Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
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Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $0.4652W HIGH $1.45
Volume
45.86 K
Value Traded
17.70 K
Short % Float
17.92%
-5.04%Week
-10.1%1 Month
-21%3 Month
-23.22%6 Month
-99.95%5 Year
-100%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
2.09 M
EPS (TTM)
-2.23
P/E Ratio
-
Ent. Value
-1.78 M
Total Shares
4.51 M
Float Shares
4.50 M
Insiders
0.17%
Institutions
1.50%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
OGEN Catalyst Timeline
Dated clinical, regulatory and corporate events for Oragenics Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Oragenics Inc.
431Total events
13Upcoming
67Tier-1 (high impact)
2007 to 2028Coverage
Upcoming catalysts 2
Event history 50
◆Oral PresentationONP-002FiledPresentation
CMO James P. Kelly to present ONP-002 intranasal delivery platform case study at IPAC-RS 2026 Nasal Innovation Forum
concussionsource ↗
▲Enrollment UpdateONP-002FiledTrial
Nine participants dosed in Phase IIa trial
mTBI (concussion)source ↗
◆Topline ReadoutONP-002FiledClinical Data
Phase IIa data readout
concussion (mild traumatic brain injury)source ↗
●NDA SubmissionONP-002FiledRegulatory Filing
FDA Accelerated Approval Filing (if eligible)
concussionsource ↗
▲Enrollment CompleteONP-002FiledTrial
All three Australian Phase IIa trial sites active and enrolling
mTBI (concussion)source ↗
●Type B MeetingONP-002FiledFDA Meeting
Type B meeting request submitted to FDA
mTBI (concussion)source ↗
▲First Patient DosedONP-002FiledTrial
Alfred Health enrolls first participant
mTBI (concussion)source ↗
▲Partnership / LicenseCardioDialysisCorporate
Oragenics signs LOI to license CardioDialysis from Sigyn Therapeutics for TBI and neurodegenerative diseases
Traumatic Brain Injury (TBI) and other chronic neurodegenerative diseasessource ↗
◆Trial InitiationONP-002FiledTrial
ONP-002 Phase IIa clinical trials ongoing for concussion and mTBI
concussion and mild traumatic brain injury (mTBI)source ↗
▲Trial InitiationONP-002FiledTrial
Alfred Hospital activated as second site in Phase IIa trial
concussion and mild traumatic brain injurysource ↗
▲Enrollment UpdateONP-002FiledTrial
Four patients enrolled and dosed at Mackay Base Hospital
concussion and mild traumatic brain injurysource ↗
▲Trial InitiationONP-002FiledTrial
Royal Adelaide Hospital site initiation visit and staff training completed
concussion / mild traumatic brain injurysource ↗
▲First Patient DosedONP-002FiledTrial
First patient dosed in Phase IIa trial of ONP-002 for mTBI
mild traumatic brain injury (mTBI)source ↗
●Enrollment UpdateONP-002FiledTrial
Enrollment underway at Mackay Base Hospital; 2 patients enrolled
mild traumatic brain injury (mTBI)source ↗
▲First Patient DosedONP-002FiledTrial
First patient dosed in Phase IIa trial of ONP-002 for mTBI
mild traumatic brain injury (mTBI) / concussionsource ↗
◆Enrollment UpdateONP-002FiledTrial
Two additional Australian sites expected to be activated in Q2 2026
mild traumatic brain injury (mTBI) / concussionsource ↗
▲First Patient DosedONP-002FiledTrial
First patient dosed in Phase IIa trial of ONP-002 at Mackay Base Hospital
concussion / mild traumatic brain injurysource ↗
▲Trial InitiationONP-002FiledTrial
Alfred Hospital site activated for Phase IIa trial of ONP-002
concussion / mild traumatic brain injurysource ↗
●Type C MeetingONP-002FiledFDA Meeting
Type C Meeting Request submission to FDA for ONP-002
concussion / mild traumatic brain injurysource ↗
◆Enrollment MilestoneTrial
HeadSMART II expected to surpass 2,000 enrolled patients within next year
mild traumatic brain injurysource ↗
▲Trial InitiationONP-002FiledTrial
Mackay Base Hospital activated as first clinical trial site
mild traumatic brain injury (mTBI) / concussionsource ↗
▲First Patient DosedONP-002FiledTrial
First patient dosed at Mackay Base Hospital
concussion and mild traumatic brain injurysource ↗
●Quarterly UpdateCorporate
Filed Annual Report on Form 10-K for fiscal year ended December 31, 2025
▲Trial InitiationONP-002FiledTrial
First site initiation visit completed for Phase IIa trial of ONP-002 in Australia
acute concussion and mild traumatic brain injurysource ↗
◆Enrollment UpdateONP-002FiledTrial
Remaining two sites completing RGO reviews before activation
acute concussion and mild traumatic brain injurysource ↗
▲Trial InitiationONP-002FiledTrial
First site initiation visit completed in Australia for Phase IIa trial of ONP-002
concussion and mild traumatic brain injury (mTBI)source ↗
▲Trial InitiationONP-002FiledTrial
HREC approval received for Phase IIa trial of ONP-002 in Australia
concussion and mild traumatic brain injurysource ↗
◆Trial InitiationONP-002FiledTrial
First patient dosed expected before end of March 2026
concussion and mild traumatic brain injury (mTBI)source ↗
▲First Patient DosedONP-002FiledTrial
First patient dosing expected before end of March 2026
concussion and mild traumatic brain injurysource ↗
▲Partnership / LicenseCorporate
Engaged DUCK FLATS Pharma as IND readiness and regulatory execution partner
concussion and mild traumatic brain injurysource ↗
▲Trial InitiationONP-002FiledTrial
Completed first site initiation visit (SIV) for Phase IIa trial in Australia
concussion and mild traumatic brain injury (mTBI)source ↗
▲Other Regulator MilestoneONP-002FiledEx-US Regulatory
Obtained HREC ethics approval in Australia for Phase IIa trial
concussion and mild traumatic brain injury (mTBI)source ↗
▲Quarterly UpdateCorporate
Regained full compliance with NYSE American continued listing standards
◆Trial InitiationONP-002FiledTrial
Phase IIa clinical trial initiation with first patient dosed in Australia
mild traumatic brain injury (mTBI) or concussionsource ↗
◆IND SubmissionONP-002FiledIND
IND submission preparations for U.S.-based Phase IIb clinical trials
mild traumatic brain injury (mTBI) or concussionsource ↗
Past FDA Catalysts and PDUFA Decisions
How OGEN actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2022-03-31 | Terra CoV-2 | IND Submission | IND |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
D20 / 100
Pipeline Score
$1M
Pipeline Value
Overvalued
Valuation Signal
1
Drugs Scored
0.2x
rNPV / MCap
Top 95%
Micro Cap(rank 625 of 658)
Percentile Rank
Oragenics Inc. faces pipeline headwinds (20/100), with $161M risk-adjusted pipeline value, led by ONP-002 in Mild Traumatic Brain Injury, Concussion (Phase 2), but cash runway is a concern.
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ONP-002 Small moleculeNCT06870240 | Mild Traumatic Brain Injury, Concussion | Phase 2 | NOT YET_RECRUITING | 40 | Mar 31, 2026 |
Clinical Trial Results
Readouts, endpoints and source filings for every OGEN program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| ONP-002 | concussions | Phase 2 | 2024-10-09 | strong safety profiles; strong cardiac safety margin; does not cause DNA damage; 4-fold increase in drug percentage per doseRead More | Oragenics, Inc. Updates Shareholders on Concussion Drug Progress and Phase II Trial PreparationRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Spencer JohnOfficer (Chief Financial Officer) | Grant/Award | 55,900 55,900 held | $0.00 | 07/01/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in OGEN
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in OGEN for Q2 2026. | ||||
OGEN Institutional Ownership Trends
Options Data
Option Volume
Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How OGEN ranks across every disease it competes in
Competitive Position is a premium feature
See how OGEN ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialOGEN News
OGENOragenics Chief Medical Officer to Present at IPAC-RS 2026 Nasal Innovation Forum
James P. Kelly, MD, Chief Medical Officer of Oragenics, will present at the IPAC-RS 2026 Nasal Innovation Forum on September 17, 2026. His presentation will cover the clinical translation of ONP-002, an intranasal neurosteroid for concussion treatment, including its Phase IIa trial design and future U.S. development plans. The forum focuses on advancements in nasal drug delivery.
Read more →OGENOragenics Reports Continued Clinical Progress, Provides Regulatory and NYSE American Listing Update
Oragenics, Inc. has reported progress in its Phase IIa clinical trial for ONP-002, an intranasal candidate for mTBI, with nine participants dosed across three sites in Australia. The company is also addressing a deficiency letter from NYSE American regarding its listing compliance and aims to submit a plan within the required timeframe. Despite these challenges, Oragenics remains optimistic about its clinical and regulatory advancements.
Read more →OGENOragenics Achieves Full Activation of Australian Phase IIa Trial Network — All Three Sites Now Enrolling
Oragenics has successfully activated all three sites for its Phase IIa trial in Australia, with the first participant enrolled at Alfred Health. The company is also progressing its U.S. regulatory pathway for ONP-002, aimed at treating mTBI. No serious adverse events have been reported so far, and a Phase IIa data readout is expected in Q4 2026.
Read more →OGENOragenics to Present at Sidoti’s Micro-Cap Virtual Investor Conference May 20-21
Oragenics, Inc. will present at Sidoti's Micro-Cap Virtual Investor Conference on May 20-21, 2026. The presentation will showcase the company's lead candidate, ONP-002, which is in Phase IIa trials for concussion treatment. Investors can register for the presentation and one-on-one meetings, emphasizing Oragenics' proactive investor engagement.
Read more →OGENORAGENICS PROVIDES INVESTOR UPDATE
Oragenics, Inc. has provided an investor update highlighting the active Phase IIa clinical trial of ONP-002 for concussion treatment in Australia. The company has successfully activated multiple trial sites and is progressing towards U.S. clinical trials with plans for an FDA Type C Meeting Request. Additionally, a Letter of Intent has been signed for a CNS-related medical device, expanding their strategic pipeline.
Read more →OGENOragenics Signs Letter of Intent to License CardioDialysis™ Technology from Sigyn Therapeutics to Target TBI-Induced Systemic Inflammation
Oragenics has signed a Letter of Intent to license CardioDialysis™ technology from Sigyn Therapeutics, aiming to develop treatments for Traumatic Brain Injury (TBI) and chronic neurodegenerative diseases. This partnership positions Oragenics as the only company targeting TBI-induced inflammation on both sides of the blood-brain barrier. The agreement is contingent on due diligence and board approvals, with a target closing in 90 days.
Read more →OGENOragenics Activates Second Site in Phase IIa Clinical Trial of ONP-002 for Concussion and Mild Traumatic Brain Injury.
Oragenics has activated a second site for its Phase IIa clinical trial of ONP-002, aimed at treating concussion and mild traumatic brain injury (mTBI). The trial is designed to enroll 40 patients, with initial dosing occurring within 12 hours of injury. ONP-002 is a first-in-class intranasal neurosteroid that could potentially transform treatment options for millions affected by these conditions. The company anticipates a data readout by the end of 2026, which may support future FDA applications.
Read more →OGENOragenics Reports 8 study drug doses in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain Injury
Oragenics, Inc. has initiated a Phase IIa clinical trial for ONP-002, targeting mild traumatic brain injury (mTBI) with the first doses administered at Mackay Base Hospital in Australia. The drug is positioned to potentially become the first pharmacological treatment for concussion, addressing a significant medical need given the absence of current FDA-approved options. Enrollment is ongoing, with a total of 40 patients to be included in the trial. Positive early results bolster the company's confidence in the therapeutic potential of ONP-002, which aims to tackle underlying biological processes rather than just alleviate symptoms.
Read more →OGENOragenics Doses First Patient in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain Injury
Oragenics, Inc. has initiated patient dosing in its Phase IIa clinical trial for ONP-002, targeting mild traumatic brain injury (mTBI). This milestone follows the activation of Mackay Hospital in Australia as the first clinical site. ONP-002 aims to provide a pharmacological treatment for concussion, a condition currently lacking approved therapies. The trial will evaluate safety and tolerability in patients receiving treatment within 12 hours of concussion.
Read more →OGEN▲ +11.2%on this news
Doses First Patient in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain Injury
Oragenics, Inc. has initiated patient dosing in its Phase IIa clinical trial for ONP-002 aimed at treating mild traumatic brain injuries (mTBI) and concussions. This milestone was achieved at Mackay Hospital in Australia, with the first patient dosed shortly after the site activation. ONP-002, delivered intranasally, is designed to address brain injury biology rather than merely managing symptoms, and if successful, it could become the first approved medication for mTBI in a market projected to reach over $9 billion by 2030.
Read more →OGEN▼ -7.3%on this newsshared move
Oragenics, Inc. Receives Audit Opinion with Going Concern Explanation
Oragenics, Inc. announced that its audited financial statements included an unqualified audit opinion with a going concern explanation. This disclosure follows the filing of its Annual Report on Form 10-K for the year ended December 31, 2025. The company continues to develop its lead candidate, ONP-002, for concussion and mild traumatic brain injury.
Read more →OGENORAGENICS FILES ANNUAL REPORT ON FORM 10-K
Oragenics, Inc. has filed its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, highlighting significant operational and financial achievements. The company successfully completed a $16.5 million capital raise and regained compliance with NYSE American listings, marking a decisive transformation in its operations. Furthermore, in 2026, Oragenics received ethics approval to initiate patient dosing for its lead candidate, ONP-002, in Australia. The company also aims to expand its central nervous system pipeline and file an IND with the FDA for U.S.-based clinical trials.
Read more →OGEN▲ +8.5%on this newsshared move
ORAGENICS INITIATES PHASE IIA CLINICAL TRIAL SITE ACTIVATION
Oragenics, Inc. has announced the completion of the first site initiation visit for its Phase IIa clinical trial of ONP-002 in Australia, marking a significant milestone in their clinical development process. This trial aims to evaluate the safety and preliminary effectiveness of ONP-002 for treating concussions and mild traumatic brain injuries. Two additional trial sites are under review and are expected to begin patient enrollment soon. The company emphasizes their commitment to disciplined execution in advancing ONP-002 through the clinical stages.
Read more →OGEN▼ -9.9%on this newsshared move
ORAGENICS EXPLORES EXPANSION OF CNS PLATFORM PURSUING ACQUISTION OF ASSETS IN BRAIN HEALTH, RECOVERY, AND NEUROPROTECTION
Oragenics, Inc. is considering the acquisition of additional assets in the CNS sector to enhance its platform focused on brain health and recovery. This expansion follows the positive progress of its lead candidate, ONP-002, which is currently undergoing Phase IIa clinical trials. Oragenics aims to leverage its proprietary intranasal delivery technology to establish a diversified CNS portfolio that synergizes with its existing offerings. However, no definitive agreements have been reached, and the success of any acquisition remains uncertain.
Read more →OGENOragenics Receives HREC Approval for Phase IIa Clinical Trial of ONP-002 as a Treatment for Concussion and Mild Traumatic Brain Injury in Australia required regulatory approvals secured for trial site onboarding and patient enrollment at three Australian sites
Oragenics, Inc. has announced the receipt of HREC approval to initiate a Phase IIa clinical trial for its drug candidate ONP-002, aimed at treating concussion and mild traumatic brain injury in Australia. This trial marks a significant step forward as ONP-002 could be the first pharmacological treatment for these conditions, which currently lack FDA-approved therapies. Patient enrollment is set to begin across three sites, with the first dosing expected before the end of March 2026. The company anticipates that positive outcomes from this trial may support future U.S. clinical trials pending FDA application.
Read more →OGENOragenics Receives HREC Approval for Phase IIa Clinical Trial of ONP-002 as a Treatment for Concussion and Mild Traumatic Brain Injury in Australia
Oragenics has announced that it has received final HREC approval to begin a Phase IIa clinical trial for its investigational drug ONP-002, targeting concussion and mild traumatic brain injury (mTBI). This trial is notable as there are currently no FDA-approved pharmacological treatments for mTBI, representing a significant unmet medical need. The study will involve patient enrollment at three sites in Australia, with the aim to dose the first patient by the end of March 2026. If successful, ONP-002 could redefine treatment approaches by targeting the underlying biology of mTBI rather than merely providing symptomatic relief.
Read more →OGEN▼ -5.2%on this news
Oragenics Targets Projected $9 Billion Market by Advancing First and Only Clinical-Stage Concussion and Mild Traumatic Brain Injury Therapy
Oragenics is advancing ONP-002, a novel intranasal neurosteroid, as a potential first treatment for concussion and mild traumatic brain injury (mTBI). The company is preparing to initiate a Phase 2 clinical trial in Australia, despite delays caused by hospital consolidations. The projected global market for concussion therapies is expected to exceed $9 billion by 2030, highlighting the significant opportunity for ONP-002 if approved.
Read more →OGEN▼ -7.2%on this news
Oragenics Partners with DUCK FLATS Pharma to Support FDA IND Readiness and Clinical Trial Design for Concussion Program
Oragenics has partnered with DUCK FLATS Pharma to enhance its FDA IND readiness and clinical trial design for its intranasal concussion therapy, ONP-002. This collaboration aims to align their Phase 2a clinical trial in Australia with U.S. regulatory strategies. The partnership leverages DUCK FLATS Pharma's extensive experience in drug development to navigate the regulatory landscape effectively.
Read more →OGENOragenics to Participate in SCOPE Summit 2026 Focused on Advancing Clinical Research and Patient Care
Oragenics, Inc. announced its participation in the SCOPE Summit 2026, a key conference for clinical research. The event, taking place from February 2-5 in Orlando, Florida, aligns with the company's upcoming Phase 2a trial of its concussion treatment, ONP-002. CEO Janet Huffman expressed enthusiasm for engaging with industry leaders to advance neurological care. The company aims to address significant unmet medical needs in concussion and mild traumatic brain injury.
Read more →About Oragenics Inc.
Headquarters9015 TOWN CENTER PARKWAY, LAKEWOOD RANCH, FL, 34202
Founded2004
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