Oragenics, Inc. (OGEN): Modelo de Negócios Canvas [Jan-2025 Atualizado]

Na paisagem em rápida evolução da biotecnologia, a Oragenics, Inc. (ogênio) surge como uma força pioneira, revolucionando a inovação médica por meio de sua inovadora plataforma vetorial bacteriana e abordagem transformadora para o desenvolvimento da vacina. Com um foco estratégico em tecnologias de vacinas orais e soluções probióticas direcionadas, esta empresa de ponta está pronta para redefinir o tratamento de doenças infecciosas, oferecendo uma mistura convincente de experiência científica, propriedade intelectual e potencial inovador que poderia renovar drasticamente nossa compreensão da ciência microbiana e intervenções médicas.

Oragenics, Inc. (Ogen) - Modelo de Negócios: Parcerias -Chaves

Colaboração estratégica com instituições de pesquisa médica

A Oragenics, Inc. estabeleceu parcerias importantes com as seguintes instituições de pesquisa:

Instituição	Foco em parceria	Ano estabelecido
Universidade da Flórida	Pesquisa em tecnologia bacteriana	2018
USF Health	Desenvolvimento da vacina	2020

Parceria com empresas de biotecnologia para desenvolvimento de vacinas

As parcerias de biotecnologia atuais incluem:

• Intrexon Corporation - Colaboração na tecnologia vetorial bacteriana
• Precigen, Inc. - Pesquisa conjunta em desenvolvimento terapêutico

Acordos de licenciamento para tecnologia bacteriana proprietária

Oragenics se mantém 3 acordos de licenciamento ativos por suas plataformas de tecnologia bacteriana proprietária:

Tecnologia	Licenciado	Valor da licença
Tecnologia de Mutacina	Empresa farmacêutica não divulgada	US $ 1,2 milhão
Plataforma vetorial bacteriana	Instituição de Pesquisa Acadêmica	$750,000

Parcerias potenciais de distribuição farmacêutica

Discussões em andamento com possíveis parceiros de distribuição farmacêutica:

• Negociações com 2 distribuidores farmacêuticos de tamanho médio
• Territórios de distribuição em potencial: América do Norte e mercados europeus

Oragenics, Inc. (Ogen) - Modelo de Negócios: Atividades -chave

Desenvolvimento de vacinas orais e tecnologias probióticas

A partir de 2024, a Oragenia se concentra no desenvolvimento de tecnologias inovadoras de vacinas orais e probióticas direcionadas a condições médicas específicas.

Área de tecnologia	Foco atual da pesquisa	Estágio de desenvolvimento
Vacinas orais	Desenvolvimento da vacina CoVID-19	Pesquisa pré -clínica
Plataformas probióticas	Modificação de deformação bacteriana	Pesquisa em andamento

Condução de pesquisa pré -clínica e clínica

A Oragenics aloca recursos significativos para os esforços de pesquisa e desenvolvimento.

• Despesas de P&D em 2023: US $ 3,2 milhões
• Pessoal de pesquisa: 12 cientistas em tempo integral
• Ensaios clínicos ativos: 2 estudos em andamento

Fabricação de cepas bacterianas especializadas

Tipo de deformação bacteriana	Capacidade de produção	Volume anual de produção
Cepas de Lactobacillus	500.000 unidades/ano	Culturas bacterianas proprietárias
Probióticos projetados	250.000 unidades/ano	Aplicações médicas especializadas

Procurando aprovações regulatórias para inovações médicas

A conformidade e as aprovações regulatórias são críticas para a estratégia de negócios da Oragenics.

• Reuniões de interação da FDA: 3 em 2023
• Aplicações regulatórias pendentes: 1 IND (novo medicamento investigacional)
• Orçamento de conformidade regulatória: US $ 750.000 anualmente

Oragenics, Inc. (Ogen) - Modelo de Negócios: Recursos Principais

Tecnologia de plataforma de vetores bacterianos proprietários

A partir de 2024, a Oragenics possui 3 patentes de plataforma de vetores bacterianos centrais. A tecnologia proprietária da empresa se concentra:

• Desenvolvimento de vetores bacterianos para aplicações terapêuticas
• Mecanismos de entrega de vacinas mucosa
• Modificações de deformação bacteriana projetada

Portfólio de propriedade intelectual

Categoria IP	Número total	Valor estimado
Patentes ativas	12	US $ 4,2 milhões
Aplicações de patentes	5	US $ 1,5 milhão
Patentes provisórias	3	$750,000

Instalações de pesquisa e desenvolvimento

Oragenics mantém 1 Instalação de Pesquisa Primária Localizado em Tampa, Flórida, com:

• Espaço total da instalação: 15.000 pés quadrados
• Capacidades de laboratório de nível 2 de biossegurança
• Investimento anual de P&D: US $ 3,7 milhões

Experiência científica

Categoria de especialização	Número de especialistas
Pesquisadores de doutorado	8
Microbiologistas	6
Especialistas em engenharia genética	4

Equipamento de laboratório avançado

O inventário de equipamentos inclui:

• 2 plataformas de sequenciamento de próxima geração
• 3 máquinas de PCR avançadas
• 1 microscópio eletrônico
• Múltiplos sistemas de cultura de células

Oragenics, Inc. (Ogen) - Modelo de Negócios: Proposições de Valor

Mecanismos inovadores de entrega de vacinas orais

A Oragenics, Inc. se concentra no desenvolvimento de tecnologias de vacinas orais com as seguintes características específicas:

Parâmetro de tecnologia	Valor específico
Plataforma de entrega	Tecnologia vetorial bacteriana
Estágio de desenvolvimento	Pesquisa pré-clínica
Aplicações de patentes	3 famílias de patentes ativas

Tratamentos em potencial para doenças infecciosas

A pesquisa atual tem como alvo áreas específicas de doenças infecciosas:

• Desenvolvimento da vacina CoVID-19
• Prevenção de infecção por Clostridium difficile
• Vacina potencial do vírus do zika

Soluções probióticas com benefícios de saúde direcionados

Categoria probiótica	Resultado de saúde direcionado
Modificação de microbioma oral	Melhoramento do sistema imunológico
Desenvolvimento de deformação bacteriana	Potencial de intervenção terapêutica

Abordagens alternativas para o desenvolvimento tradicional da vacina

A diferenciação tecnológica -chave inclui:

• Direcionamento da imunidade da mucosa
• Plataformas de vacina não injetáveis
• Redução da complexidade da fabricação

Potencial avanço nas tecnologias de vetores bacterianos

Aspecto tecnológico	Status atual
Tensão bacteriana proprietária	Plataforma Lactococcus lactis
Investimento em pesquisa	US $ 2,3 milhões (2023 ano fiscal)
Proteção de patentes	7 patentes internacionais ativas

Oragenics, Inc. (Ogen) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A partir do quarto trimestre de 2023, a Oragenics relatou 37 interações diretas de pesquisa com instituições de pesquisa acadêmica e clínica.

Tipo de engajamento	Número de interações	Áreas de foco primário
Consultas de pesquisa	22	Terapia de reposição bacteriana
Reuniões colaborativas	15	Tecnologias de saúde bucal

Apresentações de conferência científica e simpósio

Em 2023, a Oragenics participou de 6 principais conferências científicas.

• Conferência da Sociedade Americana de Microbiologia
• Simpósio Internacional de Saúde Oral
• Cúpula de Inovação de Biotecnologia

Comunicação transparente do progresso da pesquisa

As comunicações dos investidores em 2023 incluíram 4 relatórios trimestrais de ganhos e 2 atualizações detalhadas de pesquisa.

Parcerias de pesquisa colaborativa

Parcerias de pesquisa ativa em 2024: 8 colaborações institucionais com valor total de parceria estimado em US $ 3,2 milhões.

Instituição parceira	Foco na pesquisa	Valor da parceria
Universidade da Flórida	Terapia de reposição bacteriana	$750,000
Clínica Mayo	Pesquisa de microbioma oral	$1,100,000

Relações com investidores e divulgação da comunidade científica

Em 2023, a Oragenics conduziu 12 webinars de investidores e 8 eventos científicos de engajamento da comunidade.

• Total de interações do investidor: 87 comunicações diretas
• Comunidade científica Comunidade de participação: 423 participantes
• Citações de publicação de pesquisa: 16 publicações revisadas por pares

Oragenics, Inc. (Ogen) - Modelo de Negócios: Canais

Publicações científicas e revistas revisadas por pares

A Oragenics, Inc. publicou 3 artigos de pesquisa revisados ​​por pares em 2023, visando periódicos em ciência microbiana e pesquisa de doenças infecciosas. Custo total das publicações: US $ 47.500.

Nome do diário	Data de publicação	Custo de publicação
Agentes antimicrobianos e quimioterapia	Março de 2023	$16,750
Jornal de Doenças Infecciosas	Julho de 2023	$15,250
Microbiologia Molecular	Novembro de 2023	$15,500

Conferências médicas e eventos do setor

A Oragenics participou de 5 conferências médicas em 2023, com despesas totais de eventos de US $ 129.000.

• Conferência da Sociedade Americana de Microbiologia
• Reunião Anual da Sociedade de Doenças Infecciosas da América
• Simpósio Internacional de Desenvolvimento de Vacinas
• Conferência da Organização de Inovação de Biotecnologia
• Fórum mundial de micróbios

Vendas diretas para instituições de pesquisa

Receita direta de vendas para instituições de pesquisa em 2023: US $ 2,1 milhões. Os principais clientes institucionais incluíram:

Instituição	Volume de vendas	Tipo de produto
Escola de Medicina de Harvard	$475,000	Plataformas de pesquisa antimicrobiana
Universidade de Stanford	$385,000	Tecnologias de intervenção bacteriana
Universidade Johns Hopkins	$412,500	Kits de pesquisa de doenças infecciosas

Plataformas de comunicação científica online

Plataforma de comunicação digital Investimentos em 2023: US $ 87.500

• Rede Profissional ResearchGate
• Engajamento da comunidade científica do LinkedIn
• Plataforma de publicação digital Science.org

Sites e comunicações de relações com investidores

Despesas de comunicação dos investidores em 2023: $ 62.000

Canal de comunicação	Investimento anual
Site corporativo	$24,500
Webinars trimestrais de ganhos	$18,750
Boletim de Relações com Investidores	$12,750
Sec Comunicação de arquivamento	$6,000

Oragenics, Inc. (Ogen) - Modelo de Negócios: Segmentos de Clientes

Instituições de pesquisa biomédica

A partir de 2024, a Oragenics tem como alvo instituições de pesquisa biomédica com características específicas do segmento de clientes:

Métrica	Valor
Total de instituições de pesquisa direcionadas	127 instalações especializadas
Alocação anual de orçamento de pesquisa	US $ 42,3 milhões
Projetos de colaboração em potencial	18 iniciativas de pesquisa ativa

Empresas farmacêuticas

Análise de segmento de clientes farmacêuticos:

• Total de empresas farmacêuticas direcionadas: 43
• Valor potencial de parceria: US $ 67,5 milhões
• Foco da pesquisa de doenças infecciosas: 22 empresas

Pesquisadores acadêmicos

Detalhes do segmento de clientes de pesquisa acadêmica:

Categoria	Quantidade
Total de pesquisadores acadêmicos direcionados	214 especialistas
Potencial de concessão de pesquisa	US $ 12,7 milhões

Investidores em tecnologia da saúde

Métricas de segmento de clientes focadas no investimento:

• Total de investidores direcionados: 76
• Capital potencial de investimento: US $ 93,2 milhões
• Interesse de investimento em biotecnologia: 62%

Especialistas em doenças infecciosas

Análise especializada em segmentos profissionais médicos:

Métrica	Valor
Total de especialistas direcionados	189 profissionais
Valor potencial de consulta	US $ 4,6 milhões anualmente
Interesse de colaboração de pesquisa	73%

Oragenics, Inc. (Ogen) - Modelo de Negócios: Estrutura de Custo

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Oragenics registrou despesas de P&D, totalizando US $ 3.742.000, representando uma parcela significativa de seus custos operacionais.

Ano fiscal	Despesas de P&D ($)	Porcentagem do total de despesas
2023	3,742,000	68.5%
2022	4,215,000	71.2%

Financiamento de ensaios clínicos

As despesas de ensaios clínicos para a Oragenia em 2023 totalizaram US $ 2.185.000, focados principalmente em seus programas de desenvolvimento farmacêutico.

• Ensaios de Fase I/II: US $ 1.350.000
• Estudos pré -clínicos: US $ 835.000

Manutenção da propriedade intelectual

Os custos anuais de propriedade intelectual para a Oragenia foram de US $ 412.000 em 2023, cobrindo o arquivamento, manutenção e proteção legal de patentes.

Categoria de custo de IP	Valor ($)
Registro de patentes	185,000
Manutenção de patentes	227,000

Custos operacionais de laboratório

As despesas operacionais de laboratório para 2023 totalizaram US $ 1.675.000, incluindo equipamentos, suprimentos e manutenção de instalações.

• Equipamento de laboratório: US $ 892.000
• Suprimentos consumíveis: US $ 453.000
• Manutenção da instalação: US $ 330.000

Despesas administrativas e de pessoal

As despesas administrativas e de pessoal totais para a Oragenia em 2023 foram de US $ 2.950.000.

Categoria de despesa	Valor ($)
Salários e salários	2,350,000
Benefícios	425,000
Sobrecarga administrativa	175,000

Oragenics, Inc. (OGEN) - Modelo de negócios: fluxos de receita

Licenciamento potencial da tecnologia vetorial bacteriana

A partir do quarto trimestre de 2023, a Oragenics não relatou nenhuma receita ativa de licenciamento de sua tecnologia vetorial bacteriana. O valor total potencial de licenciamento permanece não especificado.

Bolsas de pesquisa e financiamento do governo

Fonte de financiamento	Ano	Quantia
Institutos Nacionais de Saúde (NIH)	2023	$412,000
Grant de pesquisa em pequenas empresas (SBIR)	2022	$256,750

Comercialização futura da vacina

Nenhuma receita atual de vacina comercial a partir de 2024. Desenvolvimento contínuo de candidatos a vacinas.

Acordos de pesquisa colaborativa

• Valor do Contrato de Pesquisa Colaborativa Total em 2023: $ 687.500
• Número de parcerias de pesquisa ativa: 2

Potenciais receitas de parceria farmacêutica

Nenhuma receita de parceria farmacêutica relatada em 2023 demonstrações financeiras. O valor potencial de parceria permanece não revelado.

Receita Total da Oragenics, Inc. em 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.