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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) has announced a public offering of 1,365,000 shares priced at $110.00 each, aiming for approximately $150 million in gross proceeds. The offering includes a 30-day option for underwriters to purchase an additional 204,750 shares. The funds are designated for clinical trials and manufacturing its LUNAR-COV19 vaccine. The offering is underpinned by a registration statement filed with the SEC, with closing anticipated around December 10, 2020.
Arcturus Therapeutics Holdings (NASDAQ: ARCT) announced plans for an underwritten public offering of its common stock, with all shares to be sold by the Company. Subject to market conditions, the offering includes a potential 15% overallotment option for underwriters. Proceeds will fund clinical trials and manufacturing of the LUNAR-COV19 vaccine candidate. The offering is registered under an effective SEC shelf, with a prospectus to follow. Piper Sandler & Co. and Guggenheim Securities are joint bookrunners.
Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) has commenced dosing in its Phase 1b clinical trial of ARCT-810 for Ornithine Transcarbamylase (OTC) deficiency, a rare and serious disorder. The study, involving 12 patients, will assess safety, tolerability, and pharmacokinetics at doses ranging from 0.2 mg/kg to 0.4 mg/kg. Previous studies indicated ARCT-810 was safe and well tolerated in healthy subjects, showing a favorable pharmacokinetic profile. OTC deficiency, affecting around 10,000 people worldwide, currently lacks FDA-approved treatments. Arcturus aims to leverage its mRNA platform to address this unmet medical need.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) announced its participation in Piper Sandler’s 32nd Annual Virtual Healthcare Conference, scheduled for December 1, 2020, at 10:00 a.m. ET. The company will present on The Road Ahead for COVID-19 Vaccines. Founded in 2013 and based in San Diego, Arcturus focuses on mRNA medicines and vaccines, including programs targeting COVID-19 and other diseases. The company has developed significant partnerships and holds a robust patent portfolio of 200 patents worldwide, aimed at advancing RNA therapeutic technologies.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) reported its financial results for Q3 2020, with revenues of $2.3 million, a decrease from $3.3 million in Q3 2019. Operating expenses surged to $23.3 million, primarily due to increased spending on clinical trials for ARCT-021 and ARCT-810, leading to a net loss of $21.0 million, or $0.92 per share. Despite the losses, the company’s cash position improved to $307.1 million, bolstered by equity offerings. The ARCT-021 COVID-19 vaccine candidate shows promising preliminary results, and the ARCT-810 candidate for OTC deficiency is advancing into further studies.
Arcturus Therapeutics (Nasdaq: ARCT) reported positive interim results from its Phase 1/2 study of ARCT-021, a COVID-19 vaccine candidate. Conducted in Singapore, the trial enrolled 106 subjects, revealing robust anti-spike protein IgG immune responses across multiple doses. The vaccine was well tolerated, showing a favorable safety profile. Additionally, Arcturus secured a financial commitment of up to $220 million from Singapore's Economic Development Board (EDB) to support vaccine manufacturing, including a $45 million loan linked to future sales.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) has announced its participation in several upcoming investor and scientific conferences. The company will present at the International mRNA Health Conference on November 10, 2020, at 1:40 p.m. ET, and at the Stifel Healthcare Conference on November 17, 2020, at 3:20 p.m. ET. Additionally, Arcturus will engage in a fireside chat at the Piper Sandler Healthcare Conference on November 23, 2020, at 10:00 a.m. ET. The company focuses on mRNA medicines and vaccines for infectious diseases and rare diseases.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) will release its financial results for the quarter and nine months ended September 30, 2020, after market close on November 9, 2020. A conference call and webcast will be held at 4:30 PM ET on the same day to discuss the results and provide a corporate overview. The company specializes in mRNA medicines, focusing on vaccines for infectious diseases and rare diseases of the liver and respiratory system. Founded in 2013, Arcturus has developed a pipeline that includes self-replicating mRNA vaccine candidates for COVID-19 and influenza.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) has completed the first three dose escalation cohorts in its Phase 1 study of ARCT-810, an mRNA-based therapeutic for Ornithine Transcarbamylase (OTC) deficiency. The trial is randomized, double-blind, and placebo-controlled, evaluating safety, tolerability, and pharmacokinetics. Preliminary results show good tolerability and a favorable pharmacokinetic profile. The fourth cohort is expected to complete this quarter, with final results to be reported soon. The company plans to initiate a second clinical study in patients with OTC deficiency this quarter.
Arcturus Therapeutics Holdings announced preclinical results for its vaccine LUNAR®-COV19 (ARCT-021), showing a strong antibody response and 100% protection against SARS-CoV-2 following a single dose vaccination in mice. The study indicates robust neutralizing antibody titers persisting up to day 60, along with significant T cell responses. The clinical study is on track with results expected in Q4 2020. Collaboration with Duke-NUS Medical School enhances credibility, and the company emphasizes the potential of its low-dose, single-shot vaccine approach for COVID-19 mass vaccination.
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