Form 8-K

8-K — ORAGENICS INC

Accession: 0001493152-26-016294

Filed: 2026-04-13

Period: 2026-04-13

CIK: 0001174940

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

EX-99.1 (ex99-1.htm)

GRAPHIC (ex99-1_001.jpg)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: form8-k.htm · Sequence: 1

false

0001174940

2026-04-13

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: April 13, 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

Lakewood

Ranch, Florida

34202

(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 ☐

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.

April 13, 2026, Oragenics, Inc. (the “Company”) issued a press release announcing that the first patient has been dosed in

the Company’s ongoing Phase IIa clinical trial in Australia, evaluating ONP-002, the Company’s lead candidate for the treatment

of concussion and mild traumatic brain injury (mTBI).

copy of each 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

Press Release dated April 13, 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 this 13th day of April 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

Oragenics

Doses First Patient in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain Injury

● Mackay

Base Hospital activated March 31, 2026 as first clinical trial site; first patient dosed

within days of activation — a signal of strong enrollment velocity and significant

unmet medical need

SARASOTA,

Fla., April 13, 2026 — Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company developing brain-targeted

therapeutics through proprietary intranasal delivery technology, today announced that the first patient has been dosed in its ongoing

Phase IIa clinical trial evaluating ONP-002, the Company’s lead candidate for the treatment of concussion and mild traumatic brain

injury (mTBI). The milestone was achieved at Mackay Hospital in Australia — the first site to be activated in the trial —

within days of site activation on March 31, 2026.

Concussion,

aka, mild traumatic brain injury, represents the most prominent neurological conditions without an FDA-approved pharmacological treatment.

According to the CDC, an estimated 1.7 to 3.8 million people in the U.S. experience traumatic brain injuries annually, with sports and

recreational activities among the leading causes.¹ Globally, an estimated 69 million individuals sustain traumatic brain injuries

each year. Despite this scale, no pharmacological treatments have been approved — leaving patients, military personnel, athletes,

and families with few effective options beyond rest and symptom management. If approved by the FDA, ONP-002 would be the first and only

pharmacological standard of care for a global concussion market projected to reach over $9 billion by 2030.²

The

commencement of patient dosing follows the receipt of Human Research Ethics Committee (HREC) approval in Australia and the activation

of Mackay Hospital as the first clinical site. The rapid presentation of an eligible patient immediately upon site activation underscores

the breadth and urgency of unmet clinical need in this population. Two additional Australian sites — Alfred Hospital (Melbourne)

and Royal Adelaide Hospital (Adelaide) — are progressing through site governance approvals, with activation expected in the second

quarter of 2026.

ONP-002

is a first-in-class intranasal novel neurosteroid designed to address the underlying biology of brain injury — reducing neuroinflammation,

oxidative stress, and cerebral edema — rather than simply managing symptoms. As an investigational neuroprotective intranasal drug,

ONP-002 targets the biological cascade triggered by trauma, with the potential to represent a paradigm shift from symptom management

to active neurological intervention. ONP-002 is delivered via Oragenics’ proprietary intranasal spray-dry powder device. The drug

candidate serves a nasal drug delivery market expected to reach nearly $93 billion by 2030.³

Oragenics’

Chief Executive Officer, Janet Huffman stated, “We said we would dose our first patient in Australia — and we have. Mackay

Hospital was active for only a matter of days before an eligible patient presented, and that immediacy is not a coincidence. It reflects

the reality of what we have always said: there is no pharmacological treatment for concussion, and patients and clinicians are ready

for something new. Site activation was swift and now the trial is underway. We are executing, and we intend to keep executing. For the

millions of people who suffer concussions every year and are told there is nothing that can be done — we are here to change that.”

Dr.

James Kelly, Oragenics’ Chief Medical Officer, added, “The Phase 1 safety profile gave us strong scientific confidence entering

this next phase. The HREC process is rigorous by design — it exists to protect patients, and receiving that clearance confirmed

that our trial design, safety protocols, and investigator teams meet the highest standards. As a clinician who has worked with concussion

patients for decades, this moment is deeply meaningful. ONP-002 targets the injury itself, not just the symptoms. That is a fundamentally

different approach to concussion care, and we are now putting it to the test in patients.”

Phase

IIa Trial Design

Oragenics’

Phase IIa clinical trial is a randomized, placebo-controlled study designed to evaluate 40 patients who meet enrollment criteria based

on CT scan findings, presenting symptoms, and emergency room or hospital admission. Patients will receive first dosing within 12 hours

of concussion, followed by continued treatment for up to 30 days. The trial will assess safety and tolerability parameters through follow-up

visits for nasal examinations, physical assessments, and neurocognitive testing. Feasibility will be determined according to tolerability

and participant compliance.

Oragenics

expects that findings will support its planned investigational new drug (IND) application submission to the FDA, targeting Q4 2026, for

the next phase of clinical trials to be conducted in the U.S.

Clinical

Foundation & Operational Partners

The

Phase 1 clinical trial of ONP-002 delivered a strong safety profile, with zero serious adverse events reported across all dose levels

in 40 patients, supporting advancement to Phase 2. Preclinical data demonstrated reductions in swelling, inflammation, and oxidative

stress in the brain, along with improvements in functional recovery.

Southern

Star Research, a full-service Australian clinical research organization (CRO), is managing Phase IIa trial operations. Sterling Pharma

Solutions is providing cGMP drug manufacturing services from its facility in Cary, North Carolina.

About

ONP-002

is an investigational neuroprotective, anti-inflammatory intranasal drug candidate targeting mild traumatic brain injury (mTBI) and concussion.

Designed to interrupt biological pathways involved in inflammation, oxidative stress, and brain swelling following head trauma, ONP-002

has demonstrated safety and tolerability in Phase 1 clinical trials with zero serious adverse events across all dose levels. The drug

candidate utilizes Oragenics’ proprietary intranasal delivery platform to enable rapid, targeted brain delivery — potentially

representing a paradigm shift from symptom management to active neurological intervention. Oragenics is advancing ONP-002 through Phase

IIa clinical trials in Australia, with U.S. Phase IIb trials planned to follow pending FDA investigational new drug application (IND)

approval.

About

Oragenics, Inc.

Oragenics,

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

The Company’s lead candidate, ONP-002, is being advanced as a potential first-in-class treatment for concussion, aka mild traumatic

brain injury. Oragenics is progressing ONP-002 through Phase IIa clinical trials in Australia, with U.S. clinical trials planned to follow.

The Company believes its intranasal delivery platform has potential applications across multiple neurological conditions, including Parkinson’s

disease, Alzheimer’s disease, and other neurological disorders. Oragenics is committed to developing innovative therapies that

address significant unmet medical needs in neurological care. For more information, 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. Statements in this news release 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.” Forward-looking statements include statements regarding the

Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research,

development and regulatory activities and expectations relating to product candidates, including without limitation ONP-002 and our proprietary

nasal device; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the

treatment of diseases; and the timing, conduct, interim results announcements and outcomes of our clinical trials of our product candidates,

including ONP-002 for the treatment of concussion and mTBI. These forward-looking statements are based on management’s beliefs

and assumptions and information currently available. The words “believe,” “expect,” “anticipate,”

“intend,” “estimate,” “project,” “potential,” “may,” “will,”

“could,” “should,” 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, those described in our most recent Form 10-K, Form 10-Q and other filings we make with the U.S.

Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included in this press

release and not place undue reliance on such statements. All information we set forth in this press release is as of the date hereof.

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.

Investor

& Media Contact

Investor

& Media Relations

irth

Communications

800-383-4880

ir@oragenics.com

Footnotes

American Association of Neurological Surgeons; Sports Related Head Injury / CDC TBI Data

Grand Market Research; Concussion Market (2025–2030)

Research and Markets; $92.91 Bn Nasal Drug Delivery Market Trends, Opportunities, and Forecasts, 2020–2024 & 2025–2030F

GRAPHIC

Filename: ex99-1_001.jpg · Sequence: 3

Binary file (33620 bytes)

Download ex99-1_001.jpg

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 8

v3.26.1

Cover

Apr. 13, 2026

Cover [Abstract]

Document Type

8-K

Amendment Flag

false

Document Period End Date

Apr. 13, 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

Lakewood

Ranch

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