Arcturus Therapeutics Holdings Inc. (ARCT): Business Model Canvas [11-2024 Updated]

Arcturus Therapeutics Holdings Inc. (ARCT) is at the forefront of the mRNA revolution, leveraging innovative technology to address critical healthcare needs. With a focus on unmet medical challenges such as infectious diseases and rare genetic disorders, Arcturus combines its proprietary LUNAR® delivery system and STARR® self-amplifying mRNA technology to develop cutting-edge vaccines and therapeutics. Discover how their strategic partnerships, key activities, and unique value propositions position them as a leader in the biopharmaceutical landscape.

Arcturus Therapeutics Holdings Inc. (ARCT) - Business Model: Key Partnerships

Collaboration with CSL Seqirus for mRNA vaccines

Arcturus Therapeutics has a significant collaboration with CSL Seqirus, a part of CSL Limited, for the development of mRNA vaccines. The collaboration agreement includes exclusive global rights for CSL Seqirus to research, develop, manufacture, and commercialize vaccines using Arcturus's mRNA technology. As part of this agreement, Arcturus received an upfront payment of $200 million in the fourth quarter of 2022. Additionally, the company is eligible for development milestones exceeding $1.3 billion and commercial milestones potentially totaling up to $3 billion based on net sales.

As of September 30, 2024, the total deferred revenue for this collaboration was $40.3 million, down from $87.1 million at the end of 2023. During the third quarter of 2024, Arcturus recognized $38.8 million in collaboration revenue from CSL Seqirus.

Partnerships with government entities like BARDA

Arcturus has established a partnership with the Biomedical Advanced Research and Development Authority (BARDA), securing a grant of up to $63.2 million for the development of a pandemic influenza vaccine using its self-amplifying mRNA platform. As of September 30, 2024, the remaining available funding from this grant was $41.6 million.

The BARDA contract operates on a cost-reimbursement basis, allowing Arcturus to earn revenue by covering direct expenses related to the project. For the nine months ended September 30, 2024, the company reported $12.2 million in grant revenue from BARDA.

Agreements with Ultragenyx Pharmaceutical Inc.

Arcturus has entered into agreements with Ultragenyx Pharmaceutical Inc. for the development and commercialization of mRNA therapeutics targeting rare diseases. Specific financial details regarding upfront payments or milestones from this partnership are not disclosed in the available documents, but these collaborations are expected to enhance Arcturus's portfolio in rare disease treatments.

Technical support agreements with Vinbiocare

Arcturus has partnered with Vinbiocare, a Vietnamese biopharmaceutical company, to provide technical support for the manufacturing of mRNA vaccines. This partnership allows Arcturus to leverage Vinbiocare's local manufacturing capabilities, thereby expanding its operational footprint in Southeast Asia. As of September 30, 2024, Arcturus reported contractual liabilities with Vinbiocare amounting to $2.036 million.

Partnership	Details	Financial Impact
CSL Seqirus	Collaboration for mRNA vaccines	Upfront payment: $200 million; Eligible for >$1.3 billion in development milestones; >$3 billion in commercial milestones
BARDA	Grant for pandemic influenza vaccine development	Grant amount: up to $63.2 million; Remaining funding: $41.6 million
Ultragenyx Pharmaceutical Inc.	Agreements for mRNA therapeutics	Details not disclosed
Vinbiocare	Technical support for mRNA vaccine manufacturing	Contractual liabilities: $2.036 million

Arcturus Therapeutics Holdings Inc. (ARCT) - Business Model: Key Activities

Development of mRNA vaccines and therapeutics

Arcturus Therapeutics is focused on developing messenger RNA (mRNA) vaccines and therapeutics. The company's proprietary technologies include STARR® (self-amplifying RNA) and LUNAR® (lipid-mediated delivery), which enhance the efficacy and safety of mRNA delivery. The COVID-19 vaccine ARCT-154, also known as KOSTAIVE®, received marketing authorization in Japan in 2023 and became the first commercially available self-amplifying RNA vaccine globally in September 2024. The company aims to leverage its mRNA platform for the development of vaccines targeting COVID-19, influenza, and other respiratory diseases.

Clinical trials for COVID-19 and rare diseases

Arcturus is conducting multiple clinical trials, including those for its COVID-19 vaccine candidate, KOSTAIVE®, and other therapeutic candidates for rare diseases such as ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF). The company has achieved significant milestones, including a recent $25 million milestone payment from its collaboration with CSL Seqirus upon the first commercial sale of KOSTAIVE®.

Clinical Trials	Indication	Phase	Expected Milestones
ARCT-154 (KOSTAIVE®)	COVID-19	Commercially approved	$25 million from CSL Seqirus
ARCT-810	OTC Deficiency	Phase 2	Upcoming regulatory submissions
ARCT-032	Cystic Fibrosis	Phase 1	Orphan Drug Designation in EU and USA

Manufacturing and commercialization of vaccines

Arcturus has established a global manufacturing footprint through partnerships with various contract development and manufacturing organizations (CDMOs) such as Aldevron, Catalent, and Recipharm. The company is transitioning its manufacturing capabilities to accommodate single-dose vials for COVID-19 vaccines, in line with market trends. The collaboration with CSL Seqirus enhances its commercialization strategy, allowing Arcturus to leverage CSL's extensive distribution network for its mRNA vaccines.

Regulatory compliance and submissions

Regulatory compliance is a critical activity for Arcturus, especially as it navigates the complexities of bringing mRNA vaccines to market. The company must adhere to stringent regulatory requirements set by authorities such as the FDA and EMA. In addition to KOSTAIVE®, Arcturus is actively pursuing regulatory approvals for its other therapeutic candidates, which involves submitting detailed clinical trial data and safety profiles.

Arcturus Therapeutics Holdings Inc. (ARCT) - Business Model: Key Resources

Proprietary LUNAR® delivery system

The LUNAR® delivery system is a proprietary lipid nanoparticle (LNP) technology designed to facilitate the effective delivery of RNA therapeutics. This platform addresses the major challenges in RNA drug development by ensuring the safe and efficient transport of mRNA to target tissues. The versatility of the LUNAR technology allows it to be utilized across various therapeutic areas, enhancing the potential for multiple nucleic acid medicines.

STARR® self-amplifying mRNA technology

The STARR® (Self-Amplifying RNA) technology represents a breakthrough in mRNA therapeutics, enabling a longer-lasting immune response and broader efficacy at lower doses compared to traditional mRNA approaches. This technology has been pivotal in the development of Arcturus's COVID-19 vaccine, ARCT-154 (KOSTAIVE®), which received marketing authorization in Japan in 2023, becoming the world’s first approved self-amplifying RNA vaccine.

Experienced scientific and management teams

Arcturus Therapeutics boasts a highly skilled workforce, including a team of experienced scientists and management professionals. The company's leadership has a proven track record in biotechnology and pharmaceuticals, which is critical for navigating the complexities of drug development and commercialization. As of September 30, 2024, the company’s personnel-related expenses were approximately $43.2 million for the nine months ended, reflecting the investment in human capital necessary for sustaining innovation and operational excellence.

Financial resources from collaborations and equity financing

Arcturus has strategically secured financial resources through various collaborations and equity financing. Notably, the collaboration with CSL Seqirus has provided significant funding, including an upfront payment of $200 million and potential development milestones exceeding $1.3 billion. As of September 30, 2024, the company reported cash and cash equivalents of $294.1 million. The total revenue for the nine months ended September 30, 2024, was reported at $129.5 million, showcasing the financial backing from various agreements.

Financial Metrics	Value (in thousands)
Cash and Cash Equivalents	$294,100
Upfront Payment from CSL Seqirus	$200,000
Potential Development Milestones	$1,300,000+
Total Revenue (Nine Months Ended September 30, 2024)	$129,544
Personnel-Related Expenses (Nine Months Ended September 30, 2024)	$43,234

These key resources collectively enable Arcturus Therapeutics to innovate and deliver value in the biopharmaceutical sector, positioning the company for continued growth and success in developing mRNA-based therapies. The synergy between advanced technologies, a skilled workforce, and robust financial backing is crucial for sustaining its competitive edge in the biotechnology landscape.

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

Innovative mRNA technology with superior efficacy

Arcturus Therapeutics is at the forefront of mRNA technology, leveraging its proprietary STARR® platform, which has demonstrated enhanced durability and broader immune responses at lower doses compared to conventional mRNA vaccines. This innovative approach is pivotal in addressing the challenges often faced in RNA therapeutics, particularly in effective delivery and sustained immune response.

First approved self-amplifying RNA vaccine (KOSTAIVE®)

In September 2024, Arcturus received marketing authorization approval for KOSTAIVE®, the world’s first commercially available self-amplifying RNA vaccine. This vaccine is designed for COVID-19 and has been validated through extensive clinical trials, including a significant study with 19,000 participants in Vietnam, demonstrating its safety and efficacy.

Focus on unmet medical needs in infectious and rare diseases

Arcturus is committed to addressing significant unmet medical needs, particularly in the domains of infectious diseases and rare genetic disorders. The company is advancing multiple therapeutic candidates, including ARCT-032 for cystic fibrosis, which has received Orphan Drug and Rare Pediatric Disease Designations.

Ability to quickly adapt vaccines to emerging pathogens

Arcturus's collaboration with CSL Seqirus enables rapid adaptation of vaccine formulations in response to emerging pathogens. This strategic partnership allows the company to utilize CSL Seqirus’s established global vaccine infrastructure alongside its innovative mRNA technologies, ensuring timely updates to vaccine compositions as necessary.

Value Proposition	Description	Key Metrics
Innovative mRNA technology	Utilizes STARR® platform for enhanced immune response and durability	Lower dose requirements, broader immune response
KOSTAIVE® Vaccine	First approved self-amplifying RNA vaccine for COVID-19	Approved in Japan, 19,000 participants in trials
Focus on unmet medical needs	Develops treatments for infectious and rare diseases	ARCT-032: Orphan Drug and Rare Pediatric Disease Designations
Rapid adaptation to pathogens	Collaboration with CSL Seqirus for agile vaccine updates	CSL Seqirus collaboration for multiple infectious disease vaccines

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

Direct engagement with healthcare providers

Arcturus Therapeutics maintains a robust engagement strategy with healthcare providers to ensure effective communication and collaboration regarding its mRNA therapeutics. In 2024, the company has focused on expanding its network of healthcare professionals to facilitate the adoption of its products, particularly the self-amplifying mRNA vaccine, KOSTAIVE. This engagement includes regular updates on clinical trials and product developments, aiming to enhance provider confidence and drive prescription rates.

Collaboration with government health agencies

Partnerships with government health agencies are crucial for Arcturus. The company has established collaborations with entities such as the Biomedical Advanced Research and Development Authority (BARDA) to support the development and distribution of its innovative vaccines. In 2024, these collaborations have resulted in approximately $462.1 million in upfront payments and milestones from partners, including a $25 million milestone achieved in Q3 2024.

Educational initiatives on mRNA technology benefits

Arcturus actively invests in educational initiatives aimed at healthcare providers and the public to raise awareness about the benefits of mRNA technology. The company has conducted numerous webinars and informational sessions, highlighting the advantages of its proprietary STARR® and LUNAR® platforms. These initiatives are part of a broader strategy to establish Arcturus as a thought leader in the mRNA space, thereby increasing trust and interest in its products.

Continuous updates on clinical trial progress

Arcturus commits to providing continuous updates on the progress of its clinical trials, particularly for its vaccine candidates like ARCT-154. As of September 2024, the company has reported significant advancements in its clinical trials, including the successful completion of Phase 2 trials for its LUNAR-CF program. This transparency is designed to maintain investor and public confidence and to facilitate ongoing engagement with stakeholders.

Initiative	Description	Impact
Healthcare Provider Engagement	Direct communication on product updates and clinical trials.	Increased prescription rates and provider confidence.
Government Collaborations	Partnerships with agencies like BARDA for funding and support.	Secured $462.1 million in payments and milestones.
Educational Initiatives	Webinars and informational sessions on mRNA benefits.	Enhanced public and provider awareness and trust.
Clinical Trial Updates	Regular reports on trial progress and outcomes.	Increased stakeholder engagement and confidence.

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

Direct sales to healthcare providers and institutions

Arcturus Therapeutics conducts direct sales efforts targeting healthcare providers and institutions. In 2024, the company reported collaboration revenue of $117.4 million for the nine-month period ended September 30, 2024, compared to $132.7 million in the same period of 2023. This revenue stream is crucial as the company expands its product offerings, particularly in the field of mRNA vaccines.

Partnerships with pharmaceutical distributors

Arcturus has formed strategic partnerships with pharmaceutical distributors to enhance its market reach. A significant partnership is with CSL Seqirus, through which Arcturus received an upfront payment of $200 million in 2022 and is eligible for development milestones exceeding $1.3 billion. Additionally, the company stands to gain up to $3 billion in commercial milestones based on net sales of vaccines.

Online platforms for educational outreach

Arcturus utilizes online platforms to engage in educational outreach, providing information about its mRNA technology and product candidates. This strategy supports the marketing of its COVID-19 vaccine, KOSTAIVE®, which received marketing authorization in Japan. The company’s focus on digital education helps build awareness and understanding of its innovative products among healthcare professionals and potential patients.

Participation in scientific conferences and forums

Arcturus actively participates in scientific conferences and forums to showcase its research and development efforts. This engagement facilitates networking with key opinion leaders and potential collaborators. The company’s participation in these events serves to enhance its visibility in the biotech community, driving interest in its pipeline of mRNA-based therapeutics.

Channel	Description	2024 Revenue Impact (in millions)
Direct Sales	Sales to healthcare providers and institutions	$117.4
Partnerships	Collaboration with pharmaceutical distributors like CSL Seqirus	$200.0 (upfront payment)
Online Platforms	Educational outreach on mRNA technology	Not directly quantified
Conferences	Participation in scientific conferences	Not directly quantified

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

Healthcare providers and hospitals

Arcturus Therapeutics targets healthcare providers and hospitals as primary customers for its innovative mRNA-based therapeutics and vaccines. These institutions are critical in the administration and distribution of vaccines, particularly for infectious diseases and rare genetic disorders. In 2024, Arcturus' collaboration with CSL Seqirus is expected to enhance its outreach to healthcare providers globally, especially for the distribution of the ARCT-154 vaccine, which has received marketing authorization in Japan.

Patients with rare genetic disorders

The company focuses on patients suffering from rare genetic disorders, particularly through its LUNAR platform. Arcturus has developed therapies targeting conditions such as ornithine transcarbamylase deficiency. In 2024, the company continues to advance its clinical trials, which may lead to significant treatment options for these patients. The estimated prevalence of rare diseases in the U.S. is about 1 in 10 individuals, indicating a substantial potential market for Arcturus’ products.

Government agencies and public health organizations

Arcturus engages with government agencies and public health organizations to support public health initiatives, particularly in vaccine distribution and pandemic preparedness. The company has received substantial funding through government contracts, including approximately $462.1 million in upfront payments and milestones from CSL Seqirus. This collaboration aims to leverage Arcturus’ mRNA technology to address public health needs effectively.

Pharmaceutical companies seeking mRNA technology

Another key customer segment includes pharmaceutical companies interested in leveraging Arcturus' proprietary mRNA technology for their drug development. The company’s STARR® mRNA technology has shown promise in enhancing vaccine efficacy. Collaborations with established pharmaceutical firms can lead to significant revenue streams and expansion of Arcturus' technology into broader therapeutic areas.

Customer Segment	Key Focus	Market Potential	Collaboration Impact
Healthcare Providers and Hospitals	Distribution of vaccines and therapeutics	Significant, especially with COVID-19 and rare diseases	Enhanced outreach through CSL Seqirus collaboration
Patients with Rare Genetic Disorders	Treatment development for rare diseases	Approximately 1 in 10 individuals affected in the U.S.	Advancement of clinical trials for targeted therapies
Government Agencies and Public Health Organizations	Public health initiatives and vaccine distribution	High demand for vaccines and pandemic preparedness	$462.1 million in funding from CSL Seqirus collaboration
Pharmaceutical Companies	Leveraging mRNA technology for drug development	Expanding market in therapeutics	Potential for licensing agreements and partnerships

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

R&D expenses for clinical trials and product development

Arcturus Therapeutics reported research and development (R&D) expenses of $39.1 million for the three months ended September 30, 2024, a decrease of 23.4% from $51.1 million in the same period of 2023. For the nine months ended September 30, 2024, R&D expenses totaled $151.4 million, down from $155.5 million in the previous year, reflecting a 2.7% reduction.

The breakdown of R&D expenses includes:

Category	Three Months Ended September 30, 2024 (in thousands)	Three Months Ended September 30, 2023 (in thousands)	Change
LUNAR-COVID	$12,035	$24,892	-51.7%
LUNAR-OTC	$890	$2,001	-55.5%
BARDA	$1,347	$930	+44.8%
Early-stage programs	$7,602	$2,326
Discovery technologies	$2,071	$4,662	-55.6%

Manufacturing costs for mRNA vaccines

Manufacturing costs associated with mRNA vaccine production are significant. Arcturus has established a global manufacturing footprint with partners such as Aldevron and Catalent, facilitating a supply chain capable of producing critical raw materials and drug substances. The company’s manufacturing expenses were notably high in previous years due to supply batches for Meiji, which were not incurred in 2024, contributing to a reduction in overall R&D costs.

Marketing and sales expenses

Marketing and sales expenses for Arcturus are included within general and administrative costs. For the three months ended September 30, 2024, these costs were approximately $13.3 million, reflecting a minor decrease from $13.4 million in the same period of 2023. For the nine months ended September 30, 2024, total general and administrative expenses amounted to $40.4 million, slightly increasing from $40.4 million in the previous year.

Compliance and regulatory costs

Compliance and regulatory costs are integral to Arcturus’s operations, especially given its focus on developing vaccines and therapies. These costs are embedded within R&D and general administrative expenses. As of September 30, 2024, the total operating expenses for Arcturus were $52.4 million, down from $64.5 million in the same quarter of 2023, primarily driven by reductions in R&D expenditures.

Overall, the cost structure of Arcturus Therapeutics reflects a strategic focus on managing expenses while progressing its R&D pipeline and maintaining compliance with regulatory standards.

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

Upfront payments and milestones from partnerships

Arcturus Therapeutics has established significant revenue streams through its collaborations, particularly with CSL Seqirus. The company received an upfront payment of $200 million in the fourth quarter of 2022 as part of their collaboration agreement. As of September 30, 2024, the total achieved in upfront payments and milestones from CSL Seqirus amounts to approximately $462.1 million, which includes a milestone payment of $25 million anticipated in the fourth quarter of 2024.

Royalties from vaccine sales

Arcturus is entitled to a share of net profits from COVID-19 vaccine sales, specifically a 40% share. Additionally, the company will receive low double-digit royalties on annual net sales for influenza vaccines and other specified infectious disease vaccines. The royalties will also apply to vaccines developed for pandemic preparedness.

Government grants and funding for research

In August 2022, Arcturus entered into a cost reimbursement contract with the Biomedical Advanced Research and Development Authority (BARDA) for an award of up to $63.2 million to develop a pandemic influenza vaccine. As of September 30, 2024, Arcturus has recognized grant revenue of $12.2 million from BARDA.

Potential future revenues from commercialized products

Looking ahead, Arcturus anticipates potential future revenues from commercialized products, particularly from the recently approved COVID-19 vaccine, KOSTAIVE, which became the world’s first approved self-amplifying RNA vaccine. The commercialization of KOSTAIVE is expected to generate significant revenue through sales, particularly in the Japanese market where sales are projected to commence in the fourth quarter of 2024.

Revenue Source	Amount (in millions)	Description
Upfront Payments and Milestones	$462.1	Total achieved from CSL Seqirus, including a $25 million milestone payment expected in Q4 2024
Royalties from Vaccine Sales	40% Share	Net profits from COVID-19 vaccine sales and low double-digit royalties from influenza vaccines
Government Grants	$63.2	Funding awarded by BARDA for pandemic influenza vaccine development
Grant Revenue Recognized	$12.2	Revenue recognized from BARDA as of September 30, 2024

Updated on 16 Nov 2024

Resources:

1. Arcturus Therapeutics Holdings Inc. (ARCT) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Arcturus Therapeutics Holdings Inc. (ARCT)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View Arcturus Therapeutics Holdings Inc. (ARCT)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.