false
0001174940
0001174940
2024-05-07
2024-05-07
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: May 7, 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 7, 2024, the Company issued a press release announcing a partnership with Avance Clinical, a leading Contract Research Organization
(CRO), to conduct a Phase II clinical trial in Australia. 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 7, 2024.
|
ORAGENICS,
INC.
(Registrant) |
|
|
|
BY: |
/s/
Janet Huffman |
|
|
Janet
Huffman
Chief
Financial Officer |
Exhibit
99.1
Oragenics
Partners with Avance Clinical for Phase II Concussion Trial in Australia
(May
7, 2024, Sarasota, FL) - Oragenics, Inc. (NYSE American: OGEN), a pioneer in developing innovative intranasal pharmaceuticals
for neurological disorders, today announced a partnership with Avance Clinical, a leading Contract Research Organization (CRO), to conduct
a Phase II clinical trial in Australia. This trial aims to evaluate Oragenics’ lead drug candidate, ONP-002, for mild Traumatic
Brain Injury (TBI), commonly known as concussion. ONP-002, a novel chemical entity (NCE), is delivered through a unique intranasal device
and designed to maximize drug delivery directly to the brain.
Avance
Clinical, renowned for its clinical trial management capabilities and quality of service in Australia, New Zealand, and North America,
brings over two decades of expertise in navigating the Therapeutic Goods Administration, Food and Drug Administration, and European Medicines
Agency regulatory landscapes. An Oragenics Phase I clinical trial, recently completed in Australia under the management of Avance Clinical,
demonstrated that ONP-002 is safe and well-tolerated.
“Concussion
remains a significant unmet medical need,” said Dr. Jorgen Mould, Senior Director of Scientific and Regulatory Services at Avance
Clinical. “Oragenics is poised to address this challenge, and we are delighted to be part of the team, especially given Australia’s
high incidence of sports-related concussions.”
Michael
Redmond, President of Oragenics, added, “Our collaboration with Avance Clinical during the Phase I trial was instrumental, and
we are confident in their ability to execute an effective Phase II trial that will pave the way for future treatment protocols for concussion.”
Dr.
James Kelly, Neurologist and Chief Medical Officer at Oragenics, emphasized the critical role of the Australian medical community: “Australia
has been at the forefront of diagnosing and treating head injuries. We are fortunate to work with such skilled medical professionals
in conducting this pivotal research.”
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.
v3.24.1.u1
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 2 such as Street or Suite number
+ References
+ Details
Name: |
dei_EntityAddressAddressLine2 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14a -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Apr 2024 to May 2024
Oragenics (AMEX:OGEN)
Historical Stock Chart
From May 2023 to May 2024