Arcturus Therapeutics Holdings Inc.

Good day, everyone, and welcome to today's Arcturus Therapeutics Third Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing star 1 on your telephone keypad. You may withdraw yourself from the queue by pressing star 2. Please note this call may be recorded, and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Ms. Nita Sefarzada, Vice President, Head of Investor Relations, Public Relations, and Marketing. Please go ahead.

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. Pat Chivikula, 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 statement. Please see the forward-looking statement disclaimer on the company's press release issued earlier today. as well as the risk factor section in our most recent form, 10-K, and in subsequent filings with the SEC. In addition, any forward-looking statements present our views only as of the date such statements are made. Our tourist specifically disclaims any obligation to update such statements. And with that, I will now turn the call over to Joe.

Thank you, Netta. 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 CoStave, our self-amplifying mRNA COVID-19 vaccine. We're thrilled about our recent commercial launch of CoStave in Japan. Last month, members of our senior management team, including myself, had the wonderful opportunity to travel to Japan to be vaccinated with CoastAid in Tokyo. In addition to our team from Arcturus, we shared this experience with senior management from Meiji, CSL, and Arcalis. As you can imagine, it was an experience our team will never forget. In connection with the first sale of our COVID-19 vaccine, Arcturus received a $25 million commercial milestone. On the regulatory front, CSL Securus' partner in Japan, Meiji Seika Pharma, announced earlier this year that they submitted a partial change application for an amendment to the manufacturing and marketing approval of CoStave to include domestic manufacturing sites in Japan, including Arcalis. And Arcalis is Arcturus' manufacturing joint venture in Japan. When approved, this will allow for Meiji Seika Pharma to begin selling domestically produced COSTAVE this season. The European Medicine Agency continues to review the COSTAVE marketing authorization application. I've been impressed with how our team has worked diligently with the agency as they review the first potential self-amplifying mRNA product in Europe. The process is near completion with the CHMP opinion expected next month. As we look forward to achieving marketing approval in the US, we plan to file a BLA for CoStave in the first half of next year, which will be supported by positive results from multiple phase three studies. We continue to collect meaningful clinical data for our proprietary next generation STAR mRNA platform. The company announced today another set of positive phase three results wherein ARCT2303, this is the monovalent XBB variant derivative of COSTAVE, met all four primary study objectives and key secondary objectives. The study supports co-administration of COSTAVE with licensed influenza vaccines. ARCT2303 demonstrated superior immune response versus ARCT154. as measured by neutralizing antibodies against Omicron XBB 1.5.6 in terms of geometric mean titer or GMT ratio and a seroconversion rate or SCR difference. Co-administration of ARCT 2303 and cell-based quadrivalent influenza vaccine showed non-inferior immune response versus standalone QIV administration. Co-administration of ARCT 2303 and QIV also showed non-inferior immune response versus standalone ARCT 2303 administration. And lastly, co-administration of ARCT 2303 and adjuvanted QIV in older adults showed similar responses versus standalone administration of ARCT 2303 and adjuvanted In September, the company, along with our partners, CSL, Keras, and Meiji, announced new 12-month post-vaccination data for CoStave at options 12 for the control of influenza conference. The results of a head-to-head phase 3 study demonstrated that CoStave maintained superior immunogenicity compared to the conventional mRNA vaccine, Comirnaty. for up to one year against Wuhan HU1 and Omicron BA4 and 5 and certain other variants, and at one-sixth the dose of the comparator. These results were published in the Lancet Infectious Disease. Additional Phase III data presented at the Options Conference showed that bivalent costave, also known as ARCT2301, induced superior immunogenicity over conventional bivalent mRNA vaccine Comirnaty that persisted against key variants up to six months post-vaccination. Now shifting our attention to our mRNA therapeutics franchise, let's begin with an update on ARCT032. ARCT032 is an inhaled messenger RNA therapeutic for cystic fibrosis. and it's formulated with Arcturus's lunar delivery technology that differentiates us from our competitors. In September, we received clearance of an investigational new drug application to the US Food and Drug Administration. The FDA clearance of the IND application enables Arcturus to initiate a phase two multiple ascending dose study to evaluate the safety, tolerability, and efficacy of ARCTO32 in people with cystic fibrosis. Our team is actively engaged in onboarding a substantial number of clinical sites to help us in this effort. We are fortunate to be able to be working closely with the CF Foundation in this process. The Phase II study is presently screening individuals with CF who do not qualify for or benefit from CFTR modulator medicines due to dysfunctional or absent CFTR protein and or drug intolerance. This study will allow us to evaluate FEV lung function improvement in individuals with CF. And I'm very pleased to report that the company is on track to share interim phase two proof of concept data for our CF program in the first half of 2025. I'll now move on to our ARCT 810 program. This is our messenger RNA therapeutic candidate for ornithine transcarbamylase, or OTC, deficiency. Earlier this year, Arcturus announced the expansion of the Phase II clinical program of ARCT810 into the United States. This open-label multiple-dose study evaluating pharmacodynamics and safety is currently enrolling adults and adolescents requiring clinical management for OTC deficiency. Our placebo controlled phase two European study has completed the dosing phase. These concurrent phase two studies in Europe and the US will allow us to evaluate meaningful biomarker changes in individuals with OTC deficiency. And I'm happy to report that the company is on track to share interim phase two proof of concept data in the first half of 2025. With that, I'll now pass the call to Andy.