Arcturus Therape Stock Price, News & Analysis

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.

Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) announced a collaboration with Vinbiocare Biotechnology to establish a COVID-19 vaccine manufacturing facility in Vietnam. Vinbiocare will invest $40 million upfront and manage the technology transfer necessary for production, with a capacity of up to 200 million doses annually. Arcturus will grant an exclusive license for production in Vietnam, supplying proprietary technology for the manufacturing process. This partnership aims to enhance vaccine accessibility in Vietnam and other regions.

Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) has received approval from the UK Health Research Authority to start a Phase 2 clinical study for ARCT-810, an mRNA-based treatment for Ornithine Transcarbamylase (OTC) deficiency. This study aims to assess safety, tolerability, and efficacy in up to 24 participants over 12 weeks. The trial builds on positive Phase 1 results, highlighting ARCT-810's potential to restore urea cycle function and mitigate neurological damage in OTC deficiency patients.

Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) will release its financial results for Q2 2021 on August 9, 2021, after market close. A conference call will follow at 4:30 PM ET, where investors can discuss the results. The company specializes in mRNA medicines and vaccines aimed at infectious diseases and rare conditions affecting the liver and respiratory system. Arcturus utilizes advanced technologies like LUNAR® lipid-mediated delivery and STARR™ mRNA Technology, featuring a pipeline that includes candidates for SARS-CoV-2 and Influenza vaccines.