The
information in this preliminary prospectus supplement is not complete and may be changed. This preliminary prospectus supplement
is part of an effective registration statement filed with the Securities and Exchange Commission. This preliminary prospectus
supplement and the accompanying prospectus are not an offer to sell these securities and we are not soliciting an offer
to buy these securities in any state where the offer or sale is not permitted.
Filed
Pursuant to Rule 424(b)(5)
Registration
No. 333-235763
Subject
to Completion, Dated November 19, 2020
PROSPECTUS
SUPPLEMENT
(To
Prospectus dated January 13, 2020)
Shares
of Common Stock
Pursuant
to this prospectus supplement and the accompanying prospectus, we are offering shares of our common stock, par value $0.001 per
share, (the “Common Stock”).
Our
common stock is listed on the NYSE American under the symbol “OGEN.” The last reported sale price of our common stock
on the NYSE American on November 18, 2020 was $0.467 per share. We have applied to list the shares being sold in
this offering on the NYSE American. There can be no assurances that the NYSE American will grant the application.
Investing
in our securities involves a high degree of risk. Before buying any securities, you should carefully read the discussion of material
risks of investing in our common stock under the heading “Risk Factors” beginning on page S-9 of this prospectus supplement
and the documents incorporated by reference herein and the accompanying prospectus.
Neither
the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or determined
if this prospectus supplement or the prospectus to which it relates is truthful or complete. Any representation to the contrary
is a criminal offense.
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Total
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Public
offering price(1)
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$
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$
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Underwriting
discounts and commissions(2)(3)
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$
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$
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Proceeds,
before expenses, to us
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$
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$
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(1)
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The public offering price and underwriting discount corresponds
to a public offering price per share of common stock of $ .
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(2)
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In addition, we have agreed to reimburse the underwriter
for certain of its expenses. See “Underwriting” for additional information.
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(3)
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We have granted a
45-day option to the underwriter to purchase up to additional shares of common stock (up to 15% of the number
of shares of common stock sold in the primary offering).
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We
have granted the underwriter an option for a period of 45 days from the date of this prospectus supplement to purchase
up to additional shares of common stock from us at the public offering price of
$ per share of our common stock, less underwriting discounts and commissions. If the underwriter exercises this
option in full, the total underwriting discounts and commissions will be $ and total proceeds, before
expenses, to us will be $
We
expect that delivery of the shares of our Common Stock being offered pursuant to this prospectus supplement and the accompanying
prospectus will be made to purchasers through the facilities of The Depository Trust Company on or about November , 2020.
A.G.P.
The
date of this prospectus supplement is November , 2020
TABLE
OF CONTENTS
Prospectus
Supplement
ABOUT
THIS PROSPECTUS SUPPLEMENT
This
prospectus supplement and the accompanying prospectus form part of a registration statement on Form S-3 that we filed with the
Securities and Exchange Commission, or the “SEC,” using a “shelf” registration process. This document
contains two parts. The first part consists of this prospectus supplement, which provides you with specific information about
this offering. The second part, the accompanying prospectus, provides more general information, some of which may not apply to
this offering. Generally, when we refer only to the “prospectus,” we are referring to both parts combined. This prospectus
supplement, and the information incorporated herein by reference, may add, update or change information in the accompanying prospectus.
You should read the entire prospectus supplement as well as the accompanying prospectus and the documents incorporated by reference
herein that are described under the headings “Where You Can Find More Information” and “Incorporation of Certain
Documents by Reference.” If there is any inconsistency between the information in this prospectus supplement and the accompanying
prospectus, you should rely on the information in this prospectus supplement.
You
should rely only on the information contained in this prospectus supplement and the accompanying prospectus, including the information
incorporated by reference into this prospectus supplement and the accompanying prospectus, and any free writing prospectus that
we have authorized for use in connection with this offering. We have not authorized anyone to provide you with information that
is different.
The
information contained in this prospectus supplement and the accompanying prospectus, including the information incorporated by
reference into this prospectus supplement and the accompanying prospectus, and any free writing prospectus that we have authorized
for use in connection with this offering is accurate only as of the respective dates thereof, regardless of the time of delivery
of this prospectus supplement, the accompanying prospectus or free writing prospectus, if any, or of any sale of our securities.
It is important for you to read and consider all information contained in this prospectus supplement and the accompanying prospectus,
including the information incorporated by reference into this prospectus supplement and the accompanying prospectus, and any free
writing prospectus that we have authorized for use in connection with this offering in making your investment decision. You should
also read and consider the information in the documents to which we have referred you in the sections entitled “Where You
Can Find More Information” and “Incorporation of Certain Documents by Reference” in this prospectus supplement.
We
are offering to sell, and seeking offers to buy, our securities only in jurisdictions where offers and sales are permitted. The
distribution of this prospectus supplement and the accompanying prospectus and the offering of securities in certain jurisdictions
may be restricted by law. Persons outside the United States who come into possession of this prospectus supplement and the accompanying
prospectus must inform themselves about, and observe any restrictions relating to, the offering of our securities and the distribution
of this prospectus supplement and the accompanying prospectus outside the United States. This prospectus supplement and the accompanying
prospectus do not constitute, and may not be used in connection with, an offer to sell, or a solicitation of an offer to buy,
any securities offered by this prospectus supplement and the accompanying prospectus by any person in any jurisdiction in which
it is unlawful for such person to make such an offer or solicitation.
The
industry and market data and other statistical information contained in this prospectus supplement, the accompanying prospectus
and the documents we incorporate by reference are based on management’s estimates, independent publications, government
publications, reports by market research firms or other published independent sources, and, in each case, are believed by management
to be reasonable estimates. Although we believe these sources are reliable, we have not independently verified the information.
None of the independent industry publications used in this prospectus supplement, the accompanying prospectus or the documents
we incorporate by reference were prepared on our or our affiliates’ behalf and none of the sources cited by us consented
to the inclusion of any data from its reports, nor have we sought their consent.
We
further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any
document that is incorporated by reference herein were made solely for the benefit of the parties to such agreement, including,
in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation,
warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made.
Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state
of our affairs.
References
to, “we,” “us,” “our company,” “Oragenics,” the “Company,” and similar
terms refer to Oragenics, Inc., a Florida corporation, unless the context otherwise requires.
CAUTIONARY
STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS
Certain
statements in this prospectus supplement, the accompanying prospectus and documents incorporated by reference herein that look
forward in time or express management’s expectations or beliefs with respect to the occurrence of future events are forward-looking
statements as defined under within the meaning of Section 27A of the Securities Act of 1933, as amended, or Securities Act, and
Section 21E of the Securities Exchange Act of 1934, as amended, or Exchange Act, as amended, and are subject to the safe harbor
created therein for forward-looking statements. Such statements include, but are not limited to, (i) projections of revenue, earnings,
capital structure and other financial items, (ii) statements of our plans and objectives, (iii) statements of expected future
economic performance, and (iv) assumptions underlying statements regarding us or our business. Forward-looking statements can
be identified by, among other things, the use of forward-looking language, such as “believes,” “expects,”
“estimates,” “may,” “will,” “should,” “could,” “seeks,”
“plans,” “intends,” “anticipates” or “scheduled to” or the negatives of those
terms, or other variations of those terms or comparable language, including, notably, language concerning the “impact”
or “limitations” relating to COVID-19, or by discussions of strategy or other intentions, particularly as they relate
to the development and funding of our new TerraCoV2 vaccine product candidate.
We
caution investors that actual results or business conditions may differ materially from those projected or suggested in forward-looking
statements as a result of various factors including, but not limited to, the following risks and the other factors described in
the Risk Factors section of our annual report on Form 10-K, in our quarterly reports on Form 10-Q and in our Current
Reports on Form 8-K incorporated by reference. These factors include:
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have incurred significant operating losses since our inception and cannot assure you that we will generate revenues or achieve
profitability;
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will need to raise additional capital to fully implement our business strategy and we may not be able to do so;
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Our
financial capacity and performance, including our ability to obtain funding necessary to the research, development, manufacture
and commercialization of any one or all of our product candidates;
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The
timing, progress and results of clinical trials of our product candidates, including statements regarding the timing of initiation
and completion of preclinical studies or clinical trials or related preparatory work, the period during which the results
of the trials will become available and our research and development programs;
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The
timing of any submission of filings for regulatory approval of our product candidates and our ability to obtain and maintain
regulatory approvals for our product candidates for any indication;
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Our
expectations regarding the potential benefits, activity, effectiveness and safety of our product candidates;
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Our
expectations regarding the size of the patient populations, market acceptance and opportunity for and clinical utility of
our product candidates, if approved for commercial use;
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Our
manufacturing capabilities and strategy, including the scalability and commercial viability of our manufacturing methods
and processes, and those of our contractual partners;
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Our
expectations regarding the scope of any approved indications for our product candidates;
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Our
ability to successfully commercialize our product candidates;
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The
potential benefits of and our ability to maintain our relationships and collaborations with the NIAID, the NIH, Precigen,
Eleszto Genetika, Inc. and other potential collaboration or strategic relationships;
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Our
ability to use our lantibiotic platform to develop future product candidates;
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Our
estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional
funding, including any application for future grants or funding;
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Our
ability to identify, recruit and retain key personnel;
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Our
ability to obtain, retain, protect and enforce our intellectual property position for our product candidates, and the scope
of such protection;
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Our
ability to advance the development of our new TerraCoV2 vaccine product candidate under the timelines and in accord with the
milestones it projects;
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Our
inability to achieve success in our identification of lantibiotic homologs or the manufacture and nonclinical testing of our
lantibiotic product candidates;
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Our
need to comply with extensive and costly regulation by worldwide health authorities, who must approve our product candidates
prior to substantial research and development and could restrict or delay the future commercialization of certain of our product
candidates;
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Our
ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of our product candidates
and commercialize any approved products on our expected timeframes or at all;
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The
safety, efficacy and benefits of our product candidates;
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The
content and timing of submissions to and decisions made by the FDA, other regulatory agencies and nongovernmental bodies and
actors, such as investigational review boards;
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The
effects of government regulation and regulatory developments, and our ability and the ability of the third parties with whom
we engage to comply with applicable regulatory requirements;
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capacities and performance of our suppliers and manufacturers and other third parties over whom we have limited control;
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Our
ability to maintain our listing on the NYSE American;
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The
impact of the COVID-19 pandemic on our financial condition and business operations and our ability to continue research and
development for existing product candidates on previously-projected timelines or in accord with ordinary practices, as well
as the broader governmental, global health and macro- and microeconomic responses to and consequences of the pandemic;
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may be adversely impacted by any significant broad-based financial crises and its impact on consumers, retailers and equity
and debt markets as well as our inability to obtain required additional funding to conduct our business;
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As
a public company, we must implement additional and expensive finance and accounting systems, procedures and controls as we
grow our business and organization to satisfy reporting requirements, which add to our costs and require additional management
time and resources;
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Our
competitive position and the development of and projections relating to our competitors or our industry; and
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impact of laws and regulations, including those that may not yet exist.
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We
cannot assure you that we have identified all the factors that create uncertainties. Moreover, new risks emerge from time to time
and it is not possible for our management to predict all risks, nor can we assess the impact of all risks on our business or the
extent to which any risk, or combination of risks, may cause actual results to differ from those contained in any forward-looking
statements. Except as required by law, we undertake no obligation to publicly release the result of any revision of these forward-looking
statements to reflect events or circumstances after the date of this prospectus or the respective dates of documents incorporated
by reference herein or therein that include forward-looking statements.
We
urge you to consider these factors before investing in our common stock. The forward-looking statements included in this prospectus
supplement, the accompanying prospectus and any other offering material, or in the documents incorporated by reference into this
prospectus supplement, the accompanying prospectus and any other offering material, are made only as of the date of the prospectus
supplement, the accompanying prospectus, any other offering material or the incorporated document. For more detail on these and
other risks, please see “Risk Factors” in this prospectus supplement, the accompanying prospectus, our Annual
Report on Form 10-K for our fiscal year ended December 31, 2019, filed with the SEC on March 4, 2020, as updated by our
Form 8-K Report filed with the Securities and Exchange Commission on May 8, 2020, our Quarterly Report on Form 10-Q for our quarter
ended March 31, 2020, filed with the SEC on May 15, 2020, our Quarterly Report on Form 10-Q for our quarter ended June 30, 2020,
filed with the SEC on August 14, 2020, our Quarterly Report on Form 10-Q for our quarter ended September 30, 2020, filed with
the SEC on November 10, 2020 and our other filings with the SEC.
This
prospectus supplement also contains estimates, projections and other information concerning our industry, the market and our business.
Information that is based on estimates, forecasts, projections or similar methodologies is inherently subject to uncertainties
and actual events or circumstances may differ materially from events and circumstances reflected in this information. We obtained
the industry, market and competitive position data in this prospectus from our own internal estimates and research as well as
from industry and general publications and research surveys and studies conducted by third parties.
PROSPECTUS
SUPPLEMENT SUMMARY
This
summary highlights selected information contained elsewhere or incorporated by reference in this prospectus supplement and the
accompanying prospectus. This summary may not contain all of the information that may be important to you. You should read this
prospectus supplement, the accompanying prospectus, the information incorporated by reference in each, and any related free writing
prospectus before making an investment decision. You should pay special attention to the “Risk Factors” section beginning
on page S-9 of this prospectus supplement and “Risk Factors” set forth in our most recent annual report on Form 10-K
for the year ended December 31, 2019, as updated by our recent Form 8-K Report filed with the Securities and Exchange Commission
on May 8, 2020 and in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020, and September 30,
2020, respectively and in the other documents which are incorporated by reference in this prospectus supplement and the accompanying
prospectus in their entirety to determine whether an investment in our common stock is appropriate for you.
Overview
We
are focused on the creation of the TerraCoV2 immunization product candidate to combat the novel coronavirus pandemic and the further
development of novel antibiotics against infectious disease.
Our
SARS-CoV-2 Vaccine Product Candidate— TerraCoV2
As
a result of our acquisition of one hundred percent (100%) of the total issued and outstanding common stock of Noachis Terra, Inc.
(“Noachis Terra”) we are now dedicated to the development and commercialization of a vaccine product candidate to
provide specific, long lasting immunity from the novel Severe Acute Respiratory Syndrome coronavirus (“SARS-CoV-2”),
which causes the coronavirus disease 2019 (“COVID-19”). Noachis Terra is a party to a worldwide, nonexclusive intellectual
property and biological materials license agreement with the National Institute of Allergy and Infectious Diseases (“NIAID”),
an institute within the National Institutes of Health (“NIH”), relating to certain research, patent applications and
biological materials involving pre-fusion coronavirus spike proteins and their use in the development and commercialization of
vaccine to provide specific, long lasting immunity from SARS-CoV-2.
Coronaviruses
are a family of viruses that can, when transmitted to humans, lead to upper-respiratory infections. Recent clinical reports also
suggest that the SARS-CoV-2 virus can affect other body-systems, including the nervous, cardiovascular, gastrointestinal and renal
systems. Among the recent iterations of coronaviruses to move from animal to human carriers is SARS-CoV-2 (often referred to as
COVID-19), which, beginning in Wuhan, China, in late 2019, caused a global pandemic due to its rapid spread and the relatively
high mortality rate (as compared to the seasonal influenza). In early October of 2020, the World Health Organization’s estimates
indicate the number of worldwide COVID-19 infections have exceeded 36,000,000 and the number of deaths directly attributed to
COVID-19 have exceeded 1,000,000. Aside from Remdesivir, no governmental regulatory authority in the United States has
approved a vaccine or anti-viral treatment specifically targeting SARS-CoV-2 or COVID-19. We intend to combine the research,
patent applications and biological materials covered by our NIAID license with our existing clinical research and manufacturing
capabilities to respond rapidly to this ongoing, global, public health crisis.
Coronaviruses, such as SARS -CoV-2, possess signature protein spikes on their outer capsule. The NIAID license covers patents and data
on a vaccine candidate that were created based on a stabilized pre-fusion spike trimeric protein. By stabilizing the spike protein
in the pre-fusion state, the number of immunogenic centers is increased thereby allowing for a greater likelihood of successful
antibody binding, resulting in an improved immunogenic response. The genetic code, acquired from the NIH, for the stabilized pre-fusion
spike protein was provided to Aragen Bioscience, Inc. (“Aragen”) for the purpose of insertion of the spike protein
gene sequence into a Chinese Hamster Ovary (“CHO”) cell line. Aragen is a leading contract research organization focused
on accelerating preclinical biologics product development, has extensive experience building CHO cell lines for recombinant proteins,
such as monoclonal antibodies. Aragen has successfully inserted the NIH pre-fusion spike protein gene sequence into a CHO cell
line and is currently developing both the analytical tests and identifying preliminary cell line growth conditions to optimize
the spike protein titers. Currently, “mini-pool” production and analytical development is underway. The transfer to
full-scale manufacture has begun.
The
NIH’s preclinical study shows that this spike protein, adjuvanted with the mouse specific TLR-4-agonist Sigma Adjuvant System
(“SAS”, a TLR-4 agonists) that induces T cell activation), generates neutralizing antibody titers in both a pseudovirus
neutralization assay and a plaque reduction neutralization titer (PRNT) assay. In October 2020, we received feedback to our Type
B Pre-IND Meeting Request from the FDA. The response indicated that the FDA broadly supported our planned approach to the pre-clinical
program that will support the clinical development of the Terra CoV-2, vaccine. As a result, we believe the timelines for both
filing an Investigational New Drug (“IND”) application and the commencement of the Phase 1 study will proceed on schedule.
We anticipate filing the IND in the second quarter of 2021 and immediately upon the receipt of approval from the FDA, commencing
the Phase 1 clinical study.
We
expect to use our currently available cash resources to continue to advance the development of TerraCoV2 with full development
being contingent upon the receipt of additional equity funding.
Our
Antibiotic Product Candidate-OG716
Members
of our scientific team discovered that a certain bacterial strain, streptococcus mutans, produces
MU1140, a molecule belonging to the novel class of antibiotics known as lantibiotics. Lantibiotics, such as MU1140, are highly
modified peptide antibiotics made by a small group of Gram-positive bacterial species. Approximately 60 lantibiotics have been
discovered, to date. We believe lantibiotics are generally recognized by the scientific community to be potent antibiotic agents.
In
nonclinical testing, MU1140 has shown activity against all Gram-positive bacteria against which it has been tested, including
those responsible for a number of healthcare associated infections, or HAIs. A high percentage of hospital-acquired infections
are caused by highly resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) or multidrug-resistant Gram-negative
bacteria. We believe the need for novel antibiotics is increasing as a result of the growing resistance of target pathogens to
existing FDA approved antibiotics on the market along with the increased use of currently available antibiotics due to secondary
infections in SARS-CoV-2 infected patients.
Lantibiotics
have been difficult to investigate for their clinical usefulness as therapeutic agents in the treatment of infectious diseases
due to a general inability to produce or synthesize sufficient quantities of pure amounts of these molecules. Traditional fermentation
methods can only produce minute amounts of the lantibiotic.
In
June 2012, we entered into the Lantibiotic Exclusive Channel Collaboration Agreement (“Lantibiotic ECC”) with
Precigen for the development and commercialization of the native strain of MU1140 and related homologs using Precigen’s
advanced transgene and cell engineering platforms. Through our work with Precigen, we have been able to produce a significant
increase in the fermentation titer of MU1140 compared to standard fermentation methods and have discovered a new purification
process for MU1140. Our work with Precigen generated a substantial number of homologs of MU1140. In January 2020, Precigen
consummated a reorganization of its ongoing API fermentation operations and assets into EGI which at the time was an affiliate
of Precigen. In connection with the reorganization, Precigen assigned the Lantibiotic ECC and related stock issuance agreements
to EGI. Following such reorganization, Precigen divested certain of its assets to TS Biotechnology Holdings, LLC which included
EGI and shares of Oragenics securities held by Precigen. As a result of such change by Precigen, we expect to continue
our research and development and collaboration efforts with EGI to develop potential derivatives of the MU1140 molecule using
genetically modified bacteria.
In
our pre-clinical studies to support a potential IND filing with the FDA, we tested a total of six homologs of MU1140 for certain
compound characteristics, including but not limited to: drug activity (based on minimum inhibitory concentration or “MIC”)
equal or better than “standard of care” drugs against certain drug-resistant bacteria, safety, toxicity, stability,
and manufacturability. An animal study specifically evaluated homolog efficacy in relation to survival, measurable amounts of
Clostridium difficile (“C. diff”) colony forming units, and toxin levels. Three homologs demonstrated promising
results with one homolog, OG253 achieving a 100% survival rate throughout the entire study in contrast to an approximately 30%
survival rate for the vancomycin positive control.
Based
on these early results, we selected a lead candidate, OG253, for which we had a pre-IND meeting with the FDA in November of 2015
regarding the pursuit of an IND for OG253. Following additional research and development on second generation lantibiotics, in
August of 2016, we opted to select a second generation lantibiotic, OG716, for treatment of C. diff as our new lead candidate.
OG716 is a new, orally-active homolog, that has exhibited positive results in an animal model for potential treatment of C.
diff. Generated from our MU1140 platform, this new lantibiotic showed promising efficacy in reducing clinically relevant C.
diff infections as measured by increased animal survival and decreased relapse as well as reduced production of toxins A &
B and C. diff spores.
The
timing of the filing of an IND regarding OG716 is subject to our having sufficient available human, material and financing capital,
which includes research subjects, both animal and human, given all of our anticipated needs and expected requirements in connection
with our ongoing research and development initiatives. We will continue to advance the OG716 program to the IND filing based on
the availability of both human and financial capital. Based upon the current funding available we will continue to conduct some
of the requisite studies. While we commenced certain of these studies at the end of 2019, we expect to focus on efficient and
cost-effective improvements in the manufacturing process of the product as we move to complete the pre-clinical studies required
to support our first in man Phase 1 clinical study.
Product
Candidates
Through
our wholly-owned subsidiary, Noachis Terra, we intend to begin the research and development stage for our new TerraCoV2 vaccine
product candidate. We hold a nonexclusive, worldwide intellectual property license agreement for certain research, patent applications
and biological materials relating to the use of pre-fusion coronavirus spike proteins for the development and commercialization
of a vaccine for SARS-CoV-2.
Additionally,
we are currently working with Eleszto Genetika, Inc. (as an assignee of Precigen) to use its technology to develop lantibiotics.
We seek to protect our product candidates through patents and patent applications pursuant to the terms of our license agreements.
Recent
Developments
Feedback
From U.S. Food and Drug Administration (“FDA”). In October 2020, the Company announced the receipt of feedback
to its Type B Pre-IND Meeting Request from the FDA. The response indicated provided FDA guidance in response to the
Company’s planned pre-clinical approach to support clinical development of its SARS-CoV-2 vaccine, Terra CoV-2. The
Company anticipates filing the IND in the second quarter of 2021 and immediately upon the receipt of approval from the FDA, commencing
the Phase 1 clinical study.
Funding
Update From Biomedical Advanced Research and Development Authority (“BARDA”). In September 2020, the
Company was informed of BARDA’s determination not to enter into negotiation with the Company. While BARDA noted the Company’s
submission aligned with its mission, a combination of factors, including availability of funds, precluded the agency from entering
into negotiations at that time.
Warrant
Exercises. Between July 1, 2020 and September 30, 2020, 760,000 of our previously reported remaining outstanding warrants
were exercised at an exercise price of $1.00 per share issued in connection with our July 2018 public offering (the “2018
Warrants”) and 4,882,114 warrants of our previously reported outstanding warrants to acquire shares of Common Stock at an
exercise price of $0.90 per share issued in connection with our March 2019 public offering (the “2019 Warrants”),
were exercised (the “Warrant Exercises”). The Warrant Exercises provided aggregate gross proceeds to us of $5,153,902.
Additional
Consideration Payment - NTI Acquisition. In connection with our acquisition of NTI we are obligated to pay additional
consideration to NTI’s former sole stockholder determined and based upon the exercise of our 2018 Warrants and 2019 Warrants.
As a result of Warrant Exercises, we paid $1,220,781 in additional consideration to NTI’s former sole stockholder.
Corporate
and Other Information
We
were incorporated in November 1996 and commenced operations in 1999. We consummated our initial public offering in June 2003.
We have devoted substantially all of our available resources to the commercialization of our products as well as our discovery
efforts comprising research and development, clinical trials for our product candidates, protection of our intellectual property
and the general and administrative support of these operations. We have generated limited revenues from grants and product sales
through June 30, 2016, and have principally funded our operations through the sale of debt and equity securities. In June of 2016,
we completed the sale of our consumer probiotics business to ProBiora Health, LLC and as a result, we will no longer generate
revenue from sales of consumer probiotic products.
As
of September 30, 2020, we had an accumulated deficit of $150,035,900 and we have yet to achieve profitability. We incurred net
losses of $22,021,616 and $11,968,726 for the nine months ended September 30, 2020 and 2019, respectively, and we incurred net
losses of $15,566,003 and $9,914,141 for the years ended December 31, 2019 and 2018, respectively. We expect to incur significant
and increasing operating losses for the foreseeable future as we seek to advance our product candidates through preclinical testing
and clinical trials to ultimately obtain regulatory approval and eventual commercialization. We will need to raise additional
capital. Adequate additional funding may not be available to us on acceptable terms, or at all. We expect that research and development
expenses will increase along with general and administrative costs, as we seek to grow and continue to operate our business. There
can be no assurance that additional capital will be available to us on acceptable terms, if at all.
Our
executive office is located at, 4902 Eisenhower Boulevard, Suite 125 Tampa, Florida, 33634 and our research facilities are located
at 13700 Progress Boulevard, Alachua, Florida 32615. Our telephone number is (813) 286-7900 and our website is http://www.oragenics.com.
Information on, or that can be accessed through, our website is not part of this prospectus supplement or the accompany prospectus
and should not be relied on in connection with this offering.
THE
OFFERING
The
following summary contains basic information about our Common Stock and the offering and is not intended to be complete. It does
not contain all the information that may be important to you. For a more complete understanding of our Common Stock, you should
read the section of the accompanying prospectus entitled “Description of Capital Stock.”
Common
stock offered by us:
|
|
shares
|
|
|
|
Shares
of Common Stock outstanding before this offering:
|
|
61,004,917
shares (as more fully described in the notes following this table).
|
|
|
|
Shares
of Common Stock outstanding immediately after this offering:
|
|
shares
|
|
|
|
Underwriter’s
option to purchase additional shares:
|
|
shares.
|
|
|
|
Use
of proceeds:
|
|
We
estimate that our net proceeds from this offering will be approximately $
after deducting the underwriting discounts and commissions and estimated offering expenses
payable by us. We intend to use the net proceeds from this offering primarily to continue
funding, our pre-clinical development of our SARS-CoV-2 vaccine, Terra CoV-2 and our
lantibiotics program and for general corporate purposes, including research and development
activities, capital expenditures and working capital.
See
the section titled “Use of Proceeds” in this prospectus supplement.
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|
|
|
Risk
factors:
|
|
Investing
in our securities involves a high degree of risk and purchasers of our securities may lose their entire investment. See “Risk
Factors” below and in our most recent Annual Report on Form 10-K, as updated by our Form 8-K Report filed with
the Securities and Exchange Commission on May 8, 2020, which are incorporated by reference and the other information included
elsewhere in this prospectus supplement and the accompanying prospectus for a discussion of factors you should carefully consider
before deciding to invest in our securities.
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|
|
|
Trading:
|
|
Our
shares of Common Stock currently trade on NYSE American under the symbol “OGEN”.
|
The
number of shares of our Common Stock shown above to be outstanding immediately before and after this offering is based on 61,004,917
shares outstanding as of November 6, 2020, and excludes, as of such date:
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●
|
5,801,349
shares of our Common Stock subject to outstanding options having a weighted average exercise price of $0.90 per share;
|
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|
|
|
●
|
2,207,901
shares of our Common Stock reserved for future issuance pursuant to our existing Equity Incentive Plan;
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|
|
|
●
|
20,513,145
shares of our Common Stock issuable upon exercise of warrants outstanding, having a weighted average exercise price of $1.36
per share;
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|
|
|
|
●
|
941,701
shares of our Common Stock issuable upon conversion of convertible Series A Preferred stock outstanding; and
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|
|
|
|
●
|
1,320,002
shares of our Common Stock issuable upon conversion of convertible Series B Preferred stock outstanding.
|
Except
as otherwise indicated, all information included or incorporated by reference in this prospectus supplement assumes the following:
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|
no exercise of
the outstanding options and warrants described above; and
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|
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●
|
no exercise of
the underwriter’s option to purchase additional shares.
|
RISK
FACTORS
Before
purchasing our common stock you should carefully consider the risk factors set forth below and under the heading “Risk Factors”
included in our most recent Annual Report on Form 10-K, as updated by our recent Form 8-K Report filed with the Securities and
Exchange Commission on May 8, 2020, as revised or supplemented by our subsequent Quarterly Reports on Form 10-Q, each of which
are on file with the SEC and are incorporated herein by reference, as well as all other information contained in this prospectus
supplement and the accompanying prospectus and incorporated by reference and any free writing prospectus that we have authorized
for use in connection with this offering. The risks and uncertainties described below and in our most recent Annual Report on
Form 10-K, as revised or supplemented by our subsequent Quarterly Reports on Form 10-Q, are not the only risks and uncertainties
we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our
business operations. If any of the risks described below or in our most recent Annual Report on Form 10-K, as revised or supplemented
by our subsequent Quarterly Reports on Form 10-Q, actually occur, our business, financial condition and results of operations
could suffer. As a result, the trading price of our stock could decline, perhaps significantly, and you could lose all or part
of your investment. The risks discussed below and in most recent Annual Report on Form 10-K, as revised or supplemented by our
subsequent Quarterly Reports on Form 10-Q, also include forward-looking statements and our actual results may differ substantially
from those discussed in these forward-looking statements. See the section entitled “Forward-Looking Information.”
Risks
Related To Our Financial Condition and Need For Additional Capital
We
have incurred significant losses since our inception and expect to continue to experience losses for the foreseeable future.
We
have incurred significant net losses and negative cash flow in each year since our inception, including net losses of approximately
$22.0 million and $12.0 million for the nine months ended September 30, 2020 and September 30, 2019, respectively, and approximately
$15.6 million and $11.3 million for the years ended December 31, 2019, and 2018, respectively. As of September 30, 2020, our accumulated
deficit was approximately $150.0 million. We have devoted a significant amount of our financial resources to research and development,
including our nonclinical development activities and clinical trials. We expect that the costs associated with our plans to begin
preclinical research, contract manufacturing and file an IND for our TerraCoV2 vaccine product candidate and the research and
development of our product candidates pursuant to our exclusive channel partnerships with Eleszto Genetika, Inc. (an assignee
of Precigen) in the area of lantibiotics (“Lantibiotics Program”) will continue to increase the level of our overall
expenses significantly going forward. Additionally, our NIAID license also requires the payment of certain recurring and performance-based
royalties that may negatively impact our financial capabilities. As a result, we expect to continue to incur substantial net losses
and negative cash flow for the foreseeable future. These losses and negative cash flows have had, and will continue to have, an
adverse effect on our shareholders’ equity and working capital. Because of the numerous risks and uncertainties associated
with product development and commercialization, we are unable to accurately predict the timing or amount of substantial expenses
or when, or if, we will be able to generate the revenue necessary to achieve or maintain profitability.
We
will need to raise additional capital in the future to complete the development and commercialization of our product candidates
and operate our business.
Developing
and commercializing biopharmaceutical products, including conducting nonclinical studies and clinical trials and establishing
manufacturing capabilities, and the progress of our efforts to develop and commercialize our product candidates, including our
acquisition of a vaccine product candidate is expensive, and can cause us to use our limited, available capital resources faster
than we currently anticipate. We anticipate that our cash resources as of September 30, 2020, together with the proceeds from
recent warrant exercises, will be sufficient to fund our operations as presently structured into the first quarter of 2021. Our
actual costs may ultimately vary from our current expectations, which could materially impact our use of capital and our forecast
of the period of time through which our financial resources will be adequate to support our operations. Our current cash, cash
equivalents and short-term investments are not sufficient to fully implement our business strategy and sustain our operations.
Accordingly, we will need to seek additional sources of financing and such additional financing may not be available on favorable
terms, if at all. Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs
through public or private equity offerings, debt financings or corporate or government collaboration and licensing arrangements.
If we do not succeed in raising additional funds on acceptable terms, we may be unable to complete existing nonclinical and planned
clinical trials or obtain approval of our product candidates from the FDA and other regulatory authorities. We expect capital
outlays and operating expenditures to increase over the next several years as we expand our infrastructure, and research and development
activities. Specifically, we need to raise additional capital to, among other things:
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●
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conduct
preclinical research for our TerraCoV2 vaccine product candidate, file an IND with the FDA and, if approved, engage in Phase
1 clinical trials;
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|
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●
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engage
in GMP and non-GMP manufacturing for our product candidates at the preclinical research and clinical trial stages;
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|
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●
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expand
our clinical laboratory operations;
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|
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●
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fund
our clinical validation study activities;
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|
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●
|
expand
our research and development activities; and
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|
●
|
finance
our capital expenditures and general and administrative expenses.
|
Our
present and future funding requirements will depend on many factors, including:
|
●
|
the
current and continued microeconomic impact of the COVID-19 pandemic on our ability,
the ability of our third-party contractors and suppliers to meet our development needs,
and the ability of government regulators to conduct ordinary business operations in a
timely and efficient manner, as well as the pandemic’s broader, macroeconomic impact
on the U.S., foreign and global economic markets;
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●
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the
level of research and development investment budgeted to develop our current and future product candidates through each phase
of development;
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●
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costs
of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;
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●
|
our
need or decision to acquire or license complementary technologies or acquire complementary businesses;
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●
|
changes
in test development plans needed to address any difficulties in product candidate selection for commercialization;
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●
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competing
technological and market developments;
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●
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our
interaction and relationship with the FDA, or other, regulatory agencies; and
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●
|
changes
in regulatory policies or laws that affect our operations.
|
Additional
capital may not be available on satisfactory terms, or at all. Furthermore, if we raise additional funds by issuing
equity securities, dilution to our existing stockholders could result. Any equity securities issued also may provide for rights,
preferences or privileges senior to those of holders of our common stock. If we raise additional funds by issuing debt securities,
these debt securities would have rights, preferences and privileges senior to those of holders of our common stock, and the terms
of the debt securities issued could impose significant restrictions on our operations. If we raise additional funds through collaborations
and licensing arrangements, we might be required to relinquish significant rights to our technologies or our products under development
or grant licenses on terms that are not favorable to us, which could lower the economic value of those programs to us. If adequate
funds are not available, we may have to scale back our operations or limit our research and development activities, which may
cause us to grow at a slower pace, or not at all, and our business could be adversely affected.
In
addition, we could be forced to discontinue product development and commercialization of one or more of our product candidates,
curtail or forego sales and marketing efforts, and/or forego licensing attractive business opportunities.
Risks
Relating to this Offering
The
market price of our common stock has been, and may continue to be volatile and fluctuate significantly, which could result in
substantial losses for investors.
The
trading price for our common stock has been, and we expect it to continue to be, volatile. The price at which our common stock
trades depends upon a number of factors, including our historical and anticipated operating results, our financial situation,
announcements by us or our competitors, our ability or inability to raise the additional capital we may need and the terms on
which we raise it, and general market and economic conditions. Some of these factors are beyond our control. Broad market fluctuations
may lower the market price of our common stock and affect the volume of trading in our stock, regardless of our financial condition,
results of operations, business or prospects. The closing price of our common stock as reported on the NYSE American had a high
price of $1.05 and a low price of $0.36 in the 52-week period ended December 31, 2019 and a high price of $1.49 and a low price
of $0.39 from January 1, 2020 through September 30, 2020. Among the factors that may cause the market price of our common stock
to fluctuate are the risks described in this “Risk Factors” section and other factors, including:
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results
of preclinical and clinical studies of our product candidates or those of our competitors;
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|
|
|
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●
|
regulatory
or legal developments in the U.S. and other countries, especially changes in laws and regulations applicable to our product
candidates;
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|
|
●
|
actions
taken by regulatory agencies with respect to our product candidates, clinical studies, manufacturing process or sales and
marketing terms;
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|
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●
|
introductions
and announcements of new products by us or our competitors, and the timing of these introductions or announcements;
|
|
|
|
|
●
|
announcements
by us or our competitors of significant acquisitions or other strategic transactions or capital commitments;
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|
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●
|
fluctuations
in our quarterly operating results or the operating results of our competitors;
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|
|
|
●
|
variance
in our financial performance from the expectations of investors;
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|
|
●
|
changes
in the estimation of the future size and growth rate of our markets;
|
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|
|
|
●
|
changes
in accounting principles or changes in interpretations of existing principles, which could affect our financial results;
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|
●
|
failure
of our products to achieve or maintain market acceptance or commercial success;
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●
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conditions
and trends in the markets we serve;
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●
|
changes
in general economic, industry and market conditions;
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●
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changes
in legislation or regulatory policies, practices or actions;
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●
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the
commencement or outcome of litigation involving our company, our general industry or both;
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●
|
recruitment
or departure of key personnel;
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|
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●
|
changes
in our capital structure, such as future issuances of securities or the incurrence of additional debt;
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|
|
●
|
actual
or expected sales of our common stock by our stockholders;
|
|
|
|
|
●
|
acquisitions
and financings; and
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|
|
|
|
●
|
the
trading volume of our common stock.
|
In
addition, the stock markets, in general, NYSE American and the market for biotech companies in particular, may experience a loss
of investor confidence. Such loss of investor confidence may result in extreme price and volume fluctuations in our common stock
that are unrelated or disproportionate to the operating performance of our business, financial condition or results of operations.
These broad market and industry factors may materially harm the market price of our common stock and expose us to securities class
action litigation. Such litigation, even if unsuccessful, could be costly to defend and divert management’s attention and
resources, which could further materially harm our financial condition and results of operations.
If
you purchase shares of our common stock sold in this offering, you will experience immediate and substantial dilution in the net
tangible book value of your shares. In addition, we may issue additional securities in the future, which may result in additional
dilution to investors.
The
offering price per share of common stock in this offering is considerably more than the net tangible book value per share of our
outstanding common stock. As a result, investors purchasing shares of common stock in this offering will pay a price per share
that substantially exceeds the value of our tangible assets after subtracting liabilities. Investors will incur immediate dilution
of $ per share, based on the public offering price of $ per share and the net tangible book value as of September 30,
2020. For a more detailed discussion of the foregoing, see the section entitled “Dilution” below. To the extent outstanding
stock options and warrants are exercised, or convertible preferred stock converted, there will be further dilution to new investors.
In addition, to the extent we need to raise additional capital in the future and we issue additional equity or convertible debt
securities, our then existing shareholders may experience dilution and the new securities may have rights senior to those of our
common stock offered in this offering.
Our
management team may invest or spend the proceeds of this offering in ways with which you may not agree or in ways which may not
yield a significant return.
Our
management will have broad discretion over the use of proceeds from this offering. We intend to use the net proceeds from this
offering to fund of our Terra CoV-2 research and clinical trials for working capital and general corporate purposes. Our management
will have considerable discretion in the application of the net proceeds, and you will not have the opportunity, as part of your
investment decision, to assess whether the proceeds are being used appropriately. The net proceeds may be used for corporate purposes
that do not increase our operating results or enhance the value of our common stock.
Future
sales of our common stock in the public market could cause our stock price to fall.
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. We have recently issued a significant number of shares of common stock and the number
of outstanding shares has increased from 2,738,283 shares as of December 31, 2012 to 61,004,917 as of November 6, 2020. In addition,
there were 16,017,133.483 shares of our Preferred stock outstanding which are convertible into shares of our common stock and
warrants to purchase an additional 20,513,145 shares of our common stock issuable upon exercise of warrants to investors. There
were also 5,801,349 shares issuable upon exercise of options outstanding and an additional 2,207,901 shares available for option
grants under our 2012 Equity Incentive Plan.
The
issuance of shares of our common stock under our 2012 Equity Incentive Plan is covered by Form S-8 registration statements we
filed with the Securities and Exchange Commission, or SEC, and upon exercise of the options, such shares may be resold into the
market. We have also issued shares of common stock and warrants in connection with previous private placements. Such shares are
available for resale as well as certain of the shares of common stock issuable upon exercise of the warrants. We have also issued
shares of our common stock in the private placement and financing transaction, which are deemed to be “restricted securities,”
as that term is defined in Rule 144 promulgated under the Securities Act of 1933, as amended, or Securities Act, and such shares
may be resold pursuant to the provisions of Rule 144. For example, on June 30, 2016 we issued 904,568 restricted shares
of our common stock to three accredited investors (Precigen, the KFLP and our Chairman Dr. Telling) in a private placement. The
resale of shares acquired from us in private transactions could cause our stock price to decline significantly. In addition, the
conversion of outstanding shares of Series A and Series B convertible preferred stock issued in 2017 private placements into common
stock and the subsequent sale of shares of common stock could also cause our stock price to decline significantly.
In
addition, from time to time, certain of our shareholders may be eligible to sell all or some of their restricted shares of common
stock by means of ordinary brokerage transactions in the open market pursuant to Rule 144, subject to certain limitations. In
general, pursuant to Rule 144, after satisfying a six-month holding period: (i) affiliated shareholders, or shareholders whose
shares are aggregated, may, under certain circumstances, sell within any three-month period a number of securities which does
not exceed the greater of 1% of the then-outstanding shares of common stock or the average weekly trading volume of the class
during the four calendar weeks prior to such sale and (ii) non-affiliated shareholders may sell without such limitations, in each
case provided we are current in our public reporting obligations. Rule 144 also permits the sale of securities by non-affiliates
that have satisfied a one-year holding period without any limitation or restriction.
We
are unable to estimate the number of shares that may be sold because this will depend on the market price for our common stock,
the personal or business circumstances of sellers and other factors.
We
cannot assure you that we will continue to be listed on the NYSE American.
Our
common stock commenced trading on the NYSE American (formerly the NYSE MKT) on April 10, 2013, and we are subject to certain NYSE
American continued listing requirements and standards. We may also incur costs that we have not previously incurred for expenses
for compliance with the rules and requirements of the NYSE American. We cannot provide any assurance that we will be able to continue
to satisfy the requirements of the NYSE American’s continued listing standards.
A
delisting of our common stock from the NYSE American could negatively affect the price and liquidity of our common stock and could
impair our ability to raise capital in the future.
If
our common stock is not listed on a national securities exchange, U.S. holders of warrants may not be able to exercise their warrants
without compliance with applicable state securities laws and the value of your warrants may be significantly reduced.
If
our common stock is delisted from the NYSE America and is not eligible to be listed on another national securities exchange, the
exercise of the warrants by U.S. holders may not be exempt from state securities laws. As a result, depending on the state of
residence of a holder of the warrants, a U.S. holder may not be able to exercise its warrants unless we comply with any state
securities law requirements necessary to permit such exercise or an exemption applies. Although we plan to use our reasonable
efforts to assure that U.S. holders will be able to exercise their warrants under applicable state securities laws if no exemption
exists, there is no assurance that we will be able to do so. As a result, in the event that our common stock is delisted from
the NYSE American and is not eligible to be listed on another securities exchange, your ability to exercise your warrants may
be limited. The value of the warrants may be significantly reduced if U.S. holders are not able to exercise their warrants under
applicable state securities laws.
CAPITALIZATION
The
following table sets forth our cash and capitalization as of September 30, 2020:
on
an actual basis; and
on
an as adjusted basis to give effect to our sale in this offering of shares of common stock at $ per share and
after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
You
should read this table in conjunction with “Use of Proceeds” as well as our “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” and our consolidated financial statements, including the related
notes, incorporated by reference into this prospectus supplement and the accompanying prospectus.
|
|
As
of September 30, 2020
|
|
|
|
Actual
|
|
|
Pro
Forma
|
|
|
Pro
Forma As Adjusted (1)
|
|
|
|
|
|
|
(unaudited)
|
|
Cash
and cash equivalents
|
|
$
|
10,043,613
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders’
equity
|
|
|
9,640,345
|
|
|
|
|
|
|
|
|
|
Preferred
stock, no par value; 50,000,000 shares authorized; 9,417,000 Series A shares, 6,600,000 Series B shares and 133.483 Series
C shares issued and outstanding,
|
|
|
7,174,854
|
|
|
|
|
|
|
|
|
|
Common
stock, $0.001 par value, 200,000,000 shares authorized; 61,004,917 shares issued and outstanding,
|
|
|
61,005
|
|
|
|
|
|
|
|
|
|
Additional
paid-in capital
|
|
|
152,440,386
|
|
|
|
|
|
|
|
|
|
Accumulated
deficit
|
|
|
(150,035,900
|
)
|
|
|
|
|
|
|
|
|
Total
liabilities and shareholders’ equity
|
|
|
11,282,204
|
|
|
|
|
|
|
|
|
|
The
number of shares of our Common Stock shown above to be outstanding immediately before and after this offering is based on 61,004,917
shares outstanding as of September 30, 2020, and excludes, as of such date:
|
●
|
5,801,349
shares of our Common Stock subject to outstanding options having a weighted average exercise price of $0.90 per share;
|
|
|
|
|
●
|
2,207,901
shares of our Common Stock reserved for future issuance pursuant to our existing Equity Incentive Plan;
|
|
|
|
|
●
|
20,513,145
shares of our Common Stock issuable upon exercise of warrants outstanding, having a weighted average exercise price of $1.36
per share;
|
|
|
|
|
●
|
941,701
shares of our Common Stock issuable upon conversion of convertible Series A Preferred stock outstanding; and
|
|
|
|
|
●
|
1,320,002
shares of our Common Stock issuable upon conversion of convertible Series B Preferred stock outstanding.
|
Except
as otherwise indicated, all information included or incorporated by reference in this prospectus supplement assumes the following:
|
●
|
no exercise of
the outstanding options and warrants described above; and
|
|
|
|
|
●
|
no exercise of
the underwriter’s option to purchase additional shares.
|
USE
OF PROCEEDS
We
estimate that the net proceeds from this offering will be approximately $ after deducting our estimated offering
expenses payable by us.
We
intend to use the net proceeds from this offering primarily to continue funding, our pre-clinical development of our SARS-CoV-2
vaccine, Terra CoV-2 and our lantibiotics program and for general corporate purposes, including research and development activities,
capital expenditures and working capital. As a result, our management
will retain broad discretion in the allocation and use of the net proceeds of this offering, and investors will be relying on
the judgment of our management with regard to the use of these net proceeds. Pending application of the net proceeds for the purposes
as described above, we expect to invest the net proceeds in short-term, interest-bearing securities, investment grade securities,
certificates of deposit or direct or guaranteed obligations of the U.S. government.
DIVIDEND
POLICY
To
date, we have neither declared nor paid any dividends on our common stock nor do we anticipate that such dividends will be paid
in the foreseeable future. Rather, we intend to retain any earnings to finance the growth and development of our business. Any
payment of cash dividends on our common stock in the future will be dependent, among other things, upon our earnings, financial
condition, capital requirements and other factors which the board of directors deems relevant. In addition, restrictive covenants
contained in any financing agreements entered into in the future may preclude us from paying any dividends.
We
issued 100 shares of Series C, Non-Voting, Non-Convertible, Preferred Stock (“Series C Preferred Stock”) with a stated
value of $33,847 per share to Precigen in exchange for obligations we owed to Precigen Inc. (“Precigen”). These shares
have an accruing dividend of 12% per year payable in additional shares of Series C Preferred Stock. The accruing dividend
increased to 20% per year after May 10, 2019. In January of 2018 we paid a dividend on our Series C Preferred Stock to Precigen
of 1.733 shares for the portion of the 2017 fiscal year that the Series C Preferred Stock was outstanding and in January
of 2019, we paid a dividend on our Series C Preferred Stock to Precigen of 12.208 shares. On January 27, 2020 we paid a dividend
on our Series C Preferred Stock to Precigen of 19.542 shares of additional Series C Preferred Stock. As a result of the recent
sale by Precigen of its equity interest in Oragenics to TS Biotechnology LLC, future dividend payments will be paid to
TS Biotechnology.
DILUTION
If
you invest in our securities, your interest will be diluted to the extent of the difference between the public offering price
per share you pay in this offering and the net tangible book value per share of our common stock immediately after this offering.
Our
net tangible book value as of September 30, 2020 was $9,640,345, or approximately $0.16 per share. Net tangible
book value per share is equal to the amount of our total tangible assets, less total liabilities (excludes 100 shares of Series
C Preferred Stock with a stated value of $3,384,799), divided by the aggregate number of shares of our common stock outstanding
as of September 30, 2020. Dilution in net tangible book value per share represents the difference between the public offering
price per share of our common stock in this public offering and the net tangible book value per share of our common stock immediately
after this offering.
After
giving effect to the sale of shares of our common stock in this offering at the public
offering price of $ per share and after deducting the estimated underwriting discounts and commissions
and estimated offering expenses payable by us, our as adjusted net tangible book value as of September 30, 2020 would have been
approximately $ million, or $ per share. This represents an immediate increase in net tangible book value
of $ per share to existing stockholders and immediate dilution in net tangible book value of $ per share
to new investors purchasing our common stock in this offering at the public offering price. The following table illustrates this
dilution on a per share basis:
Offering
price per share
|
|
$
|
|
|
|
|
|
|
|
Net
tangible book value per share as of September 30, 2020
|
|
$
|
0.16
|
|
Increase/Decrease
in net tangible book value per share attributable to new investors
|
|
$
|
|
|
|
|
|
|
|
As
adjusted, net tangible book value per share as of September 30, 2020 after giving effect to this offering
|
|
$
|
|
|
|
|
|
|
|
Dilution
per share to new investors in this offering
|
|
$
|
|
|
The
above discussion and table are based on 61,004,917 shares of our common stock outstanding as of September 30, 2020 and excludes
the shares of common stock issuable upon the conversion of our outstanding preferred stock and the shares of common stock issuable
upon the exercise of outstanding options and warrants, including the following securities:
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●
|
5,801,349
shares of our Common Stock subject to outstanding options having a weighted average exercise price of $0.90 per share;
|
|
|
|
|
●
|
2,207,901
shares of our Common Stock reserved for future issuance pursuant to our existing Equity Incentive Plan;
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|
|
|
|
●
|
20,513,145
shares of our Common Stock issuable upon exercise of warrants outstanding, having a weighted average exercise price of $1.36
per share;
|
|
|
|
|
●
|
941,701
shares of our Common Stock issuable upon conversion of convertible Series A Preferred stock outstanding; and
|
|
|
|
|
●
|
1,320,002
shares of our Common Stock issuable upon conversion of convertible Series B Preferred stock outstanding.
|
The
above illustration of dilution per share to the investors participating in this offering assumes no exercise of outstanding preferred
shares or options or warrants to purchase shares of our common stock. To the extent that options, warrants or preferred shares
outstanding as of September 30, 2020 or issued thereafter have been or may be exercised or converted or other shares issued, the
investors purchasing shares of our common stock in this offering may experience further dilution. In addition, we may choose
to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for
our current or future operating plans. To the extent that additional capital is raised through the sale of equity or convertible
debt securities, the issuance of these securities could result in further dilution to our stockholders.
UNDERWRITING
Under
the terms and subject to the conditions in an underwriting agreement dated the date of this prospectus supplement, the underwriter
named below has agreed to purchase, and we have agreed to sell to the underwriter, the number of shares of common stock indicated
below.
Underwriter
|
|
Number of Shares
|
|
A.G.P./Alliance Global Partners
|
|
|
|
|
Total
|
|
|
|
|
The
underwriter is offering the shares of common stock subject to its acceptance of the shares from us and subject to prior sale.
The underwriting agreement provides that the obligations of the underwriter to pay for and accept delivery of the shares of common
stock offered by this prospectus supplement are subject to the approval of certain legal matters by its counsel and to certain
other conditions. The underwriter is obligated to take and pay for all of the shares of common stock offered by this prospectus
supplement if any such shares are taken. However, the underwriter is not required to take or pay for the shares covered by the
underwriter’s over-allotment option described below.
The
underwriter initially proposes to offer part of the shares of common stock directly to the public at the offering price listed
on the cover page of this prospectus supplement and part to certain dealers. After the initial offering of the shares of common
stock, the offering price, and other selling terms may from time to time be varied by the underwriter.
We
have granted to the underwriter an option, exercisable for 45 days from the date of this prospectus supplement, to purchase additional
shares of common stock at the public offering price listed
on the cover page of this prospectus supplement, less underwriting discounts and commissions. To the extent the option is exercised,
the underwriter will become obligated, subject to certain conditions, to purchase about the same percentage of the additional
shares of common stock as the number listed next to the underwriter’s name in the preceding table bears to the total number
of shares of common stock listed next to the name of the underwriter in the preceding table.
|
|
Per
Share
|
|
|
Total
Without Over-Allotment
|
|
|
Total
With Over-Allotment
|
|
Public offering price
|
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|
|
|
|
|
|
|
|
|
|
|
Underwriting discounts and commissions
|
|
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|
|
|
|
|
|
|
|
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|
Proceeds, before expenses, to us
|
|
|
|
|
|
|
|
|
|
|
|
|
The
estimated offering expenses payable by us, exclusive of underwriting discounts and commissions, are approximately $
.
Our
common stock is listed on the NYSE American under the symbol “OGEN.”
We
and our directors and executive officers have agreed that, subject to certain exceptions, without the prior written consent of
A.G.P./Alliance Global Partners, we, and each of our directors and executive officers will not,
for a period of 90 days following the date of this prospectus supplement:
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●
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offer,
pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any
option, right or warrant to purchase, lend or otherwise transfer or dispose of, directly or indirectly, any shares of common
stock or any securities convertible into or exercisable or exchangeable for shares of common stock;
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●
|
file
any registration statement with the SEC relating to the offering of any shares of common stock, or any securities convertible
into or exercisable or exchangeable for shares of common stock; or
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●
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enter
into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership
of the shares of common stock, whether any such transaction is to be settled by delivery of shares of common stock or such
other securities, in cash or otherwise.
|
In
order to facilitate the offering of the shares of common stock, the underwriter may engage in transactions that stabilize, maintain
or otherwise affect the price of the shares of common stock. Specifically, the underwriter may sell more shares than it is obligated
to purchase under the underwriting agreement, creating a short position. A short sale is covered if the short position is No greater
than the number of shares available for purchase by the underwriter under the option to purchase additional shares. The underwriter
can close out a covered short sale by exercising the option to purchase additional shares or by purchasing shares in the open
market. In determining the source of shares to close out a covered short sale, the underwriter will consider, among other things,
the open market price of shares compared to the price available under the option to purchase additional shares. The underwriter
may also sell shares in excess of the option to purchase additional shares, creating a naked short position. The underwriter must
close out any naked short position by purchasing shares in the open market. A naked short position is more likely to be created
if the underwriter is concerned that there may be downward pressure on the price of the shares of common stock in the open market
after pricing that could adversely affect investors who purchase in this offering. As an additional means of facilitating this
offering, the underwriter may bid for, and purchase, shares of common stock in the open market to stabilize the price of the shares
of common stock. These activities may raise or maintain the market price of the shares of common stock above independent market
levels or prevent or retard a decline in the market price of the shares of common stock. The underwriter is not required to engage
in these activities and may end any of these activities at any time.
We
and the underwriter have agreed to indemnify each other against certain liabilities, including liabilities under the Securities
Act.
A
prospectus in electronic format may be made available on websites maintained by the underwriter, or selling group members, if
any, participating in this offering. The underwriter may allocate a number of shares of common stock for sale to its online brokerage
account holders. Internet distributions will be allocated by the underwriter that may make Internet distributions on the same
basis as other allocations.
The
underwriter has in the past provided investment banking and advisory services to us and our affiliates in the ordinary course
of business for which it has received compensation for such services. The underwriter may in the future provide investment banking
and advisory services to us and our affiliates in the ordinary course of business for which it may receive compensation for such
services.
Selling
Restrictions
This
prospectus supplement does not constitute an offer to sell to, or a solicitation of an offer to buy from, anyone in any country
or jurisdiction (i) in which such an offer or solicitation is not authorized, (ii) in which any person making such offer or solicitation
is not qualified to do so or (iii) in which any such offer or solicitation would otherwise be unlawful. No action has been taken
that would, or is intended to, permit a public offer of the securities or possession or distribution of this prospectus supplement
or any other offering or publicity material relating to the securities in any country or jurisdiction (other than the United States)
where any such action for that purpose is required. Accordingly, the underwriter has undertaken that it will not, directly or
indirectly, offer or sell any securities or have in its possession, distribute or publish any prospectus supplement, form of application,
advertisement or other document or information in any country or jurisdiction except under circumstances that will, to the best
of its knowledge and belief, result in compliance with any applicable laws and regulations and all offers and sales of securities
by it will be made on the same terms.
LEGAL
MATTERS
The
validity of the issuance of the securities offered hereby will be passed upon for us by Shumaker, Loop & Kendrick, LLP. Certain
legal matters in connection with the offering will be passed upon for the underwriter by McDermott Will & Emery LLP.
EXPERTS
The
financial statements incorporated in this prospectus by reference from the Company’s Annual Report on Form 10-K have been
audited by Mayer Hoffman McCann P.C., an independent registered public accounting firm, as stated in their report (which report
includes an explanatory paragraph relating to the Company’s ability to continue as a going concern), which is incorporated
herein by reference. Such financial statements have been so incorporated in reliance upon the report of such firm given upon their
authority as experts in accounting and auditing Mayer Hoffman McCann P.C. has no interest in the shares being registered in this
filing.
WHERE
YOU CAN FIND MORE INFORMATION
We
are a public company and file annual, quarterly and current reports, proxy statements and other information with the Securities
and Exchange Commission (“SEC”).You can request copies of these documents by writing to the SEC and paying a fee for
the copying cost. Our SEC filings are also available to the public at the SEC’s web site at http://www.sec.gov.
In
addition, we maintain a web site that contains information regarding our company, including copies of reports, proxy statements
and other information we file with the SEC. The address of our web site is www.oragenics.com. Except for the documents specifically
incorporated by reference into this prospectus, information contained on our website or that can be accessed through our website
does not constitute a part of this prospectus. We have included our website address only as an inactive textual reference and
do not intend it to be an active link to our website.
This
prospectus supplement and the accompanying prospectus are part of a registration statement on Form S-3 that we filed with the
SEC registering the securities that may be offered and sold hereunder. The registration statement, including exhibits thereto,
contains additional relevant information about us and these securities that, as permitted by the rules and regulations of the
SEC, we have not included in this prospectus supplement or the accompanying prospectus. A copy of the registration statement can
be obtained at the address set forth above. You should read the registration statement for further information about us and these
securities.
INFORMATION
INCORPORATED BY REFERENCE
In
this document, we “incorporate by reference” certain information we file with the SEC, which means that we can disclose
important information to you by referring to that information. The information incorporated by reference is considered to be a
part of this prospectus supplement. Any statement contained in a document incorporated by reference herein shall be deemed to
be modified or superseded for all purposes to the extent that a statement contained in this prospectus supplement or in any other
subsequently filed document that is also incorporated or deemed to be incorporated by reference, modifies or supersedes such statement.
Any statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this
prospectus supplement. We incorporate by reference the documents listed below (other than, in each case, documents or information
deemed to be furnished and not filed in accordance with SEC rules):
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Our
Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 4, 2020;
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Our
Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020 and September 30, 2020, filed with the
SEC on May 15, 2020, August 14, 2020 and November 10, 2020;
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●
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Our
Current Reports on Form 8-K, filed with the SEC on February 7, 2020, March 13, 2020, April 15, 2020, May 4, 2020, May 8, 2020,
May 29, 2020, June 5, July 10, 2020, July 22, 2020, July 27, 2020, August 14, 2020, August 18, 2020, August 20, 2020, August
24, 2020, September 11, 2020, September 28, 2020, October 6, 2020 and November 10, 2020.
|
We
hereby undertake to provide without charge to each person, including any beneficial owner, to whom a copy of this prospectus supplement
is delivered, upon written or oral request of any such person, a copy of any and all of the information that has been or may be
incorporated by reference in this prospectus supplement, including any exhibits that are specifically incorporated by reference
in such documents. Requests for such copies should be directed as follows:
Oragenics,
Inc.
4902
Eisenhower Boulevard, Suite 125
Tampa,
Florida 33634
Attention:
Investor Relations
Phone:
(813) 276-7900
PROSPECTUS
$50,000,000
Common
Stock
Warrants
Units
From
time to time, we may offer, issue and sell up to $50,000,000 of any combination of the securities described in this prospectus.
We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities
registered hereunder, including any applicable antidilution provisions.
This
prospectus provides you with a general description of the securities we may offer. Each time we offer securities, we will provide
the specific terms of these offerings and securities in one or more supplements to this prospectus. We may also authorize one
or more free writing prospectuses to be provided to you in connection with these offerings. The prospectus supplement and any
related free writing prospectus may also add, update or change information contained in this prospectus. You should carefully
read this prospectus, the applicable prospectus supplement and any related free writing prospectus, as well as any documents incorporated
by reference, before buying any of the securities being offered.
Our
common stock is listed on the NYSE American under the symbol “OGEN.” The last reported sale price of our common stock
on December 27, 2019 was $0.527 per share. The applicable prospectus supplement will contain information, where applicable, as
to any other listing, if any, on the NYSE American or any securities market or other exchange of the securities covered by the
applicable prospectus supplement.
As
of December 27, 2019, the aggregate market value of our outstanding common stock held by non-affiliates, or the public float,
was approximately $27,351,030, which was calculated based on 44,114,566 shares of our outstanding common stock held by non-affiliates
and on a price of $0.62 per share, the last reported sale price for our common stock on November 29, 2019. Pursuant to General
Instruction I.B.6 of Form S-3, in no event will we sell our securities in a public primary offering with a value exceeding one-third
of our public float in any 12-month period unless our public float subsequently rises to $75.0 million or more.
Investing
in our securities involves a high degree of risk. You should review carefully the risks and uncertainties described under the
heading “Risk Factors” contained in the applicable prospectus supplement and any related free writing prospectus,
and under similar headings in the other documents that are incorporated by reference into this prospectus.
This
prospectus may not be used to consummate a sale of any securities unless accompanied by a prospectus supplement.
The
securities may be sold directly by us to investors, through agents designated from time to time or to or through underwriters
or dealers, on a continuous or delayed basis. For additional information on the methods of sale, you should refer to the section
entitled “Plan of Distribution” in this prospectus and in the applicable prospectus supplement. If any agents or underwriters
are involved in the sale of any securities with respect to which this prospectus is being delivered, the names of such agents
or underwriters and any applicable fees, commissions, discounts and over-allotment options will be set forth in a prospectus supplement.
The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth
in a prospectus supplement.
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.
The
date of this prospectus is , 2019.
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission, or SEC,
utilizing a “shelf” registration process. Under this shelf registration statement, we may, from time to time, sell
any combination of the securities referred to herein in one or more offerings for total gross proceeds of up to $50,000,000. This
prospectus provides you with a general description of the securities we may offer.
Until
such time, if ever, as we are eligible to use General Instruction I.B.1. of Form S-3, pursuant to General Instruction I.B.6. of
Form S-3, we are permitted to use the registration statement of which this prospectus forms a part to sell, via a primary offering,
a maximum amount of securities equal to one-third of the aggregate market value of our outstanding voting and non-voting common
equity held by non-affiliates of our company in any twelve month period.
Each
time we offer a type or series of securities under this prospectus, we will provide a prospectus supplement that will contain
more specific information about the terms of the offered securities. We also may authorize one or more free writing prospectuses
to be provided to you that may contain material information relating to these offerings. This prospectus, together with applicable
prospectus supplements and any related free writing prospectuses, includes all material information relating to these offerings.
We also may add, update or change, in the prospectus supplement and in any related free writing prospectus that we may authorize
to be provided to you, any of the information contained in this prospectus or in the documents that we have incorporated by reference
into this prospectus. We urge you to read carefully this prospectus, any applicable prospectus supplement and any related free
writing prospectus, together with the information incorporated herein by reference as described under the section entitled “Where
You Can Find Additional Information” and “Incorporation of Certain Information by Reference” in this prospectus,
before buying any of the securities being offered. THIS PROSPECTUS MAY NOT BE USED TO CONSUMMATE A SALE OF SECURITIES UNLESS
IT IS ACCOMPANIED BY A PROSPECTUS SUPPLEMENT.
You
should rely only on the information that we have provided or incorporated by reference in this prospectus, any applicable prospectus
supplement and any related free writing prospectus that we may authorize to be provided to you. We have not authorized any other
person to provide you with different or additional information. No dealer, salesperson or other person is authorized to give any
information or to represent anything not contained in this prospectus, any applicable prospectus supplement or any related free
writing prospectus that we may authorize to be provided to you. You must not rely on any unauthorized information or representation.
This prospectus, any applicable supplement to this prospectus or any related free writing prospectus do not constitute an offer
to sell or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do
this prospectus, any applicable supplement to this prospectus or any related free writing prospectus constitute an offer to sell
or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer
or solicitation in such jurisdiction.
You
should not assume that the information appearing in this prospectus, any applicable prospectus supplement or any related free
writing prospectus is accurate on any date subsequent to the date on the front of the document and that any information we have
incorporated by reference is accurate the date of the document incorporated by reference, regardless of the time of delivery of
this prospectus, any applicable prospectus supplement or any related free writing prospectus or any sale of a security. Our business,
financial condition, results of operations and prospectus may have changed since those dates.
This
prospectus contains and incorporates by reference market data, industry statistics and other data that have been obtained from,
or compiled from, information made available by third parties. We have not independently verified their data. This prospectus
and the information incorporated herein by reference include trademarks, service marks and trade names owned by us or other companies.
All trademarks, service marks and trade names included or incorporated by reference into this prospectus, any applicable prospectus
supplement or any related free writing prospectus are the property of their respective owners.
This
prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made
to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents.
Copies of some of the documents referred to herein have been filed, will be filed, or will be incorporated by reference as exhibits
to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below
under the section entitled “Where You Can Find Additional Information” and “Incorporation of Certain Information
by Reference.”
PROSPECTUS
SUMMARY
The
items in the following summary are described in more detail elsewhere in this prospectus and in the documents incorporated by
reference herein. This summary provides an overview of selected information and does not contain all the information you should
consider before investing in our common stock. Therefore, you should read the entire prospectus and any free writing prospectus
that we have authorized for use in connection with this offering carefully, including the “Risk Factors” section and
other documents or information included or incorporated by reference in this prospectus before making any investment decision.
Unless
otherwise mentioned or unless the context requires otherwise, all references in this prospectus to “Oragenics” the
“Company,” “we,” “our” and “us” or similar references mean Oragenics, Inc. When
we refer to “you,” we mean the holders of the applicable securities.
Overview
We
are focused on becoming a leader in novel antibiotics against infectious disease and on developing effective treatments for oral
mucositis.
Our
Oral Mucositis Product Candidate-Clinical
In
June of 2015, we entered into a worldwide Exclusive Channel Collaboration Agreement (“Oral Mucositis ECC”) with Intrexon
Corporation (“Intrexon”) and Intrexon Actobiotics NV, a wholly-owned subsidiary of Intrexon, pursuant to which we
obtained certain exclusive rights to AG013 as a potential treatment of oral mucositis, or OM for cancer patients, which we intend
to continue to develop. AG013, is an oral rinsing solution system designed to deliver human Trefoil Factor 1 (hTFF1) to protect
and regenerate damaged mucosal lining of the oral cavity.
OM
results in a painful inflammation and mucosal ulceration in the lining of the oral cavity, throat and esophagus and is one of
the most commonly reported adverse events associated with cancer chemotherapy. Approximately 770,000 patients annually in the
US are at an increased risk of developing OM according to cancer statistics provided by the Center for Disease Control (CDC) in
2017. OM has a negative effect on patient well-being and if severe, negatively affects adherence to a patient’s cancer treatment
regimen. At present, we are not aware of any drug that is approved to prevent the condition broadly and current therapies are
primarily palliative in nature, only addressing symptom relief but not treating the underlying causes of the condition.
AG013
has been granted Orphan Drug status in the European Union. In November of 2016, the United States Food and Drug Administration
(the “FDA”) granted Fast Track designation for AG013, and we believe it may be eligible for Biologic License Application
(“BLA”) exclusivity as well. The FDA’s fast track therapy designation program is intended to facilitate the
development and expedite the review of drug candidates intended for the treatment of serious or life-threatening conditions and
that demonstrate the potential to address unmet medical needs for those conditions. Under this program, FDA can, for example,
review portions of a New Drug Application or BLA for a drug candidate before the entire application is complete, thus potentially
beginning the review process at an earlier time.
In
a Phase 1b clinical trial in 25 cancer patients with OM, AG013 was safe and well tolerated. Data published in the journal Cancer
showed a 35% reduction of the duration of ulcerative OM in the AG013-treated patients versus the placebo-treated patients.
Furthermore, close to 30% of the patients treated with AG013 were full responders while all placebo-treated patients developed
ulcerative OM. Additionally, in a Phase 1 pharmacokinetic (PK) study in 10 healthy volunteers, AG013 bacteria adhered to the buccal
mucosa and actively secrete protein locally, resulting in homogeneous exposure of the entire mucosal surface up to 24 hours after
administration of the rinse.
We
developed a Phase 2 protocol for AG013 with the FDA under the fast track designation. In August of 2016, we received feedback
from the FDA in response to our Type C meeting and the pursuit of a Phase 2 trial on AG013 for the treatment of oral mucositis
in head and neck cancer patients. We filed an Investigational New Drug (“IND”) update in March 2017 and we initiated
the Phase 2 study with AG013 in the United States in 2017 and in Europe in 2018. The Phase 2 trial was a double-blind, placebo-controlled,
2-arm, multi-center trial in which approximately 200 patients were randomized in a 1:1 ratio to receive either a placebo or AG013
following meals, beginning on the first day of chemoradiation therapy and continuing through the course of cancer treatment. The
study enrolled patients receiving chemoradiation for treatment of head and neck cancer for 7 to 9 weeks. The clinical trial was
conducted at clinical sites across the United States and Europe. The purpose of the Phase 2 study (NCT03234465) is to evaluate
the efficacy (preventing the occurrence and shortening the duration of severe oral mucositis (“SOM”), safety and tolerability
of topically administered AG013 rinse compared to the placebo for reducing the incidence and severity of OM in patients undergoing
traditional chemoradiation for the treatment of head and neck cancer. Key efficacy measures include collection of data regarding
the duration, time to development, and overall incidence of OM (World Health Organization scale used) during the active treatment
phase, beginning from the start of chemoradiation therapy until 2 weeks following its completion.
On
December 2, 2019 we announced completion of enrollment in our Phase 2 clinical trial. We expect to release top line results from
the trial in the first half of 2020.
An
interim safety analysis was requested by the FDA on patients from our Phase 2 clinical trial of AG013 for the treatment of OM.
We completed enrollment of the interim safety analysis cohort, which included 24 randomized patients in our Phase 2 clinical trial
of AG013 for the treatment OM. Nineteen of those patients were included in the unblinded safety evaluation, of which 10 received
AG013. We announced positive results from our interim safety analysis in May, 2018. The study provided information that, we believe,
likely indicates that the overall incidence of severe OM is less than would be anticipated in the general head and neck cancer
population.
Safety
was evaluated on the basis of treatment-emergent adverse events, vital signs, weight, physical examinations, clinical laboratory
assessments and the presence of AG013 in whole blood. Tolerability measures (taste, consistency and smell) were collected from
the patient diaries. In addition, the reasons for study treatment discontinuation were also summarized. Following review of the
data by an independent Data Safety Monitoring Board (DSMB), it was concluded that the clinical trial can proceed with no changes
to the study. The data analysis indicated that the distribution of adverse events was similar between AG013 and placebo. The serious
adverse events reported were consistent with those commonly reported in a head and neck cancer population receiving traditional
chemoradiation therapy treatments and included fevers, neutropenia, anemia, nausea and vomiting, infections and oral (mouth and
throat) pain and there were no reports of AG013 related bacteremia or sepsis. Of patients that discontinued participation in the
clinical study, 4 patients experienced adverse events, including 3 patients who developed nausea and vomiting, 2 patients that
were non-compliant with the study procedures and 3 patients developed severe OM.
The
DSMB met again in September 2019 and reviewed safety data on the first 100 patients who completed the trial and determined that
the clinical trial could continue with no adjustments or further review.
On
September 30, 2019, we made a poster presentation at the European Society for Medical Oncology Congress where we announced initial
blinded blended data from our Phase 2, placebo-controlled, clinical trial of AG013 in oral mucositis. The presentation described
the methods and initial blinded results from the ongoing Phase 2 clinical trial for our lead oral mucositis product candidate,
AG013. The initial blinded data, submitted in the abstract, reflected the results for 42 of the 71 enrolled and randomized patients
across 48 study sites who had completed their treatment course and demonstrated that in the blinded, combined placebo and active
treatment groups, there was sufficient evidence of efficacy and safety to continue the study. Additional data accumulated since
poster submission, indicated the blinded efficacy evaluation, which included any patient with SOM after week one of treatment
and those receiving a cumulative dose of 55 Gy (week 6 of treatment), demonstrated an overall SOM incidence of 47%, which we believe
is lower than would be expected based on historical data in the head and neck cancer population receiving this chemoradiation
regimen. The overall rate of SOM was reported in only 13.1% (110 of 842) of evaluable visits. The overall safety profile continues
to be consistent with those adverse events that normally occur in cancer patients receiving chemoradiation therapy. The study,
however, remains blinded and individual treatment responses remain to be identified.
Our
Antibiotic Product Candidate-Preclinical
Members
of our scientific team discovered that a certain bacterial strain produces MU1140, a molecule belonging to the novel class of
antibiotics known as lantibiotics. Lantibiotics, such as MU1140, are highly modified peptide antibiotics made by a small group
of Gram-positive bacterial species. Approximately 60 lantibiotics have been discovered, to date. We believe lantibiotics are generally
recognized by the scientific community to be potent antibiotic agents.
In
nonclinical testing, MU1140 has shown activity against all Gram-positive bacteria against which it has been tested, including
those responsible for a number of healthcare associated infections, or HAIs. A high percentage of hospital-acquired infections
are caused by highly resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) or multidrug-resistant Gram-negative
bacteria. We believe the need for novel antibiotics is increasing as a result of the growing resistance of target pathogens to
existing FDA approved antibiotics on the market.
Lantibiotics
have been difficult to investigate for their clinical usefulness as therapeutic agents in the treatment of infectious diseases
due to a general inability to produce or synthesize sufficient quantities of pure amounts of these molecules. Traditional fermentation
methods can only produce minute amounts of the lantibiotic.
In
June 2012, we entered into the Lantibiotic Exclusive Channel Collaboration agreement (“Lantibiotic ECC”) with Intrexon
for the development and commercialization of the native strain of MU1140 and related homologs using Intrexon’s advanced
transgene and cell engineering platforms. Through our work with Intrexon, we have been able to produce a significant increase
in the fermentation titer of MU1140 compared to standard fermentation methods and have discovered a new purification process for
MU1140. Our work with Intrexon generated a substantial number of homologs of MU1140, and we are continuing our research and development
and collaboration efforts with Intrexon to develop potential derivatives of the MU1140 molecule using genetically modified bacteria.
In
our pre-clinical studies to support a potential IND filing with the FDA, we tested a total of six homologs of MU1140 for certain
compound characteristics, including but not limited to: drug activity (based on minimum inhibitory concentration or “MIC”)
equal or better than “standard of care” drugs against certain drug-resistant bacteria, safety, toxicity, stability,
and manufacturability. An animal study specifically evaluated homolog efficacy in relation to survival, measurable amounts of
Clostridium difficile (“C. diff”) colony forming units, and toxin levels. Three homologs demonstrated promising
results with one homolog, OG253 achieving a 100% survival rate throughout the entire study in contrast to an approximately 30%
survival rate for the vancomycin positive control.
Based
on these early results, we selected a lead candidate, OG253, for which we had a pre-IND meeting with the FDA in November of 2015
regarding the pursuit of an IND for OG253. Following additional research and development on second generation lantibiotics, in
August of 2016, we opted to select a second generation lantibiotic, OG716, for treatment of C. diff as our new lead candidate.
OG716 is a new, orally-active homolog, that has exhibited positive results in an animal model for potential treatment of C.
diff. Generated from our MU1140 platform, this new lantibiotic showed promising efficacy in reducing clinically relevant C.
diff infections as measured by increased animal survival and decreased relapse as well as reduced production of toxins A &
B and C. diff spores when compared to a vancomycin positive control.
The
timing of the filing of an IND regarding OG716 is subject to our having sufficient available capital given all of our anticipated
needs and expected requirements in connection with our ongoing research and development initiatives. We expect the IND for a first-in-human
clinical study of OG716 to be filed with the FDA following our completion of the requisite studies, which we commenced in October
of 2019.
Other
Product Candidates and Technologies.
In
addition to our lantibiotics and oral mucositis product candidates, we also have other candidates and technologies in the oral
care and weight loss areas. We do not intend to continue to develop these potential product candidates and technologies without
partnering with a third party. We out-licensed the continued research and development of our weight loss product candidate in
December 2013 to, LPThera LLC, and LPThera LLC continues to work to develop a product for commercial use in pets. Our oral care
product candidate SMaRT Replacement Therapy is positioned for out-licensing opportunities.
Corporate
and Other Information
We
were incorporated in November 1996 and commenced operations in 1999. We consummated our initial public offering in June 2003.
We have devoted substantially all of our available resources to the commercialization of our products as well as our discovery
efforts comprising research and development, clinical trials for our product candidates, protection of our intellectual property
and the general and administrative support of these operations. We have generated limited revenues from grants and product sales
through June 30, 2016, and have principally funded our operations through the sale of debt and equity securities, including the
exercise of warrants issued in connection with these financing transactions. In June of 2016, we completed the sale of our consumer
probiotics business to ProBiora Health, LLC and as a result, we will no longer generate revenue from sales of consumer probiotic
products.
As
of September 30, 2019, we had an accumulated deficit of $123,755,548 and we have yet to achieve profitability. We incurred net
losses of $11,968,726 and $7,158,521 for the nine months ended September 30, 2019 and 2018, respectively, and we incurred net
losses of $9,914,141 and $6,731,525 for the years ended December 31, 2018 and 2017, respectively. We expect to incur significant
and increasing operating losses for the foreseeable future as we seek to advance our product candidates through preclinical testing
and clinical trials to ultimately obtain regulatory approval and eventual commercialization. We will need to raise additional
capital. Adequate additional funding may not be available to us on acceptable terms, or at all. We expect that research and development
expenses will increase along with general and administrative costs, as we seek to grow and continue to operate our business. There
can be no assurance that additional capital will be available to us on acceptable terms, if at all.
Our
executive office is located at, 4902 Eisenhower Boulevard, Suite 125 Tampa, Florida, 33634 and our research facilities are located
at 13700 Progress Boulevard, Alachua, Florida 32615. Our telephone number is (813) 286-7900 and our website is http://www.oragenics.com.
Information on, or that can be accessed through, our website is not part of this prospectus and should not be relied on in connection
with this offering.
For
a complete description of our business, financial condition, results of operations and other important information, we refer you
to our filings with the Securities and Exchange Commission (the “SEC”) that are incorporated by reference in this
prospectus, including our Annual Report on Form 10-K for the year ended December 31, 2018. For instructions on how to find copies
of these documents, see “Where You Can Find Additional Information” and “Incorporation of Certain Information
by Reference.”
SECURITIES
WE MAY OFFER
We
may offer shares of our common stock, warrant shares of our common stock to purchase, either individually or in combination, and/or
units consisting of some or all of such securities for total gross proceeds of up to $50.0 million, from time to time under this
prospectus, together with the applicable prospectus supplement and any related free writing prospectus, at prices and on terms
to be determined by market conditions at the time of any offering. This prospectus provides you with a general description of
the securities we may offer. Each time we offer a type or series of securities under this prospectus, we will provide a prospectus
supplement that will describe the specific amounts, prices and other important terms of the securities being offered, including
to the extent applicable:
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designation
or classification;
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aggregate
principal amount or aggregate offering price;
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maturity;
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original
issue discount, if any;
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rates
and times of payment of interest or dividends, if any;
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redemption,
conversion, exchange or sinking fund terms, if any;
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conversion
or exchange prices or rates, if any, and, if applicable, any provisions for changes to or adjustments in the conversion or
exchange prices or rates and in the securities or other property receivable upon conversion or exchange;
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ranking;
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restrictive
covenants, if any;
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voting
or other rights, if any; and
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important
U.S. federal income tax considerations.
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The
applicable prospectus supplement and any related free writing prospectus that we may authorize to be provided to you may also
add, update or change information contained in this prospectus or in documents we have incorporated by reference. However, no
prospectus supplement or free writing prospectus will offer a security that is not registered and described in this prospectus
at the time of the effectiveness of the registration statement of which this prospectus is a part.
This
prospectus may not be used to consummate a sale of securities unless it is accompanied by a prospectus supplement.
We
may sell the securities directly to investors or through underwriters, dealers or agents. We, and our underwriters or agents,
reserve the right to accept or reject all or part of any proposed purchase of securities. If we do offer securities through underwriters
or agents, we will include in the applicable prospectus supplement:
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the
names of those underwriters or agents;
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applicable
fees, discounts and commissions to be paid to them;
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details
regarding over-allotment options, if any; and
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the
estimated net proceeds to us.
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Common
Stock. We may issue shares of our common stock from time to time. Holders of our common stock are entitled to one vote
for each share held on all matters submitted to a vote of stockholders and do not have cumulative voting rights. An election of
directors by our stockholders shall be determined by a plurality of the votes cast by the stockholders entitled to vote on the
election. Holders of common stock are entitled to receive ratably any dividends as may be declared by our board of directors,
subject to any preferential dividend rights of any series of preferred stock that we may designate and issue in the future.
In
the event of our liquidation, dissolution or winding up, the holders of common stock are entitled to receive ratably our net assets
available for distribution to stockholders after the payment of all debts and other liabilities and subject to the prior rights
of any outstanding preferred stock. Holders of common stock have no preemptive, subscription, redemption or conversion rights.
There are no redemption or sinking fund provisions applicable to the common stock. The rights, preferences and privileges of holders
of common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of preferred
stock that we may designate and issue in the future.
Warrants.
We may issue warrants for the purchase of common stock, in one or more series. We may issue warrants independently or together
with common stock, and the warrants may be attached to or separate from these securities. In this prospectus, we have summarized
certain general features of the warrants. We urge you, however, to read the applicable prospectus supplement (and any free writing
prospectus that we may authorize to be provided to you) related to the particular series of warrants being offered, as well as
the complete warrant agreements and warrant certificates that contain the terms of the warrants. Forms of the warrant agreements
and forms of warrant certificates containing the terms of the warrants that may be offered have been filed as exhibits to the
registration statement of which this prospectus is a part, and supplemental warrant agreements and forms of warrant certificates
will be filed as exhibits to the registration statement of which this prospectus is a part or will be incorporated by reference
from reports that we file with the SEC before the issuance of such warrants.
Any
warrants issued under this prospectus will be evidenced by warrant certificates. Warrants may be issued under an applicable warrant
agreement that we enter into with a warrant agent. We will indicate the name and address of the warrant agent, if applicable,
in the prospectus supplement relating to the particular series of warrants being offered.
RISK
FACTORS
Investing
in our securities involves a high degree of risk. You should carefully review the risks and uncertainties described under the
heading “Risk Factors” contained in the applicable prospectus supplement and any related free writing prospectus,
and under similar headings in our Annual Report on Form 10-K for the year ended December 31, 2018, as updated by any subsequently
filed periodic reports and other documents that are incorporated by reference into this prospectus, before deciding whether to
purchase any of the securities being registered pursuant to the registration statement of which this prospectus is a part. Each
of the risk factors described in the documents referenced above could adversely affect our business, operating results and financial
condition, as well as adversely affect the value of an investment in our securities, and the occurrence of any of these risks
might cause you to lose all or part of your investment. Additional risks not presently known to us or that we currently believe
are immaterial may also significantly impair our business operations.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the documents incorporated by reference herein contain forward-looking statements. These are based on our management’s
current beliefs, expectations and assumptions about future events, conditions and results and on information currently available
to us. Discussions containing these forward-looking statements may be found, among other places, in the sections entitled “Business,”
“Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
contained in the documents incorporated by reference herein.
Any
statements in this prospectus, or incorporated herein, about our expectations, beliefs, plans, objectives, assumptions or future
events or performance are not historical facts and are forward-looking statements. Within the meaning of Section 27A of the Securities
Act and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, these forward-looking statements
include statements regarding:
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timing, progress and results of clinical trials of our Oral Mucositis therapy and other product candidates, including statements
regarding the timing of initiation and completion of preclinical studies or clinical trials or related preparatory work, the
period during which the results of the trials will become available and our research and development programs;
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the
timing of any submission of filings for regulatory approval of our product candidates and our ability to obtain and maintain
regulatory approvals for our product candidates for any indication;
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our
expectations regarding the potential benefits, activity, effectiveness and safety of our product candidates;
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our
expectations regarding the size of the patient populations, market acceptance and opportunity for and clinical utility of
our product candidates, if approved for commercial use;
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our
manufacturing capabilities and strategy, including the, scalability and commercial viability of our manufacturing methods
and processes;
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expectations regarding the scope of any approved indications for our product candidates;
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ability to successfully commercialize our product candidates;
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the
potential benefits of and our ability to maintain our relationships and collaborations with Intrexon and other potential collaboration
or strategic relationships;
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our
ability to use our Oral Mucositis and Lantibiotic platforms to develop future product candidates;
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our
estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional
funding;
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ability to identify, recruit and retain key personnel;
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our
ability to protect and enforce our intellectual property position for our product candidates, and the scope of such protection;
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financial performance;
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our
inability to achieve success in our identification of lantibiotic homologs or the manufacture and nonclinical testing of our
lantibiotic product candidates.
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we
are subject to extensive and costly regulation by the Food and Drug Administration, which must approve our product candidates
in development and could restrict or delay the future commercialization of certain of our product candidates.
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our
ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of our product candidates
and commercialize any approved products on our expected timeframes or at all.
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safety, efficacy and benefits of our product candidates.
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the
content and timing of submissions to and decisions made by the FDA and other regulatory agencies.
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the
effects of government regulation and regulatory developments, and our ability and the ability of the third parties with whom
we engage to comply with applicable regulatory requirements.
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capacities and performance of our suppliers and manufacturers and other third parties over whom we have limited control.
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ability to maintain our listing on the NYSE American.
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our
competitive position and the development of and projections relating to our competitors or our industry; and
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the
impact of laws and regulations.
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Except
as required by law, we assume no obligation to update these forward-looking statements publicly, or to revise any forward-looking
statements to reflect events or developments occurring after the date of this prospectus, even if new information becomes available
in the future.
USE
OF PROCEEDS
We
will retain broad discretion over the use of the net proceeds from the sale of the securities offered hereby. Except as described
in any applicable prospectus supplement or in any free writing prospectuses that we may authorize to be provided to you in connection
with a specific offering, we currently intend to use the net proceeds from the sale of the securities offered hereby for working
capital, capital expenditures and general corporate purposes. We may also use a portion of the net proceeds to invest in or acquire
businesses or technologies that we believe are complementary to our own, although we have no current plans, commitments or agreements
with respect to any acquisitions as of the date of this prospectus. We will set forth in the applicable prospectus supplement
or free writing prospectus our intended use for the net proceeds received from the sale of any securities sold pursuant to the
prospectus supplement or free writing prospectus. Pending these uses, we intend to invest the net proceeds in investment-grade,
interest-bearing securities.
DIVIDEND
POLICY
We
have never paid cash dividends on our common stock. Moreover, we do not anticipate paying periodic cash dividends on our common
stock for the foreseeable future. We intend to use all available cash and liquid assets in the operation and growth of our business.
Any future determination about the payment of dividends will be made at the discretion of our board of directors and will depend
upon our earnings, if any, capital requirements, operating and financial conditions and on such other factors as our board of
directors deems relevant.
Our
outstanding shares of Series C, Non-Voting, Non-Convertible, Redeemable Preferred Stock (“Series C Preferred Stock”)
with a stated value of $33,847 per share has an accruing dividend payable in additional shares of Series C Preferred Stock. The
accruing dividend increased from 12% to 20% per year after May 10, 2019. In January of 2018 and in January of 2019, we paid dividends
on our Series C Preferred Stock to Intrexon of 1.733 Series C Preferred shares and 12.208 Series C Preferred shares, respectively.
DESCRIPTION
OF CAPITAL STOCK
The
following descriptions are summaries of the material terms that are included in our amended and restated articles of incorporation
(as amended) and our bylaws (as amended) as well as the specific agreements such descriptions relate to. This summary is qualified
in its entirety by the specific terms and provisions contained in our restated articles of incorporation, bylaws and the specific
agreements described herein, copies of which we have filed as exhibits to the registration statement of which this prospectus
is a part, and by the provisions of applicable law.
Overview
Authorized
Capital Stock
Our
authorized capital stock consists of 200,000,000 shares of common stock, par value $0.001, and 50,000,000 shares of preferred
stock, without par value. As of November 8, 2019, there were 46,124,803 shares of our common stock issued and outstanding and
16,017,113.941 shares of our preferred stock issued and outstanding.
Reverse
Stock Split
Our
shareholders and Board of Directors approved a one-for-ten reverse stock split which took effect on January 19, 2018. As a result
of the reverse stock split every ten shares of our common stock was automatically combined and converted into one issued and outstanding
share of our common stock, with no change in the par value per share. All share amounts, per share amounts and share prices in
this prospectus supplement have been adjusted to reflect the reverse stock split.
Common
Stock
Voting
The
holders of our common stock are entitled to one vote for each share held of record on all matters submitted to a vote of the shareholders.
Approval of an amendment of our articles of incorporation, a merger, a share exchange, a sale of all our property or dissolution
must be approved by a majority of all votes entitled to be cast. Such votes may be cast in person or by proxy as provided in Article
I Section 8 of our bylaws.
Dividends
Our
Board of Directors, subject to any restrictions contained in (i) the Florida Business Corporation Act, or FBCA; or (ii) our amended
and restated articles of incorporation, as amended, or Articles of Incorporation, may make dividends upon our securities. Distributions
may be paid in cash, in property, or in our securities.
We
have not declared or paid any dividends on our common stock. We presently intend to retain our future earnings, if any, to fund
the development and growth of our business and, therefore, do not have plans to pay any dividends in the foreseeable future.
Other
Rights
Upon
our liquidation, dissolution or winding-up, after payment in full of our liabilities and the amounts required to be paid to holders
of any outstanding shares of preferred stock, if any, all holders of our common stock, along with the holders of our Series A
Convertible Preferred Stock and Series B Convertible Preferred Stock on an “as if” converted basis, will be entitled
to receive a pro rata distribution of all of our assets and funds legally available for distribution.
No
shares of our common stock are subject to redemption or have preemptive rights to purchase additional shares of our common stock
or any of our other securities.
Fully
Paid and Nonassessable
All
of our outstanding shares of common stock are, and the shares of common stock to be issued in this offering will be, fully paid
and nonassessable.
Preferred
Stock
Our
Board of Directors has the authority, without action by our shareholders, to designate and issue up to 50,000,000 shares of preferred
stock in one or more series or classes and to designate the rights, preferences and privileges of each series or class, which
may be greater than the rights of our common stock. These rights, preferences and privileges could include dividend rights, conversion
rights, voting rights, redemption rights, liquidation preferences, the number of shares constituting any class or series and the
designation of the class or series. Terms selected by our board of directors in the future could decrease the amount of earnings
and assets available for distribution to holders of shares of common stock or adversely affect the rights and powers, including
voting rights, of the holders of shares of common stock without any further vote or action by the stockholders. As a result, the
rights of holders of our common stock will be subject to, and may be adversely affected by, the rights of the holders of the Series
A Convertible Preferred Stock, Series B Convertible Preferred Stock, and Series C Non-Convertible Preferred Stock or any other
preferred stock that may be issued by us in the future, which could have the effect of decreasing the market price of our common
stock. As of November 8, 2019, we have 16,017,113.941 shares of preferred stock issued and outstanding.
Series
A Convertible Preferred Stock
On
May 10, 2017 and on July 25, 2017, we issued an aggregate of 12,000,000 shares of convertible preferred stock, designated as the
Series A Convertible Preferred Stock pursuant to the certificate of designation and rights filed by us with the Secretary of State
of the State of Florida, with an aggregate original purchase price and initial liquidation preference of $3.0 million. Each share
of Series A Convertible Preferred Stock was issued for an amount equal to $0.25 per share, which we refer to as the original purchase
price. On March 9, 2018, an investor converted a portion of its Series A Preferred to common stock and, as a result of the conversion,
9,417,000 shares of Series A Preferred remain outstanding.
The
following description is a summary of the material provisions of the Series A Convertible Preferred Stock and the certificate
of designation and rights and does not purport to be complete. This summary is subject to and is qualified by reference to all
the provisions of the Series A Convertible Preferred Stock and certificate of designation and rights of Series A Convertible Preferred
Stock, including the definitions of certain terms used in the certificate of designation and rights. We urge you to read this
document because it, and not this description, defines the rights of a holder of the Series A Convertible Preferred Stock. A copy
of the form of certificate of designation and rights that we filed with the Secretary of State of the State of Florida effective
May 10, 2017 as amended and restated effective November 8, 2017 has been incorporated by reference as an exhibit to the registration
statement of which this prospectus forms a part.
No
Mandatory Redemption Date or Sinking Fund
The
shares of Series A Convertible Preferred Stock do not have a mandatory redemption date and are not subject to any sinking fund.
The shares of Series A Convertible Preferred Stock will remain outstanding indefinitely unless we elect to redeem them under the
circumstances described below in “Redemption” or we otherwise repurchase them or they are converted into shares of
our common stock as described below under “Conversion Rights.”
Dividends
The
shares of Series A Convertible Preferred Stock are entitled to participate in all dividends declared and paid on shares of company
common stock on an “as if” converted basis.
Liquidation
Preference
Upon
any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary that is not a Fundamental Transaction
(as defined in the certificate of designation), the holders of Series A Convertible Preferred Stock shall be entitled to receive
out of the assets, the greater of (i) the product of the number of shares of Series A Preferred Stock then held by such holder,
multiplied by the original issue price; and (ii) the amount that would be payable to such holder in the liquidation in respect
of Common Stock issuable upon conversion of such shares of Series A Preferred Stock if all outstanding shares of Series A Preferred
Stock were converted into Common Stock immediately prior to the Liquidation.
Ranking
The
Series A Convertible Preferred Stock ranks (i) on par with the Common Stock and Series B Convertible Preferred Stock and junior
to Series C Non-Convertible Preferred Stock as to dividend rights and (ii) on par with Series B Convertible Preferred Stock, junior
to Series C Non-Convertible Preferred Stock and senior to Common Stock as to rights upon liquidation, dissolution or winding up
of the Company, whether voluntarily or involuntarily.
See
“Voting Rights—Matters Requiring Approval of Holders of Series A Convertible Preferred Stock” for a description
of the types of issuances of equity securities and other securities of our company requiring approval of holders of a majority
of shares of Series A Convertible Preferred Stock then outstanding, voting together as a class.
Redemption
To
the extent we have funds legally available therefor, at any time after the fifth anniversary of the original issue date of the
Series A Convertible Preferred Stock, we have the right to redeem all or any portion of the outstanding shares of Series A Convertible
Preferred Stock at the original issue price by providing at least seventy five (75) days written notice of such redemption to
all holders of the then outstanding shares of Series A Convertible Preferred Stock.
Conversion
Rights
The
holders of shares of Series A Convertible Preferred Stock will, at any time, be entitled to convert some or all of their Series
A Convertible Preferred Stock into the number of shares of our common stock obtained by dividing the original purchase price of
the shares to be converted by the aggregate Series A conversion price (which originally equaled the original purchase price, but
is subject to adjustment), which amount we refer to as the conversion price.
The
conversion price will be adjustable upon the occurrence of certain events and transactions to prevent dilution as described under
“Adjustments to Conversion Price to Prevent Dilution.” Any shares of our common stock issued upon conversion of the
shares of Series A Convertible Preferred Stock shall be validly issued, fully paid and non-assessable. The Company shall either
pay cash in lieu of fractional shares or round up to the next whole share. The initial conversion price was $0.25 but was adjusted
to $2.50 as a result of the Company’s reverse split of 1 for 10 on January 19, 2018. On March 9, 2018, an investor holding
Series A Preferred, provided a notice of conversion of a portion of its Series A Preferred Stock into common stock based on the
post-split adjusted conversion price.
Adjustments
to Conversion Price to Prevent Dilution
The
Series A Convertible Preferred Stock is subject to provisions that protect the holders against dilution by adjustment of the conversion
price and/or number of shares of common stock issuable upon conversion in certain events such as a subdivision, combination or
reclassification of our outstanding common stock.
Voting
Rights—Matters Requiring Approval of Holders of Series A Convertible Preferred Stock
Except
as otherwise required by law, the Series A Convertible Preferred Stock shall have no voting rights. However, as long as any shares
of Series A Convertible Preferred Stock are outstanding, we shall not, without the affirmative vote of the holders of a majority
of the then outstanding shares of the Series A Convertible Preferred Stock, (a) alter or change adversely the powers, preferences
or rights given to the Series A Convertible Preferred Stock or alter or amend the certificate of designation, (b) amend its articles
of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series A Convertible
Preferred Stock, (c) increase the number of authorized shares of Series A Convertible Preferred Stock, or (d) enter into any agreement
with respect to any of the foregoing.
Registration
Rights
The
holders of the Series A Convertible Preferred Stock were granted certain demand registration rights and piggyback registration
rights with respect to the shares of our Common Stock issuable upon conversion of the Series A Preferred Stock and exercise of
their associated warrants, subject to customary cutbacks, blackout periods and other exceptions.
Series
B Convertible Preferred Stock
On
November 8, 2017, we issued 6,600,000 shares of convertible preferred stock, designated as the Series B Convertible Preferred
Stock pursuant to the certificate of designation and rights filed by us with the Secretary of State of the State of Florida, with
an aggregate original purchase price and initial liquidation preference of $3.3 million. Each share of Series B Convertible Preferred
Stock was issued for an amount equal to $0.50 per share, which we refer to as the original purchase price.
The
following description is a summary of the material provisions of the Series B Convertible Preferred Stock and the certificate
of designation and rights and does not purport to be complete. This summary is subject to and is qualified by reference to all
the provisions of the Series B Convertible Preferred Stock and certificate of designation and rights of Series B Convertible Preferred
Stock, including the definitions of certain terms used in the certificate of designation and rights. We urge you to read this
document because it, and not this description, defines the rights of a holder of the Series B Convertible Preferred Stock. A copy
of the form of certificate of designation and rights that we filed with the Secretary of State of the State of Florida effective
November 8, 2017 has been incorporated by reference as an exhibit to the registration statement of which this prospectus forms
a part.
No
Mandatory Redemption Date or Sinking Fund
The
shares of Series B Convertible Preferred Stock do not have a mandatory redemption date and are not subject to any sinking fund.
The shares of Series B Convertible Preferred Stock will remain outstanding indefinitely unless we elect to redeem them under the
circumstances described below in “Redemption” or we otherwise repurchase them or they are converted into shares of
our common stock as described below under “Conversion Rights.”
Dividends
The
shares of Series B Convertible Preferred Stock are entitled to participate in all dividends declared and paid on shares of company
common stock on an “as if” converted basis.
Liquidation
Preference
Upon
any liquidation, dissolution or winding-up of the Company (any such event, a “Liquidation”), whether voluntary or
involuntary, each holder of shares of Series B Convertible Preferred Stock shall be entitled to receive, after payment to the
Series C Non-Convertible Preferred Stock as provided in the Certificate of Designation of Series C Non-Convertible Preferred Stock,
but on par with Series A Convertible Preferred Stock and in preference to the holders of Common Stock, an amount of cash equal
to the greater of (i) the product of the number of shares of Series B Convertible Preferred Stock then held by such holder, multiplied
by the original issue price; and (ii) the amount that would be payable to such holder in the Liquidation in respect of Common
Stock issuable upon conversion of such shares of Series B Convertible Preferred Stock if all outstanding shares of Series B Convertible
Preferred Stock were converted into Common Stock immediately prior to the Liquidation (disregarding for this purpose any and all
limitations of any kind on such conversion).
Ranking
The
Series B Convertible Preferred Stock ranks (i) on par with the Common Stock and Series A Convertible Preferred Stock and junior
to Series C Non-Convertible Preferred Stock as to dividend rights and (ii) junior to Series C Non-Convertible Preferred Stock,
on par with Series A Convertible Preferred Stock and senior to the Common Stock as to distributions of assets upon liquidation,
dissolution or winding up of the Corporation, whether voluntarily or involuntarily.
See
“Voting Rights—Matters Requiring Approval of Holders of Series B Convertible Preferred Stock” for a description
of the types of issuances of equity securities and other securities of our company requiring approval of holders of a majority
of shares of Series B Convertible Preferred Stock then outstanding, voting together as a class.
Redemption
To
the extent we have funds legally available therefor, at any time after the fifth anniversary of the original issue date of the
Series B Convertible Preferred Stock, we have the right to redeem all or any portion of the outstanding shares of Series B Convertible
Preferred Stock at the original issue price by providing at least seventy five (75) days written notice of such redemption to
all holders of the then outstanding shares of Series B Convertible Preferred Stock.
Conversion
Rights
The
holders of shares of Series B Convertible Preferred Stock will, at any time, be entitled to convert some or all of their Series
B Convertible Preferred Stock into the number of shares of our common stock obtained by dividing the original purchase price of
the shares to be converted by the aggregate Series B conversion price (which originally equaled the original purchase price, but
is subject to adjustment), which amount we refer to as the conversion price and then multiplying such product by two (2).
The
conversion price will be adjustable upon the occurrence of certain events and transactions to prevent dilution as described under
“Adjustments to Conversion Price to Prevent Dilution.” Any shares of our common stock issued upon conversion of the
shares of Series B Convertible Preferred Stock shall be validly issued, fully paid and non-assessable. The Company shall either
pay cash in lieu of fractional shares or round up to the next whole share. The initial conversion price was $0.50 but was adjusted
to $5.00 as a result of the Company’s reverse split of 1 for 10 on January 19, 2018. No shares of Series B Preferred Stock
have been converted as of the date of this Prospectus.
Adjustments
to Conversion Price to Prevent Dilution
The
Series B Convertible Preferred Stock is subject to provisions that protect the holders against dilution by adjustment of the conversion
price and/or number of shares of common stock issuable upon conversion in certain events such as a subdivision, combination or
reclassification of our outstanding common stock.
Voting
Rights—Matters Requiring Approval of Holders of Series B Convertible Preferred Stock
Except
as otherwise required by law, the Series B Convertible Preferred Stock shall have no voting rights. However, as long as any shares
of Series B Convertible Preferred Stock are outstanding, we shall not, without the affirmative vote of the holders of a majority
of the then outstanding shares of the Series B Convertible Preferred Stock, (a) amend, alter, repeal, restate or supplement (in
each case, whether by reclassification, merger, consolidation, reorganization or otherwise) the certificate of designation in
any manner that would adversely affect the holders of the Series B Convertible Preferred Stock, (b) authorize or agree to authorize
any increase in the number of shares of Series B Convertible Preferred Stock or issue any additional shares of Series B Convertible
Preferred Stock, (c) amend, alter or repeal any provision of the Certificate of Incorporation or Bylaws of the Company which would
adversely affect any right, preference, privilege or voting power of the Series B Convertible Preferred Stock or the holders thereof
or (d) agree to take any of the foregoing actions.
Registration
Rights
The
holders of the Series B Convertible Preferred Stock were granted certain demand registration rights and piggyback registration
rights with respect to the shares of our Common Stock issuable upon conversion of the Series B Preferred Stock and exercise of
their associated warrants, subject to customary cutbacks, blackout periods and other exceptions.
Series
C Non-Voting, Non-Convertible Preferred Stock
On
November 8, 2017, we issued 100 shares of non-convertible preferred stock, designated as the Series C Non-Voting, Non-Convertible
Preferred Stock pursuant to the certificate of designation and rights filed by us with the Secretary of State of the State of
Florida, with a stated value and liquidation preference equal to $33,847.9874 per share, which we refer to as the Stated Value.
The shares of Series C Non-Voting, Non-Convertible Preferred Stock are entitled to payment-in-kind (“PIK”) dividends
thereon at the annual rate of twelve percent (12%) (the “Initial Rate”) of its Stated Value, payable by issuing additional
shares of Series C Non-Voting, Non-Convertible Preferred Stock within thirty days after the end of each calendar year, pro-rata
for partial years. On January 25, 2018, we paid a dividend on our Series C Preferred Stock to Intrexon of 1.733 shares for the
portion of the 2017 fiscal year the Series C Preferred was outstanding and in January of 2019, we paid a dividend on our Series
C Preferred Stock to Intrexon of 12.208 shares.
The
following description is a summary of the material provisions of the Series C Non-Voting, Non-Convertible Preferred Stock and
the certificate of designation and rights and does not purport to be complete. This summary is subject to and is qualified by
reference to all the provisions of the Series C Non-Voting, Non-Convertible Preferred Stock and certificate of designation and
rights of Series C Non-Voting, Non-Convertible Preferred Stock, including the definitions of certain terms used in the certificate
of designation and rights. We urge you to read this document because it, and not this description, defines the rights of a holder
of the Series C Non-Voting, Non-Convertible Preferred Stock. A copy of the form of certificate of designation and rights that
we filed with the Secretary of State of the State of Florida effective November 8, 2017 has been incorporated by reference as
an exhibit to the registration statement of which this prospectus forms a part.
No
Mandatory Redemption Date or Sinking Fund
The
shares of Series C Non-Voting, Non-Convertible Preferred Stock do not have a mandatory redemption date and are not subject to
any sinking fund. The shares of Series C Non-Voting, Non-Convertible Preferred Stock will remain outstanding indefinitely unless
we elect to redeem them under the circumstances described below in “Redemption” or we otherwise repurchase them.
Dividends
The
shares of Series C Non-Voting, Non-Convertible Preferred Stock are entitled to receive dividends thereon at the annual rate of
twelve percent (12%) (the “Initial Rate”) of its Stated Value, payable by issuing additional shares of Series C Non-Voting,
Non-Convertible Preferred Stock within thirty days after the end of each calendar year pro-rata for partial years. The Initial
Rate shall be subject to increase to twenty percent (20%) automatically after May 10, 2019. In January of 2018 we paid a dividend
on our Series C Non-Voting, Non-Convertible Preferred Stock to Intrexon of 1.733 shares for the portion of the 2017 fiscal year
the Series C Non-Voting, Non-Convertible Preferred Stock was outstanding. In January of 2019 we paid a dividend on our Series
C Non-Voting, Non-Convertible Preferred Stock to Intrexon of 12.208 shares for the full fiscal year of the 2018.
Liquidation
Preference
Upon
any liquidation, dissolution or winding-up of the Company (any such event, a “Liquidation”), whether voluntary or
involuntary, each holder of shares of Series C Non-Voting, Non-Convertible Preferred Stock shall be entitled to receive, in
preference to the holders of Common Stock, Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and to
all other equity securities issued by the Corporation from time to time (the “Junior Securities”), an amount of
cash equal to the product of (i) the sum of (a) the number of shares of Series C Non-Voting, Non-Convertible Preferred Stock
then held by such holder plus (b) the number of shares of Series C Non-Voting, Non-Convertible Preferred Stock issuable to
such holder in connection with any accrued but unpaid dividends, multiplied by (ii) the Stated Value per share of Series C
Non-Voting, Non-Convertible Preferred Stock (the “Series C Liquidation Amount”) and no distributions or payments
shall be made in respect of any Junior Securities unless all Series C Liquidation Amounts, if any, are first paid in
full.
Ranking
The
Series C Non-Voting, Non-Convertible Preferred Stock ranks (i) senior to the Junior Securities as to dividend rights and (ii)
senior to the Junior Securities as to rights upon liquidation, dissolution or winding up of the Corporation, whether voluntarily
or involuntarily.
See
“Voting Rights—Matters Requiring Approval of Holders of Series C Non-Convertible Preferred Stock” for a description
of the types of issuances of equity securities and other securities of our company requiring approval of holders of a majority
of shares of Series C Non-Voting, Non-Convertible Preferred Stock then outstanding, voting together as a class.
Redemption
To
the extent we have funds legally available therefor, at any time after November 8, 2017, we have the right to redeem all or any
portion of the outstanding shares of Series C Non-Voting, Non-Convertible Preferred Stock at the Stated Value by providing at
least thirty (30) days written notice of such redemption to all holders of the then outstanding shares of Series C Non-Voting,
Non-Convertible Preferred Stock.
No
Conversion Rights
The
shares of Series C Non-Voting, Non-Convertible Preferred Stock do not have any conversion rights and are not convertible into
or exchangeable for any other property or securities of the Company.
Voting
Rights—Matters Requiring Approval of Holders of Series C Non-Voting, Non-Convertible Preferred Stock
Except
as otherwise required by law, the Series C Non-Voting, Non-Convertible Preferred Stock shall have no voting rights. However, as
long as any shares of Series C Non-Voting, Non-Convertible Preferred Stock are outstanding, we shall not, without the affirmative
vote of the holders of a majority of the then outstanding shares of the Series C Non-Voting, Non-Convertible Preferred Stock,
(a) amend, alter, repeal, restate or supplement (in each case, whether by reclassification, merger, consolidation, reorganization
or otherwise) the certificate of designation in any manner that would adversely affect the holders of the Series C Non-Voting,
Non-Convertible Preferred Stock, (b) authorize or agree to authorize any increase in the number of shares of Series C Non-Voting,
Non-Convertible Preferred Stock or issue any additional shares of Series C Non-Voting, Non-Convertible Preferred Stock, (c) amend,
alter or repeal any provision of the Certificate of Incorporation or Bylaws of the Company which would adversely affect any right,
preference, or privilege of the Series C Non-Voting, Non-Convertible Preferred Stock or the holders thereof or (d) agree to take
any of the foregoing actions.
Series
D Preferred Stock-Converted to Common Stock
On
July 13, 2018, our board of directors designated 9,364,000 shares of our preferred stock as Series D Convertible Preferred Stock
(“Series D Preferred Stock”), which were subsequently issued on July 17, 2018, none of which are currently issued
and outstanding. The preferences and rights of the Series D Preferred Stock was set forth in a Certificate of Designation (the
“Series D Certificate of Designation”). Pursuant to a transfer agency agreement between us and Continental Stock Transfer&
Trust Company, as transfer agent, the Series D Preferred Stock was issued in book-entry form and represented only by one or more
global certificates deposited with The Depository Trust Company, or DTC, and registered in the name of Cede & Co., a nominee
of DTC, or as otherwise directed by DTC. Prior to the end of 2018, all of 9,364,000 shares of Series D Preferred Stock had converted
to common stock and as such, the Company no longer has any Series D Preferred Stock outstanding.
Options
and Warrants
As
of December 27, 2019, there were 26,538,593 shares of common stock issuable upon exercise of warrants to investors at a weighted
average exercise price per share of $1.08, 2,488,293 shares issuable upon exercise of options outstanding at a weighted average
exercise price of $1.50 per share, and an additional 5,520,957 shares available for option grants under our 2012 Equity Incentive
Plan, as amended. The issuance of shares of our common stock under our 2012 Equity Incentive Plan is covered by Form S-8 registration
statements we filed with the Securities and Exchange Commission, or SEC, and upon exercise of the options, such shares may be
resold into the market. We have also issued shares of common stock and warrants in connection with previous private placements.
Such shares are available for resale as well as certain of the shares of common stock issuable upon exercise of the warrants.
We have also issued shares of our common stock in private placement and financing transactions, which are deemed to be “restricted
securities,” as that term is defined in Rule 144 promulgated under the Securities Act of 1933, as amended, or Securities
Act, and such shares may be resold pursuant to the provisions of Rule 144.
Contingent
Share Issuance-Intrexon
On
June 9, 2015, we entered into an Exclusive Channel Collaboration Agreement, (as subsequently amended on May 10, 2017 and November
8, 2017, the “ECC”), with Intrexon and Actobiotics, a wholly-owned subsidiary of Intrexon, through which we intend
to research, develop and commercialize products, including the continued development and commercialization of AG013, for use in
the treatment of oral mucositis in humans and/or the administration to humans of a trefoil factor via genetically modified bacteria
(including L. lactis) for the treatment of diseases and conditions of the oral cavity, throat, and esophagus, but, in any
case, excluding the delivery of anti-cancer effectors for the purpose of treatment or prophylaxis of cancer (collectively, the
“Program”). Contemporaneously with the ECC, we and Intrexon also entered into a Stock Issuance Agreement (as subsequently
amended on May 10, 2017 and November 8, 2017, the “SIA” or “Stock Issuance Agreement”) which authorized
the issuance of a technology access fee and the future stock issuance of our common stock to Intrexon upon the achievement of
designated milestones. We issued a Convertible Note in the amount of $5,000,000 as payment of the technology access fee associated
with the Oral Mucositis ECC which was payable, at our option, in cash or shares of our common stock. The convertible note, including
accrued interest, was repaid in December 2015 through the issuance of 338,101 shares of our common stock.
Under
the SIA, we also agreed to make certain payments to Intrexon upon our achievement of designated milestones in the form of shares
of our common stock (based upon the fair market value of the shares otherwise required to be issued) unless the issuance of such
shares would reasonably likely cause Intrexon to consolidate our financial statements with Intrexon’s financial statements,
or at our option make a cash payment to Intrexon. The Commercialization Milestone Events and amounts payable are as follows:
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(i)
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a
one-time payment of twenty-seven million five hundred thousand United States dollars ($27,500,000) within six (6) months of
the achievement of the Regulatory Approval Milestone Event meaning receiving approval from the FDA of a New Product Application
for an Oragenics Product (or equivalent regulatory action in a foreign jurisdiction);
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(ii)
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a
one-time payment of five million United States dollars ($5,000,000) within six (6) months of the achievement of the New Indication
Milestone Event meaning receiving approval from the FDA of a Supplemental FDA Application (or an equivalent filing with another
equivalent regulatory agency) which Supplemental FDA Application sought approval of an indication for use of the Oragenics
Product other than the current regulatory-approved indication; and
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(iii)
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a
one-time payment of five million United States dollars ($5,000,000) within six (6) months of the achievement of the New Product
Milestone Event meaning receiving approval from the FDA of a New Product Application that is deemed to be a different drug
product that the first Oragenics Product that was clinically pursued under the Program.
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Equity
Participation Right-Intrexon
Pursuant
to the Stock Issuance Agreement, Intrexon was also entitled, at its election, to participate in future securities offerings by
us that constitute “qualified financings” and purchase securities equal to 30% of the number of shares of common stock
or other securities sold in such offering (exclusive of Intrexon’s purchase). For this purpose, a “qualified financing”
means a sale of common stock or equity securities convertible into common stock in a public or private offering, raising gross
proceeds of at least $1,000,000, where the sale of shares is either registered under the Securities Act of 1933, as amended, at
the time of issuance or we agree to register the resale of such shares. Intrexon waived their right to participate in the July
2012, June 2016, May 2017 and November 2017, April 2018 and July 2018 Private Placements and did not elect to participate in the
March 2019 offering.
Registration
Rights
Intrexon
Corporation. Pursuant to the Stock Issuance Agreement with Intrexon dated June 5, 2012, we granted certain registration rights
to Intrexon. The registration rights consisted of “piggyback registration” rights which permit Intrexon to participate
in any firm commitment underwritten offering of securities by us, subject to underwriter cutbacks and lockups. In addition, we
are precluded from granting registration rights in connection with a private placement unless (i) all shares held by Intrexon
are, at the time of such private placement, included on a registration statement, or (ii) we agree, in connection with such private
placement, to grant Intrexon the right to include on the registration statement a number of Intrexon’s Company shares equal
to one half of the number of shares to be registered on behalf of the other holders or prospective holders. Intrexon waived its
registration rights in connection with the Company’s July 2012, June 2016, May 2017 and November 2017 Private Placements
and the March 2019 Public Offering.
Series
A Preferred Stock Private Placement. Pursuant to the May 10, 2017 Registration Rights Agreement, we granted certain demand
registration rights and piggyback registration rights with respect to the shares of our Common Stock issuable upon conversion
of the Series A Preferred Stock and the exercise of the common stock warrants that were issued commensurate with the issuance
of the Series A Preferred Stock.
Series
B Preferred Stock Private Placement. Pursuant to the November 8, 2017 Amended and Restated Registration Right Agreement, we
granted certain demand registration rights and piggyback registration rights with respect to the shares of our Common Stock issuable
upon conversion of the Series B Preferred Stock and the exercise of the common stock warrants that were issued commensurate with
the issuance of the Series B Preferred Stock. The Amended and Restated Registration Rights Agreement amended the previous registration
rights agreement entered into in connection with our Series A Preferred Stock Financing in May 2017.
The
following descriptions are summaries of the material terms that are included in our amended and restated articles of incorporation
(as amended) and our bylaws (as amended) as well as the specific agreements such descriptions relate to. This summary is qualified
in its entirety by the specific terms and provisions contained in our restated articles of incorporation, bylaws and the specific
agreements described herein, copies of which we have filed as exhibits to the registration statement of which this prospectus
is a part, and by the provisions of applicable law.
Certain
Anti-Takeover Provisions
Florida
Law
We
are not subject to the statutory anti-takeover provisions under Florida law because in our articles of incorporation we have specifically
elected to opt out of both the “control-share acquisitions” (F.S. 607.0902) and the “affiliated transactions”
(F.S. 607.0901) statutes. Since these anti-takeover statutes do not apply to a corporation that has specifically elected to opt
out of such provisions, we would not be able to invoke the protection of such statutes in the event of a hostile takeover attempt.
Articles
of Incorporation and Bylaw Provisions
Our
articles of incorporation and bylaws contain provisions that could have an anti-takeover effect. These provisions include
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authorization
of the issuance of “blank check” preferred stock that could be issued by our Board of Directors without shareholder
approval and that may be substantially dilutive or contain preferences or rights objectionable to an acquiror;
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the
ability of the Board of Directors to amend the bylaws without shareholder approval;
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vacancies
on our board may only be filled by the remaining Directors and not our shareholders; and
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requirements
that only our Board, our President or holders of more than 10% of our shares can call a special meeting of shareholders.
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These
provisions in our articles of incorporation and bylaws could delay or discourage transactions involving an actual or potential
change in control of us, including transactions in which shareholders might otherwise receive a premium for their shares over
their current prices. Such provisions could also limit the ability of shareholders to approve transactions that shareholders may
deem to be in their best interests and could adversely affect the price of our common stock.
Listing
of Common Stock
Our
common stock is currently listed on the NYSE American under the trading symbol “OGEN.”
Transfer
Agent and Registrar
The
transfer agent and registrar of our common stock is Continental Stock Transfer & Trust Company, 17 Battery Place, New York,
New York 10004, telephone: (212) 509-4000.
DESCRIPTION
OF WARRANTS
The
following description, together with the additional information that we include in any applicable prospectus supplement and in
any related free writing prospectus that we may authorize to be distributed to you, summarizes the material terms and provisions
of the warrants that we may offer under this prospectus, which may be issued in one or more series. Warrants may be offered independently
or in combination with other securities offered by any prospectus supplement. While the terms we have summarized below will apply
generally to any warrants that we may offer under this prospectus, we will describe the particular terms of any series of warrants
in more detail in the applicable prospectus supplement. The following description of warrants will apply to the warrants offered
by this prospectus unless we provide otherwise in the applicable prospectus supplement. The applicable prospectus supplement for
a particular series of warrants may specify different or additional terms.
Any
warrants issued under this prospectus may be evidenced by warrant certificates. Warrants also may be issued under an applicable
warrant agreement that we enter into with a warrant agent. We will indicate the name and address of the warrant agent, if applicable,
in the prospectus supplement relating to the particular series of warrants being offered.
We
will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from
reports that we file with the SEC, the form of warrant and/or the warrant agreement and warrant certificate, as applicable, that
contain the terms of the particular series of warrants we are offering, and any supplemental agreements, before the issuance of
such warrants. The following description summarizes the material terms and provisions of the warrants and is subject to, and qualified
in its entirety by reference to, all the provisions of the form of warrant and/or the warrant agreement and warrant certificate,
as applicable, and any supplemental agreements applicable to a particular series of warrants that we may offer under this prospectus.
We urge you to read the applicable prospectus supplement related to the particular series of warrants that we may offer under
this prospectus, as well as any related free writing prospectuses, and the complete form of warrant and/or the warrant agreement
and warrant certificate, as applicable, and any supplemental agreements, that contain the terms of the warrants.
General
We
will describe in the applicable prospectus supplement the terms of the series of warrants being offered, including:
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title of such securities;
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the
offering price and aggregate number of warrants offered;
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the
currency for which the warrants may be purchased;
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if
applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued
with each such security or each principal amount of such security;
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in
the case of warrants to purchase common stock, the number of shares of common stock, purchasable upon the exercise of one
warrant and the price at which these shares may be purchased upon such exercise;
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the
effect of any merger, consolidation, sale or other disposition of our business on the warrant agreements and the warrants;
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the
terms of any rights to redeem or call the warrants;
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the
terms of any rights to force the exercise of the warrants;
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any
provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants;
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the
dates on which the right to exercise the warrants will commence and expire;
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the
manner in which the warrant agreements and warrants may be modified;
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a
discussion of any material or special U.S. federal income tax considerations of holding or exercising the warrants;
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the
terms of the securities issuable upon exercise of the warrants; and
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any
other specific terms, preferences, rights or limitations of or restrictions on the warrants.
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Before
exercising their warrants, holders of warrants will not have any of the rights of holders of the securities purchasable upon such
exercise, including: in the case of warrants to purchase common stock, the right to receive dividends, if any, or, payments upon
our liquidation, dissolution or winding up or to exercise voting rights, if any.
Exercise
of Warrants
Each
warrant will entitle the holder to purchase the securities that we specify in the applicable prospectus supplement at the exercise
price that we describe in the applicable prospectus supplement. The warrants may be exercised as set forth in the prospectus supplement
relating to the warrants offered. Unless we otherwise specify in the applicable prospectus supplement, warrants may be exercised
at any time up to the close of business on the expiration date set forth in the prospectus supplement relating to the warrants
offered thereby. After the close of business on the expiration date, unexercised warrants will become void.
Unless
we otherwise specify in the applicable prospectus supplement, holders of the warrants may exercise the warrants by delivering
the warrant certificate representing the warrants to be exercised together with specified information, and paying the required
amount to the warrant agent in immediately available funds, as provided in the applicable prospectus supplement. We will set forth
on the reverse side of the warrant certificate and in the applicable prospectus supplement the information that the holder of
the warrant will be required to deliver to the warrant agent in connection with the exercise of the warrant.
Upon
receipt of payment and the warrant or warrant certificate, as applicable, properly completed and duly executed at the corporate
trust office of the warrant agent, if any, or any other office, including ours, indicated in the prospectus supplement, we will,
as soon as practicable, issue and deliver the securities purchasable upon such exercise. If less than all of the warrants (or
the warrants represented by such warrant certificate) are exercised, a new warrant or a new warrant certificate, as applicable,
will be issued for the remaining warrants.
Governing
Law
Unless
we otherwise specify in the applicable prospectus supplement, the warrants and any warrant agreements will be governed by and
construed in accordance with the laws of the State of New York.
Enforceability
of Rights by Holders of Warrants
Each
warrant agent, if any, will act solely as our agent under the applicable warrant agreement and will not assume any obligation
or relationship of agency or trust with any holder of any warrant. A single bank or trust company may act as warrant agent for
more than one issue of warrants. A warrant agent will have no duty or responsibility in case of any default by us under the applicable
warrant agreement or warrant, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make
any demand upon us. Any holder of a warrant may, without the consent of the related warrant agent or the holder of any other warrant,
enforce by appropriate legal action its right to exercise, and receive the securities purchasable upon exercise of, its warrants.
DESCRIPTION
OF UNITS
Units
We
may issue units consisting of any combination of our common stock and warrants. We will issue each unit so that the holder of
the unit is also the holder of each security included in the unit. As a result, the holder of a unit will have the rights and
obligations of a holder of each included security. The unit agreement under which a unit is issued may provide that the securities
included in the unit may not be held or transferred separately, at any time or at any time before a specified date.
The
summary below and that contained in any prospectus supplement is qualified in its entirety by reference to all of the provisions
of the unit agreement and/or unit certificate, and depositary arrangements, if applicable. We urge you to read the applicable
prospectus supplements and any related free writing prospectuses related to the units that we may offer under this prospectus,
as well as the complete unit agreement and/or unit certificate, and depositary arrangements, as applicable, that contain the terms
of the units.
We
will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from
reports that we file with the SEC, the form of unit agreement and/or unit certificate, and depositary arrangements, as applicable,
that contain the terms of the particular series of units we are offering, and any supplemental agreements, before the issuance
of such units.
The
applicable prospectus supplement, information incorporated by reference or free writing prospectus may describe:
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the
designation and terms of the units and of the securities comprising the units, including whether and under what circumstances
those securities may be held or transferred separately;
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any
provisions for the issuance, payment, settlement, transfer, or exchange of the units or of the securities composing the units;
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whether
the units will be issued in fully registered or global form; and
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any
other terms of the units.
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The
applicable provisions described in this section, as well as those described under “Common Stock” and “Warrants”
above, will apply to each unit and to each security included in each unit, respectively
LEGAL
OWNERSHIP OF SECURITIES
We
can issue securities in registered form or in the form of one or more global securities. We describe global securities in greater
detail below. We refer to those persons who have securities registered in their own names on the books that we or any applicable
trustee, depositary or warrant agent maintain for this purpose as the “holders” of those securities. These persons
are the legal holders of the securities. We refer to those persons who, indirectly through others, own beneficial interests in
securities that are not registered in their own names, as “indirect holders” of those securities. As we discuss below,
indirect holders are not legal holders, and investors in securities issued in book-entry form or in street name will be indirect
holders.
Book-Entry
Holders
We
may issue securities in book-entry form only, as we will specify in the applicable prospectus supplement. This means securities
may be represented by one or more global securities registered in the name of a financial institution that holds them as depositary
on behalf of other financial institutions that participate in the depositary’s book-entry system. These participating institutions,
which are referred to as participants, in turn, hold beneficial interests in the securities on behalf of themselves or their customers.
Only
the person in whose name a security is registered is recognized as the holder of that security. Global securities will be registered
in the name of the depositary or its participants. Consequently, for global securities, we will recognize only the depositary
as the holder of the securities, and we will make all payments on the securities to the depositary. The depositary passes along
the payments it receives to its participants, which in turn pass the payments along to their customers who are the beneficial
owners. The depositary and its participants do so under agreements they have made with one another or with their customers; they
are not obligated to do so under the terms of the securities.
As
a result, investors in a global security will not own securities directly. Instead, they will own beneficial interests in a global
security, through a bank, broker or other financial institution that participates in the depositary’s book-entry system
or holds an interest through a participant. As long as the securities are issued in global form, investors will be indirect holders,
and not legal holders, of the securities.
Street
Name Holders
We
may terminate a global security or issue securities that are not issued in global form. In these cases, investors may choose to
hold their securities in their own names or in “street name.” Securities held by an investor in street name would
be registered in the name of a bank, broker or other financial institution that the investor chooses, and the investor would hold
only a beneficial interest in those securities through an account he or she maintains at that institution.
For
securities held in street name, we or any applicable trustee or depositary will recognize only the intermediary banks, brokers
and other financial institutions in whose names the securities are registered as the holders of those securities, and we or any
such trustee or depositary will make all payments on those securities to them. These institutions pass along the payments they
receive to their customers who are the beneficial owners, but only because they agree to do so in their customer agreements or
because they are legally required to do so. Investors who hold securities in street name will be indirect holders, not legal holders,
of those securities.
Legal
Holders
Our
obligations, as well as the obligations of any applicable trustee or third party employed by us or a trustee, run only to the
legal holders of the securities. We do not have obligations to investors who hold beneficial interests in global securities, in
street name or by any other indirect means. This will be the case whether an investor chooses to be an indirect holder of a security
or has no choice because we are issuing the securities only in global form.
For
example, once we make a payment or give a notice to the holder, we have no further responsibility for the payment or notice even
if that holder is required, under agreements with its participants or customers or by law, to pass it along to the indirect holders
but does not do so. Similarly, we may want to obtain the approval of the holders to amend an indenture, to relieve us of the consequences
of a default or of our obligation to comply with a particular provision of an indenture, or for other purposes. In such an event,
we would seek approval only from the holders, and not the indirect holders, of the securities. Whether and how the legal holders
contact the indirect holders is up to the legal holders.
Special
Considerations for Indirect Holders
If
you hold securities through a bank, broker or other financial institution, either in book-entry form because the securities are
represented by one or more global securities or in street name, you should check with your own institution to find out:
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how
it handles securities payments and notices;
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whether
it imposes fees or charges;
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how
it would handle a request for the holders’ consent, if ever required;
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whether
and how you can instruct it to send you securities registered in your own name so you can be a holder, if that is permitted
in the future;
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how
it would exercise rights under the securities if there were a default or other event triggering the need for holders to act
to protect their interests; and
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if
the securities are in book-entry form, how the depositary’s rules and procedures will affect these matters.
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Global
Securities
A
global security is a security that represents one or any other number of individual securities held by a depositary. Generally,
all securities represented by the same global securities will have the same terms.
Each
security issued in book-entry form will be represented by a global security that we issue to, deposit with and register in the
name of a financial institution or its nominee that we select. The financial institution that we select for this purpose is called
the depositary. Unless we specify otherwise in the applicable prospectus supplement, The Depository Trust Company, New York, New
York, known as DTC, will be the depositary for all securities issued in book-entry form.
A
global security may not be transferred to or registered in the name of anyone other than the depositary, its nominee or a successor
depositary, unless special termination situations arise. We describe those situations below under “—Special Situations
When a Global Security Will Be Terminated.” As a result of these arrangements, the depositary, or its nominee, will be the
sole registered owner and legal holder of all securities represented by a global security, and investors will be permitted to
own only beneficial interests in a global security. Beneficial interests must be held by means of an account with a broker, bank
or other financial institution that in turn has an account with the depositary or with another institution that does. Thus, an
investor whose security is represented by a global security will not be a legal holder of the security, but only an indirect holder
of a beneficial interest in the global security.
If
the prospectus supplement for a particular security indicates that the security will be issued as a global security, then the
security will be represented by a global security at all times unless and until the global security is terminated. If termination
occurs, we may issue the securities through another book-entry clearing system or decide that the securities may no longer be
held through any book-entry clearing system.
Special
Considerations for Global Securities
As
an indirect holder, an investor’s rights relating to a global security will be governed by the account rules of the investor’s
financial institution and of the depositary, as well as general laws relating to securities transfers. We do not recognize an
indirect holder as a holder of securities and instead deal only with the depositary that holds the global security.
If
securities are issued only as global securities, an investor should be aware of the following:
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an
investor cannot cause the securities to be registered in his or her name, and cannot obtain non-global certificates for his
or her interest in the securities, except in the special situations we describe below;
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an
investor will be an indirect holder and must look to his or her own bank or broker for payments on the securities and protection
of his or her legal rights relating to the securities, as we describe above;
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an
investor may not be able to sell interests in the securities to some insurance companies and to other institutions that are
required by law to own their securities in non-book-entry form;
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an
investor may not be able to pledge his or her interest in the global security in circumstances where certificates representing
the securities must be delivered to the lender or other beneficiary of the pledge in order for the pledge to be effective;
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the
depositary’s policies, which may change from time to time, will govern payments, transfers, exchanges and other matters
relating to an investor’s interest in the global security;
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we
and any applicable trustee have no responsibility for any aspect of the depositary’s actions or for its records of ownership
interests in the global security, nor will we or any applicable trustee supervise the depositary in any way;
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the
depositary may, and we understand that DTC will, require that those who purchase and sell interests in the global security
within its book-entry system use immediately available funds, and your broker or bank may require you to do so as well; and
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financial
institutions that participate in the depositary’s book-entry system, and through which an investor holds its interest
in the global security, may also have their own policies affecting payments, notices and other matters relating to the securities.
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There
may be more than one financial intermediary in the chain of ownership for an investor. We do not monitor and are not responsible
for the actions of any of those intermediaries.
Special
Situations When a Global Security Will Be Terminated
In
a few special situations described below, a global security will terminate and interests in it will be exchanged for physical
certificates representing those interests. After that exchange, the choice of whether to hold securities directly or in street
name will be up to the investor. Investors must consult their own banks or brokers to find out how to have their interests in
securities transferred to their own names, so that they will be direct holders. We have described the rights of holders and street
name investors above.
Unless
we provide otherwise in the applicable prospectus supplement, a global security will terminate when the following special situations
occur:
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if
the depositary notifies us that it is unwilling, unable or no longer qualified to continue as depositary for that global security
and we do not appoint another institution to act as depositary within 90 days;
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if
we notify any applicable trustee that we wish to terminate that global security; or
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if
an event of default has occurred with regard to securities represented by that global security and has not been cured or waived.
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The
applicable prospectus supplement may also list additional situations for terminating a global security that would apply only to
the particular series of securities covered by the prospectus supplement. When a global security terminates, the depositary, and
neither we nor any applicable trustee, is responsible for deciding the names of the institutions that will be the initial direct
holders.
PLAN
OF DISTRIBUTION
We
may sell the securities covered hereby from time to time pursuant to underwritten public offerings, direct sales to the public,
negotiated transactions, block trades or a combination of these methods. A distribution of the securities offered by this prospectus
may also be effected through the issuance of derivative securities, including without limitation, warrants and subscriptions.
We may sell the securities to or through underwriters or dealers, through one or more agents, or directly to one or more purchasers.
We may distribute securities from time to time in one or more transactions:
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at
a fixed price or prices, which may be changed;
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at
market prices prevailing at the time of sale;
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at
prices related to such prevailing market prices;
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at
varying prices determined at the time of sale; or
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at
negotiated prices.
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A
prospectus supplement or supplements will describe the terms of the offering of the securities, including:
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the
name or names of the underwriters, dealers or agents participating in the offering, if any;
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the
purchase price of the securities sold by us to any underwriter or dealer and the net proceeds we expect to receive from the
offering;
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any
over-allotment options under which underwriters may purchase additional securities from us;
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any
agency fees or underwriting discounts or commissions and other items constituting agents’ or underwriters’ compensation;
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any
public offering price;
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any
discounts or concessions allowed or reallowed or paid to dealers; and
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any
securities exchange or market on which the securities may be listed.
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Only
the agents or underwriters named in each prospectus supplement will be agents or underwriters in connection with the securities
offered by a prospectus supplement.
Offers
to purchase the securities being offered by this prospectus may be solicited directly. Agents may also be designated to solicit
offers to purchase the securities from time to time. Any agent involved in the offer or sale of our securities will be identified
in a prospectus supplement. Unless the prospectus supplement states otherwise, our agent will act on a best-efforts basis for
the period of its appointment.
If
a dealer is utilized in the sale of the securities being offered by this prospectus, the securities will be sold to the dealer,
as principal. The dealer may then resell the securities to the public at varying prices to be determined by the dealer at the
time of resale.
If
an underwriter is utilized in the sale of the securities being offered by this prospectus, an underwriting agreement will be executed
with the underwriter at the time of sale and the name of any underwriter will be provided in the prospectus supplement that the
underwriter will use to make resales of the securities to the public. In connection with the sale of the securities, we, or the
purchasers of securities for whom the underwriter may act as agent, may compensate the underwriter in the form of underwriting
discounts or commissions. The underwriter may sell the securities to or through dealers, and those dealers may receive compensation
in the form of discounts, concessions or commissions from the underwriters and/or commissions from the purchasers for which they
may act as agent. Unless otherwise indicated in a prospectus supplement, an agent will be acting on a best efforts basis and a
dealer will purchase securities as a principal, and may then resell the securities at varying prices to be determined by the dealer.
Any
compensation paid to underwriters, dealers or agents in connection with the offering of the securities, and any discounts, concessions
or commissions allowed by underwriters to participating dealers will be provided in the applicable prospectus supplement. Underwriters,
dealers and agents participating in the distribution of the securities may be deemed to be underwriters within the meaning of
the Securities Act, and any discounts and commissions received by them and any profit realized by them on resale of the securities
may be deemed to be underwriting discounts and commissions. We may enter into agreements to indemnify underwriters, dealers and
agents against civil liabilities, including liabilities under the Securities Act, or to contribute to payments they may be required
to make in respect thereof and to reimburse those persons for certain expenses.
Any
common stock will be listed on the NYSE American, but any other securities may or may not be listed on a national securities exchange.
To facilitate the offering of securities, certain persons participating in the offering may engage in transactions that stabilize,
maintain or otherwise affect the price of the securities. This may include over-allotments or short sales of the securities, which
involve the sale by persons participating in the offering of more securities than were sold to them. In these circumstances, these
persons would cover such over-allotments or short positions by making purchases in the open market or by exercising their over-allotment
option, if any. In addition, these persons may stabilize or maintain the price of the securities by bidding for or purchasing
securities in the open market or by imposing penalty bids, whereby selling concessions allowed to dealers participating in the
offering may be reclaimed if securities sold by them are repurchased in connection with stabilization transactions. The effect
of these transactions may be to stabilize or maintain the market price of the securities at a level above that which might otherwise
prevail in the open market. These transactions may be discontinued at any time.
We
may authorize underwriters, dealers or other persons acting as our agents to solicit offers by certain institutions or other suitable
purchasers to purchase securities from us at the public offering price set forth in the prospectus supplement, pursuant to delayed
delivery contracts providing for payment and delivery on the date stated in each applicable prospectus supplement. Each contract
will be for an amount not less than, and the aggregate amount of securities sold pursuant to such contracts shall not be less
nor more than, the respective amounts stated in each applicable prospectus supplement. Institutions with whom the contracts, when
authorized, may be made include commercial and savings banks, insurance companies, pension funds, investment companies, educational
and charitable institutions and other institutions, but shall in all cases be subject to our approval. Delayed delivery contracts
will be subject only to those conditions set forth in each applicable prospectus supplement and include the condition that the
purchase of the securities covered by the delayed delivery contracts will not at the time of delivery be prohibited under the
laws of any jurisdiction in the United States to which the purchaser is subject. Each prospectus supplement will set forth any
commissions we pay for solicitation of these contracts. The underwriters and agents will not have any responsibility with respect
to the validity or performance of these contracts.
All
securities we may offer, other than common stock, will be new issues of securities with no established trading market. Any agents
or underwriters may make a market in these securities, but will not be obligated to do so and may discontinue any market making
at any time without notice. We cannot guarantee the liquidity of the trading markets for any securities. There is currently no
market for any of the offered securities, other than our common stock which is listed on the on the NYSE American. Any common
stock will be listed on the NYSE American but any other securities may or may not be listed on a national securities exchange.
We have no current plans for listing of the, warrants on any securities exchange or quotation system; any such listing with respect
to any particular warrants will be described in the applicable prospectus supplement or other offering materials, as the case
may be.
Any
agents and underwriters who are qualified market makers on the NYSE American may engage in passive market making transactions
in the securities on the NYSE American in accordance with Regulation M, during the business day prior to the pricing of the offering,
before the commencement of offers or sales of the securities. Passive market makers must comply with applicable volume and price
limitations and must be identified as passive market makers. In general, a passive market maker must display its bid at a price
not in excess of the highest independent bid for such security; if all independent bids are lowered below the passive market maker’s
bid, however, the passive market maker’s bid must then be lowered when certain purchase limits are exceeded. Passive market
making may stabilize the market price of the securities at a level above that which might otherwise prevail in the open market
and, if commenced, may be discontinued at any time.
We
may engage in at the market offerings into an existing trading market in accordance with Rule 415(a)(4) under the Securities Act.
In addition, we may enter into derivative transactions with third parties, or sell securities not covered by this prospectus to
third parties in privately negotiated transactions. If the applicable prospectus supplement so indicates, in connection with those
derivatives, the third parties may sell securities covered by this prospectus and the applicable prospectus supplement, including
in short sale transactions. If so, the third party may use securities pledged by us or borrowed from us or others to settle those
sales or to close out any related open borrowings of stock, and may use securities received from us in settlement of those derivatives
to close out any related open borrowings of stock. The third party in such sale transactions will be an underwriter and, if not
identified in this prospectus, will be named in the applicable prospectus supplement (or a post-effective amendment). In addition,
we may otherwise loan or pledge securities to a financial institution or other third party that in turn may sell the securities
short using this prospectus and an applicable prospectus supplement. Such financial institution or other third party may transfer
its economic short position to investors in our securities or in connection with a concurrent offering of other securities.
The
specific terms of any lock-up provisions in respect of any given offering will be described in the applicable prospectus supplement.
The
underwriters, dealers and agents may engage in transactions with us, or perform services for us, in the ordinary course of business
for which they receive compensation.
In
compliance with guidelines of the Financial Industry Regulatory Authority, Inc., or FINRA, the maximum compensation to be received
by any FINRA member or independent broker dealer may not exceed 8% of the aggregate amount of the securities offered pursuant
to this prospectus and any applicable prospectus supplement.
LEGAL
MATTERS
Unless
otherwise indicated in the applicable prospectus supplement, certain legal matters in connection with the offering and the validity
of the securities offered by this prospectus, and any supplement thereto, will be passed upon for us by Shumaker, Loop & Kendrick,
LLP.
EXPERTS
The
audited financial statements of Oragenics, Inc. as of December 31, 2018 and 2017, and for the two-year period ended December 31,
2018, included in our Annual Report on Form 10-K for the year ended December 31, 2018, incorporated by reference in this prospectus
have been audited by Mayer Hoffman McCann P.C., an independent registered public accounting firm, as stated in their report dated
March 29, 2019, which is incorporated by reference herein, and has been so incorporated in reliance upon the report of such firm
given upon their authority as experts in accounting and auditing.
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
This
prospectus is part of a registration statement we filed with the SEC. This prospectus does not contain all of the information
set forth in the registration statement and the exhibits to the registration statement. For further information with respect to
us and the securities we are offering under this prospectus, we refer you to the registration statement and the exhibits and schedules
filed as a part of the registration statement. You should rely only on the information contained in this prospectus or incorporated
by reference in this prospectus. We have not authorized anyone else to provide you with different information. We are not making
an offer of these securities in any state where the offer is not permitted. You should not assume that the information in this
prospectus is accurate as of any date other than the date on the front page of this prospectus, regardless of the time of delivery
of this prospectus or any sale of the securities offered by this prospectus.
We
file annual, quarterly and current reports, proxy statements and other information with the SEC. Our SEC filings are available
to the public at the SEC’s website at http://www.sec.gov.
Copies
of certain information filed by us with the SEC are also available on our website at www.Oragenics.com Information contained
in or accessible through our website does not constitute a part of this prospectus and is not incorporated by reference in this
prospectus.
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
The
SEC allows us to incorporate by reference the information we file with it, which means that we can disclose important information
to you by referring you to another document that we have filed separately with the SEC. You should read the information incorporated
by reference because it is an important part of this prospectus. We incorporate by reference the following information or documents
that we have filed with the SEC, excluding any portions of any Current Report on Form 8-K that are not deemed “filed”
pursuant to the General Instructions of Form 8-K:
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Our
Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on March 29, 2019 and our Form 10-K/A
for the year ended December 31, 2018, filed with the SEC on April 29, 2019;
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Our
Quarterly Reports on Form 10-Q for the quarter ended March 31, 2019, filed with the SEC on May 13, 2019, for the quarter ended
June 30, 2019 filed with the SEC on August 14, 2019 and for the quarter ended September 30, 2019 filed with the SEC on November
14, 2019;
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Our
Definitive Proxy Statement on Schedule 14A, filed with the SEC on May 16, 2019;
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Our
Current Reports on Form 8-K, filed February 22, 2019, March 15, 2019, March 20, 2019, March 21, 2019, March 25, 2019, June
21, 2019, September 6, 2019, September 23, 2019, September 25, 2019, September 30, 2019, October 22, 2019, December 2, 2019
and December 4, 2019; and
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The
description of our common stock set forth in our registration statement on Form 8-A12B, filed April 8, 2013, including any
amendments or reports filed for purposes of updating such description.
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Any
information in any of the foregoing documents will automatically be deemed to be modified or superseded to the extent that information
in this prospectus or in a later filed document that is incorporated or deemed to be incorporated herein by reference modifies
or replaces such information.
We
also incorporate by reference any future filings (other than current reports furnished under Item 2.02 or Item 7.01 of Form 8-K
and exhibits filed on such form that are related to such items) made with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d)
of the Exchange Act, including those made after the date of filing of the initial registration statement and prior to effectiveness
of the registration statement, until we file a post-effective amendment that indicates the termination of the offering of the
securities made by this prospectus. Information in such future filings updates and supplements the information provided in this
prospectus. Any statements in any such future filings will automatically be deemed to modify and supersede any information in
any document we previously filed with the SEC that is incorporated or deemed to be incorporated herein by reference to the extent
that statements in the later filed document modify or replace such earlier statements.
We
will provide to each person, including any beneficial owner, to whom a prospectus is delivered, without charge upon written or
oral request, a copy of any or all of the documents that are incorporated by reference into this prospectus but not delivered
with the prospectus, including exhibits which are specifically incorporated by reference into such documents. You may request
a copy of these filings at no cost, by writing to or telephoning us at the following address: Oragenics, Inc., 4902 Eisenhower
Boulevard, Suite 125, Tampa, Florida 33634, Attention: Corporate Secretary.
Shares
of Common Stock
PROSPECTUS
SUPPLEMENT
November
, 2020
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