Arcturus Therapeutics
 | |
| Company type | Public |
|---|---|
| Template:NASDAQ | |
| Industry | Pharmaceutical industry |
| Founded | 2013 |
| Founder | Joseph Payne and Pad Chivukula |
| Headquarters | San Diego, California, US |
Key people |
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| Products | ARCT-810 for treatment of OTCD; FDA Orphan Drug Status (2019); Phase 1 Clinical Trials initiated 2020, ARCT-021 Vaccine for COVID-19; Phase 1/2 initiated 2020, Phase 2 initiated 2021 |
| Revenue |  $21 Million (2019) |
Number of employees | 124 |
| Website | www |
Arcturus Therapeutics Holdings Inc. is a biotechnology firm based in the United States that focuses on RNA-based therapeutics targeting rare and infectious diseases. The company's proprietary lipid nanoparticle platform facilitates the delivery of nucleic acid therapies, including siRNA, mRNA, gene-editing RNA, DNA, antisense oligonucleotides, and microRNA.
The firm’s development pipeline concentrates on rare disorders such as ornithine transcarbamylase deficiency and respiratory illnesses like cystic fibrosis. Its vaccine portfolio features a COVID-19 vaccine authorized in Japan (2023) and the European Union (2025), alongside an influenza vaccine currently in preclinical stages.
History
Established in 2013 by Joseph Payne and Pad Chivukula, Arcturus is headquartered in San Diego, California. The company engineered the Lunar lipid nanoparticle delivery system to enable safe transport of therapeutic RNA or DNA molecules to targeted cells.
In September 2017, Arcturus completed a merger with Alcobra Ltd., an Israeli pharmaceutical company. Early in 2018, the board removed Joseph Payne from his CEO position. Subsequently, Payne—who was the largest shareholder at the time—sought to convene shareholder meetings to elect new board members; however, the board initially delayed these meetings unlawfully. This led to legal proceedings culminating in an Israeli court ordering the shareholder meeting to proceed.
In April 2018, the board filed claims against Payne and his proposed nominees. By May 2018, a resolution was reached resulting in the appointment of four new directors: Peter Farrell, Andrew Sassine, James Barlow, and Magda Marquet. This transition prompted resignations from prior board members and included mutual releases along with dismissal of all ongoing litigation.
This governance overhaul represented a significant turning point in Arcturus’ strategic leadership and corporate management.
Lunar
Lunar is a lipid nanoparticle delivery technology engineered to transport RNA therapeutics directly to specific cell types for in vivo protein expression. It addresses earlier limitations encountered with lipid nanoparticles such as liver toxicity and immune activation.
The Lunar platform has been utilized to deliver messenger RNA targeting liver cells for treatment of metabolic disorders including ornithine transcarbamylase deficiency (OTCD) and citrin deficiency. OTCD is the most prevalent urea cycle disorder, characterized by impaired elimination of toxic nitrogenous waste. Collaborative research with entities such as the Salk Institute demonstrated effective delivery of Factor IX mRNA for potential protein replacement therapies. Additionally, MD Anderson Cancer Center researchers employed Lunar for mRNA delivery aimed at glioma treatment.
In 2019, the RNA therapeutic ARCT-810 developed using Lunar technology was granted orphan drug designation by the FDA for OTCD, conferring seven years of market exclusivity upon approval. The FDA accepted the company’s investigational new drug application for a Phase 1b clinical trial in April 2020, with trial enrollment beginning in June 2020.
ARCT-021 and Starr
To address the COVID-19 crisis, Arcturus collaborated with Duke–NUS Medical School to create a vaccine utilizing self-amplifying mRNA technology paired with the Lunar delivery system, which improves both the magnitude and duration of protein production. The company engaged contract development and manufacturing partners Catalent and Recipharm to manufacture several batches of this mRNA vaccine candidate. Clinical testing of Lunar-COV19 began in July 2020 with healthy participants, and by December 2020, Phase 2 trials received approval from both the U.S. FDA and Singapore’s Health Sciences Authority.
Next-generation Vaccines
On August 2, 2021, Arcturus launched clinical studies for ARCT-154, an advanced vaccine candidate, in Vietnam. The subsequent day, the company announced regulatory clearance in Singapore to commence Phase I/II trials for ARCT-154 and ARCT-165, both designed to combat emerging SARS-CoV-2 variants. ARCT-154 later obtained marketing authorization in Japan in November 2023 and gained approval from the European Union in February 2025.
Additional Initiatives
Lunar-CF represents a joint effort with the Cystic Fibrosis Foundation aimed at developing novel therapies for cystic fibrosis.
Lunar-FLU is Arcturus’ proprietary program that integrates its self-amplifying mRNA Starr platform with the Lunar delivery technology to formulate a preventative influenza vaccine.
Lunar-GSD and Lunar-Rare are collaborative projects with Ultragenyx targeting treatments for glycogen storage disease type III as well as other rare conditions.
Lunar-HBV is a partnership with Janssen focused on creating therapeutic options for hepatitis B virus infection.
Lunar-NASH involves working alongside Takeda to develop therapies addressing non-alcoholic steatohepatitis (NASH) and related gastrointestinal illnesses.
Lunar-RPL and Lunar-AH are cooperative ventures with Synthetic Genomics dedicated to advancing vaccine and therapeutic innovations for infectious diseases.
External links
- Business Data for Arcturus Therapeutics: Yahoo Finance Reuters Bloomberg Nasdaq SEC Filings]