Oragenics, Inc. (OGEN): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama de biotecnología en rápida evolución, Oragenics, Inc. (OGEN) surge como una fuerza pionera, revolucionando la innovación médica a través de su innovadora plataforma de vectores bacterianos y un enfoque transformador para el desarrollo de las vacunas. Con un enfoque estratégico en las tecnologías de vacuna oral y las soluciones probióticas específicas, esta compañía de vanguardia está preparada para redefinir el tratamiento de enfermedades infecciosas, ofreciendo una combinación convincente de experiencia científica, propiedad intelectual y potencial innovador que podría reastar drásticamente nuestra comprensión de la ciencia microbiana y intervenciones médicas.

Oragenics, Inc. (OGEN) - Modelo de negocio: asociaciones clave

Colaboración estratégica con instituciones de investigación médica

Oragenics, Inc. ha establecido asociaciones clave con las siguientes instituciones de investigación:

Institución	Enfoque de asociación	Año establecido
Universidad de Florida	Investigación de tecnología bacteriana	2018
Salud de la USF	Desarrollo de vacunas	2020

Asociación con compañías de biotecnología para el desarrollo de vacunas

Las asociaciones actuales de biotecnología incluyen:

• Introxon Corporation: colaboración en tecnología de vectores bacterianos
• Precigen, Inc. - Investigación conjunta en desarrollo terapéutico

Acuerdos de licencia para tecnología bacteriana patentada

Oragénica posee 3 acuerdos de licencia activos Para sus plataformas de tecnología bacteriana patentada:

Tecnología	Concesionario	Valor de la licencia
Tecnología de mutacina	Compañía farmacéutica no revelada	$ 1.2 millones
Plataforma vectorial bacteriana	Institución de investigación académica	$750,000

Potencios de distribución farmacéutica de la distribución

Discusiones continuas con posibles socios de distribución farmacéutica:

• Negociaciones con 2 distribuidores farmacéuticos de tamaño mediano
• Territorios de distribución potenciales: América del Norte y mercados europeos

Oragenics, Inc. (OGEN) - Modelo de negocio: actividades clave

Desarrollo de tecnologías de vacunas orales y probióticos

A partir de 2024, la oragenia se centra en desarrollar innovadoras tecnologías de vacunas orales y probióticos dirigidos a afecciones médicas específicas.

Área tecnológica	Enfoque de investigación actual	Etapa de desarrollo
Vacunas orales	Desarrollo de vacunas Covid-19	Investigación preclínica
Plataformas probióticas	Modificación de la tensión bacteriana	Investigación en curso

Realización de investigaciones preclínicas y clínicas

La oragenia asigna recursos significativos para los esfuerzos de investigación y desarrollo.

• Gastos de I + D en 2023: $ 3.2 millones
• Personal de investigación: 12 científicos a tiempo completo
• Ensayos clínicos activos: 2 estudios en curso

Fabricación de cepas bacterianas especializadas

Tipo de tensión bacteriana	Capacidad de producción	Volumen de producción anual
Cepas de lactobacillus	500,000 unidades/año	Cultivos bacterianos patentados
Probióticos diseñados	250,000 unidades/año	Aplicaciones médicas especializadas

Persiguiendo aprobaciones regulatorias para innovaciones médicas

El cumplimiento y las aprobaciones regulatorias son críticas para la estrategia comercial de la oragenia.

• Reuniones de interacción de la FDA: 3 en 2023
• Aplicaciones regulatorias pendientes: 1 IND (Investigational New Medicamento)
• Presupuesto de cumplimiento regulatorio: $ 750,000 anualmente

Oragenics, Inc. (OGEN) - Modelo de negocio: recursos clave

Tecnología de plataforma de vectores bacterianos patentados

A partir de 2024, la oragenia posee 3 patentes de plataforma vectorial bacteriana central. La tecnología patentada de la compañía se centra en:

• Desarrollo del vector bacteriano para aplicaciones terapéuticas
• Mecanismos de entrega de vacunas de la mucosa
• Modificaciones de tensión bacteriana diseñada

Cartera de propiedades intelectuales

Categoría de IP	Número total	Valor estimado
Patentes activas	12	$ 4.2 millones
Solicitudes de patentes	5	$ 1.5 millones
Patentes provisionales	3	$750,000

Investigaciones y instalaciones de desarrollo

La oragenia mantiene 1 Instalación de investigación primaria Ubicado en Tampa, Florida, con:

• Espacio total de la instalación: 15,000 pies cuadrados
• Capacidades de laboratorio Nivel 2 de bioseguridad
• Inversión anual de I + D: $ 3.7 millones

Experiencia científica

Categoría de experiencia	Número de especialistas
Investigadores de doctorado	8
Microbiólogos	6
Expertos de ingeniería genética	4

Equipo de laboratorio avanzado

El inventario de equipos incluye:

• 2 plataformas de secuenciación de próxima generación
• 3 máquinas de PCR avanzadas
• 1 microscopio electrónico
• Sistemas de cultivo celular múltiples

Oragenics, Inc. (OGEN) - Modelo de negocio: propuestas de valor

Innovadores mecanismos de suministro de vacunas orales

Oragenics, Inc. se centra en desarrollar tecnologías de vacunas orales con las siguientes características específicas:

Parámetro tecnológico	Valor específico
Plataforma de entrega	Tecnología de vectores bacterianos
Etapa de desarrollo	Investigación preclínica
Solicitudes de patentes	3 familias de patentes activas

Tratamientos potenciales para enfermedades infecciosas

La investigación actual se dirige a áreas específicas de enfermedades infecciosas:

• Desarrollo de vacunas Covid-19
• Prevención de infecciones de Clostridium difficile
• Vacuna potencial del virus Zika

Soluciones probióticas con beneficios para la salud específicos

Categoría de probiótico	Resultado de salud dirigido
Modificación del microbioma oral	Mejora del sistema inmune
Desarrollo de tensión bacteriana	Potencial de intervención terapéutica

Enfoques alternativos para el desarrollo tradicional de vacunas

La diferenciación tecnológica clave incluye:

• Dirección de inmunidad de la mucosa
• Plataformas de vacuna no inyectables
• Reducción de la complejidad de la fabricación

Posible avance en las tecnologías de vectores bacterianos

Aspecto tecnológico	Estado actual
Tensión bacteriana patentada	Plataforma Lactococcus lactis
Inversión de investigación	$ 2.3 millones (año fiscal 2023)
Protección de patentes	7 patentes internacionales activas

Oragenics, Inc. (OGEN) - Modelo de negocio: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, la oragenia reportó 37 interacciones directas de investigación con instituciones de investigación académica y clínica.

Tipo de compromiso	Número de interacciones	Áreas de enfoque primario
Consultas de investigación	22	Terapia de reemplazo bacteriano
Reuniones colaborativas	15	Tecnologías de salud bucal

Conferencia científica y presentaciones de simposio

En 2023, los oragenales participaron en 6 conferencias científicas principales.

• Conferencia de la Sociedad Americana de Microbiología
• Simposio internacional de salud bucal
• Cumbre de innovación biotecnología

Comunicación transparente del progreso de la investigación

Las comunicaciones de los inversores en 2023 incluyeron 4 informes de ganancias trimestrales y 2 actualizaciones de investigación detalladas.

Asociaciones de investigación colaborativa

Asociaciones de investigación activa a partir de 2024: 8 colaboraciones institucionales con el valor total de la asociación estimado en $ 3.2 millones.

Institución asociada	Enfoque de investigación	Valor de asociación
Universidad de Florida	Terapia de reemplazo bacteriano	$750,000
Clínica de mayonesa	Investigación de microbioma oral	$1,100,000

Relaciones con inversores y alcance de la comunidad científica

En 2023, la oragenia realizó 12 seminarios web de inversores y 8 eventos de participación de la comunidad científica.

• Interacciones totales del inversionista: 87 comunicaciones directas
• Asistencia de seminarios web de la comunidad científica: 423 participantes
• Citas de publicaciones de investigación: 16 publicaciones revisadas por pares

Oragenics, Inc. (OGEN) - Modelo de negocio: canales

Publicaciones científicas y revistas revisadas por pares

Oragenics, Inc. publicó 3 artículos de investigación revisados ​​por pares en 2023, dirigidos a revistas en ciencias microbianas e investigación de enfermedades infecciosas. Costo total de publicaciones: $ 47,500.

Nombre del diario	Fecha de publicación	Costo de publicación
Agentes antimicrobianos y quimioterapia	Marzo de 2023	$16,750
Revista de Enfermedades Infecciosas	Julio de 2023	$15,250
Microbiología molecular	Noviembre de 2023	$15,500

Conferencias médicas y eventos de la industria

La oragenia participó en 5 conferencias médicas en 2023, con un gasto total de eventos de $ 129,000.

• Conferencia de la Sociedad Americana de Microbiología
• Reunión anual de la Sociedad de Enfermedades Infecciosas de América
• Simposio de desarrollo de vacunas internacionales
• Conferencia de la Organización de Innovación de Biotecnología
• Foro Mundial de Microbio

Ventas directas a instituciones de investigación

Ingresos directos de ventas a instituciones de investigación en 2023: $ 2.1 millones. Los clientes institucionales clave incluyen:

Institución	Volumen de ventas	Tipo de producto
Escuela de Medicina de Harvard	$475,000	Plataformas de investigación antimicrobianas
Universidad de Stanford	$385,000	Tecnologías de intervención bacteriana
Universidad de Johns Hopkins	$412,500	Kits de investigación de enfermedades infecciosas

Plataformas de comunicación científica en línea

Inversiones de plataforma de comunicación digital en 2023: $ 87,500

• Red de Professional de InvestigateGate
• LinkedIn Científice Community Engagement
• Plataforma de publicación digital de Science.org

Sitios web y comunicaciones de relaciones con los inversores

Gastos de comunicación de inversores en 2023: $ 62,000

Canal de comunicación	Inversión anual
Sitio web corporativo	$24,500
Seminarios web de ganancias trimestrales	$18,750
Boletín de relaciones con los inversores	$12,750
SEC presentando comunicaciones	$6,000

Oragenics, Inc. (OGEN) - Modelo de negocio: segmentos de clientes

Instituciones de investigación biomédica

A partir de 2024, la oragenia se dirige a instituciones de investigación biomédica con características específicas de segmento de clientes:

Métrico	Valor
Instituciones de investigación totalmente específicas	127 instalaciones especializadas
Asignación anual de presupuesto de investigación	$ 42.3 millones
Proyectos de colaboración potenciales	18 Iniciativas de investigación activa

Compañías farmacéuticas

Análisis de segmento de clientes farmacéuticos:

• Total de compañías farmacéuticas dirigidas: 43
• Valor de asociación potencial: $ 67.5 millones
• Enfoque de investigación de enfermedades infecciosas: 22 empresas

Investigadores académicos

Investigación académica Detalles del segmento de clientes:

Categoría	Cantidad
Investigadores académicos dirigidos totales	214 especialistas
Potencial de subvención de investigación	$ 12.7 millones

Inversores de tecnología de salud

Métricas de segmento de clientes centradas en la inversión:

• Inversores totalmente dirigidos: 76
• Capital de inversión potencial: $ 93.2 millones
• Interés de inversión biotecnología: 62%

Especialistas en enfermedades infecciosas

Análisis de segmento de profesional médico especializado:

Métrico	Valor
Total de especialistas dirigidos	189 profesionales
Valor de consulta potencial	$ 4.6 millones anuales
Interés de colaboración de investigación	73%

Oragenics, Inc. (OGEN) - Modelo de negocio: estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, los oragenos informaron que los gastos de I + D por un total de $ 3,742,000, lo que representa una parte significativa de sus costos operativos.

Año fiscal	Gastos de I + D ($)	Porcentaje de gastos totales
2023	3,742,000	68.5%
2022	4,215,000	71.2%

Financiación del ensayo clínico

Los gastos de ensayo clínico para la oragenia en 2023 ascendieron a $ 2,185,000, centrados principalmente en sus programas de desarrollo farmacéutico.

• Pruebas de fase I/II: $ 1,350,000
• Estudios preclínicos: $ 835,000

Mantenimiento de la propiedad intelectual

Los costos anuales de propiedad intelectual para la oragenia fueron de $ 412,000 en 2023, cubriendo la presentación de patentes, el mantenimiento y la protección legal.

Categoría de costos de IP	Monto ($)
Presentación de patentes	185,000
Mantenimiento de patentes	227,000

Costos operativos de laboratorio

Los gastos operativos de laboratorio para 2023 totalizaron $ 1,675,000, incluidos equipos, suministros y mantenimiento de instalaciones.

• Equipo de laboratorio: $ 892,000
• Suministros de consumo: $ 453,000
• Mantenimiento de la instalación: $ 330,000

Gastos administrativos y de personal

Los gastos administrativos y de personal total para la oragenia en 2023 fueron de $ 2,950,000.

Categoría de gastos	Monto ($)
Salarios y salarios	2,350,000
Beneficios	425,000
Sobrecarga administrativa	175,000

Oragenics, Inc. (OGEN) - Modelo de negocio: flujos de ingresos

Licencias potenciales de la tecnología vectorial bacteriana

A partir del cuarto trimestre de 2023, la oragenia no ha informado ningún ingreso activo de licencias de su tecnología vectorial bacteriana. El valor de licencia potencial total permanece sin especificar.

Subvenciones de investigación y financiación del gobierno

Fuente de financiación	Año	Cantidad
Institutos Nacionales de Salud (NIH)	2023	$412,000
Subvención de Investigación de Innovación de Pequeñas Empresas (SBIR)	2022	$256,750

Comercialización futura de vacunas

No hay ingresos actuales de vacunas comerciales a partir de 2024. Desarrollo continuo de candidatos a vacunas.

Acuerdos de investigación colaborativos

• Valor de acuerdo de investigación colaborativa total en 2023: $ 687,500
• Número de asociaciones de investigación activa: 2

Ingresos potenciales de asociación farmacéutica

No se informaron los ingresos de la asociación farmacéutica en los estados financieros de 2023. El valor potencial de la asociación permanece sin revelar.

Ingresos totales para Oragenics, Inc. en 2023: $1,356,250

Oragenics, Inc. (OGEN) - Canvas Business Model: Value Propositions

You're looking at the core of what Oragenics, Inc. (OGEN) is selling here-the unique benefits they promise to deliver to patients and the healthcare system with ONP-002. This isn't just another drug; it's a potential first-in-class intervention for a massive, underserved area.

Potential first FDA-approved pharmacological treatment for concussion.

The value proposition starts with being the pioneer. Oragenics, Inc. (OGEN) is actively working to bring what could be the first FDA-approved pharmacological treatment for concussion, specifically mild traumatic brain injury (mTBI). Honestly, the current landscape is bare; there are no FDA-approved pharmacological treatments currently available for concussion. That first-mover status is a huge part of the value.

Brain-targeted, non-invasive intranasal drug delivery.

The delivery method itself is a major differentiator. ONP-002 uses Oragenics, Inc. (OGEN)'s proprietary intranasal delivery system. This system is engineered to enable targeted, non-invasive delivery of therapeutics directly to the brain. In animal models, this intranasal route showed quick and significant distribution to all regions of the brain. Plus, they've developed a novel nanoparticle formulation that potentially increases drug percentage by 4-fold.

Here's a quick look at the advantages this delivery system aims to provide:

• Rapid onset and direct brain access.
• Non-invasive administration route.
• Excellent safety profile in animal studies.
• Low overall plasma levels compared to IV or oral routes.

Rapid access to the brain, minimizing systemic side effects.

Speed matters acutely after a head trauma. The clinical plan is aiming to administer the first dose within 8 hours of injury in Phase II human testing. By targeting the brain directly via the nasal passage, the drug is designed to interrupt the immediate biological cascade post-trauma, which preclinical models suggest reduces inflammation, oxidative stress, and brain swelling associated with concussion. Importantly, because ONP-002 is not a GABAergic compound, it does not cause fatigue.

Addressing significant unmet medical need in neurotrauma care.

The sheer scale of the problem underscores the unmet need. You can see the market size Oragenics, Inc. (OGEN) is targeting, which is a key component of the value proposition for investors and healthcare providers alike.

Metric	Value/Statistic
Global Concussion Market Estimate (by 2027)	$8.9 billion
Annual Concussions in the U.S. Alone	3.8 million
Annual Concussions Globally	Approximately 69 million
Percentage of TBI Classified as 'Mild'	Over 90%
Mild TBI Patients Not Fully Recovered by 6 Months	Over 50%
Population Developing Post-Concussion Syndrome (PCS)	Approximately 20%

To be fair, the burden extends beyond the initial injury. In the U.S. alone, TBI resulted in approximately 70,000 deaths in 2021 and leads to about half-a-million permanent disabilities each year. The value proposition is offering a treatment that could potentially prevent the chronic neurological diseases linked to these acute events, like Post-Concussion Syndrome (PCS). Finance: draft 13-week cash view by Friday.

Oragenics, Inc. (OGEN) - Canvas Business Model: Customer Relationships

You're a seasoned analyst looking at how Oragenics, Inc. (OGEN) manages its external relationships, which is critical for a clinical-stage biotech. Their customer base isn't selling widgets; it's composed of investigators, regulators, and capital providers. The relationships here are about trust, transparency, and execution on clinical milestones.

High-touch engagement with clinical investigators and key opinion leaders

Engagement with the medical and research community is centered on advancing the ONP-002 program for concussion. This involves securing top-tier partners for trial execution and manufacturing. Oragenics, Inc. has established the critical operational infrastructure for its Phase IIa trial in Australia, which is designed to assess feasibility, safety, tolerability, blood biomarker response, and pharmacokinetics/pharmacodynamics of ONP-002 in adults with mild traumatic brain injury (mTBI).

The structure of this high-touch relationship is defined by specific contracts and trial parameters:

• Human Research Ethics Committee (HREC) approval secured in Q2 2025.
• Southern Star Research appointed as the Clinical Research Organization (CRO).
• Sterling Pharma Solutions contracted for cGMP manufacturing at their Cary, North Carolina facility for planned Phase IIb trials.
• The Phase IIa study is designed to enroll up to 40 participants across two treatment arms.
• Participants are anticipated to receive a total of nine doses over five days.

This focused engagement is meant to support the goal of advancing ONP-002 toward becoming the first FDA-approved pharmacological treatment for concussion.

Transparent investor relations via shareholder updates and SEC filings

For investors, Oragenics, Inc. maintains communication through regular SEC filings and shareholder updates, a necessity given their development-stage status and recent capital activities. The company's commitment to transparency was highlighted by regaining full compliance with NYSE American's continued listing standards on October 20, 2025, resolving a stockholder equity deficiency where equity was restored above the $6.0 million threshold.

The financial context of these relationships, as of late 2025, shows significant activity aimed at funding clinical development:

Metric	Value as of Sep 30, 2025	Context/Period
Net Loss	$3.07 million	Three months ended Sep 30, 2025
Year-to-Date Net Loss	$7.56 million	Nine months ended Sep 30, 2025
Cash and Equivalents	$11.4 million	As of Sep 30, 2025
Gross Proceeds from July 2025 Financing	$16.5 million	Series H Convertible Preferred Stock
Debt Repaid in Q3 2025	$3.0 million	Short-term note
Accumulated Deficit	$224.3 million	As of Sep 30, 2025

The stock performance reflects market sentiment around these milestones; on December 2, 2025, the price was $0.85, contrasting sharply with its 52-week high of $18.90.

Direct communication with regulatory bodies (FDA, HREC)

Direct interaction with regulatory bodies is a non-negotiable part of the business. Oragenics, Inc. has been actively managing submissions to both Australian and U.S. authorities. The company submitted the Investigator's Brochure (IB) package for the Australian Phase IIa trial in Q1 2025. Furthermore, the IND package submission for the U.S. Phase IIb clinical trials is targeted for Q3 of 2025. This proactive regulatory engagement is essential to maintain the timeline for the planned Phase IIa trial initiation in Q4 2025/Q1 2026.

Future strategic relationships with potential pharmaceutical licensees

To build out its platform beyond the lead candidate, Oragenics, Inc. is establishing relationships that leverage technology for future asset development, signaling a move toward a multi-asset company. These are relationships with potential partners who could license or co-develop future assets.

Key strategic collaborations formalized in 2025 include:

• A collaboration with Receptor.AI in October 2025 to use artificial intelligence modeling to identify optimal receptor binding profiles for molecules acquired in 2023.
• A partnership with BRAINBox Solutions established in Q1 2025 to combine diagnostic biomarkers with the ONP-002 intranasal delivery system.

The company sees its proprietary intranasal delivery technology as having applications beyond concussion, positioning these AI and diagnostic partnerships to systematically explore those opportunities.

Oragenics, Inc. (OGEN) - Canvas Business Model: Channels

You're looking at how Oragenics, Inc. gets its critical operational and financial needs met, which is all about external partners and direct stakeholder outreach. For a clinical-stage company like Oragenics, Inc., these channels are less about selling a product and more about executing trials and securing capital to keep the lights on and the science moving.

Clinical Research Organizations (CROs) for trial management represent a key channel for executing the ONP-002 program. Oragenics, Inc. formalized this by selecting Southern Star Research as its CRO for the upcoming Phase IIa clinical trial of ONP-002 in Australia on July 31, 2025. This selection followed the securing of Human Research Ethics Committee (HREC) approval in Q2 2025. The company was actively working on protocol amendments post-HREC approval as of the Q3 2025 update, with Phase IIa trial initiation anticipated in Q3 2025. This operational channel is supported by a manufacturing agreement with Sterling Pharma Solutions in Cary, North Carolina, for cGMP production.

The Regulatory submissions (IND, IB) to health authorities channel is managed through direct interaction and submission packages. Oragenics, Inc. targeted the submission of the Investigator's Brochure (IB) package for the Australia Phase IIa clinical trials by Q1 2025. Furthermore, the company was targeting the submission of the Investigational New Drug (IND) package to the FDA for Phase IIb clinical trials in the US for Q3 of 2025. These submissions are the formal communication channel to the FDA to gain approval for trial expansion.

Financing, channeled through investment banks and placement agents for public offerings, has been active in 2025. While the company announced the expiration of its prior investment banking engagement agreement in February 2024, recent capital activity shows reliance on placement agents or direct offerings. The July 2025 Series H Convertible Preferred Stock and Warrants offering was a significant event, raising $16.5 million in gross proceeds, netting approximately $15.2 million after fees. This followed an earlier capital raise in Q1 2025, which brought in about $5 million in total funding.

Here's a quick look at the recent capital inflow through these channels:

Financing Event/Source	Date/Period	Gross Proceeds (USD)	Net Proceeds (USD)
Series H Convertible Preferred Stock & Warrants Offering	July 2025	$16,500,000	~$15,200,000
ATM Equity Sales (Q1 2025 component)	Q1 2025	$2,600,000 (Equity portion)	Not specified separately
Non-Dilutive Debt Funding (Q1 2025 component)	Q1 2025	$2,250,000 (Debt portion)	Not specified separately

For Direct-to-investor communication via corporate website and press releases, Oragenics, Inc. uses these platforms to manage market perception and report compliance status. A major communication point was the announcement on October 21, 2025, that the company had regained full compliance with NYSE American's continued listing standards, resolving a stockholder equity deficiency. The Q3 2025 Shareholder Update was issued on November 12, 2025, detailing operational progress. Investor awareness efforts also included participation in industry events, such as the 12th Annual Brain Health Summit at Leigh Steinberg's Super Bowl Party 2025 in Q1 2025.

Key investor communication touchpoints include:

• Regained full NYSE American compliance on October 20, 2025.
• Reported 30% reduction in research and development expenses year-over-year for the nine months ended September 30, 2025.
• Announced $11.4 million in cash and cash equivalents as of September 30, 2025.
• Formalized a strategic collaboration with Receptor.AI in Q3 2025.
• Reported a net loss of $3.06 million for the three months ending September 30, 2025.

Finance: draft 13-week cash view by Friday.

Oragenics, Inc. (OGEN) - Canvas Business Model: Customer Segments

You're looking at the core groups Oragenics, Inc. (OGEN) targets to fund its development and ultimately deliver its ONP-002 therapy. For a clinical-stage biotech, these segments are not just users; they are the lifeblood of the operation.

Institutional and retail investors providing development capital

This group provides the necessary fuel for the ONP-002 Phase IIa trial in Australia and preparation for U.S. Phase IIb trials. You need to know their recent commitment levels. In Q3 2025, the company executed a significant capital raise, bringing in approximately $16.5 million in gross proceeds via Series H Convertible Preferred Stock and Warrants. This followed an earlier Q1 2025 raise of about $5 million. Honestly, these financing activities are critical, especially since the company reported a net loss of $3.06 million for the three months ending September 30, 2025, and continues to operate without revenue. As of September 30, 2025, the cash position stood at $11.4 million, projected to fund operations through the first half of 2026, despite an accumulated deficit of $224.3 million. The ownership structure shows that institutional investors hold approximately 2.56% of the stock as of September 2025, with a total of 5 identified institutional investors.

Here's a quick look at the financial context supporting this segment:

Financial Metric	Amount as of Late 2025 Data Point	Date/Period
Gross Capital Raised (July 2025)	$16.5 million	Q3 2025
Net Cash from Financing Activities (Q3 2025)	$12.41 million	Q3 2025
Cash and Cash Equivalents	$11.4 million	September 30, 2025
Accumulated Deficit	$224.3 million	September 30, 2025
Institutional Ownership Percentage	2.56%	September 2, 2025

Regaining full compliance with NYSE American listing standards in October 2025, after resolving a stockholder equity deficiency, was a key action to maintain appeal for this segment.

Patients with mild Traumatic Brain Injury (mTBI) or concussion

This is the ultimate beneficiary group for ONP-002. The market need is substantial, given that 3.8 million concussions happen annually in the United States alone. Furthermore, a persistent issue is that about 20% of those affected can remain symptomatic for months or years, developing Post-Concussion Syndrome (PCS). Oragenics is actively engaging this population through clinical trials. The HeadSMART II trial, in collaboration with BrainBox Solutions, is one of the largest U.S. emergency department biomarker discovery studies for mTBI and is expected to enroll over 2,000 patients within the next year. The company believes early treatment could prevent chronic brain disorders resulting from mTBI.

Consider the scale of the target market:

• Annual US Concussions: 3.8 million
• Estimated Global Concussion/mTBI Market Value: $8.9 billion by 2027
• Population with Persistent Symptoms (PCS): Approximately 20% of mTBI patients
• HeadSMART II Trial Enrollment Target: Surpass 2,000 patients

The goal is to bring ONP-002 to market as the first FDA-approved pharmacological treatment for concussion, where currently none exist.

Neurologists, neurotrauma specialists, and emergency clinicians

These clinicians are the gatekeepers for acute treatment and trial participation. They need a therapy that is effective, safe, and easy to administer in high-stress environments like the Emergency Room (ER). ONP-002 is being developed for use in the acute ER setting, with a proposed regimen of 2X a day for 5-days post brain injury. The intranasal delivery system is designed to bypass the blood brain-barrier, showing quick and significant distribution to all brain regions in animal studies. The Phase IIa trial in Australia is moving forward, with protocol amendments submitted to analyze cognitive, visual motor, and patient-reported outcomes, which are key metrics for these specialists. The collaboration with BRAINBox Solutions aims to create a test-to-treat platform, which appeals directly to clinicians seeking faster, more targeted care based on diagnostic biomarkers.

Future pharmaceutical companies for licensing or acquisition

This segment represents a potential exit or major partnership event, which drives significant shareholder value. As of June 2025, Oragenics, Inc. explicitly listed ONP-002 for mTBI (concussion) and ONP-001 for various rare leukodystrophies as unlicensed products looking for licensing opportunities. The company is actively building value inflection points, such as the initiation of the ONP-002 Phase 2a clinical study by the end of Q2 2025. Furthermore, Oragenics formalized a strategic collaboration with Receptor.AI in Q3 2025 to accelerate the development of its expanded molecule portfolio beyond ONP-002, signaling an intent to build a broader neurological therapeutics platform attractive for in-licensing or acquisition. The company's proprietary intranasal delivery technology itself is a key asset, positioned in a nasal drug delivery market projected to exceed $40 billion by 2030.

Oragenics, Inc. (OGEN) - Canvas Business Model: Cost Structure

You're looking at the core spending areas for Oragenics, Inc. (OGEN) as they push their pipeline forward, especially with ONP-002. For a development-stage biopharma, the cost structure is heavily weighted toward science and compliance.

Research and Development (R&D) expenses, totaling $1.7 million for the nine months ended Q3 2025, show a strategic shift. This is down from $2.4 million in the same period of 2024, suggesting a pivot toward regulatory filings and manufacturing readiness rather than pure discovery work. Still, R&D remains a major cash burn item.

Selling, General & Administrative (SG&A) expenses were approximately $6.83 million for the Trailing Twelve Months (TTM) ending September 2025. For just the third quarter of 2025, General and Administrative (G&A) expenses specifically climbed to $2.2 million, up from $1.6 million in Q3 2024. This quarterly jump was mainly due to higher legal and professional fees, including significant accruals related to a legal settlement.

Here's a quick look at the major reported operating expenses as of late 2025:

Cost Component	Period	Amount (USD)
Research and Development (R&D)	Nine Months Ended Q3 2025	$1.7 million
Selling, General & Administrative (SG&A)	TTM Ended Sep '25	$6.83 million
General and Administrative (G&A)	Q3 2025	$2.2 million
R&D	Q3 2025	$930,894

Clinical trial costs are an embedded, and growing, part of the R&D spend. The company secured infrastructure for Phase IIa trials in Australia, which means significant future outlays for Contract Research Organization (CRO) fees and site payments are definitely on the horizon. You have to assume these costs are baked into the R&D budget until they are separately broken out.

Manufacturing and supply chain costs for drug-device units, particularly for the ONP-002 intranasal therapy, are ramping up. The reported decrease in R&D for the nine-month period is explicitly linked to a strategic pivot towards manufacturing readiness. This signals a necessary, non-negotiable cost increase as the company moves closer to potential commercialization.

Public company compliance and legal fees are a visible pressure point in the SG&A line. The increase in G&A for Q3 2025 was primarily driven by higher legal and professional fees, including accruals for a legal settlement. Furthermore, the company noted rising costs associated with patent-related legal expenses and investor relations as part of the nine-month G&A increase. The fact that Oragenics, Inc. announced regaining NYSE American compliance in late 2025 suggests that resolving prior listing deficiencies also involved specific, non-recurring professional service costs.

The key cost drivers you need to watch are:

• Higher legal and professional fees impacting G&A.
• Costs associated with patent defense and maintenance.
• Ramping up manufacturing readiness expenses.
• Future CRO and site payments for planned Phase IIa trials.

Oragenics, Inc. (OGEN) - Canvas Business Model: Revenue Streams

You're looking at a clinical-stage company, so the first thing to understand about Oragenics, Inc. (OGEN)'s revenue streams is what's missing: sales. As of late 2025, Oragenics, Inc. (OGEN) has effectively zero revenue from product sales. This is the reality for a company deep in development, meaning its financial lifeblood comes from elsewhere until a drug like ONP-002 gets that final FDA sign-off. For the first three quarters of the 2025 fiscal year (Q1, Q2, and Q3), Oragenics, Inc. reported $0 in Total Revenue across the board. The Trailing Twelve Months (TTM) revenue ending September 30, 2025, was also reported as approximately $0.0 million.

Because the company is operating at a loss-reporting a net loss of $10.9 million for the TTM ending September 30, 2025-its primary, immediate source of cash to fund operations, like the ONP-002 clinical trials, is financing activities. This is how you bridge the gap between discovery and market. The most significant recent infusion was the July 2025 public offering of Series H Convertible Preferred Stock and Warrants. This transaction brought in net proceeds of approximately $15.2 million after accounting for placement agent fees and other estimated expenses. This capital was earmarked to advance the ONP-002 Phase IIa trials, repay debt, and fund working capital.

To give you a clearer picture of how Oragenics, Inc. (OGEN) has been funding its operations, here's a look at the key financing events that serve as its current revenue substitutes:

Financing Event	Date	Gross Proceeds (Approximate)	Net Proceeds (Approximate)	Security Type
Public Offering	July 2025	$20.00 million	$15.2 million	Series H Convertible Preferred Stock and Warrants
ATM Agreement Sales	February 2025	N/A	$2.6 million	Common Stock

The structure of the July 2025 financing is important to note; the Preferred Stock is convertible into common stock at a price of $2.50 per share, which carries the risk of future dilution. Still, this capital restored stockholder equity above the $6 million threshold, allowing Oragenics, Inc. (OGEN) to regain compliance with NYSE American listing standards on October 20, 2025.

Looking further out, the potential for non-operating revenue is tied directly to the success of its pipeline and any existing partnerships. You should keep an eye on milestone payments and royalties, which represent the true long-term revenue potential for a company like this. For instance, Oragenics, Inc. (OGEN) has a licensing agreement with Norgine for PEDMARQSI, which includes potential future payments. This agreement has the potential to yield up to an additional $230 million in milestone payments and tiered royalties, on top of the $43 million upfront payment already received in March 2024. The company also mentioned in its Q2 2025 update that its focused approach may position it to achieve a successful drug development milestone, which often triggers payments under such agreements.

The expected future revenue streams for Oragenics, Inc. (OGEN) are entirely contingent on clinical and regulatory success:

• Zero revenue from product sales, as a clinical-stage company.
• Primary source is equity financing, like the $15.2 million net proceeds from the July 2025 public offering.
• Potential future milestone payments from licensing agreements, such as the Norgine deal.
• Potential future royalties or product sales post-FDA approval for ONP-002.

The company's ability to secure funding remains pivotal as it navigates the complex landscape of biopharmaceutical development. Finance: review the cash runway projections based on the $15.2 million net inflow against the Q3 2025 operating cash burn rate by next Tuesday.