Arbutus Biopharma Corporation

Good day and thank you for standing by. Welcome to the Arbutus Biopharma 2023 first quarter 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 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 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, VP of Investor Relations, Lisa Caporelli. Please go ahead.

Thank you, Eleanor. Good morning, everyone, and thank you for joining Arbutus's first 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, Dr. Mike Sophia, Chief Scientific Officer, and Dr. Karen Simms, VP of Clinical Development. Bill will begin with a corporate update, followed by Dave Hastings, who will then provide a review of the company's first quarter 2023 financial results. After our prepared remarks, we will open the call for Q&A. Doctors Sophia and Sims will be available to address your clinical and scientific questions. 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 Form 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 now turn the call over to Bill Collier. Bill?

Thank you, Lisa, and good morning, everyone, and thank you very much for joining us today. Now, Arbutus was founded with the goal of developing a functional cure for patients with chronic hepatitis B virus by advancing the development of our clinical and preclinical assets that could be combined to create a treatment regimen. At the onset of the COVID-19 pandemic in 2020, we made the strategic decision to leverage our team of virologists and their expertise in discovering, developing, and commercializing antiviral compounds to expand our core focus to include developing treatment options for COVID-19 as well as future coronavirus outbreaks. With our expanded focus and pipeline, Arbutus today is actively advancing a broad portfolio of innovative clinical candidates that address large market opportunities. We believe that both chronic HPV and coronavirus require a combination of compounds to achieve therapeutic success. And we are encouraged by the advances we've made in both our HPV and coronavirus franchises. There are over 290 million people worldwide who are chronically infected with HPV. And with current lifelong treatment options resulting in less than a 5% effective cure rate, there remains a large unmet medical need for a functional cure for chronic HPV. We believe we are well-suited to address this need, beginning with AB729, which is one of the most advanced RNAi therapeutics in development. Based on data generated to date, AB729 is the only RNAi shown to impact all three components needed for a functional cure for patients with chronic HPV. namely reducing HPV DNA, suppressing surface antigen, and reawakening the HPV-specific immune response. Given its compelling data thus far, we believe that AB729 has the potential to be a cornerstone therapy to provide a functional cure for patients with chronic HPV. We're exploring 729 in combination with other investigational and approved products through our two ongoing Phase IIa combination trials, one with Interferon and one with Vaxitex HBV antigen-specific immunotherapeutic. Both of these combination trials are expected to have preliminary data this year that potentially will help inform the combination strategy that we expect to evaluate in later stage clinical trials. Before I discuss these combination trials, though, I'd first like to take a moment to provide data from our ongoing Phase I clinical trial. Now, as we recently reported at the Global Hepatitis Summit last week, seven of nine patients treated with 729 from our Phase I clinical trial show low levels of HPV DNA and surface antigen persisting for at least a year and a half after their last dose of 729. Furthermore, data from that same trial showed that 729 treatment produces robust and comparable declines in surface antigen regardless of dose, dosing interval examined, or baseline characteristics. Now going back to the ongoing combination trials. We look forward to reporting additional 729 combination data in the first half of this year from our Phase 2A clinical trial, evaluating 729 in combination with ongoing new therapy and short courses of interferon. The trial is AB729201. We shared preliminary data from the lead-in phase of this trial late last year, which further validated 729's capacity to reduce surface antigen. Patients are now being randomized to receive interferon plus ongoing muke therapy, plus or minus additional 729 doses for either 12 or 24 weeks. The preliminary data that we plan to report in the first half of 2023 will include some of these patients who have received interferon. In the second half of 2023, we expect to report preliminary data from our Phase 2A clinical trial, AB729202, which is evaluating 729 NUC therapy and Vaxitex HPV-specific immunotherapeutic, VTP300, or placebo. Vaxitec has recently reported data from a phase 1b2a trial showing that VTP300 induced meaningful sustained reductions of surface antigen in some chronic HPV patients. Through this combination trial, we are testing whether the combination of 729 and VTP300 can lower the surface antigen enough for the host immune system to fully suppress the virus. As a reminder, we're preparing to expand the latter trial to include an additional arm with low-dose nivolumab, which is a PD-1 monoclonal antibody inhibitor approved to treat a number of cancers under the brand name Obdivo. 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 of 729 and first dose of VTP300. And we'll provide an update when we begin enrollment in this new arm of the trial. In addition, consistent with our strategy of developing a proprietary combination for the treatment of chronic HPV, we dose the first healthy subject in our phase one clinical trial with AB161 in March. AB161 is our next-generation oral HPV-specific RNA destabilizer, which is being developed as part of a potential all-oral treatment regimen to functionally cure HPV. We expect to have initial data from the single ascending dose portion of this trial in the second half of this year. Notably, at the Global Hepatitis Summit this past April, we presented preclinical data showing that 161 provides robust anti-HPV activity, including suppression of HPV RNA and surface antigen in vitro and in vivo. The differentiated anti-HPV mode of action of 161 compared to other classes of HPV inhibitors suggests that 161 may be an important component in combination to provide a functional cure of chronic HPV. Now, last week, we received the disappointing news that the FDA placed the IND application for our oral PD-L1 inhibitor, AB101, on clinical hold. Just to be clear, the Phase I clinical trial had not been initiated, and we had not dosed any patients with AB101. Therefore, we do not expect to initiate the Phase I clinical trial with 101 in the first half of this year, and we will not have initial data from this trial in the second half of 2023. We will, however, continue to work with regulatory authorities to move AB101 forward, as we believe it will be an important component in our combination therapy designed to cure HPV. Now, we also continue to build on our significant momentum with our talented team that is focused on identifying and developing new antiviral small molecules to treat COVID-19 and future coronavirus outbreaks. We are actively advancing our strategy to identify and develop compounds that target the two essential enzymes for the coronavirus lifecycle, SARS-CoV-2-Nsp5 main protease, also known as MPRO, and the NSP12 viral polymerase. These enzymes are critical for viral replication and are highly conserved across all known coronaviruses. We've recently selected AB343 as our lead oral mPro inhibitor compound to address the urgent need for oral antiviral therapies that are both potent and active against circulating SARS-CoV-2 variants and do not require ritonavir boosting. Recently, at two prestigious antiviral congresses, ICAR and ISIRV, we shared data from several in vitro preclinical studies showing the favorable details of our MPRO inhibitor AB343, namely its potent pan-coronavirus activity, activity against SARS-CoV-2 variants, resistance profile, and favorable PK supporting a ritonavir-free oral treatment. Preclinical profile of AB343 is impressive, and we're currently in IND-enabling studies and plan to initiate a phase one clinical trial in the second half of this year. AB343 is just one piece of our coronavirus development strategy. We believe the optimal treatment regimen will consist of both an MPRO inhibitor and an NSP12 inhibitor, and that such a therapy will be differentiated from other products in development. To that end, our goal is to identify and nominate an NSP12 inhibitor, which we can then take into IND enabling studies in the second half of this year. We'll be sharing more updates on these two programs as we progress throughout the year. I'll now turn the call over to Dave Hastings for a brief financial update.