Arbutus Biopharma Corporation

Good day, and thank you for standing by. Welcome to the Arbutus Third Quarter Corporate and Financial Update 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 1-1 on your telephone. You will then hear an automated message advising 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 Lisa Capparelli. Please go ahead.

Thank you, Brianna. Good morning, everyone, and thank you for joining Arbutus' third 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, Michael McAhal, Chief Operating Officer, Dr. Mike Sophia, Chief Scientific Officer, and Dr. Karen Sims, Chief Medical Officer. Bill will begin with a corporate update, followed by Dave Hastings, who will provide a review of the company's third quarter 2023 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 most recent annual report on 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?

Good morning, everyone, and thank you very much for joining us today. As you likely saw, in addition to reporting our third quarter results earlier this morning, we also announced that I will be retiring at the end of the year. I'll speak more about that shortly, but first, let's discuss our results. At Arbutus, we remain committed to our goal of developing a functional cure for patients with chronic hepatitis B virus by advancing the development of our clinical assets that can be combined to create a curative treatment regimen. Over the last few months, we've optimized our pipeline, including the discontinuation of our coronavirus research programs and our oral RNA destabilizer. This allows us to sharpen our focus and resources on our most promising clinical programs, MDUCERAN and AB101, both of which are expected to have data readouts next year. As a result of this pipeline prioritization, we are also announcing today the difficult decision to streamline our organization by reducing our workforce by 24%. We want to underscore how grateful we are to all of our employees, especially those departing the organization, for their dedication and passion in developing novel therapeutics for viral diseases at Arbutus. And while these changes primarily impact our research function, we have maintained a group of research scientists as we remain committed to continuing discovery research in chronic HPV. Now we know that changes that impact our people are not easy, and we're committed to providing those employees with support as they transition to their next roles. At the same time, we're confident that Arbutus remains positively positioned for the future. Now I'd like to provide some updates on the continued progress that we're making across our pipeline. With more than 290 million people worldwide chronically infected with HPV, and with current lifelong treatment options resulting in less than a 5% cure rate, there remains a large unmet medical need for a functional cure for chronic HPV. We believe we're well-suited to address this need with our team's extensive expertise in virology and with Imdusiran, which is one of the most advanced RNAi therapeutics in development. Based on data generated to date, IMDUCIRAN has shown to impact all three components needed for a functional cure for patients with chronic HPV. Those are reducing HPV DNA, suppressing surface antigen, and reawakening the HPV-specific immune response. Our strategy to develop a functional cure for HPV involves exploring Induceran in combination with other investigational and approved products that can further stimulate the immune system to induce functional cure in chronic HPV patients. Induceran is our lead asset, and later this week at a prestigious liver-focused medical conference, AASLD's The Liver Meeting, we will be presenting a late-breaking poster with preliminary data from our Phase IIa clinical trial that we're conducting with Barinthus Biotherapeutics, formerly known as Vaxotec. Through this clinical trial, we're testing whether the combination of imduceran, nuke therapy, and barinthesis HPV antigen-specific immunotherapeutic VTP300 can lower surface antigen and stimulate the host immune system to fully suppress the virus. As I've mentioned previously, this is an early look at data, as not all patients have received the full VTP300 or placebo dosing regimens. In addition to safety data, from an efficacy standpoint, we're hoping to see a reduction in surface antigen within 24 weeks of, sorry, we're hoping to see a reduction in surface antigen with 24 weeks of imducerine treatment that is similar to what we've seen in our other clinical trials to date. and further impact on HBSNG and HPV-specific immune activation with the addition of VTP300. We look forward to reporting these data at ASLD. Now, you may recall that we've expanded this trial to explore the addition of a low dose of the anti-PD-1 monoclonal antibody inhibitor nivolumab to the combination treatment regimen. We believe NEVO may further boost the host immune response. The data that we're reporting at ASLD will not include any data from this expanded arm as we're in the early stages of this trial. We will have more to report on this portion of the clinical trial next year. We also have a second phase 2A clinical trial that is evaluating imducerone in combination with ongoing nuke therapy and interferon in patients with chronic HPV. Earlier this year, we reported preliminary data that continues to reinforce our confidence in imduciran's ability to effectively lower surface antigen. We're continuing to follow these patients and expect to provide updates from this clinical trial in 2024. Our second HPV asset is AB101, our oral PD-L1 inhibitor that is currently in a phase 1A, 1B clinical trial. Immune checkpoints have been shown to play an important role in HPV-specific immune tolerance and in T cell activation. This double-blind, randomized, placebo-controlled clinical trial is designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB101. The trial will be conducted in three parts, starting with single and multiple ascending doses in healthy subjects and culminating with multiple doses in patients with chronic HPV. In September, we announced that we dosed the first patient in the single ascending dose group of the trial and expect initial data from that group in the first half of 2024. Finally, let me spend a moment talking about my decision to retire as CEO at the end of this year. As many of you know, I've had the privilege to lead Arbutus since June 2019, and since then, we've accomplished so much. This was a particularly challenging decision for me to make personally, and one that is completely unrelated to recent activities at Arbutus. I remain confident in Imduciran and AB101, and the ability of this team to develop these compounds to possibly provide a functional cure for patients with chronic HPV. My four year plus tenure at Arbutus is one of the most rewarding positions I've had in my career. The opportunity to lead a group of talented and passionate researchers, clinicians, and professionals with a drive to serve the HPV patient community has been a true privilege. We've achieved many successes and key milestones, and as I look to my future retirement, I'm confident in the future of Arbutus. Now, Mike McElhall will succeed me as interim CEO effective January the 1st. As many of you know, Mike is a co-founder of Arbutus and serves as our chief operating officer. He has more than 20 years of scientific, strategic, transactional, and commercial experience spanning various operating roles within Bristol-Myers Squibb, Pharmacet, Merck, and ViroPharma. The board and I have the utmost confidence in Mike's ability to be successful in leading Arbutus and to continue to create value for our shareholders. Mike has worked very closely with me over the last four plus years, and I'm confident that there will be a smooth transition. And I will also continue to be a resource for Mike as he becomes acclimated to his new role. In closing, I'm confident in Mike's leadership as he leads Arbutus into its next chapter. Induceran and AB101 are well positioned to deliver on our goal of developing a functional cure for HPV and driving value for our company as we advance these HPV assets. With that, I'll hand the call over to Dave Hastings for a brief financial update.