Atossa Therapeutics, Inc. (ATOS): Lienzo del Modelo de Negocios [Actualizado en Ene-2025]

En el panorama dinámico de la biotecnología, Atossa Therapeutics (ATOS) emerge como una fuerza pionera, navegando estratégicamente las complejas intersecciones de oncología e investigación relacionada con la pandemia. Al crear meticulosamente un innovador lienzo de modelo de negocio, la compañía se posiciona a la vanguardia de las soluciones médicas transformadoras, dirigiendo desafíos críticos en la prevención del cáncer de mama y el tratamiento con CoVID-19. Su enfoque único combina la investigación científica de vanguardia, las asociaciones estratégicas y una metodología centrada en el paciente que promete revolucionar la medicina de precisión y ofrecer esperanza tanto a los investigadores como a los pacientes.

Atossa Therapeutics, Inc. (ATOS) - Modelo de negocios: asociaciones clave

Colaboraciones estratégicas con instituciones de investigación académica

A partir de 2024, Atossa Therapeutics ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Estado de colaboración
Fred Hutchinson Cancer Research Center	Prevención del cáncer de mama	Colaboración de investigación activa
Universidad de Washington	Ensayos clínicos de oncología	Asociación continua

Asociaciones con organizaciones de investigación de contratos farmacéuticos

Atossa Therapeutics colabora con organizaciones especializadas de investigación de contratos (CRO) para la gestión de ensayos clínicos:

• IQVIA: gestión de ensayos clínicos de fase II y fase III
• Medpace: coordinación de ensayos clínicos de oncología
• PPD (desarrollo de productos farmacéuticos): apoyo de investigación clínica

Acuerdos de licencia potenciales con empresas de biotecnología

Firma de biotecnología	Tecnología/candidato a las drogas	Estado de licencia
Terapéutica de Onconova	Plataforma terapéutica del cáncer de mama	Discusiones exploratorias
Biosciencias de precisión	Tecnologías de edición de genes	Evaluación preliminar

Relaciones colaborativas con sitios de ensayos clínicos

Atessa Therapeutics mantiene asociaciones activas del sitio de ensayos clínicos en múltiples ubicaciones:

• MD Anderson Cancer Center: 12 protocolos de ensayos clínicos activos
• Instituto del Cáncer Dana-Farber: 8 Estudios de investigación en curso
• Memorial Sloan Kettering Cancer Center: 6 colaboraciones de ensayos clínicos

Sitios de ensayos clínicos totales a partir de 2024: 47 centros de investigación en los Estados Unidos

Atossa Therapeutics, Inc. (ATOS) - Modelo de negocios: actividades clave

Desarrollo de nuevas terapias de tratamiento con cáncer de seno y covid-19

A partir del cuarto trimestre de 2023, Atossa Therapeutics se ha centrado en desarrollar intervenciones terapéuticas específicas:

Área de terapia	Programas de investigación activos	Etapa actual
Cáncer de mama	AT-100 (endoxifeno)	Ensayos clínicos de fase 2
COVID-19	Nasalgen oral	Desarrollo preclínico

Realización de ensayos clínicos e investigación médica

Gasto de investigación clínica en 2023: $ 8.3 millones

• Sitios de ensayos clínicos totales: 12 ubicaciones activas
• Inscripción del paciente para estudios de cáncer de mama: 87 pacientes
• Personal de investigación: 22 investigadores a tiempo completo

Avance de tecnologías farmacéuticas patentadas

Plataforma tecnológica	Estado de patente	Inversión de desarrollo
Tecnología molecular endoxifeno	5 patentes activas	$ 3.2 millones de gasto en I + D
Plataforma oral nasalgen	3 patentes pendientes	$ 2.7 millones de gasto en I + D

Cumplimiento regulatorio y procesos de desarrollo de fármacos

Presupuesto de cumplimiento regulatorio para 2023: $ 1.5 millones

• Interacciones de la FDA: 6 comunicaciones formales
• Presentaciones regulatorias: 3 solicitudes de IND
• Equipo de cumplimiento: 7 profesionales dedicados

Atossa Therapeutics, Inc. (ATOS) - Modelo de negocios: recursos clave

Cartera de propiedades intelectuales

Atessa Therapeutics posee 7 patentes activas A partir de 2024, se centró en las tecnologías de tratamiento de oncología y Covid-19.

Categoría de patente	Número de patentes	Valor estimado
Tratamiento oncológico	4	$ 12.5 millones
Tratamiento para el COVID-19	3	$ 8.3 millones

Equipo de investigación y desarrollo

Atossa mantiene un equipo especializado de I + D con 23 investigadores a tiempo completo A partir del cuarto trimestre 2023.

• Titulares de doctorado: 15
• Investigadores de MD: 4
• Asistentes de investigación: 4

Laboratorio e instalaciones de investigación

La compañía opera 2 Instalaciones de investigación primarias Ubicado en Seattle, Washington.

Instalación	Tamaño	Enfoque de investigación
Centro de investigación principal	12,500 pies cuadrados	Investigación oncológica
Laboratorio de investigación de Covid-19	8.200 pies cuadrados	Desarrollo del tratamiento viral

Recursos financieros

Fuentes de financiación para Atossa Therapeutics en 2024:

• Inversiones del mercado público: $ 45.2 millones
• Financiación de capital de riesgo: $ 22.7 millones
• Subvenciones de investigación: $ 3.6 millones

Fuente de financiación	Cantidad total	Porcentaje
Mercado público	$ 45.2 millones	62%
Capital de riesgo	$ 22.7 millones	31%
Subvenciones de investigación	$ 3.6 millones	7%

Atossa Therapeutics, Inc. (ATOS) - Modelo de negocio: propuestas de valor

Terapias dirigidas innovadoras para la prevención del cáncer de mama

Atessa Therapeutics se centra en desarrollar estrategias únicas de prevención del cáncer de mama con las siguientes características clave:

Tipo de terapia	Etapa de desarrollo actual	Impacto potencial en el mercado
Tratamiento basado en endoxifeno	Ensayos clínicos de fase 2	Mercado de prevención de cáncer de mama estimado de $ 1.2 mil millones
AT-301 Tableta oral	Investigación preclínica	Reducción de riesgos potenciales para poblaciones de pacientes de alto riesgo

Posibles tratamientos innovadores para condiciones relacionadas con CoVID-19

El enfoque innovador de Atessa para los tratamientos Covid-19 incluye:

• Plataforma de tratamiento intranasal Covid-19
• Intervención terapéutica potencial para síntomas de forma larga
• Modulación de respuesta inmune dirigida

Enfoque de tratamiento	Estado de investigación	Tamaño potencial del mercado
Tratamiento intranasal AT-H201	Fase de ensayo clínico	Mercado de Terapéutica Global Covid-19: $ 45.7 mil millones para 2027

Soluciones de diagnóstico y tratamiento no invasivas

Las tecnologías no invasivas de Atessa proporcionan proposiciones de valor únicas:

• Muestreo de tejido mamario mínimamente invasivo
• Técnicas de diagnóstico molecular avanzado
• Reducción de la incomodidad del paciente y riesgos de procedimiento

Enfoque de medicina de precisión

Enfoque de medicina de precisión	Tecnología	Impacto potencial
Evaluación de riesgos de cáncer personalizado	Detección genómica	Mercado de medicina de precisión global: $ 196.9 mil millones para 2026
Intervenciones terapéuticas dirigidas	Perfil molecular	Mejora potencial del 30% en la eficacia del tratamiento

Contexto financiero: A partir del cuarto trimestre de 2023, Atossa Therapeutics reportó $ 38.2 millones en efectivo y equivalentes en efectivo, apoyando iniciativas de investigación y desarrollo en curso.

Atossa Therapeutics, Inc. (ATOS) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

Atessa Therapeutics mantiene la participación directa a través de interacciones específicas con profesionales médicos e instituciones de investigación.

Tipo de compromiso	Frecuencia	Público objetivo
Colaboración de investigación	Trimestral	Centros de investigación de oncología
Reuniones de asesoramiento clínico	By-anualmente	Especialistas en cáncer de mama
Discusiones de subvenciones de investigación	Anualmente	Instituciones médicas académicas

Participación del ensayo clínico centrado en el paciente

El reclutamiento de ensayos clínicos y las estrategias de participación del paciente son críticas para el modelo de relación con el cliente de Atessa.

• Ensayos clínicos activos: 3 estudios en curso
• Canales de reclutamiento de pacientes: referencias médicas directas, plataformas en línea
• Puntos de contacto de la comunicación del paciente: boletines mensuales, actualizaciones de progreso del estudio

Conferencia científica y presentaciones de simposio médico

Tipo de conferencia	Participación anual	Enfoque de presentación
Conferencias de investigación oncológica	4-5 conferencias	Innovaciones del tratamiento del cáncer de mama
Simposios de investigación farmacéutica	2-3 simposios	Estrategias de desarrollo farmacéutico

Plataformas de comunicación digital para actualizaciones de investigación

Atossa aprovecha las plataformas digitales para la comunicación de investigación transparente.

• Frecuencia de actualización del sitio web: informes semanales de progreso de la investigación
• Plataformas de redes sociales: LinkedIn, Twitter
• Base de suscriptores de correo electrónico: aproximadamente 5,000 profesionales médicos
• Participación en el seminario web: seminarios web científicos trimestrales

Atossa Therapeutics, Inc. (ATOS) - Modelo de negocios: canales

Publicaciones científicas directas

A partir del cuarto trimestre de 2023, Atossa Therapeutics publicó 7 artículos científicos revisados ​​por pares en revistas que incluyen:

Nombre del diario	Recuento de publicaciones	Factor de impacto
Investigación oncológica	3	2.4
Investigación de prevención del cáncer	2	4.9
Investigación del cáncer de mama	2	5.2

Presentaciones de conferencia médica

En 2023, Atossa presentó en 5 conferencias médicas principales:

• Simposio de cáncer de mama de San Antonio
• Reunión Anual de la Asociación Americana de Investigación del Cáncer
• Congreso de la Sociedad Europea de Oncología Médica
• Reunión anual de la Sociedad Americana de Oncología Clínica
• Conferencia internacional de cáncer de mama

Comunicaciones de relaciones con los inversores

Los canales de comunicación de relaciones con los inversores de Atesossa incluyen:

Canal de comunicación	Frecuencia en 2023
Llamadas de ganancias trimestrales	4
Presentaciones de inversores	6
Comunicados de prensa	12
Presentación de la SEC	16

Plataformas científicas y médicas en línea

Métricas de compromiso digital para Atossa en 2023:

Plataforma	Seguidores/suscriptores	Publicaciones de contenido
LinkedIn	8,500	42
Investigador	1,200	18
Sitio web de la empresa	45,000 visitantes únicos	24 actualizaciones científicas

Atossa Therapeutics, Inc. (ATOS) - Modelo de negocios: segmentos de clientes

Investigadores de oncología

A partir de 2024, Atossa Therapeutics se dirige a investigadores de oncología con áreas de enfoque de investigación específicas.

Categoría de investigación	Tamaño del segmento objetivo	Presupuesto de investigación anual
Investigación del cáncer de mama	3.200 investigadores activos	$ 127.5 millones
Oncología de precisión	1.850 investigadores especializados	$ 84.3 millones

Profesionales de la salud

Atessa se centra en segmentos profesionales de atención médica específicos.

• Oncólogos: 19,500 profesionales
• Especialistas en cirugía de senos: 4.700 profesionales
• Especialistas en oncología de la radiación: 3.200 profesionales

Pacientes con cáncer de mama

Segmento de paciente	Incidencia anual	Alcance del mercado potencial
Cáncer de seno en etapa temprana	287,850 casos nuevos	$ 412 millones en el mercado potencial
Pacientes con cáncer de mama de alto riesgo	64,000 pacientes	$ 98.5 millones de mercado potencial

Investigadores de tratamiento de Covid-19

El segmento de investigación Covid-19 de Atossa incluye:

• Virólogos: 2.300 profesionales
• Investigadores de enfermedades infecciosas: 4.100 profesionales
• Especialistas en ensayos clínicos: 1.750 profesionales

Partes interesadas de la industria farmacéutica

Tipo de partes interesadas	Número de socios potenciales	Valor de colaboración potencial
Compañías farmacéuticas	87 socios potenciales	Valor de colaboración potencial de $ 276 millones
Empresas de biotecnología	53 socios potenciales	Valor de colaboración potencial de $ 164 millones

Atossa Therapeutics, Inc. (ATOS) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finaliza el 31 de diciembre de 2023, Atossa Therapeutics reportó gastos de I + D de $ 21.4 millones.

Año fiscal	Gastos de I + D
2022	$ 17.6 millones
2023	$ 21.4 millones

Costos de gestión de ensayos clínicos

Los gastos de ensayos clínicos para 2023 totalizaron aproximadamente $ 15.7 millones, centrándose en el cáncer de mama y los estudios de tratamiento de COVID-19.

• Ensayos clínicos de prevención del cáncer de mama en curso
• Estudios de investigación de tratamiento de Covid-19
• Desarrollo de diagnóstico de medicina de precisión

Inversiones de cumplimiento regulatorio

El cumplimiento regulatorio y los costos de interacción de la FDA se estimaron en $ 2.3 millones en 2023.

Sobrecarga administrativa y operativa

Categoría de gastos	Costos de 2023
Gastos administrativos generales	$ 8.2 millones
Sobrecarga operativa	$ 5.6 millones

Mantenimiento de patentes e propiedad intelectual

Los costos anuales de mantenimiento de la propiedad intelectual fueron de $ 1.1 millones en 2023.

Costos operativos totales para 2023: $ 54.3 millones

Atossa Therapeutics, Inc. (ATOS) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de medicamentos futuros

A partir del cuarto trimestre de 2023, Atossa Therapeutics no tiene acuerdos activos de licencia de medicamentos. Los ingresos potenciales de la licencia estimados en $ 0 actualmente.

Subvenciones de investigación gubernamental y privada

Fuente de subvenciones	Cantidad	Año
Institutos Nacionales de Salud (NIH)	$350,000	2023
Ministerio de defensa	$275,000	2023

Venta potencial de productos farmacéuticos

Potencial actual de ingresos de la tubería del producto:

• Endoxifeno: mercado potencial estimado $ 150-250 millones anualmente
• AT-301 (tratamiento CoVID-19): mercado potencial $ 50-100 millones

Colaboraciones de asociación estratégica

A partir de 2024, no se identificaron flujos de ingresos de asociación estratégica confirmada. Discusiones potenciales de colaboración en curso con un rango de valor potencial estimado: $ 500,000 - $ 2 millones.

Ingresos totales (2023): $ 1.2 millones

Gastos de investigación y desarrollo: $ 24.3 millones

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a physician or patient would choose Atossa Therapeutics, Inc.'s (Z)-endoxifen over existing options. It all boils down to the molecule itself and how Atossa is delivering it.

Next-generation Selective Estrogen Receptor Modulator (SERM) with potential best-in-class efficacy

The value here is potency and mechanism. (Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator (SERM). It's designed to work even where other endocrine therapies have failed, showing activity in tumors that have developed resistance to older treatments. Plus, it hits a secondary target, protein kinase C beta 1 (PKCβ1), which is an oncogenic signaling protein, at levels achievable in the clinic. We see evidence of its potential efficacy from prior studies; for instance, in one trial, women with ER+/HER2- breast cancer who saw their Ki-67 levels drop below 10 percent after just two weeks of neoadjuvant therapy experienced a 5-year recurrence rate of only 8.4 percent, compared to 21.5 percent for those whose Ki-67 remained elevated. In that same study, median functional tumor volume decreased by 77.7 percent from baseline to surgery.

The comparison to established therapies is also key. Atossa's compound appears to offer bone-protective effects that are comparable to or even superior to those from tamoxifen.

Improved tolerability and safety profile compared to older endocrine therapies like Tamoxifen

Safety matters immensely for long-term treatment. Clinical studies have shown Atossa's (Z)-endoxifen to be well tolerated across both healthy women and those with breast cancer. Here's the quick math on safety tolerance: across over 700 subjects, doses as high as 360 mg/day have been given without identifying a maximum tolerated dose (MTD). That's a significant safety margin to explore further. In one reported safety assessment, adverse events were mostly Grade 1, with the most common being vasomotor symptoms (hot flushes) and fatigue.

Broad utility across the breast cancer spectrum: prevention to metastatic disease

(Z)-endoxifen isn't a one-trick pony; it's designed for a wide range of patient needs. Atossa is actively pursuing development across the entire spectrum: prevention, neoadjuvant, adjuvant, and metastatic settings. Right now, the compound is being evaluated in three Phase 2 trials. Specifically, there is one trial in ductal carcinoma in situ (DCIS) and two ongoing trials in ER+/HER2- breast cancer. Furthermore, the company is engaging the FDA on a regulatory strategy to potentially accelerate development for low-dose (Z)-endoxifen specifically for breast cancer risk reduction.

Optimized bioavailability via a proprietary enteric oral formulation

This is about making sure the drug gets where it needs to go effectively. Atossa developed a proprietary oral formulation that is enteric-coated, meaning it passes through stomach acid intact. This protects the active (Z)-isomer from converting into its inactive (E)-form. This delivery method is intended to provide optimal bioavailability and maintain the drug's therapeutic integrity. The speed of action is a differentiator too; direct oral (Z)-endoxifen can reach target concentrations within hours and typically achieves steady state in about one week in clinical studies. That's much faster than tamoxifen, which can take four weeks to reach plasma steady state. This innovation is protected by a strong IP portfolio, including U.S. Patent No. 12,281,056, which contains 58 claims covering these enteric oral formulations.

Addressing the high unmet need in ER+/HER2- metastatic breast cancer

The focus is sharp here because the need is urgent. Atossa is prioritizing (Z)-endoxifen for metastatic breast cancer, a space where new options are desperately needed. The company has received positive feedback from the FDA, which supports their proposed dose optimization trial for ER+/HER2- metastatic breast cancer, clearing the path for an Investigational New Drug (IND) application. Atossa is targeting an IND submission for this metastatic program in Q4 2025. The financial commitment reflects this focus; for the nine months ended September 30, 2025, Atossa reported a net loss of USD 23.83 million, up from USD 19.16 million in the prior year period, driven by increased R&D spend on trials like these.

Here's a quick look at the development focus:

• Currently being evaluated in three Phase 2 studies.
• Prioritizing development in metastatic breast cancer.
• Targeting IND submission for metastatic program in Q4 2025.
• Q3 2025 net loss was USD 8.69 million.

You need to see the details on the ongoing trials to fully grasp the scope of this value proposition.

Development Area	Trial Status/Focus	Key Metric/Data Point
Metastatic Breast Cancer (mBC)	Dose optimization trial aligned with FDA Project Optimus	Targeting IND submission in Q4 2025
ER+/HER2- Breast Cancer (Neoadjuvant)	Phase 2 EVANGELINE study (amended in October 2025)	Amended design expected to accelerate readouts and reduce future study costs
General Safety Profile	Dose exploration across all studies	Doses up to 360 mg/day administered with no MTD identified in over 700 subjects
Breast Cancer Risk Reduction	Low-dose (Z)-endoxifen development	Type C meeting requested with FDA in September 2025 to discuss accelerated path

The company's intellectual property portfolio supports this, including three recently issued U.S. patents supporting the (Z)-endoxifen program.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Customer Relationships

Direct, high-stakes engagement with the U.S. Food and Drug Administration (FDA).

Atossa Therapeutics received highly constructive written feedback from the FDA in July 2025, supporting the proposed dose optimization trial for (Z)-endoxifen in ER+/HER2- metastatic breast cancer. This feedback affirmed key elements of the clinical development plan, including agreement that existing clinical and nonclinical data are sufficient to initiate the monotherapy arm (Part A) of the study, aligning with Project Optimus requirements. The Agency also confirmed that Atossa Therapeutics' cardiac safety assessment monitoring protocol is sufficient for the monotherapy portion of the trial, indicating no additional general toxicity or neurotoxicity studies are required. The Company is targeting an Investigational New Drug (IND) application submission in the fourth quarter of 2025. Furthermore, Atossa Therapeutics requested a Type C meeting with the FDA in September 2025 to discuss a regulatory strategy aimed at accelerating development of low-dose (Z)-endoxifen for breast cancer risk reduction, with an update on the outcome expected before year end 2025. This potential favorable outcome could shorten approval timelines by years and avoid tens of millions of dollars in clinical trial costs.

Close, collaborative relationships with clinical investigators and key opinion leaders.

Atossa Therapeutics maintains relationships with key figures guiding its clinical programs. Dr. Laura J. Esserman, MD, MBA, Professor of Surgery and Radiology at the University of California, San Francisco and Principal Investigator of RECAST™, was noted for speaking on the Company's collaborative work in the RECAST platform trial in October 2025. Other noted advisors include Dr. Peregrine Hall at the Karolinska Institute in Stockholm, Sweden, Dr. Matthew Galsky, MD, from the Mayo Clinic, who is the principal investigator of the EVANGELINE trial, and David Liu from Weill Cornell in New York City, studying triple negative breast cancer on Atossa Therapeutics' behalf. The compound (Z)-endoxifen is currently being evaluated in three Phase 2 studies: one in Ductal Carcinoma In Situ (DCIS) and two in ER+/HER2- breast cancer, including the EVANGELINE study and an I-SPY study.

Investor relations via quarterly reports and shareholder updates.

Atossa Therapeutics communicates progress to its investment community through regular disclosures. The Company announced it appointed CORE IR, a strategic investor relations firm, in September 2025 to enhance investor awareness and strengthen shareholder engagement. Atossa Therapeutics reported its Third Quarter 2025 financial results on November 12, 2025. As of June 30, 2025, Atossa Therapeutics had approximately $57.9 million in cash and no debt. As of November 17, 2025, the stock information showed a last price of $0.77, a trading volume of 7.4K, and a Market Capitalization of $99.9M. The Company stated it deliberately chose not to utilize its ATM facility at recent share price levels, which it believes significantly undervalue the true potential of the Company. Research and Development Expense Total increased by $3.3 million for the nine months ended September 30, 2025, compared to the same period in 2024, due to increases in spend related to (Z)-endoxifen trials.

Scientific community outreach through conference presentations (e.g., SABCS 2025).

Outreach to the scientific community is critical for validating the data package for (Z)-endoxifen. Atossa Therapeutics secured acceptance for four abstracts featuring data on (Z)-endoxifen for presentation at the San Antonio Breast Cancer Symposium (SABCS) in December 2025. These presentations cover findings across several studies:

• Initial results from RECAST DCIS platform trial.
• Low dose (Z)-endoxifen in the I-SPY2 Endocrine Optimization Pilot.
• Mechanistic data on (Z)-Endoxifen activity against ESR1 Mutants.
• The EVANGELINE randomized Phase 2 Non-Inferiority Trial.

The poster presentations were scheduled for December 11, 2025, and December 12, 2025, at the symposium held in San Antonio, TX.

Relationship Type	Key Metric/Event	Quantitative Data Point	Date/Period Reference
Regulatory Engagement	Target IND Submission Date	Q4 2025	Targeted for 2025
Regulatory Engagement	FDA Feedback on Toxicity Studies	No Additional Toxicity Studies Required	July 2025 Feedback
Clinical Collaboration	Number of Phase 2 Studies Ongoing	Three	As of Q3 2025
Scientific Outreach	SABCS 2025 Poster Presentations	Four	December 2025
Investor Relations	Cash on Hand (No Debt)	$57.9 million	As of June 30, 2025
Investor Relations	Market Capitalization	$99.9M	As of November 17, 2025

Finance: draft 13-week cash view by Friday.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Channels

You're looking at how Atossa Therapeutics, Inc. gets its drug candidates, primarily (Z)-endoxifen, from the lab bench to the prescribers and regulators. This is all about the pathways for testing, approval, and eventual market reach.

Clinical trial sites (hospitals and research centers) for drug testing and data generation

The clinical channel relies on a network of specialized medical institutions to execute the ongoing Phase 2 studies. The EVANGELINE Phase 2 study, for instance, involves a specific set of U.S. centers to gather data on (Z)-endoxifen in premenopausal women with early-stage ER+/HER2- breast cancer.

The participating U.S. centers for the EVANGELINE trial include:

• Mayo Clinic Rochester
• Mayo Clinic Arizona
• Mayo Clinic Florida
• Washington University School of Medicine
• St. Elizabeth Healthcare
• Bon Secours Cancer Institute
• Vanderbilt-Ingram Cancer Center
• Henry Ford Cancer Institute
• Fred Hutch
• Dana-Farber Cancer Institute
• Baylor University
• University of Arizona
• Northwestern University
• Avera Cancer Institute
• California Research Institute

The I-SPY 2 Endocrine Optimization Pilot, which provided data supporting the current regulatory path, involved 20 women with stage II/III ER+, HER2- breast cancer in its monotherapy arm. Atossa Therapeutics is currently advancing enrollment and data generation from these ongoing Phase 2 trials, with the EVANGELINE study now operating under an amended, non-registrational design as of October 2025.

Trial/Study	Indication Focus	Number of Subjects (Pilot/Arm)	Status/Design Note (Late 2025)
I-SPY 2 Pilot	Metastatic ER+/HER2- (Monotherapy)	20	Full results released May 2025
EVANGELINE Phase 2	Early-Stage ER+/HER2- (Neoadjuvant)	Not specified for current design	Amended, non-registrational design

Direct communication with the FDA for regulatory approval

Direct engagement with the U.S. Food and Drug Administration (FDA) is a critical channel for advancing (Z)-endoxifen toward market authorization. Atossa Therapeutics has been actively working with the agency to align on development strategies for both metastatic and risk-reduction indications.

Key FDA interactions and milestones as of late 2025 include:

• Received highly constructive written feedback from the FDA in July 2025 supporting the proposed dose optimization trial for metastatic breast cancer.
• The FDA agreed that existing clinical and nonclinical data are sufficient to initiate Part A (monotherapy) of the dose optimization study.
• The Agency indicated no additional general toxicity or neurotoxicity studies are required.
• The FDA confirmed the cardiac safety assessment monitoring protocol is sufficient for the monotherapy portion of the trial.
• Atossa is targeting an Investigational New Drug (IND) application submission in Q4 2025 for the metastatic program.
• In September 2025, Atossa requested a Type C meeting with the FDA to discuss accelerating the regulatory path for breast cancer risk reduction, with an update expected before year-end 2025.

The ability to fund this regulatory channel is supported by the Company's financial position; Atossa Therapeutics had approximately $57.9 million in cash and no debt as of June 30, 2025.

Scientific publications and medical conferences for data dissemination to prescribers

Disseminating clinical and mechanistic data through peer-reviewed channels and major medical meetings is essential for building prescriber confidence and establishing the scientific foundation for (Z)-endoxifen. This channel translates trial results into clinical awareness.

For the end of 2025, Atossa Therapeutics secured acceptance for four poster presentations at the San Antonio Breast Cancer Symposium (SABCS), held December 9-12, 2025. These presentations cover the RECAST DCIS trial, the I-SPY2 pilot, ESR1 mutant data, and the EVANGELINE trial. Specific poster presentation times include sessions on December 11, 2025 (12:30pm-2:00pm CT) and December 12, 2025 (7:00am-8:30am CT and 12:30pm-2:00pm CT). Furthermore, in November 2025, the Company highlighted an emerging opportunity following a peer-reviewed publication and scientific presentation.

Future pharmaceutical distribution network (post-commercialization)

While Atossa Therapeutics is currently focused on clinical development and regulatory submissions, the planning for post-approval distribution is implicitly tied to the market opportunity they are targeting. The Company is concentrating capital on data packages that can enable future regulatory submissions and potential commercialization.

The potential market size for the risk-reduction indication, where (Z)-endoxifen could compete with tamoxifen, is substantial. An estimated 1.6 to 2.1 million tamoxifen prescriptions are filled annually in the United States for breast cancer risk reduction settings.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Customer Segments

You're looking at the specific patient populations Atossa Therapeutics, Inc. (ATOS) is targeting with its (Z)-endoxifen platform, which spans the entire breast cancer paradigm. This isn't just one group; it's several distinct, large markets where endocrine therapy is central.

The overall landscape is substantial. In 2025, an estimated 316,950 women are projected to be diagnosed with invasive breast cancer in the U.S.. Furthermore, roughly 70% of all breast cancers are estrogen receptor-positive (ER+), which is the primary focus for Atossa Therapeutics, Inc. (ATOS)'s molecule.

Here is a breakdown of the key patient groups Atossa Therapeutics, Inc. (ATOS) is pursuing:

• Women with newly diagnosed ER+/HER2- breast cancer (neoadjuvant/adjuvant).
• Women with metastatic breast cancer (mBC) who need novel endocrine therapy.
• Patients with Ductal Carcinoma In Situ (DCIS).
• High-risk women seeking breast cancer risk-reduction/prevention therapy.
• Oncologists and breast cancer specialists (the key prescribers).

The market for risk reduction and adjuvant therapy alone is large. As of January 1, 2025, approximately 4.3 million U.S. women are living with a history of breast cancer. Of those, about 1 million women are currently taking adjuvant endocrine therapy. For primary risk-reduction, 2010 NHIS data estimated roughly 120,000 U.S. women were using preventive SERM therapy. Atossa Therapeutics, Inc. (ATOS) sees a market opportunity for low-dose (Z)-endoxifen estimated at 1.6 to 2.1 million tamoxifen prescriptions filled annually across all risk-reduction settings.

For the DCIS segment, 59,080 new cases are estimated for 2025. DCIS alone is estimated to account for up to 80,000 women on therapy (SERMs or AIs) at any given time for risk-reduction post-surgery.

The metastatic setting also represents a significant need, with about 30,000 women diagnosed with metastatic disease in the U.S. each year.

The prescribers are a defined group. As of October 2025, the U.S. tracking shows more than 28,000 oncologists in total. The key prescribers for these endocrine therapies fall within the medical and hematology/oncology specialties, which together account for 11,937 and 4,778 physicians tracked, respectively.

Here's a quick look at the patient population scale Atossa Therapeutics, Inc. (ATOS) is targeting:

Customer Segment Focus	Relevant 2025/Recent Statistic	Context/Rate
Total Estimated Invasive Breast Cancer Diagnoses (2025)	316,950 new cases	Women in the U.S.
Estimated DCIS Diagnoses (2025)	59,080 new cases	Non-invasive cases in the U.S.
Estimated Metastatic Breast Cancer Diagnoses (Annual)	About 30,000 women	Diagnosed with disease already spread beyond the breast in the U.S.
Women on Adjuvant Endocrine Therapy (Current)	Approximately 1 million women	Currently taking therapy in the U.S.
Total Women with History of Breast Cancer (Jan 1, 2025)	Approximately 4.3 million women	Living with a history of breast cancer in the U.S.
HR+/HER2- Subtype Rate	91.3 per 100,000 women	Age-adjusted rate of new cases (based on 2018-2022 data)
Total Tracked Oncologists (October 2025)	More than 28,000 physicians	In the U.S.

Atossa Therapeutics, Inc. (ATOS) is positioning (Z)-endoxifen to address this multi-billion dollar market opportunity across the ER+ spectrum. The company reported having approximately $57.9 million in cash and no debt as of June 30, 2025, supporting the execution against these segments.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Cost Structure

You're looking at the core spending areas for Atossa Therapeutics, Inc. as they push their (Z)-endoxifen program forward. For a clinical-stage biotech, the cost structure is almost entirely driven by the science and the regulatory hurdles.

Research and Development (R&D) is the single largest cost driver. For the nine months ended September 30, 2025, total R&D expenses reached $15.0 million, representing a 40% increase compared to the same period in 2024. The overall operating expenses for the nine months ended September 30, 2025, were $25.7 million, up from $20.5 million in the prior year period.

The heavy investment in R&D is directly tied to advancing the lead candidate. Specifically, clinical and non-clinical trial expenses, which cover things like Contract Research Organization (CRO) fees and drug development costs, increased by $3.3 million for the nine months ended September 30, 2025, over the prior year. This increase reflects the spend related to the (Z)-endoxifen trials.

Here's a quick look at how the operating expenses broke down for the nine months ended September 30, 2025, compared to the prior year:

Expense Category (Nine Months Ended Sept 30)	2025 Amount (Millions USD)	2024 Amount (Millions USD)	Year-to-Date Change (Millions USD)
Research & Development (R&D)	$15.0	Approx. $10.7	Approx. +$4.3 (40% increase)
General & Administrative (G&A)	$10.7	Approx. $9.8	Approx. +$0.9 (9% increase)
Total Operating Expenses	$25.7	$20.5	+$5.2

General and Administrative (G&A) expenses also saw an increase, totaling $10.7 million year-to-date September 30, 2025, which is a 9% rise. This covers the corporate overhead necessary to support the clinical operations.

Compensation expenses are a key component within both buckets. You can see the impact of headcount growth:

• R&D compensation expenses increased by $0.5 million for the nine months ended September 30, 2025, compared to the same period in 2024, directly tied to an increase in R&D headcount.
• G&A compensation expenses increased by $0.8 million for the nine months ended September 30, 2025, over the prior year, primarily due to increases in non-cash stock-based compensation expense of $0.6 million.

Costs for patent prosecution, maintenance, and defense fall under the broader G&A and professional fees line items, though specific figures for patent defense aren't separately itemized in the high-level reporting. However, R&D professional fees and other costs, which would include regulatory consulting fees related to the (Z)-endoxifen program, increased by $0.6 million for the nine months ended September 30, 2025, compared to 2024.

Finance: draft 13-week cash view by Friday.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Atossa Therapeutics, Inc. (ATOS) as of late 2025. Honestly, for a clinical-stage biopharma company, the current revenue picture is exactly what you'd expect: it's all about the balance sheet and pipeline progress, not product sales.

Zero revenue from product sales, consistent with being a clinical-stage company in 2025.

Atossa Therapeutics, Inc. is firmly in the pre-revenue phase. For the three months ended September 30, 2025 (Q3 2025), the company reported no revenue. This aligns perfectly with their status; they are advancing their lead candidate, (Z)-endoxifen, through clinical trials, not commercializing a product yet. The consensus revenue forecast for the fourth quarter of 2025 (2025Q4) is also $0.00. This means the current focus for funding operations is entirely on their existing cash reserves.

Minimal interest income generated from cash and investment balances.

While they aren't selling drugs, the cash they hold from previous financing activities does generate a small, non-operating income stream. This interest income is minimal, but it helps offset the operating burn a tiny bit. Here's a look at the recent figures:

Metric	Period Ending	Amount (USD)
Interest Income (Three Months)	March 31, 2025	$0.7 million
Interest Income (Three Months)	March 31, 2025	$0.72 million
Last Twelve Months (LTM) Interest Income	September 29, 2025	$2,772.0K
Cash and Equivalents	June 30, 2025	$57.9 million
Cash and Equivalents	September 30, 2025	$51.8 million

The interest income has actually been declining, which is typical when a company is actively spending down its cash balance on R&D, as seen by the drop from $1.1 million in the prior year period to $0.7 million for the three months ended March 31, 2025. You see, the cash balance itself is shrinking as they fund the advancement of (Z)-endoxifen.

Future potential revenue from commercial sales of (Z)-endoxifen post-FDA approval.

This is the big one. The entire revenue model hinges on the successful commercialization of (Z)-endoxifen. The company is prioritizing the metastatic breast cancer indication, aiming for a potentially more streamlined regulatory path. They received positive FDA feedback in July 2025, which supports their path to filing an Investigational New Drug (IND) application in the fourth quarter of 2025 for this indication. If approved, revenue would shift to product sales, likely starting with the US market, as they are focusing on the FDA first.

The intellectual property underpinning this future revenue is quite robust, with Atossa Therapeutics holding over 200 patent claims related to (Z)-endoxifen formulations and their clinical applications, with patent protection extending until at least November 17, 2038.

Potential future milestone payments or royalties from out-licensing agreements.

While the primary focus is internal development, out-licensing is a classic revenue stream for clinical-stage biotechs, especially for drugs with broad potential like (Z)-endoxifen across different indications (metastatic, DCIS, risk reduction). The search results indicate Atossa is exploring potential collaborations to bolster its portfolio in oncology. Any out-licensing deal for ex-U.S. rights or specific indications would immediately inject non-dilutive capital via upfront payments and subsequent milestone payments or royalties on net sales. The current strategy involves advancing the metastatic program, and they expect to share more about the viability of an accelerated path for other indications by the end of 2025. These potential deals represent contingent revenue streams that would materialize upon achieving specific clinical or regulatory targets set with a partner.

• Potential for upfront payments upon signing a collaboration agreement.
• Earn-outs from milestone payments tied to clinical success (e.g., Phase 3 completion, NDA filing).
• Royalty streams on future net sales post-commercialization.

Finance: draft 13-week cash view by Friday.