As
filed with the Securities and Exchange Commission on January 13,
2023
Registration
No.
333-[ ]
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-3
REGISTRATION
STATEMENT
UNDER
THE SECURITIES ACT OF 1933
ORAGENICS,
INC.
(Exact
name of registrant as specified in its charter)
Florida |
|
59-3410522 |
(State
or other jurisdiction of
incorporation
or organization)
|
|
(I.R.S.
Employer
Identification
No.)
|
4902
Eisenhower Boulevard, Suite 125
Tampa,
Florida 33634
(813)
286-7900
(Address,
including zip code, and telephone number, including area code, of
principal executive offices)
Kimberly
M. Murphy
Chief
Executive Officer and President
Oragenics,
Inc.
4902
Eisenhower Boulevard, Suite 125
Tampa,
Florida 33634
(813)
286-7900
(Name,
address, including zip code, and telephone number, including area
code, of agent for service)
With copies to:
Mark
A. Catchur, Esq.
Shumaker,
Loop & Kendrick, LLP
101
East Kennedy Boulevard
Suite
2800
Tampa,
Florida 33602
Telephone:
(813) 229-7600
Facsimile:
(813) 229-1660
Approximate
date of commencement of proposed sale to the public: From time
to time after this registration statement becomes
effective.
If
the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check
the following box. ☐
If
any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to Rule 415 under
the Securities Act of 1933, other than securities offered only in
connection with dividend or interest reinvestment plans, check the
following box. ☒
If
this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration
statement number of the earlier effective registration statement
for the same offering. ☐
If
this Form is a post-effective amendment filed pursuant to Rule
462(c) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier
effective registration statement for the same offering.
☐
If
this Form is a registration statement pursuant to General
Instruction I.D. or a post-effective amendment thereto that shall
become effective on filing with the Commission pursuant to Rule
462(e) under the Securities Act, check the following box.
☐
If
this Form is a post-effective amendment to a registration statement
filed pursuant to General Instruction I.D. filed to register
additional securities or additional classes of securities pursuant
to Rule 413(b) under the Securities Act, check the following box.
☐
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated filer,” “smaller reporting
company” and “emerging growth company” in Rule 12b-2 of the
Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
|
|
|
|
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
|
|
|
|
|
Emerging
growth company |
☐ |
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided to
Section 7(a)(2)(B) of the Securities Act. ☐
The
Registrant hereby amends this Registration Statement on such date
or dates as may be necessary to delay its effective date until the
Registrant shall file a further amendment which specifically states
that the Registration Statement shall thereafter become effective
in accordance with Section 8(A) of the Securities Act of 1933, or
until this registration statement shall become effective on such
date as the Commission, acting pursuant to section 8(a), may
determine.
The information in this prospectus is not complete and may be
changed. We may not sell these securities until the registration
statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these securities
and is not soliciting an offer to buy these securities in any state
where the offer or sale is not permitted.
Subject to Completion, Dated January 13, 2023
PROSPECTUS

$40,000,000
Common
Stock
Warrants
Units
From
time to time, we may offer, issue and sell up to $40,000,000 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.
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.
Our
common stock is listed on the NYSE American under the symbol
“OGEN.” The last reported sale price of our common stock on January
12, 2023 was $7.63 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
January 12, 2023, the aggregate market value of our outstanding
common stock held by non-affiliates, or the public float, was
approximately $14,662,868, which was calculated based on 1,921,739
shares of our outstanding common stock held by non-affiliates and
on a price of $7.63 per share, the last reported sale price for our
common stock on January 12, 2023. 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” beginning on page 8 of this
prospectus, or contained in the applicable prospectus supplement
and any related free writing prospectus we have authorized for use
in connection with a specific offering, and under similar headings
in the other documents that are incorporated by reference into this
prospectus.
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
,
2023.
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 $40,000,000. 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 investing in
any of the securities 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 as of the date of the
document incorporated by reference, but not on any date subsequent
to 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 and the information incorporated herein by reference
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,” and information under
similar headings in the other documents that are incorporated by
reference into this prospectus. You should also carefully read the
information incorporated by reference into this prospectus,
including our financial statements and related notes, and the
exhibits to the registration statement of which this prospectus is
a part, 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.
We own various U.S. federal trademark applications and unregistered
trademarks, including our company name. All other trademarks or
trade names referred to in this prospectus are the property of
their respective owners. Solely for convenience, the trademarks and
trade names in this prospectus are referred to without the symbols
® and ™, but such references should not be construed as any
indication that their respective owners will not assert, to the
fullest extent under applicable law, their rights
thereto.
Overview
We
are a development-stage company dedicated to fighting infectious
diseases including coronaviruses and multidrug-resistant organisms.
Our lead product (NT-CoV2-1) is an intranasal vaccine candidate to
prevent coronavirus disease (“COVID-19”) from the SARS-CoV-2 virus
and variants thereof. The NT-CoV2-1 program leverages coronavirus
spike protein research licensed from the National Institutes of
Health and the National Research Council of Canada with a focus on
reducing viral transmission and offering a more patient-friendly
intranasal administration. Our lantibiotics program features a
novel class of antibiotics against bacteria that have developed
resistance to commercial antibiotics.
Our
SARS-CoV-2 Vaccine Product Candidate - NT-CoV2-1
Following
our May 2020 acquisition of one hundred percent (100%) of the total
issued and outstanding common stock of Noachis Terra, Inc.
(“Noachis Terra”) we are focused on the development and
commercialization of a vaccine product candidate to provide
long-lasting immunity from SARS-CoV-2, which causes 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 stabilized coronavirus spike
proteins and their use in the development and commercialization of
a vaccine to provide specific, long lasting immunity from
SARS-CoV-2. Since the acquisition we have conducted testing in
animal models, including SARS-CoV-2 challenge studies in hamsters,
using specific formulations for intramuscular administration (our
Terra CoV-2 vaccine candidate) and intranasal administration (our
NT-CoV2-1 vaccine candidate), both based on the NIAID pre-fusion
stabilized spike protein antigens. Following consideration of a
number of factors, including but not limited to the competitive
landscape, we determined to bring the intranasal vaccine candidate
NT-CoV2-1, into further development due to the greater
differentiation versus current COVID-19 vaccines and the potential
benefits of intranasal over intramuscular administration. We
believe these benefits could include a higher reduction of
transmission of SARS-CoV-2 and would offer a needle-free delivery
option. We therefore are currently focusing our development efforts
on our more highly differentiated NT-CoV2-1 vaccine
candidate.
On
July 26, 2021, we entered into a licensing agreement with the
National Research Council (“NRC”) that enables us to pursue the
development of next-generation vaccines against the SARS-CoV-2
virus and its variants. The license was subsequently amended to:
include the Omicron variant, broaden the non-exclusive field of use
to include all diseases caused by coronaviruses, and any genetic
variants thereof, to add a research protocol developed by the NRC,
and to add reagents as part of the NRC Technology licensed by us.
The NRC technologies, in combination with the licensed technologies
from the U.S. NIH used in our NT-CoV2-1 vaccine candidate, provide
us with a platform that can generate cell lines for high-yield
production of spike protein antigens for existing and emerging
variants of concern. This platform should allow production of cell
lines within six to eight weeks of spike gene sequence
availability, compared with six to nine months for traditional
production of such cell lines. The NRC technologies, developed with
support from the NRC’s Pandemic Response Challenge Program, are
expected to enable expedited evaluation of SARS-CoV-2 antigen
candidates in pre-clinical and clinical studies.
Coronaviruses
are a family of viruses that can lead to upper-respiratory
infections in humans. 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, 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). Pfizer/BioNTech received FDA approval for their
COVID-19 vaccines in August of 2021 and the Moderna vaccine in
January 2022. The Janssen vaccine is currently available in the
United States under Emergency Use Authorizations (“EUA”) by the
FDA. In July 2022, the FDA granted EUA for the Novavax COVID-19
vaccine as well. Current vaccines have reduced the rates of
hospitalization and death due to COVID-19 in vaccinated
individuals, but the transmission levels even in vaccinated
individuals has allowed SARS-CoV-2 variants to continue to
circulate. We believe given the size of the worldwide spread of
COVID-19 that even with additional vaccines available, there will
be demand for the highly differentiated NT-CoV2-1 vaccine, once
development is successfully completed. We intend to combine the
research, patent applications and biological materials covered by
our NIAID license and with our NRC license and our existing
clinical research and manufacturing capabilities to respond to this
ongoing, global, public health issue. We believe our NT-CoV2-1
vaccine holds the possibility of playing an important role in
addressing this issue.
Coronaviruses,
such as SARS-CoV-2, possess signature protein spikes on their outer
capsule. Our 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. Spike
protein antigens stabilized in the pre-fusion state have been used
successfully in the leading COVID-19 vaccines from Pfizer/BioNTech
and Moderna, which we believe reduces the risk of using the same
approach in our NT-CoV2-1 vaccine candidate. 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 pre-clinical
biologics product development, has extensive experience building
CHO cell lines for recombinant proteins, such as monoclonal
antibodies. Aragen successfully inserted the NIH pre-fusion spike
protein gene sequence into a CHO cell line and Oragenics is
currently producing Phase 1 clinical material based upon this cell
line.
We
entered into both a material transfer agreement and a non-exclusive
research license agreement with Inspirevax for the use of
intranasal mucosal adjuvants in our NT-CoV2-1 vaccine candidates.
Regarding the intranasal mucosal adjuvants of interest, BDX300 and
BDX301 are proteosome-based adjuvants comprised of proteins and
lipopolysaccharides with improved attributes including enhanced
immune response, manufacturing efficiency and the benefits of
intranasal vaccine administration. The non-exclusive license
agreement allows for the collaboration and research regarding the
intranasal delivery of vaccine during clinical development with the
opportunity to enter into a commercial agreement upon regulatory
approval of the intranasal vaccine. The NT-CoV2-1 vaccine
containing Inspirevax’s intranasal mucosal adjuvant BDX301 has been
studied in pre-clinical animal studies, including hamster viral
challenge studies and mouse immunogenicity studies. A rabbit
toxicology study has been initiated and is required for regulatory
approval prior to the Phase 1 clinical study.
A
Non-Exclusive Research License Agreement with Inspirevax was
executed in February 2022. This agreement granted the Company
non-exclusive rights to conduct non-clinical and clinical research
and trials in relation to vaccines comprising the BDX300 or BDX301
adjuvants to prevent or treat diseases caused by coronaviruses and
genetic variants thereof.
We
began pre-clinical studies in June of 2021 through our
collaboration and material transfer agreement with the NRC. We
initiated an immunogenicity study in mice to evaluate several
adjuvant candidates. On August 30, 2021, we announced the
successful completion of these mouse immunogenicity studies that
supported further development using either the intramuscular or
intranasal routes of administration. A hamster challenge study was
initiated in September of 2021 to assess inhibition of viral
replication using adjuvants specific for intramuscular and
intranasal administration. In December of 2021, we announced that
both formulations generated robust immune responses and reduced the
SARS-CoV-2 viral loads to undetectable levels in the nasal passages
and lungs five days following a viral challenge. By contrast,
hamsters in the control groups that had received saline or
adjuvants alone had no detectable immune response and substantial
viral loads. The vaccines delivered by intranasal and intramuscular
routes generated immune responses as measured by multiple assays.
On June 14, 2022, we announced that the results of these studies
were published in Nature Scientific Reports.
In
March of 2022, following a positive assessment of a rabbit-based
pilot study, we initiated a Good Laboratory Practice toxicology
study to evaluate the safety profile and immunogenicity of
NT-CoV2-1 in rabbits. This important preclinical study is designed
to provide data required to advance our intranasal vaccine
candidate into human clinical studies. The study has concluded and
we completed the full set of toxicology data, which is needed to
support the filing of an IND application for NT-CoV2-1. Based on
the findings of the final toxicology report, including a full
histopathology evaluation, we were able to confirm a safety and
immunogenicity profile that further support our plan to submit
regulatory filings required to progress to a Phase 1 clinical
study.
While
we previously had a Type B Pre-IND Meeting with the FDA on our
intramuscular vaccine product candidate, we again met with the FDA
in a Type B Pre-IND Meeting request to discuss our intranasal
vaccine product candidate. As a result of this meeting, the FDA
indicated that the Company could file an IND application for
NT-CoV2-1 following the availability of the final GLP toxicology
report for inclusion in the IND.
We
believe the benefits of our NT-CoV2-1 vaccine product candidate
through its intranasal delivery mechanism to be:
● |
Targeted
Mucosal Immunity – Conventional injectable vaccines are poor
inducers of mucosal immunity, whereas intranasal immunization can
induce strong mucosal immunity by enhancing the immune response at
the entry sites of mucosal pathogens. When the SARS-CoV-2 virus
enters the nasal cavity, the respiratory epithelial layer is the
first barrier against viral infection. The intranasal route of
vaccination provides two additional layers of protection over
intramuscular shots because (i) it produces immunoglobulin A and
resident memory B and T cells in the respiratory mucosa that are an
effective barrier to infection at those sites, and (ii)
cross-reactive resident memory B and T cells can respond earlier
than other immune cells should a viral variant start an
infection. |
● |
Needle-Free
Administration – As an obvious benefit, intranasal
administration means needle-free delivery, resulting in meaningful
differentiation for children and needle-phobic populations,
improved compliance and the potential for
self-administration. |
● |
Storage
& Transport – The currently available mRNA-based vaccines
have been delivered globally via stringent storage and transport
requirements that strain distribution logistics under the best of
circumstances. A key benefit of our NT-CoV2-1 vaccine candidate is
a significantly reduced handling burden, allowing transport at a
more manageable refrigeration temperature (5°C) that improves
access globally including remote and under-vaccinated
geographies. |
● |
Durability
– Broad initial success with mRNA vaccines has significantly
diminished COVID-19’s impact and death, but the trade-off has been
fleeting efficacy. By benefitting from the immunological properties
of the hybrid NIH/NRC construct, NT-CoV2-1 is potentially much more
durable and long-lasting than currently available mRNA-based
therapies. |
Through
assessment of a variety of factors including our pre-clinical
testing to date, the expected benefits noted above, evolving
variants and available vaccines in use, we determined to focus our
development efforts on the intranasal delivery of our vaccine
product candidate, NT-CoV2-1, which we believe is more highly
differentiated than the currently available and late-stage COVID-19
vaccines. We expect to seek to file an IND application with the FDA
and to thereafter commence a Phase 1 clinical study with NT-CoV2-1,
the protocol for which is currently under development.
We
expect to use our currently available cash resources to continue to
advance the development of NT-CoV2-1 through IND-enabling studies
and commencement of a Phase 1 clinical trial with further clinical
development being contingent upon the receipt of additional
funding, including non-dilutive government grant funding which we
continue to pursue, or partnering or out-licensing
opportunities.
Our
Antibiotic Product Candidate - Oragenics Derived Compound
(ODC-x)
Members
of our scientific team discovered that a certain bacterial strain
of Streptococcus mutans, produces Mutacin 1140 (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. Over 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 antibiotic-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.
The
timing of the filing of an IND regarding any future lantibiotic
candidate 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 expect to continue to advance our
lantibiotics program to an IND filing based on the availability of
both human and financial capital. Based upon the current funding we
expect to continue to focus on the identification of new potential
product lantibiotic candidates, efficient and cost-effective
improvements in the manufacturing processes and pre-clinical
studies required to support a first in human Phase 1 clinical
study.
In
October 2021, we were awarded a small business innovation research
grant in the amount of $250,000 (“Computer-aided Design for
Improved Lantibiotics”, R41GM136034) for the Company’s continued
research and development of lantibiotics, including its
collaborative program with the Biomolecular Sciences Institute at
Florida International University (FIU). The grant provides the
Company with funding to develop novel lantibiotics for the
treatment of ESKAPE pathogens (defined as Enterococcus faecium,
Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter
baumannii, Pseudomonas aeruginosa, and Enterobacter
spp.).
Product
Candidates.
Through
our wholly-owned subsidiary, Noachis Terra, we began the research
and development stage for our new Terra CoV-2 and NT-CoV2-1 vaccine
product candidates. 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 against SARS-CoV-2. We also hold a
non-exclusive license with the NRC that enables us to pursue the
rapid development of next-generation vaccines against the
SARS-CoV-2 (the “NIH License”) virus and its variants (the “NRC
License” and together with the NIH License the “License
Agreements”).
Additionally,
we are developing semi-synthetic lantibiotic analogs that may be
effective against systemic Gram-positive multidrug infections, and
analogs that may be effective in treating Gram-negative infections.
We seek to protect our product candidates through patents and
patent applications pursuant to the terms of our License
Agreements.
Product/Candidate |
|
Description |
|
Application |
|
Status |
|
|
|
|
|
|
|
NT-CoV2-1 |
|
Intranasal
vaccine candidate (recombinant protein + adjuvant) to provide long
lasting immunity against SARS-CoV-2 |
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Broad,
community-based vaccine immunity against SARS-CoV-2 |
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Pre-clinical |
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Antibiotics |
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Semi-synthetic
analogs of MU1140: Member of lantibiotic class of
antibiotics |
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Healthcare-associated
infections |
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Pre-clinical |
Recent
Developments
On
December 22, 2022 our board of directors approved a 1 for 60
reverse stock split of our authorized, issued and outstanding of
common stock to be effective on January 20, 2023. The par value per
common shares will remain unchanged. Except where the context
otherwise requires, share numbers in this prospectus reflect the 1
for 60 reverse stock split of our common stock.
Our
Business Development Strategy
Success
in the biopharmaceutical and product development industry relies on
the continuous development of novel product candidates. Most
product candidates do not make it past the clinical development
stage, which forces companies to look externally for innovation.
Accordingly, we expect from time to time, to seek strategic
opportunities through various forms of business development, which
can include strategic alliances, licensing deals, joint ventures,
collaborations, equity-or debt-based investments, dispositions,
mergers and acquisitions. We view these business development
activities as a necessary component of our strategies, and we seek
to enhance shareholder value by evaluating business development
opportunities both within and complementary to our current business
as well as opportunities that may be new and separate from the
development of our existing product candidates.
Corporate
and Other Information
We
were incorporated in November 1996 and commenced operations in
1999. We consummated our initial public offering in June 2003. 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. We make available free of charge on our
website our annual report on Form 10-K, quarterly reports on Form
10-Q, current reports on Form 8-K and amendments to those reports
as soon as reasonably practicable after we electronically file or
furnish such materials to the Securities and Exchange Commission
(the “SEC”). The reports are also available at www.sec.gov. We do
not incorporate by reference into this prospectus the information
on, or accessible through, our website, and you should not consider
it as part of this prospectus and it should not be relied on in
connection with this offering. We have included our website address
as an inactive textual reference only.
Implications
of Being a Smaller Reporting Company
We
are a “smaller reporting company” as defined in Rule 12b-2
promulgated under the Securities Exchange Act of 1934, as amended,
or the Exchange Act. We may remain a smaller reporting company
until we have a non-affiliate public float in excess of $250
million and annual revenues in excess of $100 million, or a
non-affiliate public float in excess of $700 million, each as
determined on an annual basis. A smaller reporting company may take
advantage of relief from some of the reporting requirements and
other burdens that are otherwise applicable generally to public
companies. These provisions include:
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being
permitted to provide only two years of audited financial
statements, in addition to any required unaudited interim financial
statements, with correspondingly reduced “Management’s Discussion
and Analysis of Financial Condition and Results of Operations”
disclosure; |
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not
being required to comply with the auditor attestation requirements
in the assessment of our internal control over financial reporting;
and |
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reduced
disclosure obligations regarding executive compensation in our
periodic reports, proxy statements and registration
statements. |
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 $40 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. We will describe in the applicable
prospectus supplement relating to any securities the particular
terms of the securities offered by that prospectus supplement. If
we indicate in the applicable prospectus supplement, the terms of
the securities may differ from the terms we have summarized below.
We may also include in the prospectus supplement information about
material United States federal income tax considerations relating
to the securities, and the securities exchange, if any, on which
the securities will be listed.
We
may sell from time to time, in one or more offerings:
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Common
stock; |
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Warrants
to purchase shares of common stock; and |
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Units
consisting of any combination of the securities listed
above. |
In
this prospectus, we refer to the common stock, warrants and units
collectively as “securities.” The total dollar amount of all
securities that we may sell pursuant to this prospectus will not
exceed $40,000,000.
This
prospectus may not be used to consummate a sale of securities
unless it is accompanied by a prospectus supplement.
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, 2021, as updated or supplemented by any
subsequently filed periodic reports and other documents as filed
with the SEC and 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 Exchange Act, these
forward-looking statements include statements regarding:
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We
have incurred significant operating losses since our inception and
cannot assure you that we will generate revenues or achieve
profitability; |
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We
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, non-dilutive or otherwise, necessary to do 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 pre-clinical 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 including as to
administration, distribution and storage; |
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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, the NRC
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 and
consultants; |
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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 NT-CoV2-1 vaccine
product candidate under the timelines and in accord with the
milestones projected; |
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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 pre-clinical 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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The
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 and the
effects of our contemplated 1 for 60 reverse stock split on our
price per share and the trading market of our common
stock; |
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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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We
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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The
impact of laws and regulations, including those that may not yet
exist. |
In
some cases, you can identify forward-looking statements by the
words “may,” “might,” “can,” “will,” “to be,” “could,” “would,”
“should,” “expect,” “intend,” “plan,” “objective,” “anticipate,”
“believe,” “estimate,” “predict,” “project,” “potential,” “likely,”
“continue” and “ongoing,” or the negative of these terms, or other
comparable terminology intended to identify statements about the
future, although not all forward-looking statements contain these
words. These statements involve known and unknown risks,
uncertainties and other factors that may cause our actual results,
levels of activity, performance or achievements to be materially
different from the information expressed or implied by these
forward-looking statements.
You
should refer to the “Risk Factors” section 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, for a
discussion of important factors that may cause our actual results
to differ materially from those expressed or implied by our
forward-looking statements. Given these risks, uncertainties and
other factors, many of which are beyond our control, we cannot
assure you that the forward-looking statements in this prospectus
will prove to be accurate, and you should not place undue reliance
on these forward-looking statements. Furthermore, if our
forward-looking statements prove to be inaccurate, the inaccuracy
may be material. In light of the significant uncertainties in these
forward-looking statements, you should not regard these statements
as a representation or warranty by us or any other person that we
will achieve our objectives and plans in any specified time frame,
or at all.
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, which may include,
without limitation, funding research, clinical and process
development and manufacturing of our product candidates. We
may also use a portion of the net proceeds to invest in,
collaborate with, acquire, or in-licensing of products or product
candidates, business 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.
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 250,000,000 (4,166,666
following the effectiveness of our 1 for 60 reverse stock on
January 20, 2023) shares of common stock, par value $0.001, and
50,000,000 shares of preferred stock, without par value.
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. One third of our
shares entitled to vote constitute a quorum for purposes of a
meeting of our shareholders.
Dividends
Subject
to preferences that may be applicable to any outstanding preferred
stock, the holders of our common stock are entitled to receive
ratably all dividends, if any, as may be declared from time to time
by our Board of Directors out of the funds legally
available.
In
the event of the liquidation, dissolution or winding up of the
Company, the holders of our common stock are entitled to share
ratably in all assets remaining after payment of liabilities,
subject to prior distribution rights of preferred stock, if any,
then outstanding. The common stock has no preemptive or conversion
rights. There are no redemption or sinking fund provisions
applicable to the common stock. All outstanding shares of common
stock are fully paid and non-assessable.
Rights
upon Liquidation
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.
Redemption
and Pre-Emptive Rights
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, and Series B 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.
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 and August 26, 2022, certain holders of
Series A Convertible Preferred Stock elected to convert to common
stock and, as a result of such conversions, 5,417,000 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 of $0.25 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 in lieu of fractional shares
rounded 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 and will be subject
to further adjustment following the Company’s contemplated 1 for 60
reverse stock split expected to be effective on January 20,
2023.
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. On August 26,
2022 a certain holder of Series B Convertible Preferred Stock
elected to convert to common stock and, as a result of such
conversion, 4,050,000 shares of Series B Convertible Preferred
Stock remain outstanding.
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 of $0.50 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 and
will be subject to further adjustment following the Company’s
contemplated 1 for 60 reverse stock split expected to be effective
on January 20, 2023.
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 to a single older 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 were 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. During the three months ended March 31,
2021, the Company provided a notice of redemption, to the holder of
the Company’s Series C Preferred Stock to redeem all outstanding
Series C Preferred Stock (which included the dividend of 26.697
shares paid on January 28, 2021 and any accrued dividends due
through the redemption date of March 13, 2021). The Series C
Preferred Stock redemption amount of approximately $5.6 million was
paid on March 15, 2021 and all outstanding shares of Series C
Preferred Stock were cancelled.
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.
Registration
Rights
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. |
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, 1 State Street 30th Floor, 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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the
title of such securities; |
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the
offering price and aggregate number of warrants
offered; |
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the
currency or currencies 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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if
applicable, the date on and after which the warrants and the
related securities will be separately transferable; |
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if
applicable, the minimum or maximum amount of such warrants which
may be exercise at any one time; |
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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, and the currency in 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
dates on which the right to exercise the warrants shall commence or
expire; |
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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
antidilution provisions of the warrant, if any; |
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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. |
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. |
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. |
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. |
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. |
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 from time to time pursuant to underwritten
public offerings, direct sales to the public, direct sales to the
public, negotiated transactions, block trades or a combination of
these methods. 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 |
We
may also sell equity securities covered by this registration
statement in an “at the market” offering as defined in Rule
415(a)(4) under the Securities Act. Such offering may be made into
an existing trading market for such securities in transactions at
other than a fixed price on or through the facilities of NYSE
American or any other securities exchange or quotation or trading
service on which such securities may be listed, quoted or traded at
the time of sale. Such at the market offerings, if any, may be
conducted by underwriters acting as principal or agent.
A
prospectus supplement or (and any related free writing prospectus
that we may authorize to be provided to you) will describe the
terms of the offering of the securities, including, to the extent
applicable:
|
● |
the
name or names of any underwriters, dealers or agents, if
any; |
|
● |
the
purchase price of the securities and the proceeds we will receive
from the sale; |
|
● |
any
over-allotment options under which underwriters may purchase
additional securities from us; |
|
● |
any
agency fees or underwriting discounts and other items constituting
agents’ or underwriters’ compensation; |
|
● |
any
public offering price; |
|
● |
any
discounts or concessions allowed or reallowed or paid to dealers;
and |
|
● |
any
securities exchange or market on which the securities may be
listed. |
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.
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. Additional legal matters may be passed upon
for us or any underwriters, dealers or agents, by counsel that we
will name in the applicable prospectus supplement.
EXPERTS
The
audited financial statements of Oragenics, Inc. as of December 31,
2021 and 2020, and for the years ended December 31, 2021 and 2020,
as set forth in its report included in our Annual Report on Form
10-K for the year ended December 31, 2021, 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 24, 2022, 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. We have included our website address as an inactive
textual reference only.
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:
|
● |
Our
Annual Report on Form 10-K for the year ended
December 31, 2021, filed with the SEC on March 24, 2022 and our
Form 10-K/A for the year ended
December 31, 2021, filed with the SEC on July 29, 2022; |
|
● |
Our
Quarterly Reports on Form 10-Q for the quarter ended March 31,
2022, filed with the SEC on May 13, 2022, for the quarter
ended June 30, 2022 filed with the SEC on August 9, 2022 and for the
quarter ended September 30, 2022 filed with the SEC on November 14, 2022; |
|
● |
Our
Definitive Proxy Statement on Schedule 14A, filed with the SEC
on October 31, 2022; |
|
● |
Our
Current Reports on Form 8-K, filed January 26, 2022, February 28, 2022, March 10, 2022, April 6, 2022, April 19, 2022, May 17, 2022, June 23, 2022, July 8, 2022, August 3, 2022, August 24, 2022, September 30, 2022, October 3, 2022, November 16, 2022, December 15, 2022, December 19, 2022, December 20, 2022, December 22, 2022 and December 23, 2022; |
|
● |
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. |
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 into this prospectus all documents
(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) that are filed by us with the SEC pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Exchange Act (i) after the date of
the initial filing of the registration statement of which this
prospectus forms a part and prior to effectiveness of the
registration statement, or (ii) after the date of this prospectus
but prior to the termination of the offering. These documents
include periodic reports, such as Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, as
well as proxy 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.
Any
statement contained in this prospectus or contained in a document
incorporated or deemed to be incorporated by reference into this
prospectus will be deemed to be modified or superseded to the
extent that a statement contained in this prospectus or any
subsequently filed supplement to this prospectus, or document
deemed to be incorporated by reference into this prospectus,
modifies or supersedes such statement.
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. Other Expenses of Issuance and Distribution.
The
following table sets forth an estimate of the fees and expenses
payable by the registrant in connection with the issuance and
distribution of the securities being registered. All amounts are
estimated except the SEC registration filing fee. All of the
expenses below will be paid by us.
|
|
|
|
SEC registration fee |
|
$ |
4,408 |
|
FINRA filing fee |
|
$ |
* |
|
Accounting fees and expenses |
|
$ |
* |
|
Legal fees and expenses |
|
$ |
* |
|
Transfer agent and registrar fees |
|
$ |
* |
|
Printing and engraving expenses |
|
$ |
* |
|
Miscellaneous |
|
$ |
* |
|
Total |
|
$ |
* |
|
* |
These
fees cannot be estimated at this time as they are calculated based
on the securities offered and the number of issuances. An estimate
of the aggregate expenses in connection with the sale and
distribution of the securities being offered will be included in
the applicable prospectus supplement. |
Item
15. Indemnification of Directors and Officers.
Under
our Bylaws, each of our directors has the right to be indemnified
by us to the maximum extent permitted by law against (i) reasonable
expenses incurred in connection with any threatened, pending or
completed civil, criminal, administrative, investigative or
arbitrative action, suit or proceeding seeking to hold the director
liable by reason of his or her actions in such capacity and (ii)
reasonable payments made by the director in satisfaction of any
judgment, money decree, fine, penalty or settlement for which he or
she became liable in such action, suit or proceeding. This right to
indemnification includes the right to the advancement of reasonable
expenses by us, to the maximum extent permitted by law. Under our
Bylaws, each of our officers who are not directors is entitled to
the same indemnification rights, including the right to the
advancement of reasonable expenses, which are provided to our
directors.
Pursuant
to the Florida Business Corporation Act, a Florida corporation has
the power to indemnify its directors and officers provided that
they act in good faith and reasonably believe that their conduct
was lawful and in the corporate interest (or not opposed thereto),
as set forth in the Business Corporation Act. Under the Business
Corporation Act, unless limited by its articles of incorporation, a
corporation must indemnify a director or officer who is wholly
successful, on the merits or otherwise, in the defense of any
proceeding to which he or she was a party because he or she is or
was a director or officer, against reasonable expenses incurred by
the director or officer in connection with the proceeding. Our
Articles of Incorporation do not contain any such limitations. The
Business Corporation Act permits a corporation to pay for or
reimburse reasonable expenses in advance of final disposition of an
action, suit or proceeding only upon (i) the director’s
certification that he or she acted in good faith and in the
corporate interest (or not opposed thereto), (ii) the director
furnishing a written undertaking to repay the advance if it is
ultimately determined that he or she did not meet this standard of
conduct, and (iii) a determination is made that the facts then
known to those making the determination would not preclude
indemnification under the Business Corporation Act.
Under
our Articles of Incorporation, no director will be liable to us or
our shareholders for monetary damages for breach of his or her
fiduciary duty as a director, to the maximum extent permitted by
law.
The
Florida Business Corporation Act also empowers a corporation to
provide insurance for directors and officers against liability
arising out of their positions, even though the insurance coverage
may be broader than the corporation’s power to indemnify. We
maintain directors’ and officers’ liability insurance for the
benefit of our directors and officers.
In
our employment agreement with Kimberly Murphy, our Chief Executive
Officer and President, we agreed to indemnify her for all claims
arising out of performance of her duties, other than those arising
out of their breach of the agreement or their gross negligence or
willful misconduct.
At
present, there is no pending litigation or proceeding involving any
of the registrant’s directors or executive officers as to which
indemnification is being sought nor is the registrant aware of any
threatened litigation that may result in claims for indemnification
by any executive officer or director.
The
registrant maintains an insurance policy covering its officers and
directors with respect to certain liabilities, including
liabilities arising under the Securities Act or
otherwise.
The
underwriting agreement, if any, entered into with respect to an
offering of securities registered hereunder will provide for
indemnification by any underwriters of any offering, our directors
and officers who sign the registration statement and our
controlling persons for some liabilities, including liabilities
arising under the Securities Act.
Item
16. Exhibits and Financial Statement Schedules.
* |
To be
filed by amendment or as an exhibit to a report pursuant to Section
13(a) or 15(d) of the Securities Exchange Act of 1934, as amended
and incorporated herein by reference. |
Item
17. Undertakings.
The
undersigned registrant hereby undertakes:
|
(1) |
To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration
statement: |
|
(i) |
To
include any prospectus required by Section 10(a)(3) of the
Securities Act; |
|
(ii) |
To
reflect in the prospectus any facts or events arising after the
effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing,
any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of
the estimated maximum offering range may be reflected in the form
of prospectus filed with the SEC pursuant to Rule 424(b) if, in the
aggregate, the changes in volume and price represent no more than a
20 percent change in the maximum aggregate offering price set forth
in the “Calculation of Registration Fee” table in the effective
registration statement; and |
|
(iii) |
To
include any material information with respect to the plan of
distribution not previously disclosed in the registration statement
or any material change to such information in the registration
statement; |
provided,
however, that subparagraphs (i), (ii) and (iii) above shall not
apply if the information required to be included in a
post-effective amendment by those paragraphs is contained in the
periodic reports filed with or furnished to the SEC by the
registrant pursuant to Section 13 or Section 15(d) of the Exchange
Act that are incorporated by reference in the registration
statement, or is contained in a prospectus filed pursuant to Rule
424(b) that is part of the registration statement.
|
(2) |
That,
for the purpose of determining any liability under the Securities
Act, each such post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein,
and the offering of such securities at that time shall be deemed to
be the initial bona fide offering thereof. |
|
(3) |
To
remove from registration by means of a post-effective amendment any
of the securities being registered which remain unsold at the
termination of the offering. |
|
(4) |
That,
for the purpose of determining liability under the Securities Act
to any purchaser: |
|
(i) |
Each
prospectus filed by a registrant pursuant to Rule 424(b)(3) shall
be deemed to be part of the registration statement as of the date
the filed prospectus was deemed part of and included in the
registration statement; and |
|
(ii) |
Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5)
or (b)(7) as part of a registration statement in reliance on Rule
430B relating to an offering made pursuant to Rule 415(a)(1)(i),
(vii) or (x) for the purpose of providing the information required
by Section 10(a) of the Securities Act shall be deemed to be part
of and included in the registration statement as of the earlier of
the date such form of prospectus is first used after effectiveness
or the date of the first contract of sale of securities in the
offering described in the prospectus. As provided in Rule 430B, for
liability purposes of the issuer and any person that is at that
date an underwriter, such date shall be deemed to be a new
effective date of the registration statement relating to the
securities in the registration statement to which the prospectus
relates, and the offering of such securities at that time shall be
deemed to be the initial bona fide offering thereof. Provided,
however , that no statement made in a registration statement or
prospectus that is part of the registration statement or made in a
document incorporated or deemed incorporated by reference into the
registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of
contract of sale prior to such effective date, supersede or modify
any statement that was made in the registration statement or
prospectus that was part of the registration statement or made in
any such document immediately prior to such effective
date. |
|
(5) |
That,
for the purpose of determining liability of the registrant under
the Securities Act to any purchaser in the initial distribution of
the securities, the undersigned registrant undertakes that in a
primary offering of securities of the undersigned registrant
pursuant to this registration statement, regardless of the
underwriting method used to sell the securities to the purchaser,
if the securities are offered or sold to such purchaser by means of
any to the following communications, the undersigned registrant
will be a seller to the purchaser and will be considered to offer
or sell such securities to such purchaser: |
|
(i) |
Any
preliminary prospectus or prospectus of the undersigned registrant
relating to the offering required to be filed pursuant to Rule
424; |
|
(ii) |
Any
free writing prospectus relating to the offering prepared by or on
behalf of the undersigned registrant or used or referred to by the
undersigned registrant; |
|
(iii) |
The
portion of any other free writing prospectus relating to the
offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the
undersigned registrant; and |
|
(iv) |
Any
other communication that is an offer in the offering made by the
undersigned registrant to the purchaser. |
|
(6) |
That,
for purposes of determining any liability under the Securities Act,
each filing of the registrant’s annual report pursuant to Section
13(a) or 15(d) of the Exchange Act (and, where applicable, each
filing of an employee benefit plan’s annual report pursuant to
Section 15(d) of the Exchange Act) that is incorporated by
reference in the registration statement shall be deemed to be a new
registration statement relating to the securities offered therein,
and the offering of such securities at that time shall be deemed to
be the initial bona fide offering thereof. |
|
(7) |
That,
for purposes of determining any liability under the Securities Act,
(i) the information omitted from the form of prospectus filed as
part of the registration statement in reliance upon Rule 430A and
contained in the form of prospectus filed by the registrant
pursuant to Rule 424(b)(l) or (4) or 497(h) under the Securities
Act shall be deemed to be a part of the registration statement as
of the time it was declared effective; and (ii) each post-effective
amendment that contains a form of prospectus shall be deemed to be
a new registration statement relating to the securities offered
therein, and the offing of such securities at that time shall be
deemed to be the initial bona fide offering thereof. |
|
(8) |
To
file an application for the purpose of determining the eligibility
of the trustee to act under subsection (a) of Section 310 of the
Trust Indenture Act of 1939, as amended (the “Act”), in accordance
with the rules and regulations prescribed by the SEC under Section
305(b)(2) of the Act. |
Insofar
as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers and controlling persons of
the registrant pursuant to existing provisions or arrangements
whereby the registrant may indemnify a director, officer or
controlling person of the registrant against liabilities arising
under the Securities Act, or otherwise, the registrant has been
advised that in the opinion of the SEC such indemnification is
against public policy as expressed in the Securities Act and is,
therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by
the registrant of expenses incurred or paid by a director, officer
or controlling person of the registrant in the successful defense
of any action, suit or proceeding) is asserted by such director,
officer or controlling person in connection with the securities
being registered, the registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in
the Securities Act and will be governed by the final adjudication
of such issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the
registrant certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form S-3 and has
duly caused this registration statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in the City of
Tampa, State of Florida on January 13, 2023.
|
ORAGENICS,
INC. |
|
|
|
|
By: |
/s/
Kimberly M. Murphy |
|
|
Kimberly
M. Murphy, |
|
|
Chief
Executive Officer, and Principal
Executive
Officer
|
POWER OF ATTORNEY
KNOW
ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints Kimberly Murphy as his or
her true and lawful attorney-in-fact and agent, with full power of
substitution and re-substitution, for him or her and in his or her
name, place and stead, in any and all capacities, to sign any and
all amendments (including post-effective amendments) to this
Registration Statement, and to sign any registration statement for
the same offering covered by the Registration Statement that is to
be effective upon filing pursuant to Rule 462(b) promulgated under
the Securities Act of 1933, as amended, and to file the same, with
all exhibits thereto, and other documents in connection therewith,
with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents, and each of them, full power and
authority to do and perform each and every act and thing requisite
and necessary to be done in connection therewith and about the
premises, as fully to all intents and purposes as he or she might
or could do in person, hereby ratifying and confirming all that
said attorneys-in-fact and agents, or any of them, or their, his or
her substitute or substitutes, may lawfully do or cause to be done
by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, as amended, this
registration statement has been signed below by the following
persons in the capacities indicated and on January 13,
2023.
Signature |
|
Title |
|
|
|
/s/
Kimberly M. Murphy
|
|
Principal Executive Officer, Chief Executive Officer,
|
Kimberly M.
Murphy |
|
Interim Chief
Financial Officer and Director |
|
|
|
/s/
Charles L. Pope
|
|
|
Charles
L. Pope |
|
Chairman and Director |
|
|
|
/s/
Robert C. Koski
|
|
|
Robert C.
Koski |
|
Director |
|
|
|
/s/
Frederick W. Telling
|
|
|
Frederick W.
Telling |
|
Director |
|
|
|
/s/
Alan W. Dunton
|
|
|
Alan W.
Dunton |
|
Director |
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