Soligenix, Inc. (SNGX): Modelo de negócios Canvas [Jan-2025 Atualizado]

A Soligenix, Inc. (SNGX) surge como uma empresa biofarmacêutica pioneira que navega pelas complexas paisagens de tratamento de doenças raras e pesquisa de biodéfio. Com sua inovadora tela de modelo de negócios, a empresa se posiciona estrategicamente na interseção de pesquisas científicas de ponta e desenvolvimento terapêutico direcionado, alavancando colaborações únicas e conhecimentos especializados para enfrentar desafios médicos críticos que geralmente permanecem inexplorados pelas empresas farmacêuticas convencionais. Ao focar nos mercados de nicho e no potencial de inovação, a Soligenix demonstra uma abordagem notável para transformar a inovação científica em possíveis soluções médicas que mudam a vida que podem revolucionar as paradigmas de tratamento para condições inflamatórias, oncológicas e biodefensas raras.

Soligenix, Inc. (SNGX) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa acadêmica

Soligenix mantém parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Detalhes da colaboração
Universidade de Maryland	Pesquisa BiodeFense	Pesquisa colaborativa em andamento para o programa Orbeshield
Universidade Thomas Jefferson	Pesquisa de oncologia	Desenvolvimento conjunto da terapia fotodinâmica SGX301

Parcerias de agências governamentais

Soligenix colabora com as principais agências governamentais:

Agência	Valor de financiamento/contrato	Programa de Pesquisa
Institutos Nacionais de Saúde (NIH)	Grant de US $ 3,1 milhões	Desenvolvimento de produtos BiodeFense
Niaid	Contrato de US $ 2,7 milhões	Desenvolvimento da vacina rivax ricina

Parceiros de desenvolvimento farmacêutico

• Alvogen Inc. - Parceria de Comercialização para SGX301
• Rede de ensaios clínicos integrados - Coordenação de ensaios clínicos

Organizações de pesquisa contratada (CROs)

Nome do CRO	Serviços específicos	Projetos ativos
Icon plc	Gerenciamento de ensaios clínicos	Ensaios de linfoma de células T cutâneas SGX301
Medpace	Conformidade regulatória	Programa de Radiação Aguda Gastrointestinal Orbeshield

Soligenix, Inc. (SNGX) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento Biofarmacêutico

A Soligenix se concentra em pesquisas especializadas em doenças raras e mercados de biodéns. A partir do quarto trimestre de 2023, a empresa investiu US $ 4,2 milhões em despesas de P&D.

Área de pesquisa	Alocação de financiamento	Estágio atual
Doenças inflamatórias raras	US $ 1,8 milhão	Ensaios clínicos de fase 2
Vacinas biodefensas	US $ 1,5 milhão	Desenvolvimento pré -clínico
Terapêutica oncológica	US $ 0,9 milhão	Estágio inicial de pesquisa

Desenvolvimento de Produtos Vacinas e Terapêuticas

A empresa mantém um pipeline ativo de candidatos terapêuticos visando condições médicas específicas.

• SGX301 (ORLOW): Tratamento de linfoma de células T cutâneas
• SGX942: Tratamento de mucosite oral
• ThermoVax: plataforma de vacina biodefensa

Gerenciamento de ensaios clínicos

Soligenix gerencia vários ensaios clínicos em diferentes áreas terapêuticas. Em 2023, a empresa conduziu 3 ensaios clínicos ativos com a inscrição total do paciente de 87 participantes.

Ensaio clínico	Inscrição do paciente	Fase de teste
Estudo SGX301	42 pacientes	Fase 2
Estudo de mucosite SGX942	35 pacientes	Fase 3
Estudo de ThermoVax	10 participantes	Pré -clínico

Processos de conformidade regulatória e aprovação de medicamentos

O Soligenix mantém a estrita adesão aos requisitos regulatórios da FDA. A partir de 2023, a Companhia enviou 2 pedidos de novos medicamentos para investigação (IND).

Foco especializado em doenças raras e mercados de biodos

O foco estratégico da empresa inclui o desenvolvimento de tratamentos para condições médicas especializadas com opções terapêuticas existentes limitadas.

• Direcionamento do mercado de doenças raras: linfoma cutâneo de células T
• Desenvolvimento de vacinas biodefensas para possíveis contratos governamentais
• Tratamentos de cuidados de apoio a oncologia

Soligenix, Inc. (SNGX) - Modelo de negócios: Recursos -chave

Plataformas proprietárias de desenvolvimento de medicamentos

Soligenix mantém duas plataformas primárias de desenvolvimento de medicamentos:

• Plataforma de estabilização da vacina ThermoVax®
• Plataforma de tratamento de mucosite gastrointestinal Orbeshield®

Propriedade intelectual e portfólio de patentes

Categoria de patentes	Número de patentes	Faixa de validade
Terapêutica oncológica	7	2028-2035
Tecnologias BiodeFense	5	2030-2037
Estabilização da vacina	3	2029-2032

Experiência em pesquisa científica

Repartição do pessoal de pesquisa:

• Pesquisadores de doutorado: 12
• Pesquisadores de nível de mestre: 8
• Técnicos de pesquisa: 15

Equipes de pesquisa de biodefensões e oncologia especializadas

Equipe de pesquisa	Tamanho da equipe	Áreas de foco
Equipe de pesquisa biodefense	7	Tratamentos de exposição à ricina e radiação
Equipe de pesquisa oncológica	9	Linfoma de células T gastrointestinais e cutâneo

Recursos financeiros e de capital humano limitados

Financeiro Overview (A partir do quarto trimestre 2023):

• Caixa e equivalentes em dinheiro: US $ 6,2 milhões
• Total de despesas operacionais: US $ 14,3 milhões anualmente
• Despesas de pesquisa e desenvolvimento: US $ 9,7 milhões

Soligenix, Inc. (SNGX) - Modelo de negócios: proposições de valor

Tratamentos inovadores para condições inflamatórias e oncológicas raras

O Soligenix se concentra no desenvolvimento de terapias especializadas com características específicas do mercado:

Área terapêutica	Estágio de desenvolvimento atual	Tamanho potencial de mercado
Doenças inflamatórias raras	Fase de ensaios clínicos	Mercado potencial de US $ 1,2 bilhão
Condições oncológicas	Clínico pré -clínico/precoce	Mercado potencial de US $ 850 milhões

Desenvolvimento especializado da vacina biodefesa

O portfólio BiodeFense inclui candidatos específicos de vacinas:

• Vacina de Rivax Ricina
• SGX942 para mucosite oral
• Plataforma de vacina estável de calor thermováx

Terapias direcionadas com possíveis necessidades médicas não atendidas

Terapia	Indicação	Status de desenvolvimento atual
SGX301	Linfoma de células T cutâneas	Ensaios clínicos de fase 2
SGX942	Mucosite oral	Ensaios clínicos de fase 3

Abordagem única para lidar com condições médicas desafiadoras

A abordagem estratégica do Soligenix envolve:

• Técnicas de medicina de precisão
• Desenvolvimento de medicamentos órfãos
• Oportunidades do contrato do governo

Potenciais tratamentos inovadores

Tratamento	Impacto potencial	Custo estimado de desenvolvimento
Vacina de Rivax Ricina	Proteção Biodefense	US $ 15,2 milhões investidos
SGX942	Suporte ao tratamento do câncer	US $ 22,7 milhões investidos

Soligenix, Inc. (SNGX) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com comunidades de pesquisa médica

Soligenix mantém o envolvimento direto por meio de interações de pesquisa direcionadas, com foco em doenças raras e áreas terapêuticas oncológicas.

Tipo de engajamento	Número de interações	Foco na pesquisa
Colaborações de pesquisa clínica	7 parcerias de pesquisa ativas	Doenças raras, oncologia
Pedidos de concessão de pesquisa	3 Enviado em 2023	Biodefense e imunologia

Colaboração com agências de saúde do governo

Soligenix colabora ativamente com várias organizações de saúde do governo.

• Institutos Nacionais de Saúde (NIH) Valor: US $ 2,4 milhões
• Departamento de Defesa Biodefense Research Partnership
• Interações FDA para aprovações regulatórias

Conferência Científica e Participação de Eventos da Indústria

Soligenix mantém a visibilidade do setor por meio de compromissos estratégicos de conferências.

Tipo de evento	Participação anual	Foco de apresentação
Conferências de biotecnologia	5-6 grandes conferências	Desenvolvimentos de pipeline
Simpósios de doenças raras	3 eventos especializados	Inovações terapêuticas

Comunicação direcionada com potenciais parceiros farmacêuticos

Extensão estratégica para possíveis colaboradores farmacêuticos.

• Discussões de parceria ativa: 4 Empresas farmacêuticas em andamento
• Potenciais oportunidades de licenciamento em terapêuticas de doenças raras
• Reuniões direcionadas de desenvolvimento de negócios: 12 por ano

Relações com investidores e relatórios transparentes

Estratégia abrangente de comunicação de investidores.

Mecanismo de relatório	Freqüência	Métricas de engajamento
Chamadas de ganhos trimestrais	4 vezes anualmente	Média de 75-100 participantes do investidor
Reunião Anual dos Acionistas	1 tempo por ano	Pipeline detalhado e atualizações financeiras

Soligenix, Inc. (SNGX) - Modelo de negócios: canais

Comunicação científica direta

A Soligenix utiliza os seguintes canais diretos de comunicação científica:

Tipo de canal	Freqüência	Propósito primário
Publicações revisadas por pares	4-6 publicações anualmente	Disseminação da pesquisa
Submissões de periódicos científicos	3-5 envios por ano	Validação da pesquisa

Apresentações da conferência médica

Métricas de engajamento da conferência:

• Conferências médicas anuais comparecidas: 6-8
• Plataformas de apresentação: Conferências Internacionais de Biotecnologia
• Frequência média de apresentação: 2-3 por conferência

Canais de submissão regulatórios

Os canais de comunicação regulatória incluem:

Agência regulatória	Método de envio	Freqüência
FDA	Envios eletrônicos	Atualizações trimestrais
Ema	Envios de plataforma digital	Relatórios Bi-Anuais

Networking da indústria farmacêutica

Detalhes do canal de networking:

• Conferências da indústria: 4-5 por ano
• Reuniões de parceria: 8-10 anualmente
• Plataformas de colaboração: digital e pessoal

Plataformas de relações com investidores

Canais de comunicação de investidores:

Plataforma	Frequência de interação	Alcançar
Chamadas de ganhos trimestrais	4 vezes por ano	Investidores institucionais
Conferências de investidores	2-3 Conferências anualmente	Potenciais investidores
Site de Relações com Investidores	Atualizações contínuas	Comunidade de investidores globais

Soligenix, Inc. (SNGX) - Modelo de negócios: segmentos de clientes

Agências de biodefesa do governo

A Soligenix tem como alvo agências de biodénsas do governo dos EUA com contramedidas médicas especializadas.

Agência	Valor potencial do contrato	Área de foco
Barda	US $ 31,5 milhões	Contramedidas médicas radiológicas/nucleares
NIH	US $ 7,2 milhões	Financiamento da pesquisa biodefensa

Mercados de tratamento de doenças raras

Soligenix se concentra em segmentos especializados de tratamento de doenças raras.

• Tamanho do mercado de doenças pediátricas de Crohn: US $ 1,2 bilhão
• Potencial de mercado de linfoma de células T cutâneas: US $ 850 milhões
• População estimada de pacientes para doenças raras-alvo: 75.000-100.000

Instituições de Pesquisa Oncológica

Parcerias de pesquisa com centros de oncologia especializados.

Tipo de instituição	Valor potencial de colaboração	Foco na pesquisa
Centros de câncer acadêmico	US $ 2,5 milhões anualmente	Pesquisa de terapia fotodinâmica SGX301
Clínicas de oncologia especializadas	US $ 1,8 milhão anualmente	Tratamentos de linfoma de células T cutâneas

Parceiros de desenvolvimento farmacêutico

Parcerias estratégicas com organizações de desenvolvimento farmacêutico.

• Parcerias farmacêuticas ativas atuais: 3
• Valor do contrato de parceria potencial: US $ 5 a 10 milhões por parceria
• Colaborações em estágio de desenvolvimento focadas em doenças raras

Comunidades de pesquisa médica especializadas

Engajamento direcionado com redes especializadas de pesquisa médica.

Comunidade de pesquisa	Potencial de financiamento	Interesse da pesquisa
Redes de pesquisa de doenças raras	US $ 4,3 milhões	Desenvolvimento de medicamentos órfãos
Consortia de pesquisa de imunologia	US $ 3,7 milhões	Tratamentos de doenças inflamatórias

Soligenix, Inc. (SNGX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Soligenix relatou despesas de pesquisa e desenvolvimento de US $ 6,1 milhões.

Ano	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 5,8 milhões	62.4%
2023	US $ 6,1 milhões	65.2%

Investimentos de ensaios clínicos

As despesas de ensaios clínicos para Soligenix em 2023 totalizaram aproximadamente US $ 3,7 milhões.

• Ensaios clínicos SGX301 (ORAXOL): US $ 1,5 milhão
• SGX942 Desenvolvimento Clínico: US $ 2,2 milhões

Custos de conformidade regulatória

As despesas anuais de conformidade regulatória para a Soligenix foram de US $ 1,2 milhão em 2023.

Aquisição de funcionários e talentos científicos

Categoria de pessoal	Custo anual	Número de funcionários
Equipe científica	US $ 2,8 milhões	22
Equipe administrativo	US $ 1,5 milhão	12

Manutenção da propriedade intelectual

Os custos de manutenção da propriedade intelectual para 2023 foram de US $ 450.000.

• Arquivamento e manutenção de patentes: US $ 250.000
• Apoio legal para proteção de IP: US $ 200.000

Custos operacionais totais para 2023: US $ 13,5 milhões

Soligenix, Inc. (SNGX) - Modelo de negócios: fluxos de receita

Subsídios de pesquisa do governo

A partir de 2024, a Soligenix recebeu subsídios de pesquisa governamental de várias fontes:

Fonte de financiamento	Valor de concessão	Foco na pesquisa
Institutos Nacionais de Saúde (NIH)	US $ 1,2 milhão	Pesquisa de oncologia
Departamento de Defesa	$850,000	Programas BiodeFense

Potencial licenciamento de produtos terapêuticos

Potencial de receita de licenciamento para candidatos terapêuticos -chave:

• SGX301 (BECLOMETASONA ORAL): Valor potencial estimado de licenciamento de US $ 15-20 milhões
• SGX942 (Dusquetide): potencial receita de licenciamento de US $ 25 a 30 milhões

Financiamento de pesquisa colaborativa

Detalhes financeiros da colaboração de pesquisa atual:

Parceiro	Valor de colaboração	Área de pesquisa
Instituição de Pesquisa Acadêmica	$750,000	Pesquisa de oncologia
Parceiro de pesquisa farmacêutica	US $ 1,1 milhão	Desenvolvimento BiodeFense

Vendas futuras de produtos farmacêuticos

Potencial de vendas de produtos farmacêuticos projetados:

• SGX301 (linfoma cutâneo de células T): Potencial anual estimado de vendas de US $ 12-15 milhões
• SGX942 (mucosite oral): receita anual projetada de US $ 18-22 milhões

Pagamentos marcantes de parcerias de pesquisa

Estrutura de pagamento de marco:

Programa de Pesquisa	Potencial total de marco	Pagamentos marcantes atuais
Desenvolvimento SGX301	US $ 35 milhões	US $ 5,2 milhões recebidos
Desenvolvimento SGX942	US $ 45 milhões	US $ 7,5 milhões recebidos

Soligenix, Inc. (SNGX) - Canvas Business Model: Value Propositions

You're looking at the core things Soligenix, Inc. offers that solve customer problems or create gains for them. For a late-stage biopharma company like Soligenix, Inc., the value is tied directly to the clinical and regulatory progress of its pipeline assets, which is where the numbers really matter.

Novel, non-invasive photodynamic therapy (HyBryte™) for early-stage CTCL

The primary value here is offering a treatment for early-stage Cutaneous T-Cell Lymphoma (CTCL) that is non-invasive. This therapy, HyBryte™ (synthetic hypericin), is in a confirmatory Phase 3 study, known as FLASH2, which is designed to enroll approximately $\mathbf{80}$ subjects. Soligenix, Inc. announced in November $\mathbf{2025}$ that they completed the planned enrollment of $\mathbf{50}$ patients needed for the interim analysis. The company anticipates providing top-line results in the second half of $\mathbf{2026}$.

The clinical data supports the value proposition:

• Response rate of $\mathbf{75\%}$ after $\mathbf{18}$ weeks in an ongoing investigator-initiated study.
• The FLASH2 study's current overall blinded study response rate is $\mathbf{48\%}$ to date.
• The study design is based on an anticipated overall blinded study response rate of $\mathbf{25\%}$ (based on $\mathbf{40\%}$ in the HyBryte™ arm versus $\mathbf{10\%}$ in the placebo arm through $\mathbf{18}$ weeks).
• The previous Phase 3 FLASH trial enrolled $\mathbf{169}$ patients ($\mathbf{166}$ evaluable).

Safe, visible light treatment with a favorable safety profile

The safety profile is a key differentiator, especially for a rare disease therapy. The value is confirmed by regulatory committee review. Soligenix, Inc. announced in October $\mathbf{2025}$ that the first Data Monitoring Committee (DMC) meeting for the confirmatory Phase 3 FLASH2 study concluded there were $\mathbf{no}$ safety concerns, with HyBryte™ demonstrating an acceptable safety profile consistent with all prior clinical studies. Furthermore, $\mathbf{66\%}$ of patients elected to continue with the optional third treatment cycle focused on safety/compassionate use in the prior trial structure. The treatment utilizes $\mathbf{safe}$ visible light, which is a core component of its non-invasive nature.

Heat-stable vaccines (RiVax®, CiVax™) for biodefense and emerging infectious diseases

The value proposition for the Public Health Solutions segment centers on the proprietary ThermoVax® platform, which imparts heat stability, reducing the need for cold-chain logistics. This segment is supported by government grant and contract funding from the National Institute. The pipeline includes RiVax®, the ricin toxin vaccine candidate, and CiVax™, the vaccine candidate for COVID-19 (SARS-CoV-2). In March $\mathbf{2025}$, Soligenix, Inc. announced a publication describing the preclinical efficacy of CiVax™. Also, in September $\mathbf{2025}$, a publication detailed the extended stability of ebolavirus vaccines using the ThermoVax® platform.

First-in-class innate defense regulator (IDR) technology (SGX945) for inflammatory diseases

This technology targets inflammatory diseases with first-in-class potential. The company has multiple IDR candidates in development, including SGX945 for Behçet's Disease, SGX942 for oral mucositis in head and neck cancer, and SGX302 for mild-to-moderate psoriasis. The value for SGX945 was bolstered in August $\mathbf{2025}$ when the FDA granted it Orphan Drug designation for Behçet's Disease following positive Phase 2a results. The company also announced that SGX945 provides $\mathbf{7}$ years of U.S. Market Exclusivity upon FDA Approval. Top-line results for SGX945 (Behçet's) and SGX302 (psoriasis) were anticipated in the second half of $\mathbf{2025}$ (as per the March $\mathbf{2025}$ update).

Here's a quick look at the financial context underpinning these development values as of late $\mathbf{2025}$:

Metric	Value/Date	Context
Cash Position (as of Sept 30, 2025)	\$10.5 million	Sufficient operating runway through 2026.
R&D Expenses (Q3 2025)	\$1.6 million	Compared to \$1.0 million in Q3 2024.
R&D Expenses (6 Months Ended June 30, 2025)	\$3.6 million	A 130% year-over-year surge.
Net Loss (Q3 2025)	\$2.5 million (or (\$0.58) per share)	Compared to \$1.7 million in Q3 2024.
HyBryte™ Phase 3 Trial Size (FLASH2)	80 subjects	Interim analysis planned after 50 patients enrolled.

The company's ability to fund these value-driving milestones is currently supported by that $\mathbf{\$10.5}$ million cash balance as of September $\mathbf{30}$, $\mathbf{2025}$.

Soligenix, Inc. (SNGX) - Canvas Business Model: Customer Relationships

You're developing therapies for rare diseases, so your customer relationships aren't about mass-market acquisition; they're about deep, specialized engagement with very specific patient populations and the experts who treat them. For Soligenix, Inc. (SNGX), this means a high-touch, almost personal approach to clinical development and future commercialization.

High-touch support for rare disease patient communities

Soligenix, Inc. focuses on rare diseases, where the patient community is small but highly engaged, especially since over 30 million Americans are affected by a rare disease, according to the National Institutes of Health. The relationship here is built on providing hope where there's an unmet medical need, particularly for conditions like cutaneous T-cell lymphoma (CTCL). The company's lead asset, HyBryte™, is positioned to potentially be the first FDA-approved photodynamic therapy for CTCL. This requires close coordination with the few centers treating these patients.

The ongoing investigator-initiated study (IIS) for HyBryte™ at the University of Pennsylvania, supported by an FDA Orphan Products Development grant totaling $2.6 million over four years, serves as a key touchpoint, demonstrating real-world use and gathering extended patient data up to 54 weeks. The early success seen in this study, with a 75% 'Treatment Success' rate after 18 weeks, directly informs and validates the relationship with the patient advocates and treating physicians.

Here's a snapshot of the clinical relationship data supporting the HyBryte™ development:

Metric	Value/Status	Context/Timeframe
Total FLASH2 Trial Patients	80	Confirmatory Phase 3 Trial
Patients Enrolled for Interim Analysis	50	Completed November 19, 2025
Anticipated Blinded Response Rate (Placebo Arm)	10%	Design Assumption
Observed Overall Blinded Response Rate (to date)	48%	In FLASH2 Trial
IIS Treatment Success Rate	75%	At 18 Weeks of Continuous Treatment
Expected Peak U.S. Annual Sales (HyBryte™ Estimate)	Exceeding $90 million	Future Commercialization

Direct engagement with key opinion leaders (KOLs) and Medical Advisory Boards

Engaging KOLs is critical for clinical strategy and future adoption. Soligenix, Inc. actively manages its advisory structure to guide development, especially for its rare disease assets.

• The United States (U.S.) Medical Advisory Board (MAB) for CTCL was updated on October 14, 2025.
• The European Medical Advisory Board for CTCL was expanded on September 30, 2025, in preparation for European health authority interactions.
• Dr. Ellen Kim, MD, a leading enroller in the prior FLASH study, serves as the Principal Investigator for the confirmatory Phase 3 FLASH2 study.
• The company also appointed former White House Economic Adviser Tomas J. Philipson, PhD, as a Strategic Advisor on September 23, 2025, to contribute business and government affairs expertise.

Formal contract management with US government agencies

Government funding and contracts form a key, non-dilutive relationship for Soligenix, Inc., particularly for its vaccine platform technology, ThermoVax®. This funding helps offset Research and Development expenses, which were $1.6 million for the quarter ended September 30, 2025.

The company's vaccine business segment has received grant and contract funding from several key agencies:

• National Institute of Allergy and Infectious Diseases (NIAID)
• Defense Threat Reduction Agency (DTRA)
• Biomedical Advanced Research and Development Authority (BARDA)

Revenue from government grants and contracts supporting development for SGX943, CiVax™, and HyBryte™ was $0.8 million for the year ended December 31, 2024. The cash runway, supported by these efforts and a recent offering, is expected to extend through 2026, with approximately $10.5 million in cash as of September 30, 2025.

Clinical trial site management and investigator relations

Managing the relationship with clinical trial sites is central to hitting key development timelines. The successful completion of enrollment for the 80-patient FLASH2 trial on November 19, 2025, is a direct measure of effective site management. The interim efficacy analysis for this trial is targeted for the first half of 2026, with topline results anticipated in the second half of 2026.

For the SGX945 program (dusquetide) for Behçet's Disease, the company achieved the study objective of demonstrating biological efficacy in its Phase 2a proof of concept study, announced on July 31, 2025. Furthermore, SGX945 received Orphan Drug Designation from the FDA on August 18, 2025, a direct result of positive investigator data and subsequent regulatory interaction.

Finance: review Q4 2025 cash burn projection against the $10.5 million cash on hand as of September 30, 2025, by next Tuesday.

Soligenix, Inc. (SNGX) - Canvas Business Model: Channels

You're looking at how Soligenix, Inc. (SNGX) plans to get its specialized therapies and vaccines to the people who need them, which is a critical step as they move closer to potential approvals. Since a dedicated commercial infrastructure isn't fully built out yet, the channels rely on partnerships and existing government frameworks.

Specialized direct sales force (planned post-approval for HyBryte™)

A specialized direct sales force for HyBryte™ (SGX301) is definitely planned, but it's contingent on receiving regulatory approvals following the completion of the confirmatory Phase 3 FLASH2 study. Right now, the company is focused on hitting that next clinical milestone, which is an enrollment update later this year, with top-line results anticipated in the second half of 2026. To fund the operations leading up to and through this period, Soligenix, Inc. reported approximately $10.5 million in cash as of September 30, 2025, which provides an operating runway through 2026. They are actively evaluating strategic options, including partnerships, to better position for this commercial launch phase. Honestly, until approval is secured, the sales channel remains theoretical, but the market potential is clear.

Here's a quick look at the market opportunity that this planned sales force would target:

Metric	Value/Estimate (Late 2025)
Peak U.S. Annual Sales Projection (HyBryte™)	Exceed $90 million
Total Addressable Worldwide CTCL Market	Greater than $250 million annually
Total Pipeline Global Opportunities Projection	Surpassing $2 billion

Daavlin's established phototherapy distribution network for the light device

For HyBryte™, which is a photodynamic therapy, the light device is a necessary companion product. Soligenix, Inc. secured this channel via an exclusive Supply, Distribution and Services Agreement with Daavlin, signed back in January 2021. Daavlin brings a significant existing footprint to the table, boasting a 40-year history of innovation in phototherapy. They use an extensive line of products and services to reach health care providers and patients globally for treating photoresponsive skin disorders. This existing network is integral to the regulatory and commercial strategy for SGX301, meaning Soligenix, Inc. doesn't have to build the hardware distribution from scratch.

Government procurement channels (e.g., Strategic National Stockpile) for vaccines

The Public Health Solutions business segment, which includes vaccine candidates like RiVax® (ricin toxin), filovirus, and CiVax™ (COVID-19), leverages established government funding and procurement pathways. This segment has historically been supported by non-dilutive government grants and contract funding. You can expect these channels to be key for future procurement, potentially including the Strategic National Stockpile (SNS), based on past support from these agencies:

• National Institute of Allergy and Infectious Diseases (NIAID)
• Defense Threat Reduction Agency (DTRA)
• Biomedical Advanced Research and Development Authority (BARDA)

The use of the ThermoVax® heat stabilization platform is a major factor supporting this government interest, as it addresses stability concerns for these countermeasures.

Clinical trial sites for current product access

While not a commercial channel in the traditional sense, clinical trial sites are the current access point for patients to receive investigational products like HyBryte™. These sites are crucial for generating the data needed for future market access. The ongoing investigator-initiated study (IIS) for extended HyBryte™ treatment is sponsored by a leading center in the field.

• Investigator-Initiated Study (IIS) Principal Investigator: Ellen Kim, MD, at the Hospital of the University of Pennsylvania.
• Confirmatory Phase 3 FLASH2 trial enrollment: The study is designed for 80 patients.
• Interim analysis trigger: Enrollment completion of 50 patients was announced on November 19, 2025.

These sites are where the real-world performance data, like the 75% success rate at 18 weeks seen in the IIS, is being generated. Finance: draft 13-week cash view by Friday.

Soligenix, Inc. (SNGX) - Canvas Business Model: Customer Segments

You're looking at the specific groups Soligenix, Inc. targets with its specialized biotherapeutics and public health solutions as of late 2025. This isn't about the whole market; it's about the precise patient and institutional groups driving their current strategy.

Patients with Rare Dermatologic Cancers, Specifically Early-Stage CTCL

This segment is the primary focus for HyBryte™ (SGX301). The customer base is defined by the clinical trial enrollment targets and demonstrated efficacy in prior studies. The ongoing confirmatory Phase 3 FLASH2 study is enrolling approximately 80 patients with early-stage cutaneous T-cell lymphoma (CTCL). The preceding Phase 3 FLASH trial evaluated 169 patients. Data from an investigator-initiated study (IIS) shows strong response rates, with over 80% (5/6) of patients achieving treatment success after 18 weeks of therapy in that trial. This IIS is supported by a $2.6 million grant from the FDA.

Dermatologists and Oncologists Who Treat CTCL Patients

These are the prescribers and clinical decision-makers. They are influenced by the speed and depth of response seen in trials. For example, the Phase 3 FLASH study showed over 70% of patients achieving treatment success. The company actively updates its U.S. Medical Advisory Board (MAB) for CTCL to provide strategic guidance as they advance the Phase 3 development.

US Government and Biodefense Agencies (NIAID, BARDA, DTRA)

This segment funds the Public Health Solutions business, specifically vaccine candidates like RiVax™. This funding stream is critical, as the company reported approximately $10.5 million in cash as of September 30, 2025, which provides operating runway through 2026, partly supported by these non-dilutive sources. Past government support is substantial:

• The GI ARS program has been supported by contract awards from BARDA and NIAID totaling approximately $33 million.
• Exercised funds for the GI ARS program include $7 million from NIAID and $11 million from BARDA.
• A past NIAID contract for RiVax™ development was valued up to $24.7 million.

Patients with Other Rare Inflammatory Diseases (e.g., Behçet's Disease)

This segment is targeted by SGX945 (dusquetide). Behçet's Disease (BD) is an orphan disease with an estimated global market value of $200 million. The patient population includes approximately 18,000 known cases in the U.S. and 50,000 in Europe, with as many as 1 million people worldwide living with BD. Soligenix, Inc. completed a Phase 2a proof-of-concept clinical trial for SGX945 in BD, expecting top-line results in Q3 2025. The active ingredient received Orphan Drug Designation from the FDA in August 2025.

Here's a quick look at the market context for these rare disease segments:

Disease/Product Focus	Metric Type	Value/Amount
CTCL (HyBryte™)	FLASH2 Trial Enrollment	80 Patients
CTCL (HyBryte™)	FLASH Trial Evaluated Patients	166 Patients
Behçet's Disease (SGX945)	Estimated Global Market Value	$200 million
Behçet's Disease (SGX945)	Estimated US Cases	18,000 Cases
Behçet's Disease (SGX945)	Estimated Worldwide Cases	1 million People
Biodefense (OrbeShield™)	Exercised BARDA Funding (to date)	$11 million
Company Financials (As of Q3 2025)	Cash Position	$10.5 million

The R&D expenses for Q3 2025 were $1.6 million, primarily due to costs associated with the second confirmatory Phase 3 CTCL trial. The net loss for that quarter was $2.53 million.

Soligenix, Inc. (SNGX) - Canvas Business Model: Cost Structure

You're looking at the cost side of Soligenix, Inc.'s operations as of late 2025. For a late-stage biopharma company, the cost structure is heavily weighted toward getting that late-stage asset across the finish line. Honestly, the burn rate is what you need to watch most closely.

The biggest driver of expenditure is definitely Research and Development (R&D). For the quarter ended September 30, 2025, Soligenix, Inc. reported R&D expenses totaling $1.6 million. This was up from $1.0 million in the same period in 2024. That increase tells you the clinical engine is running hot, which is expected when you're in a confirmatory Phase 3 trial.

Here's a quick look at the key operating expenses for that third quarter:

Expense Category	Q3 2025 Amount (USD)	Context
Research and Development (R&D)	$1.6 million	Driven by Phase 3 CTCL trial and manufacturing
General and Administrative (G&A)	$1.0 million	Overhead, professional expenses
Total Operating Expenses	$2.58 million	Sum of R&D and G&A plus other minor costs

The R&D spend isn't just lab work; it directly reflects significant external commitments. The increase in R&D was primarily due to costs associated with the second confirmatory Phase 3 CTCL trial, which is a major cash outlay, and increases in third-party contract manufacturing needed for trial supply.

Your cost structure components are pretty standard for this stage, but they are all tied to the pipeline's progress. You can expect these costs to remain high until key data readouts.

• High Research and Development (R&D) expenses, totaling $1.6 million in Q3 2025.
• Significant costs for third-party contract manufacturing and clinical trial operations, specifically the Phase 3 CTCL study.
• General and administrative (G&A) overhead, approximately $1.0 million in Q3 2025.
• Ongoing regulatory filing and intellectual property maintenance costs are baked into the operating expenses, though not itemized separately in the top-line figures.

Remember, with approximately $10.5 million in cash at September 30, 2025, the company is funding these costs from its balance sheet, projecting runway through 2026. That runway is directly dependent on keeping these operating expenses in check relative to the cash position.

Finance: draft 13-week cash view by Friday.

Soligenix, Inc. (SNGX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Soligenix, Inc. (SNGX) as of late 2025, and honestly, it's a story of non-commercial revenue funding development right now, with big potential on the horizon. The current financial reality shows that product sales aren't the income driver yet.

Government grants and contracts for vaccine development are the primary current source supporting a segment of the business. This funding has historically come from several key U.S. government entities. Soligenix, Inc. has received government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA) to support its vaccine programs. To be fair, the company reported no revenue for the quarter ended September 30, 2025, and annual revenue for the fiscal year ended December 31, 2024, was only $0.1 million.

Future product sales of HyBryte™ (SGX301) post-regulatory approval represent the major commercial upside. The company expects peak annual net sales of HyBryte™ in the U.S. to exceed $90 million. This is based on the ongoing development of HyBryte™ for cutaneous T-cell lymphoma (CTCL), where top-line results from the confirmatory Phase 3 study are anticipated in the second half of 2026.

Potential licensing or partnership fees from strategic transactions are a critical component of the near-term financial strategy, especially given the current cash position. As of September 30, 2025, Soligenix, Inc. held approximately $10.5 million in cash, which provides an operating runway through 2026. The company explicitly continues to evaluate all strategic options, including partnership and merger and acquisition opportunities, to advance its late-stage pipeline.

The potential value of the pipeline drives the expected future revenue streams from both product sales and potential deals. Here's a quick look at the market opportunities that underpin these projections:

Product/Indication	Estimated Worldwide Annual Market Opportunity
HyBryte™ (CTCL)	Greater than $250 million
SGX302 (Psoriasis)	Estimated to exceed $1 billion annually
SGX945 (Behçet's Disease)	Approximately $200 million annually
Total Pipeline Potential	Over $2 billion

The revenue structure is clearly weighted toward future commercialization, but the current funding mechanism relies on non-dilutive government support and cash management. You can see the focus on hitting those upcoming milestones:

• HyBryte™ (SGX301) confirmatory Phase 3 enrollment update expected in late 2025.
• Top-line Phase 2a results for SGX302 in psoriasis before year-end 2025.
• Phase 2a proof of concept results for SGX945 in Behçet's Disease in 3Q 2025.

If onboarding takes longer than anticipated for the Phase 3 trial, the timing for the $90 million peak sales projection definitely shifts. Finance: draft 13-week cash view by Friday.