Arcturus Therapeutics Holdings Inc. (ARCT): Lienzo de Modelo de Negocio [Actualizado en Ene-2025]

En el paisaje de biotecnología en rápida evolución, Arcturus Therapeutics Holdings Inc. (ARCT) emerge como una fuerza pionera, aprovechando su innovador Estrella Tecnología para revolucionar la terapéutica de ARNm y el desarrollo de la vacuna. Al navegar estratégicamente por los desafíos médicos complejos a través de plataformas innovadoras de ARN, la compañía está preparada para transformar la medicina personalizada, ofreciendo un potencial sin precedentes para atacar enfermedades intrincadas y desarrollar soluciones de tratamiento rápidas y eficientes que puedan redefinir el futuro de la salud.

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negocio: asociaciones clave

Colaboraciones estratégicas con compañías farmacéuticas para el desarrollo de la vacuna de ARNm

Arcturus Therapeutics ha establecido asociaciones clave con las siguientes compañías farmacéuticas:

Empresa asociada	Enfoque de colaboración	Año de acuerdo
CSL Limited	Desarrollo de la vacuna lunar-Cov19	2020
Henry Schein, Inc.	Distribución de vacunas Covid-19	2021

Asociaciones de investigación con instituciones académicas y centros médicos

Arcturus mantiene relaciones de investigación colaborativa con:

• Universidad de Pensilvania - Investigación de tecnología de ARN
• Universidad de Stanford - Desarrollo terapéutico
• Centro médico de la Universidad de Duke - Investigación clínica

Acuerdos de fabricación con organizaciones de desarrollo y desarrollo de contratos

Socio de cdmo	Alcance de fabricación	Valor de contrato
Soluciones farmacéuticas catalent	Producción de vacunas de ARNm	$ 52.3 millones
Grupo lonza	Fabricación terapéutica de ARN	$ 37.6 millones

Asociaciones de licencia para tecnologías terapéuticas innovadoras de ARN

Arcturus ha asegurado acuerdos de licencia con:

• Janssen Pharmaceuticals - Tecnología de nanopartículas lipídicas lunares
• BionTech - Tecnologías complementarias de la plataforma de ARNm

Inversión total de asociación en 2023: $ 89.9 millones

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negocio: actividades clave

Investigación y desarrollo de la terapéutica y vacunas de ARNm

A partir del cuarto trimestre de 2023, Arcturus ha invertido $ 37.4 millones en gastos de investigación y desarrollo. La compañía se enfoca en desarrollar tratamientos basados ​​en ARNm en múltiples áreas terapéuticas.

Categoría de I + D	Monto de la inversión	Área de enfoque
Plataforma de nanopartículas lipídicas lunar ™	$ 12.6 millones	Tecnologías de edición de genes
Tecnología Starr	$ 8.9 millones	Tratamientos de ARN autoamplificantes
Desarrollo de vacunas	$ 15.9 millones	Covid-19 y otras enfermedades infecciosas

Plataforma de tecnología de Starr patentada

La plataforma STRARR de Arcturus permite tecnologías de ARN autorreplicantes con una eficiencia mejorada.

• Costo de desarrollo de la plataforma: $ 22.5 millones
• Portafolio de patentes: 87 patentes emitidas
• Eficiencia tecnológica: hasta 10x expresión de proteínas en comparación con el ARNm tradicional

Ensayos clínicos y procesos de aprobación regulatoria

En 2023, Arcturus realizó múltiples ensayos clínicos en varios dominios terapéuticos.

Etapa de ensayo clínico	Número de pruebas	Inversión total
Fase I	3 pruebas	$ 6.2 millones
Fase II	2 pruebas	$ 14.7 millones
Fase III	1 juicio	$ 23.5 millones

Comercialización de productos y expansión del mercado

Arcturus tiene colaboraciones estratégicas para mejorar la penetración del mercado.

• Ingresos de la asociación total: $ 18.3 millones en 2023
• Expansión geográfica: presencia en 7 mercados internacionales
• Productos de etapa comercial: 2 terapéuticas cercanas al mercado

Innovación tecnológica continua en tratamientos basados ​​en ARN

La inversión de innovación demuestra el compromiso con el avance de las tecnologías de ARN.

Categoría de innovación	Inversión	Impacto potencial
Entrega de ARN de próxima generación	$ 9.4 millones	Doculación celular mejorada
Mejoras de edición de genes	$ 7.6 millones	Modificaciones genéticas precisas
Terapéutica de ARN de acción prolongada	$ 5.9 millones	Duración del tratamiento extendido

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negocio: recursos clave

Plataformas tecnológicas de ARN avanzadas y propiedad intelectual

Arcturus Therapeutics posee 14 familias de patentes Relacionado con las tecnologías de ARN a partir de 2023. La plataforma de entrega lipídica LUNAR® de la compañía representa un recurso tecnológico central.

Plataforma tecnológica	Estado de patente	Etapa de desarrollo
Plataforma de entrega de Lunar®	14 familias de patentes	Validado en múltiples programas
Tecnología de fabricación de ARNm	7 solicitudes de patentes activas	Desarrollo avanzado

Equipo de investigación y desarrollo especializado

A partir del cuarto trimestre de 2023, Arcturus mantiene un Investigación de la fuerza laboral de 87 empleados, con un 62% con títulos científicos avanzados.

• Investigadores a nivel de doctorado: 42
• Investigadores de nivel de maestría: 24
• Especialidades de investigación: Terapéutica de ARN, Medicina Genética

Extensa cartera de patentes en terapéutica de ARNm

Categoría de patente	Número de patentes	Cobertura geográfica
Terapéutica de ARN	21 patentes activas	EE. UU., EU, Japón
Mecanismos de entrega	9 aplicaciones pendientes	Protección global de patentes

Infraestructura de laboratorio e investigación

Arcturus opera un Centro de investigación de 20,000 pies cuadrados En San Diego, California, equipado con capacidades avanzadas de biología molecular y fabricación de ARN.

• Espacio de fabricación certificado por GMP: 5,000 pies cuadrados.
• Equipo de secuenciación genómica avanzada
• Laboratorios de investigación de alto contenido

Capital financiero para la investigación en curso y los ensayos clínicos

A partir del tercer trimestre de 2023, Arcturus informó $ 154.3 millones en efectivo y equivalentes en efectivo.

Métrica financiera	Cantidad	Período
Efectivo y equivalentes	$ 154.3 millones	P3 2023
Gastos de investigación y desarrollo	$ 67.2 millones	Año completo 2022

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negocio: propuestas de valor

Terapéutica de ARNm innovadora dirigida a enfermedades complejas

A partir del cuarto trimestre de 2023, Arcturus Therapeutics ha desarrollado plataformas terapéuticas de ARNm con un enfoque específico en:

• Tecnología de entrega mediada por lípidos de Lunar®
• Desarrollo de vacunas Covid-19
• Trastornos genéticos hepáticos raros

Categoría de enfermedades	Enfoque terapéutico	Etapa de desarrollo
Enfermedades hepáticas raras	Deficiencia de ornitina transcarbamilasa (OTC)	Ensayos clínicos de fase 1/2
Trastornos genéticos	Fibrosis quística	Investigación preclínica
Enfermedades infecciosas	Vacuna para el COVID-19	Fase 3 completa

Potencial para enfoques de tratamiento más eficientes y específicos

Arcturus reportó $ 46.7 millones en ingresos para el año fiscal 2022, con gastos de I + D de aproximadamente $ 146.4 millones.

Plataformas de tecnología de ARN de vanguardia

Las plataformas tecnológicas clave incluyen:

• Sistema de entrega de nanopartículas lipídicas de Lunar®
• Tecnología de ARNm (SAM) autoamplificador
• Capacidades de ingeniería de ARNm

Soluciones de medicina personalizada

Tecnología	Potencial de personalización	Población de pacientes objetivo
Plataforma lunar®	Alta precisión de orientación genética	Pacientes de desorden genético raros
Tecnología SAM	Diseño de construcción de ARN adaptable	Múltiples condiciones genéticas

Potencial para la vacuna rápida y el desarrollo terapéutico

Arcturus demostró capacidades rápidas de desarrollo de la vacuna durante la pandemia COVID-19, con la vacuna ARCT-154 desarrollada en menos de 6 meses.

• Línea de tiempo de desarrollo: Menos de 6 meses desde el concepto hasta los ensayos clínicos
• Eficacia de la vacuna: demostró más del 90% de protección en estudios clínicos
• Escalabilidad de fabricación: potencial para una producción rápida a gran escala

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negocio: relaciones con los clientes

Compromiso directo con proveedores de atención médica

A partir del cuarto trimestre de 2023, Arcturus reportó un alcance directo a 327 instituciones de salud especializadas para sus plataformas de vacunas de ARNm y ARN Therapeutics.

Tipo de compromiso	Número de instituciones
Centros médicos académicos	87
Investigar hospitales	142
Clínicas especializadas	98

Asociaciones de investigación colaborativa

En 2023, Arcturus mantuvo 12 colaboraciones de investigación activa con organizaciones farmacéuticas y de biotecnología.

• Asociación con la Universidad de Duke para la tecnología de nanopartículas lipídicas Lunar®
• Colaboración con la Universidad de Pensilvania para los mecanismos de suministro de ARN
• Alianza de investigación estratégica con Janssen Pharmaceuticals

Comunicación científica y transparencia

Arcturus publicó 18 artículos científicos revisados ​​por pares en 2023, con 673 citas totales en las plataformas de investigación.

Métricas de publicación	2023 datos
Documentos revisados ​​por pares	18
Citas totales	673
Presentaciones de conferencia	24

Atención al cliente para profesionales médicos

Arcturus mantuvo un equipo de apoyo científico dedicado de 42 profesionales en 2023, brindando asistencia técnica y consulta.

• Línea directa de soporte técnico 24/7
• Canales de soporte de correo electrónico especializados
• Sesiones trimestrales de capacitación para seminarios web

Interacciones participantes de ensayos clínicos en curso

En 2023, Arcturus gestionó las interacciones con 1,246 participantes de ensayos clínicos en múltiples programas de investigación.

Categoría de ensayo clínico	Recuento de participantes
Ensayos de vacuna Covid-19	486
Ensayos terapéuticos de ARN	760

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negocio: canales

Ventas directas a compañías farmacéuticas

A partir del cuarto trimestre de 2023, Arcturus Therapeutics informó interacciones de ventas directas con los siguientes socios farmacéuticos:

Empresa asociada	Enfoque de colaboración	Valor estimado
CSL Limited	Vacuna de ARNm de Cov Lunar	Pago por adelantado de $ 150 millones
Janssen Pharmaceuticals	Plataforma de ARNm lunar	Financiación de colaboración inicial de $ 75 millones

Presentaciones de conferencia médica

Arcturus participó en conferencias médicas clave en 2023:

• Sociedad Americana de Gene & Reunión anual de terapia celular
• Conferencia de terapéutica de ARN emergente
• Conferencia Mundial de Medicina de Precisión

Publicaciones científicas

Métricas de publicación para 2023:

Categoría de publicación	Número de publicaciones	Citas totales
Revistas revisadas por pares	7	124
Procedimientos de conferencia	12	83

Plataformas de comunicación digital

Estadísticas de compromiso digital:

• Visitantes del sitio web de la compañía: 42,500 mensuales
• Seguidores de LinkedIn: 8,700
• Seguidores de Twitter: 3.200

Canales de presentación regulatoria

Interacciones regulatorias en 2023:

Agencia reguladora	Presentaciones	Estado
FDA	3 aplicaciones IND	2 aprobado
EMA	2 aplicaciones de ensayos clínicos	1 aprobado

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negocio: segmentos de clientes

Compañías farmacéuticas

Arcturus Therapeutics se dirige a compañías farmacéuticas con tecnologías de vacunas de ARNm y ADN. A partir del cuarto trimestre de 2023, la compañía reportó posibles ingresos de colaboración de $ 12.3 millones.

Socio farmacéutico	Valor de colaboración	Enfoque tecnológico
Moderna	$ 3.5 millones	plataforma de vacuna ARNm
Janssen Pharmaceuticals	$ 6.2 millones	Desarrollo de la vacuna contra el ADN

Instituciones de investigación

Arcturus colabora con múltiples instituciones de investigación para el desarrollo terapéutico avanzado.

• Asociación de Investigación de la Universidad de Stanford
• Proyectos de colaboración de los Institutos Nacionales de Salud (NIH)
• Programa de Investigación de Vacunas de la Universidad de California

Proveedores de atención médica

Los segmentos de atención médica objetivo incluyen hospitales, clínicas y centros de inmunización. El mercado total direccionable estimado en $ 425 millones en 2024.

Pacientes con necesidades médicas insatisfechas

Arcturus se centra en trastornos genéticos raros y afecciones médicas desafiantes.

Condición médica	Población de pacientes	Valor de mercado potencial
Fibrosis quística	70,000 pacientes	$ 185 millones
Deficiencia de transcarbamilasa de ornitina	1 en 14,000 nacimientos	$ 52 millones

Mercados de desarrollo de vacunas

Arcturus apunta a los mercados de vacunas globales con tecnologías innovadoras de ARNm.

• Desarrollo de vacunas Covid-19
• Investigación de vacuna contra la influenza
• Vacunas de enfermedades infecciosas emergentes

Tamaño del mercado global de vacunas para 2024: $ 59.2 mil millones, con tecnologías de ARNm que representan una participación de mercado del 12.5%.

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, Arcturus Therapeutics reportó gastos totales de I + D de $ 156.3 millones. El desglose de los costos de I + D incluye:

Categoría de costos de I + D	Monto ($)
Desarrollo de la vacuna ARNm	68.4 millones
Plataforma de nanopartículas lipídicas Lunar®	42.7 millones
Programas de medicina genética	45.2 millones

Inversiones de ensayos clínicos

Los gastos de ensayo clínico para 2023 totalizaron $ 87.2 millones, con la siguiente asignación:

• Ensayos clínicos de vacuna Covid-19: $ 35.6 millones
• Terapias genéticas de enfermedades raras: $ 29.8 millones
• Ensayos de enfermedades hepáticas: $ 21.8 millones

Mantenimiento de patentes e propiedad intelectual

Los costos de propiedad intelectual para 2023 fueron de $ 12.5 millones, que incluyen:

Categoría de costos de IP	Monto ($)
Presentación de patentes y enjuiciamiento	7.3 millones
Gestión de cartera de IP	5.2 millones

Desarrollo de la plataforma tecnológica

Plataforma de nanopartículas lipídicas Lunar® Los costos de desarrollo en 2023 fueron de $ 53.6 millones, con inversiones clave en:

• Mejora de la plataforma: $ 28.4 millones
• Optimización de tecnología: $ 15.2 millones
• Nueva investigación de mecanismo de entrega: $ 10 millones

Costos operativos y administrativos

Los gastos operativos totales para 2023 alcanzaron $ 92.1 millones, distribuidos de la siguiente manera:

Categoría de costos operativos	Monto ($)
Gastos administrativos generales	42.6 millones
Ventas y marketing	29.5 millones
Instalaciones e infraestructura	20 millones

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negocio: flujos de ingresos

Venta potencial de vacuna y productos terapéuticos

Para el año fiscal 2023, Arcturus Therapeutics reportó ingresos totales de $ 14.9 millones, derivados principalmente del desarrollo de la vacuna COVID-19 y las tecnologías terapéuticas de ARNm.

Categoría de productos	Ingresos estimados (2023)
Vacuna para el COVID-19	$ 8.4 millones
Terapéutica de ARNm	$ 6.5 millones

Acuerdos de colaboración de investigación

Arcturus ha establecido múltiples acuerdos de colaboración de investigación que generan fuentes de ingresos adicionales.

• Colaboración con CSL Limited: pagos potenciales de hitos de hasta $ 200 millones
• Asociaciones de investigación en curso que generan $ 3.2 millones en fondos de investigación colaborativa

Plataformas de tecnología de licencia

Arcturus genera ingresos mediante la licencia de su tecnología de entrega de nanopartículas lipídicas LUNAR® patentadas.

Categoría de licencias	Ingresos anuales
Licencias de tecnología Lunar®	$ 2.7 millones

Subvenciones de investigación gubernamental y privada

Arcturus recibe fondos de instituciones de investigación gubernamentales y privadas.

• Subvenciones de los Institutos Nacionales de Salud (NIH): $ 1.5 millones
• Subvenciones de la Fundación de Investigación Privada: $ 750,000

Pagos de hitos de asociaciones farmacéuticas

Las asociaciones farmacéuticas proporcionan ingresos potenciales significativos a través de logros de hitos.

Asociación	Pagos potenciales de hitos
Asociación limitada CSL	Hasta $ 200 millones
Otras colaboraciones farmacéuticas	Aproximadamente $ 50 millones

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Value Propositions

Potential for lower dose requirements and superior immune response via STARR sa-mRNA.

The self-replicating RNA-based prophylactic vaccine technology is expected to provide lower dose requirements due to superior immune response and sustained protein expression when compared to non-self-replicating RNA-based vaccines. You can see this potential in the data from the ARCT-2304 program for Pandemic Influenza A Virus H5N1, where single doses at 1.5 µg, 5 µg, and 12 µg induced a humoral immune response similar to or higher than the MF59-adjuvanted pandemic vaccine.

The durability of the immune response is also a key value point. Head-to-head data for the ARCT-154 vaccine demonstrated that the self-amplifying mRNA (sa-mRNA) maintained superior immunogenicity compared to the conventional mRNA vaccine Comirnaty® for up to 12 months post-vaccination, and this was achieved at one-sixth the dose (5 µg vs 30 µg, respectively).

Effective and safe delivery of RNA therapeutics to target tissues using LUNAR.

The LUNAR® lipid-mediated delivery system is a multi-component drug delivery system built upon a library of over 250 proprietary lipids. This allows for customization of formulations for the indication and target cell type of interest. For the cystic fibrosis (CF) program, ARCT-032, which uses the inhaled LUNAR platform, showed encouraging interim Phase 2 data, with participants receiving 10 mg doses daily over 28 days showing a trend towards mucus plug reduction.

For the OTC deficiency program, ARCT-810, which also utilizes LUNAR delivery, demonstrated that the technology was generally safe and well tolerated in Phase 2 studies, with interim results showing stable ammonia levels in all patients during treatment.

Addressing high unmet medical needs in rare diseases (CF, OTC deficiency).

Arcturus Therapeutics Holdings Inc. is focusing its resources on developing therapeutics for rare diseases where the need is significant. For CF, ARCT-032 is intended for people who do not qualify for or benefit from available treatment options. For OTC deficiency, ARCT-810 is designed to address the underlying cause by enabling liver cells to produce the OTC enzyme, offering a solution where there are currently limited options for symptomatic patients.

The company is planning to initiate a 12-week safety and preliminary efficacy study in up to 20 CF participants in the first half of 2026. For OTC deficiency, alignment with regulatory agencies around pivotal trial strategy for both pediatric and adult populations is planned for the first half of 2026.

Customizable platform for diverse nucleic acid medicines (mRNA, siRNA, etc.).

The underlying technology is highly versatile, which is a major value driver for future pipeline expansion. The company's technologies are covered by an extensive patent portfolio consisting of over 500 patents and patent applications across the U.S., Europe, Japan, China, and other countries. This platform supports a broad range of modalities.

Here's a look at the diverse nucleic acid medicines the platform can be applied toward:

• Messenger RNA (mRNA)
• Small Interfering RNA (siRNA)
• Circular RNA
• Antisense RNA
• Self-Amplifying RNA (sa-mRNA)
• DNA
• Gene Editing Therapeutics

The financial health supports this platform development; Arcturus Therapeutics Holdings Inc. reported cash, cash equivalents and restricted cash of approximately $273.8 million as of March 31, 2025, with the cash runway expected to extend into 2028 following resource re-allocation.

The breadth of the platform is summarized below:

Platform Component	Key Feature/Metric	Associated Program Example
STARR® Technology	Expected lower dose requirements due to sustained protein expression.	ARCT-2304 (Pandemic Influenza)
LUNAR® Delivery	Library of over 250 proprietary lipids for customization.	ARCT-032 (CF) - Inhaled delivery
Modality Versatility	Supports mRNA, siRNA, circular RNA, antisense RNA, sa-mRNA, DNA, and gene editing.	ARCT-810 (OTC Deficiency) - IV infusion
Intellectual Property	Covered by over 500 patents and patent applications.	KOSTAIVE® (Commercial COVID-19 Vaccine)

The company reported a net loss of approximately $13.5 million for the three months ended September 30, 2025.

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Customer Relationships

You're looking at how Arcturus Therapeutics Holdings Inc. manages its key relationships, which heavily rely on high-value, strategic external parties rather than a broad consumer base. This is all about deep, focused engagement with partners, regulators, and the investment community.

High-touch, long-term strategic alliances with major pharmaceutical partners.

Arcturus Therapeutics Holdings Inc. structures its most critical relationships around collaborations, which form a primary source of its funding and commercial reach. These alliances generate revenue through license fees, consulting fees, technology transfer fees, reservation fees, and collaborative payments from pharmaceutical and biotechnology partners. For the three months ended September 30, 2025, total revenue was reported at $17.2 million, a decrease of $24.5 million compared to the same period in 2024. The decrease in revenue reflects lower milestone revenues recognized under the CSL collaboration agreement as KOSTAIVE transitions from a development program to the commercial phase. The KOSTAIVE COVID-19 vaccine has launched in Japan. The company is focused on continuing support from CSL to commercialize KOSTAIVE in Asia and Europe.

Metric	Period Ended September 30, 2025	Period Ended June 30, 2025	Period Ended March 31, 2025
Revenue from Alliances (3 Months)	$17.2 million	$28.3 million	$29.4 million
Revenue from Alliances (9/6 Months)	$74.8 million (9 Months)	$57.7 million (6 Months)	N/A

Direct engagement with key opinion leaders, physicians, and patient advocacy groups.

Direct engagement is vital for validating clinical progress in rare disease areas. Arcturus Therapeutics Holdings Inc. actively presents data to these groups to reinforce commitment to its pipeline candidates. For instance, the company hosted a virtual Key Opinion Leader (KOL) presentation of ARCT-810 Phase 2 interim data for Ornithine Transcarbamylase (OTC) deficiency on Monday, June 30, 2025, at 12:00 p.m. ET. This presentation featured KOLs like Marshall Summar, MD, an expert in urea cycle disorders. Also, conversations at the NACFC (North American Cystic Fibrosis Conference) with CF patients, physicians, investigators, and global experts reinforced the commitment to advance ARCT-032 further into development.

The company's pipeline focus includes:

• ARCT-810 for OTC deficiency, showing improved urea cycle function.
• ARCT-032 for cystic fibrosis (CF), with interim Phase 2 data presented in September 2025.

Intensive regulatory alignment efforts for pivotal trial designs (e.g., ARCT-810 Phase 3).

Achieving alignment with regulatory bodies dictates the path to market for its core therapeutics. Planned alignment with regulatory agencies around the pivotal trial strategy for ARCT-810 for OTC deficiency, covering both pediatric and adult populations, remains on track for the first half of 2026. Similarly, discussions with the FDA and other regulatory agencies for the ARCT-032 (CF) program regarding Phase 3 design are anticipated in the first half of 2026. The ARCT-2304 pandemic influenza vaccine candidate received U.S. FDA Fast Track Designation in April 2025.

Key regulatory milestones planned for 2026 include:

• Phase 3 trial design alignment for ARCT-810 with the FDA and other agencies.
• Discussions for Phase III initiation for ARCT-032.

Dedicated investor relations for transparent communication on clinical catalysts.

Arcturus Therapeutics Holdings Inc. maintains a regular cadence of communication with the investment community to discuss clinical catalysts and financial health. The company hosted its Third Quarter 2025 Earnings Call on Monday, November 10, 2025, at 4:30 p.m. ET. Prior to that, the Second Quarter 2025 Earnings Call took place on August 11, 2025, also at 4:30 p.m. ET. The company was active in investor outreach, participating in events like the Guggenheim Second Annual Healthcare Innovation Conference on November 12, 2025. The investor base shows significant institutional interest, with institutional ownership reported at 95.32%, while insider ownership stands at 8.17%. The analyst target price is set at $32.88. The company has extended its cash runway into 2028 following planned cost reductions.

Investor Relations Contact Information (as of Q1 2025):

• VP, Head of IR/PR/Marketing: Neda Safarzadeh.
• Email: IR@ArcturusRx.com.

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Channels

You're looking at how Arcturus Therapeutics Holdings Inc. gets its products and value propositions to its customers and partners as of late 2025. This involves a mix of established global partners, dedicated regional manufacturing, and the clinical trial network that serves as the initial access point for its therapeutic candidates.

Global commercial infrastructure of CSL Seqirus for vaccine distribution

Arcturus Therapeutics Holdings Inc. relies on its ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus for vaccine distribution channels. This partnership covers programs for SARS-CoV-2 (COVID-19), specifically the KOSTAIVE vaccine, and influenza. The transition of the COVID program to the commercial phase is impacting operational expenses, with a reported decrease in general and administrative expenses expected due to this transition. Regulatory milestones tied to this channel included an MAA (Marketing Authorization Application) filing in the United Kingdom anticipated in Q2 2025 for KOSTAIVE.

The financial output from these strategic alliances, which includes payments from the CSL Seqirus collaboration, is a primary revenue component for Arcturus Therapeutics Holdings Inc.

Reporting Period End Date	Revenue from Strategic Alliances and Collaborations
March 31, 2025 (Q1)	$29.4 million
June 30, 2025 (Q2)	$28.3 million
September 30, 2025 (Q3)	$17.2 million
Six Months Ended June 30, 2025	$57.7 million
Nine Months Ended September 30, 2025	$74.8 million

ARCALIS manufacturing and supply chain for Japanese market access

For the Japanese market, Arcturus Therapeutics Holdings Inc. utilizes its joint venture in Japan, ARCALIS, which is focused on the manufacture of mRNA vaccines and therapeutics. This entity is a key part of the supply chain, especially following the submission of a partial change application by Meiji Seika Pharma to include Japanese manufacturing sites, such as ARCALIS, Inc., for KOSTAIVE® approval. Furthermore, Arcturus Therapeutics Holdings Inc. is planning to transfer its cystic fibrosis manufacturing process technology to ARCALIS.

Direct out-licensing and technology transfer to biotech/pharma partners

The channel for direct engagement with partners involves revenue generated from license fees, consulting fees, technology transfer fees, and collaborative payments from research and development arrangements. This represents the direct monetization of Arcturus Therapeutics Holdings Inc.'s enabling technologies, such as LUNAR® lipid-mediated delivery and STARR® mRNA technology (sa-mRNA). The company's extensive patent portfolio, covering over 500 patents and patent applications across the U.S., Europe, Japan, and China, underpins these technology transfer channels.

Clinical trial sites and specialized treatment centers for therapeutic candidates

Clinical trial sites and specialized treatment centers serve as the initial channel for accessing patients for the therapeutic candidates, ARCT-032 for cystic fibrosis (CF) and ARCT-810 for OTC deficiency.

• ARCT-032 Phase 2 study (NCT06747858) is advancing, with interim data expected in September 2025 from the first 9 enrolled participants.
• Enrollment for the ARCT-032 study is expected to complete by year-end 2025.
• A follow-up 12-week study for ARCT-032 is planned to begin in the first half of 2026, enrolling up to 20 CF participants.
• For ARCT-810, a prior placebo-controlled European study completed dosing in 8 OTC deficient individuals (0.3 mg/kg cohort).
• A separate Phase 1 vaccine trial (NCT06602531) completed recruitment of 212 adults across multiple sites in the U.S..

Meetings with the FDA and other regulatory agencies to discuss pivotal trials and Phase III initiation for these therapeutics are anticipated in the first half of 2026.

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Customer Segments

You're looking at the core groups Arcturus Therapeutics Holdings Inc. serves as of late 2025, focusing on both their rare disease pipeline and their established vaccine partnerships. It's a mix of specialized patient groups and large institutional buyers.

Patients with Ornithine Transcarbamylase (OTC) deficiency

• Target population in Europe and the U.S. is approximately 10,000 people.
• Treatment candidate ARCT-810 aims to express functional OTC enzyme in the liver.
• Phase 2 data review in June 2025 showed ARCT-810 significantly and consistently reduced biomarker glutamine to levels within the normal range.
• Pivotal trial strategy alignment with regulatory agencies is planned for the first half of 2026.

Cystic Fibrosis (CF) patients intolerant to or non-responsive to current CFTR modulators

• ARCT-032 is the inhaled mRNA therapeutic candidate for CF.
• Interim Phase 2 data in October 2025 showed observed mucus plug reduction after 28 days of treatment in Class I CF adults.
• A 12-week safety and preliminary efficacy study in up to 20 CF participants is planned to start in the first half of 2026.

Global pharmaceutical and biotechnology companies seeking advanced mRNA platforms

This segment is primarily engaged through strategic alliances and collaborations, which form a key part of Arcturus Therapeutics Holdings Inc.'s revenue base, though these streams have seen recent fluctuations.

Financial Metric (As of Q3 2025)	Amount	Context
Revenue (Three Months Ended Sept 30, 2025)	$17.2 million	Represents a decrease of $24.5 million compared to Q3 2024.
Revenue (Nine Months Ended Sept 30, 2025)	$74.8 million	Represents a decrease of $54.7 million compared to the same period in 2024.
Primary Revenue Source	License fees, consulting, technology transfer fees, reservation fees, and collaborative payments	Revenue streams tied to R&D arrangements with partners.
Cash Position (As of Sept 30, 2025)	$237.3 million	Cash, cash equivalents and restricted cash balance.

Government and public health agencies for infectious disease vaccine supply

This segment is characterized by large-scale supply agreements, particularly for pandemic preparedness and seasonal vaccines, though recent revenue has been lower due to supply agreement activity changes.

• Revenue decline in Q3 2025 was partly attributed to reduced revenue from government agencies.
• The company has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus.
• Work on the BARDA pandemic flu program (ARCT-2304) had Phase 1 results expected in 2025, funded under contract number 75A50122C00007.
• A definitive supply agreement was executed with the Israeli Ministry of Health for the COVID-19 vaccine candidate (ARCT-021).

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Cost Structure

High Research and Development (R&D) expenses are central to Arcturus Therapeutics Holdings Inc.'s cost structure, reflecting the intensive nature of advancing its messenger RNA (mRNA) pipeline, specifically ARCT-032 for cystic fibrosis (CF) and ARCT-810 for ornithine transcarbamylase (OTC) deficiency.

Total operating expenses were $119.8 million for the nine months ended 9/30/2025.

The company's cost breakdown for the nine months ended September 30, 2025, shows a significant shift in spending priorities:

Expense Category	Amount for Nine Months Ended 9/30/2025	Comparison to Nine Months Ended 9/30/2024
Research and Development Expenses	$87.7 million	Decrease from $151.4 million
Total Operating Expenses (Required Figure)	$119.8 million	Not explicitly stated as a comparison

Manufacturing and clinical trial costs, which are primary components of R&D, saw reductions due to program transitions. The decrease in R&D expenses was primarily driven by lower manufacturing costs for the LUNAR-COVID program, reflecting its transition to the commercial phase, and additional decreases from LUNAR-FLU and LUNAR-CF programs. Still, these reductions were partially offset by higher clinical costs for Phase 2 of the LUNAR-CF program.

General and administrative (G&A) expenses also showed a downward trend, which you'd expect given the focus on core development. For the three months ended September 30, 2025, G&A expenses totaled $10.4 million, down from $13.3 million in the third quarter of 2024. These expenses cover necessary overhead, including patent maintenance and legal fees, though the company expects G&A to continue to decrease slightly in fiscal year 26, driven by lower share-based compensation costs.

The cost management strategy is clear: focus spending on the highest-potential assets while reducing burn. This is supported by the balance sheet position and forward-looking statements:

• Cash, cash equivalents and restricted cash stood at $237.3 million as of September 30, 2025.
• The U.S. BLA filing for KOSTAIVE was delayed indefinitely due to FDA regulatory changes.
• Additional cost reductions were planned in the fourth quarter of 2025.
• These actions, combined with delaying the Phase 3 CF clinical trial commencement until 2027, extend the cash runway into 2028.

The CFO confirmed the decision to reduce additional expenses to extend the runway specifically for the CF and OTC deficiency programs.

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Revenue Streams

You're looking at the financial engine of Arcturus Therapeutics Holdings Inc. (ARCT) as of late 2025. The revenue picture is dominated by partnerships right now, with the transition of KOSTAIVE® affecting the recognition schedule.

The total recognized revenue for the nine months ended September 30, 2025, was $74.8 million. This figure is down significantly from the $129.54 million reported for the same nine-month period in 2024.

Collaboration revenue from partners is the core component. This includes license fees, consulting fees, technology transfer fees, reservation fees, and collaborative payments from research and development arrangements with biotechnology and pharmaceutical partners. The recent revenue decline was primarily driven by reduced revenue from the CSL collaboration, which reflects lower supply agreement activity and a lower amortization of the upfront payment as KOSTAIVE progresses toward commercialization.

Here's a snapshot of the key financial metrics around these revenue streams:

Metric	Amount (9 Months Ended 9/30/2025)	Comparison Point
Total Revenue	$74.8 million	Down from $129.54 million in 9M 2024
Q3 2025 Revenue	$17.2 million	Down from $41.7 million in Q3 2024
Cash, Cash Equivalents, Restricted Cash	$237.3 million (as of 9/30/2025)	Down from $293.9 million (as of 12/31/2024)
Expected Cash Runway	Extended into 2028	Achieved through cost reductions planned in Q4 2025

Regarding commercial product sales, KOSTAIVE®, the self-amplifying mRNA COVID vaccine, is approved in Japan through the joint venture ARCALIS and partner Meiji Seika Pharma. While the structure involves a potential net profit share, the specific financial terms for this stream aren't detailed in the latest filings, though the transition away from development revenue has impacted current figures. The U.S. BLA filing for KOSTAIVE has been delayed indefinitely due to changes in FDA regulatory requirements.

Grant revenue from government agencies for specific vaccine development programs is another source, though it contributed to the overall revenue decline for the nine-month period. For example, the ARCT-2304 H5N1 vaccine candidate has received support from the U.S. Department of Health and Human Services/BARDA under contract number 75A50122C0007.

Future product sales from wholly-owned rare disease therapeutics post-regulatory approval represent the next major potential revenue shift. Arcturus Therapeutics Holdings Inc. is focused on advancing these candidates:

• ARCT-032 for cystic fibrosis (CF), with interim Phase 2 data expected from the first nine enrolled participants in September 2025.
• ARCT-810 for ornithine transcarbamylase (OTC) deficiency, with ongoing Phase 2 dosing.

The company is planning a 12-week safety and preliminary efficacy study for ARCT-032 to start in the first half of 2026. The successful progression of these wholly-owned assets is key to future, non-collaboration-dependent revenue streams.

Finance: draft 13-week cash view by Friday.