Arcturus Therape Stock Price, News & Analysis

Arcturus Therapeutics has received FDA allowance for its IND application regarding the Phase 2 clinical study of its vaccine candidate ARCT-021, based on preceding favorable data from the Phase 1/2 study. The Phase 2 trial will involve 600 participants, evaluating both safety and immunogenicity. The aim is to inform dosing for a prospective Phase 3 study planned for Q2 2021, pending successful results. The ARCT-021 vaccine shows promise for a differentiated profile and may potentially require only a single dose for adequate protection against SARS-CoV-2.

Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) has selected ARCT-032, an aerosolized mRNA therapeutic candidate, for Cystic Fibrosis (CF) treatment. This candidate aims to express functional CFTR protein in the lungs, addressing the root cause of CF lung disease. The development is backed by preclinical data showing potential to restore CFTR activity in affected models. The company emphasizes ARCT-032's capability to benefit all CF patients, regardless of genetic mutations, enhancing existing treatment options.

Arcturus Therapeutics Holdings announced approval from the Singapore Health Sciences Authority to conduct a Phase 2 clinical study for its COVID-19 vaccine candidate, ARCT-021. This follows promising results from the Phase 1/2 trial, which demonstrated a robust immune response in all participants. The Phase 2 study aims to identify the best vaccination regimen ahead of a global Phase 3 study anticipated in Q2 2021. Preliminary preclinical data indicated significant protection from SARS-CoV-2 in animal models, further supporting the candidate's potential efficacy.

Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) has announced a public offering of 1,365,000 shares priced at $110.00 each, aiming for approximately $150 million in gross proceeds. The offering includes a 30-day option for underwriters to purchase an additional 204,750 shares. The funds are designated for clinical trials and manufacturing its LUNAR-COV19 vaccine. The offering is underpinned by a registration statement filed with the SEC, with closing anticipated around December 10, 2020.

Arcturus Therapeutics Holdings (NASDAQ: ARCT) announced plans for an underwritten public offering of its common stock, with all shares to be sold by the Company. Subject to market conditions, the offering includes a potential 15% overallotment option for underwriters. Proceeds will fund clinical trials and manufacturing of the LUNAR-COV19 vaccine candidate. The offering is registered under an effective SEC shelf, with a prospectus to follow. Piper Sandler & Co. and Guggenheim Securities are joint bookrunners.

Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) has commenced dosing in its Phase 1b clinical trial of ARCT-810 for Ornithine Transcarbamylase (OTC) deficiency, a rare and serious disorder. The study, involving 12 patients, will assess safety, tolerability, and pharmacokinetics at doses ranging from 0.2 mg/kg to 0.4 mg/kg. Previous studies indicated ARCT-810 was safe and well tolerated in healthy subjects, showing a favorable pharmacokinetic profile. OTC deficiency, affecting around 10,000 people worldwide, currently lacks FDA-approved treatments. Arcturus aims to leverage its mRNA platform to address this unmet medical need.

Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) announced its participation in Piper Sandler’s 32nd Annual Virtual Healthcare Conference, scheduled for December 1, 2020, at 10:00 a.m. ET. The company will present on The Road Ahead for COVID-19 Vaccines. Founded in 2013 and based in San Diego, Arcturus focuses on mRNA medicines and vaccines, including programs targeting COVID-19 and other diseases. The company has developed significant partnerships and holds a robust patent portfolio of 200 patents worldwide, aimed at advancing RNA therapeutic technologies.

Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) reported its financial results for Q3 2020, with revenues of $2.3 million, a decrease from $3.3 million in Q3 2019. Operating expenses surged to $23.3 million, primarily due to increased spending on clinical trials for ARCT-021 and ARCT-810, leading to a net loss of $21.0 million, or $0.92 per share. Despite the losses, the company’s cash position improved to $307.1 million, bolstered by equity offerings. The ARCT-021 COVID-19 vaccine candidate shows promising preliminary results, and the ARCT-810 candidate for OTC deficiency is advancing into further studies.

Arcturus Therapeutics (Nasdaq: ARCT) reported positive interim results from its Phase 1/2 study of ARCT-021, a COVID-19 vaccine candidate. Conducted in Singapore, the trial enrolled 106 subjects, revealing robust anti-spike protein IgG immune responses across multiple doses. The vaccine was well tolerated, showing a favorable safety profile. Additionally, Arcturus secured a financial commitment of up to $220 million from Singapore's Economic Development Board (EDB) to support vaccine manufacturing, including a $45 million loan linked to future sales.