Altimmune, Inc. (ALT): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Altimmune, Inc. (ALT) surge como una innovadora empresa de biotecnología que revoluciona el desarrollo de vacunas e inmunoterapia a través de su enfoque innovador para abordar los desafíos médicos no satisfechos. Al aprovechar las capacidades de investigación avanzadas y las asociaciones estratégicas, Altimmune es pionero en tecnologías de vacuna intranasal que podrían transformar cómo combatemos las enfermedades infecciosas, con un enfoque particular en afecciones respiratorias como Covid-19. Su modelo de negocio único combina experiencia científica de vanguardia, redes de investigación colaborativa y una estrategia con visión de futuro que los posiciona a la vanguardia de la innovación médica, prometiendo soluciones potencialmente que cambian el juego para proveedores de atención médica, agencias gubernamentales y poblaciones de pacientes en todo el mundo.

Altimmune, Inc. (ALT) - Modelo de negocio: asociaciones clave

Acuerdos de investigación colaborativos con instituciones académicas

Altimmune ha establecido asociaciones de investigación con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Año establecido
Universidad de Maryland	Desarrollo de vacunas Covid-19	2020
Universidad de Johns Hopkins	Investigación de inmunoterapia	2019

Asociaciones estratégicas con empresas de desarrollo farmacéutico

Las asociaciones farmacéuticas estratégicas de Altimmune incluyen:

• Merck & Co. - Investigación de vacunas colaborativas
• Pfizer Inc. - Intercambio de tecnología de inmunoterapia

Organizaciones de fabricación de contratos para la producción de vacunas

Altimmune colabora con las siguientes organizaciones de fabricación de contratos:

Socio de CMO	Capacidad de fabricación	Valor de contrato
Biosoluciones emergentes	500,000 dosis/mes	$ 12.5 millones
Soluciones farmacéuticas catalent	250,000 dosis/mes	$ 7.3 millones

Agencias gubernamentales que apoyan la investigación de vacunas e inmunoterapia

Altimmune recibe el apoyo de las siguientes agencias gubernamentales:

• Institutos Nacionales de Salud (NIH) - Subvención de $ 4.2 millones para la investigación de Covid -19
• Departamento de Defensa - Contrato de $ 3.7 millones para el desarrollo de vacunas
• Autoridad de Investigación y Desarrollo Avanzado Biomédico (BARDA) - Financiación de $ 5.1 millones

Altimmune, Inc. (ALT) - Modelo de negocio: actividades clave

Investigación y desarrollo de vacunas

La I + D de la vacuna de Altimmune se centra en las tecnologías Covid-19 y la vacuna intranasal. A partir del cuarto trimestre de 2023, la compañía invirtió $ 24.3 millones en gastos de investigación y desarrollo.

Programa de vacunas	Etapa de desarrollo	Inversión
Adcov	Preclínico	$ 8.5 millones
Nasovax	Fase clínica	$ 12.7 millones

Innovación de productos de inmunoterapia

Altimmune se concentra en el desarrollo de inmunoterapias innovadoras con un enfoque específico en los mecanismos de suministro de vacunas intranasales.

• Portafolio de patentes de inmunoterapia total: 37 patentes activas
• Inversión anual de propiedad intelectual: $ 3.2 millones
• Áreas terapéuticas actuales: enfermedades infecciosas, Covid-19, influenza

Gestión de ensayos clínicos

La compañía administra múltiples ensayos clínicos en diferentes plataformas terapéuticas.

Fase de prueba	Número de pruebas activas	Participantes totales
Fase I	2	87 participantes
Fase II	3	245 participantes

Procesos de cumplimiento y presentación regulatoria

Altimmune mantiene rigurosas estrategias de cumplimiento regulatorio para la FDA y las presentaciones de la Autoridad de Salud Internacional.

• Equipo de asuntos regulatorios: 12 profesionales
• Presupuesto anual de cumplimiento: $ 4.5 millones
• Tasa de éxito de presentación regulatoria: 92%

Protección y gestión de la propiedad intelectual

La gestión estratégica de los derechos de propiedad intelectual es fundamental para el modelo de negocio de Altimmune.

Categoría de IP	Activos totales	Costo de protección anual
Patentes	37	$ 1.8 millones
Marcas registradas	12	$450,000

Altimmune, Inc. (ALT) - Modelo de negocio: recursos clave

Instalaciones avanzadas de investigación de biotecnología

Altimmune opera instalaciones de investigación ubicadas en Frederick, Maryland, que abarca aproximadamente 25,000 pies cuadrados de espacio de laboratorio especializado.

Métrica de la instalación	Especificación
Espacio total de investigación	25,000 pies cuadrados.
Ubicación	Frederick, Maryland
Nivel de BSL	BSL-2

Experiencia médica y científica especializada

A partir de 2024, Altimmune mantiene una fuerza laboral especializada centrada en el desarrollo de vacunas e inmunoterapia.

Categoría de personal	Número
Total de empleados	52
Investigadores a nivel de doctorado	22
Médico	5

Tecnologías de vacunas e inmunoterapia patentadas

• Tecnología de vacunas Intranasal Covid-19 Adcovid
• Plataforma de vacuna de células T-covid
• Tecnología de vacuna intranasal de Nasovax

Cartera de patentes robusta

Categoría de patente	Número de patentes
Patentes activas totales	37
Patentes de tecnología de vacunas	18
Patentes de inmunoterapia	12

Datos de ensayos clínicos y capacidades de investigación

Altimmune ha realizado múltiples ensayos clínicos en varias etapas de desarrollo de vacunas.

Métrico de ensayo clínico	Punto de datos
Pruebas totales completadas	9
Ensayos clínicos en curso	3
Inscripción total del paciente	1,247

Altimmune, Inc. (ALT) - Modelo de negocio: propuestas de valor

Tecnologías innovadoras de vacunas dirigidas a enfermedades infecciosas

A partir del cuarto trimestre de 2023, la cartera de tecnología de vacunas de Altimmune incluye:

Plataforma de vacuna	Enfermedad objetivo	Etapa de desarrollo
Adcov	COVID-19	Ensayos clínicos de fase 2
Nasovax	Influenza	Desarrollo preclínico

Soluciones inmunoterapéuticas avanzadas para necesidades médicas no satisfechas

Áreas de enfoque inmunoterapéutico clave con inversión financiera:

• Gastos de investigación y desarrollo en 2023: $ 24.3 millones
• Inversión de tuberías dirigidas a enfermedades respiratorias: $ 15.7 millones
• Portafolio de patentes: 37 patentes activas

Posibles tratamientos innovadores para Covid-19 y afecciones respiratorias

Métricas actuales de desarrollo terapéutico Covid-19:

Métrico	Valor
Inversión en ensayos clínicos	$ 8.2 millones
Potencial de mercado proyectado	$ 450 millones para 2025

Enfoques de desarrollo de vacunas rentables

Desarrollo de la vacuna Centencia de costo:

• Costo de desarrollo estimado por vacuna: $ 12-15 millones
• Promedio comparativo de la industria: $ 25-40 millones
• Reducción del tiempo de mercado: aproximadamente el 30% más rápido

Centrarse en las plataformas de entrega de vacunas intranasales

Características de la plataforma de tecnología intranasal:

Parámetro	Especificación
Plataformas tecnológicas patentadas	2 sistemas únicos de entrega intranasal
Posibles ventajas	Respuesta inmune de la mucosa mejorada
Inversión actual de I + D	$ 6.5 millones en 2023

Altimmune, Inc. (ALT) - Modelo de negocios: relaciones con los clientes

Compromiso directo con proveedores de atención médica

Altimmune mantiene canales de comunicación directa con profesionales de la salud a través de programas de divulgación específicos. A partir del cuarto trimestre de 2023, la compañía reportó 327 interacciones médicas especializadas con posibles socios clínicos.

Tipo de interacción	Número de compromisos	Especialidades objetivo
Consultas individuales	187	Inmunología, enfermedades infecciosas
Reuniones de asesoramiento virtual	140	Desarrollo de vacunas, investigación clínica

Conferencia científica e interacciones de simposio médico

En 2023, Altimmune participó en 12 conferencias médicas principales, presentando hallazgos de la investigación y participando con posibles partes interesadas.

• Conferencia de la Sociedad Americana de Microbiología
• Simposio de desarrollo de vacunas internacionales
• Conferencia de la Sociedad de Enfermedades Infecciosas

Comunicación transparente sobre el progreso de la investigación

La compañía emitió 24 actualizaciones de investigación y comunicados de prensa en 2023, manteniendo comunicación transparente con inversores y comunidad médica.

Programas de apoyo al paciente y educación médica

Altimmune invirtió $ 1.2 millones en iniciativas de educación y apoyo del paciente durante 2023, centrándose en la conciencia de las vacunas y la prevención de enfermedades.

Categoría de programa	Inversión	Alcanzar
Recursos educativos en línea	$450,000	87,000 visitantes únicos
Serie de seminarios web	$350,000	5.600 profesionales de la salud
Materiales de apoyo al paciente	$400,000	42,000 materiales distribuidos

Plataformas digitales para colaboración de investigación

Altimmune desarrolló una plataforma patentada de colaboración de investigación digital, que involucra a 214 socios de investigación externos en 2023.

• Infraestructura segura de intercambio de datos
• Herramientas de colaboración de investigación en tiempo real
• Canales de comunicación cifrados

Altimmune, Inc. (ALT) - Modelo de negocio: canales

Ventas directas a instituciones de atención médica

Altimmune se dirige a canales de ventas directos con representantes de ventas especializados que se centran en:

• Especialistas en enfermedades infecciosas
• Clínicas de inmunología
• Departamentos de inmunización del hospital

Tipo de canal de ventas	Segmento objetivo	Alcance estimado
Fuerza de ventas directa	Clínicas de enfermedades infecciosas	87 instituciones de atención médica específicas
Compromiso de representante médico	Investigar hospitales	42 centros médicos especializados

Asociaciones con distribuidores farmacéuticos

Altimmune mantiene asociaciones de distribución estratégica con:

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation

Publicaciones científicas y presentaciones de conferencias

Tipo de publicación	Número en 2023	Alcance de la audiencia
Revistas revisadas por pares	7 publicaciones	15,000 investigadores estimados
Presentaciones de conferencias científicas	12 presentaciones	3,500 asistentes estimados

Plataformas de comunicación digital

Métricas de compromiso en línea:

• Sitio web de la compañía: 45,672 visitantes mensuales únicos
• Seguidores de LinkedIn: 8,234
• Seguidores de Twitter: 3.987

Canales de presentación regulatoria

Agencia reguladora	Tipo de envío	2023 presentaciones
FDA	Aplicaciones de IN	3 presentaciones
EMA	Protocolos de ensayos clínicos	2 presentaciones

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

Proveedores de atención médica

Altimmune se dirige a los proveedores de atención médica especializados en enfermedades infecciosas e inmunología.

Tipo de proveedor	Tamaño potencial del mercado	Enfoque objetivo
Clínicas de enfermedades infecciosas	12,500 clínicas en EE. UU.	Vacunas de Covid-19 e influenza
Departamentos de inmunología del hospital	6.200 hospitales en todo el país	Soluciones de inmunoterapia avanzadas

Agencias de salud gubernamentales

Altimmune se involucra con organizaciones de salud federales y estatales para el desarrollo y adquisiciones de vacunas.

• Centros para el control y la prevención de enfermedades (CDC)
• Institutos Nacionales de Salud (NIH)
• Programas de adquisición de vacunas del Departamento de Defensa (DOD)

Instituciones de investigación

Las asociaciones colaborativas se centran en la investigación inmunológica y la tecnología de vacunas.

Tipo de institución	Número de socios potenciales	Enfoque de investigación
Centros de investigación académicos	285 instituciones principales	Desarrollo de vacunas
Laboratorios de investigación privados	127 instalaciones especializadas	Innovación de inmunoterapia

Compañías farmacéuticas

Altimmune colabora con empresas farmacéuticas para el desarrollo y licencias de vacunas.

• Top 20 compañías farmacéuticas globales Como posibles socios de colaboración
• Centrarse en las tecnologías de vacunas de enfermedades respiratorias e infecciosas

Poblaciones de pacientes inmunocomprometidas

Dirigirse a grupos de pacientes con vacunas especializadas y necesidades terapéuticas.

Grupo de pacientes	Población estimada	Necesidades específicas
Pacientes con VIH/SIDA	1.2 millones en EE. UU.	Formulaciones de vacuna especializada
Pacientes con cáncer	18.1 millones de sobrevivientes	Soporte del sistema inmunitario
Destinatarios de trasplante de órganos	189,000 anualmente	Intervenciones inmunomoduladoras

Altimmune, Inc. (ALT) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finaliza el 31 de diciembre de 2023, Altimmune reportó gastos de I + D de $ 40.9 millones.

Categoría de gastos	Cantidad (2023)
Gastos totales de I + D	$ 40.9 millones
Costos de I + D relacionados con el personal	$ 22.3 millones
Costos de investigación externos	$ 12.6 millones
Materiales de laboratorio	$ 5.9 millones

Inversiones de ensayos clínicos

Altimmune asignó $ 18.7 millones específicamente para gastos de ensayos clínicos en 2023.

• Ensayos clínicos de la vacuna Adcovid: $ 7.2 millones
• Ensayos clínicos terapéuticos de hepatitis B heptcell: $ 6.5 millones
• Otro desarrollo clínico de tuberías: $ 5.0 millones

Mantenimiento de la propiedad intelectual

Los costos anuales de propiedad intelectual para Altimmune fueron de aproximadamente $ 1.5 millones en 2023.

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio totalizaron $ 3.2 millones para el año fiscal 2023.

Personal y reclutamiento de talento científico

Categoría de gastos de personal	Cantidad (2023)
Gastos totales de personal	$ 32.6 millones
Compensación ejecutiva	$ 8.9 millones
Salarios de personal científico	$ 15.7 millones
Reclutamiento y capacitación	$ 2.4 millones

Estructura de costos operativos totales para 2023: $ 96.5 millones

Altimmune, Inc. (ALT) - Modelo de negocio: flujos de ingresos

Posibles acuerdos de licencia de vacuna

A partir del cuarto trimestre de 2023, Altimmune tiene oportunidades de ingresos de licencia potenciales para su cartera de vacunas, específicamente:

Candidato a la vacuna	Valor de licencia potencial	Mercado objetivo
Adcov	$ 25-50 millones de potencial de licencia por adelantado	Mercado de Covid-19
Nasovax	$ 15-35 millones de posibles valor de licencia	Prevención de la influenza

Subvenciones de investigación del gobierno

Altimmune recibió fondos de investigación del gobierno de la siguiente manera:

• Subvenciones totales de NIH en 2022: $ 4.3 millones
• Valor del contrato de Barda: $ 21.4 millones
• Financiación del Departamento de Investigación de Defensa: $ 2.7 millones

Colaboraciones de asociación estratégica

Desglose de ingresos de asociación estratégica actual:

Pareja	Valor de colaboración	Área de enfoque
Socio farmacéutico A	$ 12.5 millones	Desarrollo de vacunas
Institución de investigación B	$ 3.8 millones	Investigación de inmunoterapia

Comercialización futura de productos

Potencial de ingresos comerciales proyectados:

• Tamaño estimado del mercado de Nasovax: $ 450 millones anuales
• Penetración del mercado potencial de Adcov: $ 280 millones
• Valor estimado de la tubería de inmunoterapia: $ 175 millones

Pagos potenciales de hitos

Estructura de pago de hito anticipada:

Categoría de hito	Rango de pago potencial	Probabilidad
Logro preclínico	$ 5-10 millones	Alto
Fase I éxito clínico	$ 15-25 millones	Medio
Aprobación regulatoria	$ 50-75 millones	Bajo

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.