Release Date: August 05, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Arcturus Therapeutics Holdings Inc (ARCT, Financial) reported a significant increase in revenue for Q2 2024, reaching $49.9 million, up from $10.5 million in Q2 2023.
- The company remains on track for the commercial launch of its self-amplifying mRNA COVID-19 vaccine, Kostaive, in Japan in Q4 2024.
- Positive Phase 3 efficacy, immunogenicity, and safety data for Kostaive were published, showing 100% efficacy against severe COVID-19 in healthy individuals aged 18-59.
- The company has a strong cash position with $317.2 million in cash, cash equivalents, and restricted cash as of June 30, 2024.
- Arcturus Therapeutics Holdings Inc (ARCT) has expanded its pipeline with multiple ongoing clinical trials, including ARCT-032 for cystic fibrosis and ARCT-810 for OTC deficiency.
Negative Points
- Total operating expenses increased to $71 million for Q2 2024, up from $65.9 million in Q2 2023.
- The company reported a net loss of $17.2 million for Q2 2024, although this is an improvement from the $52.6 million loss in Q2 2023.
- There is uncertainty regarding the timing and approval of the Kostaive COVID-19 vaccine in Europe, with CSL providing commercial guidance.
- The manufacturing and commercial success of Kostaive in Japan is dependent on the approval of the ARCALIS manufacturing plant and subsequent sales by Meiji.
- The company has not provided specific guidance on the revenue recognition process for Kostaive, leading to some uncertainty about future financial performance.
Q & A Highlights
Q: Can you provide more details on the CF Phase 2 study, including its duration and endpoints? Also, have you dosed the seventh patient in the Phase 1b study?
A: We will provide full details on the Phase 2 CF study later this year. We intend to recruit CF patients ineligible for modulator treatment and those eligible but not prescribed modulators. The Phase 1b study dosing has completed with no serious adverse events observed. The focus now is on the Phase 2 study.
Q: What is the status of the COVID vaccine approval in Europe, and are there any updates on potential orders for 2024 and 2025?
A: CSL will provide commercial guidance in Europe and the US. The review is active and ongoing as planned. We defer to CSL for specific guidance on orders and sales.
Q: What would you consider good data from the EU portion of the OTC trial, and how is recruitment going in the US study?
A: We are looking for safety and tolerability data from the EU trial, which will help us access younger, sicker patients. Recruitment in the US has just started, and we will provide updates in future calls.
Q: Can you provide an update on the manufacturing progress for the 4 million doses ordered by Meiji?
A: ARCALIS has completed two GMP batches and is working on the final batch. Upon completion, ARCALIS and Meiji will seek PMDA approval for commercial production. Initial doses will come from US and European CDMOs.
Q: How will you recognize revenue for Kostaive? Will it be when ordered by CSL, manufactured, or shipped to Japan?
A: Revenue recognition will depend on Meiji's sales in Japan. We will earn a commercial milestone upon delivery, and sales will be reported by Meiji to CSL, who will then determine the profit split.
Q: Does the safety profile of ARCT-032 give you confidence to advance it into other indications with an inhaled formulation?
A: Yes, the safety data from Phase 1 and 1b trials gives us confidence to expand the platform in the lung. However, we will wait for efficacy readouts from the Phase 2 trial before allocating more resources.
Q: What is the timeline for interim data from the Phase 2 ARCT-032 trial, and what are the key biomarkers for the ARCT-810 trial?
A: We aim to get the Phase 2 ARCT-032 trial data as soon as possible. For ARCT-810, we are focusing on safety, tolerability, and biomarkers like ammonia, glutamate, and urea genesis to design an efficient pivotal trial.
Q: When should we expect the top-line readout for the Omicron XBB.23.03 vaccine trial, and what are the next steps?
A: The trial has completed enrollment, and data will come in throughout the year. The primary goal is to support regulatory applications globally.
Q: What is the projected timeline for the Japanese regulatory approval of the updated JN.1 vaccine?
A: The timeline is suitable for a market launch this year, similar to other approved vaccines. We expect to launch and market it successfully within this year.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
