Arcturus Therapeutics Holdings Inc.

Good afternoon everyone. Welcome to the ArcTurist Therapeutics third quarter 2025 earnings 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. Also today's call is being recorded and if you should need any operator assistance during the call today please press star 0 at any time. Now, at this time, I'd like to turn things over to Netta Safarzadeh, Vice President, Head of Investor Relations, Public Relations, and Marketing. Please go ahead, ma'am.

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. Patrick Vekula, 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 represent our views only as of the date such statements are made. Our trust 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. I will begin today with an update on our ARCT 032 program. This is our messenger RNA therapeutic candidate for cystic fibrosis, or CF. ARCTO32 utilizes Arcturus's lunar lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. Expression of a functional copy of the CFTR mRNA in the lungs of people with CF has the potential to restore CFTR activity and mitigate the downstream effects that cause progressive lung disease. In October, the company announced interim data from its ongoing phase two clinical trial of ARCT032. Treatment with inhaled 10 milligram doses daily over 28 days in six class one CF adults was generally safe and well tolerated. A protocol pre-specified analysis of high resolution computed tomography lung scans or HRCT lung scans using FDA 501K cleared AI technology revealed reductions in mucus burden in four of the six Class 1 CF participants in our second cohort. The ongoing third cohort is enrolling up to six subjects to assess the safety and tolerability of the 15 milligram dose daily over 28 days and the impact on the efficacy endpoints. The company intends to evaluate daily dosing of ARCTO32 over a 12-week duration in up to 20 CF participants. Safety and preliminary efficacy data will be collected in this study, which is planned to begin in the first half of 2026 after the third cohort top-line data is understood. Two weeks ago, I, along with our team, had the privilege of attending the North American Cystic Fibrosis Conference in Seattle. It was great to meet with the CF Foundation leadership team and share our enthusiasm for the Class 1 population based on our encouraging data. I met with the physicians and principal investigators involved in our ongoing clinical trials and was very pleased to hear their anecdotes, positivity, and encouragement. I enjoyed meeting with multiple CT scan experts and felt their passion as they described the present and future importance of HRCT imaging data in lung disease trials. I affirmed my appreciation of the significant unmet medical need represented by Class 1 CF and other CFTR modulator non-responders here in the United States. There is an even higher prevalence of people with Class 1 CF in countries outside the U.S. especially in Europe, India, the Middle East, and Israel. All in all, the conversations with the CF Foundation, people with Class 1 CF, their physicians, investigators, CT scan experts, and global CF representatives, this all reinforced Arcturus' commitment to advance ARCTO32 further into development. The safety and tolerability profile data, along with the before and after treatment HRCT scan images showing mucus plug reduction were well received by the CF community. We look forward to collecting additional and potentially meaningful clinical data in 2026 for our CF program. Moving on to the ARCT 810 program. This is our messenger RNA therapeutic candidate for ornithine transcarbamylase deficiency or OTC deficiency. With positive interim phase two data in hand, the company is diligently preparing for meetings with regulatory agencies in the first half of 2026 to discuss pivotal trial strategy for both pediatric and adult populations. Understanding what the FDA requires for ARC-T810's path to approval is the next key milestone for this program. We aim to provide more details pertaining to these regulatory alignment meetings in the first half of 2026. I will now provide regulatory updates for our partnered COVID-19 vaccine program, also known as CoStave. Our Japanese partner, Meiji Seika Pharma, has launched the two-dose vial of CoStave updated for the JN1 variant XEC in Japan. This is the first time the two-dose vial presentation is being distributed in Japan. Meiji received approval from the Pharmaceuticals and Medical Devices Agency, or PMDA, in August. Also in August, the company published the phase three manuscript on the immunogenicity and safety of our self-amplifying mRNA COVID-19 vaccine, ARCT2303. The study shows that ARCT2303 induces a robust immune response against SARS-CoV-2 and can be co-administered with licensed influenza vaccines in adults with no impact on safety or immunogenicity of either vaccine. The results were published in eClinical Medicine. Moving on to ARCT 2304. This is our next-gen star vaccine candidate for pandemic A slash H5N1 influenza virus. This is the program contracted with and funded in part by BARDA. We conducted a phase one study in 132 young adults and 80 older adults. ARCT 2304 induced a humoral immune response after a single dose in all tested dose levels. The administration of a second dose of ARCT 2304 further increased immune responses. ARCT 2304 in dose levels of 1.5, 5, and 12 micrograms induced a hemagglutinin specific immune response similar to or higher than the MF59 adjuvanted pandemic vaccine in both young and older adults. No safety or tolerability concerns were raised from available data. These data further validate our STAR-SA mRNA platform. The study results support the further development of the self-amplifying mRNA pandemic influenza vaccine candidate. With that, I'll now pass the call to Andy.