Arcturus Therapeutics Holdings Inc. (ARCT): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage en évolution rapide de la biotechnologie, Arcturus Therapeutics Holdings Inc. (ARCT) apparaît comme une force pionnière, tirant parti de son révolutionnaire Starr Technologie pour révolutionner les thérapies de l'ARNm et le développement des vaccins. En parcourant stratégiquement des défis médicaux complexes à travers des plateformes d'ARN innovantes, l'entreprise est prête à transformer la médecine personnalisée, offrant un potentiel sans précédent pour cibler les maladies complexes et développer des solutions de traitement rapides et efficaces qui pourraient redéfinir l'avenir de Healthcare.

Arcturus Therapeutics Holdings Inc. (ARCT) - Modèle commercial: partenariats clés

Collaborations stratégiques avec des sociétés pharmaceutiques pour le développement du vaccin contre l'ARNm

Arcturus Therapeutics a établi des partenariats clés avec les sociétés pharmaceutiques suivantes:

Entreprise partenaire	Focus de la collaboration	Année des accords
CSL Limited	Développement du vaccin Lunar-CoV19	2020
Henry Schein, Inc.	Distribution du vaccin Covid-19	2021

Partenariats de recherche avec les établissements universitaires et les centres médicaux

Arcturus entretient des relations de recherche en collaboration avec:

• Université de Pennsylvanie - Recherche technologique de l'ARN
• Université de Stanford - Développement thérapeutique
• Duke University Medical Center - Recherche clinique

Accords de fabrication avec des organisations de développement et de production de contrats

Partenaire CDMO	Champ de fabrication	Valeur du contrat
Solutions pharmatriques catalennes	Production de vaccins ARNm	52,3 millions de dollars
Groupe Lonza	Fabrication thérapeutique à l'ARN	37,6 millions de dollars

Licence des partenariats pour les technologies thérapeutiques innovantes de l'ARN

Arcturus a obtenu des accords de licence avec:

• Janssen Pharmaceuticals - technologie de nanoparticules lipidiques lunaires
• BIONTECH - Technologies complémentaires de plate-forme d'ARNm

Investissement total de partenariat en 2023: 89,9 millions de dollars

Arcturus Therapeutics Holdings Inc. (ARCT) - Modèle d'entreprise: activités clés

Recherche et développement des thérapies et des vaccins de l'ARNm

Au quatrième trimestre 2023, Arcturus a investi 37,4 millions de dollars dans les frais de recherche et de développement. L'entreprise se concentre sur le développement de traitements basés sur l'ARNm dans plusieurs domaines thérapeutiques.

Catégorie de R&D	Montant d'investissement	Domaine de mise au point
Plate-forme de nanoparticules lipidiques lunar ™	12,6 millions de dollars	Technologies d'édition de gènes
Starr Technology	8,9 millions de dollars	Traitements ARN auto-amplifiant
Développement	15,9 millions de dollars	Covid-19 et autres maladies infectieuses

Plateforme de technologie Starr propriétaire

La plate-forme Starr d'Arcturus permet d'auto-répliquer les technologies d'ARN avec une efficacité améliorée.

• Coût de développement de la plate-forme: 22,5 millions de dollars
• Portefeuille de brevets: 87 brevets délivrés
• Efficacité technologique: jusqu'à 10x expression protéique par rapport à l'ARNm traditionnel

Essais cliniques et processus d'approbation réglementaire

En 2023, Arcturus a mené de multiples essais cliniques dans divers domaines thérapeutiques.

Étape d'essai clinique	Nombre de procès	Investissement total
Phase I	3 essais	6,2 millions de dollars
Phase II	2 essais	14,7 millions de dollars
Phase III	1 essai	23,5 millions de dollars

Commercialisation des produits et expansion du marché

Arcturus a des collaborations stratégiques pour améliorer la pénétration du marché.

• Revenus de partenariat total: 18,3 millions de dollars en 2023
• Expansion géographique: présence sur 7 marchés internationaux
• Produits de scène commerciale: 2 thérapies quasi marché

Innovation technologique continue dans les traitements basés sur l'ARN

L'investissement en innovation démontre un engagement à faire progresser les technologies d'ARN.

Catégorie d'innovation	Investissement	Impact potentiel
Livraison d'ARN de nouvelle génération	9,4 millions de dollars	Ciblage cellulaire amélioré
Améliorations d'édition de gènes	7,6 millions de dollars	Modifications génétiques précises
Thérapeutique ARN à longue durée	5,9 millions de dollars	Durée du traitement prolongé

Arcturus Therapeutics Holdings Inc. (ARCT) - Modèle d'entreprise: Ressources clés

Plates-formes technologiques et propriété intellectuelle avancées

Arcturus Therapeutics tient 14 familles de brevets lié aux technologies d'ARN en 2023. La plate-forme de livraison médiée par les lipides Lunar® de l'entreprise représente une ressource technologique de base.

Plate-forme technologique	Statut de brevet	Étape de développement
Plateforme de livraison Lunar®	14 familles de brevets	Validé dans plusieurs programmes
technologie de fabrication d'ARNm	7 demandes de brevet actives	Développement avancé

Équipe de recherche et développement spécialisée

Depuis le Q4 2023, Arcturus maintient un Travail de recherche de 87 employés, avec 62% détenant des degrés scientifiques avancés.

• Rechercheurs de doctorat: 42
• Chercheurs de niveau Masters: 24
• Spécialités de recherche: thérapeutique ARN, médecine génétique

Portfolio des brevets étendus dans l'ARNm Therapeutics

Catégorie de brevet	Nombre de brevets	Couverture géographique
Thérapeutique à l'ARN	21 brevets actifs	États-Unis, UE, Japon
Mécanismes de livraison	9 applications en attente	Protection mondiale des brevets

Infrastructure de laboratoire et de recherche

Arcturus exploite un Installation de recherche de 20 000 pieds carrés À San Diego, en Californie, équipé d'une biologie moléculaire avancée et de capacités de fabrication d'ARN.

• Espace de fabrication certifié GMP: 5 000 pieds carrés.
• Équipement de séquençage génomique avancé
• Laboratoires de recherche à haut contactions

Capital financier pour la recherche en cours et les essais cliniques

Au troisième rang 2023, Arcturus a rapporté 154,3 millions de dollars en espèces et équivalents en espèces.

Métrique financière	Montant	Période
Espèce et équivalents	154,3 millions de dollars	Q3 2023
Frais de recherche et de développement	67,2 millions de dollars	Année complète 2022

Arcturus Therapeutics Holdings Inc. (ARCT) - Modèle d'entreprise: propositions de valeur

Thérapeutique d'ARNm innovante ciblant les maladies complexes

Depuis le Q4 2023, Arcturus Therapeutics a développé des plateformes thérapeutiques d'ARNm en mettant l'accent sur:

• Technologie de livraison médiée par les lipides Lunar®
• Développement du vaccin Covid-19
• Troubles génétiques du foie rares

Catégorie de maladie	Focus thérapeutique	Étape de développement
Maladies hépatiques rares	Ornithine Transcarbamylase (OTC)	Essais cliniques de phase 1/2
Troubles génétiques	Fibrose kystique	Recherche préclinique
Maladies infectieuses	Vaccin contre le covid-19	Phase terminée 3

Potentiel d'approches de traitement plus efficaces et ciblées

Arcturus a déclaré 46,7 millions de dollars de revenus pour l'exercice 2022, avec des dépenses de R&D d'environ 146,4 millions de dollars.

Plates-formes technologiques de l'ARN de pointe

Les plates-formes technologiques clés comprennent:

• Système de livraison de nanoparticules lipidiques Lunar®
• Technologie de l'ARNm d'auto-amplification (SAM)
• Capacités d'ingénierie de l'ARNm

Solutions de médecine personnalisées

Technologie	Potentiel de personnalisation	Cible de la population de patients
Plate-forme Lunar®	Précision de ciblage génétique élevée	Patients de troubles génétiques rares
Technologie SAM	Conception de construction d'ARN adaptable	Multiples conditions génétiques

Potentiel de vaccin rapide et de développement thérapeutique

Arcturus a démontré des capacités rapides de développement des vaccins pendant la pandémie Covid-19, avec un vaccin ARCT-154 développé en moins de 6 mois.

• Chronologie du développement: Moins de 6 mois du concept aux essais cliniques
• Efficacité du vaccin: une protection démontrée de plus de 90% dans les études cliniques
• Évolutivité de la fabrication: potentiel d'une production rapide à grande échelle

Arcturus Therapeutics Holdings Inc. (ARCT) - Modèle d'entreprise: relations clients

Engagement direct avec les prestataires de soins de santé

Depuis le quatrième trimestre 2023, Arcturus a signalé une sensibilisation directe à 327 institutions de soins de santé spécialisées pour ses plateformes de vaccin contre l'ARNm et de thérapeutiques ARN.

Type d'engagement	Nombre d'institutions
Centres médicaux académiques	87
Hôpitaux de recherche	142
Cliniques spécialisées	98

Partenariats de recherche collaborative

En 2023, Arcturus a maintenu 12 collaborations de recherche active avec des organisations pharmaceutiques et biotechnologiques.

• Partenariat avec Duke University for Lunar® Lipid Nanoparticle Technology
• Collaboration avec l'Université de Pennsylvanie pour les mécanismes de livraison d'ARN
• Alliance de recherche stratégique avec Janssen Pharmaceuticals

Communication scientifique et transparence

Arcturus a publié 18 articles scientifiques évalués par des pairs en 2023, avec 673 citations totales sur les plateformes de recherche.

Métriques de publication	2023 données
Documents évalués par des pairs	18
Total des citations	673
Présentations de conférence	24

Support client pour les professionnels de la santé

Arcturus a maintenu une équipe de soutien scientifique dédiée à 42 professionnels en 2023, fournissant une assistance technique et une consultation.

• Hotline de support technique 24/7
• Canaux d'assistance par e-mail spécialisés
• Sessions de formation de webinaires trimestriels

Interactions des participants en cours d'essai clinique

En 2023, Arcturus a géré les interactions avec 1 246 participants à l'essai clinique dans plusieurs programmes de recherche.

Catégorie d'essais cliniques	Comptage des participants
Essais de vaccinations Covid-19	486
Essais thérapeutiques à l'ARN	760

Arcturus Therapeutics Holdings Inc. (ARCT) - Modèle d'entreprise: canaux

Ventes directes aux sociétés pharmaceutiques

Depuis le quatrième trimestre 2023, Arcturus Therapeutics a signalé des interactions de ventes directes avec les partenaires pharmaceutiques suivants:

Entreprise partenaire	Focus de la collaboration	Valeur estimée
CSL Limited	Vaccin contre l'ARNm lunaire	Paiement initial de 150 millions de dollars
Janssen Pharmaceuticals	Plate-forme d'ARNm lunaire	Financement de collaboration initiale de 75 millions de dollars

Présentations de la conférence médicale

Arcturus a participé à des conférences médicales clés en 2023:

• Société américaine de gène & Réunion annuelle de thérapie cellulaire
• Conférence émergente de l'ARN thérapeutique
• Conférence du monde de la médecine de précision

Publications scientifiques

Métriques de publication pour 2023:

Catégorie de publication	Nombre de publications	Total des citations
Journaux évalués par des pairs	7	124
Actes de conférence	12	83

Plateformes de communication numérique

Statistiques de l'engagement numérique:

• Visiteurs du site Web de l'entreprise: 42 500 mois
• LinkedIn adepte: 8 700
• Twitter abonnés: 3200

Canaux de soumission réglementaires

Interactions réglementaires en 2023:

Agence de réglementation	Soumissions	Statut
FDA	3 Applications IND	2 approuvé
Ema	2 applications d'essais cliniques	1 approuvé

Arcturus Therapeutics Holdings Inc. (ARCT) - Modèle d'entreprise: segments de clientèle

Sociétés pharmaceutiques

Arcturus Therapeutics cible les sociétés pharmaceutiques avec des technologies d'ARNm et de vaccin contre l'ADN. Au quatrième trimestre 2023, la société a déclaré des revenus de collaboration potentiels de 12,3 millions de dollars.

Partenaire pharmaceutique	Valeur de collaboration	Focus technologique
Moderne	3,5 millions de dollars	plate-forme de vaccin contre l'ARNm
Janssen Pharmaceuticals	6,2 millions de dollars	Développement du vaccin contre l'ADN

Institutions de recherche

Arcturus collabore avec plusieurs institutions de recherche pour le développement thérapeutique avancé.

• Partenariat de recherche de l'Université de Stanford
• Projets collaboratifs des National Institutes of Health (NIH)
• Programme de recherche sur les vaccins de l'Université de Californie

Fournisseurs de soins de santé

Les segments de soins de santé cibles comprennent les hôpitaux, les cliniques et les centres d'immunisation. Marché total adressable estimé à 425 millions de dollars en 2024.

Patients ayant des besoins médicaux non satisfaits

Arcturus se concentre sur les troubles génétiques rares et les conditions médicales difficiles.

Condition médicale	Population de patients	Valeur marchande potentielle
Fibrose kystique	70 000 patients	185 millions de dollars
Carence en ornithine transcarbamylase	1 naissance sur 14 000	52 millions de dollars

Marchés de développement des vaccins

Arcturus cible les marchés mondiaux des vaccins avec des technologies d'ARNm innovantes.

• Développement du vaccin Covid-19
• Recherche de vaccin contre la grippe
• Vaccins émergents des maladies infectieuses

Taille du marché mondial des vaccins pour 2024: 59,2 milliards de dollars, avec des technologies d'ARNm représentant une part de marché de 12,5%.

Arcturus Therapeutics Holdings Inc. (ARCT) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2023, Arcturus Therapeutics a déclaré des dépenses totales de R&D de 156,3 millions de dollars. La répartition des coûts de R&D comprend:

Catégorie de coût de R&D	Montant ($)
Développement du vaccin ARNm	68,4 millions
Plate-forme de nanoparticules lipidiques lunar®	42,7 millions
Programmes de médecine génétique	45,2 millions

Investissements d'essais cliniques

Les dépenses d'essai cliniques pour 2023 ont totalisé 87,2 millions de dollars, l'allocation suivante:

• Essais cliniques du vaccin Covid-19: 35,6 millions de dollars
• Thérapies génétiques rares de maladies: 29,8 millions de dollars
• Essais sur les maladies hépatiques: 21,8 millions de dollars

Entretien de la propriété brevet et intellectuelle

Les coûts de propriété intellectuelle pour 2023 étaient de 12,5 millions de dollars, notamment:

Catégorie de coûts IP	Montant ($)
Dépôt de brevet et poursuite	7,3 millions
Gestion du portefeuille IP	5,2 millions

Développement de la plate-forme technologique

Plate-forme de nanoparticules lipidiques lunar® Les coûts de développement en 2023 étaient de 53,6 millions de dollars, avec des investissements clés dans:

• Amélioration de la plate-forme: 28,4 millions de dollars
• Optimisation technologique: 15,2 millions de dollars
• Nouvelle recherche sur le mécanisme de livraison: 10 millions de dollars

Coûts opérationnels et administratifs

Les dépenses opérationnelles totales pour 2023 ont atteint 92,1 millions de dollars, distribuée comme suit:

Catégorie de coûts opérationnels	Montant ($)
Frais administratifs généraux	42,6 millions
Ventes et marketing	29,5 millions
Installations et infrastructures	20 millions

Arcturus Therapeutics Holdings Inc. (ARCT) - Modèle d'entreprise: Strots de revenus

Vaccinaux potentiels et ventes de produits thérapeutiques

Pour l'exercice 2023, Arcturus Therapeutics a déclaré un chiffre d'affaires total de 14,9 millions de dollars, principalement dérivé du développement du vaccin Covid-19 et des technologies thérapeutiques de l'ARNm.

Catégorie de produits	Revenus estimés (2023)
Vaccin contre le covid-19	8,4 millions de dollars
thérapeutique d'ARNm	6,5 millions de dollars

Accords de collaboration de recherche

Arcturus a établi plusieurs accords de collaboration de recherche générant des sources de revenus supplémentaires.

• Collaboration avec CSL Limited: paiements de jalons potentiels jusqu'à 200 millions de dollars
• Des partenariats de recherche en cours générant 3,2 millions de dollars de financement de recherche collaborative

Plateformes technologiques de licence

Arcturus génère des revenus grâce à la licence de sa technologie de livraison de nanoparticules de nanoparticules lipidiques propriétaires.

Catégorie de licence	Revenus annuels
Licence de technologie Lunar®	2,7 millions de dollars

Subventions de recherche gouvernementales et privées

Arcturus reçoit des financements de gouvernement et d'institutions de recherche privées.

• Concessions des National Institutes of Health (NIH): 1,5 million de dollars
• Concessions de la Fondation de recherche privée: 750 000 $

Payments d'étape provenant des partenariats pharmaceutiques

Les partenariats pharmaceutiques fournissent des revenus potentiels importants grâce à des réalisations marquantes.

Partenariat	Paiements de jalons potentiels
CSL Partnership limité	Jusqu'à 200 millions de dollars
Autres collaborations pharmaceutiques	Environ 50 millions de dollars

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.