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Company Overview
Arcturus Therapeutics Holdings Inc. is a globally recognized RNA medicines and vaccines company, founded in 2013 and based in San Diego, California. The company is distinguished by its focus on the application of advanced RNA technologies to develop innovative therapeutic solutions, with a strong emphasis on addressing rare diseases and enhancing public health outcomes. Through its pioneering work in RNA therapeutics, particularly in the development of self-amplifying messenger RNA (sa-mRNA) vaccines, Arcturus has established itself as a critical player in the biopharmaceutical research and development arena.
Core Technologies and Platforms
At the heart of Arcturus Therapeutics is a suite of enabling technologies that underscore its scientific expertise and research capabilities. The company leverages its proprietary LUNAR® lipid-mediated delivery system and STARR® mRNA Technology to facilitate the efficient delivery of nucleic acid medicines. These platforms enable the creation of a versatile range of products, including:
- Self-amplifying mRNA (sa-mRNA) vaccines – designed to elicit robust and durable immune responses using lower doses compared to conventional mRNA vaccines.
- RNA therapeutic candidates – targeting rare diseases such as liver and respiratory conditions, including therapeutic interventions for disorders like ornithine transcarbamylase deficiency and cystic fibrosis.
- Nucleic acid medicines – encompassing a broad array of modalities including small interfering RNA, circular RNA, antisense RNA, and gene editing therapeutics.
Research and Development Focus
Arcturus is deeply committed to expansive research and innovation. It actively pursues advanced nucleic acid technologies supported by an extensive patent portfolio that spans multiple regions including the U.S., Europe, Japan, and China. This intellectual property foundation not only safeguards its innovative work but also reinforces its competitive stance within the industry. The company’s R&D framework is built on a robust pipeline of clinical and preclinical projects, reflecting years of accumulated expertise in drug discovery and development of novel therapeutic modalities.
Strategic Collaborations and Market Position
Understanding the multifaceted challenges of the biotechnology sector, Arcturus has maintained a disciplined approach towards strategic collaborations. Its partnerships with prominent global biotechnology firms have enhanced its capability to develop and commercialize novel mRNA vaccines and therapeutics. A notable collaboration includes its joint venture in Japan, through which it has successfully advanced the world's first approved sa-mRNA COVID-19 vaccine. By combining its technical expertise with the commercial and regulatory strengths of its partners, Arcturus is positioned well within an increasingly competitive market segment that values innovation, scientific rigor, and timely execution.
Competitive Landscape and Value Proposition
Arcturus operates within a highly competitive field of biotechnology and RNA-based therapeutics, competing with firms that also invest heavily in novel medical technologies. What sets Arcturus apart is its concentrated focus on rare diseases and its ability to harness advanced mRNA delivery systems that maximize the therapeutic potential of low-dose formulations. Its differentiated approach is underpinned by a deep understanding of molecular biology and nanotechnology, enabling the development of safe and efficacious treatments that can be rapidly adapted to meet evolving healthcare challenges.
Business Model and Revenue Generation
The company generates revenue primarily through licensing its proprietary RNA technologies, strategic collaborations, and co-development agreements with industry partners. By concentrating on breakthrough products in special niche markets such as rare diseases, Arcturus maintains a focused business model that emphasizes quality, innovation, and operational efficiency rather than high-volume sales. This model has allowed it to allocate significant resources towards further research and regulatory advancement, ensuring a continuous stream of innovation and value creation for its stakeholders.
Expertise, Authoritativeness, and Industry Engagement
Arcturus Therapeutics reflects deep industry expertise through its scientific publications, active participation in global regulatory discussions, and a management team with extensive experience in drug discovery and therapeutic development. The company remains actively engaged in academic and clinical dialogues, ensuring that its approaches to RNA therapeutic development remain at the cutting edge of biomedical science. Such engagement fosters trust and validates the company’s methodologies among peers, investors, and public health experts alike.
Summary
In summary, Arcturus Therapeutics Holdings Inc. represents a paradigm shift in the field of RNA medicines and nucleic acid therapeutics. Its integration of innovative technology platforms, commitment to scientific excellence, and strategic market positioning have collectively defined it as a compelling entity in the biotech landscape. The company’s robust portfolio of patented technologies and its collaborative approach to overcoming healthcare challenges underscore its lasting impact on the development of next-generation medicines.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) announced the successful dosing of all subjects in the first cohort of its Phase 1/2 clinical study for ARCT-021, a self-replicating mRNA vaccine for COVID-19. The study aims to evaluate safety and immunogenicity in younger adults, with clinical data expected in Q4 2020. Preclinical results demonstrated 100% seroconversion after a single low-dose administration, indicating promising efficacy. The vaccine is designed for low-dose, single administration, potentially facilitating mass vaccination efforts against COVID-19.
Arcturus Therapeutics Holdings announced progress in its clinical pipeline, with the initiation of Phase 1/2 studies for its COVID-19 mRNA vaccine candidate, ARCT-021, in collaboration with Duke-NUS Medical School. Dosing of subjects is expected imminently, with initial data anticipated by Q4 2020. Additionally, the Phase 1 study for ARCT-810, targeting ornithine transcarbamylase deficiency, continues. The company successfully raised $280 million in 2020 through equity offerings, enhancing its financial position, boasting a cash balance of $136.1 million as of June 30, 2020.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) announced the appointment of Lance Kurata as Chief Legal Officer, effective August 10, 2020. Formerly a partner at Mintz, Kurata brings extensive expertise in biotechnology law, focusing on transactions and intellectual property, which is critical as Arcturus advances its mRNA therapeutic platform. The company anticipates significant clinical trial data this year for its COVID-19 vaccine candidate ARCT-021 and the investigational therapy ARCT-810 for Ornithine Transcarbamylase deficiency.
Arcturus Therapeutics Holdings Inc. announced the closing of its public offering of 3,753,773 shares at $53.00 each, after the underwriters fully exercised their option for an additional 489,622 shares. The offering generated approximately $200 million in gross proceeds. The funds are designated for the development of the LUNAR-COV19 vaccine, along with advancing other therapeutic programs, early research, and corporate purposes. The offering was made under a shelf registration statement effective since May 2020, with Citigroup, Guggenheim Securities, and Barclays as joint managers.
Arcturus Therapeutics Holdings (NASDAQ: ARCT) announced a public offering of 3,264,151 shares at $53.00 each, aiming to raise approximately $173 million. The gross proceeds will support the development of its LUNAR-COV19 vaccine and other clinical programs. Additionally, an option for underwriters to purchase 489,622 more shares is available. The closing of the offering is expected by July 31, 2020. This follows an effective shelf registration statement filed with the SEC earlier this year.
Arcturus Therapeutics Holdings (Nasdaq: ARCT) has secured a binding term sheet with Israel's Ministry of Health to supply its COVID-19 vaccine candidate, LUNAR-COV19. This makes Israel the second country to reserve this vaccine. The final supply agreement is expected within 30 days, contingent on achieving clinical and regulatory milestones. Arcturus aims to produce hundreds of millions of doses in 2020 and 2021, following successful clinical developments and partnerships, including a recent trial approval in Singapore.
Arcturus Therapeutics Holdings (Nasdaq: ARCT) has received approval from the Singapore Health Sciences Authority to proceed with the Clinical Trial Application for its COVID-19 vaccine candidate, LUNAR-COV19. This vaccine employs the innovative STARR™ mRNA technology, which may elicit strong immune responses at low doses. Initial preclinical data indicates that a single dose can boost antibody levels for 50 days. The upcoming human trial will assess safety and immune response in up to 108 adults, including older adults, marking a significant step in Arcturus’ efforts to develop effective COVID-19 vaccines.
Arcturus Therapeutics (Nasdaq: ARCT) announced the formation of a Vaccine Platform Scientific Advisory Board (SAB) with top experts in virology and vaccine development for its LUNAR-COV19 COVID-19 vaccine program. The SAB's insights aim to enhance the vaccine's development pathway. The company is on track for clinical trials scheduled for summer 2020. Arcturus utilizes innovative self-replicating mRNA technology, potentially requiring only a single low-dose administration for effective immunity. The SAB includes notable figures like former Kansas Governor Jeff Colyer and Duke-NUS professor Ooi Eng Eong.
On June 11, 2020, Arcturus Therapeutics Holdings announced that CEO Joseph Payne will present at the Raymond James Human Health Innovation Conference, scheduled for June 15-18, 2020. The presentation is set for 3:00 pm Eastern Time on June 18. Arcturus, based in San Diego, focuses on developing messenger RNA therapeutics for rare diseases and vaccines. The company's innovative technologies include LUNAR® lipid-mediated delivery and STARR™ mRNA Technology. Arcturus has a diverse pipeline targeting conditions like Ornithine Transcarbamylase Deficiency and SARS-CoV-2.
Arcturus Therapeutics has commenced a Phase 1 study for ARCT-810, an mRNA-based therapeutic targeting Ornithine Transcarbamylase (OTC) deficiency. The first healthy volunteer has been dosed in this double-blind, placebo-controlled trial, assessing safety, tolerability, and pharmacokinetics. OTC deficiency, a serious urea cycle disorder affecting approximately 10,000 globally, currently lacks FDA-approved treatments. The ARCT-810 program, leveraging Arcturus’ LUNAR delivery platform, aims to express the OTC enzyme in liver cells, potentially preventing severe neurological damage.
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