Form 8-K - Current report
May 17 2024 - 8:00AM
Edgar (US Regulatory)
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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: May 17, 2024
(Date
of earliest event reported)
Oragenics,
Inc.
(Exact
name of registrant as specified in its charter)
FL |
|
001-32188 |
|
59-3410522 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
Number) |
1990
Main Street
Suite
750
Sarasota,
FL |
|
34236 |
(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) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
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 |
|
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
8.01. OTHER INFORMATION.
On
May 17, 2024, the Company issued a press release announcing the company’s Scientific Advisory Board was presenting at a webinar
regarding Neurotrauma Medicine. A copy of the Press Release is attached hereto as Exhibit 99.2 and is incorporated by reference herein.
ITEM
9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(d)
Exhibits
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 May 17, 2024.
|
ORAGENICS,
INC.
(Registrant) |
|
|
|
BY: |
/s/
Janet Huffman |
|
|
Janet
Huffman
Chief
Financial Officer |
Exhibit 99.2
Oragenics,
Inc. to Host Webinar Panel on Neurotrauma Medicine
SARASOTA,
Fla., May 17, 2024 (GLOBE NEWSWIRE) — Oragenics, Inc. (NYSE American: OGEN), a pioneering pharmaceutical company specializing
in intranasal treatments for neurological disorders, today announced that the company will host a webinar panel on Neurotrauma Medicine
Monday, May 20, 2024, at 12:00 PM ET.
The
discussion will address the unmet medical need in Traumatic Brain Injury (TBI), commonly known as concussion, explore common causes,
and examine its association with other long-term neurological disorders. Additionally, the company will present its lead drug candidate,
ONP-002, an innovative neurosteroid designed to treat mild TBI and discuss its outcomes from preclinical and Phase I trials, as well
as details of an upcoming Phase II clinical trial to be conducted in acute and emergency departments. Details for the webinar are as
follows:
Webinar
Topic: Neurotrauma Medicine
When:
Monday, May 20, 2024
Time:
12:00 PM Eastern Time
Register:
Webinar Link
About
Oragenics, Inc.
Oragenics
is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious
diseases, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann
Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please
visit www.oragenics.com.
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, including without limitation statements regarding the ability of the Company to timely and
successfully undertake Phase II clinical trials using its novel drug-device combination for the treatment of mild Traumatic Brain Injury.
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 Company’s ability to advance the development of its product candidates, including the neurology assets, under
the timelines and in accord with the milestones it projects; the Company’s ability to raise capital and obtain funding, non-dilutive
or otherwise, for the development of its product candidates; the regulatory application process, research and development stages, and
future clinical data and analysis relating to its product candidates, including any meetings, decisions by regulatory authorities, such
as the FDA and investigational review boards, whether favorable or unfavorable; the Company’s ability to obtain, maintain and enforce
necessary patent and other intellectual property protection; the nature of competition and development relating to concussion treatments;
the Company’s expectations as to the outcome of preclinical studies and clinical trials and the potential benefits, activity, effectiveness
and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; 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 is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating
the forward-looking statements included 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.
Oragenics,
Inc.
Janet
Huffman, Chief Financial Officer
813-286-7900
jhuffman@oragenics.com
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