false
0001174940
0001174940
2026-03-10
2026-03-10
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: March 10, 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
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
8.01. OTHER INFORMATION.
On
March 10, 2026, Oragenics, Inc. (the “Company”) issued a press release announcing that it had received final Human Research
Ethics Committee (HREC) approval in Australia to commence the Company’s Phase IIa clinical trial evaluating the Company’s
lead drug candidate, ONP-002, for the treatment of concussion and mild traumatic brain injury (mTBI).
On
March 11, 2026, the Company issued a press release announcing that the Company is exploring discussions with third parties regarding
the potential acquisition of additional assets in the central nervous system (CNS) space.
On
March 12, 2026, the Company intends to issue a press release announcing today announced it has completed the first site initiation visit
(SIV) for its Phase IIa clinical trial of ONP-002 in Australia.
A
copy of each of the Press Releases is attached hereto as Exhibits 99.1, 99.2 and 99.3, respectively, and is incorporated by reference
herein.
ITEM
9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(d)
Exhibits
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release dated March 10, 2026. |
| |
|
|
| 99.2 |
|
Press Release dated March 11, 2026. |
| |
|
|
| 99.3 |
|
Press Release dated March 12, 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 11th day of March 2026.
| |
ORAGENICS,
INC. |
| |
(Registrant) |
| |
|
| |
BY: |
/s/
Janet Huffman |
| |
|
Janet
Huffman
Chief
Executive Officer |
Exhibit 99.1
FOR
IMMEDIATE RELEASE
Oragenics
Receives HREC Approval for Phase IIa Clinical Trial of ONP-002 as a Treatment for Concussion and Mild Traumatic Brain Injury in Australia
All
required regulatory approvals secured for trial site onboarding and patient enrollment at three Australian sites
Potential
first and only pharmacological treatment for the most prominent neurological condition without an FDA-approved therapeutic
SARASOTA,
Fla., March 10, 2026 (BUSINESS WIRE) — Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company developing
brain-targeted therapeutics through proprietary intranasal delivery technology, today announced that it has received final Human Research
Ethics Committee (HREC) approval in Australia to commence its Phase IIa clinical trial evaluating its lead drug candidate, ONP-002, for
the treatment of concussion also known as mild traumatic brain injury (mTBI). Oragenics has now secured all necessary regulatory approvals
and submitted all required filings to proceed with clinical site onboarding at three sites in Australia, with Bayside Health (Alfred
Health) serving as the Lead Site.
Traumatic
brain injury ranks as the most prominent neurological condition without an FDA-approved therapeutic. 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 exist — leaving patients, military personnel, athletes, and families without effective intervention
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
ONP-002
is a first-in-class intranasal neurosteroid designed to address the underlying biology of mTBI — 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, potentially representing a paradigm shift from symptom management to active neurological
intervention. It would also enter a nasal drug delivery market expected to reach nearly $93 billion by 2030.³
“Concussion
and mTBI represent areas of enormous unmet medical need, and we have spent years building toward this moment responsibly and rigorously.
With our Australian HREC and governance approvals now in place, we have everything we need to move forward expeditiously with clinical
site onboarding and patient enrollment in Australia. We expect to dose our first patient before the end of March. This is a major milestone
for Oragenics — but more importantly, it is a meaningful step toward bringing a potential breakthrough therapy to a patient population
that has had no viable treatment options. For the millions of people who suffer from mTBI every year and are told there is nothing that
can be done, we are here to change that,” said Janet Huffman Oragenics Chief Executive Officer.
“The
HREC approval process is thorough by design — it exists to protect patients and ensure
that only protocols with sound scientific rationale and rigorous safeguards move forward.
We believe receiving this clearance confirms that our trial design, safety protocols, and
investigator teams meet the highest standards. As a clinician who has worked with concussion
patients for decades, I understand the significance of this moment. ONP-002 targets the injury
itself, not just the symptoms. That is a fundamentally different approach to mTBI care, and
we are now putting it to the test in patients. The Phase 1 safety profile gives us strong
confidence as we advance into this next phase,” said Dr James Kelly Oragenics Chief
Medical Officer.
Oragenics’
approved 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 are expected to receive first dosing
within 12 hours of injury, 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.
The
Phase IIa clinical data readout is projected before year-end 2026. Oragenics expects that findings will support its planned investigational
new drug (IND) application submission to the FDA for further clinical trials in the U.S.
1
American Association of Neurological Surgeons; Sports Related Head Injury / CDC TBI Data
2
Grand Market Research; Concussion Market (2025–2030)
3
Research and Markets; $92.91 Bn Nasal Drug Delivery Market Trends, Opportunities, and Forecasts, 2020–2024 & 2025–2030F
The
Phase 1 clinical trial of ONP-002 delivered a strong safety profile supporting advancement to Phase 2, with zero serious adverse events
across all dose levels. Preclinical data demonstrated reductions in swelling, inflammation, and oxidative stress in the brain, along
with improvements in functional recovery.
Southern
Star Research, a leading full-service Australian clinical research organization (CRO), is expected to manage all aspects of the Phase
IIa trial from start to finish.
About
ONP-002
ONP-002
is an investigational neuroprotective, anti-inflammatory intranasal drug candidate targeting mild traumatic brain injury (mTBI). Designed
to potentially interrupt biological pathways involved in inflammation, oxidative stress, and 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. clinical 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 mild traumatic brain injury.
Oragenics is progressing ONP-002 through Phase IIa clinical trials in Australia, with U.S. clinical trials planned to follow pending
FDA investigational new drug application (IND) approval. The Company believes its intranasal delivery platform has potential applications
across multiple neurological conditions, including Parkinson’s disease, Alzheimer’s disease, PTSD, and anxiety 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 our 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 for 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, circumstances should change, except as otherwise required by law.
Investor
Contact:
800-383-4880
ir@oragenics.com
Exhibit 99.2
FOR
IMMEDIATE RELEASE
ORAGENICS
EXPLORES EXPANSION OF CNS PLATFORM
PURSUING
ACQUISTION OF ASSETS IN BRAIN HEALTH, RECOVERY, AND NEUROPROTECTION
SARASOTA,
Fla., March 11, 2026 (BUSINESS WIRE) — Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company pioneering
brain-targeted therapeutics through proprietary intranasal delivery technology, today announced that it is exploring discussions with
third parties regarding the potential acquisition of additional assets in the central nervous system (CNS) space, with a specific focus
on brain health and brain recovery indications that demonstrate strategic synergies with the Company’s lead candidate ONP-002 and
its proprietary intranasal drug delivery platform.
The
Company’s portfolio expansion initiative is being pursued independently of its existing partnership with Receptor.AI, which focuses
on artificial intelligence-enabled CNS drug discovery. Together, these two parallel strategies — traditional asset acquisition
and AI-driven discovery — reflect Oragenics desire to build a diversified, platform-anchored CNS portfolio.
No
definitive agreements have been reached, and there can be no assurance that any transaction will be completed on terms acceptable to
the Company, or at all. The Company will disclose any material transaction in accordance with applicable securities laws and regulations.
Strategic
Rationale
Oragenics’
CNS portfolio expansion strategy is grounded in the Company’s belief that its proprietary intranasal delivery platform represents
a broadly applicable technology with potential across multiple brain health and brain recovery indications. The Company is evaluating
acquisition candidates on the following criteria:
| |
● |
Brain
Health and Brain Recovery Focus: Candidates targeting neurological conditions involving brain injury, neuroinflammation, cognitive
impairment, or recovery of brain function |
| |
● |
Platform
Synergy: Assets that are well-suited for intranasal delivery or that would benefit from the Company’s existing CNS regulatory
and clinical development capabilities |
| |
● |
Clinical
Stage and Data: Candidates with meaningful preclinical or early clinical evidence that can be efficiently advanced through development |
| |
● |
Strategic
Fit: Opportunities that complement — without displacing — the Company’s commitment to advancing ONP-002 through
Phase IIa in Australia and into U.S.-based Phase IIb trials |
ONP-002
Provides the Foundation
Oragenics’
decision to actively pursue CNS portfolio expansion is grounded in the progress of its lead program. The Phase IIa clinical trial of
ONP-002 is now in active site initiation, with the first site initiation visit completed in Australia and two additional sites in Australia
completing final Research Governance reviews prior to patient enrollment.
ONP-002
is the only pharmacological candidate in clinical development targeting the underlying biology of concussion and mild traumatic brain
injury — reducing neuroinflammation, oxidative stress, and cerebral edema at the source. Phase 1 demonstrated safety and tolerability
in 40 patients with zero serious adverse events. There are currently no FDA-approved pharmacological treatments for concussion or mTBI.
Following
Phase IIa in Australia, the Company plans to submit an IND application to the FDA for continued US based clinical trials in 2027 to advance
the development of ONP-002.
“ONP-002
is advancing in human trials right now – and that progress is exactly what gives us the confidence to continue to look forward.
We believe our intranasal delivery platform is not a single-drug asset. It is a technology designed to get therapeutics into the brain
rapidly, non-invasively, and effectively. We believe there are real opportunities in the brain health and brain recovery space that could
benefit from this platform – some of which we have begun to explore. Our goal isintend to build a CNS company that makes a meaningful
impact on how the work treats diseases of the brain. That starts with ONP-002, and it should not stop there.” – Janet Huffman,
Chief Executive Officer, Oragenics, Inc.
About
the Intranasal Delivery Platform
Oragenics’
proprietary intranasal drug delivery system is designed to enable rapid, non-invasive delivery of therapeutic compounds directly to the
brain via the olfactory and trigeminal nerve pathways, bypassing the blood-brain barrier. We believe the platform has the potential to
address a fundamental challenge in CNS drug development: delivering therapeutics to the brain with efficiency, speed, and tolerability.
Oragenics believes the platform has broad applicability across multiple brain health indications, positioning the Company to build a
pipeline anchored in a differentiated and defensible delivery technology.
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 our 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; the timing, conduct, interim results announcements and outcomes of our clinical trials for our product
candidates, including ONP-002 for the treatment of concussion and mTBI; our acquisition strategy and prospects; and our ability to finance
our operations. 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, circumstances
should change, except as otherwise required by law.
ABOUT
ORAGENICS
Oragenics,
Inc. (NYSE American: OGEN) is a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal
drug delivery technology. The Company’s lead candidate, ONP-002, is a first-in-class intranasal neurosteroid in Phase IIa clinical
development for the treatment of concussion and mild traumatic brain injury (mTBI) — conditions affecting an estimated 69 million
people globally each year with no approved pharmacological treatment. Oragenics intranasal delivery platform is designed to enable rapid,
non-invasive delivery of therapeutics directly to the brain bypassing the blood-brain barrier. The Company is exploring broadening its
CNS pipeline strategy through both internal development and strategic business development. For more information, visit www.Oragenics.com.
Investor
Contact:
800-383-4880
ir@oragenics.com
Exhibit 99.3
ORAGENICS
INITIATES PHASE IIA CLINICAL TRIAL SITE ACTIVATION
FIRST
SITE INITIATION VISIT COMPLETED IN AUSTRALIA
SARASOTA,
Fla., March 12, 2026 (BUSINESS WIRE) — Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company pioneering
brain-targeted therapeutics through proprietary intranasal delivery technology, today announced it has completed the first site initiation
visit (SIV) for its Phase IIa clinical trial of ONP-002 in Australia. The visit marks the formal launch of clinical trial operations
at the first of three planned trial sites in Australia, including completion of site staff training, protocol orientation, and site regulatory
documentation.
The
remaining two clinical trial sites are currently completing their Research Governance Office (RGO) reviews — the final administrative
step required following Human Research Ethics Committee (HREC) approval before each site can activate to begin patient enrollment and
dosing. The Company expects these reviews to be completed in the near term, at which point all three sites will be positioned to enroll
patients.
The
Phase IIa trial initiation follows the Company’s receipt of HREC approval earlier this year, which represented the final regulatory
clearance required to commence clinical site contract finalization, activation, and onboarding.
Phase
IIa Clinical Trial Overview
The
Phase IIa trial is a randomized, placebo-controlled study evaluating the safety, tolerability, and preliminary clinical signals of ONP-002
in patients presenting with acute concussion and mild traumatic brain injury. Key design parameters include:
| |
● |
Enrollment
target: 40 patients across three Australian clinical sites |
| |
● |
Dosing
window: First dose administered within 12 hours of concussion onset |
| |
● |
Primary
endpoints: Safety (adverse events, nasal examinations), neurocognitive follow-up assessments, and participant compliance/tolerability |
| |
● |
Trial
status: First SIV complete; two remaining sites in RGO final review prior to activation |
“We
said we would advance ONP-002 into patients in Australia — and that process is now underway. Our first site is trained, operational,
and ready to enroll. The remaining sites are completing their final governance reviews, and we expect them to follow shortly. This is
the kind of measured, disciplined execution that clinical development demands, and our team is delivering. Patient dosing is the next
step, and we are ready.” — Chief Executive Officer, Janet Huffman.
“Site
initiation marks the transition from regulatory preparation to active clinical operations. Our investigators are trained on the protocol,
safety procedures are in place, and our CRO is coordinating operations across all three sites . The RGO review process at the remaining
sites is proceeding as expected. We anticipate completing site activation across all three locations in the near term and beginning patient
enrollment shortly thereafter.”
—
Chief Medical Officer, Dr James Kelly M.D.
About
ONP-002
ONP-002
is a first-in-class intranasal neurosteroid in Phase IIa clinical development for the treatment of concussion and mild traumatic brain
injury. Unlike current approaches limited to symptom management and rest, ONP-002 is designed to interrupt the neuroinflammatory cascade
triggered by brain trauma — reducing neuroinflammation, oxidative stress, and cerebral edema at the source. Phase 1 clinical trials
in 40 patients demonstrated ONP-002 was safe and well-tolerated across all dose levels with zero serious adverse events (SAEs). There
are currently no FDA-approved pharmacological treatments for concussion or mTBI.
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 our 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; the timing, conduct, interim results announcements and outcomes of our clinical trials for our product
candidates, including ONP-002 for the treatment of concussion and mTBI; our acquisition strategy and prospects; and our ability to finance
our operations. 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, circumstances
should change, except as otherwise required by law.
ABOUT
ORAGENICS
Oragenics,
Inc. (NYSE American: OGEN) is a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal
drug delivery technology. The Company’s lead candidate, ONP-002, is a first-in-class intranasal neurosteroid in Phase IIa clinical
development for the treatment of concussion and mild traumatic brain injury (mTBI) — conditions affecting an estimated 69 million
people globally each year with no approved pharmacological treatment. Oragenics’ intranasal delivery platform is designed to enable
rapid, non-invasive delivery of therapeutics directly to the brain by bypassing the blood-brain barrier. The Company is exploring broadening
its CNS pipeline strategy through both internal development and strategic business development. For more information, visit www.Oragenics.com.
Investor
Contact:
800-383-4880
ir@oragenics.com
