Arbutus Biopharma Corporation

Good day and thank you for standing by and welcome to Arbutus by Pharma Corporation's 2022 Third Quarter Financial Results and Corporate Update Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during your session, you'll need to press star 1-1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lisa Caporelli, Vice President of Investor Relations. You may begin.

Thanks, Justin. Good morning, everyone, and thank you for joining Arbutus' third quarter 2022 financial results and corporate update call. Joining me today from the Arbutus Executive Team are Bill Collier, President and Chief Executive Officer, David Hastings, Chief Financial Officer, Dr. Gaston Piccio, Chief Development Officer, and Dr. Mike Sophia, Chief Scientific Officer. Bill will begin with a corporate update, followed by Dave, who will provide a review of the company's third quarter 2022 financial results. After opening remarks, we will open the call for Q&A. Gaston and Mike will be available to address clinical development and research-related questions. 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 most recent annual report on Form 10-K, quarterly report on Form 10-Q to be filed later today, and from time to time in other documents filed with the SEC. With that, I'll turn the call over to Bill Collier. Bill?

Thank you, and thank you, everyone, for joining us today. We really do appreciate your continued interest and support of Arbutus Biopharma. Now, this morning, we issued our third quarter 2022 financial results and corporate update press release. which highlights the significant progress we've made in advancing our preclinical and clinical programs in support of our mission to develop a functional cure for hepatitis B virus and to treat COVID-19 and future coronavirus outbreaks. Late last week, we issued a press release and hosted a webcast focusing on the encouraging off-treatment data with our lead clinical asset, AB729, And this data was also presented as a poster at the AASLD Medical Congress on Monday. This morning, I'd like to review a few key highlights of the AASLD data and provide some updates on our programs as they relate to our milestones planned for the remainder of this year. So first of all, we believe that AB729 is one of the most advanced RNAi therapeutics in development. and continue to believe that 729 can be a cornerstone therapeutic in the treatment regimen for HBV. AB729 is capable of suppressing HBV DNA, reducing surface antigen, and immunologically controlling HBV, hitting all three of the components that we consider critical to achieving a functional cure. At AASLD, we revealed additional data for 729 that supports this claim by showing the following. First, nine out of nine patients with chronic HPV that were treated with 729 plus a nuke for one year and were eligible to stop all therapy were able to control HPV biomarkers while off all therapy. Their surface antigen remained well below pre-study levels, and their HPV DNA remained suppressed. Second, none of these nine patients had clinical relapse, and none met the protocol-defined criteria to restart nuke therapy. And third, there was some level of reawakening of HPV-specific immunity. This was not only shown by maintaining surface antigen below baseline levels without therapy, but also through control of bursts of viral replication without restarting treatment. So we're extremely impressed by this data. And for the first time, the medical field has seen the ability of an RNAi therapeutic to control HPV disease biomarkers while off treatment. While the criteria for a functional cure, which consists of undetectable HPV DNA and surface antigen for six months after therapy, has not yet been met, we do believe that this data suggests that we can ultimately get there. Now, we also presented data from a preclinical study that assessed the ability of monotherapy and combination treatment with AB101, our small molecule oral PD-L1 inhibitor, and an HPV-targeting RNAi agent to reinvigorate HPV-specific T cell activity in an HPV mouse model. We were pleased that this confirmed liver engagement and HPV immune enhancement of AB101 and further supports our development strategy of potentially using 101 in combination with 729 in our pursuit of a functional cure in HPV. I'd now like to switch to the key milestones that we anticipate for the remainder of this year and provide an update on our progress towards achievement. Now, we anticipate reporting preliminary data from our Phase IIa clinical trial evaluating 729 in combination with interferon in chronic HPV patients. In this trial, patients receive AB729 for 24 weeks and are then randomized to receive either 729 plus a NUC plus interferon or NUC plus interferon for 12 to 24 weeks. The goal of this trial is to determine the additive, if any, benefit that interferon provides in addition to AB729. Our other HPV preclinical assets, AB101, our oral PD-L1 inhibitor compound, and AB161, our oral RNA destabilizer, are both in IND-enabling studies, which are on track to complete this year. And also in our coronavirus program, by year end, we expect to nominate a clinical candidate that inhibits the SARS-CoV-2 NSP5 main protease inhibitor, or MPRO. So the rest of the year will be quite busy for us as we continue to progress our HPV and coronavirus assets, and I look forward to providing updates as we achieve these milestones. I'll now turn the call over to Dave Hastings for a brief financial update.