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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 (Nasdaq: ARCT) has received FDA clearance to proceed with a clinical trial for ARCT-2304, a self-amplifying mRNA vaccine candidate targeting H5N1 pandemic influenza. The Phase 1 clinical trial, funded by BARDA, will evaluate safety, reactogenicity, and immunogenicity in approximately 200 healthy adults in the United States. The vaccine utilizes Arcturus' STARR® self-amplifying mRNA technology and is part of the company's preparation efforts for potential future pandemics.
Arcturus Therapeutics reported Q3 2024 financial results and pipeline updates. Key highlights include a $25 million commercial milestone from first KOSTAIVE® sales in Japan, and Phase 2 studies for Cystic Fibrosis and OTC Deficiency on track for proof-of-concept data in H1 2025. Revenue was $41.7 million, down from $45.2 million in Q3 2023. Net loss improved to $6.9 million ($0.26 per share) compared to $16.2 million ($0.61 per share) last year. The company maintains a strong cash position of $294.1 million, with runway through Q1 2027.
Arcturus Therapeutics (Nasdaq: ARCT), a commercial mRNA vaccines and medicines company, announced it will release its Q3 2024 financial results on November 7, 2024, after market close. The company will also host a conference call and webcast at 4:30 pm ET on the same day to discuss the results and provide a corporate update. The call can be accessed domestically at 1-800-274-8461 and internationally at 1-203-518-9814 using the conference ID: ARCTURUS. A webcast link will be available for streaming.
CSL and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine ARCT-154 maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated:
1. Higher antibody levels against multiple SARS-CoV-2 strains, including Wuhan-Hu-1 and Omicron variants.
2. Effectiveness at one-sixth the dose of Comirnaty® (5 μg vs 30 μg).
3. Superior durability of immune response in both younger and older adults.
Additionally, their bivalent vaccine ARCT-2301 showed superior immunogenicity over Comirnaty® bivalent vaccine up to six months post-vaccination. The sa-mRNA platform vaccine targeting the JN.1 variant is now approved in Japan under the name KOSTAIVE®.
CSL (CSLLY) and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated ARCT-154 elicited superior antibody persistence against multiple SARS-CoV-2 strains at one-sixth the dose of Comirnaty®.
Key findings include:
- ARCT-154 showed superior neutralizing antibodies against Wuhan-Hu-1 strain at Day 361
- Similar advantages were observed against Omicron BA.4-5 and other variants
- A bivalent formula, ARCT-2301, also demonstrated superior immunogenicity over Comirnaty®
The sa-mRNA COVID-19 vaccine is approved in Japan under the name KOSTAIVE® for adults 18 and older.
CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older. The vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine for the October COVID-19 vaccination campaign.
KOSTAIVE® is the world's first commercially available sa-mRNA COVID-19 vaccine. Clinical evidence supports its safety and effectiveness, with data showing superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA vaccines and immunity lasting up to one year. This approval aligns with recent World Health Organization recommendations and demonstrates CSL and Arcturus' commitment to innovative vaccine technology for viral respiratory diseases.
CSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older. The vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine for the October 2024 vaccination campaign.
KOSTAIVE® is the world's first commercially available sa-mRNA COVID-19 vaccine for adults. Clinical data showed superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA vaccines and immunity lasting up to one year. This approval aligns with recent World Health Organization recommendations and demonstrates CSL and Arcturus' commitment to innovative vaccine technology for viral respiratory diseases.
Arcturus Therapeutics (Nasdaq: ARCT) has received FDA clearance for its Investigational New Drug (IND) application for ARCT-032, an inhaled mRNA therapeutic for cystic fibrosis (CF). This clearance allows Arcturus to initiate a Phase 2 multiple ascending dose study to evaluate the safety, tolerability, and efficacy of ARCT-032 in CF patients. The study will focus on individuals who do not qualify for or benefit from CFTR modulator therapy.
Dr. Juergen Froehlich, Chief Medical Officer of Arcturus, stated that this development provides an opportunity to further validate their LUNAR® technology for delivering mRNA via inhalation. The study will assess ARCT-032 administered over several weeks at multiple dose levels in CF patients.
Arcturus Therapeutics Holdings Inc. (ARCT), a global mRNA medicines company, has announced its participation in several upcoming investor and scientific conferences in September 2024. These include:
- Wells Fargo 2024 Healthcare Conference (Fireside Chat) on September 4
- RNA Leaders USA Conference (Presentation) on September 5
- H.C. Wainwright 26th Annual Global Investment Conference (Presentation) on September 9
- Cantor Fitzgerald Annual Healthcare Conference (Fireside Chat) on September 18
Arcturus focuses on developing infectious disease vaccines and addressing unmet medical needs in liver and respiratory rare diseases. Investors can access webcast links for these events through the Investor Relations/Events section of the company's website.
Arcturus Therapeutics (ARCT) announced its Q2 2024 financial results and pipeline progress. Key highlights include:
1. IND submitted for Phase 2 trial of ARCT-032 for cystic fibrosis
2. ARCT-810 (OTC deficiency) Phase 2 interim data expected in Q4
3. Kostaive® on track for Q4 commercial launch in Japan
4. Q2 revenue of $49.9 million, up from $10.5 million in Q2 2023
5. Net loss of $17.2 million ($0.64 per share) compared to $52.6 million ($1.98 per share) in Q2 2023
6. Cash position of $317.2 million as of June 30, 2024
The company's pipeline progress and financial results demonstrate continued advancement in mRNA therapeutics and a strengthened financial position.