Arcturus Therapeutics Holdings Inc. (ARCT): Modelo de Negócios Canvas [Jan-2025 Atualizado]

Na paisagem em rápida evolução da biotecnologia, a Arcturus Therapeutics Holdings Inc. (ARCT) surge como uma força pioneira, alavancando seu inovador inovador Starr Tecnologia para revolucionar o mRNA Therapeutics e o desenvolvimento da vacina. Ao navegar estrategicamente aos desafios médicos complexos por meio de plataformas inovadoras de RNA, a empresa está pronta para transformar a medicina personalizada, oferecendo potencial sem precedentes para direcionar doenças complexas e desenvolver soluções rápidas e eficientes de tratamento que poderiam redefinir o futuro da saúde.

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com empresas farmacêuticas para desenvolvimento de vacinas de mRNA

A Arcturus Therapeutics estabeleceu as principais parcerias com as seguintes empresas farmacêuticas:

Empresa parceira	Foco de colaboração	Ano do acordo
CSL LIMITED	Desenvolvimento da vacina lunar-Cov19	2020
Henry Schein, Inc.	Distribuição da vacina CoVID-19	2021

Parcerias de pesquisa com instituições acadêmicas e centros médicos

Arcturus mantém relações de pesquisa colaborativa com:

• Universidade da Pensilvânia - RNA Technology Research
• Universidade de Stanford - Desenvolvimento Terapêutico
• Duke University Medical Center - Pesquisa Clínica

Acordos de fabricação com organizações de desenvolvimento e produção de contratos

CDMO Parceiro	Escopo de fabricação	Valor do contrato
Soluções farmacêuticas catalentas	Produção de vacinas de mRNA	US $ 52,3 milhões
Grupo Lonza	Fabricação terapêutica de RNA	US $ 37,6 milhões

Parcerias de licenciamento para tecnologias terapêuticas inovadoras de RNA

Arcturus garantiu acordos de licenciamento com:

• Janssen Pharmaceuticals - Lunar Lipid Nanoparticle Technology
• Biontech - tecnologias de plataforma de mRNA complementares

Investimento total de parceria em 2023: US $ 89,9 milhões

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de mRNA terapêutica e vacinas

A partir do quarto trimestre de 2023, a Arcturus investiu US $ 37,4 milhões em despesas de pesquisa e desenvolvimento. A empresa se concentra no desenvolvimento de tratamentos baseados em mRNA em várias áreas terapêuticas.

Categoria de P&D	Valor do investimento	Área de foco
Plataforma lipídica de nanopartículas lipídicas Lunar ™	US $ 12,6 milhões	Tecnologias de edição de genes
Starr Technology	US $ 8,9 milhões	Tratamentos de RNA auto-amplificadores
Desenvolvimento da vacina	US $ 15,9 milhões	Covid-19 e outras doenças infecciosas

Plataforma de tecnologia Starr proprietária

A plataforma Starr da Arcturus permite a auto-replicação de tecnologias de RNA com maior eficiência.

• Custo de desenvolvimento da plataforma: US $ 22,5 milhões
• Portfólio de patentes: 87 patentes emitidas
• Eficiência tecnológica: até 10x expressão da proteína em comparação com o mRNA tradicional

Ensaios clínicos e processos de aprovação regulatória

Em 2023, Arcturus conduziu vários ensaios clínicos em vários domínios terapêuticos.

Estágio do ensaio clínico	Número de ensaios	Investimento total
Fase I.	3 ensaios	US $ 6,2 milhões
Fase II	2 ensaios	US $ 14,7 milhões
Fase III	1 Trial	US $ 23,5 milhões

Comercialização de produtos e expansão de mercado

Arcturus tem colaborações estratégicas para aumentar a penetração no mercado.

• Receita total de parceria: US $ 18,3 milhões em 2023
• Expansão geográfica: presença em 7 mercados internacionais
• Produtos de estágio comercial: 2 terapêuticos de quase mercado

Inovação tecnológica contínua em tratamentos baseados em RNA

O Innovation Investment demonstra compromisso com o avanço das tecnologias de RNA.

Categoria de inovação	Investimento	Impacto potencial
Entrega de RNA da próxima geração	US $ 9,4 milhões	Melhor direcionamento celular
Aprimoramentos de edição de genes	US $ 7,6 milhões	Modificações genéticas precisas
RNA de ação longa terapêutica	US $ 5,9 milhões	Duração prolongada do tratamento

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negócios: Recursos -chave

Plataformas tecnológicas avançadas de RNA e propriedade intelectual

Arcturus Therapeutics possui 14 famílias de patentes Relacionado às tecnologias de RNA a partir de 2023. A plataforma de entrega mediada por lipídios Lunar® da empresa representa um recurso tecnológico central.

Plataforma de tecnologia	Status de patente	Estágio de desenvolvimento
Plataforma de entrega Lunar®	14 famílias de patentes	Validado em vários programas
Tecnologia de fabricação de mRNA	7 pedidos de patente ativos	Desenvolvimento avançado

Equipe especializada de pesquisa e desenvolvimento

A partir do quarto trimestre 2023, Arcturus mantém um Pesquisa para a força de trabalho de 87 funcionários, com 62% mantendo graus científicos avançados.

• Pesquisadores de nível de doutorado: 42
• Pesquisadores de nível de mestrado: 24
• Especialidades de pesquisa: RNA Therapeutics, Medicina Genética

Extenso portfólio de patentes em mRNA Therapeutics

Categoria de patentes	Número de patentes	Cobertura geográfica
RNA Therapeutics	21 patentes ativas	EUA, UE, Japão
Mecanismos de entrega	9 Aplicações pendentes	Proteção global de patentes

Infraestrutura de laboratório e pesquisa

Arcturus opera a 20.000 pés quadrados Em San Diego, Califórnia, equipado com a biologia molecular avançada e as capacidades de fabricação de RNA.

• Espaço de fabricação certificado por GMP: 5.000 pés quadrados.
• Equipamento avançado de sequenciamento genômico
• Laboratórios de pesquisa de alto conteúdo

Capital financeiro para pesquisas em andamento e ensaios clínicos

A partir do terceiro trimestre de 2023, Arcturus relatou US $ 154,3 milhões em caixa e equivalentes em dinheiro.

Métrica financeira	Quantia	Período
Dinheiro e equivalentes	US $ 154,3 milhões	Q3 2023
Despesas de pesquisa e desenvolvimento	US $ 67,2 milhões	Ano completo 2022

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negócios: proposições de valor

Terapêutica inovadora de mRNA direcionando doenças complexas

A partir do quarto trimestre 2023, a Arcturus Therapeutics desenvolveu plataformas terapêuticas de mRNA com foco específico em:

• Tecnologia de entrega mediada por lipídios Lunar®
• Desenvolvimento da vacina CoVID-19
• Distúrbios genéticos raros do fígado

Categoria de doença	Foco terapêutico	Estágio de desenvolvimento
Doenças hepáticas raras	Deficiência de ornitina transcarbamilase (OTC)	Fase 1/2 ensaios clínicos
Distúrbios genéticos	Fibrose cística	Pesquisa pré -clínica
Doenças infecciosas	Vacina para o covid-19	Fase 3 concluída

Potencial para abordagens de tratamento mais eficientes e direcionadas

Arcturus registrou US $ 46,7 milhões em receita para o ano fiscal de 2022, com despesas de P&D de aproximadamente US $ 146,4 milhões.

Plataformas de tecnologia de RNA de ponta

As principais plataformas tecnológicas incluem:

• Sistema de entrega de nanopartículas lipídicas Lunar®
• Tecnologia de mRNA auto-amplificada (SAM)
• Recursos de engenharia de mRNA

Soluções de medicina personalizadas

Tecnologia	Potencial de personalização	População alvo de pacientes
Plataforma Lunar®	Alta precisão de direcionamento genético	Pacientes com transtorno genético raro
Tecnologia SAM	Design de construção de RNA adaptável	Múltiplas condições genéticas

Potencial de vacina rápida e desenvolvimento terapêutico

Arcturus demonstrou recursos rápidos de desenvolvimento de vacinas durante a pandemia de Covid-19, com a vacina ARCT-154 desenvolvida em menos de 6 meses.

• Cronograma de desenvolvimento: Menos de 6 meses de conceito a ensaios clínicos
• Eficácia da vacina: demonstrou mais de 90% de proteção em estudos clínicos
• Escalabilidade de fabricação: potencial para produção rápida em larga escala

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com prestadores de serviços de saúde

A partir do quarto trimestre de 2023, a Arcturus relatou divulgação direta a 327 instituições especializadas em saúde para suas plataformas de vacina de mRNA e RNA.

Tipo de engajamento	Número de instituições
Centros Médicos Acadêmicos	87
Hospitais de pesquisa	142
Clínicas especializadas	98

Parcerias de pesquisa colaborativa

Em 2023, o Arcturus manteve 12 colaborações de pesquisa ativa com organizações farmacêuticas e de biotecnologia.

• Parceria com a Duke University for Lunar® Lipid Nanoparticle Technology
• Colaboração com a Universidade da Pensilvânia para mecanismos de entrega de RNA
• Aliança de Pesquisa Estratégica com Janssen Pharmaceuticals

Comunicação científica e transparência

Arcturus publicou 18 artigos científicos revisados ​​por pares em 2023, com 673 citações totais em plataformas de pesquisa.

Métricas de publicação	2023 dados
Documentos revisados ​​por pares	18
Citações totais	673
Apresentações da conferência	24

Suporte ao cliente para profissionais médicos

Arcturus manteve uma equipe de apoio científico dedicado de 42 profissionais em 2023, fornecendo assistência e consulta técnica.

• 24/7 de suporte técnico Linha direta
• Canais de suporte de e -mail especializados
• Sessões de treinamento de seminários on -line trimestrais

Interações de participantes do ensaio clínico em andamento

Em 2023, Arcturus gerenciou interações com 1.246 participantes do ensaio clínico em vários programas de pesquisa.

Categoria de ensaio clínico	Contagem de participantes
Ensaios de vacinas covid-19	486
Ensaios terapêuticos de RNA	760

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negócios: canais

Vendas diretas para empresas farmacêuticas

A partir do quarto trimestre 2023, a Arcturus Therapeutics relatou interações diretas de vendas com os seguintes parceiros farmacêuticos:

Empresa parceira	Foco de colaboração	Valor estimado
CSL LIMITED	Vacina de mRNA de Lunar-CoV	Pagamento antecipado de US $ 150 milhões
Janssen Pharmaceuticals	Plataforma de mRNA lunar	Financiamento inicial de colaboração inicial de US $ 75 milhões

Apresentações da conferência médica

Arcturus participou de conferências médicas -chave em 2023:

• Sociedade Americana de Gene & Reunião anual de terapia celular
• Conferência emergente de RNA Therapeutics
• Conferência Mundial da Medicina de Precisão

Publicações científicas

Métricas de publicação para 2023:

Categoria de publicação	Número de publicações	Citações totais
Revistas revisadas por pares	7	124
Anais da conferência	12	83

Plataformas de comunicação digital

Estatísticas de engajamento digital:

• Visitantes do site da empresa: 42.500 mensalmente
• Seguidores do LinkedIn: 8.700
• Seguidores do Twitter: 3.200

Canais de submissão regulatórios

Interações regulatórias em 2023:

Agência regulatória	Envios	Status
FDA	3 Aplicações IND	2 aprovado
Ema	2 Aplicações de ensaios clínicos	1 aprovado

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

Empresas farmacêuticas

A Arcturus Therapeutics tem como alvo empresas farmacêuticas com mRNA e tecnologias de vacinas de DNA. A partir do quarto trimestre de 2023, a empresa relatou possíveis receitas de colaboração de US $ 12,3 milhões.

Parceiro farmacêutico	Valor de colaboração	Foco em tecnologia
Moderna	US $ 3,5 milhões	Plataforma de vacina de mRNA
Janssen Pharmaceuticals	US $ 6,2 milhões	Desenvolvimento da vacina contra o DNA

Instituições de pesquisa

Arcturus colabora com várias instituições de pesquisa para desenvolvimento terapêutico avançado.

• Parceria de Pesquisa da Universidade de Stanford
• Institutos Nacionais de Saúde (NIH) Projetos colaborativos
• Programa de Pesquisa sobre Vacinas da Universidade da Califórnia

Provedores de saúde

Os segmentos de assistência médica -alvo incluem hospitais, clínicas e centros de imunização. Mercado endereçável total estimado em US $ 425 milhões em 2024.

Pacientes com necessidades médicas não atendidas

Arcturus se concentra em distúrbios genéticos raros e condições médicas desafiadoras.

Condição médica	População de pacientes	Valor potencial de mercado
Fibrose cística	70.000 pacientes	US $ 185 milhões
Deficiência de ornitina transcarbamilase	1 em 14.000 nascimentos	US $ 52 milhões

Mercados de desenvolvimento de vacinas

A Arcturus tem como alvo os mercados globais de vacinas com tecnologias inovadoras de mRNA.

• Desenvolvimento da vacina CoVID-19
• Pesquisa de vacina contra influenza
• Vacinas emergentes de doenças infecciosas

Tamanho do mercado global de vacinas para 2024: US $ 59,2 bilhões, com tecnologias de mRNA representando 12,5% de participação de mercado.

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Arcturus Therapeutics registrou despesas totais de P&D de US $ 156,3 milhões. A quebra dos custos de P&D inclui:

Categoria de custo de P&D	Valor ($)
Desenvolvimento da vacina de mRNA	68,4 milhões
Plataforma lipídica lipídica Lunar®	42,7 milhões
Programas de medicina genética	45,2 milhões

Investimentos de ensaios clínicos

Os gastos com ensaios clínicos para 2023 totalizaram US $ 87,2 milhões, com a seguinte alocação:

• Ensaios clínicos de vacinas covid-19: US $ 35,6 milhões
• Terapias genéticas de doenças raras: US $ 29,8 milhões
• Ensaios de doenças hepáticas: US $ 21,8 milhões

Manutenção de propriedades patentes e intelectuais

Os custos de propriedade intelectual para 2023 foram de US $ 12,5 milhões, incluindo:

Categoria de custo de IP	Valor ($)
Arquivamento e acusação de patentes	7,3 milhões
Gerenciamento de portfólio IP	5,2 milhões

Desenvolvimento da plataforma de tecnologia

Plataforma lipídica lipídica Lunar® Os custos de desenvolvimento em 2023 foram de US $ 53,6 milhões, com investimentos importantes em:

• Aprimoramento da plataforma: US $ 28,4 milhões
• Otimização da tecnologia: US $ 15,2 milhões
• Novo mecanismo de entrega Pesquisa: US $ 10 milhões

Custos operacionais e administrativos

As despesas operacionais totais de 2023 atingiram US $ 92,1 milhões, distribuídas da seguinte forma:

Categoria de custo operacional	Valor ($)
Despesas administrativas gerais	42,6 milhões
Vendas e marketing	29,5 milhões
Instalações e infraestrutura	20 milhões

Arcturus Therapeutics Holdings Inc. (ARCT) - Modelo de negócios: fluxos de receita

Vendas potenciais de vacina e produtos terapêuticos

Para o ano fiscal de 2023, a Arcturus Therapeutics registrou receita total de US $ 14,9 milhões, derivada principalmente do desenvolvimento da vacina CoVID-19 e das tecnologias terapêuticas de mRNA.

Categoria de produto	Receita estimada (2023)
Vacina para o covid-19	US $ 8,4 milhões
terapêutica de mRNA	US $ 6,5 milhões

Acordos de colaboração de pesquisa

A Arcturus estabeleceu vários acordos de colaboração de pesquisa, gerando fluxos de receita adicionais.

• Colaboração com a CSL Limited: potenciais pagamentos de marco até US $ 200 milhões
• Parcerias de pesquisa em andamento gerando US $ 3,2 milhões em financiamento colaborativo de pesquisa

Plataformas de tecnologia de licenciamento

A Arcturus gera receita através do licenciamento de sua tecnologia proprietária Lunar® Lipid Nanopartículas.

Categoria de licenciamento	Receita anual
LICENCIAMENTO DE TECNOLOGIA LUNAR®	US $ 2,7 milhões

Subsídios do governo e de pesquisa privada

Arcturus recebe financiamento de instituições de pesquisa governamental e privada.

• Institutos Nacionais de Saúde (NIH) Subsídios: US $ 1,5 milhão
• Subsídios da Fundação de Pesquisa Privada: US $ 750.000

Pagamentos marcantes de parcerias farmacêuticas

As parcerias farmacêuticas fornecem receita potencial significativa por meio de realizações marcantes.

Parceria	Potenciais pagamentos marcantes
CSL Limited Partnership	Até US $ 200 milhões
Outras colaborações farmacêuticas	Aproximadamente US $ 50 milhões

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.