Arbutus Biopharma Corporation

Good day, and thank you for standing by. Welcome to the Arbutus Biopharma Q2 conference call. 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 11 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. 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, please go ahead.

Thanks, Jada. Good morning, everyone, and thank you for joining Arbutus' second quarter 2023 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. Mike Sophia, Chief Scientific Officer, and Dr. Karen Sims, Chief Medical Officer. Bill will begin with a corporate update, followed by Dr. Sims, who will review recent data shared at a medical congress. Dave Hastings will then provide a review of the company's second quarter 2023 financial results. After our prepared remarks, we will open the call for Q&A. Dr. Sophia will be joining us at that time to address 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, our quarterly report on Form 10-Q, which will be filed later today, and from time to time in our other documents filed with the SEC. With that, I'll turn the call over to Bill Collier. Bill?

Thank you, Lisa, and good morning, everyone, and thank you for joining us today. Our goal at Arbutus has always been to develop a combination of therapeutic agents that will lead to a functional cure of chronic hepatitis B. And today, we are excited to share with you the continued progress that we've made in advancing this effort. We believe that AB729, which we will now refer to by its generic name, Imduciran, has the potential to be a cornerstone therapy to functionally cure chronic HPV. To date, we've generated meaningful inpatient data showing that Imdusiran appears to be the only RNAi to impact both surface antigen and the reawakening of the HPV-specific immune response. And the effects of Imdusiran are sustained in some patients even after all therapy is discontinued. We remain impressed with the compelling safety and efficacy profile of Induceran and look forward to evaluating Induceran in combination not only with other available compounds, but ultimately with our early stage HPV assets that are concurrently progressing. We expect additional combination data from our ongoing Phase IIa clinical trial with our partner, Vaxitec, in the second half of this year. And with this, we continue to be well-positioned to advance our goal of developing a functional cure for HPV and driving value for our company as we advance our broad pipeline of HPV assets. Now, with respect to our early-stage HPV assets, this morning we announced our CTA has been approved for us to initiate a Phase I clinical trial with AB101, our oral PD-L1 inhibitor, in New Zealand. As you may recall, the FDA placed the IND application for AB101 on clinical hold before we had initiated a trial or dosed any patients. To get AB101 into a clinical trial as quickly as possible, we made the strategic decision to work with New Zealand to advance AB101 while, in parallel, working to address the FDA concerns. We continue to believe that AB101 as an oral and thus more rapidly titratable checkpoint inhibitor compared to an antibody approach has the potential to be an important component of a combination therapy that could be combined with imduceram to provide a functional cure for HPV. Now the phase one clinical trial for our RNA destabilizer AB161 is ongoing. 161 is our next generation oral HPV-specific RNA destabilizer, which is being developed as part of a potential all-oral treatment regimen to functionally cure HPV. We expect to have initial data from the single ascending dose portion of this trial in the second half of the year. Now, beyond our HBV assets, we remain committed to identifying and developing new antiviral small molecules to treat COVID-19 and future coronavirus outbreaks. Our strategy is to target the two essential enzymes for the coronavirus lifecycle, SARS-CoV-2 NSP5 main protease, also known as MPRO, and NSP12 viral polymerase. These enzymes are critical for viral replication and are highly conserved across all known coronaviruses. AB343 is our lead oral mPro inhibitor designed to address the urgent need for oral antiviral therapies that are both potent and active against circulating SARS-CoV-2 variants and that do not require ritonavir boosting. The preclinical profile of AB343 is impressive, and we're currently in IND-enabling studies with plans to complete those studies in the second half of this year. Ultimately, we believe that the optimal treatment regimen will consist of both an MPRO inhibitor and an NSP12 inhibitor, differentiating this therapy from other strategies. To that end, our goal is to identify and nominate an NSP12 inhibitor, which we can then take into IND-enabling studies in the second half of this year. And we'll be sharing more updates on these two programs as we progress through the year. Before turning the call over to our new Chief Medical Officer, Dr. Karen Sims, to review the IMDUCIRAN data, I'd like first to congratulate Karen on her appointment as CMO at Arbutus. Karen has been with the company since 2017 and has played a crucial role in the clinical development of Indusiran. And I'm very happy that Karen has assumed this role and confident that she and her team will continue to effectively execute our mission. So over to you, Karen.