Oragenics

What Oragenics does

Oragenics, Inc. (NYSE American: OGEN) is a clinical-stage biopharmaceutical company headquartered in Sarasota, Florida, that is developing therapeutics for neurological conditions using a proprietary intranasal drug delivery platform. The platform, acquired from Odyssey Health in October 2023, is engineered to deliver therapeutic compounds directly to the brain via the olfactory and trigeminal nerve pathways as a spray-dry powder formulation, bypassing the blood-brain barrier and reducing systemic exposure. The lead asset, ONP-002, is a first-in-class intranasal neurosteroid targeting the underlying neuroinflammation, oxidative stress, and cerebral edema associated with concussion and mild traumatic brain injury (mTBI), an indication with no FDA-approved pharmacological treatment despite an estimated 69 million annual global TBI incidents and a projected $9B+ concussion market by 2030. ONP-002 completed a Phase I trial in 40 patients with zero serious adverse events and is currently in a 40-patient Phase IIa trial in Australia, with a U.S. Phase IIb trial planned pending an IND submission targeted by December 31, 2026.

The company's pipeline is built around a platform-plus-modules architecture: the Odyssey acquisition contributed the intranasal delivery technology, the ONP-002 lead candidate, and a Niemann Pick Disease Type C program, while a May 2026 LOI to exclusively license CardioDialysis from Sigyn Therapeutics would add an extracorporeal blood purification modality to address TBI-induced inflammation on both sides of the blood-brain barrier. Pipeline expansion beyond ONP-002 is supported by an October 2025 partnership with Receptor.AI, which applies generative AI to predict receptor binding profiles and prioritize candidates across Alzheimer's, Parkinson's, PTSD, opioid addiction, and anxiety disorders. Legacy infectious disease programs (Terra CoV-2 intranasal vaccine and lantibiotics) remain on investor materials but appear deprioritized.

Oragenics is pre-revenue and finances operations through equity capital markets, including a $16.5M Series H Convertible Preferred Stock and warrants offering in July 2025, an extended ATM facility with Dawson James Securities, and multiple prior public offerings between 2023 and 2024. The company has no commercial product, no recurring revenue, and disclosed Q1 2026 R&D expense of $0.6M and G&A of $1.6M, with $6.1M of cash and a FY2025 10-K that received a going concern explanatory paragraph in March 2026. Drug manufacturing has been relocated from China to Sterling Pharma Solutions' cGMP facility in Cary, North Carolina. The go-to-market model is currently investor-relations-led (conferences, press releases, IR website) and is expected to transition to enterprise healthcare channels only if and when ONP-002 receives FDA approval.

Name

Oragenics

Legal name

Oragenics, Inc.

Website

https://oragenics.com

Company type

Public

Founded year

1996

Operating status

Operating

Headcount range

1–10 employees

Short description

Oragenics is a pre-revenue, clinical-stage biopharmaceutical company developing ONP-002, a first-in-class intranasal neurosteroid for concussion and mild traumatic brain injury, delivered via its proprietary intranasal spray-dry powder platform that bypasses the blood-brain barrier. The company targets an unserved $9B+ TBI market and is currently conducting a Phase IIa trial in Australia.

Ownership category

akta.pro rank

Product category

Clinical-stage neurological therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Medical and Diagnostic Laboratories (6215), Scientific Research and Development Services (5417)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Biological Products, (No Disgnostic Substances) (2836), Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industries

Gene Therapy Delivery Devices & Administration Systems (catheters, intrathecal, ocular delivery) (HLAAACAL), Companion Diagnostic (CDx) Co-Development Services (biopharma partnerships, clinical strategy) (HLAAAMAB)

Keywords

• Intranasal drug delivery
• Concussion therapeutics
• Neurological drug development
• Traumatic brain injury treatment
• Clinical-stage biopharmaceutical

Headquarters

HQ city

Tampa

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Pre-revenue / Clinical Development Stage: Oragenics is currently a clinical-stage biotechnology company with no commercial products on the market and no recurring revenue. The company finances operations primarily through equity capital raises (public offerings of common stock, preferred stock, and warrants) and an at-the-market (ATM) sales agreement with Dawson James Securities. Future revenue is anticipated to be generated through product commercialization of ONP-002 (subject to FDA approval) and licensing royalties from partnered technologies such as CardioDialysis (3% royalty on revenue following FDA market clearance).

Go-to-market motion3 records

Marketing channels6 records

Core offering

Oragenics is a clinical-stage biopharmaceutical company developing intranasal therapeutics for neurological conditions. Its lead candidate ONP-002 is a first-in-class intranasal neurosteroid in Phase IIa clinical trials for concussion and mild traumatic brain injury, delivered via a proprietary intranasal spray-dry powder platform that bypasses the blood-brain barrier. The company has no commercial products on the market and no recurring revenue.

Product overview

Oragenics operates a platform-plus-modules architecture anchored by its proprietary intranasal spray-dry powder delivery platform (acquired from Odyssey Health in October 2023), which serves as the enabling technology for the company's CNS-focused drug development pipeline. The lead module is ONP-002, a first-in-class intranasal neurosteroid in Phase IIa clinical trials for concussion and mild traumatic brain injury in Australia, with U.S. Phase IIb trials planned to follow pending FDA IND submission. Secondary modules within the acquired Odyssey asset bundle include a drug candidate for Niemann Pick Disease Type C. The company is also pursuing platform expansion through the in-licensing (under LOI) of Sigyn Therapeutics' CardioDialysis™ extracorporeal blood purification technology for TBI, which would complement ONP-002 in a dual-modality approach targeting inflammation on both sides of the blood-brain barrier. Pipeline expansion is further supported by a strategic partnership with Receptor.AI for AI-driven CNS drug discovery applied to molecules acquired in 2023, targeting indications such as Alzheimer's disease, Parkinson's disease, PTSD, opioid addiction, and anxiety disorders. Legacy programs still referenced on the company's investor materials include the Terra CoV-2 (NT-CoV2-1) intranasal COVID-19 vaccine candidate and the lantibiotics novel antibiotics program.

Differentiator

Problem solved

Functional benefit

Products and services

• ONP-002 First-in-class intranasal neurosteroid in Phase IIa clinical development for concussion and mild traumatic brain injury. Designed to interrupt biological pathways involved in inflammation, oxidative stress, and brain swelling following head trauma. Demonstrated safety and tolerability in Phase 1 trials in 40 patients with zero serious adverse events.
• Proprietary Intranasal Spray-Dry Powder Delivery Platform Proprietary intranasal drug delivery system that enables rapid, non-invasive delivery of therapeutic compounds directly to the brain via the olfactory and trigeminal nerve pathways, bypassing the blood-brain barrier. Broadly applicable across multiple neurological conditions.
• Terra CoV-2 (NT-CoV2-1) Intranasal vaccine candidate for COVID-19 leveraging coronavirus spike protein research licensed from the NIH and the National Research Council of Canada, focused on variant-agnostic protection. Legacy program now deprioritized.
• Lantibiotics Program Novel class of antibiotics (lantibiotics) targeting multidrug-resistant bacteria, representing one of Oragenics' historical infectious disease development programs.
• Niemann Pick Disease Type C Drug Candidate Drug candidate for treatment of Niemann Pick Disease Type C, acquired as part of the Odyssey Health asset acquisition along with the proprietary formulation and nasal delivery system.
• CardioDialysis (Licensed from Sigyn Therapeutics) Extracorporeal blood purification technology for traumatic brain injury and neurodegenerative diseases, designed to clear inflammatory cytokines and endotoxins from the bloodstream. Complements ONP-002 in a proposed dual-modality approach targeting inflammation on both sides of the blood-brain barrier.

Quantifiable outcome

• Zero serious adverse events across all dose levels in 40 patients in Phase 1 trial of ONP-002
• +5 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature3 records

Scale indicators13 records

Recent moves6 records

Expansion highlights6 records

Regional players

• ANI Pharmaceuticals: U.S. specialty pharma with CNS and rare disease focus, including niche neurology assets. Comparable U.S.-based small-cap specialty pharma navigating CNS commercialization and pipeline expansion.

Direct peers

• Intra-Cellular Therapies: CNS specialty pharma with FDA-approved Caplyta and an expanding neurology/psychiatry pipeline. Comparable clinical-stage CNS profile and small-cap trajectory to a recently approved neurology drug candidate.
• Impel Pharmaceuticals: Specialty pharma focused on intranasal drug delivery (POD technology) for CNS indications. Closely comparable to Oragenics in building a franchise around proprietary intranasal delivery to bypass the blood-brain barrier.
• BioDelivery Sciences International: Specialty pharma built on intranasal and transmucosal drug delivery platforms for pain and CNS indications. Comparable platform-based CNS delivery model, now part of Collegium Pharmaceutical.
• Axsome Therapeutics: Clinical-stage and recently commercial CNS specialty biopharma that advanced a first-in-class mechanism through FDA approval (Auvelity). Highly comparable as a small CNS-focused company navigating clinical execution, regulatory milestones, and partnership dynamics in neurology.
• Sage Therapeutics: CNS-focused biopharma with FDA-approved neuroactive steroid Zurzuvae and a deep neurology pipeline. Closely comparable to Oragenics in targeting neurosteroid mechanisms and CNS indications with high unmet need, despite operating at larger scale.
• Tonix Pharmaceuticals: Clinical-stage CNS biopharma with intranasal drug delivery programs and neurology/psychiatry pipeline. Directly comparable in pursuing intranasal CNS therapeutics and operating at small-cap clinical-stage scale.

Broad incumbents

• Acadia Pharmaceuticals: Established CNS specialty biopharma with multiple approved neurology products (Nuplazid, Daybue). Comparable commercial-stage CNS franchise but operates with substantially greater resources and revenue base than Oragenics.

Emerging players

• Mind Medicine (MindMed): Clinical-stage CNS biotech developing psychedelic-inspired therapies for anxiety, PTSD, and CNS disorders. Comparable emerging CNS biotech pursuing first-in-class neurological mechanisms with comparable small-cap profile.
• BioAxone BioSciences: Clinical-stage biotech developing therapeutics for traumatic brain injury and CNS indications. Directly comparable as a small-cap peer focused on TBI treatment and CNS drug development.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/Oragenics
• LinkedInlinkedin.com/company/oragenics-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries1 record

Funding overview

Funding rounds19 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Oragenics