Arcturus Therape Stock Price, News & Analysis

Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) is a commercial messenger RNA (mRNA) medicines and vaccines company in the pharmaceutical preparation manufacturing industry. Founded in 2013 and based in San Diego, California, Arcturus focuses on liver and respiratory rare disease therapeutics and infectious disease vaccines. The company operates on RNA-based platforms and develops both therapeutic candidates and vaccine programs using proprietary delivery and mRNA technologies.

According to company disclosures, Arcturus has enabling technologies that support its mRNA pipeline: LUNAR® lipid-mediated delivery, STARR® self-amplifying mRNA (sa-mRNA) technology, and in-house mRNA drug substance and drug product manufacturing expertise. These capabilities underpin its internal programs and collaborations and are intended to support multiple types of nucleic acid medicines, including messenger RNA, small interfering RNA (siRNA), circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics.

Business focus and therapeutic areas

Arcturus describes itself as a commercial mRNA medicines company focused on liver and respiratory rare disease therapeutics and infectious disease vaccines. Its disclosed rare disease pipeline includes RNA therapeutic candidates that may potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF). For CF, the investigational inhaled mRNA therapy ARCT-032 uses the LUNAR® lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. Company materials state that expression of a functional copy of CFTR mRNA in the lungs of people with CF has the potential to restore CFTR activity and address downstream effects that contribute to progressive lung disease.

For OTC deficiency, Arcturus is advancing ARCT-810, an mRNA therapeutic candidate designed to replace the OTC enzyme and restore urea cycle activity. Interim Phase 2 data described by the company indicate biomarker changes such as decreases in glutamine levels to within normal range and stable ammonia levels in treated participants who remained on standard of care, as well as observations related to ureagenesis function. The company has reported that ARCT-810 has been generally safe and well tolerated in single-dose Phase 1/1b and multi-dose Phase 2 studies across both healthy volunteers and OTC-deficient participants.

Infectious disease vaccines and KOSTAIVE®

Arcturus is active in infectious disease vaccines, particularly for SARS-CoV-2 and influenza. The company states that it developed KOSTAIVE®, described as the first self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine in the world to be approved. KOSTAIVE is part of a broader collaboration with CSL Seqirus on mRNA vaccines for COVID-19, influenza and certain other infectious diseases. Company and partner disclosures reference regulatory activity for KOSTAIVE, including marketing authorization applications and approvals in certain jurisdictions, and an updated two-dose vial presentation targeting the SARS-CoV-2 Omicron JN.1 variant XEC.

Beyond COVID-19, Arcturus and its collaborators are evaluating additional sa-mRNA vaccine candidates. These include ARCT-2138, an sa-mRNA seasonal influenza vaccine candidate encoding hemagglutinin and neuraminidase of four influenza strains, and ARCT-2304, an sa-mRNA vaccine candidate for pandemic influenza A virus H5N1 that has received U.S. FDA Fast Track Designation. Company-reported Phase 1 data for these programs describe immunogenicity across dose levels and age groups, as well as safety and tolerability observations within the tested ranges.

RNA platforms and technology base

Arcturus emphasizes the breadth of its RNA therapeutics platforms. The LUNAR® lipid-mediated delivery system is used to transport RNA payloads, including aerosolized delivery to the lungs in the CF program. The STARR® sa-mRNA technology is used to create self-amplifying mRNA constructs for vaccines such as KOSTAIVE and other sa-mRNA candidates. The company also highlights its mRNA drug substance and drug product manufacturing expertise, which supports both internal development and partnered programs.

According to repeated company descriptions, these platforms can be applied toward multiple nucleic acid modalities: messenger RNA, siRNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus reports that its technologies are covered by an extensive patent portfolio comprising over 500 patents and patent applications across the U.S., Europe, Japan, China and other countries.

Collaborations, partnerships and geographic footprint

Arcturus leverages collaborations and joint ventures to advance and commercialize its mRNA programs. It has an ongoing global collaboration with CSL Seqirus for innovative mRNA vaccines, including KOSTAIVE and influenza vaccine candidates. In Japan, Arcturus participates in a joint venture called ARCALIS, which is focused on the manufacture of mRNA vaccines and therapeutics. Company disclosures also reference distribution and regulatory activities in Japan through Meiji Seika Pharma under a distribution agreement with CSL Seqirus for KOSTAIVE.

The company generates revenue through strategic alliances and collaborations. In its financial updates, Arcturus describes primary revenue streams as license fees, consulting and related technology transfer fees, reservation fees and collaborative payments from research and development arrangements with pharmaceutical and biotechnology partners. Grant revenue, including funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA), contributes to support for certain vaccine programs such as ARCT-2304.

Clinical development and regulatory interactions

Arcturus regularly reports clinical and regulatory milestones for its programs. In cystic fibrosis, interim Phase 2 data for ARCT-032 in adults with Class I CF have included safety and tolerability observations over 28 days of daily inhaled dosing, exploratory lung function analyses, and AI-enhanced high-resolution computed tomography (HRCT) imaging that showed reductions in mucus burden in a subset of participants. The company has indicated plans for a 12-week safety and preliminary efficacy study in CF participants and discussions with regulatory agencies regarding future pivotal studies.

For OTC deficiency, the company has reported Phase 2 interim data suggesting improvements in biomarkers associated with urea cycle function in participants treated with ARCT-810. Arcturus has stated that it is preparing for meetings with the U.S. FDA and other regulatory agencies to discuss the clinical significance of these biomarker changes and to align on Phase 3 trial design, including pediatric studies.

In the vaccine portfolio, Arcturus and CSL Seqirus have advanced KOSTAIVE through clinical development and regulatory submissions in multiple regions. Company disclosures also describe Phase 1 studies for ARCT-2138 and ARCT-2304, with reported immunogenicity results and safety profiles that support further development of sa-mRNA influenza vaccine candidates.

Stock listing and corporate structure

Arcturus Therapeutics Holdings Inc. is incorporated in Delaware and its common stock is listed on The Nasdaq Stock Market LLC under the trading symbol ARCT. The company reports its financial results and material events through periodic and current reports filed with the U.S. Securities and Exchange Commission (SEC), including Forms 10-Q, 10-K and 8-K, as well as notifications such as Form 12b-25 when applicable.

SEC filings confirm that Arcturus remains a reporting company with securities registered under Section 12(b) of the Securities Exchange Act of 1934. Filings also document corporate governance and management changes, such as the amicable separation of the Chief Financial Officer and the appointment of an interim principal financial and accounting officer, along with related compensation and equity arrangements.

Intellectual property and manufacturing

Arcturus underscores the importance of intellectual property protection for its RNA platforms. The company states that its technologies are covered by an extensive patent portfolio with more than 500 patents and patent applications across major jurisdictions, including the U.S., Europe, Japan and China. This portfolio is intended to protect its LUNAR® delivery technology, STARR® sa-mRNA constructs, and other aspects of its RNA therapeutics and vaccine platforms.

In addition to IP, Arcturus highlights internal capabilities in mRNA drug substance and drug product manufacturing. These capabilities support both clinical development and, in collaboration with partners, the transition of certain programs such as KOSTAIVE from development to commercial phases. The ARCALIS joint venture in Japan is focused on manufacturing of mRNA vaccines and therapeutics, providing additional infrastructure for production.

Risk profile and sector context

As a company in the mRNA therapeutics and vaccines field, Arcturus operates in a sector characterized by clinical, regulatory and commercial risk. Company press releases and SEC filings include cautionary notes regarding forward-looking statements, emphasizing that clinical outcomes, regulatory decisions, and commercial performance may differ from expectations. Investors evaluating ARCT stock often review Arcturus’ clinical data updates, regulatory interactions, collaboration progress and financial disclosures to assess the company’s development trajectory within the broader biotechnology and pharmaceutical manufacturing landscape.