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OGEN

ORAGENICS INC

Pharmaceutical preparations·Phase 2·Lakewood Ranch, FL, United States·CEO: Ms. Janet Huffman
Neurology

OGEN evidence brief

What we can confirm

BioSniper Score:
6.2 / 10
Market Cap:
$2.2M
Lead Asset:
onp-002 (Phase 2)

What it means

The company data is ready for cross-source review; unsupported conclusions remain unknown.

What to watch

Market Cap: $2.2M · Lead Asset: onp-002 (Phase 2)
BioSniper AIPage evidence connected

Prepared research question

What matters most for OGEN—catalysts, financial risk and supporting evidence?

Run cited research

Traceable citations · Unknowns marked

BioSniper AI · OGEN

Oragenics Inc. is a clinical-stage biopharmaceutical company developing intranasal therapeutics for neurological conditions, with its lead candidate ONP-002 targeting concussion and mild traumatic brain injury (mTBI).

Key risk: Capital insufficiency

6.2/10

BioSniper Score

Based on 3 of 6 signals

Limited data coverage

Market Cap

$2.2M

Cash Runway

—

Lead Asset

onp-002 (Phase 2)

Next Catalyst

—

Financial data as of Jun 30, 2026.

Tracking 1 pipeline candidate for ORAGENICS INC.

Similar companies

AI OverviewAI overview is shown in English only.

Oragenics Inc. is a clinical-stage biopharmaceutical company developing intranasal therapeutics for neurological conditions, with its lead candidate ONP-002 targeting concussion and mild traumatic brain injury (mTBI).

  • Lead candidate ONP-002 is in a Phase IIa clinical trial for concussion/mTBI, with patient enrollment and dosing active in Australia as of May 2026 [news].
  • Cash and equivalents were $3.9M as of 2026-06-30, with net income of -$2.5M and shareholders' equity of $3.7M [sec].
  • The company expects to need additional capital to complete planned clinical trials, regulatory filings, and any future commercialization efforts [sec_mda · as of 2026-08-13].
  • ONP-002, if approved, would be the first pharmacological standard of care for a global concussion market projected to exceed $9 billion by 2030 [sec_mda · as of 2026-05-08].
  • Oragenics is listed on the NYSE American under ticker OGEN and continues to provide updates on its clinical and regulatory progress [news].

What works

  • ONP-002 addresses a large unmet need in concussion/mTBI, a market projected to reach over $9 billion by 2030, with no FDA-approved pharmacological standard of care currently [sec_mda · as of 2026-05-08].
  • The company has a proprietary intranasal delivery platform that targets the brain, potentially offering a differentiated therapeutic approach [news].
  • Clinical progress is being made: the Phase IIa trial is active, with multiple sites enrolling patients and dosing underway [news].

What to weigh

  • Oragenics is a development-stage company with no approved products and has generated negative net income (-$2.5M as of 2026-06-30) [sec].
  • The company faces significant capital requirements and has stated that additional capital is needed to complete planned trials and commercialization; failure to secure funding could delay or eliminate programs [sec_mda · as of 2026-08-13].
  • Cash reserves are limited ($3.9M as of 2026-06-30), which may constrain operations and development timelines without near-term financing [sec].
  • Any future equity or debt financing could result in dilution or senior claims against the company [sec_mda · as of 2026-08-13].

From the filings

Quoted directly from source documents.

  • ONP-002 is in Phase IIa clinical trial for concussion/mTBI

    “Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biopharmaceutical company developing brain-targeted therapeutics through its proprietary intranasal delivery platform, today provided an update on its Phase IIa clinical trial”

    News · August 28, 2026

  • Additional capital is required to complete planned activities

    “Additional capital will still be required to complete planned clinical trials, regulatory filings, and any future commercialization efforts.”

    SEC MD&A · August 13, 2026

  • Concussion market projected to exceed $9 billion by 2030

    “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.”

    SEC MD&A · May 8, 2026

Risks & what to watch (3)›

Key risks

  • Capital insufficiency — The company states additional capital is required to complete trials and commercialization; failure to secure funding could delay or eliminate programs [sec_mda · as of 2026-08-13].
  • No approved products — Oragenics is a development-stage company with no approved products and negative net income [sec].
  • Shareholder dilution — Raising funds through equity or convertible securities could result in significant dilution to existing shareholders [sec_mda · as of 2026-08-13].

What to watch

  • Enrollment and dosing progress in the Phase IIa trial of ONP-002, with updates on patient numbers and site activations [news].
  • The company's ability to secure additional financing or strategic partnerships to fund ongoing development [sec_mda · as of 2026-08-13].
  • Regulatory milestones, including any FDA interactions or pathway updates for ONP-002 [news].
  • NYSE American continued listing status and any corporate updates from the company [news].

Sources: News · SEC MD&A · Generated October 4, 2026 · How we verify sources →

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Evidence & data

Score breakdownBased on 3 of 6 signals · derived from public data

Cash RunwayN/A

Cash runway data unavailable

Financial Health9.3

D/E 0.50 · 0% dilution

Pipeline Maturity6.0

Lead: Phase 2

Pipeline Breadth3.3

1 candidate

Catalyst MomentumN/A

No upcoming catalysts tracked

Insider SignalN/A

No insider transactions in the last 180 days

Pipeline

Financials

Short Interest

as of Apr 28, 2026
% of float
16.2%
Days to cover
7.2
Shares short
703,470
Daily short volume (Oct 12, 2026)
45.3%

Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →

OGEN short interest

Governance

Frequently asked questions

What is the AI investment thesis for ORAGENICS INC?

Oragenics Inc. is a clinical-stage biopharmaceutical company developing intranasal therapeutics for neurological conditions, with its lead candidate ONP-002 targeting concussion and mild traumatic brain injury (mTBI).

What is ORAGENICS INC's lead drug candidate?

ORAGENICS INC's most advanced tracked candidate is onp-002 (Phase 2) for mild traumatic brain injury ("mTBI" or "concussion").

Who is the CEO of ORAGENICS INC?

Ms. Janet Huffman is the chief executive officer of ORAGENICS INC (OGEN).

Where is ORAGENICS INC headquartered?

ORAGENICS INC (OGEN) is headquartered in Lakewood Ranch, FL, United States.

What therapeutic areas does ORAGENICS INC focus on?

ORAGENICS INC develops therapies across Neurology.

923 companies304,846 SEC filings22,682 clinical trials100% citation-verification pass rate (7d)How we verify →

The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.