Arcturus Therape Stock Price, News & Analysis

Arcturus Therapeutics announced promising results from their Phase 1 and Phase 1b interim trials of ARCT-032, an inhaled mRNA therapeutic for cystic fibrosis (CF). The trials, presented at the 47th European Cystic Fibrosis Conference, demonstrated that ARCT-032 is safe and well-tolerated with no serious adverse events reported. Among the 36 study participants, 4 adults with CF showed a +4.0% average absolute improvement in lung function (FEV1) and a +5.8% relative change on Day 8 after two doses. The data aligns with pre-clinical CF ferret model results. Participants with different CF mutations and those on Trikafta® showed favorable responses. Mild-to-moderate febrile reactions were noted in some healthy volunteers but were managed with albuterol. No serious adverse events or dose-limiting toxicities were observed.

Arcturus Therapeutics announced positive interim data for its inhaled investigational mRNA therapeutic, ARCT-032, targeting cystic fibrosis (CF). The Phase 1b trial showed an average 4% improvement in FEV1 among the first four CF patients after two administrations. The treatment was well tolerated with no serious adverse events. These results will be presented at the European Cystic Fibrosis Conference on June 7, 2024. This study supplements the favorable data from the Phase 1 single ascending dose study in healthy volunteers, indicating potential advancements for ARCT-032 in treating CF.

CSL and Arcturus Therapeutics announced pivotal data published in Nature Communications demonstrating the efficacy and tolerability of their novel self-amplifying (sa-mRNA) COVID-19 vaccine, ARCT-154. The vaccine, the first of its kind approved in Japan, showed 100% efficacy against severe COVID-19 in healthy adults aged 18-59 and over 90% efficacy in older adults or those with comorbidities. The study, covering phases 1 through 3b, indicated that two 5 μg doses were well-tolerated and provided robust protection against multiple strains, including Omicron BA 4/5. The results underline the potential of the sa-mRNA technology to offer long-lasting immunity and superior protection compared to traditional mRNA vaccines.

CSL and Arcturus Therapeutics announced that Nature Communications published results from an integrated phase 1/2/3a/3b study on ARCT-154, a self-amplifying mRNA COVID-19 vaccine. The study demonstrates that two 5 μg doses of ARCT-154 were well-tolerated and provided significant protection against multiple COVID-19 strains. The vaccine showed 100% efficacy against severe COVID-19 in healthy individuals aged 18-59 and over 90% efficacy in at-risk populations. These results add to previous findings showing superior immunogenicity to Omicron BA 4/5 and longer-lasting immunity compared to conventional mRNA boosters. The vaccine's approval in Japan marks a significant milestone in the fight against COVID-19.

Arcturus Therapeutics (Nasdaq: ARCT), a global leader in mRNA medicines, announced its participation in several upcoming investor and scientific conferences. These include the TIDES USA on May 16, 2024, H.C. Wainwright BioConnect on May 20, 2024, Piper Sandler Lung Investor Conference on May 23, 2024, and Goldman Sachs Healthcare Conference on June 12, 2024. These events will feature presentations and fireside chats, providing the company with opportunities to showcase its advancements in infectious disease vaccines and treatments for liver and respiratory rare diseases.

Arcturus Therapeutics announces a positive first-quarter financial update and pipeline progress. The commercial manufacture of Kostaive is on track for the delivery of 4 million doses in Q3. The European Marketing Authorization decision is expected in Q3. Multiple Phase 3 trials demonstrate the breadth of the STARR vaccine platform. Important Phase 1 data for ARCT-2138 is anticipated in Q3. JP Morgan will monetize the company's investment in ARCALIS JV in Japan. Financially, revenues decreased due to the CSL agreement, while operating expenses increased. The net loss was $26.8 million, but the cash position remains strong, with a cash runway of at least three years.