Arcturus Therapeutics Holdings Inc. reports developments as a commercial messenger RNA medicines and vaccines company focused on liver and respiratory rare disease therapeutics and infectious disease vaccines. Its news commonly covers pipeline progress for cystic fibrosis and ornithine transcarbamylase deficiency programs, including LUNAR-CF, ARCT-032, LUNAR-OTC and ARCT-810, as well as updates tied to its LUNAR lipid-mediated delivery and STARR self-amplifying mRNA technologies.
Company updates also address KOSTAIVE COVID-19 vaccine activity, partnered vaccine programs with CSL Seqirus, the ARCALIS manufacturing joint venture in Japan, collaboration revenue, research and development spending, quarterly financial results, investor conference participation, and executive or board changes.
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.
Arcturus Therapeutics (Nasdaq: ARCT) announced promising preclinical data for its COVID-19 vaccine candidate, LUNAR-COV19, demonstrating robust adaptive immune responses. Key findings include a significant increase in CD8+ T-cells and a balanced Th1/Th2 response. The STARR™ mRNA technology elicited higher anti-spike protein antibodies compared to conventional mRNA across all doses, particularly at lower doses. With plans for human clinical trials set for summer 2020, the results indicate strong support for the vaccine's effectiveness and potential for clinical protection against COVID-19.