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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 22, 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 22, 2024, Oragenics, Inc. (the “Company”) issued a press release announcing the appointment of Dr. William “Frank”
Peacock, as its Chief Clinical Officer. Dr. Peacock will conduct the Company’s anticipated Phase II clinical trial for treating
concussion in Emergency Departments. A copy of the Press Release is attached hereto as Exhibit 99.1 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 22nd, 2024.
|
ORAGENICS,
INC.
(Registrant) |
|
|
|
BY: |
/s/
Janet Huffman |
|
|
Janet
Huffman
Chief
Financial Officer |
Exhibit
99.1
Oragenics
Appoints William “Frank” Peacock
MD as Chief Clinical Officer
Dr.
Peacock to Oversee Upcoming Phase II Clinical Trial for Treating Concussion in the Emergency Department
SARASOTA,
Fla., May 22, 2024 (GLOBE NEWSWIRE) — Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal
pharmaceuticals for the treatment of neurological disorders, today announced it has appointed Dr. William “Frank” Peacock
as its Chief Clinical Officer, who will conduct its anticipated Phase II clinical trial for treating concussion in the Emergency
Department (“ED”). Oragenics’ lead drug candidate, ONP-002, is combined with its intranasal device intended for the
treatment of mild Traumatic Brain Injury (mTBI), commonly known as concussion, in the field and emergency departments. ONP-002 is a new
chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. A 40-patient Phase
I study was completed and showed the drug to be safe and well-tolerated.
Dr.
Peacock is currently the Vice Chair for Emergency Medicine Research at Baylor College of Medicine and a past Professor at the Cleveland
Clinic Lerner College of Medicine. He is also the Principal Investigator of a trial for a company developing blood biomarkers for the
identification of concussion in the emergency department, which is analyzing acute blood markers that are elevated after concussion to
not only ensure concussion is identified but also as a predictor of potential severity and longer-term complications. Dr. Peacock is
a world-renowned speaker and researcher. He has been instrumental in the approval and use of high sensitivity blood troponins for acute
coronary syndrome failure in emergency settings, which can be seen in the JAMA Cardiology publication, Efficacy of High-Sensitivity
Troponin T in Identifying Very-Low-Risk Patients with Possible Acute Coronary Syndrome, and he is the editor of the first book of
“Biomarkers of Traumatic Brain Injury”.
“I
am excited to join Oragenics as its Chief Clinical Officer at such an important and pivotal time in the company’s clinical program.
I have been involved with concussion care in the emergency department throughout my 30-plus-year career. My role with the HeadSMART blood
biomarker trial has shown me that we need biomarkers to trigger a treatment in the ER. We are searching for that treatment, and I am
looking forward to testing ONP-002 to help determine if it can improve patient outcomes in our upcoming Phase II clinical trials,”
said Dr. Peacock.
“We
are fortunate to have such an esteemed emergency medicine physician and researcher join our team in this important role at Oragenics.
Given his understanding of blood biomarkers, throughout his career, his intimate knowledge in emergency medicine protocols and close
ties with leading enrollment centers for TBI clinical research, we believe he will play an invaluable role in the success of Oragenics
and planned Phase II trials. We are currently working with Avance Clinical, CRO, for our Phase II trial,” stated Michael Redmond,
President of Oragenics.
In
preclinical animal models, ONP-002 has been shown to acutely improve molecular and behavioral outcomes following brain injury. In addition,
intranasal delivery of the drug as a nanoparticle has been shown to enhance brain exposure and metabolism in animals. “Our Phase
I human study has shown ONP-002 to be well tolerated in humans. The Phase II trial is designed to establish a time to first dose, relationships
between drug application and blood biomarker levels, and the evaluation of patient symptom severity in the first few hours and days after
injury,” said Dr. Peacock.
Concussion
is an unmet medical need. There are an estimated 69 million concussions annually reported worldwide. Common causes of concussion include
falls, motor vehicle accidents, and contact sports. Other neurological disorders, including Alzheimer’s Disease, Parkinson’s
Disease, and Chronic Traumatic Encephalopathy (CTE), have been linked to concussion. Post-concussion syndrome is linked to long-term
disability and occurs in as high as 20% of concussed patients.
About
Oragenics
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 trial 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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