UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
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QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For
the quarterly period ended June 30, 2008.
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OR
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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 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.
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Large
accelerated filer
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Accelerated
filer
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Non-accelerated
filer
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Smaller
reporting company
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Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yeso
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 11, 2008, there were 38,316,585 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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Balance
Sheets as of June 30, 2008 (unaudited) and December 31, 2007
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3
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Statements
of Operations for the Three and Six Months ended June 30, 2008 and
2007
(unaudited)
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4
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Statements
of Cash Flows for the Six Months ended June 30, 2008 and 2007
(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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8
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Item
4T.
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Controls
and Procedures
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16
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PART
II - OTHER INFORMATION
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Item
1A.
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Risk
Factors
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17
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Item
2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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20
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Item
4.
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Submission
of Matters to a Vote of Security Holders
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21
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Item
5.
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Other
Information
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22
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Item
6.
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Exhibits
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23
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PART
I - FINANCIAL INFORMATION
ITEM
1. FINANCIAL
STATEMENTS
Oragenics,
Inc.
Balance
Sheets
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June
30,
2008
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December
31,
2007
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(Unaudited)
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Assets
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Current
assets:
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Cash
and cash equivalents
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$
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3,634,145
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$
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475,508
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Prepaid
expenses and other current assets
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215,999
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116,520
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Total
current assets
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3,850,144
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592,028
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Property
and equipment, net
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413,878
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559,349
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Total
assets
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$
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4,264,022
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$
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1,151,377
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Liabilities
and stockholders’ equity
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Current
liabilities:
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Accounts
payable and accrued expenses
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$
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253,395
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$
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244,994
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Current
portion of note payable
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69,215
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-
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Deferred
compensation
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42,750
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86,500
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Total
current liabilities
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365,360
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331,494
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Stockholders’
equity:
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Preferred
stock, no par value; 20,000,000 shares authorized; none issued and
outstanding at June 30, 2008 and December 31, 2007
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-
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-
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Common
stock, $0.001 par value; 100,000,000 shares authorized; 38,316,585
and
28,002,443 shares issued and outstanding at June 30, 2008 and December
31,
2007, respectively
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38,316
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28,002
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Additional
paid-in-capital
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19,717,887
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14,762,674
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Accumulated
deficit
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(15,857,541
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(13,970,793
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Total
stockholders’ equity
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3,898,662
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819,883
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Total
liabilities and stockholders’ equity
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$
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4,264,022
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$
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1,151,377
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See
accompanying notes.
Oragenics,
Inc.
Statements
of Operations
(Unaudited)
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Three
months ended
June
30
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Six
months ended
June
30
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2008
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2007
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2008
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2007
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Revenue
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$
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-
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$
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26,673
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$
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125,000
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$
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59,761
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Operating
expenses:
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Research
and development
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492,667
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401,353
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971,040
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772,276
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General
and administration
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618,886
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221,612
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1,066,608
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439,425
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Total
operating expenses
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1,111,553
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622,965
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2,037,648
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1,211,701
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Loss
from operations
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(1,111,553
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(596,292
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(1,912,648
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(1,151,940
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Other
income:
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Interest
income
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9,731
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4,567
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14,330
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14,393
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Gain
on sale of property and equipment
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-
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-
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4,860
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-
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Sales
tax refund
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6,710
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-
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6,710
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-
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Total
other income
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16,441
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4,567
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25,900
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14,393
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Net
loss
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$
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(1,095,112
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$
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(591,725
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$
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(1,886,748
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$
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(1,137,547
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Basic
and diluted net loss per share
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$
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(0.03
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$
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(0.03
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$
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(0.06
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$
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(0.05
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Shares
used to compute basic and diluted net loss per share
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33,694,363
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23,198,927
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31,768,114
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20,764,214
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See
accompanying notes.
Oragenics,
Inc.
Statements
of Cash Flows
(Unaudited)
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Six
months ended
June
30
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2008
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2007
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Operating
activities
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Net
loss
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$
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(1,886,748
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$
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(1,137,547
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Adjustments
to reconcile net loss to net cash used in operating
activities:
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Depreciation
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125,581
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137,997
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Gain
on sale of property and equipment
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(4,860
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-
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Stock-based
compensation expense resulting from fair value based
method
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454,527
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99,036
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Changes
in operating assets and liabilities:
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Prepaid
expenses and other current assets
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(84,479
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(151,093
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Accounts
payable and accrued expenses
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8,401
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92,620
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Deferred
compensation
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(43,750
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(45,500
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Net
cash used in operating activities
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(1,431,328
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(1,004,487
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Investing
activities
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Purchases
of property and equipment
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(17,500
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(6,079
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Proceeds
from sale of property and equipment
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27,250
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-
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Net
cash provided by (used in) investing activities
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9,750
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(6,079
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Financing
activities
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Net
proceeds from note payable
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69,215
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-
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Net
proceeds from issuance of common stock
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4,511,000
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454,757
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Net
cash provided by financing activities
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4,580,215
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454,757
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Net
increase (decrease) in cash and cash equivalents
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3,158,637
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(555,809
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Cash
and cash equivalents at beginning of period
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475,508
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707,278
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Cash
and cash equivalents at end of period
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$
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3,634,145
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$
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151,469
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See
accompanying notes.
Oragenics,
Inc.
Notes
to Financial Statements
(Unaudited)
1. Organization
and Significant Accounting Policies
Oragenics,
Inc. (d/b/a ONI BioPharma, Inc., formerly known as Oragen, 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, 2008 and
December 31, 2007 and for the three and six months ended June 30, 2008 and
2007
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, 2008 are not necessarily
indicative of the results that may be expected for the year ended December
31,
2008 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, 2007 which are
included in our Annual Report on Form 10-KSB filed with the Securities and
Exchange Commission on March 18, 2008. In that report the Company disclosed
that
it expects to incur substantial expenditures to further develop each of its
technologies. It further stated 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.
2. Net
Loss
Per Share
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.
3. Income
Taxes
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 FIN 48, the Company did not recognize a change
in its tax liabilities or assets as of June 30, 2008.
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, 2008. 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, 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
July 1, 2013. We intend to use the net proceeds of the private placement,
including any proceeds from exercise of the warrants, for working capital and
general corporate purposes.
6.
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Stock
Options Issued During 2nd
Quarter, 2008
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During
the quarter, the Company issued 2,780,000 stock options of which 1,191,667
vested immediately. The remaining options that have yet to vest will vest
subject to the price of the stock reaching certain levels. The stock options
were granted (1) to existing employees to supplement or replace options that
were previously granted that had exercise prices far out-of-the-money, and
(2)
to executive employees who recently joined the Company. This increase in the
number of options granted was partially offset by the number of stock options
that have been forfeited. Since the beginning of the 2nd
Quarter,
2008, through the date of this filing, 715,000 options that were previously
granted have been forfeited. From January, 1, 2008 to the date of this filing,
850,000 stock options have been forfeited. It is important to note that stock
options compensation expense is a non-cash expense.
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.
Oragenics,
Inc. d/b/a ONI Biopharma, Inc, (the “Company” or “ONI”) has changed its strategy
as it has the name under which it does business. ONI is no longer strictly
a
research and development company, but, as management expects, is now securely
on
the road towards the commercialization of some of its products. ONI is also
moving forward with the clinical testing of other products to achieve
registration in as timely a manner as possible. These opportunities have derived
from our focus on creating novel technologies that apply to individual products
as well as platforms from which numerous products can be developed.
Second
Quarter Highlights
During
the quarter the following significant events occurred:
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·
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Officer
and Board of Director Changes. During
the quarter, our Board of Directors appointed Mr. Stanley B. Stein
as
President and Chief Executive Officer and David B. Hirsch as Chief
Operating Officer and Chief Financial Officer. During the quarter,
our
Board of Directors also appointed Mr. Kevin H. Sills as an independent
director and Dr. Marc Siegel as a director. The change in management
and
the additions to our Board of Directors has brought a greater depth
of
experience for us to draw upon in our commercialization
efforts.
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|
·
|
Launch
of Probiora3. We
announced the test marketing of our oral probiotic product, Probiora3
through chewable tablets which we believe help to whiten teeth
and improve
breath. Probiora3 is a unique combination of safe, naturally occurring
bacteria that are released in the mouth by chewing on a mint-flavored
tablet that we have designed to be used twice daily.
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|
·
|
Name
Change.
On
May 13, 2008 we announced that we approved our name change to “ONI
BioPharma Inc.” which is how we will refer to ourselves until we are able
to seek shareholder approval to amend our articles of incorporation
in
order to formally change our name. We believe the new name more
accurately
reflects the broad range of scientific platforms and products we
have
under development.
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|
·
|
Financing
Transaction. On
June 12, 2008 we announced that we had entered into a stock purchase
agreement with accredited investors, pursuant to which we received
net
proceeds of $2,515,000, which will be used for general corporate
purposes.
In the transaction we issued 5,777,778 shares of common stock and
warrants
to acquire 5,777,778 shares of common stock at an exercise price
of $1.30
per share.
|
|
·
|
Amex
Compliance Extension. We
obtained an extension from the American Stock Exchange to meets
its
requirements for continued listing. Our deadline for meeting Amex’s
continued listing requirements which require us to have minimum
shareholder equity of $4,000,000 is October 27, 2008. Additionally,
these
AMEX minimum listing requirements will increase the minimum shareholder
equity requirement to $6,000,000 at year end. Our plan is to have
in
excess of $6,000,000 in shareholder equity by year end, thereby
complying
with current and future AMEX listing
requirements.
|
Since
ONI’s inception, the Company has funded a significant portion of its operations
from the public and private sales of its securities. There have been no
significant revenues from operations during the last two years. All of our
revenues have been from sponsored research agreements and various governmental
grants. At this time we have not generated revenues from sales of products.
Management
believes that we are now positioned over the next several months to generate
revenues from a number of technologies. Furthermore, with respect to products
that are not ready for immediate commercialization, we are taking what we regard
to be concrete steps in completing the research and development of pending
products and platforms. Consequently, our proofs of concept are essentially
complete, and we are taking the steps necessary to bring our product portfolio
to market, with the expectation, but not assurance that our products, where
necessary will be approved for marketing.
Business
Objectives and Milestones
We
have a
number of products and platforms. For ease in understanding., we have broken
these products and platforms down into four distinct categories; (1) Consumer
Products, which consists of ProBiora3 and LPT3-04, (2) Diagnostics, which
consists of the IVIAT and CMAT platforms, (3) Antibiotics, which consists the
DPOLT lantibiotic synthesis platform, and (4) SMaRT replacement
therapy.
Consumer
Products
The
specific goal for our consumer products is to rapidly and effectively
commercialize ProBiora3 and LPT3-04.
Probiora3™
(Probiotics)
We
have
made strides in its commercialization efforts regarding our oral probiotic,
ProBiora3. We are currently in the final stages in the development of a
comprehensive global marketing strategy for the Probiora3 technology. We expect
to unveil this comprehensive strategy in the near future. We believe ProBiora3
to be a safe and efficacious treatment for oral care including the gums, teeth
and breath.
Although
it will take some time to generate sufficient sales that may be produced by
such
efforts, we expect the product to be profitable. Furthermore, we will expect
to
comply with applicable regulations with respect to each foreign jurisdiction
in
which we expect to sell the product, and intend to test the product on a
continuing basis to increase the amount of benefits that we may claim with
respect to it. Currently, we are planning to market ProBiora3 in the United
States this September. In order to effectively launch the product, we have
retained experts in marketing, sales, media, design, and regulatory
matters.
Despite
our commitment to commercializing ProBiora3, there can be no assurances that
it
will meet its timeline for commercialization or that the product will meet
our
sales projections that are anticipated.
Probiora3
contains three naturally occurring, live microorganisms that helps 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. Because probiotic treatments may
be
marketed as a cosmetic or as "health supplements" in certain geographic areas
without the need for extensive regulatory oversight, we believe we can expedite
our marketing efforts. Two sets of subjects completed our Probiora3 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.
LPT3-04™
We
have
made material progress with respect to commercialization of our weight loss
product LPT3-04. We are currently exploring several marketing and packaging
options and anticipate a product launch of LPT3-04 in the first-half of 2009.
However, there can be no assurances that the product will launch at that time.
Initial clinical testing has shown the need for coating of the product to
eliminate an uncomfortable side-effect of transient nausea. Management expects
that a number of coatings will eliminate this side-effect.
LPT3-04
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, LPT3-04 is orally available,
and
we believe it has an excellent safety and tolerability profile.
Diagnostics
The
goal
of our Diagnostics unit is to utilize the IVIAT and C MAT 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. There are a number of profitable
business models to realize value from these platforms.
One
model
that already has proven itself, is that of a third-party diagnostic company
that
requests genetic markers or targets from ONI. Such third-party diagnostic
company pays for the markers or targets that it uses as well as a license fee
if
the diagnostic kit that encompasses the markers or targets receives regulatory
approval.
IVIAT™
and CMAT™
The
first
major commercial effort that we have undertaken utilizing the CMAT 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 CMAT diagnostic platform, we
have discovered what we believe to be unique genetic markers that appear during
the earliest stages of colorectal cancer. At this time we are in active
discussions with a major company in the diagnostics market to determine the
potential of these markers. We intend to form a collaborative arrangement with
the diagnostics company referred to herein to test and subsequently incorporate
the CMAT markers into a diagnostic blood test for the early detection of
colorectal cancer.
Although
we are aggressively undertaking the completion of this arrangement, there can
be
no assurances that such genetic markers 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.
Our
IVIAT
platform, which revolves around the extraction of gene targets for infectious
diseases, has also made progress. We are currently in discussions with major
foundations and institutions with respect to diseases of epidemic
proportions.
CMAT
and
IVIAT are technologies that enable the simple, fast identification of novel
and
potentially important gene targets associated with the natural onset and
progression of infections, cancers and other diseases in humans and other living
organisms, including plants. These technologies offer the potential to generate
and develop a number of product candidates as diagnostics or therapeutics for
future out-licensing to corporate partners, particularly in the areas of cancer
and infectious diseases.
Antibiotics
DPOLT™
(Differentially Protected Orthogonal Lantionine
Technology)
Through
the DPOLT platform, we believe we have the ability to synthesize lantibiotic
molecules that have historically been un-synthesizable. In proving this concept,
the company is currently in the process of using the platform to synthesize
the
MU 1140 molecule. We have extensively studied MU 1140, in its naturally
occurring state. As a result of such tests, MU 1140 has proven itself to be
a
uniquely effective antibiotic. If our efforts to synthesize MU 1140 are
successful, we believe we will then have the ability to produce the synthetic
version of the molecule in commercial quantities. We will then have the ability
to use the DPOLT platform to potentially synthesize numerous other
lantibiotics.
DPOLT
is
a solid and/or liquid phase peptide synthesis platform technology that has
broad
application for the cost-effective manufacture of a number of commercially
important bioactive peptides. Scientific literature has demonstrated that
various Lantibiotics are highly effective at accomplishing their goals of
killing off foreign bacteria. These Lantibiotics, which include our lead
antibiotic, MU 1140, are a potentially important class of antibiotics, and
constitute a family of polycyclic peptides that are produced by bacteria, and
are highly modified structurally. However, attempts to study Lantibiotics for
their potential usefulness as therapeutic agents have been hindered by the
difficulty of producing sufficient pure material in amounts adequate for
clinical testing let alone commercialization. DPOLT provides a basis to overcome
this impediment to further research and development in this area as we believe
it constitutes a platform from which such Lanitbiotics would be able to be
produced in sufficiently pure quantities for research and ultimately
commercialization.
SMaRT
Replacement Therapy™
We
currently have FDA approval for Phase 1B clinical trial for SMaRT. It may make
sense for us to commence this clinical trial in Mexico where there appears
to be
broad public health demand for this product.
SMaRT
Replacement Therapy is a single, painless one time topical treatment to teeth
that has the potential to offer significant lifelong protection against dental
caries (tooth decay). The therapy is based on genetically altering the
bacterium, Streptococcus mutans (S. mutans), which is the primary etiologic
agent in tooth decay. Present in the normal flora of the mouth, S. mutans
convert dietary sugar to lactic acid; the lactic acid, in turn, causes the
erosion of tooth enamel that results in the destruction of the tooth surface
and
eventually the entire tooth. SMaRT Replacement Therapy permanently replaces
resident acid-producing S. mutans with a patented genetically modified strain
of
S. mutans that does not produce lactic acid. Applied topically to tooth surfaces
with a cotton-tipped swab, the therapy may require only one application.
Global
Expansion
We
are in
active negotiations with various parties in Mexico to create a research and
development business, and ultimately, a base for clinical studies, manufacturing
and distribution of our products in Mexico, Central America, South America
and
the Caribbean. We hope to benefit from collaboration with a leading academic
center as well as working with individual or corporate partners.
Although
discussions have been on going for some time, there is a risk that an agreement
that is satisfactory to the Company cannot be completed.
Critical
Accounting Policies
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
September 2006, the Financial Accounting Standards Board (“FASB”) issued SFAS
No. 157, Fair
Value Measurements (“SFAS
157”). 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 is effective for fiscal
years beginning after November 15, 2007. In February 2008, the FASB
deferred the effective date of SFAS 157 until the fiscal year beginning after
November 15, 2008 for all non-financial assets and non-financial liabilities,
except those that are recognized or disclosed at fair value in the financial
statements on a recurring basis (at least annually). The partial adoption of
SFAS 157 for financial assets and liabilities did not have a material effect
on
the Company’s financial statements. The remaining requirements of SFAS 157 are
not expected to have a material effect on the Company’s financial
statements.
In
February 2007, the FASB issued SFAS No. 159, The
Fair Value Option for Financial Assets and Financial
Liabilities
(“SFAS
159”), which gives entities the option to measure eligible financial assets, and
financial liabilities at fair value on an instrument by instrument basis, that
are otherwise not permitted to be accounted for at fair value under other
accounting standards. The election to use the fair value option is available
when an entity first recognizes a financial asset or financial liability.
Subsequent changes in fair value must be recorded in earnings. This statement
is
effective as of the beginning of a Company’s first fiscal year after
November 15, 2007. The adoption of SFAS 159 did not have an effect on the
Company’s financial statements as it did not elect this fair value
option.
In
June
2007, the FASB ratified Emerging Issues Task Force Issue No. 06-11,
Accounting
for Income Tax Benefits of Dividends on Share-Based Payment Awards
(“EITF
06-11”). EITF 06-11 specifies how companies should recognize the income tax
benefit received on dividends that are (a) paid to employees holding
equity-classified nonvested shares, equity-classified nonvested share units,
or
equity-classified outstanding share options and (b) charged to retained
earnings under SFAS 123(R). The adoption of EITF 06-11 did not have a material
impact on the Company’s financial statements.
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), Business
Combinations
(“SFAS
141R”). SFAS 141R establishes principles and requirements for an acquiring
entity to recognize and measure in its financial statements the identifiable
assets acquired, the liabilities assumed, any noncontrolling interest in the
acquired entity and the goodwill acquired. SFAS 141R expands on required
disclosures to improve the statement users’ abilities to evaluate the nature and
financial effects of business combinations. SFAS 141R is effective for fiscal
years beginning after December 15, 2008. The Company is currently
evaluating the potential impact, if any, of the adoption of SFAS 141R on its
financial statements.
In
December 2007, the FASB issued SFAS No. 160, Noncontrolling
Interests in Consolidated Financial Statements—an amendment of ARB
No. 51
(“SFAS
160”). SFAS 160 requires that a noncontrolling interest in a subsidiary be
reported within equity and the amount of consolidated net income attributable
to
the noncontrolling interest be identified in the consolidated financial
statements. SFAS 160 calls for consistency in the manner of reporting changes
in
the parent’s ownership interest and requires fair value measurement of any
noncontrolling equity investment retained in a deconsolidation. SFAS No.
160 also establishes disclosure requirements that clearly identify and
distinguish between the interests of the parent and the interests of the
noncontrolling owners. SFAS No. 160 is effective for fiscal years beginning
after December 15, 2008. The Company is currently evaluating the potential
impact, if any, of the adoption of SFAS 160 on its financial
statements.
In
March
2008, the FASB issued SFAS No. 161, Disclosures
about Derivative Instruments and Hedging Activities — an amendment of FASB
Statement No. 133 (“SFAS
161”). This statement amends SFAS No. 133 by requiring enhanced
disclosures about an entity’s derivative instruments and hedging activities, but
does not change SFAS No. 133’s scope or accounting. SFAS 161
requires increased qualitative, quantitative and credit-risk disclosures about
the entity’s derivative instruments and hedging activities. SFAS 161 is
effective for fiscal years, and interim periods within those fiscal years,
beginning after November 15, 2008, with earlier adoption permitted. The
adoption of SFAS 161 is not expected to have a material impact on the Company’s
financial statements.
Results
of Operations
Three
Months Ended June 30, 2008 and 2007
We
had no
revenues in the three months ended June 30, 2008 compared with $26,673 in
revenues in the same period in 2007. Our first quarter operating expenses
increased by 78.4% to $1,111,553 in the three months ended June 30, 2008 from
$622,965 in the same period in 2007. Research and development (R&D) expenses
increased 22.8% to $492,667 in the three months ended June 30, 2008 from
$401,353 in the same period in 2007. This increase was primarily due to clinical
trials for our LPT3-04 weight loss product. General and administration (G&A)
expenses increased 179.3% to $618,886 in the three months ended June 30, 2008
from $221,612 in the same period in 2007, reflecting the shift in corporate
focus to commercialization. The increase can be attributed to the Company’s
recruitment of a new management team, the continued use of outside consultants
for business development to help facilitate our marketing plans for our
technology and from stock option compensation expense (see Note 6, Notes to
Financial Statements, p. 6).
Interest
income increased 113.1% to $9,731 in the three months ended June 30, 2008 from
$4,567 during the same period in 2007. This increase is primarily due to the
Company’s strengthened cash position.
We
incurred net losses of $1,095,112 and $591,725 during the three months ended
June 30, 2008 and 2007, respectively. The increase in our net loss was
principally caused by the increase in general and administrative expenses due
to
the shift in Company focus from development to commercialization and increases
in stock option expense.
Six
Months Ended June 30, 2008 and 2007
We
had
revenues of $125,000 in the six months ended June 30, 2008 compared with $59,761
in revenues in the same period in 2007. Our operating expenses increased by
68.2% to $2,037,648 in the six months ended June 30, 2008 from $1,211,701 in
the
same period in 2007. Research and development (R&D) expenses increased 25.7%
to $971,040 in the six months ended June 30, 2008 from $772,276 in the same
period in 2007. This increase was primarily due to clinical trials for our
LPT3-04 weight loss product. General and administration (G&A) expenses
increased 142.7% to $1,066,608 in the six months ended June 30, 2008 from
$439,425 in the same period in 2007, reflecting the shift in corporate focus
to
commercialization. The increase can be attributed to the increased cash position
due to our financing and the exercise of warrants, and the Company’s recruitment
of a new management team and the continued use of outside consultants for
business development to help facilitate our marketing plans for our technology
and from stock option compensation expense (see Note 6, Notes to Financial
Statements, p. 6).
Interest
income decreased 0.4% to $14,330 in the six months ended June 30, 2008 from
$14,393 during the same period in 2007.
We
incurred net losses of $1,886,748 and $1,137,547 during the six months ended
June 30, 2008 and 2007, respectively. The increase in our net loss was
principally caused by the increase in general and administrative expenses due
to
the shift in Company focus from development to commercialization and increase
in
stock options expense.
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 six months ended June 30, 2008, we have received proceeds from the
following: (i) award of a two-year $500,000 NSF Phase II grant for our DPOLT
technology; (ii) outstanding warrants to acquire 4,536,364 shares of our common
stock were exercised which provided $1,996,000 in proceeds to us and resulted
in
the issuance of 4,536,364 shares of our common stock; and (iii) the sale of
5,777,778 shares of our common stock in a private placement to accredited
investors at a price of $0.45 per share resulting in proceeds of $2,600,000
before fees and expenses.
Our
operating activities used cash of $1,431,328 for the six months ended June
30,
2008 and $1,004,487 for the six months ended June 30, 2007. Our working capital
was $3,484,784 as of June 30, 2008. Cash used by operations in the six months
ended June 30, 2008 resulted primarily from our net loss from operations of
$1,912,648.
Our
investing activities provided net cash of $9,750 during the six month period
ended June 30, 2008 versus net cash of $6,079 for the same period ending June
30, 2007.
Our
financing activities for the six months ended June 30, 2008 provided net cash
of
$4,580,215 from the issuance of shares in private placements, the exercise
of
warrants, and the financing of insurance premiums. Additional details of our
financing activities are provided below:
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
June 12, 2013. We intend to use the net proceeds of the private placement,
including any proceeds from exercise of the warrants, for working capital and
general corporate purposes.
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 warrants expire 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) following which the exercise price reverted back to
$0.58. Prior to the expiration of the August 2007 Warrants, 3,386,364 were
issued upon exercise at the amended exercise price resulting in additional
working capital proceeds to us of $1,490.000. The remaining unexercised August
2007 warrants expired unexercised on August 8, 2008.
On March 6,
2006, we issued a total of 1,500,000 shares of our common stock and warrants
to
purchase 1,500,000 shares of our common stock in a private placement to
accredited investors. We received gross proceeds of $600,000 in the private
placement and incurred estimated costs of approximately $75,000 resulting in
net
proceeds of approximately $525,000. Each warrant is exercisable on or before
February 8, 2008 to acquire one share of common stock at a price of $0.60
per share (the “March 2006 Warrants”). On January 17, 2008 we amended the
March 2006 Warrants. Pursuant to the amendment, the warrant exercise price
was
reduced to $0.44, which was the fair market value on the date of the amendment.
Prior to the expiration of the March 2006 Warrants, 1,150,000 were issued upon
exercise at the amended exercise price resulting in additional working capital
proceeds to us of $506,000. The remaining unexercised March 2006 Warrants
expired and are no longer outstanding.
Warrant
Exercises Q1 2007
On December 14,
2005, we issued a total of 2,937,500 shares of our common stock and warrants
to
purchase 2,937,500 shares of our common stock in a private placement to
accredited investors. The issuance of the shares of common stock and warrants
was made pursuant to the exemptions from registration provided by
Section 4(2) of the Securities Act and Regulation D promulgated there
under. We received gross proceeds of $1,175,000 in the private placement and
incurred estimated costs of approximately $70,000 resulting in net proceeds
of
approximately $1,105,000. The warrants representing shares of common stock
were
exercisable by the accredited investors at any time over a two-year period
at an
exercise price of $0.60 per share. On January 16, 2007, we called all
outstanding warrants associated with our December, 2005 private placement
pursuant to the terms of the warrant. A total of 1,387,500 warrants were
exercised that provided $832,500 in additional working capital and following
the
call of the warrants no further warrants associated with the private placement
remain outstanding.
Fusion
Stock Purchase Agreement Termination
On
May 23, 2005, we entered into a stock purchase agreement with Fusion
Capital Fund II, LLC (“Fusion Capital”). Pursuant to the terms of the stock
purchase agreement, Fusion Capital has agreed to purchase from us up to
$9,000,000 of our common stock over a 30 month period commencing from the date
of the stock purchase agreement. The stock purchase agreement has expired per
the 30-month contract terms. On August 12, 2008, we sent Fusion our Notice
of
Termination of the stock purchase agreement and expect to withdraw the
previously filed registration statement relating to the stock purchase
agreement. In connection with the stock purchase agreement and pursuant thereto,
we have issued an aggregate 205,732 shares to Fusion Capital and received
aggregate proceeds of approximately $200,000 in 2006 and since that time we
have
not issued any other shares to Fusion Capital.
On
February 15, 2008, we were awarded a two year NSF SBIR Phase II grant to
advance development of its small peptide antibiotic synthesis program using
the
Company’s proprietary DPOLT. This federal grant will support 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 $125,000 of these restricted funds
with
the remaining balance to be issued during the remaining two-year grant period.
While
management is encouraged by the aforementioned financing, the proceeds are
insufficient, alone, to regain final compliance with the American Stock
Exchange’s continued listing requirements. We have until October 27, 2008
to achieve compliance with AMEX’s minimum shareholder equity requirement of
$4,000,000. There can be no assurance that we will be able to do so and if
we
are not able to do so we will be subject to delisting by AMEX. Additionally,
these AMEX minimum listing requirements will increase the minimum shareholder
equity requirement to $6,000,000 at year end. Our plan is to have in excess
of
$6,000,000 in shareholder equity by year end, thereby complying with current
and
future AMEX listing requirements.
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, regulatory
matters, 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 $15,857,541 as of June 30, 2008. The net loss from
operations for the second quarter of 2008 was $1,111,553.
Cash
used in operations for the year ended December 31, 2007 was $1,913,760 and
for
the six months ending June 30, 2008 was $1,431,328. As of June 30, 2008, our
principal source of liquidity was $3,634,145 of cash and cash equivalents.
Our
current and historical 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
primarily to the commercialization of our consumer products, clinical testing,
as well as conducting basic research. These factors place a significant strain
on our limited financial resources. Our ultimate success depends on our ability
to continue to generate revenue and to raise capital for our operations.
Our
capital requirements for 2008 will depend on numerous factors, including the
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 income from our
consumer products and our ability to raise additional capital through 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.
We
will
continue to seek additional funds for conducting
preclinical studies for our LPT3-04
weight loss agent,
and the
commercialization of Probiora3 and LPT3-04. As
we
move into more advanced stages concerning our product development and testing
is
likely to increase our monthly budget accordingly. Our available
working capital at
June
30, 2008 is $3,484,784
which
includes the proceeds from the sale of common stock as discussed above. While
we
believe our available working capital is sufficient for us to continue to
operate through the next twelve months, we expect to continue to need to raise
capital to operate beyond this period. If additional capital is not raised,
we
would likely need to adjust our anticipated plan of operations until we are
able
to acquire the necessary funds.
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
effective as of the end of the period covered by this report.
Changes
in Internal Controls
We
have
also evaluated our internal controls for financial reporting, and there have
been no significant changes in our internal controls or in other factors that
could significantly affect those controls subsequent to the date of their last
evaluation.
PART
II - OTHER INFORMATION
ITEM
1A. RISK FACTORS
You
should carefully consider the risks described below which update the risk
factors contained in our Annual Report on Form 10KSB for the year ended December
31, 2007, as well as the risks described in the risk factors in such form 10KSB
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 incorporated herein by reference modifies or
replaces such statement. All of these risks may impair our business operations.
The forward-looking statements in this Form 10-Q and
in the documents incorporated herein by reference 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.
We
have a limited operating history with significant losses and expect losses
to
continue for the foreseeable future.
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. No assurances can be given when this will occur or that
we will ever be profitable.
We
may continue to require additional financing in the
future
If
we are
not able to generate sufficient revenues or raise additional capital, among
other things:
|
·
|
We
may need to curtail or cease operations and be unable to pursue further
development of our technologies;
|
|
·
|
We
may be unable to pursue patenting our small molecule weight loss
agent and
development of our technologies and
products;
|
|
·
|
We
may have to lay-off personnel;
|
|
·
|
We
could be unable to continue to make public
filings;
|
|
·
|
We
may be de-listed from the American Stock Exchange;
and
|
|
·
|
Our
licenses for our SMaRT Replacement Therapy technology and MU 1140
technology could be terminated which would significantly harm our
business.
|
At
June
30, 2008 and December 31, 2007, we had working capital of approximately
$3,484,784 and $260,534, respectively. The report of independent registered
public accounting firm’s report as of and for the year ended December 31, 2007,
includes an explanatory paragraph stating that our recurring losses from
operations and limited working capital raise substantial doubt about our ability
to continue as a going concern. We have an operating cash flow deficit of
$1,431,328 for the six months ended June 30, 2008 and have sustained operating
cash flow deficit of $1,913,760 in 2007. Our ability to obtain additional
funding may determine our ability to continue as a going concern. Our financial
statements do not include any adjustments that might result from the outcome
of
this uncertainty.
We
can offer you no assurance the government and the public will accept our
licensed patented technologies. If they do not, we will be unable to generate
sufficient revenues from our technologies, which may cause us to cease
operations.
The
commercial success of our DPOLT platform, SMaRT Replacement Therapy, Probiora3,
LPT3-04 and other technologies will depend in part on government and public
acceptance of their production, distribution and use. Biotechnology has enjoyed
and continues to enjoy substantial support from the scientific community,
regulatory agencies and many governmental officials in the United States and
around the world. Future scientific developments, media coverage and political
events may diminish such support. Public attitudes may be influenced by claims
that health products based on biotechnology are unsafe for consumption or pose
unknown risks to the environment or to traditional social or economic practices.
Securing governmental approvals for, and consumer confidence in, such products
poses numerous challenges, particularly outside the United States. The market
success of technologies developed through biotechnology such as ours could
be
delayed or impaired in certain geographical areas because of such factors.
Products based on our technologies may compete with a number of traditional
dental therapies and drugs manufactured and marketed by major pharmaceutical
companies and other biotechnology companies. Market acceptance of products
based
on our technologies will depend on a number of factors including potential
advantage over alternative treatment methods. We can offer you no assurance
that
dentists, physicians, patients or the medical and dental communities in general
will accept and utilize products developed from our technologies. If they do
not, we may be unable to generate sufficient revenues from our technologies,
which may cause us to have to cease operations.
Risk
Factors Relating to our Common Stock
We
may be unable to maintain the listing of our common stock on the American Stock
Exchange and that would make it more difficult for stockholders to dispose
of
their common stock.
Our
common stock is listed on the American Stock Exchange. We cannot guarantee
that
it will always be listed. The American Stock Exchange rules for continual
listing include minimum market capitalization and other requirements, which
we
may not meet in the future, particularly if the price of our common stock
declines or we are unable to raise additional capital to continue operations.
Under our plan that has been filed with the AMEX, we expect to meet the minimum
listing requirements in a timely basis.
On
April
25, 2007 we received notification from the American Stock Exchange (“AMEX”) that
we were not in compliance with AMEX’s continued listing requirements because our
shareholders’ equity is less than $2,000,000 and we have experienced losses from
continuing operations and/or net losses in two of our most recent fiscal years.
We submitted a plan on May 24, 2007 to AMEX for regaining compliance with all
of
the continued listing standards. On July 2, 2007, AMEX notified the Company
that
it had completed its review and has determined that the Company’s compliance
plan made a reasonable demonstration of the Company’s ability to regain
compliance with the continued listing standards by the end of the plan period,
October 27, 2008, and was therefore continuing the Company’s listing pursuant to
an extension. On May 14, 2008, the Company received a notice from AMEX that
a review of the Company’s Form 10-KSB for the year ended December 31, 2007
and Form 10-Q for the period ended March 31, 2008 indicated that it did not
meet certain of AMEX’s additional continued listing standards. Specifically, the
Company was not in compliance with Section 1003(a)(ii) of the Company Guide
because its stockholders’ equity is less than the required $4,000,000 and
because it has losses from continuing operations and net losses in three of
its
four most recent fiscal years. The Company provided a revised plan of compliance
and supporting documentation, dated June 13, 2008, (the “Plan”) to AMEX with
respect to its previously announced noncompliance with Section 1003(a)(i)
of the Company Guide and such Plan was subsequently approved by AMEX.
The
proceeds from our recent financings and warrant exercises are insufficient,
alone, to regain compliance with AMEX listing requirements by the end of the
extension period. We have until October 27, 2008 to regain AMEX compliance
but
there can be no assurance that we will be able to do so.
If
our
common stock is de-listed from the American Stock Exchange, trading in our
common stock would be conducted, if at all, on the NASDAQ’s OTC Bulletin Board
in the United States. This would make it more difficult for stockholders to
dispose of their common stock and more difficult to obtain accurate quotations
on our common stock. This could have an adverse effect on the price of our
common stock.
Our
stock price historically has been volatile and our stock’s trading volume has
been low.
Because
of the low trading volume and lack of market liquidity, some institutional
investors may find it difficult to buy an sell our stock in a sufficiently
timely manner, which makes an investment in our Company’s stock less appealing.
The market price of our common stock has been and is expected to continue to
be
highly volatile. Factors, including announcements of technological innovations
by us or other companies, regulatory matters, new or existing
products
or procedures, concerns about our financial position, operating results,
litigation, government regulation, developments or disputes relating to
agreements, patents or proprietary rights, may have a significant impact on
the
market price of our stock. In addition, potential dilutive effects of future
sales of shares of common stock by us and by stockholders, including Fusion
Capital, and subsequent sales of common stock acquired by the holders of
warrants and options could have an adverse effect on the market price of our
shares.
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 anticipated needs for and availability
of
working capital, (b) our future 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 SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
We
issued
the following restricted securities during the period covered by this report
to
the named individual pursuant to exemptions under the Securities Act of 1933
including Section 4(2):
On
June
12, 2008, we issued an aggregate of 5,777,778 shares of common stock to
accredited investors at a price of $0.45 per share pursuant to a private
offering of the Company’s stock. One of the investors, Mr. George T. Hawes, a
significant shareholder and affiliate, acquired 5,557,778 shares in the private
offering and the other accredited investor acquired the remaining shares. The
aforementioned private offering investors also received a commensurate number
of
warrants to purchase 5,777,778 shares of common stock at a price of $1.30 per
share. These warrants expire five years from their vesting date on June 12,
2013.
The
private placement offering and sale of the common stock and warrants was made
in
reliance upon the exemption from registration provided by Section 4(2) of
the Securities Act of 1933 as a transaction by the issuer not involving a public
offering.
At
our
Annual Meeting of Shareholders held on April 8, 2008 our shareholders voted
on
two proposals:
Proposal
1 Election of Directors
Elected
each of the following four nominees as directors, each to hold office until
their successors are duly elected and qualified. The vote for each director
was
as follows:
Nominee
|
|
For
|
|
Withheld
|
|
Jeffrey
D. Hillman
|
|
|
16,847,014
|
|
|
251,921
|
|
Richard
T. Welch
|
|
|
16,899,264
|
|
|
199,671
|
|
Derek
G. Hennecke
|
|
|
16,899,264
|
|
|
199,671
|
|
Stanley
B. Stein
|
|
|
16,837,014
|
|
|
261,921
|
|
Proposal
2 Approval of the Company’s amendment to its Amended and Restated 2002 Stock
Option and Incentive Plan to increase the number of shares available from
3,000,000 to 5,000,000
For
|
|
Against
|
|
Abstain
|
|
|
11,434,220
|
|
|
277,023
|
|
|
1,240,183
|
|
ITEM
5. OTHER INFORMATION.
On
May 23, 2005, we entered into a stock purchase agreement with Fusion
Capital Fund II, LLC (“Fusion Capital”). Pursuant to the terms of the stock
purchase agreement, Fusion Capital has agreed to purchase from us up to
$9,000,000 of our common stock over a 30 month period commencing from the date
of the stock purchase agreement. The stock purchase agreement has expired per
the 30-month contract terms. On August 12, 2008, we sent Fusion our Notice
of
Termination of the stock purchase agreement and expect to withdraw the
previously filed registration statement relating to the stock purchase
agreement. In connection with the stock purchase agreement and pursuant thereto,
we have issued an aggregate 205,732 shares to Fusion Capital and received
aggregate proceeds of approximately $200,000 in 2006 and since that time we
have
not issued any other shares to Fusion Capital.
ITEM
6. EXHIBITS
Exhibit
Number
|
|
Exhibit
Description
|
|
Form
|
|
File
No
|
|
Exhibit
|
|
Filing
Date
|
|
Filed
Herewith
|
10.1
|
|
Securities
Purchase Agreement dated June 12, 2008
|
|
8-K
|
|
001-32188
|
|
|
|
6/16/2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.2
|
|
Employment
Agreement of David B. Hirsch
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31.1
|
|
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.
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31.2
|
|
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.
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32.1
|
|
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).
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32.2
|
|
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).
|
|
|
|
|
|
|
|
|
|
X
|
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 10th
day of
August, 2007.
|
|
|
|
ORAGENICS,
INC.
|
|
|
|
|
BY: |
/s/
Stanley B. Stein
|
|
Stanley
B. Stein, President and Chief Executive
Officer
|
EXHIBIT
INDEX
Exhibit
Number
|
|
Exhibit
Description
|
|
Form
|
|
File
No
|
|
Exhibit
|
|
Filing
Date
|
|
Filed
Herewith
|
10.1
|
|
Securities
Purchase Agreement dated June 12, 2008
|
|
8-K
|
|
001-32188
|
|
|
|
6/16/2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.2
|
|
Employment
Agreement of David B. Hirsch
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31.1
|
|
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.
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31.2
|
|
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.
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32.1
|
|
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).
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32.2
|
|
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).
|
|
|
|
|
|
|
|
|
|
X
|