Internal
Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission ("COSO") and SEC guidance on
conducting such assessments. Based on that evaluation, they concluded that,
during the period covered by this report, such internal controls and
procedures were effective to detect the inappropriate application of US
GAAP rules as more fully described below. This was due to deficiencies that
existed in the design or operation of our internal controls over financial
reporting that adversely affect our internal controls and that may be
considered to be material weaknesses. Such deficiencies and
weaknesses were largely attributable to the significant lack of available
financial resources and corresponding personnel reductions experienced by us
during the period. Management believes that the material weaknesses
set forth below did not have an effect on our financial results.
For the
period referenced above, the matters involving internal controls and procedures
that our management considered to be material weaknesses were: (1) lack of
a functioning audit committee due to a lack of a majority of independent
members and a lack of outside directors on our board of directors, resulting in
ineffective oversight in the establishment and monitoring of required
internal controls and procedures; (2) inadequate staffing and supervision
that could lead to the untimely identification and resolution of accounting and
disclosure matters and failure to perform timely and effective reviews, (3)
limited documentation of our system of internal control, (4) insufficient
personnel to employ segregation of duties; (5) lack of formal written policies
and procedures for accounting and financial reporting with respect to the
requirements and application of U.S. GAAP and SEC disclosure requirements and
related documentation; (6) deficiencies in our material technology systems and
(7) ineffective controls over period end financial disclosure and reporting
processes. In addition, our corporate governance activities and processes are
not always formally documented or adequately communicated. Specifically,
decisions made by the board to be carried out by management should be documented
and communicated on a timely basis to reduce the likelihood of any
misunderstandings regarding key decisions affecting our operations and
management.
Management
already has begun to address the identified material weaknesses and deficiencies
in our internal controls as set forth above. For example, our Board
of Directors approved of the promotion of our Controller on June 29, 2009 to
Chief Financial Officer. Further, the appointment of two new
directors, and the intention to appoint one or more outside directors, will
permit the establishment of a fully functioning audit
committee. Management expects to review various facets of our
information processing system, such as cash disbursements, sales and billing,
cash receipts and other procedures. We continue to evaluate and
address these weaknesses to ensure adherence to our policies, completeness of
reporting, segregation of incompatible duties and compliance with generally
accepted accounting principles; and we intend to continue to monitor and
evaluate these and other factors affecting our internal controls as our
available liquidity permits. Until such time, our internal controls
over financial reporting may be subject to additional material weaknesses and
deficiencies that we have not yet identified.
In an
effort to remediate the identified material weaknesses and
other deficiencies and enhance our internal controls, we plan to initiate
the following series of measures:
As
sufficient funds become available to us, we expect to create a position to
segregate duties consistent with control objectives and will increase our
personnel resources and technical accounting expertise within the
accounting function. In addition, we also plan to appoint one or more
outside directors to our board of directors who shall be appointed to an
audit committee resulting in a fully functioning audit committee who will
undertake the oversight in the establishment and monitoring of
required internal controls and procedures such as reviewing and approving
estimates and assumptions made by management as funds become available to
us. Management believes that the appointment of one or more outside
directors, who shall be appointed to a fully functioning audit committee,
will remedy the lack of a functioning independent audit committee and a lack of
outside directors on our Board.
We
anticipate that these initiatives will take time to fully implement following
the period of insufficient financial resources we experienced. While we received
additional funding on June 29, 2009, such funding may not be sufficient to
address our operational needs or the weaknesses we have
identified. We cannot guarantee that any measures we take will
remediate the material weaknesses that we have identified, or that any
additional material weaknesses will not arise in the future. In
addition, our size prevents us from being able to employ sufficient resources to
enable us to have adequate segregation of duties within our internal control
system. Management is required to apply its judgment in evaluating the
cost-benefit relationship of possible controls and procedures.
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate. All internal control systems, no matter
how well designed, have inherent limitations. Therefore, even those systems
determined to be effective can provide only reasonable assurance with respect to
financial statement preparation and presentation. Because of the inherent
limitations of internal control, there is a risk that material misstatements may
not be prevented or detected on a timely basis by internal control over
financial reporting. However, these inherent limitations are known features of
the financial reporting process. Therefore, it is possible to design into the
process safeguards to reduce, though not eliminate, this risk.
Changes
in Internal Controls Over Financial Reporting
PART
II – OTHER INFORMATION
We are
not a party to any pending legal proceeding that is not in the
ordinary course of business or otherwise material to our financial condition or
business.
In
addition to the other information set forth in this Form 10-Q, you should
carefully consider the factors discussed in Part I, Item 1A, subsection “Risk
Factors” of our Annual Report on Form 10-K for the fiscal year ended
December 31, 2008 which could materially affect our business, financial
condition or future results of operations. The risks described in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2008 are
not the only risks that we face. Additional risks and uncertainties not
currently known to us or that we currently deem to be immaterial may also
materially adversely affect our business, financial condition and future results
of operations. Other than as set forth below, there have been no material
changes from the risk factors previously disclosed in Item 1A, subsection “Risk
Factors” to Part I of our Annual Report on Form 10-K for the fiscal year
ended December 31, 2008.
You
should carefully consider the risks described below before making an investment
decision in our securities. These risk factors are effective as of the date of
this Form 10-Q and shall be deemed to be modified or superseded to the extent
that a statement contained in our future filings modifies or replaces such
statement. All of these risks may impair our business operations. The
forward-looking statements in this Form 10-Q involve risks and uncertainties and
actual results may differ materially from the results we discuss in the
forward-looking statements. If any of the following risks actually occur, our
business, financial condition or results of operations could be materially
adversely affected. In that case, the trading price of our stock could decline,
and you may lose all or part of your investment.
Risks
Related to Our Business
We
have a limited operating history with significant losses and expect to continue
to experience losses for the foreseeable future and our independent auditors
have expressed doubt about our ability to continue as a going
concern.
We have
yet to establish any history of profitable operations. Our
profitability will require the successful commercialization of one or more of
the technologies we either license or own. Since our organization, we have
incurred operating losses and negative cash flow from operating activities as a
result of minimal sales coupled with our significant clinical development,
research and development, general and administrative, sales and marketing and
business development expenses. Furthermore, our cash burn rate and expenses have
recently increased significantly due to our aggressive commercialization,
marketing and international initiatives. We expect to incur losses for at least
the next several years as we expand our sales and marketing capabilities, make
use of the sales and marketing capabilities of third parties and continue our
clinical trials and research and development activities. Losses have
totaled approximately:
$2,849,398
for the six months ended June 30, 2009
$6,021,742
for the year ended December 31, 2008
$2,311,712
for the year ended December 31, 2007
$2,935,719
for the year ended December 31, 2006
These
losses, among other things, have had and will continue to have an adverse effect
on our working capital, total assets and stockholders’ deficit. In light of our
recurring losses, accumulated deficit and cash flow difficulties, the report of
our independent registered public accounting firm on our financial statements
for the year ended December 31, 2008 contains an explanatory paragraph raising
substantial doubt about our ability to continue as a going concern. Our
financial statements do not include any adjustments that may be necessary in the
event we are unable to continue as a going concern.
We have
experienced losses from operations during the last three years and have an
accumulated deficit of $22,841,933 as of June 30, 2009 and $19,992,535 as of
December 31, 2008. We have an operating cash flow deficit of
$2,001,894 for the six months ended June 30, 2009 and $3,835,190 for the year
ended December 31, 2008 and we sustained operating cash flow deficits of
$1,913,760 and $2,224,538 in 2007 and 2006, respectively. In the fourth quarter
of 2008 and first quarter of 2009, we incurred significant additional expenses
that were attributable to our delisting from the NYSE Alternext and listing on
the NYSE Euronext Alternext Paris Exchange (the "New Paris
Listing”). Our accounts payable and accrued expenses have also
increased due to the listing issues as well as due to other operational changes
instituted in connection with the launch of our consumer products. At
June 30, 2009, December 31, 2008 and December 31, 2007, we had working capital
(deficit) of approximately ($462,275), ($500,672) and $260,534,
respectively.
The
Company's principal source of liquidity at June 30, 2009 was $1,819,686 in cash
and cash equivalents. The Company currently has sufficient capital to
operate for the remainder of 2009.
We
continue to require additional financing to operate beyond 2009.
We may
not have sufficient capital to sustain our operations beyond 2009 and we may
require additional financing. If we should need additional capital for
operations and are not able to raise additional capital, among other things, we
could:
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·
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be
forced to reorganize under the protection of the Federal Bankruptcy
Laws;
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·
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need
to scale back or cease our marketing and development
efforts;
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·
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be
forced to cease operations;
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·
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be
unable to pursue further development of our
technologies;
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·
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be
forced to sell off our technologies prior to maximizing their potential
value;
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·
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be
unable to aggressively market our
products;
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·
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be
unable to pursue patenting some of our technologies and development of our
technologies and products;
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·
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have
to lay-off personnel;
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·
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be
unable to continue to make public filings;
and
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·
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have
our licenses for our SMaRT™ Replacement Therapy technology and MU 1140
technology could be terminated.
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There can
be no assurance that we would be able to raise additional capital and any of
these events would significantly harm our business.
Our business may be adversely
affected by the current economic recession.
The
domestic and international economies are experiencing a significant recession.
This recession has been magnified by the tightening of the credit markets. The
domestic and international markets may remain depressed for an undeterminable
period of time. A prolonged recession could have a material adverse
effect on the Company's revenues, profits and its ability to obtain additional
financing if sales revenue is insufficient to sustain our operations as
needed. In such event, we could be forced to limit our marketing and
development efforts and significantly curtail or suspend our
operations, including laying-off employees, recording asset impairment
write-downs and other measures. We must generate significant revenues to achieve
and maintain profitability.
We
must spend at least $1 million annually on development of our MU 1140™ and
SMaRT™ Replacement Therapy technologies and $100,000 annually as minimum
royalties under our license agreements with the University of Florida Research
Foundation, Inc. We must also comply with certain other conditions of our
licenses. If we do not, our licenses to these and other technologies may be
terminated, and we may have to cease operations.
We hold
our MU 1140™ and SMaRT™ Replacement Therapy technologies under licenses from the
University of Florida Research Foundation, Inc. Under the terms of the licenses,
we must spend at least $1 million per year on development of those technologies
before the first commercial sale of products derived from those technologies. In
addition, we must pay $25,000 per quarter as minimum royalties to the University
of Florida Research Foundation, Inc. under our license agreements. The
University of Florida Research Foundation, Inc. may terminate our licenses in
respect of our MU 1140™ and our SMaRT™ Replacement Therapy technology and
technology if we breach our obligations to timely pay monies to it, submit
development reports to it or commit any other breach of the covenants contained
in the license agreements. There is no assurance that we will be able to comply
with these conditions. If our license is terminated, our investment in
development of our SMaRT™ Replacement Therapy™ and MU 1140™ technologies will
become valueless and we may have to cease operations.
Until
commercial sales of any products developed from these licensed technologies take
place, we will not be earning revenues from the sale of products derived from
them and will, therefore, have to raise the money we must spend on development
of our technologies by other means, such as commercialization and sale of our
consumer products, or the sale of our common stock. There is no assurance we
will achieve a sufficient level of sales to provide such funding or be able to
raise the financing necessary to meet our obligations under our licenses. If we
cannot, we may lose our licenses to these technologies and have to cease
operations.
If
we fail to maintain an effective system of internal controls, we may not be able
to accurately report our financial results or prevent fraud which could subject
us to regulatory sanctions, harm our business and operating results and cause
the trading price of our stock to decline.
Effective
internal controls required under Section 404 of the Sarbanes-Oxley Act of
2002 are necessary for us to provide reliable financial reports and effectively
prevent fraud. If we cannot provide reliable financial reports or prevent fraud,
our business, reputation and operating results could be harmed. We have
discovered, and may in the future discover, areas of our internal controls that
need improvement. For example, “material weaknesses” were identified in
our quarter ended June 30, 2009 which means that there was “a
significant deficiency, or a combination of significant deficiencies, that
results in more than a remote likelihood that a material misstatement of the
annual or interim financial statements will not be prevented or detected.”
During this period, we were under significant operational stress due to a lack
of liquidity and much of our staff was terminated. During this period
and until we can complete our remediation efforts including the re-staffing and
training of our accounting personnel, we have a higher risk of deficiencies in
our financial reporting. We cannot be certain that the measures we have taken or
intend to take will ensure that we maintain adequate controls over our financial
processes and reporting in the future. Any failure to implement required new or
improved controls or difficulties encountered in their implementation could
subject us to regulatory sanctions, harm our business and operating results or
cause us to fail to meet our reporting obligations. Inferior internal controls
could also harm our reputation and cause investors to lose confidence in our
reported financial information, which could have a negative impact on the
trading price of our stock.
Forward-Looking
Statements
This 10-Q
contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended and Section 21E of the Securities Exchange
Act of 1934, as amended. Such forward-looking statements include statements
regarding, among other things, (a) our need for and availability of working
capital, (b) our financing plans, (c) our strategies, (d) our projected sales
and profitability,(e) anticipated trends in our industry. Forward-looking
statements, which involve assumptions and describe our future plans, strategies,
and expectations, are generally identifiable by use of the words “may,” “will,”
“should,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project”
or the negative of these words or other variations on these words or comparable
terminology. This information may involve known and unknown risks,
uncertainties, and other factors that may cause our actual results, performance,
or achievements to be materially different from the future results, performance,
or achievements expressed or implied by any forward-looking statements. These
statements may be found under “Management’s Discussion and Analysis or Plan of
Operation” and “Business,” as well as in this 10-Q generally. Actual events or
results may differ materially from those discussed in forward-looking statements
as a result of various factors, including, without limitation, the risks
outlined under “Risk Factors” and matters described in this 10-Q generally. In
light of these risks and uncertainties, there can be no assurance that the
forward-looking statements contained in this filing will in fact occur. In
addition to the information expressly required to be included in this filing, we
will provide such further material information, if any, as may be necessary to
make the required statements, in light of the circumstances under which they are
made, not misleading.
ITEM 2. UNREGISTERED SALE OF EQUITY
SECURITIES AND USE OF PROCEEDS
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(a)
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We
issued the following restricted securities during the period covered by
this report, which were not previously included in our form 8K filing on
July 6, 2009, to the named individual pursuant to exemptions under the
Securities Act of 1933 including
Section 4(2):
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On April
15, 2009, we issued 100,000 warrants at $.50 per share as part of the short term
loan agreement we entered with an accredited investor.
On June
29, 2009, we issued 250,000 shares to Brian Bohunicky as payment of deferred
compensation amounts we owed Mr. Bohunicky. The price of the shares
issued was based on the closing market value of our common stock on June 29,
2009 of $0.10.
On June
29, 2009, we also issued 343,750 shares to our employee Martin Handfield, as
payment of deferred compensation amounts we owed Mr. Handfield. The
price of the shares issued was based on the closing market value of our common
stock on June 29, 2009 of $0.10.
ITEM
5. OTHER INFORMATION
On August 13, 2009, the compensation
committee approved an increase in our Chief Executive Officer and President,
David Hirsch's annual base compensation from $150,000 to $225,000 effective
as of the beginning of the month. In addition, the compensation committee
approved the acceleration of the vesting of outstanding option awards previously
made to Mr. Hirsch and to Dr. Jeffrey Hillman, our Chief
Science Officer and founder, that had not yet vested. A portion of the
shares covered by the original option awards, (433,333 shares for Mr.
Hirsch and 500,000 shares for Dr. Hillman) vested upon our stock price
reaching certain levels in the future. Following the acceleration of
vesting by the compensation committee, Mr. Hirsch's grant of options to acquire
500,000 shares of our common stock at $0.49 per share are now fully
vested and exercisable (including the 433,333 shares impacted by the
acceleration of vesting) and Dr. Hillman's grant of options to acquire
700,000 shares of our common stock at $0.85 per share are now fully vested
and exercisable (including the 500,000 shares impacted by the acceleration of
vesting). All other terms of the prior option awards, including
the share amounts covered by the options and exercise
price remained the same.
ITEM
6. EXHIBITS
Incorporated by reference to Exhibits
filed after signature page.
SIGNATURES
In
accordance with the requirements of the Exchange Act, the registrant caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized
on this 14th day of
August, 2009.
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ORAGENICS,
INC.
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/s/
David B. Hirsch
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David
B. Hirsch, President and Chief Executive Officer
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EXHIBIT
INDEX
Incorporated
by Reference
Exhibit
Number
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Exhibit
Description
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Form
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File
No
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Exhibit
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Filing
Date
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Filed
Herewith
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10.1
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Securities
Purchase Agreement dated June 29, 2009 by and between the Company and the
Koski Family Limited Partnership (including the Form of the Promissory
Note and Form of Warrant)
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8-K
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001-32188
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10.1
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7/6/09
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10.2
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Secured
Promissory Note
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8-K
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001-32188
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10.2
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7/6/09
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10.3
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Security
Agreement
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8-K
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001-32188
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10.3
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7/6/09
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31.1
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Certification
of Principal Executive Officer pursuant to Rule 13a-14 and Rule 15d-14(a),
promulgated under the Securities and Exchange Act of 1934, as
amended.
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X
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31.2
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Certification
of Principal Financial Officer pursuant to Rule 13a-14 and Rule 15d-14(a),
promulgated under the Securities and Exchange Act of 1934, as
amended.
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X
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32.1
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Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 (Chief Executive Officer).
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X
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32.2
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Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 (Chief Financial Officer).
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X
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