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Oragenics outlines ONP-002 concussion trial path

Oragenics details upcoming scientific presentation on ONP-002 and outlines ongoing Phase IIa trial and planned IND submission for U.S. development.

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8-K

Rhea-AI Filing Summary

Oragenics, Inc. (OGEN) reported that its Chief Medical Officer, Dr. James P. Kelly, is scheduled to present on September 17, 2026 at the IPAC-RS 2026 Nasal Innovation Forum, highlighting clinical progress for ONP-002, its first-in-class intranasal neurosteroid candidate for concussion. The presentation and a related investor presentation deck dated September 16, 2026 will be made available on the company’s website and are furnished, not filed, under Regulation FD. ONP-002 is being advanced through an ongoing Phase IIa feasibility trial in Australia following Phase I safety studies and is supported by a proprietary breath-powered intranasal delivery device designed to target the brain while minimizing systemic exposure. Oragenics also disclosed plans to submit an Investigational New Drug application in the United States in the fourth quarter of 2026 to enable further clinical development, including anticipated U.S. Phase IIb trials.

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Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Event date September 17, 2026 Date of Dr. Kelly’s presentation at IPAC-RS 2026 Nasal Innovation Forum
Event duration September 16–17, 2026 Dates of the IPAC-RS 2026 Nasal Innovation Forum
Session time 9:40 AM ET Scheduled start time for Dr. Kelly’s Successful Case Studies session presentation
Clinical trial phase Phase IIa Feasibility trial for ONP-002 currently enrolling at three sites in Australia
IND timing Q4 2026 Anticipated submission timing for ONP-002 Investigational New Drug application
Australian trial sites 3 sites Number of sites in Australia enrolling patients in the Phase IIa feasibility trial
Completed clinical phase Phase I Single and multiple ascending dose safety trials for ONP-002 completed with favorable safety and tolerability
Regulation FD regulatory
"By filing this on 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"
Regulation FD is a rule that prevents company insiders, like executives, from sharing important information with some people before others get it. It matters because it helps ensure all investors have equal access to key news, making the stock market fairer and reducing chances of insider trading.
Phase IIa feasibility trial medical
"A Phase IIa feasibility trial is currently enrolling at three sites in Australia"
Investigational New Drug (IND) application regulatory
"the Company is advancing its Investigational New Drug (IND) application, with submission anticipated in Q4 2026"
An investigational new drug (IND) application is a formal request submitted to a drug regulator asking permission to begin testing a new medicine in people. It compiles lab results, manufacturing details and proposed human trial plans so regulators can judge safety before human studies start; for investors, an accepted IND is a key milestone that opens the clinical development pathway and can materially change a company’s risk profile and potential value, like getting a license to road-test a prototype.
intranasal neurosteroid medical
"ONP-002, Oragenics’ first-in-class intranasal neurosteroid candidate for the treatment of concussion"
breath-powered intranasal device technical
"the design of the Company’s proprietary breath-powered intranasal delivery device"
neuroinflammation medical
"to reduce neuroinflammation, oxidative stress, and cerebral edema through the proposed simultaneous activation"
Neuroinflammation is the brain or spinal cord’s immune reaction to injury, infection, or abnormalities, where cells and molecules become active to protect or repair nervous tissue. It matters to investors because it underlies many neurological diseases and is a common target for drugs and diagnostic tools; positive or negative trial results, safety signals, or new therapies can change a company’s value much like a major repair plan or recall would affect a carmaker’s prospects.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Oragenics (OGEN) announce in this 8-K filing?
Oragenics announced that Chief Medical Officer James P. Kelly, MD will present ONP-002 clinical data at the IPAC-RS 2026 Nasal Innovation Forum on September 17, 2026, and that a related presentation and press release dated September 16, 2026 are being furnished as exhibits.

What is ONP-002 in Oragenics’ (OGEN) development pipeline?
ONP-002 is a first-in-class intranasal neurosteroid being investigated for the treatment of mTBI (concussion). It is designed to reduce neuroinflammation, oxidative stress, and cerebral edema by activating multiple neuroprotective pathways using a proprietary intranasal delivery device.

What clinical stage is ONP-002 currently in for Oragenics (OGEN)?
ONP-002 has completed Phase I single and multiple ascending dose safety trials with a favorable profile. An ongoing Phase IIa feasibility trial is currently enrolling at three sites in Australia, and U.S. Phase IIb trials are planned to follow.

When does Oragenics (OGEN) plan to submit its IND for ONP-002?
Oragenics is advancing its Investigational New Drug application for ONP-002, with submission anticipated in Q4 2026. This IND is expected to support anticipated U.S. clinical development, including planned Phase IIb trials.

What is notable about the ONP-002 delivery platform mentioned by Oragenics (OGEN)?
ONP-002 is manufactured as a spray-dried nanoparticle powder and delivered via a proprietary breath-powered intranasal device engineered to target the superior nasal roof for direct olfactory nerve, brain delivery, aiming to minimize systemic exposure.

Where and when is Oragenics’ Chief Medical Officer presenting ONP-002?
Dr. James P. Kelly is scheduled to present during Session 4: Successful Case Studies at the IPAC-RS 2026 Nasal Innovation Forum on September 17, 2026, beginning at 9:40 AM ET, at Liberty House in Jersey City, New Jersey.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0001174940 0001174940 2026-09-16 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)

 

 

 

FL   001-32188   59-3410522

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification Number)

 

9015 Town Center Parkway

Suite 143

Sarasota, FL

   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 ☐

 

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 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.

 

By 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.

 

On 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.

 

A 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

 

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 September 16, 2026.

 

 

ORAGENICS, INC.

  (Registrant)
   
  BY: /s/ Janet Huffman
   

Janet Huffman

    Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 

 

 

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

 

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

 

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

 

 

 

Source: View Original Filing on SEC EDGAR

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