As
filed with the Securities and Exchange Commission on March 17,
2006.
|
Registration
No.
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SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
-------------------
FORM
S-3
REGISTRATION
STATEMENT
UNDER
THE SECURITIES ACT OF 1933
------------------------
(Name
of
small business issuer in its charter)
Florida
|
|
2836
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59-3410522
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(State
or Other Jurisdiction of Organization
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|
(Primary
Standard Industrial Classification Code)
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(IRS
Employer Identification #)
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ORAGENICS,
INC.
13700
Progress Boulevard
Alachua,
Florida 32615
Tel:
(386) 418-4018
|
|
Robert
T. Zahradnik
4000
NW 51 Street, H-140
Gainesville,
Florida 32606
Tel:
(386) 418-4018
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(Address
and telephone of registrant’s executive office)
|
|
(Name,
address and telephone number of agent for
service)
|
Copies
to:
|
Darrell
C. Smith, Esq.
Shumaker,
Loop & Kendrick, LLP
101
E. Kennedy Boulevard
Suite
2800
Tampa,
Florida 33602
Tel:
(813) 229-7600
Fax:
(813) 229-1660
|
|
Approximate
date of commencement of proposed sale to the public: From time to time after
the
effective date of this Registration Statement.
If
the only securities being registered on this form are being offered pursuant
to
dividend or interest investment plans, please check the following
box. o
If
any of the securities being registered on this form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act
of 1933, other than securities offered only in connection with dividend or
interest reinvestment plans, check the following
box. ý
If
this form is filed to register additional securities for an offering pursuant
to
Rule 462(b) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same
offering. o
If
this form is a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. o
If
this form is a registration statement pursuant to General Instruction I.D.
or a
post-effective amendment thereto that shall become effective upon filing with
the Commission pursuant to Rule 462(e) under the Securities Act, check the
following box. o
If
this form is a post-effective amendment to a registration statement filed
pursuant to General Instruction I.D. filed to register additional securities
or
additional classes of securities pursuant to Rule 413(b) under the Securities
Act, check the following box. o
CALCULATION
OF REGISTRATION FEE
Securities
to be Registered
|
Amount
to be Registered(1)
|
Proposed
Maximum
Offering
Price Per Share(2)
|
Proposed
Maximum
Aggregate
Offering Price(2)
|
Amount
of
Registration
Fee(2)
|
Shares
of common stock, par value $0.001
|
3,000,000
|
$0.51
|
$1,530,000
|
$164
|
|
|
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(1)
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|
The
shares being registered consist of 1,500,000 shares of our common
stock
issued and outstanding and 1,500,000 shares issuable upon exercise
of
common stock purchase warrants outstanding as of the date hereof,
and such
indeterminate number of additional shares of common stock issuable
for no
additional consideration by reason of any stock dividend, stock
split,
recapitalization or other similar transaction effected without
the receipt
of consideration, which results in an increase in the number of
outstanding shares of our common stock. In the event of a stock
split,
stock dividend or similar transaction involving our common stock,
in order
to prevent dilution, the number of shares registered shall be
automatically increased to cover the additional shares in accordance
with
Rule 416(a) under the Securities Act of 1933.
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|
|
|
|
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(2)
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Estimated
solely for the purpose of computing the registration fee required
by
Section 6(b) of the Securities Act and computed pursuant to Rule
457(c)
under the Securities Act based upon the average of the high $0.52
and low
$0.50 prices of the common stock on March 15, 2006, as quoted on
the
American Stock Exchange. It is not known how many shares will be
purchased
under this registration statement or at what price shares will
be
purchased.
|
The
registrant hereby amends this registration statement on such date or dates
as
may be necessary to delay its effective date until the registrant shall file
a
further amendment which specifically states that this registration statement
shall thereafter become effective in accordance with section 8(A) of the
Securities Act of 1933, or until the registration statement shall become
effective on such date as the Commission, acting under said section 8(A), may
determine.
The
information in this prospectus is not complete and may be changed. The selling
shareholders named in this prospectus may not sell their securities until the
registration statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these securities and neither
we nor the selling shareholders are soliciting an offer to buy these securities
in any state where the offer or sale is not permitted.
Subject
to completion, dated March 17,
2006
Prospectus
ORAGENICS,
INC.
3,000,000
Shares
of common stock,
This
prospectus covers up to 3,000,000 shares of our common stock, $0.001 par value
per share, of which 1,500,000 of the shares are currently issued and outstanding
and 1,500,000 of the shares are issuable upon exercise of outstanding warrants,
which may be offered for resale by the selling shareholders named in this
prospectus and the persons to whom such selling shareholders may transfer their
shares. We do not know if any or all of the warrants will be exercised or if
any
or all of the shares will be resold. No securities are being offered or sold
by
us pursuant to this prospectus. The selling shareholders acquired the common
stock and warrants to purchase common stock in transactions that were exempt
from the registration requirements of federal and state securities laws. See
page 15 under the heading “Selling Shareholders.” Our filing of the registration
statement, of which this prospectus is a part, is intended to satisfy our
obligations to the selling shareholders identified in this prospectus to
register for resale shares issued to them.
Pursuant
to this prospectus, the selling shareholders may sell some or all of the shares
they hold through ordinary brokerage transactions, directly to market makers
of
our shares, or through any of the other means described in the “Plan of
Distribution” section of this prospectus, beginning on page 17. Except for the
exercise of warrants, the selling shareholders, and not us, will receive all
of
the proceeds from any sales of the shares, less any brokerage or other expenses
of the sale incurred by them.
We
will pay all registration expenses including, without limitation, all Securities
and Exchange Commission (“SEC”) and blue sky registration and filing fees,
printing expenses, transfer agents’ and registrars’ fees, and the fees and
disbursements of our outside counsel in connection with this offering, but
the
selling shareholders will pay all selling expenses including, without
limitation, any underwriters’ or brokers’ fees or discounts relating to the
shares registered hereby, or the fees or expenses of separate counsel to the
selling shareholders.
Each
selling shareholder and any broker executing selling orders on behalf of the
selling shareholders, may be deemed to be an “underwriter” as such term is
defined in the Securities Act of 1933, and any commissions paid or discounts
or
concessions allowed to any such person and any profits received on resale of
the
securities offered hereby may be deemed to be underwriting compensation under
the Securities Act.
Our
common stock is listed on the American Stock Exchange with the ticker symbol
“ONI.” On March 15, 2006, the closing price of our common stock on the American
Stock Exchange was $0.50 per share. Our principal executive offices are located
at 13700 Progress Boulevard, Alachua, FL. 32615, and our telephone number is
(386) 418-4018.
_________________
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved of these securities or determined if this prospectus
is
truthful or complete. Any representation to the contrary is a criminal
offense.
_________________
Investing
in our common stock involves a high degree of risk. Please carefully consider
the “Risk Factors” beginning on page 4 of this prospectus.
The
date of this prospectus is _______, 2006.
TABLE
OF CONTENTS
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Page
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About
this Prospectus
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i
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Prospectus
Summary
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1
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Risk
Factors
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4
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Special
Note Regarding Forward-Looking Statements
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14
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Use
of Proceeds
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15
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Selling
Shareholders
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15
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Plan
of Distribution
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17
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Legal
Matters
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18
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Experts
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18
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Information
Incorporated by Reference
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19
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Where
You Can Find More Information
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19
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About
This Prospectus
The
selling shareholders named in this prospectus may sell up to 3,000,000 shares
of
our common stock, of which 1,500,000 of the shares are currently issued and
outstanding and 1,500,000 of the shares are issuable upon exercise of
outstanding warrants. This prospectus provides you with a general description
of
the common stock the selling shareholders may offer. You should read this
prospectus as well as additional information described under “Where You Can Find
More Information” and “Information Incorporated by Reference.”
You
should rely only on the information contained or incorporated by reference
in
this prospectus. Neither we nor the selling shareholders have authorized anyone
to provide you with different information. This prospectus is not an offer
to
sell, nor is it a solicitation of an offer to buy, these securities in any
state
where the offer or sale is not permitted. You should not assume that the
information contained in this prospectus is accurate as of any date other than
the date on the front cover page. Our business, financial condition, results
of
operations and prospects may have changed since that date.
PROSPECTUS
SUMMARY
This
summary highlights selected information from this prospectus and should be
read
together with the more detailed information and financial data and statements
contained elsewhere and incorporated by reference in this prospectus. You should
read the entire prospectus carefully, especially the discussion of the risks
of
purchasing our securities in "Risk Factors" on page 4.
Overview
We
are an
early-stage biotechnology company aimed at adding value to novel technologies
and products sourced from innovative research at the University of Florida
and
other academic centers, as well as discovered internally. Our strategy is to
in-license or internally discover and to develop products through human
proof-of-concept studies (Phase II clinical trials of the U.S. Food and Drug
Administration’s (FDA) regulatory process) prior to partnering with major
pharmaceutical, biotechnology or healthcare product firms for advanced clinical
development and commercialization. Since inception, we have funded a significant
portion of our operations from the public and private sales of our securities.
We have generated no significant revenues from operations during the last two
years. All of our revenues have been from a sponsored research agreement and
SBIR grants which have expired. We have not generated revenues from sales of
products.
We
hope
to be in a position to continue to develop several products, each of which
addresses potentially large market opportunities:
Replacement
therapy
is a
single, painless one time topical treatment that has the potential to offer
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, Streptococcus
mutans
converts
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. Replacement therapy permanently replaces resident acid
producing Streptococcus
mutans
with a
patented genetically engineered strain of Streptococcus
mutans
that
does not produce lactic acid. Applied topically to tooth surfaces with a swab,
the therapy requires only one application. We have begun Phase I clinical trials
and expect to partner with a major healthcare products or pharmaceutical company
prior to initiating Phase III clinical trials. To facilitate further patient
recruitment in our Phase I clinical trial, we opened an additional clinical
site
in June 2005, however, we have had very limited patient enrollment through
December 31, 2005 due to the rigorous requirements for enrollment imposed upon
us by the FDA. In January 2006, we concluded this study and discussed with
the
FDA our problems with patient enrollment and how we could modify our protocol
to
allow us to move forward in our clinical trials. A formal re-submission of
an
amended protocol was filed with the FDA on March 9, 2006 and we anticipate
instituting a second Phase I clinical study by the end of the second quarter
of
2006. We remain committed to complete the human safety study of replacement
therapy to the satisfaction of the FDA and we expect the cost in 2006 will
be
approximately $350,000.
Mutacin
1140 (MU 1140™)
is a
highly potent bactericidal peptide that is produced by our strain of
Streptococcus
mutans.
Our
proprietary mutacin was discovered by our researchers during the course of
developing replacement therapy and is a novel antibiotic that has broad-spectrum
antimicrobial activity against essentially all Gram-positive bacteria including
vancomycin-resistant Staphylococcus
aureus.
The
antibiotic currently is in preclinical stages of development. During the second
quarter of 2005, we completed development of a proprietary manufacturing process
for mutacin 1140, which overcame a previous hurdle to that molecule’s
development. We are now able to manufacture in sufficient quantities to allow
us
to conduct preclinical studies needed to enable the filing of an Investigational
New Drug (IND) application. If we are able to secure adequate funding, we plan
to continue to perform in vitro antimicrobial susceptibility and toxicity
testing during the first half of 2006 before performing more detailed animal
safety and efficacy studies using mutacin 1140. For example, in March and April
2006 we plan to conduct two preclinical studies with MU 1140™, utilizing
independent testing labs, that will provide information on Tier 2 spectrum
of
activity against clinically important Gram-positive bacteria and the
effectiveness in a drug resistant Staphylococcus
aureus
infected
animal model system. Upon adequate funding and successful completion of this
testing and the animal studies we expect to be positioned to file an IND in
the
fourth quarter of 2006.
Probiotics
are live
microorganisms that confer health benefits to the host when administered in
adequate amounts; the use of yogurt containing live Lactobacillus
cultures
is an example of a probiotic application. We have identified three natural
strains of bacteria that provide significant protection against the causative
organisms of periodontal disease and dental caries. 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 that
with
adequate funding, we may achieve commercialization of our probiotic product
in
these markets by late 2006. We are continuing our efforts to seek partners
in
Europe and Asia for market opportunities for our oral probiotic technology.
European and Asian companies have signaled their intent to establish a licensing
agreement with us, while another potential partner is completing a laboratory
evaluation of the product before moving forward with possible licensing
discussions. We expect to initiate a human trial within the next two months
to
support product claims for Probiora 3™. While there can be no assurances,
this study should be completed during the third quarter of 2006. If successfully
developed, our oral rinse product will be one of the first probiotics to be
marketed for the maintenance of oral health.
IVIAT
and CMAT
are
technologies we licensed from iviGene Corporation. Two of our directors own
an
aggregate 19.1% interest in iviGene Corporation. These technologies 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
licensed technologies offer the potential to generate and develop a number
of
product candidates for future out-licensing to corporate partners, particularly
in the area of cancer and tuberculosis, as well as agricultural and other
non-human uses.
Business
Objectives and Milestones
The
specific goal of our business is to successfully develop, clinically test and
obtain FDA approval for sales of products based on our licensed, patented
technologies. Our strategy is to develop novel technologies through human
proof-of-concept studies (Phase II clinical trials) prior to partnering with
major pharmaceutical, biotechnology or health care product firms for advanced
clinical development and commercialization. Upon successful completion of
proof-of-concept studies, we intend to consider sublicensing our licensed,
patented technologies to one or more strategic partners that would be
responsible for advanced clinical development, completing the U.S. Food and
Drug
Administration’s approval process, and manufacturing and marketing our products.
In order to accomplish these objectives, we must obtain additional capital
and
take the following actions:
Replacement
Therapy
1.
|
Initiate
second Phase I clinical safety trial.
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Mutacin 1140
1.
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Complete
preclinical studies, including animal toxicity and efficacy, required
for
an investigational new drug application submission.
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2.
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Submit
an investigational new drug application to the
FDA.
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Probiotic
Technology
1.
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Develop
appropriate manufacturing and packaging systems.
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2.
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Complete
one human study.
|
The
above
actions, 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. The time period
for the development of our technologies could change depending on the progress
of our ability to negotiate a partnering arrangement, as well as our efforts
to
raise additional capital. Our available working capital is not sufficient to
enable us to operate through the second quarter of 2006, at which time we will
need to cease all operations until we are able to raise additional capital.
We
have a contractual obligation to pay a minimum royalty of $25,000 per quarter
and spend or cause to be spent an aggregate of $1,000,000 per annum toward
research, development and regulatory prosecution, in order to maintain our
license with the University of Florida Research Foundation, Inc. for our
replacement therapy and Mutacin 1140 technologies. If we are unable to make
these payments, our license could be terminated which will substantially
diminish the value of our company.
We
were
incorporated in Florida in 1996. We amended our articles of incorporation on
May
8, 2002, in order to change our name from Oragen, Inc. to Oragenics, Inc. and
to
increase our authorized capital from 100,000 shares of common stock to
100,000,000 shares of common stock and 20,000,000 shares of preferred stock.
Our
executive office is located at 13700 Progress Boulevard, Alachua, FL 32615.
This
is also our mailing address. Our registered office is 4730 S.W. 103 Way,
Gainesville, Florida 32608. Our telephone number is (386) 418-4018. Our
corporate website is at www.oragenics.com.
We do
not intend the reference to our web address to incorporate by reference in
this
prospectus the information on our website. The information on our website is
not
intended to be part of this prospectus and you should not rely on it when making
a decision to invest in our securities. Unless the context otherwise requires,
the terms “we,” “our,” “us,” “the company” and “Oragenics” refer to Oragenics,
Inc., a Florida corporation, and not to the selling shareholders.
RISK
FACTORS
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 prospectus 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 prospectus 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.
Risks
Associated with Our Company
We
will require additional financing to sustain our operations and without it
we
will not be able to continue operations.
We
have
incurred annual operating losses of $3,251,378, $3,077,888 and $1,672,954,
respectively, during the past three fiscal years of operation. As a result,
at
December 31, 2005 we had an accumulated deficit of $8,723,362. We have generated
minimal revenues to date and our revenues have not been sufficient to sustain
our operations. Although we recently completed two financings totaling
$1,775,000 for the private placement of equity securities, we do not currently
expect to have sufficient capital to sustain our operations beyond the second
quarter of 2006. If we are not able to raise additional capital, among other
things:
·
|
We
will need to cease operations and be unable to pursue further development
of our technologies;
|
·
|
We
will have to lay-off our personnel;
|
·
|
We
could be unable to continue to make public
filings;
|
·
|
We
will be delisted from the American Stock Exchange;
and
|
·
|
Our
licenses for our replacement technology and Mutacin 1140 technology
could
be terminated which would significantly harm our
business.
|
At
December 31, 2005, we had working capital of approximately $675,000. The
independent registered public accounting firm’s report for the year ended
December 31, 2005, includes an explanatory paragraph to their audit opinion
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 $3,434,382 for the year ended December
31, 2005, and have sustained operating cash flow deficits of $2,745,243 in
2004
and $1,218,910 in 2003. Our
ability to obtain additional funding will 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
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 limited revenues
to
date have not been related to the commercialization or licensing of our products
and have not been sufficient to sustain our operations. We expect that our
revenues will not be sufficient to sustain our operations for the foreseeable
future. Our profitability will require the successful commercialization of
our
replacement therapy, probiotic and Mutacin 1140 technologies. No assurances
can
be given when this will occur or that we will ever be
profitable.
We
must spend at least $1 million annually on development of our replacement
therapy and Mutacin
1140 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 technologies may be terminated, and we may have to cease operations.
We
hold
our replacement therapy and Mutacin 1140
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. If we do not,
our licenses on these technologies could be terminated. We also hold a license
for our IVIAT and CMAT technologies from iviGene Corporation, which required
us
to either fund two full time resources or invest $200,000 annually toward
development of these technologies. Until commercial sales of any developed
products take place, we will not be earning revenues from the sale of products
and will, therefore, have to raise the money we must spend on development of
our
technologies by other means, such as the sale of our common stock. There is
no
assurance we will 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.
The
University of Florida Research Foundation, Inc. may terminate our licenses
in
respect of our replacement therapy technology and our Mutacin 1140
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 replacement therapy and Mutacin 1140 technologies will become
valueless and we may have to cease operations. In addition, iviGene Corporation
may terminate our license in respect of our IVIAT and CMAT technologies if
we
breach or are unable to meet our obligations under the terms of our license.
There can be no assurance that we will be able to comply with the obligations
of
our license with iviGene Corporation. If our license is terminated we will
be
unable to develop these technologies.
If
we are unable to maintain regulatory clearance or obtain approval for our
technologies, we will be unable to generate revenues and may have to cease
operations.
Only
our
replacement therapy technology has been granted clearance to begin Phase 1
human
clinical trials by the FDA. Clinical trials on our replacement therapy are
expected to take 4-5 years to fully complete. Our other technologies have not
been cleared for testing in humans. Our technologies have not been cleared
for
marketing by the FDA or foreign regulatory authorities and they will not be
able
to be commercially distributed in the United States or any international markets
until such clearances are obtained. Before regulatory approvals can be obtained,
our technologies will be subject to extensive preclinical and clinical testing.
These processes are lengthy and expensive. We cannot assure that such trials
will demonstrate the safety or effectiveness of our technologies. There is
a
possibility that our technologies may be found to be unsafe or ineffective
or
otherwise fail to satisfy regulatory requirements. If we are unable to resolve
the FDA's concerns, we will not be able to proceed further to obtain regulatory
approval for that technology. If we fail to maintain regulatory clearance for
our replacement therapy or fail to obtain FDA clearance for our other
technologies, we may have to cease operations.
Our
product candidates are in the preliminary development stage, and may not be
effective at a level sufficient to support a profitable business venture. If
they are not, we will be unable to create marketable products, and we may have
to cease operations.
All
of
our product candidates are in the preliminary development stage. Although we
have current data which indicates the promise of the concept of our replacement
therapy and Mutacin 1140 technologies, we can offer you no assurance that
the technologies will be effective at a level sufficient to support a profitable
business venture. If they are not, we will be unable to create marketable
products, we will not generate revenues from our operations, and we may have
to
cease operations. The science on which our replacement therapy and
Mutacin 1140 technologies are based may also fail due to flaws or
inaccuracies on which the data are based, or because the data are totally or
partially incorrect, or not predictive of future results. If our science proves
to be flawed, incorrect or otherwise fails, we will not be able to create a
marketable product or generate revenues and we may have to cease
operations.
The
success of our research and development activities is uncertain. If they do
not
succeed, we will be unable to generate revenues from our operations and we
will
have to cease doing business.
We
intend
to continue with research and development of our technologies for the purpose
of
licensing these technologies to third parties or obtaining regulatory approval
to manufacture and market them. Research and development activities, by their
nature, preclude definitive statements as to the time required and costs
involved in reaching certain objectives. Actual costs may exceed the amounts
we
have budgeted and
actual time may exceed our expectations. If research and development requires
more funding than we anticipate, then we may have to reduce technological
development efforts or seek additional financing. There can be no assurance
that
we will be able to secure any necessary additional financing or that such
financing would be available on favorable terms. Additional financings could
result in substantial dilution to existing stockholders. We anticipate we will
remain engaged in research and development for a considerable
period of time, and there can be no assurance that we will be able to generate
adequate revenue from operations.
Each
of the technologies we are developing for eventual commercialization will face
various forms of competition from other products in the
marketplace.
The
pharmaceutical and biotechnology industries are characterized by intense
competition, rapid product development and technological change. Most of the
competition that the products developed from our technologies will face will
come from companies that are large, well established and have greater financial,
marketing, sales and technological resources than we have. Commercial success
of
our technologies will depend on our ability and the ability of our sublicensees
to compete effectively in product development areas such as, but not limited
to,
drug safety, efficacy, ease of use, patient or customer compliance, price,
marketing and distribution. There can be no assurance that competitors will
not
succeed in developing products that are more effective than the products
developed from our technologies or that would render our products obsolete
and
non-competitive.
We
rely on the significant experience and specialized expertise of our senior
management and must retain and attract qualified scientists and other highly
skilled personnel in a highly competitive job environment to maintain and grow
our business.
Our
performance is substantially dependent on the continued services and on the
performance of our senior management and our team of research scientists, who
have many years of experience and specialized expertise in our business. Our
performance also depends on our ability to retain and motivate our other
executive officers and key employees. The loss of the services of our Chief
Executive Officer, Robert T. Zahradnik and our Chief Scientific Officer, Dr.
Jeffrey D. Hillman, and any of our other executive officers or of our
researchers could harm our ability to develop and commercialize our
technologies. We have no “key man” life insurance policies. We have a three year
employment agreement with Dr. Hillman, which automatically renews for one-year
terms unless 90 days written notice is given by either party.
Our
future success also depends on our ability to identify, attract, hire, train,
retain and motivate highly skilled technical, managerial and research personnel.
If we fail to attract, integrate and retain the necessary personnel, our ability
to maintain and build our business could suffer significantly.
It
is possible that our replacement therapy and oral
probiotic technologies will be less effective in humans than they have been
shown to be in animals. It is possible our Mutacin
1140
technology will be shown to be ineffective or harmful in humans. If any of
these
technologies are shown to be ineffective or harmful in humans, we will be unable
to generate revenues from them, and we may have to cease
operations.
To
date
the testing of our replacement therapy technology has been undertaken solely
in
animals. Those studies have proven our genetically altered strain of
S. mutans
to be
effective in preventing tooth decay in animals. It is possible that our strain
of S.
mutans
will be
shown to be less effective in preventing tooth decay in humans in clinical
trials. If our replacement therapy technology is shown to be ineffective in
preventing tooth decay in humans, we will be unable to commercialize and
generate revenues from this technology. To date the testing of our oral
probiotic technology has been undertaken solely in animals. Those studies have
shown our technology to be effective at helping to reduce certain bacteria
that
are believed to cause periodontal disease. It is possible that our probiotic
technology will not be effective in reducing those bacteria and will not improve
periodontal health. If our oral probiotic technology is shown to be ineffective
or harmful to humans, we will be unable to commercialize it and generate
revenues from sales. To date the testing of the antibiotic substance,
Mutacin 1140,
has
been undertaken solely in the laboratory. We have not yet conducted animal
or
human studies of Mutacin 1140.
It
is possible that when these studies are conducted, they will show that
Mutacin 1140
is
ineffective or harmful. If Mutacin 1140
is
shown to be ineffective or harmful, we will be unable to commercialize it and
generate revenues from sales of Mutacin 1140.
If
we are unable to generate revenues from our technologies, we may have to cease
operations.
It
is possible we will be unable to find a method to produce Mutacin 1140 in
large-scale commercial quantities. If we cannot, we will be unable to undertake
the clinical trials that are required in order to obtain FDA permission to
sell
it, we will be unable to generate revenues from product sales, and we may have
to cease operations.
Our
antibiotic technology, Mutacin 1140,
is
a substance produced by our genetically altered strain of S. mutans.
To
date, it has been produced only in laboratory cultures. In March 2005 we
successfully developed a methodology for manufacturing Mutacin 1140 in
quantities sufficient to undertake the preclinical studies necessary to prepare
an Investigational New Drug (IND) application to the FDA. We believe we will
be
able to optimize this methodology to allow large-scale commercial production
of
the antibiotic. However, this methodology may not be feasible for large-scale
manufacture of the Mutacin 1140 antibiotic. If we are not able to optimize
this
methodology, we will be unable to generate revenues from this technology and
we
may have to cease operations.
If
clinical trials for our product candidates are unsuccessful or delayed, we
will
be unable to meet our anticipated development and commercialization timelines,
which could cause our stock price to decline and we may have to cease
operations.
Before
obtaining regulatory approvals for the commercial sale of any products, we
must
demonstrate through preclinical testing and clinical trials that our products
are safe and effective for use in humans. Conducting clinical trials is a
lengthy, time-consuming and expensive process.
Completion
of clinical trials may take several years. Commencement and rate of completion
of clinical trials may be delayed by many factors, including:
•
lack of efficacy during the clinical trials;
•
unforeseen safety issues;
•
slower than expected patient recruitment; and
•
government or regulatory delays.
Results
from preclinical testing and early clinical trials are often not predictive
of
results obtained in later clinical trials. A number of new products have shown
promising results in clinical trials, but subsequently failed to establish
sufficient safety and efficacy data to obtain necessary regulatory approvals.
Data obtained from preclinical and clinical activities are susceptible to
varying interpretations, which may delay, limit or prevent regulatory approval.
In addition, regulatory delays or rejections may be encountered as a result
of
many factors, including perceived defects in the design of the clinical trials
and changes in regulatory policy during the period of product development.
Any
delays in, or termination of, our clinical trials will materially and adversely
affect our development and commercialization timelines, which would adversely
affect our business and cause our stock price to decline and may cause us to
cease operations.
We
intend to consider relying on third parties to pay the majority of costs
relating to regulatory approvals necessary to manufacture and sell products
using our technologies. If we are unable to obtain agreements with third parties
to fund such costs, we will have to fund the costs ourselves. We may be unable
to do so, and if we are not, we may have to cease operations.
We
intend
to consider sublicensing our technologies to strategic partners prior to
commercialization. If we do so, our sublicensees will pay the costs of any
remaining clinical trials, and manufacturing and marketing of our technologies.
If we are unable to sublicense our technologies, we will have to pay for the
costs of Phase II and III trials and new drug applications to the FDA ourselves.
We would also have to set up our own manufacturing facilities and find our
own
distribution channels. This would greatly increase our future capital
requirements and we cannot be assured we would be able to obtain the necessary
financing. If we cannot obtain financing, we may have to cease
operations.
If
our expected collaborative partnerships do not materialize or fail to perform
as
expected, we will be unable to develop our products as
anticipated.
We
expect
to enter into collaborative arrangements with third parties to develop certain
products by sublicensing our technologies to strategic partners. We cannot
assure you that we will be able to enter into these collaborations or that,
if
entered, they will produce successful products. If we fail to maintain our
existing collaborative arrangements or fail to enter into additional
collaborative arrangements, the number of products from which we could receive
future revenues would decline.
Our
dependence on collaborative arrangements with third parties subjects us to
a
number of risks. These collaborative arrangements may not be on terms favorable
to us. Agreements with collaborative partners typically allow partners
significant discretion in electing whether or not to pursue any of the planned
activities. We cannot control the amount and timing of resources our
collaborative partners may devote to products based on the collaboration, and
our partners may choose to pursue alternative products. Our partners may not
perform their obligations as expected. Business combinations or significant
changes in a collaborative partner's business strategy may adversely affect
a
partner's willingness or ability to complete its obligations under the
arrangement. Moreover, we could become involved in disputes with our partners,
which could lead to delays or termination of the collaborations and
time-consuming and expensive litigation or arbitration. Even if we fulfill
our
obligations under a collaborative agreement, our partner can terminate the
agreement under certain circumstances. If any collaborative partner were to
terminate or breach our agreement with it, or otherwise fail to complete its
obligations in a timely manner, our chances of successfully commercializing
products would be materially and adversely affected.
If
our intellectual property rights do not adequately protect our products or
technologies, or if third parties claim we are infringing their intellectual
property rights, others could compete against us more directly or we could
suffer significant litigation. Such results could prevent us from marketing
our
products and hurt our profitability
Our
success depends in part on our ability to obtain patents or rights to patents,
protect trade secrets, operate without infringing upon the proprietary rights
of
others, and prevent others from infringing on our patents, trademarks and other
intellectual property rights. We will be able to protect our intellectual
property from unauthorized use by third parties only to the extent that it
is
covered by valid and enforceable patents, trademarks and licenses. Patent
protection generally involves complex legal and factual questions and,
therefore, enforceability of patent rights cannot be predicted with certainty.
Patents, if issued, may be challenged, invalidated or circumvented. Thus, any
patents that we own or license from others may not provide adequate protection
against competitors. In addition, any future patent applications may fail to
result in patents being issued. Also, those patents that are issued may not
provide us with adequate proprietary protection or competitive advantages
against competitors with similar technologies. Moreover, the laws of certain
foreign countries do not protect intellectual property rights to the same extent
as do the laws of the United States.
In
addition to patents and trademarks, we rely on trade secrets and proprietary
know-how. We seek protection of these rights, in part, through confidentiality
and proprietary information agreements. These agreements may not provide
meaningful protection or adequate remedies for violation of our rights in the
event of unauthorized use or disclosure of confidential and proprietary
information. Failure to protect our proprietary rights could seriously impair
our competitive position.
In
the
event of an infringement or violation, we may face litigation and may be
prevented from pursuing product development or commercialization. We may receive
in the future, notice of claims of infringement of other parties’ proprietary
rights. Infringement or other claims could be asserted or prosecuted against
us
in the future and it is possible that past or future assertions or prosecutions
could harm our business. We received notification from B.C. International
Corporation on July 29, 2002 that a gene utilized in our licensed, patented
strain of S.
mutans
infringes a patent which it holds under a license. Their notification did not
state that they intended to pursue legal remedies. Our management does not
believe the gene in question infringes that patent. We have sent them
correspondence setting out our position and we have not heard anything further
from them. If necessary, we would need to be prepared to assert our rights
vigorously with respect to such matter, which we may not be able to do without
sufficient funding. If litigation should ensue and we are unsuccessful in that
litigation, we could be enjoined for a period of time from marketing products
which infringe any valid patent rights held or licensed by B.C. International
Corporation and/or we could owe substantial damages.
We
are subject to substantial government regulation, which could materially
adversely affect our business.
The
production and marketing of products which may be developed from our
technologies and our ongoing research and development, preclinical testing
and
clinical trial activities are subject to extensive regulation and review by
numerous governmental authorities. Most of the technologies we are developing
must undergo rigorous preclinical and clinical testing and an extensive
regulatory approval process before they can be marketed. This
process
makes it longer, harder and more costly to bring products which may be developed
from our technologies to market, and we cannot guarantee that any of such
products will be approved. The pre-marketing approval process can be
particularly expensive, uncertain and lengthy, and a number of products for
which FDA approval has been sought by other companies have never been approved
for marketing. In addition to testing and approval procedures, extensive
regulations also govern marketing, manufacturing, distribution, labeling, and
record-keeping procedures. If we do not comply with applicable regulatory
requirements, such violations could result in warning letters, non-approval,
suspensions of regulatory approvals, civil penalties and criminal fines, product
seizures and recalls, operating restrictions, injunctions, and criminal
prosecution.
Delays
in or rejection of FDA or other government entity approval of our technologies
may also adversely affect our business. Such delays or rejection may be
encountered due to, among other reasons, government or regulatory delays, lack
of efficacy during clinical trials, unforeseen safety issues, slower than
expected rate of patient recruitment for clinical trials, inability to follow
patients after treatment in clinical trials, inconsistencies between early
clinical trial results and results obtained in later clinical trials, varying
interpretations of data generated by clinical trials, or changes in regulatory
policy during the period of product development in the United States. In the
United States more stringent FDA oversight in product clearance and enforcement
activities could result in our experiencing longer approval cycles, more
uncertainty, greater risk, and higher expenses. Even if regulatory approval
of a
product is granted, this approval may entail limitations on uses for which
the
product may be labeled and promoted. It is possible, for example, that we may
not receive FDA approval to market products based on our licensed, patented
technologies for broader or different applications or to market updated products
that represent extensions of our basic technologies. In addition, we may not
receive FDA approval to export our products based on our licensed, patented
technologies in the future, and countries to which products are to be exported
may not approve them for import.
Any
manufacturing facilities would also be subject to continual review and
inspection. The FDA has stated publicly that compliance with manufacturing
regulations will be scrutinized more strictly. A governmental authority may
challenge our compliance with applicable federal, state and foreign regulations.
In addition, any discovery of previously unknown problems with one of our
products or facilities may result in restrictions on the product or the
facility, including withdrawal of the product from the market or other
enforcement actions.
From
time
to time, legislative or regulatory proposals are introduced that could alter
the
review and approval process relating to our technologies. It is possible that
the FDA will issue additional regulations further restricting the sale of our
proposed products. Any change in legislation or regulations that govern the
review and approval process relating to our future technologies could make
it
more difficult and costly to obtain approval for new products based on our
technologies, or to produce, market, and distribute such products if
approved.
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 replacement therapy, oral probiotics and
Mutacin 1140 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.
We
may be exposed to product liability claims if products based on our technologies
are marketed and sold. Because our liability insurance coverage will have
limitations, if a judgment is rendered against us in excess of the amount of
our
coverage, we may have to cease operations.
Because
we are testing new technologies, and will be involved either directly or
indirectly in the manufacturing and distribution of the technologies, we are
exposed to the financial risk of liability claims in the event that the use
of
the technologies results in personal injury or death. There can be no assurance
that we will not experience losses due to product liability claims in the
future, or that adequate insurance will be available in sufficient amounts,
at
an acceptable cost, or at all. A product liability claim, product recall or
other claim, or claims for uninsured liabilities or in excess of insured
liabilities, may have a material adverse effect on our business, financial
condition and results of operations. Although we currently carry $2,000,000
in
general liability insurance, such insurance may not be sufficient to cover
any
potential liability. We could be sued for a large sum of money and held liable
in excess of our liability coverage.
If we
cannot pay the judgment, we may have to cease operations.
There
is uncertainty relating to favorable third-party reimbursement in the United
States. If we can't obtain third party reimbursement for products based on
our
technologies, it could limit our revenue.
In
the
United States, success in obtaining payment for a new product from third parties
such as insurers depends greatly on the ability to present data which
demonstrates positive outcomes and reduced utilization of other products or
services as well as cost data which shows that treatment costs using the new
product are equal to or less than what is currently covered for other products.
If we are unable to obtain favorable third party reimbursement and patients
are
unwilling or unable to pay for our products out-of-pocket, it could limit our
revenue and harm our business.
We
have limited resources which exposes us to potential risks resulting from new
internal control requirements under Section 404
of the Sarbanes-Oxley Act of 2002.
In
addition, in our system of internal controls we may rely on the internal
controls of third parties such as payroll service providers. In our evaluation
of our internal controls, we will consider the implication of our reliance
on
the internal controls of third parties. Until we have completed our evaluation,
we are unable to determine the extent of our reliance on those controls, the
extent and nature of the testing of those controls, and remediation actions
necessary where that reliance cannot be adequately evaluated and
tested.
Risk
Factors Relating to our Common Stock
Any
sale of our common stock to Fusion Capital under its Common Stock Purchase
Agreement with us will cause dilution and the sale of the shares of common
stock
acquired by Fusion Capital thereunder could cause the price of our common stock
to decline.
We
have
entered into a stock purchase agreement with Fusion Capital to sell up to $9.0
million of our common stock to them. However, Fusion Capital neither has the
right nor the obligation to purchase any shares of our common stock on any
trading days that the market price of our common stock is less than $0.75.
Our
common stock price has traded below $0.75 and as of March 15, 2006 was trading
below $0.75, which prohibits the
availability
of funding from Fusion Capital under our agreement with them. The
purchase price for the common stock to be sold to Fusion Capital pursuant to
the
common stock purchase agreement with Fusion Capital will fluctuate based on
the
price of our common stock. All shares acquired by Fusion Capital and resold
pursuant to a registration statement will be freely tradable. Fusion Capital
may
sell none, some or all of the shares of common stock purchased from us at any
time. We expect that the shares offered pursuant to the registration statement
we filed in connection with our obligation under the Fusion Capital transaction
will be sold over a period of up to 30 months from the date of the effectiveness
of the registration statement. Depending upon market liquidity at the time,
a
sale of such shares at any given time could cause the trading price of our
common stock to decline. The sale of a substantial number of shares of our
common stock, or anticipation of such sales, could make it more difficult for
us
to sell equity or equity-related securities in the future at a time and at
a
price that we might otherwise wish to effect
sales. As long as our stock price is below $0.75 we will not be able to sell
any
shares of our common stock to Fusion Capital in which case our ability to
acquire needed capital will be adversely affected and our business could be
harmed.
Our
stock price historically has been volatile and our stock’s trading volume has
been low.
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 stockholders and by the Company, including
Fusion Capital pursuant to this prospectus and subsequent sale of common stock
by the holders of warrants and options could have an adverse effect on the
market price of our shares.
Although
our common stock began trading on the American Stock Exchange under the symbol
“ONI” on May 20, 2004, the trading price of our common stock has been, and may
be, subject to wide fluctuations in response to a number of factors, many of
which are beyond our control. These factors include:
·
|
quarter-to-quarter
variations in our operating results;
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·
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the
results of testing, technological innovations, or new commercial products
by us or our competitors;
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governmental
regulations, rules, and orders;
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·
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general
conditions in the healthcare, dentistry, or biotechnology industries;
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·
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comments
and/or earnings estimates by securities analysts;
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developments
concerning patents or other intellectual property rights;
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·
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litigation
or public concern about the safety of our
products;
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announcements
by us or our competitors of significant acquisitions, strategic
partnerships, joint ventures or capital
commitments;
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·
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additions
or departures of key personnel;
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·
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release
of escrow or other transfer restrictions on our outstanding shares
of
common stock or sales of additional shares of common
stock;
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adverse
announcements by our competitors; and
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·
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the
additional sale of common stock by us in a capital raising
transaction.
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Historically,
the daily trading volume of our common stock has been relatively low. We cannot
guarantee that an active public market for our common stock will be sustained
or
that the average trading volume will remain at present levels or increase.
In
addition, the stock market in general, has experienced significant price and
volume fluctuations. Volatility in the market price for particular companies
has
often been unrelated or disproportionate to the operating performance of those
companies. Broad market factors may seriously harm the market price of our
common stock, regardless of our operating performance. In addition, securities
class action litigation has often been initiated following periods of volatility
in the market price of a company's securities. A securities class action suit
against us could result in substantial costs, potential liabilities, and the
diversion of management's attention and resources. Since our initial public
offering and through March 15, 2006 our stock price has fluctuated from $4.45
to
$0.35 per share. To the extent our stock price fluctuates and/or remains low,
it
could impair our ability to raise capital through the offering of additional
equity securities.
Future
sales of our common stock may depress our stock
price.
The
market price of our common stock could decline as a result of sales of
substantial amounts of our common stock in the public market, or the perception
that these sales could occur. In addition, these factors could make it more
difficult for us to raise funds through future offerings of common stock. As
of
March 15, 2006, there were 19,646,117 shares of our common stock
outstanding, with another 4,765,000 shares of common stock issuable upon
exercise of warrants to investors and underwriters, 1,260,000 shares issuable
upon exercise of options issued and an additional 240,000 shares available
for
issuance under our stock option plans. The issuance of our stock underlying
these options is covered by an S-8 registration statement we filed with the
SEC
and may be resold into the market. As of March 15, 2006, we had approximately
1,320,106 shares of common stock held in escrow pursuant to Canadian law and
underwriter requirements in connection with our initial public offering pursuant
to escrow agreements. These remaining shares are subject to release from escrow
and until such time are subject to the limitations of the respective escrow
agreements. Of these shares 1,230,115 are held by principals of the Company
and
two former directors of the Company and 89,991 are held by the University of
Florida Research Foundation, Inc. Through March 15, 2006, approximately
6,970,649 shares held by principals (including former directors) and 509,949
shares held by the University of Florida Research Foundation, Inc. have been
released from escrow. The released shares held by the principals (excluding
former directors) may be resold into the market under Rule 144. This could
cause
the market price of our common stock to drop significantly. The shares held
by
the University of Florida Research Foundation, Inc. are eligible for resale
without restriction once released from escrow.
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.
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 NASD’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.
The
Securities and Exchange Commission has adopted Rule 3a51-1 which establishes
the
definition of a “penny
stock,”
for the purposes relevant to us, as any equity security that has a market price
of less than $5.00 per share or with an exercise price of less than $5.00 per
share, subject to certain exceptions. For any transaction involving a penny
stock, unless exempt, Rule 15g-9 require:
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• |
that
a broker or dealer approve a person’s account for transactions in
penny
stocks; and
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• |
the
broker or dealer receives from the investor a written agreement to
the
transaction, setting forth the identity and quantity of the penny
stock to be purchased.
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• |
obtain
financial information and investment experience objectives of the
person;
and
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• |
sets
forth the basis on which the broker or dealer made the suitability
determination; and
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• |
that
the broker or dealer received a signed, written agreement from the
investor prior to the transaction.
|
Generally,
brokers may be less willing to execute transactions in securities subject to
the
“penny
stock”
rules. This may make it more difficult for investors to dispose of our
common stock and cause a decline in the market value of our stock.
Disclosure
also has to be made about the risks of investing in penny
stocks
in both public offerings and in secondary trading and about the commissions
payable to both the broker-dealer and the registered representative, current
quotations for the securities and the rights and remedies available to an
investor in cases of fraud in penny stock transactions. Finally, monthly
statements have to be sent disclosing recent price information for the penny
stock held in the account and information on the limited market in penny
stocks.
Risk
Factors Relating to this Offering
The
sale of shares by the selling stockholders as contemplated by the registration
statement filed by us may encourage our other shareholders to sell their stock
and have an adverse impact on the market price of our common stock and the
issuance of shares upon exercise of the warrants will result in dilution to
our
existing shareholders.
The
sale
of our common stock by the selling stockholders named in the registration
statement we filed as contemplated thereby will increase the number of our
publicly traded shares, which could depress the market price of our common
stock. Moreover, the mere prospect of resales by the selling stockholders as
contemplated by the registration statement could depress the market price for
our common stock. The issuance of any shares pursuant to any exercise of the
warrants will dilute the equity interest of existing shareholders and could
have
an adverse effect on the market price of our common stock.
The
perceived
risk of dilution may cause our shareholders to sell their shares, which
would
contribute to a decline in the price of our common stock. Moreover, the
perceived risk of dilution and the resulting downward pressure on our stock
price could encourage investors to engage in short sales of our common
stock. By
increasing the number of shares offered for sale, material amounts of
short-selling could further contribute to progressive price declines in
our
common stock.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus 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 projected sales and
profitability, (b) our growth strategies, (c) anticipated trends in our
industry, (d) our future financing plans, and (e) our anticipated needs for
working capital. 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 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 prospectus 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.
USE
OF PROCEEDS
We
will
not receive any proceeds from the resale of the common stock by the selling
shareholders including the resale of any common shares that the warrant holders
acquire upon exercise of the warrants. If all of the warrants are exercised,
we
would receive additional proceeds of $900,000. It is uncertain when, if ever,
we
will receive any proceeds from exercise of the warrants.
SELLING
SHAREHOLDERS
The
following table presents information regarding the selling
shareholders.
Other
than as set forth below, neither the selling shareholders nor any of its
affiliates has held a position or office, or had any other material
relationship, with us. Unless otherwise indicated, the percentage of outstanding
shares beneficially owned is based on 19,646,117 shares issued and outstanding
at March 15, 2006. The percentage of shares beneficially owned after the
offering assumes the resale by the selling shareholder of all of the shares
covered by this registration statement and the retention of all shares
previously owned.
Selling
Stockholders
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Shares
Beneficially
Owned
Before
Offering
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|
Percentage
of Outstanding
Shares
Beneficially
Owned
Before
Offering
|
|
Shares
to be
Sold
in the
Offering
|
|
Percentage
of Outstanding
Shares
Beneficially
Owned
After
Offering
|
|
Jeffrey
D. Hillman (1)
|
|
4,852,358
|
|
24..6
|
%
|
125,000
|
|
24.1
|
%
|
Robert
T. Zahradnik(2)
|
|
884,333
|
|
4.5
|
%
|
125,000
|
|
3.9
|
%
|
David
J. Gury Revocable Trust (3)
|
|
177,066
|
|
*
|
|
125,000
|
|
*
|
|
George
T. Hawes (4)
|
|
4,175,767
|
|
19.7
|
%
|
1,175,000
|
|
14.5
|
%
|
Cristi
Hawes Mohr (5)
|
|
228,000
|
|
1.2
|
%
|
200,000
|
|
*
|
|
Albion
J. Fitzgerald (6)
|
|
500,000
|
|
2.5
|
%
|
500,000
|
|
*
|
|
William
F. Matlack (7)
|
|
337,500
|
|
1.7
|
%
|
250,000
|
|
*
|
|
Cleo
Christine Allen (8)
|
|
267,500
|
|
1.4
|
%
|
200,000
|
|
|
|
Richard
Lee Hendricks (9)
|
|
322,400
|
|
1.6
|
%
|
300,000
|
|
*
|
|
|
|
11,744,924
|
|
|
|
3,000,000
|
|
|
|
_____________________
*
less
than one percent
(1) |
Jeffrey
D. Hillman is our Founder and Chief Scientific Advisor and serves
on our
Board of Directors. He has sole voting and investment power over
the
shares. The shares being registered hereby include 62,500 shares
of common
stock and 62,500 shares of common stock able to be acquired upon
the
exercise of warrants at $0.60 per share.
|
(2) |
Robert T. Zahradnik is our President and Chief Executive
Officer and serves on our Board of Directors. He has sole voting and
investment power over the shares. The shares being registered hereby
include 62,500 shares of common stock and 62,500 shares of common stock
able to be acquired upon the exercise of warrants at $0.60 per share.
Of
the shares not included in this registration statement, 3,333 shares
are
issuable upon the exercise of options at $3.90 per
share. |
(3) |
The shares being registered are titled to David
Gury and
Karen Gury Trustees UA April 26, 2004 for the David J. Gury Revocable
Trust and include 62,500 shares of common stock and 62,500 shares of
common stock able to be acquired upon the exercise of warrants at $0.60
per share. David J. Gury is our Chairman and serves on our Board of
Directors and as trustee has shared voting and investment power over
the
shares. Of the shares not included in this registration statement,
51,666
shares are issuable upon the exercise of options at prices ranging
between
$2.35 and $3.90 per share. |
(4)
|
George
T. Hawes serves on our Board of Directors. The shares being registered
hereby include 587,500 shares of common stock and 587,500 shares
of common
stock able to be acquired upon the exercise of warrants at $0.60
per
share. Of the shares not included in this registration statement,
1,000,000 shares are issuable upon the exercise of warrants at
$0.60 per
share.
|
(5) |
The shares being registered hereby include 100,000
shares
of common stock and 100,000 shares of common stock able to be acquired
upon the exercise of warrants at $0.60 per share.
|
(6) |
The shares being registered hereby include 250,000
shares
of common stock and 250,000 shares of common stock able to be acquired
upon the exercise of warrants at $0.60 per share.
|
(7) |
The shares being registered hereby include 125,000
shares
of common stock and 125,000 shares of common stock able to be acquired
upon the exercise of warrants at $0.60 per share. Of the shares not
included in this registration statement, 37,500 shares are issuable
upon
the exercise of warrants. |
(8) |
The shares being registered hereby include 100,000
shares
of common stock and 100,000 shares of common stock able to be acquired
upon the exercise of warrants at $0.60 per share.
|
(9) |
The shares being registered hereby include 150,000
shares
of common stock and 150,000 shares of common stock able to be acquired
upon the exercise of warrants at $0.60 per share.
|
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. 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 thereunder. 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.
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. The warrants representing shares of common stock are exercisable
by
the accredited investors at any time over a two-year period at an exercise
price
of $0.60 per share. This prospectus covers the resale of the shares acquired
by
the accredited investors and the shares underlying the warrants issued in the
private placement.
We
are
registering the shares of common stock and the shares of common stock issuable
upon exercise of the warrants to permit the resale of these shares of common
stock by the holders from time to time after the date of this prospectus. The
selling shareholders and any of their pledgees, assignees, donees and
successors-in-interest may, from time to time, sell any or all of their resale
shares of common stock on any stock exchange, market or trading facility on
which the shares are traded or in private transactions. These sales may be
at
fixed or negotiated prices. A selling shareholder may use any one or more of
the
following methods when selling shares:
|
•
|
ordinary
brokerage transactions and transactions in which the broker dealer
solicits purchasers;
|
|
•
|
block
trades in which the broker dealer will attempt to sell the shares
as agent
but may position and resell a portion of the block as principal to
facilitate the transaction;
|
|
•
|
purchases
by a broker dealer as principal and resale by the broker dealer for
its
account;
|
|
•
|
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
|
•
|
privately
negotiated transactions;
|
|
•
|
settlement
of short sales entered into after the date of this prospectus;
|
|
•
|
broker
dealers may agree with the selling shareholders to sell a specified
number
of such shares at a stipulated price per share;
|
|
•
|
a
combination of any such methods of sale;
|
|
•
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise; or
|
|
•
|
any
other method permitted pursuant to applicable law.
|
|
|
|
The
selling shareholders may also sell shares under Rule 144 under the Securities
Act of 1933, as amended (the “Securities
Act”),
if
available, rather than under this prospectus.
Broker
dealers engaged by the selling shareholders may arrange for other brokers
dealers to participate in sales. Broker dealers may receive commissions or
discounts from the selling shareholders (or, if any broker dealer acts as agent
for the purchaser of shares, from the purchaser) in amounts to be negotiated.
Each selling shareholder does not expect these commissions and discounts
relating to the sale of shares to exceed the amount that is customary in the
types of transactions involved.
In
connection with the sale of our common stock or interests therein, the selling
shareholders may enter into hedging transactions with broker-dealers or other
financial institutions, which may in turn engage in short sales of the common
stock in the course of hedging the positions they assume. The selling
shareholders may also sell shares of our common stock short and deliver these
securities to close out their short positions, or loan or pledge the common
stock to broker-dealers that in turn may sell these securities. The selling
shareholders may also enter into option or other transactions with
broker-dealers or other financial institutions or the creation of one or more
derivative securities which require the delivery to such broker-dealer or other
financial institution of shares offered by this prospectus, which shares such
broker-dealer or other financial institution may resell pursuant to this
prospectus (as supplemented or amended to reflect such
transaction).
The
selling shareholders and any broker dealers or agents that are involved in
selling the shares may be deemed to be “underwriters” within the meaning of the
Securities Act in connection with such sales. In such event, any commissions
received by such broker dealers or agents and any profit on the resale of the
shares purchased by them may be deemed to be underwriting commissions or
discounts under the Securities Act. Each selling shareholder has informed the
Company that it does not have any agreement or understanding, directly or
indirectly, with any person to distribute the Common Stock.
The
Company is required to pay certain fees and expenses incurred by the Company
incident to the registration of the shares. The Company has agreed to indemnify
the selling shareholders against certain losses, claims, damages and
liabilities, including liabilities under the Securities Act.
Because
selling shareholders may be deemed to be “underwriters” within the meaning of
the Securities Act, they will be subject to the prospectus delivery requirements
of the Securities Act. In addition, any securities covered by this prospectus
which qualify for sale pursuant to Rule 144 under the Securities Act may be
sold
under Rule 144 rather than under this prospectus. Each selling shareholder
has
advised us that they have not entered into any agreements, understandings or
arrangements with any underwriter or broker-dealer regarding the sale of the
resale shares. There is no underwriter or coordinating broker acting in
connection with the proposed sale of the resale shares by the selling
shareholders.
We
agreed
to keep the registration statement of which this prospectus is part effective
until the earlier of (i) the date on which the shares may be resold by the
selling shareholders without volume restrictions pursuant to Rule 144(k) or
(ii)
all of the shares have been sold pursuant to the registration statement of
which
this prospectus is part or Rule 144 under the Securities Act or any other Rule
of similar effect. The resale shares will be sold only through registered or
licensed brokers or dealers if required under applicable state securities laws.
In addition, in certain states, the resale shares may not be sold unless they
have been registered or qualified for sale in the applicable state or an
exemption from the registration or qualification requirement is available and
is
complied with.
Under
applicable rules and regulations under the Exchange Act, any person engaged
in
the distribution of the resale shares may not simultaneously engage in market
making activities with respect to our common stock for a period of two business
days prior to the commencement of the distribution. In addition, the selling
shareholders will be subject to applicable provisions of the Exchange Act and
the rules and regulations thereunder, including Regulation M, which may limit
the timing of purchases and sales of shares of our common stock by the selling
shareholders or any other person. We will make copies of this prospectus
available to the selling shareholders and have informed them of the need to
deliver a copy of this prospectus to each purchaser at or prior to the time
of
the sale.
LEGAL
MATTERS
Certain
legal matters with respect to the securities offered through this prospectus
will be passed upon for us by Shumaker, Loop & Kendrick, LLP.
EXPERTS
The
financial statements of Oragenics, Inc. as of December 31, 2005 and for the
year
then, appearing in Oragenics, Inc.’s Annual Report (Form 10-KSB) for the year
ended December 31, 2005, and incorporated by reference in this Prospectus and
Registration Statement, have been audited by Kirkland Russ Murphy & Tapp,
PA, independent registered public accounting firm, as set forth in their report
thereon (which contains an explanatory paragraph describing conditions that
raise substantial doubt about Oragenics, Inc.’s ability to continue as a going
concern as described in Note 1 to the financial statements). Such financial
statements are incorporated herein by reference in reliance upon such report
given on the authority of such firm as experts in accounting and
auditing.
The
financial statements of Oragenics, Inc. for the year ended December 31, 2004
appearing in Oragenics, Inc.’s Annual Report (Form 10-KSB) for the year ended
December 31, 2005, and incorporated by reference in this Prospectus and
Registration Statement, have been audited by Ernst & Young LLP, independent
registered public accounting firm, as set forth in their report thereon (which
contains an explanatory paragraph describing conditions that raise substantial
doubt about Oragenics, Inc.’s ability to continue as a going concern as
described in Note 1 to the financial statements). Such financial statements
are
incorporated herein by reference in reliance upon such report given on the
authority of such firm as experts in accounting and auditing.
INFORMATION
INCORPORATED BY REFERENCE
The
SEC
allows us to “incorporate by reference” into this prospectus information we file
with them, which means that we are disclosing important information to you
by
referring you to those documents. The information incorporated by reference
is
considered to be part of this prospectus, and information that we file later
with the SEC will automatically update and supersede previously filed
information, including information contained in this document. We
incorporate by reference the documents listed below and any future filings
we
will make with the SEC, including filings after the date of the initial
registration statement and prior to effectiveness of the registration statement,
under Sections 13 (a), (c), 14 or 15(d) of the Securities and Exchange Act
of
1934, as amended, until this offering has been completed:
· |
Our
Annual Report on Form 10-KSB for the year ended December 31, 2005 filed
on
March 8, 2006.
|
· |
Our
Current Report on Form 8-K filed on January 12,
2006.
|
· |
Our
Current Report on Form 8-K filed on March 6,
2006.
|
· |
Our
Current Report on Form 8-K filed on March 10,
2006.
|
· |
The
description of our common stock contained in our registration statement
on
Form 8-A No.
001-32188 filed with the SEC on May 19, 2004 under Section 12(b) of
the
Exchange Act, including any amendment or report filed for the purpose
of
updating such description.
|
You
may
obtain free copies of these filings and other documents incorporated by
reference in this prospectus by requesting them in writing or by telephone
from us at the following address:
Oragenics,
Inc.
13700
Progress Boulevard
Alachua,
Florida 32615
Attention:
Chief Financial Officer
(386)
418-4018 X232
If
you
request any incorporated documents from us, we will mail them to you by
first-class mail, or another equally prompt
means, within one business day after we receive your request.
WHERE
YOU CAN FIND MORE INFORMATION
We
have
filed with the Securities and Exchange Commission (the “Commission”) a
registration statement on Form S-3 under the Securities Act relating to the
shares of common stock that may be offered by the selling stockholders. This
prospectus is included as a part of that registration statement and we have
omitted from this prospectus additional information contained in the
registration statement as provided by the rules and regulations of the SEC.
For
further information about us and the securities offered in this prospectus,
you
should review the registration statement and information incorporated by
reference therein.
We
file
annual, quarterly and current reports, proxy statements and other information
with the Commission under the Securities Exchange Act of 1934, as amended
(“Exchange Act”). You may read and copy this information at the following
location of the Commission:
Public
Reference Room
100
F
Street, N.E., Room 1580
Washington,
D.C. 20549
You
may
also obtain copies of this information by mail from the Public Reference Room
of
the Commission, 100 F Street, N.E., Room 1580, Washington, D.C. 20549, at
prescribed rates. You may obtain information on the operation of the Public
Reference Room by calling the Commission at 1-800-SEC-0330.
The
Commission also maintains a website that contains reports, proxy statements
and
other information about issuers, like us, who file electronically with the
Commission. Our SEC filings are also available to you free of charge at the
SEC’s web site. The address of that site is http://www.sec.gov.
PART
II.
INFORMATION
NOT REQUIRED IN PROSPECTUS
ITEM
14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The
estimated expenses of this offering, all of which are to be paid by the
registrant, are as follows:
SEC
Registration Fee
|
|
$
|
164
|
|
Accounting
Fees and Expenses
|
|
|
15,000
|
|
Legal
Fees and Expenses
|
|
|
13,500
|
|
Miscellaneous
Expenses
|
|
|
1,336
|
|
TOTAL
|
|
$
|
30,000
|
|
_________________
ITEM
15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
As
provided in our bylaws and under Florida law, our directors shall not be
personally liable to our company or any other person for monetary damages for
breach of duty of care or any other duty owed to our company as a director,
unless the breach of or failure to perform those duties
constitutes:
|
*
|
a
violation of criminal law, unless the director had reasonable cause
to
believe his conduct was lawful, or had no reasonable cause to believe
his
conduct was unlawful;
|
|
*
|
a
transaction from which the director received an improper personal
benefit,
directly or indirectly;
|
|
*
|
in
a proceeding by or in the right of our company or a shareholder,
an act or
omission which involves a conscious disregard for the best interests
of
our company or which involves willful misconduct;
|
|
*
|
in
a proceeding by or in the right of someone other than our company
or a
shareholder, an act of recklessness or an act or omission which was
committed in bad faith or with malicious purpose or in a manner exhibiting
wanton and willful disregard of human rights, safety, or property;
or
|
|
*
|
a
distribution made in violation of Florida
law.
|
Our
bylaws provide that we are required to indemnify any director, officer, employee
or agent made a party to a proceeding because he is or was our director,
officer, employee or agent against liability incurred in the proceeding if
he
acted in good faith and in a manner the director reasonably believed to be
in or
not opposed to our best interests and, in the case of any criminal proceeding,
he had no reasonable cause to believe his conduct was unlawful.
Our
bylaws and Florida law also provide that we shall indemnify a director, officer,
employee or agent who has been successful on the merits or otherwise in the
defense of any proceeding to which he was a party, or in defense of any claim,
issue or matter therein, because he is or was a director, officer, employee
or
agent of our company against expenses actually and reasonably incurred by him
in
connection with such defense.
ITEM
16. EXHIBITS.
The
following exhibits are filed as part of this registration statement, pursuant
to
Item 601 of Regulation S-B.
|
|
Incorporated
by
Reference
|
|
Exhibit
Number
|
Exhibit
Description
|
Form
|
File
No
|
Exhibit
|
Filing
Date
|
Filed
Herewith
|
|
|
|
|
|
|
|
4.1
|
Specimen
Stock Certificate
|
SB-2
|
333-100568
|
4.1
|
10/16/02
|
|
4.2
|
Securities
Purchase Agreement, dated January 6, 2006 among the purchasers and
Oragenics, Inc.
|
Form
8-K
|
000-50614
|
4.1
|
3/10/06
|
|
4.3
|
Registration
Rights Agreement dated January 6, 2006, among the investors and Oragenics,
Inc.
|
Form
8-K
|
000-50614
|
4.2
|
3/10/06
|
|
4.4
|
Specimen
warrant certificate
|
Form
8-K
|
000-50614
|
4.3
|
3/10/06
|
|
5.1
|
Opinion
of Shumaker, Loop & Kendrick, LLP
regarding legality of the securities being registered
|
|
|
|
|
X
|
23.1
|
Consent
of Kirkland Russ Murphy & Tapp, PA
|
|
|
|
|
X
|
23.2
|
Consent
of Ernst & Young LLP
|
|
|
|
|
X
|
23.3
|
Consent
of Shumaker, Loop & Kendrick, LLP (included in exhibit
5.1)
|
|
|
|
|
|
24.
|
Power
of Attorney (signature page)
|
|
|
|
|
|
ITEM
17. UNDERTAKINGS.
The
undersigned registrant hereby undertakes:
|
(1)
|
To
file, during any period in which offers or sales are being made,
a
post-effective amendment to this registration statement:
|
|
(i)
|
To
include any prospectus required by Section 10(a)(3) of the Securities
Act
of 1933;
|
|
(ii)
|
To
reflect in the prospectus any facts or events arising after the effective
date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent
a
fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease
in
volume of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any deviation
from
the low or high end of the estimated maximum offering range may be
reflected in the form of prospectus filed with the Commission pursuant
to
Rule 424(b) if, in the aggregate, the changes in volume and price
represent no more than a 20 percent change in the maximum aggregate
offering price set forth in the “Calculation of Registration Fee” table in
the effective registration statement; and
|
|
(iii)
|
To
include any material information with respect to the plan of distribution
not previously disclosed in the registration statement or any material
change to such information in the registration statement;
|
provided,
however,
that
paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this section do not apply
if
the registration statement is on Form S-3 and the information required to be
included in a post-effective amendment by those paragraphs is contained in
reports filed with or furnished to the Commission by the registrant pursuant
to
Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are
incorporated by reference in the registration statement, or is contained in
a
form of prospectus filed pursuant to Rule 424(b) that is part of the
registration statement.
(2)
That, for the purpose of determining any liability under the Securities Act
of
1933, each such post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial
bona
fide offering thereof.
(3)
To file a post-effective amendment to remove from registration any of the
securities which remain unsold at the end of the offering.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933
(the
“Act”) may be permitted to directors, officers and controlling persons of the
small business issuer pursuant to the foregoing provisions, or otherwise, the
small business issuer has been advised that in the opinion of the SEC such
indemnification is against public policy as expressed in the Act and is,
therefore, unenforceable.
In
the
event that a claim for indemnification against such liabilities (other than
the
payment by the registrant of expenses incurred or paid by a director, officer
or
controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person
in connection with the securities being registered, the registrant will, unless
in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the Act
and
will be governed by the final adjudication of such issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies
that
it has reasonable grounds to believe that it meets all of the requirements
for
filing of this Form S-3 Registration Statement and has duly caused this
registration statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in Alachua, Florida, on this 17th
day of
March, 2006.
|
ORAGENICS,
INC. |
|
|
|
|
|
|
BY:
|
/s/
Robert T. Zahradnik
|
|
|
Robert
T. Zahradnik, President, Chief Executive Officer and
Director
|
|
|
|
|
BY:
|
/s/
Paul A. Hassie
|
|
|
Paul
A. Hassie, Secretary, Treasurer, Principal Accounting Officer and
Chief
Financial Officer
|
POWER
OF ATTORNEY
KNOW
ALL
PERSONS BY THESE PRESENTS, that each of the undersigned hereby constitutes
and appoints
Robert T. Zahradnik and Paul A. Hassie, jointly and severally, as his or her
true and lawful attorneys-in-fact and agents, each with full power of
substitution and resubstitution, for him or her and on his or her behalf to
sign, execute and file this Registration Statement and any or all amendments
(including, without limitation, post-effective amendments) to this Registration
Statement, and to file the same, with all exhibits thereto and any and all
documents required to be filed with respect therewith, with the Securities
and
Exchange Commission or any regulatory authority, granting unto such
attorneys-in-fact and agents full power and authority to do and perform each
and
every act and thing requisite and necessary to be done in connection therewith
and about the premises in order to effectuate the same as fully to all intents
and purposes as he or she might or could do if personally present, hereby
ratifying and confirming all that such attorneys-in-fact and agents, or his
or
her substitute or substitutes, may lawfully do or cause to be done.
Pursuant
to the requirements of the Securities Act of 1933, this Form S-3 Registration
Statement has been signed by the following persons in the capacities and on
the
dates indicated:
Signature
|
Title
|
Date
|
/s/
Robert T. Zahradnik
Robert
T. Zahradnik
|
President,
Principal Executive Officer and Director
|
March
17, 2006
|
|
|
|
/s/
Paul A. Hassie
Paul
A. Hassie
|
Principal
Accounting Officer and
Chief
Financial Officer
|
March
17, 2006
|
|
|
|
/s/
David J. Gury
David
J. Gury
|
Chairman
of the Board of Directors
|
March
17, 2006
|
|
|
|
/s/
Brian Anderson
Brian
Anderson
|
Member
of the Board of Directors
|
March
17, 2006
|
|
|
|
/s/
Jeffrey D. Hillman
Jeffrey
D. Hillman
|
Member
of the Board of Directors
|
March
17, 2006
|
|
|
|
/s/ George
T. Hawes
George
T. Hawes
|
Member
of the Board of Directors
|
March
17, 2006
|
EXHIBITS.
The
following exhibits are filed as part of this registration statement, pursuant
to
Item 601 of Regulation S-B.
|
|
Incorporated
by
Reference
|
|
Exhibit
Number
|
Exhibit
Description
|
Form
|
File
No
|
Exhibit
|
Filing
Date
|
Filed
Herewith
|
|
|
|
|
|
|
|
4.1
|
Specimen
Stock Certificate
|
SB-2
|
333-100568
|
4.1
|
10/16/02
|
|
4.2
|
Securities
Purchase Agreement, dated January 6, 2006 among the purchasers and
Oragenics, Inc.
|
Form
8-K
|
000-50614
|
4.1
|
3/10/06
|
|
4.3
|
Registration
Rights Agreement dated January 6, 2006, among the investors and Oragenics,
Inc.
|
Form
8-K
|
000-50614
|
4.2
|
3/10/06
|
|
4.4
|
Specimen
warrant certificate
|
Form
8-K
|
000-50614
|
4.3
|
3/10/06
|
|
5.1
|
Opinion
of Shumaker, Loop & Kendrick, LLP
regarding legality of the securities being registered
|
|
|
|
|
X
|
23.1
|
Consent
of Kirkland Russ Murphy & Tapp, PA
|
|
|
|
|
X
|
23.2
|
Consent
of Ernst & Young LLP
|
|
|
|
|
X
|
23.3
|
Consent
of Shumaker, Loop & Kendrick, LLP (included in exhibit
5.1)
|
|
|
|
|
|
24.
|
Power
of Attorney (signature page)
|
|
|
|
|
|