Arbutus Biopharma Corporation

Ladies and gentlemen, thank you for standing by, and welcome to the Abrutus Pharmaceutical BioPharma Corporation 2021 Third Quarter Financial Results Conference Call. At this time, all participants are in 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 on your telephone keypad. Please be advised that today's conference is being recorded. If you require further assistance, please press star zero. I would now like to hand the conference over to Lisa Caporelli, Vice President of Investor Relations. Please go ahead.

Thank you, Angie. Good morning, everyone, and thank you for joining Arbutus' third quarter financial and business 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, PTO, Chief Development Officer, and Dr. Mike Sophia, Chief Scientific Officer. Bill will begin with a review of recent accomplishments and clinical developments, followed by Mike Sophia, who will provide an update on our research efforts with an oral PD-L1 inhibitor. Dave Hastings will then provide a review of the company's third quarter financial results. After our opening remarks, we will open the call up for Q&A. Gaston Piccio will be available to address clinical development-related questions at that time. 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, and our other periodic reports filed with the SEC from time to time. I'll now turn the call over to Bill. Bill?

Thank you, Lisa, and thank you, everybody, for joining us today. We really appreciate your interest in Arbutus Biopharma. Now, this morning we issued our third quarter financial and business update press release, which highlights the significant progress we've achieved this year towards our goal, which is to develop a proprietary portfolio of products with different mechanisms of action that, when used in combination, result in a functional cure for patients living with chronic hepatitis B. We're taking a three-pronged approach that's intended to, one, reduce HBV surface antigen, two, suppress HBV DNA, and three, boost the host immune system, and intend to accomplish this with our RNAi therapeutic 729, our oral capsid inhibitor 836, and our oral PD-L1 program, where we recently commenced IND-enabling studies. So I'd like to start by walking through the clinical advancements we've made with this approach, starting with reducing surface antigen with our lead compound, 729, the RNAi therapeutic. As you know, 729 is specifically designed to reduce all hepatitis B viral antigens, including hepatitis B surface antigen. And we're seeing this activity in our ongoing phase 1A, 1B clinical trial. In fact, data to date has shown that AB729 consistently provides a mean 1.8 log reduction in hep B surface antigen, which is sustained over time in patients with chronic HPV. In addition, AB729 continues to show a favorable safety and tolerability profile. Also, in addition to reporting significant drops in S antigen, some 729 patients have shown increased HBV-specific immune responses, which further supports our rationale for combination therapy to include an immunomodulatory agent. Now, next week at AASLD, we will report additional data from additional cohorts of patients in this clinical trial in a poster presentation. And in that presentation, among other things, we will show that 729 repeat dosing remains generally safe and well tolerated. We'll show that robust mean declines in surface antigen were sustained with repeat dosing of 729 with no meaningful differences observed to date between 60 milligram or 90 milligram doses or dosing intervals, which included every 4, 8, or 12 weeks. And we'll also show that S-antigen suppression to levels below 100 international units per mL, which is a clinically relevant threshold which could inform when to stop therapies, is maintained in some subjects up to 20 weeks following the last dose of 729. As we continue to unveil more data with 729, we continue to believe that the drug has the potential to be a cornerstone agent in future HPV combination regimens. Our strategy is to evaluate 729 in combination with our own novel agents and with other approved or investigational agents with complementary mechanisms of action to set the foundation for future trials. Now, we've made great progress in advancing 729 in clinical trial development. This quarter, we initiated and dosed the first patient in our own Phase IIa randomized open-label proof-of-concept clinical trial to evaluate 729 in combination with ongoing standard-of-care NUC therapy and short courses of PEG interferon in 40 patients with chronic HPV infection. Based on clinical data from our Phase I program, we selected 60 milligrams every eight weeks as the dose and dosing schedule for this trial and other trials. We're currently in the process of opening sites, screening patients, and we will provide further updates on this trial when appropriate. And then from a collaboration standpoint, 729 is being evaluated in an ongoing Phase IIa triple combination trial with Assembly Bioscience's lead HPV core inhibitor and a nucleoside analog. Assembly is conducting this trial and expecting to see data in 2022. Also, activities to initiate separate Phase IIa clinical trials with ANTIOS and Vaxitec are ongoing. We expect that the arm that will include 729 in the ANTIOS clinical trial will commence this quarter, and that the Vaxitec clinical trial will initiate in early 2022. Both trials are designed to evaluate a triple combination of 729, a nucleoside analog, and either the ANTIOS or Vaxitec's proprietary agent. I'd now like to move on to the second arm of our approach, that's to suppress HPV DNA with our next generation oral capsid inhibitor, 836. Now, 836 is specifically designed to completely block viral replication in infected cells by preventing the assembly of functional viral capsids. Preclinical data suggests that 836 may have the potential for increased efficacy and an enhanced resistance profile compared to previous capsid inhibitors. Preliminary data from healthy volunteers and HPV patients in our Phase 1A, 1B clinical trial is on track to report out by the end of this year. And these data may support the initiation of a Phase 2 combination clinical trial with our own proprietary compounds. The third arm of our approach is to boost the immune system, which we hope to do with our oral PD-L1 program. for which we recently commenced IND enabling studies. And after my prepared remarks, I'll turn the call over to Mike Sophia to provide more details about this exciting compound. Now, ultimately, we strive to have a convenient all oral combination treatment for hepatitis B patients. And to achieve that, we're progressing our research efforts with an oral RNA destabilizer program. and look forward to providing updates on our lead optimization efforts in 2022. In addition to our efforts in HBV, our internal research program to identify new antiviral small molecules to treat COVID-19 and future coronavirus outbreaks continues to make progress. So as you can see, Despite the challenging impact of the pandemic, the team at Arbutus has been relentless in their efforts to continue the advancement of our clinical and research programs to meet our corporate goals, to address the needs of patients, and to increase shareholder value. I really am very grateful for the team's commitment and dedication to finding a cure for hepatitis B and for the treatment of coronaviruses. So with that, I'll turn the call over to Mike Sophia for an update on our PD-L1 program. Mike.