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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 has reported preliminary findings from its ongoing clinical study of ARCT-154 and ARCT-165. The data reveals a significant 50-fold increase in neutralizing antibody levels against SARS-CoV-2 following a boost with ARCT-154. The vaccine candidates show activity against various variants and will be evaluated for effectiveness against the omicron variant, with initial data expected in Q1 2022. The Phase 1/2 trials are being conducted in the U.S. and Singapore, with regulatory submissions for ARCT-154 expected soon in Vietnam.
Arcturus Therapeutics (NASDAQ: ARCT) has announced the appointment of Dr. Jing Marantz, an accomplished biopharma executive, to its Board of Directors. Dr. Marantz brings extensive clinical expertise and industry experience, having held senior positions at prominent biopharma companies such as Acceleron and Alnylam Pharmaceuticals. CEO Joseph Payne expressed confidence in Dr. Marantz's ability to contribute to the advancement of Arcturus's vaccine programs, including those targeting COVID-19 and other mRNA-based therapeutic candidates.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) will participate in the Piper Sandler’s 33rd Annual Virtual Healthcare Conference from November 30 to December 02, 2021. A pre-recorded fireside chat will be available on-demand starting November 22, 2021, at 10:00 a.m. ET. Founded in 2013 and based in San Diego, Arcturus specializes in mRNA medicines and vaccines, with a pipeline that includes candidates for COVID-19, influenza, and various rare diseases. The company utilizes advanced technologies like LUNAR® and STARR™ to develop innovative therapies.
Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) announced the approval of stock options for 16 newly-hired employees, totaling 185,700 shares. The options, with an exercise price of $36.65 per share, are a part of the employment compensation package and will vest over four years. This move is in accordance with Nasdaq Rule 5635(c)(4) as an inducement for accepting employment. The stock options are contingent upon filing a Form S-8 Registration Statement, which has already been filed.
Arcturus Therapeutics Holdings announced the completion of enrollment for its ARCT-154 COVID-19 vaccine trial, involving over 17,000 participants, and plans to submit an Emergency Use Authorization (EUA) application with Vietnam's Ministry of Health. A Phase 3c sub-study is also underway, aiming for comparison with AstraZeneca's vaccine. Financial results for Q3 2021 show revenues of $2.4 million and a net loss of $54.1 million. Operating expenses have increased significantly, particularly in research and development, which totaled $45.4 million.
Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) will announce its third quarter financial results for the period ending September 30, 2021, post-market on November 8, 2021. A conference call is scheduled for 4:30 PM EST on the same day, allowing investors to engage directly with company leaders. The company, focused on mRNA medicines, has a diverse pipeline including vaccines for COVID-19 and influenza, along with treatments for rare diseases. Investors can access the call via a provided webcast link.
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.