Oragenics (NYSE: OGEN) advances ONP-002 trial and targets 2026 U.S. IND

Filing Impact

(Moderate)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Oragenics, Inc. filed an update highlighting clinical, regulatory and financial progress. Its Phase IIa trial of ONP-002 for concussion and mild traumatic brain injury is active in Australia, with multiple hospital sites initiated, patients enrolled and dosed, and no serious adverse events reported so far.

The company is preparing a U.S. Investigational New Drug application, targeting an FDA Type C meeting request in Q2 2026 and full IND submission by the end of 2026. Oragenics reported a Q1 2026 cash balance of $6.1 million, higher research and development spending, slightly lower general and administrative costs, and noted an active at-the-market equity facility. It also signed a Letter of Intent to license a complementary CNS-related medical device and will present to investors at Sidoti’s Micro-Cap Virtual Investor Conference.

Insights

Oragenics advances ONP-002 into active Phase IIa while managing limited cash through an ATM facility.

Oragenics is transitioning from planning to execution on ONP-002, with a 40-patient Phase IIa concussion trial underway in Australia and no serious adverse events reported to date. Multiple hospital sites are activated or near activation, which supports enrollment momentum.

Regulatory work for U.S. development is structured around two milestones: an FDA Type C meeting request in Q2 2026 and an IND submission by year-end 2026. These steps are key gating events for potential U.S. Phase II trials but remain subject to regulatory feedback and successful completion of IND-enabling work.

Financially, the company reported a Q1 2026 cash balance of $6.1 million, with research and development expenses of $0.6 million and general and administrative expenses of $1.6 million. An at-the-market facility, with a new S-3 declared effective, provides ongoing access to equity capital, which can support development but may introduce dilution depending on usage.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

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, and exhibit attachments filed with this report.

Key Figures

Cash balance: $6.1 million R&D expenses: $0.6 million G&A expenses: $1.6 million +5 more

8 metrics

Cash balance $6.1 million Q1 2026 cash as of March 31, 2026

R&D expenses $0.6 million Q1 2026, up 89% vs. same period 2025

G&A expenses $1.6 million Q1 2026, down 4% vs. same period 2025

Phase IIa enrollment target 40 patients ONP-002 concussion feasibility study in Australia

Type C meeting timing Q2 2026 Planned FDA Type C Meeting Request for ONP-002

IND submission goal End of 2026 Target timing for ONP-002 U.S. IND filing

First dose window Within 12 hours Initial dosing after concussion in Phase IIa trial

Follow-up duration 30 days Neurocognitive follow-up period in Phase IIa trial

Key Terms

Phase IIa, Investigational New Drug, Type C Meeting Request, at-the-market, +2 more

6 terms

Phase IIa medical

"Our Phase IIa randomized, placebo-controlled feasibility study of ONP-002 in Australia is no longer a future event"

Phase IIa is an early mid-stage clinical study that tests whether a new drug or treatment shows the intended biological effect in patients and helps identify the best dose. Think of it as a focused test-drive to see if a medicine does what it’s supposed to and what dose is tolerable before larger trials. Investors watch Phase IIa results because positive findings reduce technical risk and can materially increase the program’s value, while negative results raise the likelihood of costly delays or failure.

Investigational New Drug regulatory

"we are targeting submission of the full Investigational New Drug application by the end of 2026"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

Type C Meeting Request regulatory

"we are targeting submission of a Type C Meeting Request to the FDA in the second quarter of 2026"

A Type C meeting request is a formal ask by a drug or medical-device sponsor to a regulatory agency for discussion on development or review issues that don’t fit into urgent or routine categories. Investors care because the meeting can clarify data requirements, resolve scientific questions, or identify hurdles that affect approval timing and project value — like consulting an expert mid‑project to avoid costly delays or surprises.

at-the-market financial

"ATM facility active: New S-3 filed January 2026; SEC review completed and the facility is available"

"At-the-market" is a method for companies to sell new shares of stock directly into the open market over time, rather than all at once. It allows companies to raise money gradually, similar to selling slices of a pie instead of the entire pie at once, which can help manage the sale's impact on the stock price. This approach gives investors a steady supply of shares while providing companies with flexible funding options.

mild traumatic brain injury medical

"ONP-002, is a first-in-class intranasal neurosteroid in Phase IIa clinical trials for the treatment of concussion and mild traumatic brain injury"

A mild traumatic brain injury (mTBI), often called a concussion, is a short-lived disturbance in brain function caused by a blow, jolt, or sudden movement of the head that can produce headaches, dizziness, memory problems or brief loss of consciousness. Investors watch mTBI because it drives demand for diagnostics, treatments and rehabilitation, influences potential legal and insurance costs, and can affect healthcare spending, product approval prospects and company valuations in medical and sports-related sectors.

Letter of Intent financial

"we have now signed a Letter of Intent to pursue a licensing agreement for a complementary CNS-related medical device"

A letter of intent is a document that shows an agreement in principle between parties to work towards a future deal or transaction. It outlines their intentions and key terms, acting like a roadmap before a formal contract is signed. For investors, it signals serious interest and helps clarify expectations early in the process.

Understanding 8-K Material Events →

05/19/2026 - 08:38 AM

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 18, 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

of 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 ☐

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 attached presentation (the “Presentation”) from time to time with potential investors, and will host one-on-one meetings with investors at Sidoti’s Micro-Cap Virtual Investor Conference, taking place on May 20-21, 2026. A copy of the Presentation is attached hereto as Exhibit 99.1 and is incorporated herein by reference. 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 disclosures.

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 May 18, 2026, issued a press release providing an update to its Shareholders. On May 19, 2026, the Company issued a press release announcing that it was making a presentation and meeting with investors at Sidoti’s Micro-Cap Virtual Investor Conference.

A copy of the Press Releases are attached hereto as Exhibit 99.2 and 99.3, respectively and are incorporated by reference herein.

ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.

(d) Exhibits

Exhibit No.		Description
99.1		Presentation.

99.2		Press Release dated May 18, 2026.

99.3		Press Release dated May 19, 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 this 19^th day of May 2026.

	ORAGENICS, INC. (Registrant)

	BY:	/s/ Janet Huffman
		Janet Huffman
		Chief Executive Officer

Exhibit 99.1

Exhibit 99.2

ORAGENICS PROVIDES INVESTOR UPDATE

A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER

Sarasota, FL — May 18, 2026 — Oragenics, Inc. (NYSE American: OGEN)

Dear Fellow Shareholders,

Since our last investor update, Oragenics has continued to execute across all fronts — in the clinic, in the regulatory pipeline, on our balance sheet, and strategically. We have reached a pivotal moment: our Phase IIa clinical trial of ONP-002 is active in Australia, patients are being enrolled and dosed, and we have now signed a Letter of Intent to pursue a licensing agreement for a complementary CNS-related medical device. Our focus is sharper than ever — and the progress we are making reflects that.

Below is a full account of what has been accomplished and what is coming next.

PHASE IIa CLINICAL TRIAL — EXECUTION UNDERWAY

ONP-002 | First-in-Class Intranasal Neurosteroid for Concussion / mTBI

Our Phase IIa randomized, placebo-controlled feasibility study of ONP-002 in Australia is no longer a future event — it is happening now. Key clinical updates:

	●	Mackay Base Hospital — site formally activated March 31, 2026. Site staff trained, protocol in place, drug on site. Patient enrollment began immediately upon activation.
	●	First patient dosed at Mackay within days of activation — which we believe is a strong signal of clinical site readiness and real-world demand for the trial.
	●	Alfred Hospital (Melbourne) - site formally activated in April 2026. Site staff trained and drug on site. Patients are actively being screened for enrollment.
	●	Royal Adelaide Hospital — Site initiation visit and staff training completed in May 2026. Formal site activation is pending final Research Governance Office approval processes and is anticipated imminently.
	●	Southern Star Research continues to manage CRO operations across all sites.
	●	Zero serious adverse events have been recorded.

Trial design: 40-patient enrollment target | Randomized, placebo-controlled | First dose within 12 hours of concussion | 30-day follow-up with neurocognitive testing | Primary endpoints: safety, tolerability, and feasibility.

U.S. IND PROGRAM — ON CRITICAL PATH

In parallel with the Australian Phase IIa trial, Oragenics is actively advancing the regulatory program required to bring ONP-002 to U.S. clinical trials. Our scientific and regulatory team is progressing across all IND-enabling disciplines — including pharmacology, toxicology, chemistry and manufacturing controls, and clinical protocol design.

Two near-term milestones anchor our U.S. pathway. First, we are targeting submission of a Type C Meeting Request to the FDA in the second quarter of 2026 — a formal pre-IND interaction that allows the Company to receive FDA guidance on the U.S. clinical development path before committing to full study designs. Second, we are targeting submission of the full Investigational New Drug application by the end of 2026, which would position Oragenics to initiate U.S.-based clinical trials in 2027.

We believe both milestones are on track. Our regulatory consulting partners continue to drive the technical work, and the scientific team provides weekly progress updates. We remain confident in our ability to meet these timelines.

STRATEGIC PIPELINE EXPANSION — LOI SIGNED

Licensing Agreement LOI Executed — CNS Medical Device

Oragenics has signed a Letter of Intent (LOI) to pursue a licensing agreement for a complementary CNS-related medical device. We believe this transaction, if completed, could expand the Company’s addressable indication set beyond ONP-002 while reinforcing Oragenics’ strategic identity as a CNS platform company.

Key deal structure considerations:

●

Licensing structure carves out TBI indication rights while allowing the licensor to pursue other indications independently.

●

Additive to the CNS pipeline narrative: alongside ONP-002 and the CNS candidate molecules identified through our Receptor.AI collaboration, we believe this device will expand our addressable indication set and strengthen our platform.

FINANCIAL POSITION

Key Financial Metrics

Q1 2026 for the three months ended March 31, 2026:

	●	Cash balance: $6.1 million
	●	Research and development expenses were $0.6 million – increased 89% from the same period in 2025
	●	General and administrative expenses were $ 1.6 million – decreased 4% from the same period in 2025

Capital Markets Activity:

	●	ATM facility active: New S-3 filed January 2026; SEC review completed and the facility is available to the Company upon request.
	●	ATM activity generated proceeds in Q1 2026; the Company continues to evaluate optimal timing for future capital raises in connection with clinical and regulatory milestones.

CORPORATE & OPERATIONAL MILESTONES

Annual Shareholder Meeting

●

Annual Meeting scheduled for June 29, 2026..

ANTICIPATED UPCOMING CATALYSTS

The following milestones represent near-term value inflection points for the Company and our shareholders:

	●	Additional Australian clinical trial site activations (Royal Adelaide Hospital — expected near-term)
	●	Multi-patient enrollment progress update
	●	Type C Meeting Request submitted to FDA
	●	Annual Shareholder Meeting (June 29, 2026)
	●	IND submission to FDA - 2026
	●	Phase IIa data readout - 2026

About Oragenics, Inc.

Oragenics, Inc. (NYSE American: OGEN) is a clinical-stage biopharmaceutical company focused on pioneering neurological therapeutics for patients with unmet medical needs. The Company’s lead asset, ONP-002, is a first-in-class intranasal neurosteroid in Phase IIa clinical trials for the treatment of concussion and mild traumatic brain injury — a condition affecting an estimated 69 million people worldwide annually for which no FDA-approved pharmacological treatment currently exists. Delivered via a proprietary intranasal device, ONP-002 is designed to bypass the blood-brain barrier to directly reduce neuroinflammation and oxidative stress at the source of injury. 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. There can be no assurances that the transactions contemplated by the Letter of Intent will be consummated on the terms described therein or at all.

CONTACT INFORMATION

Investor Relations:

irth Communications

ir@oragenics.com

Exhibit 99.3

Oragenics to Present at Sidoti’s Micro-Cap Virtual Investor Conference May 20-21

Sarasota, FL — May 19, 2026 — Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a clinical-stage biopharmaceutical company pioneering neurological therapeutics, will present and host one-on-one meetings with investors at Sidoti’s Micro-Cap Virtual Investor Conference, taking place on May 20-21, 2026.

The presentation will begin at 3:15 ET on May 21, 2026 and can be accessed live here: https://sidoti.zoom.us/webinar/register/WN_4MxVYrk0Sl2JK5ByzTN6Pg. Oragenics will also host virtual one-on-ones with investors on Wednesday and Thursday, May 20-21, 2026. To register for the presentation or one-on-ones, visit www.sidoti.com/events. Registration is free and you don’t need to be a Sidoti client.

About Sidoti Events, LLC (“Events”) and Sidoti & Company, LLC (“Sidoti”)

In 2023, Sidoti & Company, LLC , Sidoti & Company, LLC formed an affiliate company, Sidoti Events, LLC in order to focus exclusively on its rapidly growing conference business and to more directly serve the needs of presenters and attendees. The relationship allows Sidoti Events to draw on the over 25 years of experience Sidoti has as a premier provider of independent securities research focused specifically on small and microcap companies and the institutions that invest in their securities, with most of its coverage in the $200 million-$5 billion market cap range. Sidoti’s coverage universe comprises approximately 150 equities, of which almost 70 percent participate in the firm’s rapidly growing Company Sponsored Research (“CSR”) and Sidoti Lighthouse Equity Research (“Lighthouse”) programs. Sidoti Events is a leading provider of corporate access through the many investor conferences it hosts each year. By virtue of its direct ties to Sidoti, Sidoti Events benefits from Sidoti’s small- and microcap-focused nationwide sales force, which has connections with over 2,500 institutional relationships in North America. This enables Sidoti Events to provide multiple forums for meaningful interaction for small and microcap issuers and investors specifically interested in companies in the sector.

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 and mild traumatic brain injury. Oragenics is progressing ONP-002 through Phase IIa clinical trials in Australia, with U.S. Phase IIb trials planned to follow. The Company believes its intranasal delivery platform has potential applications across multiple neurological conditions. 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

Investor & Media Contact

Investor & Media Relations

irth Communications

800-383-4880

ir@oragenics.com

Source: View Original Filing on SEC EDGAR

FAQ

What clinical progress did Oragenics (OGEN) report for ONP-002?

Oragenics reported its Phase IIa trial of ONP-002 in Australia is active, with multiple hospital sites initiated, patients enrolled and dosed, and zero serious adverse events recorded so far. The 40-patient study is randomized and placebo-controlled, with 30-day neurocognitive follow-up.

What are Oragenics’ key U.S. regulatory milestones for ONP-002?

Oragenics plans to submit a Type C Meeting Request to the FDA in Q2 2026 and target full Investigational New Drug submission by the end of 2026. If accepted, this would position the company to start U.S.-based clinical trials for ONP-002 in 2027.

What is Oragenics’ cash position and recent spending trend?

For Q1 2026, Oragenics reported a cash balance of $6.1 million. Research and development expenses were $0.6 million, up 89% from the same 2025 period, while general and administrative expenses were $1.6 million, down 4%, reflecting greater clinical investment and modest cost control.

How is Oragenics (OGEN) funding its development programs?

Oragenics maintains an at-the-market equity facility supported by an S-3 registration filed in January 2026 and now effective. The company generated proceeds from this ATM in Q1 2026 and indicates it will evaluate future usage alongside clinical and regulatory milestones.

What strategic pipeline expansion did Oragenics announce?

Oragenics signed a Letter of Intent to pursue a licensing agreement for a complementary CNS-related medical device. If completed, the company believes this could broaden its addressable indications beyond ONP-002 and strengthen its positioning as a CNS-focused platform company.

When will Oragenics present to investors at Sidoti’s conference?

Oragenics will present at Sidoti’s Micro-Cap Virtual Investor Conference on May 20-21, 2026. The company’s main presentation is scheduled for 3:15 ET on May 21, 2026, with additional virtual one-on-one investor meetings held across both conference days.

Filing Exhibits & Attachments

22 documents

Oragenics (NYSE: OGEN) advances ONP-002 trial and targets 2026 U.S. IND

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