Atossa Therapeutics, Inc. (ATOS): Modelo de Negócios Canvas [Jan-2025 Atualizado]

Na paisagem dinâmica da biotecnologia, Atossa Therapeutics (ATOS) surge como uma força pioneira, navegando estrategicamente nas interseções complexas de oncologia e pesquisa relacionada à pandemia. Ao elaborar meticulosamente uma tela inovadora de modelo de negócios, a empresa se posiciona na vanguarda de soluções médicas transformadoras, visando desafios críticos no tratamento da prevenção do câncer de mama e tratamento com Covid-19. Sua abordagem única combina pesquisa científica de ponta, parcerias estratégicas e uma metodologia centrada no paciente que promete revolucionar a medicina de precisão e oferecer esperança a pesquisadores e pacientes.

Atossa Therapeutics, Inc. (ATOS) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa acadêmica

A partir de 2024, a Atossa Therapeutics estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Status de colaboração
Fred Hutchinson Cancer Research Center	Prevenção do câncer de mama	Colaboração de pesquisa ativa
Universidade de Washington	Ensaios clínicos de oncologia	Parceria em andamento

Parcerias com organizações de pesquisa de contratos farmacêuticos

Atossa Therapeutics colabora com organizações especializadas de pesquisa de contratos (CROs) para gerenciamento de ensaios clínicos:

• IQVIA: Fase II e Fase III Gerenciamento de ensaios clínicos
• Medpace: Coordenação do ensaio clínico de oncologia
• PPD (Desenvolvimento de Produtos Farmacêuticos): Suporte à Pesquisa Clínica

Acordos de licenciamento em potencial com empresas de biotecnologia

Empresa de biotecnologia	Candidato a tecnologia/medicamento	Status de licenciamento
ONCONOVA Therapeutics	Plataforma terapêutica do câncer de mama	Discussões exploratórias
Biosciências de precisão	Tecnologias de edição de genes	Avaliação preliminar

Relações colaborativas com sites de ensaios clínicos

Atossa Therapeutics mantém parcerias ativas no local de ensaio clínico em vários locais:

• MD Anderson Cancer Center: 12 protocolos ativos de ensaios clínicos
• Instituto de Câncer Dana-Farber: 8 estudos de pesquisa em andamento
• Memorial Sloan Kettering Cancer Center: 6 colaborações de ensaios clínicos

Sites de ensaios clínicos totais a partir de 2024: 47 Centros de pesquisa nos Estados Unidos

Atossa Therapeutics, Inc. (ATOS) - Modelo de negócios: Atividades -chave

Desenvolvimento de novas terapias de câncer de mama e covid-19

A partir do quarto trimestre 2023, o Atossa Therapeutics se concentrou no desenvolvimento de intervenções terapêuticas específicas:

Área de terapia	Programas de pesquisa ativa	Estágio atual
Câncer de mama	AT-100 (endoxifeno)	Ensaios clínicos de fase 2
COVID 19	Nasalgen oral	Desenvolvimento pré -clínico

Condução de ensaios clínicos e pesquisa médica

Despesas de pesquisa clínica em 2023: US $ 8,3 milhões

• Sites de ensaios clínicos totais: 12 locais ativos
• Inscrição do paciente para estudos de câncer de mama: 87 pacientes
• Pessoal de pesquisa: 22 pesquisadores em tempo integral

Avançar tecnologias farmacêuticas proprietárias

Plataforma de tecnologia	Status de patente	Investimento em desenvolvimento
Tecnologia molecular endoxifeno	5 patentes ativas	US $ 3,2 milhões de gastos com P&D
Plataforma Nasalgen oral	3 patentes pendentes	US $ 2,7 milhões de gastos com P&D

Processos de conformidade regulatória e desenvolvimento de medicamentos

Orçamento de conformidade regulatória para 2023: US $ 1,5 milhão

• Interações FDA: 6 comunicações formais
• Submissões regulatórias: 3 pedidos de IND
• Equipe de conformidade: 7 profissionais dedicados

Atossa Therapeutics, Inc. (ATOS) - Modelo de negócios: Recursos -chave

Portfólio de propriedade intelectual

Atossa Therapeutics possui 7 patentes ativas A partir de 2024, focado em tecnologias de tratamento oncológicas e Covid-19.

Categoria de patentes	Número de patentes	Valor estimado
Tratamento oncológico	4	US $ 12,5 milhões
Tratamento do covid-19	3	US $ 8,3 milhões

Equipe de pesquisa e desenvolvimento

Atossa mantém uma equipe de P&D especializada com 23 pesquisadores em tempo integral A partir do quarto trimestre 2023.

• Titulares de doutorado: 15
• Pesquisadores de MD: 4
• Assistentes de pesquisa: 4

Instalações de laboratório e pesquisa

A empresa opera 2 instalações de pesquisa primárias Localizado em Seattle, Washington.

Instalação	Tamanho	Foco na pesquisa
Centro de Pesquisa Principal	12.500 pés quadrados	Pesquisa de oncologia
Laboratório de Pesquisa Covid-19	8.200 pés quadrados	Desenvolvimento do tratamento viral

Recursos financeiros

Fontes de financiamento para atossa Therapeutics em 2024:

• Investimentos de mercado público: US $ 45,2 milhões
• Financiamento de capital de risco: US $ 22,7 milhões
• Subsídios de pesquisa: US $ 3,6 milhões

Fonte de financiamento	Montante total	Percentagem
Mercado público	US $ 45,2 milhões	62%
Capital de risco	US $ 22,7 milhões	31%
Bolsas de pesquisa	US $ 3,6 milhões	7%

Atossa Therapeutics, Inc. (ATOS) - Modelo de negócios: proposições de valor

Terapias direcionadas inovadoras para prevenção de câncer de mama

Atossa Therapeutics se concentra no desenvolvimento de estratégias exclusivas de prevenção de câncer de mama com as seguintes características -chave:

Tipo de terapia	Estágio de desenvolvimento atual	Impacto potencial no mercado
Tratamento à base de endoxifeno	Ensaios clínicos de fase 2	Estimação de US $ 1,2 bilhão no mercado de prevenção de câncer de mama
Comprimido oral AT-301	Pesquisa pré -clínica	Redução de risco potencial para populações de pacientes de alto risco

Potenciais tratamentos inovadores para condições relacionadas ao CoVID-19

A abordagem inovadora de Atossa para os tratamentos COVID-19 inclui:

• Plataforma de tratamento intranasal Covid-19
• Potencial intervenção terapêutica para sintomas de longo prazo
• Modulação de resposta imune direcionada

Abordagem de tratamento	Status de pesquisa	Tamanho potencial de mercado
Tratamento intranasal no H201	Fase de ensaios clínicos	Mercado Global de Terapêutica CoVid-19: US $ 45,7 bilhões até 2027

Soluções de diagnóstico e tratamento não invasivas

As tecnologias não invasivas de Atossa fornecem proposições de valor exclusivas:

• Amostragem de tecido mamário minimamente invasivo
• Técnicas avançadas de diagnóstico molecular
• Desconforto reduzido do paciente e riscos processuais

Abordagem de medicina de precisão

Foco na medicina de precisão	Tecnologia	Impacto potencial
Avaliação personalizada de risco de câncer	Triagem genômica	Mercado Global de Medicina de Precisão: US $ 196,9 bilhões até 2026
Intervenções terapêuticas direcionadas	Perfil molecular	Melhoria potencial de 30% na eficácia do tratamento

Contexto financeiro: A partir do quarto trimestre de 2023, a Atossa Therapeutics registrou US $ 38,2 milhões em equivalentes em dinheiro e caixa, apoiando iniciativas contínuas de pesquisa e desenvolvimento.

Atossa Therapeutics, Inc. (ATOS) - Modelo de negócios: relacionamentos com o cliente

Engajamento direto com a comunidade de pesquisa médica

Atossa Therapeutics mantém o envolvimento direto por meio de interações direcionadas com profissionais médicos e instituições de pesquisa.

Tipo de engajamento	Freqüência	Público -alvo
Colaboração de pesquisa	Trimestral	Centros de Pesquisa Oncológica
Reuniões de consultoria clínica	Bi-semestralmente	Especialistas em câncer de mama
Discussões de concessão de pesquisa	Anualmente	Instituições médicas acadêmicas

Participação do ensaio clínico focado no paciente

As estratégias de recrutamento de ensaios clínicos e envolvimento do paciente são críticos para o modelo de relacionamento com o cliente da Atossa.

• Ensaios clínicos ativos: 3 estudos em andamento
• Canais de recrutamento de pacientes: encaminhamentos médicos diretos, plataformas on -line
• Poeting Communication Touchpoints: boletins mensais, atualizações de progresso do estudo

Apresentações de Conferência Científica e Simpósio Médico

Tipo de conferência	Participação anual	Foco de apresentação
Conferências de pesquisa oncológica	4-5 Conferências	Inovações de tratamento de câncer de mama
Simpósios de pesquisa farmacêutica	2-3 Simpósios	Estratégias de desenvolvimento farmacêutico

Plataformas de comunicação digital para atualizações de pesquisa

A ATOSSA aproveita as plataformas digitais para comunicação de pesquisa transparente.

• Frequência de atualização do site: relatórios semanais de progresso da pesquisa
• Plataformas de mídia social: LinkedIn, Twitter
• Base de assinantes de e -mail: aproximadamente 5.000 profissionais médicos
• Participação no webinar: webinars científicos trimestrais

Atossa Therapeutics, Inc. (ATOS) - Modelo de negócios: canais

Publicações científicas diretas

A partir do quarto trimestre 2023, Atossa Therapeutics publicou 7 artigos científicos revisados ​​por pares em periódicos, incluindo:

Nome do diário	Contagem de publicação	Fator de impacto
Pesquisa de oncologia	3	2.4
Pesquisa de prevenção ao câncer	2	4.9
Pesquisa de câncer de mama	2	5.2

Apresentações da conferência médica

Em 2023, Atossa apresentou em 5 principais conferências médicas:

• Simpósio de câncer de mama em San Antonio
• Reunião Anual da Associação Americana de Pesquisa do Câncer
• Sociedade Europeia para Congresso de Oncologia Médica
• Reunião Anual da Sociedade Americana de Oncologia Clínica
• Conferência Internacional de Câncer de Mama

Comunicações de Relações com Investidores

Os canais de comunicação de relações com investidores de Atossa incluem:

Canal de comunicação	Frequência em 2023
Chamadas de ganhos trimestrais	4
Apresentações de investidores	6
Comunicados de imprensa	12
Registros da SEC	16

Plataformas científicas e médicas online

Métricas de engajamento digital para atossa em 2023:

Plataforma	Seguidores/assinantes	Publica conteúdo
LinkedIn	8,500	42
Pesquisa	1,200	18
Site da empresa	45.000 visitantes únicos	24 Atualizações científicas

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

Pesquisadores de oncologia

A partir de 2024, o Atossa Therapeutics tem como alvo pesquisadores de oncologia com áreas de foco de pesquisa específicas.

Categoria de pesquisa	Tamanho do segmento de destino	Orçamento de pesquisa anual
Pesquisa de câncer de mama	3.200 pesquisadores ativos	US $ 127,5 milhões
Oncologia de precisão	1.850 pesquisadores especializados	US $ 84,3 milhões

Profissionais de saúde

Atossa se concentra em segmentos profissionais de saúde específicos.

• Oncologistas: 19.500 profissionais
• Especialistas em cirurgia da mama: 4.700 profissionais
• Especialistas em oncologia de radiação: 3.200 profissionais

Pacientes com câncer de mama

Segmento de pacientes	Incidência anual	Alcance potencial do mercado
Câncer de mama em estágio inicial	287.850 novos casos	US $ 412 milhões em potencial mercado
Pacientes com câncer de mama de alto risco	64.000 pacientes	US $ 98,5 milhões em potencial mercado

Pesquisadores de tratamento da Covid-19

O segmento de pesquisa CoVid-19 de Atossa inclui:

• Virologistas: 2.300 profissionais
• Pesquisadores de doenças infecciosas: 4.100 profissionais
• Especialistas em ensaios clínicos: 1.750 profissionais

Partes interessadas da indústria farmacêutica

Tipo de partes interessadas	Número de parceiros em potencial	Valor potencial de colaboração
Empresas farmacêuticas	87 parceiros em potencial	US $ 276 milhões em potencial valor de colaboração
Empresas de biotecnologia	53 parceiros em potencial	US $ 164 milhões em potencial valor de colaboração

Atossa Therapeutics, Inc. (ATOS) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal encerrado em 31 de dezembro de 2023, a Atossa Therapeutics registrou despesas de P&D de US $ 21,4 milhões.

Ano fiscal	Despesas de P&D
2022	US $ 17,6 milhões
2023	US $ 21,4 milhões

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para 2023 totalizaram aproximadamente US $ 15,7 milhões, com foco no câncer de mama e nos estudos de tratamento de Covid-19.

• Ensaios clínicos de prevenção de câncer de mama em andamento
• Estudos de pesquisa de tratamento CoVID-19
• Desenvolvimento diagnóstico de medicina de precisão

Investimentos de conformidade regulatória

A conformidade regulatória e os custos de interação da FDA foram estimados em US $ 2,3 milhões em 2023.

Overhead administrativo e operacional

Categoria de despesa	2023 custos
Despesas administrativas gerais	US $ 8,2 milhões
Sobrecarga operacional	US $ 5,6 milhões

Manutenção de propriedades patentes e intelectuais

Os custos anuais de manutenção da propriedade intelectual foram de US $ 1,1 milhão em 2023.

Custos operacionais totais para 2023: US $ 54,3 milhões

Atossa Therapeutics, Inc. (ATOS) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de medicamentos

A partir do quarto trimestre 2023, a Atossa Therapeutics não possui acordos ativos de licenciamento de medicamentos. Receita potencial do licenciamento estimado em US $ 0 atualmente.

Subsídios do governo e de pesquisa privada

Fonte de concessão	Quantia	Ano
Institutos Nacionais de Saúde (NIH)	$350,000	2023
Departamento de Defesa	$275,000	2023

Vendas potenciais de produtos farmacêuticos

Potencial atual de receita do pipeline de produtos:

• Endoxifeno: mercado potencial estimado $ 150-250 milhões anualmente
• AT-301 (tratamento covid-19): mercado potencial $ 50-100 milhões

Colaborações de parceria estratégica

A partir de 2024, nenhum fluxo de receita de parceria estratégica confirmada identificada. Potenciais discussões de colaboração em andamento com o valor estimado de valor potencial: US $ 500.000 - US $ 2 milhões.

Receita total (2023): US $ 1,2 milhão

Despesas de pesquisa e desenvolvimento: US $ 24,3 milhões

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.