Arbutus Biopharma Corporation

Good day and thank you for standing by. Welcome to the Arbutus Biopharma Corporation fourth quarter and year-end 2022 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 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 today's conference is being recorded. I would like to hand the conference over to your speaker today. Lisa Capparelli, please go ahead.

Thank you, Kevin. Good morning, everyone, and thank you for joining Arbutus' fourth quarter and year-end 2022 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, and Dr. Mike Sophia, Chief Scientific Officer. Bill will begin with a corporate update, followed by Dr. Sophia, who will provide an overview of our newly nominated coronavirus compound, AB343. Dave Hastings will then provide a review of the company's fourth quarter and year-end 2022 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 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 to 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. Good morning, everyone, and thank you for joining us today. We appreciate your continued interest and support of Arbutus Biopharma. This morning we issued a press release with our fourth quarter and year-end 2022 financials, as well as an update on the significant progress we made last year in advancing our proprietary compounds, moving us closer to our goals of potentially achieving a functional cure for chronic HPV, as well as a novel and superior treatment for coronavirus. We also highlighted our anticipated milestones for 2023, which include announcing AB729 data from our two ongoing Phase 2A combination trials and additional off-treatment data from our Phase 1B clinical trials. We also intend to initiate in 2023 three Phase 1 clinical trials with our early stage compounds, namely AB101, our oral PD-L1 inhibitor, AB161, our oral RNA destabilizer, and AB343, our newly nominated NSP5 main protease inhibitor in development for coronavirus infection. Suffice it to say, 2023 will be a busy year for us with potentially four compounds in the clinic by the end of the year. With respect to our mission to achieve a functional cure for patients with chronic HPV, we believe it's necessary to suppress HPV DNA, reduce surface antigen, and boost the immune system. And data that we generated last year from our Phase 1B clinical trial tells us that AB729 can potentially achieve all three of these goals. This sets AB729 apart from other RNAi therapeutics in development. First, AB729 has shown reawakening of HPV-specific immunity, as well as a decrease in exhausted T cells in some patients. In addition, a small subset of patients who met eligibility requirements to discontinue all HPV therapies following AB729 treatment were able to control their HPV biomarkers while off treatment. Surface antigen levels in those patients remained well below pretrial levels. Furthermore, their HPV DNA remains low, suggesting establishment of host immune control. Now, these data reinforce our belief that AB729 is one of the most advanced RNAi therapeutics in development, and that it has the potential to be a cornerstone therapeutic in the treatment regimen for chronic HPV, which leads me to our two ongoing Phase IIa clinical trials with AB729, one in combination with interferon and one in combination with Vaxitex therapeutic vaccine VTP300. At the end of 2022, we complete an enrollment and announce preliminary data from the lead-in phase of AB729201. The phase 2A clinical trial was 729 in combination with ongoing nucleoside analog therapy and short courses of interferon. The first 15 patients who reached week 16 of treatment after receiving two doses of AB729 on day 1 and week 8 plus nuke therapy showed a mean surface antigen decline of 1.5 logs. which is comparable to the decline observed at the same time point in our Phase 1b clinical trial. These preliminary data further validate AB729's capacity to reduce surface antigen. As patients complete the lead-in phase, they are being randomized to receive interferon plus nuke therapy plus or minus additional 729 doses for either 12 or 24 weeks. and we expect to have preliminary data from some of these patients who have received Interferon in the first half of 2023. Our second phase 2A clinical trial, AB729202, which is evaluating 729, NUC therapy, and VTP300 or placebo, is being expanded to include an additional arm with low-dose nivolumab, which is a PD-1 monoclonal antibody inhibitor, that's approved for a number of types of cancer under the brand name Optivo. We are adding nivolumab, more commonly known as Nevo, to determine if the addition of Nevo to the VTP300 combination will further stimulate immune-mediated reduction of surface antigen after the initial treatment with 729. This amendment is currently under regulatory review, On regulatory approval, we intend to enroll 20 patients on ongoing muke therapy who will receive 60 milligrams of 729 every eight weeks for 24 weeks, followed by VTP300 plus a low dose of nolumab. The NEVO dose that we will use is one-tenth the dose approved for oncology indications, which we believe to be a safe yet efficacious dose. Patients will remain on their NUKE therapy during the 48 weeks of dosing with 729, VTP300, and NEVO. Like all our trials, we will follow patients for 24 to 48 weeks after completion of the treatment period. As a reminder, dosing in this amended portion of the trial is expected to commence in the first half of 2023, and preliminary data from the original portion of the clinical trial that is, those patients who receive 729, NUKE, and VTP300 or placebo, is expected in the second half of 2023. To round out our HBV assets, last year we nominated and conducted IMD enabling studies with AB101 as our oral PD-L1 inhibitor and with AB161 as our oral RNA destabilizer. Both of these programs could play a role in developing a proprietary all-oral combination therapy to provide a functional cure for patients with chronic HPV. We are on track to initiate phase one clinical trials with each of these compounds, and we expect to report initial data this year. We'll share more details when each of these trials commences. Finally, as Dave will reiterate in a moment, we are in a strong financial position. with cash runway into Q4 of 2024. I'll now ask Mike Sophia to review our progress in the coronavirus.