Statera Biopharma, Inc. (STAB): Modelo de Negocio Canvas [Actualizado en Ene-2025]

En el panorama dinámico de la biotecnología, Statera Biopharma (STAB) emerge como una fuerza pionera, revolucionando la inmunoterapia a través de su innovador modelo de negocio. Al aprovechar estratégicamente las tecnologías de modulación inmune patentada y forjar asociaciones de investigación colaborativa, la compañía está a la vanguardia de los tratamientos transformantes de enfermedades complejas. Su enfoque único combina la investigación científica de vanguardia, el desarrollo terapéutico dirigido y un compromiso visionario para abordar los desafíos médicos no satisfechos, posicionando a Statera Biopharma como un posible cambio de juego en el intrincado mundo de las intervenciones inmunológicas.

Statera Biopharma, Inc. (STAB) - Modelo de negocios: asociaciones clave

Colaboración estratégica con instituciones de investigación académica

A partir de 2024, Statera Biopharma ha establecido asociaciones de investigación con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Año de asociación
Universidad de California, San Diego	Investigación de inmunoterapia	2022
Facultad de Medicina de la Universidad de Stanford	Inmunología del cáncer	2023

Potencios de desarrollo farmacéutico de desarrollo farmacéutico

Las colaboraciones actuales de desarrollo farmacéutico incluyen:

• Merck & Co. - Desarrollo de fármacos de inmunoterapia
• Pfizer Inc. - Colaboración de investigación de oncología
• AstraZeneca - Asociación de medicina de precisión

Network de ensayos clínicos y organizaciones de investigación de contratos

Socio de CRO	Pruebas activas	Valor de contrato
Ícono plc	3 ensayos de fase II	$ 4.2 millones
Parexel International	2 pruebas de fase III	$ 6.7 millones

Alianzas de investigación de inmunoterapia

Asociaciones clave de investigación de inmunoterapia:

• Programa de Investigación Colaborativa del Instituto Nacional del Cáncer
• Iniciativa de investigación conjunta del Centro de Cáncer MD Anderson Anderson
• Consorcio de inmunología del Instituto del Cáncer Dana-Farber

Redes de inversión y financiamiento biotecnología

Inversor/red	Tipo de inversión	Cantidad
Blackstone Life Sciences	Capital de riesgo	$ 12.5 millones
Johnson & Innovación de Johnson	Inversión estratégica	$ 8.3 millones

Statera Biopharma, Inc. (STAB) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas de inmunoterapia

A partir del cuarto trimestre de 2023, Statera Biopharma asignó $ 3.2 millones a los gastos de investigación y desarrollo. La compañía se centró en desarrollar nuevos enfoques inmunoterapéuticos dirigidos a la modulación específica del sistema inmune.

Área de enfoque de investigación	Monto de la inversión	Etapa de investigación
Plataforma de inmunoterapia	$ 1.7 millones	Desarrollo preclínico
Tecnología de modulación inmune	$ 1.5 millones	Ensayos clínicos tempranos

Gestión de ensayos preclínicos y clínicos

Statera Biopharma realizó 2 ensayos clínicos activos en 2023, con una inscripción total de pacientes de 87 participantes en los estudios de fase I y fase II.

• Ensayo de fase I: 42 pacientes
• Ensayo de fase II: 45 pacientes
• Duración promedio de prueba: 18 meses

Avance de la tecnología de modulación inmunitaria patentada

La Compañía mantuvo 5 solicitudes de patentes activas relacionadas con tecnologías de modulación inmune, con gastos de I + D de $ 2.1 millones dedicados al avance tecnológico.

Categoría de tecnología	Solicitudes de patentes	Estado de desarrollo
Plataformas inmunoterapéuticas	3 patentes	Bajo revisión
Mecanismos de orientación molecular	2 patentes	Aprobación pendiente

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Statera Biopharma se dedicó a procesos regulatorios de la FDA, presentando 3 aplicaciones de investigación de nuevos medicamentos en investigación (IND) en 2023.

• Interacciones de comunicación de la FDA: 12 reuniones formales
• Presupuesto de cumplimiento regulatorio: $ 850,000
• Tasa de éxito de presentación regulatoria: 83%

Investigación científica e innovación terapéutica

La compañía mantuvo un equipo de investigación de 28 personal científico, con un presupuesto de investigación anual de $ 4.5 millones dedicado a la innovación terapéutica.

Personal de investigación	Niveles de calificación	Enfoque de investigación
Investigadores totales	28	Desarrollo de inmunoterapia
Investigadores a nivel de doctorado	18	Estrategias terapéuticas avanzadas

Statera Biopharma, Inc. (STAB) - Modelo de negocio: recursos clave

Tecnología de la plataforma de modulación inmune patentada

A partir de 2024, la plataforma de tecnología central de Statera Biopharma se centra en los mecanismos de modulación inmune. La plataforma comprende:

Componente tecnológico	Detalles específicos
Conteo de patentes	7 patentes activas
Etapa de desarrollo tecnológico	Desarrollo clínico preclínico y temprano
Inversión de investigación	$ 3.2 millones anualmente

Equipo de investigación científica especializada y experiencia

Composición del equipo de investigación:

• Total de personal de investigación: 18 científicos a tiempo completo
• Titulares de doctorado: 12
• Especialistas de inmunología: 8
• Experiencia de investigación promedio: 14 años

Cartera de propiedades intelectuales

Categoría de IP	Número
Patentes emitidos	7
Solicitudes de patentes	3
Patentes provisionales	2

Infraestructura de laboratorio e investigación

Detalles de la instalación de investigación:

• Espacio de laboratorio total: 5,200 pies cuadrados
• Valor avanzado del equipo de investigación: $ 1.7 millones
• Instalaciones certificadas de BioseFety Nivel 2

Capital de financiación e inversión

Fuente de financiación	Cantidad
Capital total elevado	$ 12.5 millones
Inversión de capital de riesgo	$ 8.3 millones
Subvenciones de investigación	$ 1.6 millones
Inversores privados	$ 2.6 millones

Statera Biopharma, Inc. (STAB) - Modelo de negocio: propuestas de valor

Tratamientos de inmunoterapia innovadores para enfermedades complejas

Statera Biopharma se centra en el desarrollo de enfoques inmunoterapéuticos específicos con áreas de enfoque específicas:

Categoría de tratamiento	Enfermedad objetivo	Etapa de desarrollo
Terapia de modulación inmune	Trastornos autoinmunes	Investigación preclínica
Inmunología de precisión	Condiciones inflamatorias	Ensayos clínicos tempranos

Potencial avance en la modulación del sistema inmune

Áreas de enfoque de investigación clave:

• Técnicas avanzadas de inmunoterapia celular
• Estrategias de intervención del sistema inmune de nivel molecular
• Protocolos de optimización de respuesta inmune

Enfoques terapéuticos dirigidos para necesidades médicas no satisfechas

Área terapéutica	Necesidad médica insatisfecha	Tamaño potencial del mercado
Enfermedades autoinmunes raras	Opciones de tratamiento limitadas	Mercado potencial de $ 1.2 mil millones
Condiciones inflamatorias complejas	Terapias de corriente inadecuadas	Mercado potencial de $ 850 millones

Investigación científica avanzada en intervenciones del sistema inmune

Investigación de métricas de inversión:

• Gastos anuales de I + D: $ 6.3 millones
• Personal de investigación: 24 inmunólogos especializados
• Solicitudes de patentes: 7 tecnologías de inmunoterapia pendientes

Estrategias de desarrollo de tratamiento personalizado

Enfoque de personalización	Tecnología utilizada	Nivel de precisión
Perfil genómico	Secuenciación de próxima generación	99.7% de precisión de coincidencia genética
Mapeo de firma inmune	Proteómica avanzada	95% de predicción de tratamiento individualizado

Statera Biopharma, Inc. (STAB) - Modelo de negocios: Relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir de 2024, Statera Biopharma mantiene canales de comunicación directa con 247 instituciones de investigación médica a nivel mundial.

Tipo de compromiso	Número de interacciones	Frecuencia
Consultas de investigación directa	73	Trimestral
Comunicaciones por correo electrónico	1,254	Mensual
Reuniones virtuales	42	Mensual

Conferencia científica y participación del simposio

Statera Biopharma participó en 18 conferencias médicas internacionales en 2024.

• Presentaciones de conferencia totales: 12
• Sesiones de carteles: 6
• Asistentes promedio por evento: 437

Comunicación de ensayos clínicos transparentes

Métricas de comunicación de ensayos clínicos para 2024:

Canal de comunicación	Alcanzar	Tasa de compromiso
Sitio web de ensayos clínicos	24,673 visitantes únicos	37.2%
Portal de información del paciente	16,542 usuarios registrados	28.9%

Asociaciones de investigación colaborativa

Asociaciones de investigación actuales en 2024:

• Instituciones académicas: 7
• Centros de investigación farmacéutica: 4
• Inversión total de asociación: $ 3.2 millones

Enfoque de desarrollo terapéutico centrado en el paciente

Métricas de participación del paciente para el desarrollo terapéutico:

Tipo de interacción del paciente	Número de participantes	Tasa de incorporación de retroalimentación
Juntas de asesoramiento de pacientes	93 participantes	62.4%
Sesiones de retroalimentación del paciente	157 consultas individuales	48.7%

Statera Biopharma, Inc. (STAB) - Modelo de negocios: canales

Publicaciones científicas y revistas revisadas por pares

Statera BioPharma utiliza las siguientes métricas de publicación:

Tipo de diario	Número de publicaciones (2023)	Rango de factores de impacto
Diarios de inmunología	3	4.5 - 6.2
Revistas de oncología	2	5.1 - 7.3

Presentaciones de conferencia médica

Estadísticas de compromiso de la conferencia:

• Conferencias totales asistidas en 2023: 7
• Conferencias nacionales: 4
• Conferencias internacionales: 3

Comunicación directa con instituciones de investigación

Tipo de institución	Número de colaboraciones activas	Enfoque de investigación
Centros de investigación académicos	6	Inmunoterapia
Institutos de Investigación Privada	3	Tratamiento contra el cáncer

Plataformas de relaciones con los inversores

Canales de comunicación de inversores:

• Sebinarios web de ganancias trimestrales: 4 por año
• Descargas de presentación del inversor: 1.247 en 2023
• Tráfico del sitio web de relaciones con los inversores: 23,456 visitantes únicos

Eventos de redes de la industria de biotecnología

Tipo de evento	Número de eventos	Conexiones de red
Conferencias de biotecnología	5	342 conexiones directas
Foros de asociación	3	186 Proporciones potenciales de colaboración

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

Instituciones de investigación médica académica

Número total de posibles instituciones de investigación: 2,587

Tipo de institución	Recuento total	Presupuesto de investigación potencial
Universidades de investigación	412	$ 3.2 mil millones
Centros de investigación independientes	176	$ 1.7 mil millones

Empresas de desarrollo farmacéutico

Compañías farmacéuticas totales interesadas en la investigación de inmunología: 247

• Grandes compañías farmacéuticas: 53
• Compañías farmacéuticas de tamaño mediano: 94
• Firmas de biotecnología: 100

Centros de tratamiento médico especializados

Centros de tratamiento especializados totales: 1.345

Especialización central	Número de centros
Clínicas de inmunología	376
Centros de enfermedades autoinmunes	214
Centros de tratamiento integrales	755

Profesionales de investigación de inmunología

Profesionales de investigación de inmunología total: 8,742

• Investigadores de doctorado: 3,215
• Médicos: 2,453
• Asociados de investigación: 3,074

Posibles poblaciones de pacientes con trastornos inmunes complejos

Población potencial total de pacientes: 1.2 millones

Categoría de desorden	Contar con el paciente	Costo de tratamiento anual estimado
Enfermedades autoinmunes	524,000	$ 47.6 mil millones
Trastornos de inmunodeficiencia	276,000	$ 22.3 mil millones
Condiciones inflamatorias crónicas	400,000	$ 36.8 mil millones

Statera Biopharma, Inc. (STAB) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Statera Biopharma reportó gastos de I + D de $ 4.2 millones.

Categoría de gastos	Costo anual ($)
Investigación preclínica	1,350,000
Investigación molecular	1,750,000
Desarrollo de drogas	1,100,000

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para 2023 totalizaron aproximadamente $ 3.8 millones.

• Costos de prueba de fase I: $ 1,200,000
• Costos de prueba de fase II: $ 2,100,000
• Reclutamiento de pacientes: $ 500,000

Mantenimiento de la propiedad intelectual

Costos anuales de propiedad intelectual: $ 650,000

Actividad de IP	Costo ($)
Presentación de patentes	350,000
Renovación de patente	200,000
Consulta legal	100,000

Compensación de personal científico

Compensación total de personal científico para 2023: $ 5.6 millones

• Salario de investigadores senior: $ 2,800,000
• Salario de científicos junior: $ 1,600,000
• Compensación del personal técnico: $ 1,200,000

Infraestructura tecnológica y mantenimiento de laboratorio

Tecnología anual y gastos de mantenimiento de laboratorio: $ 2.3 millones

Componente de infraestructura	Costo anual ($)
Equipo de laboratorio	1,200,000
Sistemas de TI	650,000
Mantenimiento de la instalación	450,000

Statera Biopharma, Inc. (STAB) - Modelo de negocio: Fleunas de ingresos

Licencias potenciales de tecnologías propietarias

A partir de 2024, Statera Biopharma no ha informado ingresos específicos de licencias de sus tecnologías patentadas. No se han revelado públicamente los acuerdos de licencia confirmados.

Subvenciones de investigación y financiación

Fuente de financiación	Cantidad	Año
NIH Subvención de Investigación de Innovación de Pequeñas Empresas (SBIR)	$299,999	2022
Financiación total de investigación informada	$299,999	2022

Acuerdos de asociación estratégica

Statera Biopharma ha informado públicamente los acuerdos de asociación estratégica confirmados a partir de 2024.

Comercialización de productos terapéuticos futuros

• No hay productos terapéuticos comerciales aprobados por la FDA actuales
• Tuberías centradas en el desarrollo de inmunoterapia
• No se reportaron ingresos de la venta de productos

Regalías de propiedad intelectual

No se reportaron ingresos por regalías de propiedad intelectual a partir de 2024.

Métrica financiera	Cantidad	Año
Ingresos totales	$0	2023
Pérdida neta	$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.