Arbutus Biopharma Corporation (NASDAQ:ABUS) Q2 2023 Earnings Call Transcript

Bill Collier: Yes, so good question. Our goal was to do an update from this study in the first half of the year, which we delivered at EASL. And as Karen said in her comments, we now have to let this study run a little bit further. I think Karen and I both agree that doing too many small updates is maybe not helpful. We should probably wait until we have, some more meaning for more complete data sets. So I think what we’re going to do is wait until January when we, we typically release our expectations and guidance for the 2024 year. And I think we’ll put something in there about when we expect a further update from this study.

Unidentified Analyst: Great. So I assume that that will include, what are the professional steps to a one-stage as well?

Bill Collier: Well, yes. I mean, as always, with clinical trials, you have to wait to read out what the data says, and then we’ll be guided by that as to how we determine next steps. I see. Okay. And then moving on, the other triple-combination study, the 2002 study. I mentioned with VTP-300.[Technical Difficulty] can you expect, in terms of our endpoints measurements, would that be comparable to the 201 study?

Bill Collier: Karen do you want to take that?

Karen Sims: Yes, sure. Thanks for the question. So, as we’ve alluded, we plan to report some preliminary data from that study before the end of the year. And typically, certainly surface antigen is a very important endpoint for us. While our clinical trials was induced around as the foundation of many of these combination studies, there’s certainly data around surface antigen that we would expect to present at that time. Beyond that, as most of our trials, we really just need to see where we are, with the number of subjects reaching certain milestones by the time, we’re ready to report that data. And the completeness of the data sets we have at that time will really dictate what we’re able to share. So, certainly surface antigen beyond that, is truly the common.

Unidentified Analyst: Okay. Understood. And then switching gears, one question about 161, as we expect, single ascending dose data lately this year. So clearly, safety data are very important. But what type of, should we expect to see some type of advocacy data, specifically F-antigen or RNA data? And what would be the next step for 161 with these data processes?

Karen Sims: Yes, I can address that as well. So as we’ve mentioned, we are in a phase one clinical trial with AB-161, meaning that we are in healthy subjects at this point with that trial. So, early data sharing would certainly be, as you alluded to, mostly around safety in order to get into the pharmacodynamic responses of AB-161, we need to be in the Hepatitis B patient population, which, we wouldn’t be ready to share any data from, by the end of this year. So, for this particular trial, just safety data would be what we would be sharing.

Unidentified Analyst: Great. Got it. Thank you so much for taking our questions and looking forward to a day of the rate up later this year.

Bill Collier: Thank you, Thomas.

Operator: Thank you. One moment for our next question, please. Our next question comes from Roy Buchanan of JMP. Please go ahead.

Roy Buchanan: Hey, great. Thanks for taking the questions. I guess the first one on AB-101, pretty quick, getting the clinical trial set up ex-U.S. there. So, nicely done on that. I guess just any details you can give us around the phase one, what it’s going to look like. I assume it’s not exotic. Just that. And then what’s the path with the FDA from here on? What do you do? What are the next steps there, I guess? And what’s the conversation look like with the FDA? Thanks.

Bill Collier: Yes. Thank you, Roy. So as we revealed today, and previously, actually, the FDA provided their comments and concerns, in their clinical hold letter. And they predominantly focused on certain aspects of clinical trial design and some pre-clinical data. But we were able to switch to New Zealand and submit the CTA. Importantly, we did attach the clinical hold letter from the FDA in our CTA application to New Zealand. So, we’re encouraged that, we’ll be able to start that study this quarter in New Zealand. And as that data emerges, we’ll have the ability to continue conversations with the FDA and chart a path forward. Beyond that, Karen, anything you want to say about the design of the study or?

Karen Sims: No, in particular, Roy, as you alluded to, it’s nothing surprising, at this point in the study in terms of initiating in healthy subjects and then moving into, chronic hepatitis B patients. So, yes, from that standpoint, yes, nothing terribly exotic as you mentioned, our typical study. But, yes, we are very much looking forward to getting this initiated, as soon as possible. We’re very excited that we have a path forward.

Roy Buchanan: Okay, great. But you would expect to include CHB patients in this same trial?

Karen Sims: No, we actually are. So, it is an umbrella study, which is similar to our other small molecule studies that we’ve worked in the Hepatitis B space. So, it is a similar trial design initiating in healthy subjects and then moving on to chronic Hepatitis B subjects within the same trial.