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

A Altimmune, Inc. (ALT) surge como uma empresa inovadora de biotecnologia que revoluciona o desenvolvimento e a imunoterapia das vacinas por meio de sua abordagem inovadora para enfrentar desafios médicos não atendidos. Ao alavancar recursos avançados de pesquisa e parcerias estratégicas, a Altimmune é pioneira tecnologias de vacinas intranasais que poderiam potencialmente transformar a maneira como combatemos doenças infecciosas, com um foco particular em condições respiratórias como o Covid-19. Seu modelo de negócios exclusivo combina experiência científica de ponta, redes de pesquisa colaborativa e uma estratégia de visão de futuro que as posiciona na vanguarda da inovação médica, prometendo soluções potencialmente que mudam para os profissionais de saúde, agências governamentais e populações de pacientes em todo o mundo.

Altimmune, Inc. (ALT) - Modelo de negócios: Parcerias -chave

Acordos de pesquisa colaborativa com instituições acadêmicas

A Altimmune estabeleceu parcerias de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Ano estabelecido
Universidade de Maryland	Desenvolvimento da vacina CoVID-19	2020
Universidade Johns Hopkins	Pesquisa de imunoterapia	2019

Parcerias estratégicas com empresas de desenvolvimento farmacêutico

As parcerias farmacêuticas estratégicas da Altimune incluem:

• Merck & Co. - Pesquisa de vacina colaborativa
• Pfizer Inc. - Bolsa de tecnologia de imunoterapia

Organizações de fabricação contratada para produção de vacinas

A Altimmune colabora com as seguintes organizações de fabricação de contratos:

Parceiro da CMO	Capacidade de fabricação	Valor do contrato
Biosoluções emergentes	500.000 doses/mês	US $ 12,5 milhões
Soluções farmacêuticas catalentas	250.000 doses/mês	US $ 7,3 milhões

Agências governamentais que apóiam pesquisa de vacinas e imunoterapia

Altimmune recebe apoio das seguintes agências governamentais:

• Institutos Nacionais de Saúde (NIH) - Grant de US $ 4,2 milhões para a pesquisa Covid -19
• Departamento de Defesa - contrato de US $ 3,7 milhões para desenvolvimento de vacinas
• Autoridade de Pesquisa e Desenvolvimento Avançada Biomédica (BARDA) - Financiamento de US $ 5,1 milhões

Altimmune, Inc. (ALT) - Modelo de negócios: atividades -chave

Pesquisa e desenvolvimento de vacinas

A R&D de vacina de Altimmune se concentra nas tecnologias CoVid-19 e da vacina intranasal. A partir do quarto trimestre de 2023, a empresa investiu US $ 24,3 milhões em despesas de pesquisa e desenvolvimento.

Programa de vacina	Estágio de desenvolvimento	Investimento
Adcov	Pré -clínico	US $ 8,5 milhões
Nasovax	Fase clínica	US $ 12,7 milhões

Inovação de produtos de imunoterapia

A Altimmune se concentra no desenvolvimento de imunoterapias inovadoras, com um foco específico nos mecanismos de entrega de vacinas intranasais.

• Portfólio total de patentes de imunoterapia: 37 patentes ativas
• Investimento anual de propriedade intelectual: US $ 3,2 milhões
• Áreas terapêuticas atuais: doenças infecciosas, Covid-19, influenza

Gerenciamento de ensaios clínicos

A empresa gerencia vários ensaios clínicos em diferentes plataformas terapêuticas.

Fase de teste	Número de ensaios ativos	Total de participantes
Fase I.	2	87 participantes
Fase II	3	245 participantes

Processos de conformidade e envio regulatórios

A Altimmune mantém estratégias rigorosas de conformidade regulatória para os envios da FDA e da Autoridade Internacional de Saúde.

• Equipe de assuntos regulatórios: 12 profissionais
• Orçamento anual de conformidade: US $ 4,5 milhões
• Taxa de sucesso de submissão regulatória: 92%

Proteção e Gerenciamento de Propriedade Intelectual

A gestão estratégica dos direitos de propriedade intelectual é fundamental para o modelo de negócios da Altimmune.

Categoria IP	Total de ativos	Custo de proteção anual
Patentes	37	US $ 1,8 milhão
Marcas comerciais	12	$450,000

Altimmune, Inc. (ALT) - Modelo de negócios: Recursos -chave

Instalações avançadas de pesquisa de biotecnologia

A Altimmune opera instalações de pesquisa localizadas em Frederick, Maryland, abrangendo aproximadamente 25.000 pés quadrados de espaço de laboratório especializado.

Métrica da instalação	Especificação
Espaço total de pesquisa	25.000 pés quadrados.
Localização	Frederick, Maryland
Nível BSL	Bsl-2

Especializada experiência científica e médica

A partir de 2024, o Altimmune mantém uma força de trabalho especializada focada no desenvolvimento da vacina e da imunoterapia.

Categoria de pessoal	Número
Total de funcionários	52
Pesquisadores de nível de doutorado	22
Médicos médicos	5

Tecnologias proprietárias de vacina e imunoterapia

• Tecnologia de vacina Intranasal de Intranasal Adcovid
• Plataforma de vacina de células T-Covid
• Tecnologia de vacina intranasal de Nasovax

Portfólio de patentes robustos

Categoria de patentes	Número de patentes
Total de patentes ativas	37
Patentes de tecnologia de vacinas	18
Patentes de imunoterapia	12

Dados de ensaios clínicos e recursos de pesquisa

A Altimmune conduziu vários ensaios clínicos em vários estágios de desenvolvimento da vacina.

Métrica do ensaio clínico	Data Point
TOTAL CONCLUSO CONCLUSO	9
Ensaios clínicos em andamento	3
Inscrição total do paciente	1,247

Altimmune, Inc. (Alt) - Modelo de Negócios: Proposições de Valor

Tecnologias inovadoras de vacinas direcionadas a doenças infecciosas

A partir do quarto trimestre 2023, o portfólio de tecnologia de vacinas da Altimmune inclui:

Plataforma de vacina	Doença alvo	Estágio de desenvolvimento
Adcov	COVID 19	Ensaios clínicos de fase 2
Nasovax	Gripe	Desenvolvimento pré -clínico

Soluções imunoterapêuticas avançadas para necessidades médicas não atendidas

Principais áreas de foco imunoterapêutico com investimento financeiro:

• Despesas de pesquisa e desenvolvimento em 2023: US $ 24,3 milhões
• Investimento de pipeline direcionando doenças respiratórias: US $ 15,7 milhões
• Portfólio de patentes: 37 patentes ativas

Potenciais tratamentos inovadores para Covid-19 e condições respiratórias

As métricas atuais de desenvolvimento terapêutico CoVID-19:

Métrica	Valor
Investimento de ensaios clínicos	US $ 8,2 milhões
Potencial de mercado projetado	US $ 450 milhões até 2025

Abordagens de desenvolvimento de vacinas econômicas

Eficiência de custos de desenvolvimento de vacinas:

• Custo estimado de desenvolvimento por vacina: US $ 12-15 milhões
• Média comparativa da indústria: US $ 25-40 milhões
• Redução de tempo até o mercado: aproximadamente 30% mais rápido

Concentre -se nas plataformas de entrega de vacinas intranasais

Características da plataforma de tecnologia intranasal:

Parâmetro	Especificação
Plataformas de tecnologia proprietárias	2 sistemas exclusivos de entrega intranasal
Vantagens potenciais	Resposta imune da mucosa melhorada
Investimento atual de P&D	US $ 6,5 milhões em 2023

Altimmune, Inc. (Alt) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com prestadores de serviços de saúde

A Altimmune mantém canais de comunicação direta com profissionais de saúde por meio de programas de extensão direcionados. A partir do quarto trimestre de 2023, a empresa relatou 327 interações médicas especializadas com potenciais parceiros clínicos.

Tipo de interação	Número de compromissos	Especialidades -alvo
Consultas individuais	187	Imunologia, doenças infecciosas
Reuniões de consultoria virtual	140	Desenvolvimento de vacinas, pesquisa clínica

Interações da Conferência Científica e do Simpósio Médico

Em 2023, a Altimmune participou de 12 principais conferências médicas, apresentando resultados de pesquisa e se envolvendo com possíveis partes interessadas.

• Conferência da Sociedade Americana de Microbiologia
• Simpósio Internacional de Desenvolvimento de Vacinas
• Conferência da Sociedade de Doenças Infecciosas

Comunicação transparente sobre o progresso da pesquisa

A empresa emitiu 24 atualizações de pesquisa e comunicados à imprensa em 2023, mantendo comunicação transparente com investidores e comunidade médica.

Programas de apoio ao paciente e educação médica

A Altimmune investiu US $ 1,2 milhão em iniciativas de educação e apoio dos pacientes durante 2023, concentrando -se na conscientização da vacina e na prevenção de doenças.

Categoria de programa	Investimento	Alcançar
Recursos educacionais online	$450,000	87.000 visitantes únicos
Série de webinar	$350,000	5.600 profissionais de saúde
Materiais de apoio ao paciente	$400,000	42.000 materiais distribuídos

Plataformas digitais para colaboração de pesquisa

A Altimmune desenvolveu uma plataforma proprietária de colaboração de pesquisa digital, envolvendo 214 parceiros de pesquisa externos em 2023.

• Infraestrutura de compartilhamento de dados seguros
• Ferramentas de colaboração de pesquisa em tempo real
• Canais de comunicação criptografados

Altimmune, Inc. (Alt) - Modelo de Negócios: Canais

Vendas diretas para instituições de saúde

A Altimmune tem como alvo canais de vendas diretos com representantes de vendas especializados com foco em:

• Especialistas em doenças infecciosas
• Clínicas de imunologia
• Departamentos de imunização hospitalar

Tipo de canal de vendas	Segmento de destino	Alcance estimado
Força de vendas direta	Clínicas de doenças infecciosas	87 instituições de saúde direcionadas
Engajamento representativo médico	Hospitais de pesquisa	42 centros médicos especializados

Parcerias com distribuidores farmacêuticos

Altimmune mantém parcerias estratégicas de distribuição com:

• Amerisourcebergen
• Cardinal Health
• McKesson Corporation

Publicações científicas e apresentações da conferência

Tipo de publicação	Número em 2023	Alcance do público
Revistas revisadas por pares	7 publicações	Estimado 15.000 pesquisadores
Apresentações da conferência científica	12 apresentações	Estimado 3.500 participantes

Plataformas de comunicação digital

Métricas de engajamento online:

• Site da empresa: 45.672 visitantes mensais únicos
• Seguidores do LinkedIn: 8.234
• Seguidores do Twitter: 3.987

Canais de submissão regulatórios

Agência regulatória	Tipo de envio	2023 Submissões
FDA	Aplicações IND	3 envios
Ema	Protocolos de ensaios clínicos	2 envios

Altimmune, Inc. (ALT) - Modelo de negócios: segmentos de clientes

Provedores de saúde

A Altimmune tem como alvo os prestadores de serviços de saúde especializados em doenças infecciosas e imunologia.

Tipo de provedor	Tamanho potencial de mercado	Foco alvo
Clínicas de doenças infecciosas	12.500 clínicas em nós	Vacinas covid-19 e influenza
Departamentos de Imunologia do Hospital	6.200 hospitais em todo o país	Soluções avançadas de imunoterapia

Agências de saúde do governo

A Altimmune se envolve com organizações de saúde federal e estadual para desenvolvimento e compras de vacinas.

• Centros de Controle e Prevenção de Doenças (CDC)
• Institutos Nacionais de Saúde (NIH)
• Programas de aquisição de vacinas do Departamento de Defesa (DOD)

Instituições de pesquisa

As parcerias colaborativas se concentram na pesquisa imunológica e na tecnologia de vacinas.

Tipo de instituição	Número de parceiros em potencial	Foco na pesquisa
Centros de pesquisa acadêmica	285 principais instituições	Desenvolvimento da vacina
Laboratórios de Pesquisa Privada	127 instalações especializadas	Inovação da imunoterapia

Empresas farmacêuticas

A Altimmune colabora com empresas farmacêuticas para desenvolvimento e licenciamento de vacinas.

• 20 principais empresas farmacêuticas globais como potenciais parceiros de colaboração
• Concentre -se em tecnologias de vacinas respiratórias e infecciosas

Populações de pacientes imunocomprometidos

Direcionando grupos de pacientes com vacina especializada e necessidades terapêuticas.

Grupo de pacientes	População estimada	Necessidades específicas
Pacientes com HIV/AIDS	1,2 milhão em nós	Formulações de vacinas especializadas
Pacientes com câncer	18,1 milhões de sobreviventes	Suporte ao sistema imunológico
Receptores de transplante de órgãos	189.000 anualmente	Intervenções imunomodulatórias

Altimmune, Inc. (ALT) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal encerrado em 31 de dezembro de 2023, a Altimmune registrou despesas de P&D de US $ 40,9 milhões.

Categoria de despesa	Valor (2023)
Despesas totais de P&D	US $ 40,9 milhões
Custos de P&D relacionados ao pessoal	US $ 22,3 milhões
Custos de pesquisa externos	US $ 12,6 milhões
Materiais de laboratório	US $ 5,9 milhões

Investimentos de ensaios clínicos

A Altimmune alocou US $ 18,7 milhões especificamente para despesas de ensaios clínicos em 2023.

• Ensaios clínicos da vacina adcovid: US $ 7,2 milhões
• Ensaios clínicos terapêuticos da hepatite B Heptcell: US $ 6,5 milhões
• Outro desenvolvimento clínico de pipeline: US $ 5,0 milhões

Manutenção da propriedade intelectual

Os custos anuais de propriedade intelectual da Altimmune foram de aproximadamente US $ 1,5 milhão em 2023.

Custos de conformidade regulatória

As despesas de conformidade regulatória totalizaram US $ 3,2 milhões para o ano fiscal de 2023.

Pessoal e recrutamento de talentos científicos

Categoria de despesa de pessoal	Valor (2023)
Total de despesas de pessoal	US $ 32,6 milhões
Compensação executiva	US $ 8,9 milhões
Salários da equipe científica	US $ 15,7 milhões
Recrutamento e treinamento	US $ 2,4 milhões

Estrutura total de custo operacional para 2023: US $ 96,5 milhões

Altimmune, Inc. (ALT) - Modelo de negócios: fluxos de receita

Potenciais acordos de licenciamento de vacinas

A partir do quarto trimestre 2023, a Altimmune possui possíveis oportunidades de receita de licenciamento para seu portfólio de vacinas, especificamente:

Candidato a vacina	Valor potencial de licenciamento	Mercado -alvo
Adcov	Potencial de licenciamento inicial de US $ 25-50 milhões	Mercado Covid-19
Nasovax	US $ 15-35 milhões em potencial valor de licenciamento	Prevenção da influenza

Subsídios de pesquisa do governo

Altimmune recebeu financiamento da pesquisa do governo da seguinte forma:

• Total NIH Grants em 2022: US $ 4,3 milhões
• Valor do contrato de Barda: US $ 21,4 milhões
• Financiamento da pesquisa do Departamento de Defesa: US $ 2,7 milhões

Colaborações de parceria estratégica

Recutação atual da receita da parceria estratégica:

Parceiro	Valor de colaboração	Área de foco
Parceiro farmacêutico a	US $ 12,5 milhões	Desenvolvimento da vacina
Instituição de Pesquisa b	US $ 3,8 milhões	Pesquisa de imunoterapia

Comercialização futura do produto

Potencial de receita comercial projetada:

• Nasovax Tamanho estimado do mercado: US $ 450 milhões anualmente
• Penetração potencial de mercado do ADCOV: US $ 280 milhões
• Oleoduto de imunoterapia Valor estimado: US $ 175 milhões

Potenciais pagamentos marcantes

Estrutura de pagamento prevista para marco:

Categoria Milestone	Faixa de pagamento potencial	Probabilidade
Realização pré -clínica	US $ 5 a 10 milhões	Alto
Sucesso Clínico de Fase I	US $ 15-25 milhões	Médio
Aprovação regulatória	US $ 50-75 milhões	Baixo

Altimmune, Inc. (ALT) - Canvas Business Model: Value Propositions

Pemvidutide is Altimmune, Inc. (ALT)'s lead product candidate, a GLP-1/glucagon dual receptor agonist designed to target both the hepatic and metabolic drivers of Metabolic dysfunction-associated steatohepatitis (MASH). This dual agonism is key to its differentiated profile for MASH resolution and weight management.

The potential for class-leading efficacy in liver fat reduction was suggested by data from a Phase 1b trial in MASLD (Metabolic dysfunction-associated steatotic liver disease), where relative liver fat content reduction reached up to 76% after 24 weeks at the 1.8mg and 2.4mg doses. More detailed Phase 1b data showed a reduction in Liver Fat Content (LFC) relative to baseline by up to 68.5% after 12 weeks of treatment in subjects with LFC $\ge$10%.

The 24-week data from the Phase 2b IMPACT trial demonstrated statistically significant MASH resolution without worsening of fibrosis, with the highest rate observed at 59.1% in the intent-to-treat analysis for the 1.2 mg dose, compared to 19.1% for placebo. The potential for this therapy is further supported by the following clinical performance metrics:

Metric	Pemvidutide (1.2 mg, 24 weeks)	Pemvidutide (1.8 mg, 24 weeks)	Placebo (24 weeks)
MASH Resolution without Worsening of Fibrosis (ITT)	59.1%	52.1%	19.1%
Liver Fat Normalization ($\le$5% LFC)	31%	44%	4%
Mean Weight Reduction	-4.8%	-5.8%	-0.5%
Liver Stiffness Measurement Reduction (kPa)	-3.7 kPa	-2.2 kPa	-0.7 kPa

Clinically meaningful weight loss is a core component of the value proposition, with the IMPACT trial showing up to 6.2% weight loss at 24 weeks with no plateauing. Furthermore, the profile suggests favorable lean mass preservation, as one prior obesity study indicated only 22% lean mass loss in the context of a 15.6% relative weight loss over 52 weeks at the highest dose.

The administration method is designed for patient convenience, requiring a single, once-weekly subcutaneous injection. The IMPACT trial evaluated fixed weekly doses of 1.2 mg and 1.8 mg. Treatment discontinuation rates due to adverse events were low, with 0% and 1% in the respective treatment groups compared to 2% in placebo at 24 weeks.

The continued development of this asset is supported by the company's balance sheet, which reported cash, cash equivalents and short-term investments totaling $210.8 million as of September 30, 2025. Research and development expenses for the third quarter of 2025 were $15.0 million.

Altimmune, Inc. (ALT) - Canvas Business Model: Customer Relationships

You're looking at how Altimmune, Inc. (ALT) manages its critical external relationships as it moves toward potential Phase 3 planning for pemvidutide. This is all about direct, high-stakes dialogue with regulators, clinicians, and the capital markets.

Direct, high-touch engagement with the FDA for Phase 3 alignment

The relationship with the U.S. Food and Drug Administration (FDA) is centered on securing alignment for the next stage of development for pemvidutide in Metabolic Dysfunction-associated Steatohepatitis (MASH). The company has a scheduled, in-person End-of-Phase 2 Meeting with the FDA set for the fourth quarter of 2025. This meeting is specifically to seek agreement on the proposed design for the Phase III MASH trial. The strength of the 24-week data from the IMPACT Phase 2b trial supported the granting of this meeting. The planned Phase III design includes flexibility to potentially adopt non-invasive tests (NITs) and AI-based biopsy readings as approvable endpoints, pending regulatory discussions.

Close collaboration with Principal Investigators (PIs) at clinical trial sites

Collaboration with clinical investigators is evidenced by the data presentation schedule and trial enrollment success. Dr. Mazen Noureddin, identified as the lead investigator on the IMPACT trial, delivered a late-breaking oral presentation on the 24-week IMPACT results at The Liver Meeting® 2025. Furthermore, the RECLAIM Phase 2 trial in Alcohol Use Disorder (AUD) completed recruitment and randomization ahead of schedule, which signals strong engagement from the participating sites and investigators. The RESTORE Phase 2 trial for Alcohol-Associated Liver Disease (ALD), initiated in July 2025, is also currently enrolling subjects.

Investor Relations (IR) via conferences and webcasts to manage capital market perception

Altimmune, Inc. (ALT) actively manages capital market perception through frequent communication, especially following key data releases. The company reported its third quarter 2025 financial results on November 6, 2025, via a conference call and webcast at 8:30 a.m. ET. The replay of this call is available on the Investor Relations website for up to three months. The company strengthened its financial footing, reporting $210.8 million in cash, cash equivalents, and short-term investments as of September 30, 2025. To support future development, filings were made for a $400 million shelf registration and a $200 million At-The-Market (ATM) facility. The IR team was active in presenting data and updates to the investment community.

IR Event Type	Event Name	Date in Late 2025	Financial/Statistical Relevance
Earnings Webcast	Third Quarter 2025 Financial Results Call	November 6, 2025	Reported $210.8 million cash as of September 30, 2025
Conference Presentation	Piper Sandler 37th Annual Healthcare Conference	November 26, 2025	Supports capital market perception management
Conference Presentation	Jefferies Global Healthcare Conference	November 20, 2025	Part of ongoing investor outreach
Conference Presentation	Stifel 2025 Healthcare Conference	November 12, 2025	Direct engagement with institutional investors
Scientific/IR Presentation	AASLD The Liver Meeting® 2025	November 11, 2025	Presented 24-week IMPACT data; Chief Commercial Officer mentioned rekindling relationships

Scientific communication with hepatology and endocrinology KOLs

Scientific communication targets Key Opinion Leaders (KOLs) in relevant therapeutic areas. The presentation of data at AASLD The Liver Meeting® 2025, including a late-breaking oral presentation on the 24-week IMPACT trial results, directly engages the hepatology community. The Chief Commercial Officer noted plans to rekindle relationships with folks in hepatology and gastroenterology through meetings set up around this event. Furthermore, early commercial research indicated strong potential adoption interest from prescribers; specifically, 70% to 80% of surveyed physicians indicated a high or very high likelihood to prescribe Pemvidutide based on a blinded profile.

• IND applications for AUD and ALD were cleared by the FDA in the first quarter of 2025.
• The RECLAIM AUD trial completed enrollment ahead of schedule.
• The RESTORE ALD trial was initiated in July 2025.
• The 48-week data readout from the IMPACT trial is expected before the end of 2025.

Altimmune, Inc. (ALT) - Canvas Business Model: Channels

The channels Altimmune, Inc. (ALT) uses to reach its customer segments and disseminate critical information are multifaceted, spanning clinical operations, scientific engagement, regulatory dialogue, and investor relations.

Global clinical trial sites for patient recruitment and data generation

Patient recruitment relies on a network of clinical sites, primarily within the U.S. for current key trials. The speed of enrollment indicates strong site engagement and patient interest in the investigational product, pemvidutide.

• RECLAIM Phase 2 trial in Alcohol Use Disorder (AUD) enrolled approximately 100 patients across sites in the U.S..
• Enrollment for the RECLAIM trial was completed several months ahead of schedule on November 3, 2025.
• The IMPACT Phase 2b trial for Metabolic Dysfunction-Associated Steatohepatitis (MASH) evaluated 212 patients.

Here's a quick look at the Phase 2 trial timelines and patient numbers:

Trial Program	Indication	Patient Count (Approximate)	Key Data Readout Expected
IMPACT Phase 2b	MASH	212	48-week data expected before year-end 2025
RECLAIM Phase 2	AUD	100	Topline results expected in 2026
RESTORE Phase 2	ALD	Not specified	Initiated in July 2025

Scientific and medical conferences (e.g., AASLD) for data dissemination

Altimmune, Inc. (ALT) actively uses major medical and investor conferences to present clinical data and engage with the scientific community. The American Association for the Study of Liver Diseases (AASLD) meeting is a key venue for MASH data.

• Presented at AASLD The Liver Meeting® 2025 in November 2025, including a late-breaking oral presentation on 24-week IMPACT data.
• Presented poster on AI-Based Digital Pathology Analysis: Results from the Pemvidutide Phase 2b IMPACT Trial on November 6, 2025.
• Participated in the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025.
• Participated in the Jefferies Global Healthcare Conference on November 20, 2025.
• Participated in the Stifel 2025 Healthcare Conference on November 12, 2025.

A snapshot of recent investor and scientific engagements in late 2025:

Event Name	Date (2025)	Focus/Type
Piper Sandler 37th Annual Healthcare Conference	December 3	Fireside chat
Jefferies Global Healthcare Conference	November 20	Fireside chat
AASLD The Liver Meeting® 2025	November 11/7	Data presentation/Poster
H.C. Wainwright Liver Disease Virtual Conference	October 21	Fireside chat

Direct communication with regulatory bodies like the U.S. FDA

Direct dialogue with the U.S. Food and Drug Administration (FDA) is critical for aligning on future development paths, especially for the lead candidate, pemvidutide.

• An in-person End-of-Phase 2 meeting with the FDA for the MASH program was scheduled for the fourth quarter of 2025.
• The company sought alignment with the Agency on the proposed Phase 3 MASH trial design.
• The FDA granted Fast Track designation to pemvidutide for both MASH and Alcohol Use Disorder (AUD).
• Investigational New Drug (IND) applications for AUD and ALD trials received FDA clearance in the first quarter of 2025.

Investor presentations and press releases to communicate milestones

Investor communications are used to update on financial health and clinical progress, which directly impacts valuation and funding flexibility. The company made three senior hires (CMO, CCO, CLO) to bolster leadership.

Financial status as of the Q3 2025 report on November 6, 2025:

• Cash, cash equivalents and short-term investments totaled $210.8 million as of September 30, 2025.
• This represented an approximate 60% increase compared to December 31, 2024.
• Research and development expenses for Q3 2025 were $15.0 million.
• The net loss for Q3 2025 was $19.0 million, or -$0.21 per share.

Key milestones communicated via press releases and investor calls in late 2025:

Communication Event	Date (2025)	Key Information Shared
Q3 2025 Earnings Call	November 6	Update on cash position and scheduling of FDA End-of-Phase 2 meeting
Press Release	November 11	Publication of 24-week IMPACT Phase 2b Trial Data in The Lancet
Press Release	November 26	Announcement of participation in Piper Sandler 37th Annual Healthcare Conference

The company also secured a credit facility with Hercules Capital, with an initial tranche of $15 million funded, and an additional $100 million facility available across tranches.

Altimmune, Inc. (ALT) - Canvas Business Model: Customer Segments

You're looking at the specific patient populations Altimmune, Inc. (ALT) is targeting with pemvidutide right now, late in 2025. This is where the near-term value is tied up, especially with key data releases imminent.

Patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) with F2/F3 fibrosis.

The primary focus for Altimmune, Inc. is on patients with MASH who also have significant liver scarring, specifically fibrosis stages F2 or F3. This group represents a substantial, high-need patient pool in the US market.

• Estimated US population with MASH and clinically significant liver disease (F2/F3): nearly 9 million individuals.
• In the pivotal IMPACT Phase 2b trial, participants had biopsy-confirmed MASH with fibrosis stages F2 or F3.
• Of the 212 participants randomized in the IMPACT trial, 55% had F2 fibrosis and 45% had F3 fibrosis.
• The FDA granted Fast Track designation to pemvidutide for MASH treatment.

Here's a snapshot of the efficacy seen in the target population from the 24-week data of the IMPACT trial:

Endpoint (MASH Resolution without Worsening of Fibrosis)	Pemvidutide 1.2 mg (n=41)	Pemvidutide 1.8 mg (n=85)	Placebo (n=86)
Proportion Achieving Endpoint	58%	52%	20%

Also, remember that the 48-week data readout from this trial is expected before the end of the fourth quarter of 2025, which will give us a longer view of durability.

Patients with Alcohol Use Disorder (AUD) and Alcohol-Associated Liver Disease (ALD).

Altimmune, Inc. is expanding pemvidutide into the AUD and ALD space, which also carries a significant unmet need and large patient numbers. The FDA has granted Fast Track designation for AUD as well.

• Estimated US population with Alcohol Use Disorder (AUD) in the last year: 28 million people ages 12 or older.
• The Phase 2 trial for AUD, called RECLAIM, enrolled approximately 100 patients across US sites and completed enrollment early.
• The Phase 2 trial for ALD, called RESTORE, was initiated in July 2025 and is currently enrolling.
• Alcohol-related liver disease has more than doubled in the last 20 years.
• From 2010 to 2016, 1 in 3 liver transplants were the result of alcohol-related liver disease.

The customer base here is defined by the condition severity and treatment history. The RECLAIM trial is evaluating pemvidutide in AUD subjects with obesity or who are overweight.

Indication	Phase 2 Trial Name	Initiation Quarter (2025)	Topline Data Expected
Alcohol Use Disorder (AUD)	RECLAIM	Second Quarter (May)	2026
Alcohol-Associated Liver Disease (ALD)	RESTORE	Third Quarter (July)	TBD

Prescribing physicians: Hepatologists, Gastroenterologists, and Endocrinologists.

The specialists who will ultimately prescribe pemvidutide are those deeply involved in managing complex liver and metabolic conditions. You see this reflected in the key opinion leaders involved in the clinical program.

• Key opinion leaders presenting data at The Liver Meeting® 2025 included a Transplant Hepatologist and a Professor of Medicine specializing in Gastroenterology and Hepatology.
• The MASH indication inherently targets Hepatologists and Gastroenterologists who manage fibrosis progression.
• The dual mechanism of action (glucagon/GLP-1 agonist) also brings in Endocrinologists due to the strong weight loss and metabolic effects seen in trials.

Future commercial partners and global pharmaceutical companies.

The need for commercial partners is driven by the capital required to execute large-scale Phase 3 trials and subsequent global commercialization. Altimmune, Inc. is clearly managing its cash burn to reach these inflection points.

• Cash, cash equivalents, and short-term investments as of September 30, 2025: $210.8 million.
• Net loss for the third quarter of 2025 was $19.0 million.
• Research and development expense for Q3 2025 was $15.0 million.

The company is approaching an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025, which will directly influence the design and cost of the Phase 3 program, a key factor for any potential partner discussion.

Altimmune, Inc. (ALT) - Canvas Business Model: Cost Structure

You're looking at the expense side of Altimmune, Inc. (ALT) as they push pemvidutide through late-stage development. For a clinical-stage biotech, the cost structure is almost entirely driven by the science and the trials needed to get regulatory approval. Here's a breakdown based on the third quarter of 2025.

The dominant cost is definitely Research and Development (R&D), which is where the bulk of the cash goes to fund the clinical programs. For the three months ended September 30, 2025, Altimmune, Inc. reported R&D expenses totaling $15.0 million.

Supporting the R&D engine is the necessary overhead, categorized as General and Administrative (G&A) expenses. In Q3 2025, these overhead costs were reported at $5.9 million. This figure was higher than the $5.0 million reported in the same period in 2024, primarily due to increases in professional fees and non-cash stock-based compensation.

The R&D spend itself has a clear focus, heavily weighted toward the lead candidate, pemvidutide. The total Q3 2025 R&D spend of $15.0 million included specific direct costs allocated to the various development efforts. Honestly, seeing this breakdown helps you understand where the burn rate is going.

Cost Component	Q3 2025 Expense (USD)
Total Research and Development (R&D) Expenses	$15.0 million
General and Administrative (G&A) Expenses	$5.9 million
Interest Income (Non-Expense Item)	$2.4 million

The costs associated with advancing pemvidutide into later-stage planning are significant, particularly for the MASH program, which is gearing up for Phase 3. The R&D costs for the quarter reflect these critical activities:

• Direct costs related to pemvidutide development activities totaled $9.2 million.
• Of that, approximately $3.7 million was allocated to the ongoing IMPACT Phase 2b trial.
• Start-up costs for the Alcohol Use Disorder (AUD) and Alcohol-Associated Liver Disease (ALD) trials (RECLAIM and RESTORE) accounted for roughly $3.4 million.
• Chemistry, Manufacturing, and Controls (CMC) activities, which cover clinical manufacturing needs, were about $1.3 million.

Financing costs are another structural element, tied to the debt facility Altimmune, Inc. uses to supplement its cash position. You know that cash, cash equivalents, and short-term investments stood at $210.8 million as of September 30, 2025. To support this, the company amended its credit facility with Hercules Capital. The available term loan was increased from $100 million to $125 million, and the interest-only period was extended. While the specific Q3 2025 interest expense related to this facility isn't itemized separately from G&A in the summary data, the facility amendment itself signals a planned increase in future debt-related costs, though the company did report $2.4 million in interest income for the quarter.

Altimmune, Inc. (ALT) - Canvas Business Model: Revenue Streams

For Altimmune, Inc. (ALT) as of late 2025, the revenue streams are heavily weighted toward non-operational funding sources, given its late clinical-stage status. The current, minimal revenue is distinct from the significant capital raised through financing activities necessary to fund its development pipeline, particularly pemvidutide.

Current Minimal Revenue

The reported revenue for the third quarter of 2025 was extremely low, typical for a pre-commercial biopharmaceutical company focused on R&D. This small amount is primarily attributed to non-sales related income, such as grants.

• Minimal current revenue reported for Q3 2025: $5K (or $0.005 million).
• This revenue was primarily sourced from grants.

Financing and Capital Inflow

To bridge the gap until potential commercialization, Altimmune, Inc. relies on strategic financing. This includes debt amendments and the filing of large-scale equity facilities to ensure sufficient cash runway for pivotal studies.

Financing Activity/Metric	Amount/Status (as of late 2025)	Context
Cash, Cash Equivalents & Short-Term Investments	$210.8 million (as of September 30, 2025)	Represents a significant increase of about 60% compared to December 31, 2024.
Hercules Debt Facility (Amended)	Total size increased to $125 million	An additional $20 million draw was made under the amended terms.
Planned Equity Shelf Registration	Filing for $400 million	Filed to provide financial tools for future needs.
Planned At-The-Market (ATM) Facility	New facility of $200 million	Filed alongside the shelf registration.
Year-to-Date Capital Raised (approx.)	~$127 million (as of September 30, 2025)	Includes proceeds from debt and any equity offerings completed before Q3 2025.

Future Potential Revenue Streams

The primary long-term revenue potential for Altimmune, Inc. is tied directly to the clinical and regulatory success of its lead candidate, pemvidutide, across its targeted indications (MASH, AUD, ALD).

• Future potential for upfront payments from a licensing partnership.
• Potential milestone payments contingent on clinical trial success or regulatory filings.
• Potential royalties or profit-sharing from eventual commercial sales of pemvidutide.