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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 (Nasdaq: ARCT), a global mRNA medicines company, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The event is scheduled for Tuesday, August 13, 2024, at 9:30 am Eastern Time in Boston. Arcturus specializes in developing infectious disease vaccines and treatments for liver and respiratory rare diseases.
Investors and interested parties can access a webcast and replay of Arcturus' presentation through the company's website. The presentation will be available in the 'Investor Relations/Events' section at https://ir.arcturusrx.com/investor-calendar. This conference appearance provides an opportunity for Arcturus to showcase its progress and potential to a wider audience of growth-oriented investors.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT), a global mRNA medicines company, has announced it will release its financial results for the second quarter of 2024 after the market close on Monday, August 5, 2024. The company will also host a conference call and webcast at 4:30 pm Eastern Time on the same day to discuss the results.
Arcturus focuses on developing infectious disease vaccines and medicines for liver and respiratory rare diseases. Investors and interested parties can join the earnings call using the provided domestic and international phone numbers or access the webcast through the company's website.
Arcturus Therapeutics (ARCT), a company specializing in mRNA medicines, provided updates on its ARCT-810 and ARCT-032 programs. The ARCT-810 Phase 2 study for OTC deficiency completed enrollment in Europe, with data expected later this year. This program is expanding in the U.S. to include more severely affected patients. ARCT-032, aimed at treating cystic fibrosis (CF), will submit an IND for a Phase 2 multiple ascending dose study within 60 days, based on positive safety data from previous trials. Key updates include the completion of subject enrollment in Europe for ARCT-810, the expansion of this program in the U.S., and promising preliminary results for ARCT-032 in treating CF patients.
Arcturus Therapeutics (Nasdaq: ARCT) has announced the appointment of Dr. Moncef Slaoui to its Board of Directors. Dr. Slaoui, known for his role as Chief Scientific Advisor for Operation Warp Speed, brings extensive experience in pharmaceutical innovation, development, and commercialization. He has held numerous leadership positions, including at GlaxoSmithKline, where he was instrumental in the development of 14 new vaccines. Dr. Slaoui aims to advance Arcturus' pipeline of mRNA vaccines and therapeutics using next-generation technologies.
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.