Arcturus Therapeutics Q2 2024 Financials and Pipeline Update

Arcturus Therapeutics Holdings Inc., a San Diego-based company specializing in messenger RNA (mRNA) medicines, reported its financial performance for the second quarter ending June 30, 2024, and provided several corporate updates.

Joseph Payne, President & CEO of Arcturus Therapeutics, expressed satisfaction with the company’s trajectory, particularly highlighting the upcoming commercial launch of Kostaive® in Japan and the progressive clinical development of their mRNA therapeutics pipeline. Payne noted the importance of the safety data gathered for cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency candidates, ARCT-032 and ARCT-810, respectively.

Dr. Juergen Froehlich, Chief Medical Officer, emphasized that the safety data supports the continuation of clinical trials for these rare disease programs. He elaborated on the Phase 2 study for ARCT-032, which aims to treat CF patients who are either ineligible for modulator treatments or are not prescribed them despite eligibility. Additionally, Dr. Froehlich announced that the dosing phase of the European Phase 2 ARCT-810 study was nearing completion, with interim data expected by Q4. An additional Phase 2 study has commenced in the United States to include younger and more severely affected patients.

Key corporate highlights include:

1. IND Application Submission: In July, the company submitted an Investigational New Drug (IND) application for a Phase 2 study to evaluate ARCT-032 in cystic fibrosis patients. 
2. Phase 1 Interim Data Presentation: Arcturus presented interim data at the 47th Annual European Cystic Fibrosis Conference, highlighting the safety and tolerability of ARCT-032 in initial trials.
3. Phase 2 Study Enrollment for ARCT-810: In July, Arcturus completed enrollment for the European ARCT-810 Phase 2 study, encompassing eight participants with OTC deficiency. The study is being expanded in the U.S. to include younger patients with more severe disease.
4. Kostaive® Data Publication: In May, pivotal data from a Phase 3 study of Kostaive® was published in Nature Communications, demonstrating its efficacy and safety in preventing COVID-19. The vaccine showed 100% efficacy against severe COVID-19 in healthy adults aged 18-59 and over 90% efficacy in high-risk groups.
5. Regulatory Progress: Meiji initiated a partial change application with Japan’s PMDA to support the use of Kostaive® JN.1 for the 2024/2025 season. The European Medicines Agency (EMA) review is ongoing, and a Phase 3 study for an Omicron variant version of Kostaive® has completed enrollment.
6. New Director Appointment: Dr. Moncef Slaoui was appointed as a new independent director to the Arcturus Board of Directors in June.

Financially, Arcturus reported significant revenue growth, with $49.9 million in Q2 2024, up from $10.5 million in Q2 2023. This increase was attributed mainly to the CSL agreement's impact on Kostaive® manufacturing activities and clinical trial expenses. Over six months ending June 30, 2024, revenue decreased slightly by $2.9 million compared to the same period in 2023, attributed to timing and value of milestone achievements.

Operating expenses rose to $71.0 million in Q2 2024 compared to $65.9 million in Q2 2023, driven by increased clinical and manufacturing costs. Research and development expenses grew to $58.7 million in Q2 2024 from $52.7 million in Q2 2023. General and administrative expenses remained relatively stable, with $12.3 million in Q2 2024 compared to $13.2 million in Q2 2023.

Arcturus reported a net loss of $17.2 million in Q2 2024, a significant improvement from a net loss of $52.6 million in Q2 2023. For the six months ending June 30, 2024, the net loss was $44.0 million, contrasted with a net loss of $1.8 million for the same period in 2023.

The company’s cash position remained strong, with $317.2 million in cash, cash equivalents, and restricted cash as of June 30, 2024. Arcturus continues to benefit from milestone payments from CSL, supporting ongoing developments in their pipeline and extending their cash runway approximately through the first quarter of fiscal year 2027.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!