Arbutus Biopharma Corporation

Good day, and thank you for standing by. Welcome to the Arbitus Biopharma 2024 Second Quarter Financial Results and Corporate Update. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Lisa Capparelli, Vice President of Investor Relations. Please go ahead.

Thank you, Jill. Good morning, everyone, and thank you for joining Arbutus' second quarter 2024 financial results and corporate update call. Joining me today from the Arbutus executive team are Mike McElhall, Interim President and Chief Executive Officer, Dr. Karen Sims, Chief Medical Officer, Dave Hastings, Chief Financial Officer, and Dr. Mike Sophia, Chief Scientific Officer. Mike McElhall will begin with a corporate update, followed by Karen, who will review our ongoing clinical programs. Dave will then provide a review of the company's second quarter 2024 financial results. After our prepared remarks, we will open the call for Q&A. Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements, which are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in our annual report on Form 10-K, our quarterly report on Form 10-Q, which we filed today, and from time to time in other documents filed with the SEC. With that, I'll turn the call over to Mike McElhall. Mike?

Good morning, everyone, and thank you for joining us today. In the second quarter of 2024, we made significant advancements in our pursuit of developing a functional cure for patients with hepatitis B and driving value for our company and shareholders. Most importantly, we presented positive data from two Phase IIa clinical trials combining our RNAi therapeutic, Mduciran, with different immunomodulators. Both of these datasets support the continued development of imduceran as a cornerstone in an HPV functional cure treatment regimen. Of note, the IMPROVE-1 clinical trial demonstrated undetectable hepatitis B surface antigen in 33% of patients from cohort A1 who were treated with 48 weeks of imduceran and 24 weeks of interferon. More importantly, 67% of those patients with baseline surface antigen less than 1,000 international units per mil had undetectable hepatitis B surface antigen. In addition, six patients, four from cohort A1 and two from cohort A2, who achieved undetectable surface antigen after receiving Induceran plus 24 weeks of interferon, stopped all therapy and maintained undetectable surface antigen and HPV DNA in early follow-up. a precursor to a functional cure. To put this in context, if these six patients continue to maintain undetectable levels of HPV DNA and surface antigen for 24 weeks while off all therapy, they would be considered functionally cured. We look forward to following the trajectory of these patients and potentially achieving our goal of reaching a functional cure rate that is equal to or greater than 20%, a goal that aligns with a number of KOLs in the HPV field. We are now prioritizing advancing imduceran into Phase IIb clinical development, and preparations are ongoing. In addition to the follow-up data from the patients from IMPROVE-1 that are trending towards a functional cure, we expect to report preliminary data from the Nivolumab arm of the IMPROVE-2 trial evaluating imduceran plus VTP300 in the second half of this year. As a reminder, improved to includes an additional cohort of patients who received imduceran plus nucleoside analog therapy for 24 weeks, followed by VTP300 plus up to two low doses of nivolumab, an approved anti-PD-1 monoclonal antibody. Because we are now focused on advancing imduceran into Phase IIb clinical development and ensuring we have the resources to do so, We have made the difficult decision to further streamline the company by eliminating our HPV discovery efforts. These actions will result in a reduction in workforce of 40% affecting our discovery research and GNA functions. We know changes that impact our people are not easy, and we are committed to providing our departing employees with support as they transition to their next roles. At the same time, we are confident that Arbutus remains well positioned for the future. I want to emphasize how grateful we are to all our employees, especially those departing, for their dedication and passion in developing novel therapeutics that may lead to a functional cure in hepatitis B. In addition to eliminating our research discovery efforts, we have also decided, prior to dosing any patients, to discontinue our recently initiated IMPROVE-3 trial, also known as AB729203, which was a Phase IIa trial evaluating the addition of dervalumab to imduceran. Our decision to discontinue the IMPROVE III clinical trial is not related to any concerns regarding imduceran or our belief that the addition of controlled checkpoint inhibition may be a key component of a functional cure regimen. The decision was based solely on prioritization of resources for the advancement of imduceran into a Phase IIb clinical trial and the projected availability of IMPROVE III clinical data given the advancement of AB101 through phase 1 clinical development. I want to emphasize that our decision to discontinue this clinical trial has no impact on our oral small molecule PD-L1 checkpoint inhibitor, AB101, that is differentiated from checkpoint antibodies and is currently in a phase 1A, 1B clinical trial. Recall, AB101 is liver-centric and in preclinical studies had typical small molecule pharmacokinetics and therefore likely a much shorter duration of effect than long-acting antibodies. These features were designed with the goal of minimizing systemic exposures and reducing the chance of immune-related adverse events that are often seen with checkpoint antibodies. It is for these reasons that we continue to remain excited about the potential of AB101 in hepatitis B and are continuing to evaluate multiple ascending doses of AB101 in healthy subjects in our Phase 1A, 1B clinical trials. Importantly, the actions today have allowed us to extend our projected cash runway into the fourth quarter of 2026. Before I turn the call over to Karen, I would like to provide a brief update on the litigation with Moderna and Pfizer-BioNTech around our L&P intellectual property. In the Moderna case, next steps include expert reports and expert depositions. The court has set April 21, 2025 as a trial date for this case, which is, of course, subject to change. The Pfizer-BioNTech lawsuit is ongoing with no updates at this time. With that, I'll now turn the call over to Karen to review the data we presented at EASL. Karen?