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2023-02-24 iso4217:USD xbrli:shares iso4217:USD xbrli:shares
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934.
Date
of Report:
February 24, 2023
(Date
of earliest event reported)
Oragenics, Inc.
(Exact
name of registrant as specified in its charter)
FL |
|
001-32188 |
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59-3410522 |
(State
or other jurisdiction
of incorporation)
|
|
(Commission
File
Number)
|
|
(IRS
Employer
Identification
Number)
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4902 Eisenhower Boulevard,
Suite 125
Tampa,
FL
|
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33634 |
(Address
of principal executive offices) |
|
(Zip
Code) |
813-286-7900
(Registrant’s
telephone number, including area code)
(Former
Name or Former Address, if changed since last
report)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425) |
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|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12) |
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|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common Stock |
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OGEN |
|
NYSE American |
Indicate
by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (§230.405 of
this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934
(§240.12b-2 of this chapter).
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
pursuant to Section 13(a) of the Exchange Act. ☐
Item
1.01 Entry Into a Material Definitive Agreement.
On
February 24, 2023, Oragenics, Inc. (the “Company”) entered into an
At the Market Offering Agreement (the “Sales Agreement”) with
Ladenburg Thalmann & Co. Inc. (the “Agent”), pursuant to which
the Company may issue and sell, from time to time, shares of its
common stock (the “Shares”), depending on market demand, with the
Agent acting as the sales agent or principal (the “Offering”).
Sales of the Shares may be made by any method permitted by law
deemed to be an “at the market offering” as defined in Rule
415(a)(4) of the Securities Act of 1933, as amended (the
“Securities Act”), including, without limitation, sales made
directly on or through the NYSE American. The Agent will use its
commercially reasonable efforts to sell the Shares requested by the
Company to be sold on its behalf, consistent with the Agent’s
normal trading and sales practices, under the terms and subject to
the conditions set forth in the Sales Agreement. The Company has no
obligation to sell any of the Shares. The Company may instruct the
Agent not to sell the Shares if the sales cannot be effected at or
above the price designated by the Company from time to time and the
Company may at any time suspend sales pursuant to the Sales
Agreement.
The Company will pay the Agent a commission of up to 3.0% of the
gross proceeds from the sale of Shares by the Agent under the Sales
Agreement. The Company has also agreed to reimburse the Agent for
the fees and disbursements of its counsel, payable upon execution
of the Sales Agreement, in an amount not to exceed $75,000, in
addition to certain ongoing disbursements of its legal counsel up
to $4,000 per calendar quarter. In addition, the Company has agreed
to provide customary indemnification rights to the
Agent.
Any
sales of Shares under the Sales Agreement will be made pursuant to
the Company’s Registration Statement on Form S-3 (File No.
333-269225), including the related prospectus, filed with the
Securities and Exchange Commission (the “SEC”) on January 13, 2023
and declared effective on January 25, 2023, as supplemented by the
prospectus supplement dated February 24, 2023, and any applicable
additional prospectus supplements related to the Offering that form
a part of the Registration Statement.
The
aggregate market value of Shares eligible for sale in the Offering
and under the Sales Agreement will be subject to the limitations of
General Instruction I.B.6 of Form S-3, to the extent required under
such instruction. The prospectus supplement filed with the SEC on
February 24, 2023 is only offering Shares having an aggregate
offering price of $5,000,000. The Company will be required to file
another prospectus supplement in the event it determines to offer
more than $5,000,000 of Shares in accordance with the terms of the
Sales Agreement, to the extent then permitted under General
Instruction I.B.6 of Form S-3.
The
Company intends to use the net proceeds from this Offering to
continue funding its pre-clinical development of its SARS-CoV-2
vaccine, Terra CoV-1 and its lantibiotics program and for general
corporate purposes, including research and development activities,
capital expenditures, and working capital. The precise amount and
timing of the application of these proceeds will depend upon a
number of factors, such as the timing and progress of our research
and development efforts, our funding requirements and the
availability and costs of other funds.
The foregoing description of the Sales Agreement does not purport
to be complete and is qualified in its entirety by reference to the
Sales Agreement, which is filed as Exhibit 1.1 to this report and
is incorporated herein by reference. A copy of the legal opinion of
Shumaker, Loop & Kendrick, LLP regarding the legality of the
issuance and sale of the Shares is filed as Exhibit 5.1 to this
report and is incorporated by reference herein.
This
Current Report on Form 8-K does not constitute an offer to sell any
securities or a solicitation of an offer to buy any securities, nor
shall there be any sale of any securities in any state or
jurisdiction in which such an offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction.
Item
8.01. Other Information.
As
previously reported, on January 20, 2023, the Company undertook a
1-for-60 reverse stock split of its authorized, issued and
outstanding shares of common stock. The par value per common share
remained unchanged. Immediately following the reverse stock split,
the Company had 2,024,657 shares of common stock issued outstanding
(including shares issued due to rounding as a result of the recent
reverse stock split).
As of
December 31, 2022, the Company’s cash and cash equivalents balance
is expected to be approximately $11.4 million. The Company
anticipates that its cash resources as of December 31, 2022, will
be sufficient to fund its operations as presently structured
through the third quarter of 2023. The Company’s research and
development of its Terra CoV-1 vaccine product candidate continues.
The Company is currently evaluating formulation options and
considering regulatory pathways to advance the program. The Company
is strategically assessing multiple opportunities inclusive of
further regulatory guidance and requirements and the potential
implications thereof. As a result, the Company now anticipates
being in a position to file an IND application in the United States
or Canada and to thereafter commence a Phase 1 clinical study with
NT-CoV2-1, the protocol for which is under development, during the
second half of 2023.
Forward-Looking Statements
This
communication contains “forward-looking statements” within the
meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are based on management’s beliefs and assumptions and
information currently available. The words “believe,” “expect,”
“anticipate,” “intend,” “estimate,” “project” and similar
expressions that do not relate solely to historical matters
identify forward-looking statements. Investors should be cautious
in relying on forward-looking statements because they are subject
to a variety of risks, uncertainties, and other factors that could
cause actual results to differ materially from those expressed in
any such forward-looking statements. These factors include, but are
not limited to, the following: the Company’s ability to advance the
development of its vaccine candidate and lantibiotics candidate
under the timelines and in accord with the milestones it projects;
the Company’s ability to obtain funding, non-dilutive or otherwise,
for the development of the vaccine and lantibiotic product
candidates, whether through its own cash on hand, or another
alternative source; the regulatory application process, research
and development stages, and future clinical data and analysis
relating to vaccines and lantibiotics, including any meetings,
decisions by regulatory authorities, such as the FDA and Canadian
regulatory authorities and investigational review boards, whether
favorable or unfavorable; the potential application of our vaccine
candidate to variants and other coronaviruses; the Company’s
ability to obtain, maintain and enforce necessary patent and other
intellectual property protection and license agreements; the nature
of competition and development relating to COVID-19 immunization
and therapeutic treatments and demand for vaccines and antibiotics;
the Company’s expectations as to the outcome of preclinical
studies, nasal administration, transmission, manufacturing, storage
and distribution; other potential adverse impacts such as delays in
regulatory review, interruptions to manufacturers and supply
chains, adverse impacts on healthcare systems and disruption of the
global economy; the ability to sustain compliance with our listing
requirements; and general economic and market conditions and risks,
as well as other uncertainties described in our filings with the
U.S. Securities and Exchange Commission. All information set forth
in this press release is as of the date hereof. You should consider
these factors in evaluating the forward-looking statements included
in this press release and not place undue reliance on such
statements. We do not assume any obligation to publicly provide
revisions or updates to any forward-looking statements, whether as
a result of new information, future developments or otherwise,
should circumstances change, except as otherwise required by
law.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits
* Non-material schedules and exhibits have been omitted pursuant to
Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to
furnish supplemental copies of any of the omitted schedules and
exhibits upon request by the SEC.
SIGNATURES
In
accordance with the requirements of the Exchange Act, the
registrant caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized on this 24th day
of February, 2023.
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ORAGENICS,
INC.
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|
(Registrant) |
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BY:
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/s/
Kimberly Murphy
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Kimberly
Murphy
Chief
Executive Officer and President
|
Oragenics (AMEX:OGEN)
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Oragenics (AMEX:OGEN)
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