Arcturus Therapeutics Holdings Inc.

Hello and welcome everyone joining today's Arcturus Therapeutics second quarter 2026 earnings call. At this time, all participants are in a listen-only mode. Later, you will have an opportunity to ask questions during the question and answer session. To register to ask a question at any time, please press star 1 on your telephone keypad. Please note this call is being recorded and we are standing by should you need any assistance. It is now my pleasure to turn the meeting over to Neda Safarzadeh, 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, Dr. Alan Cohen, our Chief Medical Officer, and Dennis Mulroy, our Chief Financial Officer. Dr. Pat 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 this 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. Arcturus specifically disclaims any obligation to update such statements. And with that, I will now turn the call over to Joe.

Thank you, Neda, and it's good to be with you again, everybody. The second quarter of 2026 was marked by continued execution across our rare disease pipeline. and important strategic developments for Arcturus' vaccine franchise. Today, I'll provide updates on our rare disease programs, ARCT 032 and ARCT 810, and summarize today's good news regarding our vaccine enterprise. I will then turn the call over to Alan for additional clinical updates and to Dennis to review our financial results. Starting with ARCT 032, our inhaled mRNA therapeutic candidate for CF. During the quarter, our Phase 2 study continued to advance on schedule with active screening and enrollment ongoing across sites in the United States, Israel, and Turkey. These international sites are important for our recruitment strategy given the higher prevalence of individuals living with Class 1 CF in Israel and Turkey. As a reminder, Cohort 4 is evaluating 10 mg of ARCTO32 administered daily by inhalation over a 12-week treatment period. The study is monitoring for safety and evidence of early clinical benefit, including pulmonary function measures such as percent predicted FEV1 and lung clearance index or LCI. In addition, quality of life measures and high resolution CT imaging data are being collected. The decision to advance our CF program into phase three is expected in the fourth quarter or Q4 2026. If Arcturus decides to proceed into a Phase III trial, this decision triggers additional and very meaningful contributions from Thermo Fisher, including manufacturing support, clinical research, and related services. Turning to ARCTA10, this is our mRNA therapeutic candidate for Ornithine Transcarbamylase Deficiency, or OTC deficiency. We are pleased to update the market today that we've completed enrollment in our ongoing Phase II study. and all enrolled subjects have completed study drug dosing. This represents an important operational milestone for our OTC program. And with the dosing phase of the study completed, our team is now evaluating the phase two clinical data along with the supplementary data requested by the FDA in the Type C meeting earlier this year. These data will inform upcoming regulatory discussions across both adult and pediatric development. We expect to communicate the Phase 2 clinical study data later this year in Q3 2026. Concurrent with the data readout, we will provide additional details regarding the regulatory path forward for our OTC deficiency program. Now on to our vaccine division. Today we announced the conclusion of our SA mRNA collaboration with CSL Securus. and on behalf of Arcturus, I wanted to express sincere gratitude to the outstanding team at CSL. They've been a great partner to help shepherd this first-in-class, next-generation SA mRNA technology to where it is today, a validated platform with approvals in over 30 countries. We are pleased to regain global rights to our commercial COVID vaccine product, CoStave, and to our self-amplifying mRNA platform. Having strategic control of this validated vaccine platform is an exciting opportunity for our company. The Arcturus SA mRNA platform is validated. It's proven to be efficacious with an immune response that is durable and superior in comparative studies. It's been reviewed by several regulatory agencies to be safe and well tolerated. The manufacturing process is commercial ready, scalable, fast with lower COGS attributed to a significantly lower dose level. Several global regulatory agencies have reviewed and approved Arcturus' SA mRNA vaccine platform as represented by COSTAVE, which has been approved for licensure in Europe, Japan, and more recently, the United Kingdom, with the regulatory path forward into the United States also clearly understood. The Arcturus vaccine platform is pandemic ready. The U.S. government is keenly aware of this next generation SA mRNA platform. It is likely not a matter of if, rather a matter of when this platform will be called upon to address future epidemics of infectious disease. Under the agreement, Arcturus regained global rights to CoStave and the broader infectious disease vaccine portfolio, including seasonal influenza, pandemic influenza, RSV, and EBV vaccine programs. The agreement also resolves the arbitration related to European regulatory approval milestone payment. CSL Securus wired a one-time cash payment of $12 million to Arcturus and Arcturus is released from liabilities, including those associated with an R&D credit, with an aggregate value of approximately $16 million. With strategic control of the portfolio returned to Arcturus, we are evaluating opportunities to maximize its future value, including further commercialization and partnering pathways. And with that, I'll turn the call over to Alan for a more detailed update on our clinical programs.