Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q2 2024 Earnings Call Transcript August 5, 2024 4:30 PM ET

Company Participants

Neda Safarzadeh - VP, Head of IR, Public Relations and Marketing
Joe Payne - President and CEO
Andy Sassine - CFO

Conference Call Participants

Joohwan Kim - Canaccord Genuity
Yasmeen Rahimi - Piper Sandler
Evan Wang - Guggenheim Securities
Myles Minter - William Blair
Yanan Zhu - Wells Fargo
Yigal Nochomovitz - Citigroup
Samantha Schaeffer - Cantor Fitzgerald
Ed Arce - H.C. Wainwright
Yale Jen - Laidlaw & Company

Operator

Greetings and welcome to Arcturus Therapeutics' Second Quarter 2024 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations and Marketing. Thank you, Neda. You may begin.

Neda Safarzadeh

Thank you, operator. Good afternoon and welcome to Arcturus Therapeutics quarterly financial update and pipeline progress call. Today's call will be led by Joe Payne, our President and CEO; and Andy Sassine, our CFO. Dr. Pad Chivukula, our CSO and COO, will join them for the Q&A session.

Before we begin, I would like to remind everyone that the statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results, performance, and achievements to differ materially from those expressed or implied by the statements. Please see the forward-looking statement disclaimer on the Company's press release issued earlier today, as well as the risk factors section in our most recent Form 10-K and in subsequent filings with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made. Arcturus specifically disclaims any obligation to update such statements.

And with that, I will now turn the call over to Joe.

Joe Payne

Thank you, Neda. It's good to be with you again everybody. We look forward to providing our updates today on our quarterly investor call. I will begin my remarks with an update on progress with our vaccine franchise led by Kostaive, our self-amplifying mRNA COVID-19 vaccine. We're happy to report that we remain on track for the Kostaive Q4 commercial launch in Japan. Our manufacturing team is working diligently to deliver commercial batches of Kostaive this quarter. On the regulatory front, our partner Meiji has submitted a partial change application to Japan's PMDA to support the use of the updated Kostaive JN.1 COVID-19 vaccine for the upcoming 2024 and 2025 season. The European Medicine Agency, or EMA, continues to review the Kostaive Marketing Authorization application or MAA. The review is ongoing as planned.