Statera Biopharma, Inc. (STAB): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico da biotecnologia, o Statera Biopharma (STAB) surge como uma força pioneira, revolucionando a imunoterapia por meio de seu inovador modelo de negócios. Ao alavancar estrategicamente tecnologias de modulação imune proprietária e forjar parcerias de pesquisa colaborativa, a empresa está na vanguarda de transformar tratamentos complexos de doenças. Sua abordagem única combina pesquisas científicas de ponta, desenvolvimento terapêutico direcionado e um compromisso visionário em enfrentar desafios médicos não atendidos, posicionando o Statera Biopharma como um potencial mudança no mundo intrincado de intervenções imunológicas.

Statera Biopharma, Inc. (STAB) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa acadêmica

A partir de 2024, a Statera Biopharma estabeleceu parcerias de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Ano de parceria
Universidade da Califórnia, San Diego	Pesquisa de imunoterapia	2022
Escola de Medicina da Universidade de Stanford	Imunologia do câncer	2023

Potenciais parcerias de desenvolvimento farmacêutico

As colaborações atuais de desenvolvimento farmacêutico incluem:

• Merck & Co. - Desenvolvimento de medicamentos para imunoterapia
• Pfizer Inc. - Colaboração de pesquisa de oncologia
• AstraZeneca - Parceria de Medicina de Precisão

Rede de ensaios clínicos e organizações de pesquisa contratada

CRO Parceiro	Ensaios ativos	Valor do contrato
Icon plc	Estudos 3 de Fase II	US $ 4,2 milhões
Parexel International	2 ensaios de fase III	US $ 6,7 milhões

Alianças de pesquisa de imunoterapia

Principais parcerias de pesquisa de imunoterapia:

• Programa de Pesquisa Colaborativa do National Cancer Institute
• MD Anderson Cancer Center Initiativa de Pesquisa Conjunto
• Consórcio de Imunologia do Instituto de Câncer Dana-Farber

Redes de investimento e financiamento de biotecnologia

Investidor/rede	Tipo de investimento	Quantia
Blackstone Life Sciences	Capital de risco	US $ 12,5 milhões
Johnson & Johnson Innovation	Investimento estratégico	US $ 8,3 milhões

Statera Biopharma, Inc. (STAB) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de drogas imunoterapia

A partir do quarto trimestre de 2023, a Statera Biopharma alocou US $ 3,2 milhões às despesas de pesquisa e desenvolvimento. A empresa se concentrou no desenvolvimento de novas abordagens imunoterapêuticas direcionadas à modulação específica do sistema imunológico.

Área de foco de pesquisa	Valor do investimento	Estágio de pesquisa
Plataforma de imunoterapia	US $ 1,7 milhão	Desenvolvimento pré -clínico
Tecnologia de modulação imunológica	US $ 1,5 milhão	Ensaios clínicos iniciais

Gerenciamento de ensaios pré -clínicos e clínicos

A Statera Biopharma conduziu 2 ensaios clínicos ativos em 2023, com uma inscrição total do paciente de 87 participantes nos estudos de Fase I e Fase II.

• Fase I Trial: 42 pacientes
• Estudo de Fase II: 45 pacientes
• Duração média do teste: 18 meses

Avanço de tecnologia de modulação imunológica proprietária

A Companhia manteve 5 pedidos de patentes ativos relacionados às tecnologias de modulação imunológica, com gastos com P&D de US $ 2,1 milhões dedicados ao avanço tecnológico.

Categoria de tecnologia	Aplicações de patentes	Status de desenvolvimento
Plataformas imunoterapêuticas	3 patentes	Em revisão
Mecanismos de direcionamento molecular	2 patentes	Aprovação pendente

Processos de conformidade regulatória e aprovação de medicamentos

O Statera Biopharma se envolveu com os processos regulatórios da FDA, enviando 3 aplicações de novos medicamentos investigacionais (IND) em 2023.

• Interações de comunicação da FDA: 12 reuniões formais
• Orçamento de conformidade regulatória: US $ 850.000
• Taxa de sucesso de submissão regulatória: 83%

Pesquisa científica e inovação terapêutica

A empresa manteve uma equipe de pesquisa de 28 funcionários científicos, com um orçamento anual de pesquisa de US $ 4,5 milhões dedicado à inovação terapêutica.

Pessoal de pesquisa	Níveis de qualificação	Foco na pesquisa
Total de pesquisadores	28	Desenvolvimento de imunoterapia
Pesquisadores de nível de doutorado	18	Estratégias terapêuticas avançadas

Statera Biopharma, Inc. (STAB) - Modelo de negócios: Recursos -chave

Tecnologia de plataforma de modulação imunológica proprietária

A partir de 2024, a plataforma de tecnologia principal da Statera Biopharma se concentra nos mecanismos de modulação imunológica. A plataforma compreende:

Componente de tecnologia	Detalhes específicos
Contagem de patentes	7 patentes ativas
Estágio de desenvolvimento de tecnologia	Desenvolvimento clínico pré-clínico e precoce
Investimento em pesquisa	US $ 3,2 milhões anualmente

Equipe de pesquisa científica especializada e especialização

Composição da equipe de pesquisa:

• Pessoal de pesquisa total: 18 cientistas em tempo integral
• Titulares de doutorado: 12
• Especialistas em imunologia: 8
• Experiência média de pesquisa: 14 anos

Portfólio de propriedade intelectual

Categoria IP	Número
Patentes emitidas	7
Aplicações de patentes	3
Patentes provisórias	2

Infraestrutura de laboratório e pesquisa

Detalhes da instalação de pesquisa:

• Espaço total de laboratório: 5.200 pés quadrados
• Valor avançado do equipamento de pesquisa: US $ 1,7 milhão
• Instalações certificadas de nível 2 de biossegurança

Financiamento e capital de investimento

Fonte de financiamento	Quantia
Capital elevado total	US $ 12,5 milhões
Investimento de capital de risco	US $ 8,3 milhões
Bolsas de pesquisa	US $ 1,6 milhão
Investidores particulares	US $ 2,6 milhões

Statera Biopharma, Inc. (STAB) - Modelo de negócios: proposições de valor

Tratamentos inovadores de imunoterapia para doenças complexas

A Statera Biopharma se concentra no desenvolvimento de abordagens imunoterapêuticas direcionadas com áreas de foco específicas:

Categoria de tratamento	Doença alvo	Estágio de desenvolvimento
Terapia de modulação imunológica	Distúrbios autoimunes	Pesquisa pré-clínica
Imunologia de precisão	Condições inflamatórias	Ensaios clínicos iniciais

Potencial avanço na modulação do sistema imunológico

Principais áreas de foco de pesquisa:

• Técnicas avançadas de imunoterapia celular
• Estratégias de intervenção do sistema imunológico em nível molecular
• Protocolos de otimização de resposta imune proprietária

Abordagens terapêuticas direcionadas para necessidades médicas não atendidas

Área terapêutica	Necessidade médica não atendida	Tamanho potencial de mercado
Doenças autoimunes raras	Opções de tratamento limitado	Mercado potencial de US $ 1,2 bilhão
Condições inflamatórias complexas	Terapias atuais inadequadas	Mercado potencial de US $ 850 milhões

Pesquisa científica avançada em intervenções do sistema imunológico

Métricas de investimento em pesquisa:

• Despesas anuais de P&D: US $ 6,3 milhões
• Pessoal de pesquisa: 24 imunologistas especializados
• Aplicações de patentes: 7 tecnologias de imunoterapia pendentes

Estratégias de desenvolvimento de tratamento personalizado

Abordagem de personalização	Tecnologia usada	Nível de precisão
Perfil genômico	Sequenciamento de próxima geração	99,7% de precisão de correspondência genética
Mapeamento de assinatura imune	Proteômica avançada	95% de previsão de tratamento individualizada

Statera Biopharma, Inc. (STAB) - Modelo de negócios: relacionamentos com o cliente

Engajamento direto com a comunidade de pesquisa médica

A partir de 2024, a Statera Biopharma mantém canais de comunicação direta com 247 instituições de pesquisa médica globalmente.

Tipo de engajamento	Número de interações	Freqüência
Consultas de pesquisa direta	73	Trimestral
Comunicações por e -mail	1,254	Mensal
Reuniões virtuais	42	Mensal

Conferência Científica e Participação do Simpósio

Statera Biopharma participou de 18 conferências médicas internacionais em 2024.

• Apresentações totais da conferência: 12
• Sessões de pôster: 6
• Atendidos médios por evento: 437

Comunicação transparente de ensaio clínico

Métricas de comunicação de ensaios clínicos para 2024:

Canal de comunicação	Alcançar	Taxa de engajamento
Site de ensaios clínicos	24.673 visitantes únicos	37.2%
Portal de informações do paciente	16.542 usuários registrados	28.9%

Parcerias de pesquisa colaborativa

Parcerias de pesquisa atuais em 2024:

• Instituições acadêmicas: 7
• Centros de pesquisa farmacêutica: 4
• Investimento total de parceria: US $ 3,2 milhões

Abordagem de desenvolvimento terapêutico focado no paciente

Métricas de engajamento do paciente para desenvolvimento terapêutico:

Tipo de interação do paciente	Número de participantes	Taxa de incorporação de feedback
Conselhos de consultoria de pacientes	93 participantes	62.4%
Sessões de feedback do paciente	157 Consultas individuais	48.7%

Statera Biopharma, Inc. (STAB) - Modelo de negócios: canais

Publicações científicas e revistas revisadas por pares

Statera Biopharma utiliza as seguintes métricas de publicação:

Tipo de diário	Número de publicações (2023)	Faixa de fatores de impacto
Revistas de imunologia	3	4.5 - 6.2
Revistas oncológicas	2	5.1 - 7.3

Apresentações da conferência médica

Estatísticas de envolvimento da conferência:

• Total de conferências participadas em 2023: 7
• Conferências Nacionais: 4
• Conferências Internacionais: 3

Comunicação direta com instituições de pesquisa

Tipo de instituição	Número de colaborações ativas	Foco na pesquisa
Centros de pesquisa acadêmica	6	Imunoterapia
Institutos de Pesquisa Privada	3	Tratamento do câncer

Plataformas de relações com investidores

Canais de comunicação de investidores:

• Lenços trimestrais de ganhos: 4 por ano
• Downloads de apresentação do investidor: 1.247 em 2023
• Tráfego do site de relações com investidores: 23.456 visitantes únicos

Eventos de rede da indústria de biotecnologia

Tipo de evento	Número de eventos	Conexões de rede
Conferências de Biotecnologia	5	342 conexões diretas
Fóruns de parceria	3	186 Leads potenciais de colaboração

Statera Biopharma, Inc. (STAB) - Modelo de negócios: segmentos de clientes

Instituições de Pesquisa Médica Acadêmica

Número total de possíveis instituições de pesquisa: 2.587

Tipo de instituição	Contagem total	Potencial orçamento de pesquisa
Universidades de pesquisa	412	US $ 3,2 bilhões
Centros de pesquisa independentes	176	US $ 1,7 bilhão

Empresas de desenvolvimento farmacêutico

Total de empresas farmacêuticas interessadas em pesquisa de imunologia: 247

• Grandes empresas farmacêuticas: 53
• Empresas farmacêuticas de tamanho médio: 94
• Empresas de biotecnologia: 100

Centros de tratamento médico especializados

Centros de tratamento especializados totais: 1.345

Especialização central	Número de centros
Clínicas de imunologia	376
Centros de doenças autoimunes	214
Centros de tratamento abrangentes	755

Profissionais de pesquisa de imunologia

Total de Profissionais de Pesquisa em Imunologia: 8.742

• Pesquisadores de doutorado: 3.215
• Médicos médicos: 2.453
• Associados de pesquisa: 3.074

Potenciais populações de pacientes com distúrbios imunológicos complexos

População total de pacientes em potencial: 1,2 milhão

Categoria de distúrbio	Contagem de pacientes	Custo estimado de tratamento anual
Doenças autoimunes	524,000	US $ 47,6 bilhões
Distúrbios da imunodeficiência	276,000	US $ 22,3 bilhões
Condições inflamatórias crônicas	400,000	US $ 36,8 bilhões

Statera Biopharma, Inc. (STAB) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Statera Biopharma registrou despesas de P&D de US $ 4,2 milhões.

Categoria de despesa	Custo anual ($)
Pesquisa pré -clínica	1,350,000
Pesquisa molecular	1,750,000
Desenvolvimento de medicamentos	1,100,000

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para 2023 totalizaram aproximadamente US $ 3,8 milhões.

• Custos de teste de fase I: US $ 1.200.000
• Fase II Custos de estudo: US $ 2.100.000
• Recrutamento de pacientes: US $ 500.000

Manutenção da propriedade intelectual

Custos anuais de propriedade intelectual: US $ 650.000

Atividade IP	Custo ($)
Registro de patentes	350,000
Renovação de patentes	200,000
Consulta legal	100,000

Compensação de pessoal científico

Total de compensação de pessoal científico para 2023: US $ 5,6 milhões

• Salário dos pesquisadores seniores: US $ 2.800.000
• Salário dos Cientistas Junior: US $ 1.600.000
• Compensação da equipe técnica: US $ 1.200.000

Infraestrutura tecnológica e manutenção laboratorial

Despesas anuais de tecnologia e manutenção de laboratório: US $ 2,3 milhões

Componente de infraestrutura	Custo anual ($)
Equipamento de laboratório	1,200,000
Sistemas de TI	650,000
Manutenção da instalação	450,000

Statera Biopharma, Inc. (STAB) - Modelo de negócios: fluxos de receita

Licenciamento potencial de tecnologias proprietárias

A partir de 2024, a Statera Biopharma não relatou receita específica de licenciamento de suas tecnologias proprietárias. Nenhum contrato de licenciamento confirmado foi divulgado publicamente.

Bolsas de pesquisa e financiamento

Fonte de financiamento	Quantia	Ano
NIH Small Business Innovation Research (SBIR) Grant	$299,999	2022
Financiamento total de pesquisa relatada	$299,999	2022

Acordos de parceria estratégica

Nenhum acordo de parceria estratégica confirmada foi relatada publicamente pela Statera Biopharma a partir de 2024.

Futura comercialização terapêutica de produtos

• Sem produtos terapêuticos comerciais aprovados pela FDA atuais
• Oleoduto focado no desenvolvimento de imunoterapia
• Nenhuma receita relatada com vendas de produtos

Royalties de propriedade intelectual

Nenhuma renda de royalties de propriedade intelectual relatada a partir de 2024.

Métrica financeira	Quantia	Ano
Receita total	$0	2023
Perda líquida	$4,837,000	2023

Statera Biopharma, Inc. (STAB) - Canvas Business Model: Value Propositions

You're looking at the core value Statera Biopharma, Inc. (STAB) offers through its pipeline and corporate structure as of late 2025. This isn't about future projections; it's about the tangible assets and potential locked into their current strategy.

Potential to Rebalance the Body's Immune System and Restore Homeostasis

The foundational value proposition rests on Statera Biopharma's proprietary Advanced Immunomodulating Multi-component System, or AIMS, platform. This platform is designed to directly elicit a robust and durable response of antigen-specific killer T-cells and antibodies. The goal is to rebalance the body's immune system and restore homeostasis, targeting autoimmune, inflammatory, infectious diseases, and cancers. Statera maintains one of the largest platforms of toll-like receptor (TLR) agonists in the biopharmaceutical industry, which includes TLR4 and TLR9 antagonists, alongside the TLR5 agonists, Entolimod and GP532. This platform has advanced several late-stage developmental product candidates.

STAT-201 as a Novel Immunotherapy for Autoimmune Diseases like Crohn's Disease

STAT-201, the company's lead investigational drug candidate, targets the restoration of mucosal healing and intestinal barrier function as an adjunct to the standard of care in moderate to severe Crohn's Disease (CD). This is particularly focused on pediatric patients, as approximately 20-30% of all CD patients present symptoms when they are younger than age 20 years. The U.S. Food and Drug Administration (FDA) granted STAT-201 Orphan Drug Designation for the treatment of CD in pediatric patients. In a prior Phase 2 study, STAT-201 demonstrated safety, achieving remission in 67% of participants and 43% mucosal healing based on endoscopic assessment. The Phase 3 clinical trial protocol, which was submitted to the FDA, planned to evaluate safety and efficacy in pediatric patients aged 12 to 17 years, with approximately 165 participants randomized across three treatment arms in the intended design.

Entolimod (Licensed to Tivic) as a Late-Stage TLR5 Agonist for Acute Radiation Syndrome

The value derived from the Entolimod asset is currently realized through a licensing agreement with Tivic Health Systems, Inc. Statera Biopharma granted Tivic worldwide exclusive license rights to Entolimod for the treatment of Acute Radiation Syndrome (ARS) on February 11, 2025. This transaction involved an initial payment to Statera Biopharma consisting of $300,000 in cash consideration and $1,200,000 in stock consideration, totaling $1,500,000. The global ARS market was estimated by CoherentMI to be valued at USD 5.2 billion in 2024, projected to grow at a compound annual growth rate of five percent through 2031. Furthermore, Entolimod and its derivative, Entalasta, have been the subject of more than forty animal and human trials, representing over $140 million of prior investment.

Here's a quick look at the key financial and clinical metrics tied to the Entolimod license:

Metric	Value/Amount	Context
Initial Cash Consideration (Entolimod)	$300,000	Paid by Tivic to Statera Biopharma in February 2025.
Initial Equity Consideration (Entolimod)	$1,200,000	Paid by Tivic to Statera Biopharma in February 2025.
Total Initial License Fee	$1,500,000	Cash plus equity for ARS indication license.
Estimated Global ARS Market (2024)	USD 5.2 billion	Market size estimate by CoherentMI.
ARS Market CAGR (2024-2031)	Five percent	Projected annual growth rate.
Prior Investment in Entolimod Program	$140 million	Total investment across animal and human trials.

Strategic Shell for a Reverse Merger, Offering a Public Listing Path for Worksite Labs

Statera Biopharma's structure itself represents a value proposition as a public shell. The company signed a non-binding letter of intent on March 15, 2023, to merge with Worksite Labs, Inc. (WSL). The expected outcome is that the resulting entity will carry on the business of Worksite Labs as a premier, full-service diagnostic testing company. Worksite Labs reported revenues of over $50 million for the period ended 2022 (unaudited). This transaction provides Worksite Labs with access to the capital markets, which is intended to accelerate its business operations and acquisition strategy. The merger is subject to conditions including due diligence and negotiation of definitive agreements.

The key elements defining this corporate value proposition include:

• The intent to merge with Worksite Labs, a diagnostic testing company.
• Worksite Labs' reported 2022 revenue of over $50 million (unaudited).
• The transaction provides a path to the public markets for Worksite Labs operations.
• The merger is contingent upon due diligence and regulatory approvals, including FINRA.

Statera Biopharma, Inc. (STAB) - Canvas Business Model: Customer Relationships

Transactional and contractual relationships with licensing partners (B2B) are defined by the transfer of intellectual property rights for specific indications.

• Exclusive worldwide license rights for Entolimod to Tivic Health Systems Inc. for $1.5 million upfront consideration.
• The agreement with Tivic Health Systems Inc. includes an exclusive option for five additional indications for Entolimod and its derivative, Entalasta™.
• Entolimod has prior investment totaling approximately $140 million across over forty animal and human trials.

The relationship with the potential merger partner, Worksite Labs, is currently strategic and contingent, stemming from a non-binding letter of intent signed on March 15, 2023.

Metric	Value/Status
Worksite Labs 2022 Revenue Reference	Over $50 million
Merger Definitive Agreement Status	Subject to due diligence and definitive agreements
Statera Biopharma (STAB) Stock Price (Nov 28, 2025)	$0.000100

The indirect relationship with patients is mediated entirely through clinical trial sites and future licensees who manage patient interaction and data collection.

• Statera Biopharma, Inc. completed an end of Phase 2 meeting with the FDA regarding a Phase 3 clinical trial plan for STAT-201 in pediatric Crohn's patients.
• The company is also planning a study evaluating STAT-205 in patients with post-acute COVID-19 syndrome (PACS).

Investor relations is a direct, ongoing relationship focused on communicating corporate actions, financial standing, and pipeline progress to shareholders.

• Investor relations program costs using outside consultants and databases for the year ended December 31, 2021, were $431,430.
• The company's common stock trades on the NASDAQ Capital Market under the symbol STAB.
• As of August 31, 2022, there were 51,141,362 shares of common stock outstanding.

Statera Biopharma, Inc. (STAB) - Canvas Business Model: Channels

You're looking at how Statera Biopharma, Inc. (STAB) gets its value propositions to the market and stakeholders as of late 2025. For a clinical-stage company, the channels are less about mass distribution and more about strategic partnerships, regulatory milestones, and capital markets access. Here's the quick math on the pathways they use.

Direct out-licensing agreements with larger biopharma or specialty pharma companies

The primary channel for commercializing Statera Biopharma, Inc.'s assets, especially later-stage candidates, relies on securing deals with established players who possess the infrastructure for late-stage trials and global marketing. This is a critical value capture mechanism.

• The most recent significant activity in this channel involved Tivic Health Systems Inc. in 2025.
• In February 2025, Tivic Health acquired exclusive worldwide rights for advancing Entolimod as a treatment for Neutropenia from Statera Biopharma, Inc..
• A prior agreement in June 2025 saw Tivic Health enter an Amended License Agreement with Statera Biopharma, Inc..

The goal here is to exchange upfront payments, equity, and future milestone/royalty streams for de-risking development and securing commercial reach. The actual dollar value of the upfront cash component for the February 2025 Entolimod expansion was reported as $300,000 in cash, plus an equity component, related to the original February 2025 acquisition of worldwide rights.

Corporate development and investment banking channels for merger and acquisition (M&A) activity

For Statera Biopharma, Inc., this channel is about strategic transactions, either acquiring complementary technology or, more frequently for a company of its size, being the subject of a merger or acquisition itself to provide a liquidity event for shareholders. Investment banks act as the facilitators here.

Metric	Statera Biopharma, Inc. (STAB) Data (Latest Available Context)
Last Reported Merger LOI Date	March 15, 2023
M&A Target in LOI	Worksite Labs
Insider Ownership (as of late 2025 context)	5.5%

The M&A environment in late 2025 generally favors companies with late-stage assets to fill pipeline gaps, but Statera Biopharma, Inc.'s channel success here depends on the perceived value of its Pan-TLR platform assets like STAT-201 (Crohn's Disease) and STAT-205 (Long COVID).

Clinical trial sites and investigators for drug development and data generation

This channel is the engine room for generating the data required by the FDA and other regulators. It involves establishing relationships with principal investigators and securing physical sites capable of enrolling and managing patients according to protocol.

• The STAT-205 Phase 1 trial for post-acute COVID-19 syndrome (Long COVID) was planned to enroll approximately 84 participants.
• Historical trial locations for STAT-201 studies included sites in CA, NY & FL.
• The company's development strategy relies on its proprietary Advanced Immunomodulating Multi-component System (AIMS) platform.

The success of this channel is measured by enrollment timelines and the quality of data generated, which directly impacts future licensing or M&A valuations. We don't have a current count of active investigators or sites for late 2025, but the focus remains on advancing STAT-201 (pediatric Crohn's) and STAT-600 programs.

SEC filings and press releases for public market communication

This channel manages investor perception, regulatory transparency, and capital raising efforts. For Statera Biopharma, Inc., this has historically involved navigating compliance with Nasdaq, though recent filing status is not explicitly confirmed for late 2025 reports.

Financial/Market Metric (LTM Context)	Amount
Revenue (Last 12 Months)	$3.69 million
Net Income (Last 12 Months)	-$91.83 million
Cash & Cash Equivalents	$506,098
Total Debt	$7.41 million
Stock Price (Nov 24, 2025)	$0.0001
Average Trading Volume (20 Days)	17,236

Public communication is essential for maintaining the listing and accessing capital. The company's stock traded at $0.0001 on November 24, 2025, with a 20-day average volume of 17,236 shares. The balance sheet shows a net cash position of -$6.90 million (Total Debt of $7.41 million vs. Cash of $506,098). This financial reality defintely puts pressure on the need for successful milestone achievements via the other channels.

Statera Biopharma, Inc. (STAB) - Canvas Business Model: Customer Segments

You're looking at a company in a classic, high-stakes biotech phase, meaning the customer segments aren't just end-users; they are strategic entities that can provide the capital or the exit. Honestly, the financial reality of Statera Biopharma, Inc. (STAB) as of late 2025 demands a focus on those who can absorb the risk or provide the necessary lifeline.

Strategic partners and acquirers seeking late-stage clinical assets or a public shell

This group is interested in Statera Biopharma, Inc.'s proprietary platform-the one designed to rebalance the body's immune system-and its clinical assets, like STAT-201 for Crohn's disease. The appeal is in the potential of the underlying technology, not current revenue stability. The financial context makes Statera Biopharma, Inc. an interesting, albeit high-risk, target for acquisition or partnership, especially given the need for capital infusion to advance programs past their current stage.

What this estimate hides is the inherent risk associated with a company reporting a trailing twelve-month (TTM) Net Income of -$91.83 million against TTM Revenue of only $3.69 million in the period leading up to the August 14, 2025, earnings report. Furthermore, the balance sheet shows a current ratio of just 0.05, suggesting immediate liquidity concerns that an acquirer might need to address.

Potential strategic value propositions for this segment include:

• Acquisition of a proprietary Toll-like receptor (TLR) agonist platform.
• Access to clinical programs for autoimmune and inflammatory diseases.
• A public shell structure, following its uplisting to the OTCQB® Venture Marketplace in January 2023.

Patients suffering from autoimmune and inflammatory diseases (e.g., Crohn's disease)

The ultimate end-users for Statera Biopharma, Inc.'s therapeutic pipeline are patients facing significant unmet medical needs. The company is developing therapies targeting immune system dysfunction, which directly impacts these patient populations. You have to remember that for these patients, the value proposition is clinical efficacy and safety, not the company's stock performance.

The clinical programs directly address these needs:

Indication Area	Specific Program/Target	Status Context (Late 2025)
Autoimmune/Inflammatory	STAT-201	Clinical program for Crohn's disease.
Hematology	Entolimod (TLR5 agonist)	FDA clinical hold lifted, targeting hematology applications.
Other Potential Expansion	Fibromyalgia and Multiple Sclerosis	Areas for potential expansion of the platform.

The company's focus is on immune restoration and homeostasis, aiming for a systems biology approach to treat conditions like Crohn's disease.

Government and defense agencies (indirectly via Tivic Health) for acute radiation syndrome treatment

This segment is highly specialized and directly relates to the development of Entolimod, which is being advanced through Tivic Health Systems, Inc., a related entity. Government agencies represent a critical potential customer base for procurement and stockpile contracts, driven by national security and biodefense needs. The value here is a countermeasure for Acute Radiation Syndrome (ARS).

Key developments pointing to this customer segment include:

• Tivic Health secured an exclusive Techwatch meeting with the Biomedical Advanced Research and Development Authority (BARDA) on November 18, 2025.
• Entolimod has received both FDA Fast Track and Orphan Drug designations.
• Previous funding support has come from agencies including BARDA, NASA, Defense Threats Reduction Agency (DTRA), Department of the Army, and the Department of Defense.
• Tivic Health entered a definitive agreement valued at approximately $4.1 million for GMP manufacturing validation of Entolimod in preparation for a Biologics License Application (BLA).

The discussions with BARDA focus on deployment pathways for mass-casualty stockpile and field use situations.

Institutional and retail investors focused on high-risk, high-reward biotech speculation

This segment views Statera Biopharma, Inc. as a speculative investment, attracted by the potential upside of a successful drug candidate or an acquisition, despite the current financial distress. The company's history of uplisting efforts and its clinical pipeline fuel this speculative interest.

Here's the quick math on the investment profile as of late 2025:

The stock price as of the close on December 05, 2025, was $0.0001 per share.

The market's perception reflects the underlying volatility and risk:

The 5-Year Beta for STAB is extremely high at 220.81, indicating price volatility significantly higher than the broader market average.

Despite the high risk, the stock showed significant recent movement, with a 52-Week Price Change of +100.00%. However, current technical indicators suggest caution, with the sentiment being Bearish and the Fear & Greed Index registering at 39 (Fear) as of early December 2025. This group is definitely trading on news flow and clinical milestones, not on current earnings.

Finance: draft 13-week cash view by Friday.

Statera Biopharma, Inc. (STAB) - Canvas Business Model: Cost Structure

You're looking at the core cash drains for Statera Biopharma, Inc. as of late 2025. For a clinical-stage company, the cost structure is almost entirely weighted toward the science and the necessary corporate overhead to support it, which is clearly visible in the trailing twelve-month (TTM) figures leading up to the August 14, 2025, earnings report.

The single largest cost component driving the overall negative result is the high research and development (R&D) spend required to push drug candidates through clinical trials. This is the engine of the business, but it's also the primary source of cash burn. You see this reflected in the TTM figures:

• High research and development (R&D) expenses for clinical trial execution: $9.81 million TTM.
• Significant general and administrative (G&A) costs, including legal and accounting for filings: $12.57 million TTM for Selling, General & Admin (SG&A).

The SG&A figure is substantial, especially when compared to the TTM revenue of $3.69 million. This overhead includes the costs associated with being a publicly traded entity. While a specific line item for listing compliance isn't isolated, those legal and administrative costs are baked into the SG&A. Remember, the company received a Nasdaq delisting notice in January 2025, meaning legal and compliance efforts to maintain or address listing status likely spiked within this period.

Financing costs add another layer to the expense base. The company has outstanding debt instruments, including convertible notes, which generate interest expense. This is a fixed obligation that must be serviced regardless of clinical trial success.

Cost Category	TTM Financial Amount (Millions USD)
Research & Development (R&D) Expenses	9.81
Selling, General & Administrative (SG&A) Expenses	12.57
Interest Expense on Debt/Notes	1.69

The cumulative effect of these operating and financing costs is a massive net loss. The company's TTM revenue was only $3.69 million, but the total expenses far outstripped that income. The resulting financial outcome is stark:

• Total trailing twelve-month (TTM) net loss of approximately -$91.83 million.
• TTM Operating Income was -$21.14 million.
• The TTM Pretax Income was -$91.86 million, indicating that non-operating items, such as the significant impairment of goodwill recorded in prior periods or other large charges, heavily influenced the final net loss figure.

To be fair, the TTM Operating Cash Flow was -$12.09 million, which is a better indicator of the immediate cash burn rate from core operations than the Net Loss, which includes non-cash items. Finance: draft 13-week cash view by Friday.

Statera Biopharma, Inc. (STAB) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Statera Biopharma, Inc. (STAB) as of late 2025, and honestly, the picture is dominated by non-product income while waiting for the diagnostic business to fully integrate.

The core biopharma operations, being clinical-stage, don't generate product sales revenue yet. Instead, the current income is lumpy, relying on one-off deals. This makes forecasting tough, you see.

The latest available financial snapshot shows the following for the Trailing Twelve Months (TTM):

Metric	Amount (USD)	Context
Trailing Twelve-Month (TTM) Revenue	$3.69 million	Primary source is licensing and collaboration payments.
TTM Gross Profit	$2.59 million	Resulting in a TTM Gross Profit Margin of approximately 70.19%.
Example Licensing Payment	$1.5 million	Acquired by Tivic Health Systems for worldwide license rights to Entolimod.
Worksite Labs 2022 Revenue	Over $50 million	Unaudited revenue figure from the diagnostics business prior to the merger.

The revenue streams are structured around strategic partnerships and the expected shift toward the diagnostic business following the proposed combination with Worksite Labs, Inc. This defintely changes the revenue profile moving forward.

Here are the key components driving the current and near-term revenue:

• Non-recurring licensing fees and milestone payments from strategic partners.
• Collaboration revenue from development agreements.
• Trailing twelve-month (TTM) revenue of approximately $3.69 million, primarily from licensing.
• Potential future revenue from the Worksite Labs diagnostic business post-merger.

The expectation is that the resulting entity will carry on the business of Worksite Labs as a premier, full-service diagnostic testing company, which previously generated revenues of over $50 million in 2022.

Finance: draft 13-week cash view by Friday.