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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 Inc. (Nasdaq: ARCT) has announced the appointment of Dr. Nirdosh Jagota as Chief Regulatory Officer and Dr. Dushyant B. Varshney as Chief Technology Officer. Dr. Jagota brings over 30 years of regulatory experience, previously holding roles at Merck and Genentech. Dr. Varshney, with over 25 years in biotech, has a strong background in product lifecycles at organizations such as Kite Pharma and Pfizer. These additions aim to enhance Arcturus’ manufacturing capabilities and regulatory engagement as they advance their pipeline of RNA therapeutics and vaccines.
Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) announced the approval of stock options for five new employees, totaling 57,200 shares, contingent upon filing a Form S-8 Registration Statement. The options have an exercise price of $46.98, based on the closing stock price on October 15, 2021. They come with a ten-year term and vest over four years. This inducement grant is part of each individual's compensation package and supports Arcturus' focus on developing mRNA medicines, including vaccines for infectious diseases and therapies for rare liver and respiratory diseases.
Arcturus Therapeutics has initiated the Phase 3b dosing of ARCT-154, a self-replicating RNA vaccine targeting the SARS-CoV-2 delta variant. This trial, approved by the Vietnam Ministry of Health, aims to enroll approximately 20,000 participants, with half receiving the vaccine. Following a review of safety data from 1,000 Phase 1/2/3a participants, the company is on track to file for Emergency Use Authorization (EUA) in December 2021. This advancement brings Arcturus closer to offering a potentially best-in-class vaccine option in Vietnam and beyond.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) has met with Vietnam's President Nguyen Xuan Phuc and Vingroup's CEO Nguyen Viet Quang to discuss their recent collaboration for COVID-19 vaccine manufacturing. CEO Joseph Payne expressed optimism about expanding this collaboration, highlighting Vietnam's proactive public health strategy. This collaboration aims to support Vietnam's vaccination efforts against COVID-19 variants. Arcturus specializes in mRNA medicines and has a diverse pipeline of RNA therapeutics and vaccines.
Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) has successfully completed the dosing of 100 participants in the Phase 1 trial for its ARCT-154 vaccine and has received approval to proceed to Phase 2 and Phase 3a. The Phase 2 trial will involve an additional 300 participants, while Phase 3a will assess safety and immunogenicity in 600 more. Phase 3b is set to begin with 20,000 participants in early October. Arcturus aims to file for Emergency Use Authorization in Vietnam by December, addressing the urgent need for effective vaccines against COVID-19 variants.
Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) will participate in Citi's 16th Annual BioPharma Virtual Conference 2021.
Founded in 2013 in San Diego, California, Arcturus is focused on clinical-stage messenger RNA medicines, particularly in infectious disease vaccines and rare liver and respiratory diseases. The company's advanced technologies include LUNAR® lipid-mediated delivery and STARR™ mRNA Technology. Arcturus has a diverse pipeline, including candidates for SARS-CoV-2, Influenza, and Ornithine Transcarbamylase Deficiency, among others.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) announces its participation in several upcoming investor and scientific conferences, showcasing its advancements in mRNA medicines for infectious diseases and rare liver and respiratory conditions. Key events include presentations at the Wells Fargo Virtual Healthcare Conference on September 10, the H.C. Wainwright Global Investment Conference on September 13, and others through September 30. Investors can access links for conference details on Arcturus’ website.
Arcturus Therapeutics Holdings announced its Q2 2021 financial results, reporting $2.0 million in revenue, a decline from $2.3 million in Q2 2020. The net loss was approximately $54.6 million, or ($2.07) per share, compared to a loss of $10.3 million in the previous year. Operating expenses surged to $55.7 million, largely due to R&D investments. Arcturus is advancing its vaccine candidates, including ARCT-021 and ARCT-154, with promising NHP data. They received additional funding from Vinbiocare and have cash reserves to sustain operations for over two years.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) has received approval for a Clinical Trial Application (CTA) from Singapore's Health Sciences Authority for two of its STARR™ mRNA vaccine candidates, ARCT-154 and ARCT-165. The upcoming Phase 1/2 trial aims to evaluate their efficacy as primary vaccinations and boosters against SARS-CoV-2 variants, including Delta. Funding for the trial is partly sourced from a secured grant. Preclinical studies show strong immune responses in non-human primates for these vaccine candidates, thus positioning Arcturus for significant developments in the vaccine market.
Arcturus Therapeutics (NASDAQ: ARCT) announced that its partner, Vinbiocare, has received approval from the Vietnam Ministry of Health for a Clinical Trial Application (CTA) to proceed with a Phase 1/2/3 clinical study of ARCT-154, targeting SARS-CoV-2 variants, including Delta. The trial will enroll up to 21,000 participants and assess safety, immunogenicity, and efficacy. If successful, Emergency Use Approval (EUA) is anticipated. Preclinical data shows ARCT-154 induced strong neutralizing antibody responses to variants of concern, particularly the Delta variant.