Arbutus Biopharma Corporation

Good day and thank you for standing by. Welcome to the Arbutus Biopharma 2022 First Quarter Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your first speaker today, Lisa Caporelli, Vice President of Investor Relations. Thank you, and please go ahead.

Thank you, Operator. Good morning, everyone, and thank you for joining Arbutus' first quarter 2022 financial results and corporate update call. Joining me today from the Arbutus executive team are Bill Collier, President and Chief Executive Officers, David Hastings, Chief Financial Officer, Dr. Gaston, PTO, Chief Development Officer, and Dr. Mike Sophia, Chief Scientific Officer. Bill will begin with a corporate update, followed by Dr. Sophia, who will provide an update on our preclinical programs. Dave Hastings will then provide a review of the company's first quarter 2022 financial results. After opening remarks, we will open the call up for Q&A. that Don Piccio will be available to address clinical-related questions. Before we begin, we'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, quarterly report on Form 10-Q, to be filed later today and from time to time in other documents filed with the FEC. I will now turn the call over to Bill. Bill?

Thank you, Lisa, and good morning, everybody. Thank you for joining us. We appreciate your continued interest and support in Arbutus Biopharma. As you saw in this morning's press release with our first quarter 2022 financial and corporate update, We are on track to deliver on multiple key milestones across our chronic hepatitis B and coronavirus programs. In fact, we anticipate reporting data from four clinical trials that are evaluating either 729 or 836 during this year. And importantly, as Dave will discuss later in this call, we are well positioned financially with a projected cash runway into the second quarter of of 2024. Now, before I turn the call over to Mike Sophia to run through the progress the team has made in advancing our proprietary early research compounds, I'd like to highlight some of the progress we've achieved towards our three-pronged HPV strategy to provide a functional cure for chronic HPV infection. As you know, that three-pronged approach consists of suppressing S-antigen reducing HPV DNA, and boosting the immune system. Starting with our lead HPV compound, 729, our proprietary RNAi therapeutic. In clinical trials to date, 729 has shown a sustained reduction in S antigen, and in some patients, an increased HPV-specific immune response. To further assess this activity, 729 together with standard of care nucleoside analog is currently being evaluated in combination with other approved or investigational compounds in two Phase IIa clinical trials, with a third trial expected to begin enrollment shortly. The first trial, AB729201, is assessing the safety and tolerability of 729 plus interferon in patients with muke-suppressed chronic HPV. This trial, initiated last year, is continuing to enroll patients and is on track to report initial data in the second half of 2022. The second trial is being conducted by Assembly Bio and is evaluating 729 with Assembly's core inhibitor, Bebicordia. Late in the first quarter, Assembly reported that this trial was fully enrolled with data expected in the second half of 2022. The third trial, AB729202, will evaluate the safety, antiviral activity, and immunogenicity of Vaxitex therapeutic vaccine or placebo after administration of 729, again, in new suppressed chronic HPV patients. Sites are being activated for this trial with plans to dose patients in the first half of 2022. As we explore 729 in these Phase IIa clinical trials, the goal is to utilize these learnings to identify the best combination of compounds that we can then explore in Phase IIb as we focus on developing a functional cure for HPV. One last point I'd like to make about 729. We anticipate reporting additional key data from the Phase 1A, 1B clinical trial, AB729001, at a medical conference this year. That data will include new on-treatment data for patients enrolled in Cohort K, which are HPV, DNA negative, and E antigen positive patients that receive 90 milligrams of 729 every eight weeks. It will also include additional data for patients in cohorts E, F, G, I, and J. These cohorts assessed 60 milligram or 90 milligram every four, eight, or 12 weeks, as well as long-term follow-up data for patients who completed treatment and have discontinued 729 and discontinued nuke therapy. We're looking forward to seeing the treatment discontinuation data, as this will be our first glimpse into potential functional cure data, albeit with a small subset of patients. Now, in addition, our next-generation oral capsid inhibitor, AB836, in combination with nuke therapy, is designed to eliminate viral replication and reduce HPV DNA. Preliminary data that we reported last year from our clinical trial AB836001 has shown that 836 is generally safe and well tolerated and provides robust antiviral activity. We're on track to report data from this trial in the first half of 2022. Now moving on to our coronavirus efforts. We're focusing on identifying and developing new antiviral small molecules to treat COVID-19 and future coronavirus outbreaks. Our research efforts are focused on two essential targets critical for replication across all coronaviruses, nsp5 protease and nsp12 polymerase. We're continuing to advance our efforts to nominate an NSP5 protease or MPRO clinical candidate that we can move into IND-enabling studies this year. We're also continuing the lead optimization activities for an NSP12 viral polymerase candidate. Finally, we continue to assess the potential opportunity in oncology with our oral PD-L1 program. I'm really proud of the progress that the Arbutus team continues to make in advancing these compounds and look forward to sharing data throughout the year. I'll now turn the call over to Dr. Mike Sophia for an update on our HPV preclinical assets. Over to you, Mike.