Form 8-K

8-K — ORAGENICS INC

Accession: 0001493152-26-042843

Filed: 2026-09-16

Period: 2026-09-16

CIK: 0001174940

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

EX-99.1 (ex99-1.htm)

EX-99.2 (ex99-2.htm)

GRAPHIC (ex99-1_001.jpg)

GRAPHIC (ex99-1_002.jpg)

GRAPHIC (ex99-1_003.jpg)

GRAPHIC (ex99-1_004.jpg)

GRAPHIC (ex99-1_005.jpg)

GRAPHIC (ex99-1_006.jpg)

GRAPHIC (ex99-1_007.jpg)

GRAPHIC (ex99-1_008.jpg)

GRAPHIC (ex99-1_009.jpg)

GRAPHIC (ex99-1_010.jpg)

GRAPHIC (ex99-1_011.jpg)

GRAPHIC (ex99-1_012.jpg)

GRAPHIC (ex99-1_013.jpg)

GRAPHIC (ex99-1_014.jpg)

GRAPHIC (ex99-1_015.jpg)

GRAPHIC (ex99-1_016.jpg)

GRAPHIC (ex99-1_017.jpg)

GRAPHIC (ex99-1_018.jpg)

GRAPHIC (ex99-1_019.jpg)

GRAPHIC (ex99-1_020.jpg)

GRAPHIC (ex99-1_021.jpg)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: form8-k.htm · Sequence: 1

false

0001174940

2026-09-16

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: September 16, 2026

(Date

of earliest event reported)

Oragenics,

Inc.

(Exact

name of registrant as specified in its charter)

001-32188

59-3410522

(State

or other jurisdiction

incorporation)

(Commission

File

Number)

(IRS

Employer

Identification

Number)

9015

Town Center Parkway

Suite

143

Sarasota,

34202

(Address

of principal executive offices)

(Zip

Code)

813-286-7900

(Registrant’s

telephone number, including area code)

1990

Main Street

Suite

750

Sarasota,

FL 34236

(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 ☐

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

7.01 REGULATION FD DISCLOSURE.

Oragenics,

Inc. (“Oragenics” or the “Company”) expects to use the presentation attached hereto as Exhibit 99.1, which is

incorporated herein by reference (the “Presentation”) on September 17, 2026 in connection with a presentation by the Company’s

Chief Medical Officer, James P. Kelly, in the Successful Case Studies session at the IPAC-RS 2026 Nasal Innovation Forum on Thursday,

September 17, 2026. Additionally, the Presentation will be available under the “Presentations” tab in the “News and

Media” section of the Company’s website, located at www.oragenics.com.

filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality

of any information in this report that is required to be disclosed solely by reason of Regulation FD.

The

information contained in the Presentation is summary information that is intended to be considered in the context of the Company’s

Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release

or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained

in this report, although it may do so from time to time as its management believes is warranted. Any such updating may be made through

the filing of other reports or documents with the SEC, through press releases or through other public disclosure.

The

information presented in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 shall not be deemed to be “filed”

for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject

to the liabilities of that section, unless the Company specifically states that the information is to be considered “filed”

under the Exchange Act or specifically incorporates it by reference into a filing under the Securities Act of 1933, as amended, or the

Exchange Act.

ITEM

8.01 OTHER EVENTS.

September 16, 2026, the Company issued a press release announcing that its Chief Medical Officer is scheduled to present in the Successful

Case Studies session at the IPAC-RS 2026 Nasal Innovation Forum on Thursday, September 17, 2026.

copy of the Press Releases is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

ITEM

9.01. FINANCIAL STATEMENTS AND EXHIBITS.

(d)

Exhibits

Exhibit

No.

Description

99.1

Presentation, dated September 16, 2026.

99.2

Press Release, dated September 16, 2026

104

Cover

page Interactive Data File (embedded in the cover page formatted in Inline XBRL)

SIGNATURES

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 September 16, 2026.

ORAGENICS,

INC.

(Registrant)

BY:

/s/

Janet Huffman

Janet

Huffman

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

EX-99.2

Filename: ex99-2.htm · Sequence: 3

Exhibit 99.2

Oragenics

Chief Medical Officer to Present at IPAC-RS 2026 Nasal Innovation Forum

Presentation

Highlights Clinical Translation of ONP-002 Intranasal Delivery Platform for Concussion Treatment

●

James P. Kelly, MD, Chief Medical Officer of Oragenics, is scheduled to present in the Successful Case Studies session at the IPAC-RS

2026 Nasal Innovation Forum on Thursday, September 17, 2026

●

Presentation is expected to address development and clinical translation of ONP-002, including the intranasal delivery platform, Phase

IIa trial design, and anticipated path to U.S. clinical development

●

Forum convenes leading pharmaceutical scientists, device developers, and regulators focused on nasal drug delivery

SARASOTA,

Fla., September 16, 2026 (GLOBE NEWSWIRE) — Oragenics (NYSE American: OGEN), a clinical-stage biotechnology company developing

brain-targeted therapeutics through proprietary intranasal delivery technology, today announced that James P. Kelly, MD, Chief Medical

Officer, is scheduled to present at the IPAC-RS 2026 Nasal Innovation Forum on Thursday, September 17, 2026. The event is being held

September 16–17, 2026, at Liberty House in Jersey City, New Jersey.

Dr.

Kelly is scheduled to present during Session 4: Successful Case Studies, beginning at 9:40 AM ET. His presentation is expected to address

the development and clinical translation of ONP-002, Oragenics’ first-in-class intranasal neurosteroid candidate for the treatment

of concussion — a condition with no currently approved pharmacological treatments.

The

presentation is expected to highlight the scientific rationale underlying ONP-002’s proposed mechanism of action, including its

potential ability to reduce neuroinflammation, oxidative stress, and cerebral edema through the proposed simultaneous activation of multiple

neuroprotective pathways. Dr. Kelly is expected to discuss the design of the Company’s proprietary breath-powered intranasal delivery

device, the ongoing Phase IIa feasibility trial in Australia, and the clinical design framework for anticipated U.S. development.

ONP-002

is manufactured as a powder and delivered via a lightweight intranasal device engineered to direct the drug to the superior nasal roof

for direct olfactory nerve, brain delivery, minimizing systemic exposure. A Phase IIa feasibility trial is currently enrolling at three

sites in Australia, and the Company is advancing its Investigational New Drug (IND) application, with submission anticipated in Q4 2026.

Dr.

Kelly stated, “The IPAC-RS Nasal Innovation Forum is an ideal venue to share the science underpinning our intranasal platform with

the formulation, device, and regulatory community. Concussion represents a significant unmet need, and we are excited to present our

progress toward potentially bringing the first pharmacological treatment for this condition to patients.”

The

IPAC-RS Nasal Innovation Forum is an annual pharmaceutical industry forum dedicated to nasal drug delivery, convening scientists, device

innovators, and regulatory experts to discuss formulation science, device technology, manufacturing best practices, and regulatory strategy.

About

ONP-002

is a first-in-class intranasal neurosteroid being investigated for the treatment of mTBI (concussion). There are currently no FDA-approved

pharmacological treatments for mTBI. ONP-002 is designed to reduce neuroinflammation, oxidative stress, and cerebral edema through gene

amplification of multiple neuroprotective pathways simultaneously. The compound is spray-dry manufactured into a nanoparticle powder

and delivered via a proprietary breath-powered intranasal device designed to maximize olfactory deposition and direct brain delivery

while minimizing systemic exposure. Phase I single and multiple ascending dose safety trials have been completed with a favorable safety

and tolerability profile. A Phase IIa feasibility trial is currently enrolling in Australia.

About

Oragenics

is a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal delivery technology.

The Company’s lead candidate, ONP-002, is being developed as a potential first-in-class treatment for mTBI (concussion). Oragenics

is advancing ONP-002 through Phase IIa clinical trials in Australia, with U.S. Phase IIb trials planned to follow pending IND submission.

The Company’s intranasal delivery platform has potential applications across a range of acute and chronic neurological conditions.

For more information, visit www.oragenics.com.

Forward-Looking

Statements

This

press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private

Securities Litigation Reform Act of 1995. Statements concerning the Company’s expectations, plans, business outlook, or future

performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance, or

other matters are forward-looking statements. These statements include, but are not limited to, statements regarding the expected timing

and outcomes of the Company’s Phase IIa and planned Phase IIb clinical trials, the Company’s regulatory strategy and engagement

with the FDA, the anticipated timing of the Company’s IND submission, the potential applications of Oragenics’ intranasal

delivery platform, and the Company’s ability to advance its clinical programs with available capital. These forward-looking statements

are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ

materially, including risks related to the clinical development process, patient enrollment and trial execution, regulatory approval

processes, the Company’s ability to secure adequate funding for operations, and those risks set forth in Oragenics’ most

recent Forms 10-K, 10-Q, and other SEC filings available through EDGAR at www.sec.gov. Oragenics undertakes no obligation to update or

revise any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press

release, except as may be required by law.

CONTACTS

Investor

Relations

irth

Communications

1-866-976-4784

IR@oragenics.com

Media

Relations

irth

Communications

1-866-976-4784

media@irthcommunications.com

Source:

Oragenics

GRAPHIC

Filename: ex99-1_001.jpg · Sequence: 4

Binary file (118095 bytes)

Download ex99-1_001.jpg

GRAPHIC

Filename: ex99-1_002.jpg · Sequence: 5

Binary file (522538 bytes)

Download ex99-1_002.jpg

GRAPHIC

Filename: ex99-1_003.jpg · Sequence: 6

Binary file (190329 bytes)

Download ex99-1_003.jpg

GRAPHIC

Filename: ex99-1_004.jpg · Sequence: 7

Binary file (85876 bytes)

Download ex99-1_004.jpg

GRAPHIC

Filename: ex99-1_005.jpg · Sequence: 8

Binary file (94032 bytes)

Download ex99-1_005.jpg

GRAPHIC

Filename: ex99-1_006.jpg · Sequence: 9

Binary file (268899 bytes)

Download ex99-1_006.jpg

GRAPHIC

Filename: ex99-1_007.jpg · Sequence: 10

Binary file (142807 bytes)

Download ex99-1_007.jpg

GRAPHIC

Filename: ex99-1_008.jpg · Sequence: 11

Binary file (335676 bytes)

Download ex99-1_008.jpg

GRAPHIC

Filename: ex99-1_009.jpg · Sequence: 12

Binary file (129415 bytes)

Download ex99-1_009.jpg

GRAPHIC

Filename: ex99-1_010.jpg · Sequence: 13

Binary file (246599 bytes)

Download ex99-1_010.jpg

GRAPHIC

Filename: ex99-1_011.jpg · Sequence: 14

Binary file (161649 bytes)

Download ex99-1_011.jpg

GRAPHIC

Filename: ex99-1_012.jpg · Sequence: 15

Binary file (256591 bytes)

Download ex99-1_012.jpg

GRAPHIC

Filename: ex99-1_013.jpg · Sequence: 16

Binary file (317989 bytes)

Download ex99-1_013.jpg

GRAPHIC

Filename: ex99-1_014.jpg · Sequence: 17

Binary file (231577 bytes)

Download ex99-1_014.jpg

GRAPHIC

Filename: ex99-1_015.jpg · Sequence: 18

Binary file (216361 bytes)

Download ex99-1_015.jpg

GRAPHIC

Filename: ex99-1_016.jpg · Sequence: 19

Binary file (288098 bytes)

Download ex99-1_016.jpg

GRAPHIC

Filename: ex99-1_017.jpg · Sequence: 20

Binary file (288661 bytes)

Download ex99-1_017.jpg

GRAPHIC

Filename: ex99-1_018.jpg · Sequence: 21

Binary file (233938 bytes)

Download ex99-1_018.jpg

GRAPHIC

Filename: ex99-1_019.jpg · Sequence: 22

Binary file (236719 bytes)

Download ex99-1_019.jpg

GRAPHIC

Filename: ex99-1_020.jpg · Sequence: 23

Binary file (219670 bytes)

Download ex99-1_020.jpg

GRAPHIC

Filename: ex99-1_021.jpg · Sequence: 24

Binary file (339963 bytes)

Download ex99-1_021.jpg

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 29

v3.26.3

Cover

Sep. 16, 2026

Cover [Abstract]

Document Type

8-K

Amendment Flag

false

Document Period End Date

Sep. 16, 2026

Entity File Number

001-32188

Entity Registrant Name

Oragenics,

Inc.

Entity Central Index Key

0001174940

Entity Tax Identification Number

59-3410522

Entity Incorporation, State or Country Code

Entity Address, Address Line One

9015

Town Center Parkway

Entity Address, Address Line Two

Suite

143

Entity Address, City or Town

Sarasota

Entity Address, State or Province

Entity Address, Postal Zip Code

34202

City Area Code

813

Local Phone Number

286-7900

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Common

Stock

Trading Symbol

OGEN

Security Exchange Name

NYSEAMER

Entity Emerging Growth Company

false

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Cover page.

+ References

No definition available.

+ Details

Name:

dei_CoverAbstract

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

Period Type:

duration

- Definition

For 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

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The 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

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 2 such as Street or Suite number

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine2

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 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:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 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:

Period Type:

duration

- Definition

Commission 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

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 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:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 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:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean 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.

+ References

Reference 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:

Period Type:

duration

- Definition

Boolean 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.

+ References

Reference 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:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 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:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 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:

Period Type:

duration

- Definition

Boolean 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.

+ References

Reference 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:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean 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.

+ References

Reference 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:

Period Type:

duration