Arbutus Biopharma Corporation

Good day and thank you for standing by. Welcome to the RBDS Biopharma fourth quarter and year end 2023 financial results and corporate 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'll need to press star 11 on your telephone and then hear an automated message advising 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 first speaker today, Lisa Caporelli, VP of Investor Relations. Please go ahead.

Thank you, Stephen. Good morning, everyone, and thank you for joining Arbutus' fourth quarter and year-end 2023 Financial Results and Corporate Update call. Joining me today from the Arbutus executive team are Mike McAhaugh, Interim President and Chief Executive Officer, Dr. Karen Sims, Chief Medical Officer, David 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 fourth quarter and year-end 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 annual report on Form 10-K and from time to time in our other documents filed with the SEC. With that, I'll now turn the call over to Mike McElhall. Mike?

Thank you, Lisa. Good morning, everyone, and thank you for joining us today. In 2023, we made several important strategic choices to best position Arbutus for long-term success. In addition to streamlining our focus and resources on HPV, which extended our cash runway into the first quarter of January, 2026, we also announced my appointment as interim president and CEO. As a co-founder of Arbutus, I am honored to have this opportunity to lead my colleagues in our mission to develop a functional cure for the millions of people chronically infected with hepatitis B virus. I'm excited for my new role and plan to leverage my extensive scientific, strategic, transactional, and commercial experience with antiviral and infectious disease companies to continue to move Arbutus forward. In 2024, Our focus is to position Arbutus for continued success and create value for all our stakeholders. We remain committed to advancing the development of our proprietary clinical assets in HPV, including Induceram, our RNAi therapeutic, and AB101, our oral PD-L1 checkpoint inhibitor. There remains a need for finite and more efficacious HPV treatments that further improve long-term outcomes and increase functional cure rates. as fewer than 5% of patients currently achieve functional cure with currently approved nukes or interferon. Our goal is to develop a treatment for chronic hepatitis B virus patients that results in at least a 20% functional cure rate to address this large unmet medical need. HPV is a complex virus that will most likely require a combination of compounds that inhibit viral replication, lower the viral antigen burden, and boost the immune response. We are executing on our three-pronged approach to functionally cure HPV with a combination therapy that includes imduceran as a cornerstone. A combination that includes imduceran, AB101, and a nuke is our ultimate goal. That said, our current strategy is evaluating imduceran in combination with other agents in multiple Phase IIa clinical trials with the goal of gaining valuable insights on efficacy, safety, and optimal dosing to help inform the design of a Phase IIb clinical trial with imduceran as the cornerstone therapy. Throughout 2024, we anticipate reporting data from our two ongoing Phase IIa clinical trials with imduceran, including the potential to see patients with undetectable surface antigen. Achieving undetectable surface antigen levels in either of our current Phase IIa clinical trials would certainly be an important validation of imduceran's role and potentially achieving a functional cure for hepatitis B patients. This year, we also anticipate data from our healthy subject portion of our Phase 1A-1B clinical trial with AB101, our immune modulator. We expect to report preliminary safety and, importantly, preliminary receptor occupancy and target engagement data in this population. With the potential of AB101 to boost the host immune response, Our goal is to move AB 101 through the clinic as quickly as possible to prepare it for a possible combination with Inducerant. I'd like to say a few brief words about our ongoing intellectual property litigation efforts before closing out this section of the call. All of our scientists take great pride in the intellectual property they develop, which takes great effort, time, resources, and expense. It is for these reasons that we continue to protect and defend our intellectual property including our LNP delivery technology, which is the subject of ongoing lawsuits against Moderna and Pfizer-BioNTech. An important step in the litigation for Moderna took place on February 8th of this year. This was the date of the Markman hearing, also known as a claim construction hearing, where the court heard each party's interpretation of the construction of claims in the disputed patents. We anticipate the judge to issue his order from the hearing within 60 days of February 8th. The next steps will include expert testimony and depositions. In addition, the Court has set April 21, 2025 as the trial date for this case. That date is subject to the Court's availability. With respect to the Pfizer-BioNTech lawsuit, the only update I can provide is that the lawsuit is ongoing, but is behind the Moderna lawsuit as it was filed later. A date for the claim construction hearing for that case has not yet been set. When able, we will provide updates on both the Pfizer and Moderna lawsuits, but please keep in mind that given the legal sensitivities, we're limited in what we can say. I'll now turn the call over to Karen Sims to provide an update on the continued progress we are making across our pipeline. Karen?