Arcturus Therapeutics Reports Q1 2024 Financials and Pipeline Update

Arcturus Therapeutics Holdings Inc., a global leader in mRNA medicines, has announced its financial results for Q1 2024 and shared significant corporate updates. The company, recognized for its innovative developments in infectious disease vaccines and treatments for liver and respiratory rare diseases, is making substantial progress in both its vaccine and therapeutic pipelines.

CEO Joseph Payne expressed optimism about the company's trajectory, particularly with the impending commercialization of Kostaive®, an mRNA COVID-19 vaccine. Collaborating with CSL and Meiji Seika Pharma, the company is set to deliver 4 million doses of Kostaive® in Q3 2024. An approval decision for the European Marketing Authorization Application for Kostaive® is also anticipated in Q3.

The company's vaccine platform, STARR®, continues to show promising results. Phase 3 trials for Kostaive® have demonstrated the vaccine's breadth and durability. Additionally, the ARCT-2138 (LUNAR-FLU) Phase 1 trial, focusing on a quadrivalent seasonal influenza vaccine, is expected to yield topline immunogenicity and safety data in Q3. Further updates on ARCT-810 (LUNAR-OTC) Phase 2 and ARCT-032 (LUNAR-CF) Phase 1b clinical trials will be revealed on July 1st.

In March, Arcturus, alongside CSL and Meiji, reported that their bivalent COVID-19 vaccine candidate, ARCT-2301, met primary endpoints in a Phase 3 study in Japan. The study, which involved 930 participants, showed non-inferiority and superiority in neutralizing antibody responses against the Omicron BA.4/5 and Wuhan strains compared to a licensed mRNA vaccine. No serious adverse events were attributed to ARCT-2301.

Furthermore, Arcturus and CSL have initiated a Phase 3 pivotal study for the ARCT-2303 vaccine, which includes the Omicron XBB.1.5 variant. This study aims to collect additional immunogenicity and safety data to support U.S. product licensure. Approximately 1,680 participants in the southern hemisphere will be recruited for this study, which also assesses co-administration with seasonal influenza vaccines.

Financially, Arcturus reported Q1 2024 revenues of $38.0 million, a decrease from $80.3 million in the same period the previous year. This drop was mainly due to the CSL agreement, which had generated significant revenues in Q1 2023. However, increased revenue from the BARDA agreement partially offset this decrease. Operating expenses rose to $68.4 million from $65.5 million, driven by higher research and development costs and general administrative expenses.

The company's research and development (R&D) expenses were $53.6 million, reflecting ongoing investments in their internal OTC and cystic fibrosis programs, as well as early-stage and discovery technologies. General and administrative expenses increased to $14.9 million due to higher personnel, travel, consulting, and facility-related costs.

Arcturus reported a net loss of $26.8 million for Q1 2024, compared to a net income of $50.8 million in Q1 2023. Despite the loss, the company's financial position remains robust, with $345.3 million in cash and equivalents as of March 31, 2024. This financial stability is bolstered by significant upfront payments and milestones from CSL, which are expected to continue supporting ongoing development programs.

In strategic moves, Arcturus has engaged JP Morgan to monetize its investment in ARCALIS, a joint venture in Japan focused on mRNA vaccine manufacturing. CFO Andrew Sassine highlighted that the company is on track to qualify for commercial milestones under the CSL collaboration with the commencement of Kostaive® revenues in Japan.

Arcturus remains committed to advancing its pipeline of innovative mRNA therapeutics and vaccines, with upcoming clinical data updates and milestones poised to reinforce its position as a leader in the biotechnology sector.