Release Date: May 08, 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) remains on track to deliver the initial 4 million doses of its COVID-19 vaccine to Japan in Q3, supporting the upcoming vaccination season.
- The ARCT-2301 COVID-19 vaccine candidate showed superior immunogenicity and neutralizing antibody response compared to a conventional mRNA comparator in a Phase 3 study.
- Arcturus is expanding its vaccine platform globally, with a marketing authorization application filed with the European Medicines Agency for its COVID-19 vaccine.
- The ARCT-2138 quadrivalent seasonal influenza vaccine program is progressing well, with Phase 1 top-line data expected in Q3.
- Arcturus reported a revenue increase to $38 million in Q1 2024 from $30.9 million in Q4 2023, driven by increased activity across its CSL program.
Negative Points
- The company reported a net loss of approximately $26.8 million in Q1 2024, widening from a net loss of $11.7 million in the previous quarter.
- Total operating expenses increased to $68.4 million in Q1 2024 from $49.1 million in Q4 2023, primarily due to increased R&D expenses.
- The increase in R&D expenses was significant, rising to $53.6 million in Q1 2024 from $36.6 million in the previous quarter.
- Arcturus's cash, cash equivalents, and restricted cash slightly decreased to $345.3 million as of March 31, 2024, from $348.9 million on December 31, 2023.
- While the company is initiating commercialization of its COVID-19 vaccine, the full financial impact and revenue from this are not expected to be realized until Q4 2024.
Q & A Highlights
Q: Can you provide details on the July 1st meeting regarding the ARCTO. 32 cystic fibrosis program?
A: Joseph Payne, President and CEO, mentioned that by July 1st, the enrollment for the ARCTO. 32 cystic fibrosis program is expected to be completed. They plan to share Phase 2 data and a progress update for the OTC program, focusing on a subset of patients. This information will likely be communicated through a press release.
Q: What are the expectations around Japan's order for Coastave in 2025, and what are the current manufacturing capabilities of R-Calif for producing both COVID and flu vaccines?
A: Andrew Sassine, CFO, explained that they are optimistic about R-Calif's future ability to produce vaccines for the Japanese market, pending GMP approval expected in Q3. Future orders and opportunities will be guided by their partners, CSL and Meiji.
Q: Can you confirm changes in the ARCT-10 dosing format and the rationale behind these changes?
A: Joseph Payne clarified that based on learnings from early trials, they have optimized the premedication protocol and adjusted the dosing regimen to reduce infusion-related reactions. These adjustments are typical for this type of product and have been applied to the ongoing Phase 2 trial.
Q: What are the financial expectations from the initial 4 million doses of the COVID vaccine to be delivered to Japan?
A: Andrew Sassine mentioned that the specifics of financial arrangements and revenue booking would be detailed more in the fourth quarter. He highlighted the profit-sharing arrangement with CSL and indicated a three-way split due to the involvement of multiple partners.
Q: What updates can we expect on July 1st regarding the ARCT-10 and ARCTO. 32 programs?
A: Joseph Payne stated that for ARCT-10, they are looking for biomarker changes in more advanced and younger patients. For ARCTO. 32, the focus will be on safety and tolerability from two administrations of the therapy, with additional details on the dosing regimen to be shared.
Q: How is the monetization of the investment in the catalyst 38% owned JV in Japan progressing?
A: Andrew Sassine explained that they engaged JPMorgan to explore strategic options for monetizing the investment, emphasizing the strategic decision to become an asset-light entity. This move aligns with their focus on working with established CDMOs globally.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
