Q2 2024 Arbutus Biopharma Corp Earnings Call

Stewart: Stewart. We expect to report preliminary data from the nivolumab arm of the improved two trial evaluating IMDUCERAN plus VTP300 in the second half of this year. As a reminder, improved to include an additional cohort of patients who received IMDUCERAN plus NUQISID analog therapy for 24 weeks, followed by VTP300 plus up to two low doses of NIVOLUMAB and approved anti-PD1 monoclonal antibody.

Expect to report preliminary data from the new volume of arm of the improved two trial evaluating <unk> plus <unk> 300 in the second half of this year. As a reminder, improved two includes an additional cohort of patients who received inducer and plus nucleoside analogue therapy for 24 weeks followed by <unk>.

<unk> 300, plus up to two low doses of new volume add an approved anti PD one monoclonal antibody.

Michael Sofia: Because we are now focused on advancing IMDUCERAN into phase 2B clinical development and ensuring we have the resources to do so, we have made the difficult decision to further streamline the company by eliminating our HPV discovery efforts. These actions will result in a reduction workforce of 40%, affecting our discovery research and GNA functions. We know changes that impact our people are not easy, and we are committed to providing our departing employees with support as they transition to their new next roles. At the same time, we are confident that Arbutus remains well positioned for the future.

Michael J. McElhaugh: Because we are now focused on advancing Imduceran into Phase 2b clinical development and ensuring we have the resources to do so, we have made the difficult decision to further streamline the company by eliminating our HPV discovery efforts. I want to emphasize how grateful we are to all our employees, especially those who are departing, for their dedication and passion in developing novel therapeutics that may lead to a functional cure for hepatitis B. The decision was based solely on prioritizing resources for the advancement of Midustiran into a Phase IIb clinical trial and the projected availability of improved Phase III clinical data given the advancement of AB101 through Phase I clinical development.

Because we are now focused on advancing <unk> into phase III clinical development and ensuring we have the resources to do so we have made the difficult decision to further streamline the company by eliminating our HBV discovery efforts.

These actions will result in a reduction in workforce of 40% affecting our discovery research and G&A functions.

Michael Sofia: I want to emphasize how grateful we are to all our employees, especially those departing, for their dedication and passion in developing novel therapeutics that may lead to a functional cure in hepatitis B.

Michael Sofia: In addition to eliminating our research discovery efforts, we have also decided, prior to dosing any patients, to discontinue our recently initiated improved 3 trial, also known as AB729203, which was a Phase 2A trial evaluating the addition of their value map to IMDUCERAN. Our decision to discontinue the improved 3 clinical trial is not related to any concerns regarding the IMDUCERAN or our belief that the addition of controlled checkpoint inhibition may be a key component of a functional cure regimen. The decision was based solely on prioritization of resources for the advancement of MdUCERAN into a phase 2B clinical trial and the projected availability of improved 3 clinical data, given the advancement of AB101 through phase 1 clinical development.

Karen Sims: I want to emphasize that our decision to discontinue this clinical trial has no impact on our oral small molecule PDL1 checkpoint inhibitor, AB101, that is differentiated from checkpoint antibodies and is currently in a phase 1A1B clinical trial. Recall, AB101 is liver-centric and in pre-critical studies had typical small molecule pharmacokinetics and therefore likely a much shorter duration of effect than long-acting antibodies. These features were designed with the goal of minimizing systemic exposures and reducing the chance of immune-related adverse events that are often seen with checkpoint antibodies. It is for these reasons that we continue to remain excited about the potential of AB101 in hepatitis B and are continuing to evaluate multiple ascending doses of AB101 in healthy subjects in our Phase 1A/1B clinical trial.

Michael J. McElhaugh: Recall, AB101 is liver-centric and in preclinical studies had typical small molecule pharmacokinetics and, therefore, likely a much shorter duration of effect than long-acting antibodies. The court has set April 21st, 2025 as a trial date for this case, which is, of course, subject to change. The Pfizer-BioNTech lawsuit is ongoing, with no updates at this time. With that said, I'll now turn the call over to Karen to review the data we presented at EASEL.

101 is liver centric and in preclinical studies had typical small molecule pharmacokinetics, and therefore likely a much shorter duration of effect and long acting antibodies. These.

These features were designed with the goal of minimizing systemic exposures and reducing the chance of immune related adverse events that are often seen with checkpoint antibodies. It.

It is for these reasons that we continue to remain excited about the potential of <unk> hundred one in hepatitis B and are continuing to evaluate multiple ascending doses of <unk> 101 in healthy subjects in our phase <unk> clinical trial.

Michael Sofia: Importantly, the actions today have allowed us to extend our projected cash runway into the fourth quarter of 2026.

Speaker Change: Importantly, the actions today have allowed us to extend our projected cash runway into the fourth quarter of 2026.

Michael Sofia: Before I turn the call over to Karen, I would like to provide a brief update on the litigation with Moderna and Pfizer-BioNTech around our L&T intellectual property.

Speaker Change: Before I turn the call over to Karen I would like to provide a brief update on the litigation with Madonna and Pfizer beyond tech around our LNP intellectual property.

Michael Sofia: Security. In the Moderna case, next steps include expert reports and expert depositions. The court has set April 21, 2025, as a trial date for this case, which is, of course, subject to change.

Michael Sofia: The Pfizer Beyond Tech lawsuit is ongoing, with no updates at this time.

Michael Sofia: With that, I'll now turn the call over to Karen to review the data we presented at EASL.

Karen Sims: Karen? Thanks, Mike, and good morning, everyone. The end of treatment data we reported at the EASL Congress in June was from our ongoing state-to-A combination clinical trials, evaluating enduceram with two immunomodulatory approaches, and supports advancing the development of enduceram as the cornerstone therapeutic of an HBV functional cure regimen that reduces surface damage to presses HBV DNA and boosts immune system. The first trial improved one, evaluated the safety, tolerability, and antiviral activity of a 24-week lead-in of enduceram, 60 milligrams, given every eight weeks, followed by 12 or 24 weeks of weekly interferon, with or without additional doses of enduceram in NUCS-approved chronic hepatitis B patients.

Karen Sims: At the end of interferon treatment, patients remained on their new therapy for an additional 24 weeks, and at that point, if protocol criteria were met, they could stop their new therapies and remain off all therapy for 48 weeks of follow-up. While we presented the full end of treatment preliminary data set for all four patient cohorts at EASL, I will focus on the two cohorts of patients in the trial that received 24 weeks of interferon. As more patients in these cohorts reached and maintained undetectable surface antigen levels than in the 12-week interferon cohort. 12 patients received 24 weeks of enduceram dosing, followed by 24 weeks of weekly interferon, with continued enduceram dosing every eight weeks, and four of those 12 patients, or 33 percent, had undetectable surface antigen at the end of treatment.

Speaker Change: Patients or 33% had undetectable surface antigen at the end of treatment all four patients maintained undetectable surface antigen after stopping interferon treatment and continuing just their nuc therapy for 24 weeks.

Karen Sims: All four patients maintained undetectable surface antigen after stopping interferon treatment and continuing just their new therapy for 24 weeks. These same four patients discontinued their new therapy and are in follow-up, and if they continued to maintain undetectable surface antigen and HBB DNA levels for another 24 weeks, they will be considered functionally cured. Of notes, there are also two patients that received 24 weeks of Enduceram, followed by 24 weeks of interferon with no additional doses of Enduceram, but also reached and maintained undetectable surface antigen and have discontinued new therapy. So in total, there are six patients from the 24-week interferon cohort that achieved sustained surface antigen loss, have zero converted with high surface antibody levels, and are now being followed off all therapy to assess for a functional cure.

Karen: Same for patients discontinue their new therapy and follow up and if they continue to mean maintain undetectable surface antigen and HBV DNA levels for another 24 weeks they will be considered functionally cured.

Karen: Of note. There are also two patients that received 24 weeks of them just around followed by 24 weeks of interferon with no additional doses of <unk>, but also reached and maintained undetectable surface antigen and have discontinued nuc therapy.

Karen Sims: The 33 percent response rate seen with 24 weeks of interferon is one of the highest response rates seen in the field, including from studies testing interferon treatment durations of 48 weeks. In addition, unlike other RNAi candidates in development that have been evaluated in combination with interferon, enduceram was administered less frequently and at a lower dose. The key opinion leaders in the HBB field have found these data to be impressive. There has been prior skepticism around the use of interferon and HBB functional cure regimen, especially since 48 weeks of interferon treatment is not always well tolerated.

Karen Sims: This clinical trial evaluated 24 weeks of interferon treatment, which is one of the shortest courses leading to sustained surface antigen loss in patients with HPV to date. Additionally, in this clinical trial, interferon was generally safe and well tolerated, giving us, and others in the field, the belief that this may be a viable treatment regimen to advance into a phase two clinical trial.

Karen Sims: This clinical trial evaluated 24 weeks of interferon treatment, which is one of the shortest courses leading to sustained surface antigen loss in patients with HPV to date. Additionally, in this trial, interferon was generally safe and well-tolerated, giving us and others in the field the belief that this may be a viable treatment regimen to advance into a Phase IIb clinical trial. At the end of treatment, week 48, if patients met protocol criteria, they could stop their nuc therapy and continue to be followed for 48 weeks without any treatment.

Karen Sims: Our second trial, improved to, is evaluating the safety and immunogenicity of a 24 week leading within Deuteron, followed by Brinthus Biotherapeutic immunotherapeutic DTP-300, while continuing new therapies. At the end of treatment, week 48, is patient met protocol criteria that could stop their new therapies and continue to be followed for 48 weeks off all treatment. During the 24 weeks in Deuteron, we saw 1.8 logs decline in surface antigen from baseline on average. This decline in surface antigen, seen within Deuteron treatment alone, is in line with data we have seen to date from our other clinical trials.

Karen Sims: During the 24-week inducer and read-in period, we saw a 1.8 log decline in surface antigen from baseline on average. This decline in surface antigen, seen with inducer and treatment alone, is in line with data we have seen to date from our other clinical trials. Statistical significance was achieved in mean surface antigen levels between the treatment arm of five patients and placebo with six patients, reaching the 24-week post-end-of-treatment time point. The data from this trial support our hypothesis that by first lowering surface antigen with inducerin, we increase the patient's ability to respond to additional treatment.

Karen Sims: In addition, 95% of patients had surface antigen levels less than 100 IUs per mL at the time of dosing with DTP-300 or placebo. And after VTP-300 administration, more patients maintain surface antigen thresholds of less than 100 or less than 10 IUs per mL versus placebo through 24 weeks post-end treatment. The statistical significance was achieved in mean surface antigen levels between the treatment arm of five patients and placebo, with six patients reaching the 24 weeks post-end treatment time point. The data from this trial supports our thesis that by first lowering surface antigen within Deuteron, we increase the patient's ability to respond to additional treatment.

Karen: So through 24 weeks post end of treatment.

Karen: Statistical significance was achieved a mean surface antigen levels between the treatment arm.

Karen: Five patients and placebo was six patients, reaching the 24 week post end of treatment time points.

Speaker Change: The data from this trial supports our thesis that by first lowering surface antigen with investor and we increase the patient's ability to respond to additional treatment.

Karen Sims: For a call that we've expanded, the improves to clinical trial to evaluate the addition of a low dose of the anti-PV-1 monoclonal antibody Nevolumabs to the Deuteron and DTP-300 combination treatment regimen. We believe Nevolumab may further boost the host immune response. We are on track to report preliminary data from this portion of the trial later this year.

Karen: Recall that we've expanded the improved clinical trial to evaluate the addition of a low dose of the anti PD, one monoclonal antibody and the volume up to the induced ran in BCP 300 combination treatment regimen.

Speaker Change: We believe <unk> may further boosts the host immune response.

Karen Sims: Now let's briefly review the Phase 1A-1B clinical trial with AB 101. As Mike mentioned, AB 101, our liver-centric oral small molecule PDL-1 checkpoint inhibitor, is differentiated from checkpoint inhibitor antibodies and is developed for potential use in combination with induced Iran as a potential treatment. The Phase 1A-1B clinical trial consists of three parts, starting with single and then multiple ascending doses in healthy subjects, and culminating with multiple doses in patients with chronic hepatitis B. Last quarter, we reported data from Part 1 showing that AB 101 is generally well tolerated, with evidence of dose-dependent receptor occupancy. In the 25 milligram cohort, all five valuable subjects showed evidence of PDL-1 receptor occupancy between 60 and 100 percent, indicating that AB 101 is interacting with intended targets.

Karen Sims: In the 25-milligram cohort, all five evaluable subjects showed evidence of PD-L1 receptor occupancy between 50 and 100 percent, indicating that AB101 is interacting with its intended target. We are now in Part 2 of this trial, where cohorts of healthy subjects are receiving multiple ascending doses of AB101.

Karen Sims: We are now in Part 2 of this trial, where cohorts of healthy subjects are receiving multiple ascending doses of AB 101. We anticipate announcing preliminary data from Part 2 later this year. Our goal is to move as quickly as possible into Part 3, which will enroll patients with chronic hepatitis B. We believe that the immune checkpoint pathway plays an important role in HPV-specific immune tolerance and antisoal activations, and the addition of a checkpoint inhibitor in combination with induced Iran could potentially further enhance HPV-specific immune responses.

Karen: With that I'll turn the call over to Dave Hastings for a brief financial update Steve.

Michael J. McElhaugh: Thanks, Karen, and good morning, everybody. We ended the second quarter of 2024 with approximately $148.5 million of cash, cash equivalents, and investments in marketable securities. During the first half of 2024, we received $44.1 million of net proceeds from the issuance of common shares under Arbutus' at-the-market offering program. These cash inflows were offset by $33.8 million of cash used in operations. Importantly, we continue to believe we have the financial and human resources necessary to advance our clinical stage HBV pipeline. Importantly, with the actions we announced today, we extended our cash runway into the fourth quarter of 2026. With that, I'll turn the call back to Mike.

Dave Hastings: Thanks, Karen and good morning, everybody.

Dave Hastings: We ended the second quarter of 2024 with approximately $148 5 million of cash cash equivalents and investments and marketable securities compared to.

Michael Sofia: We received 148.5 million of cash, cash equivalents, and investments in marketable securities compared to approximately 132 million as of December 31, 2023. During the first half of 2024, we received 44.1 million of net proceeds from the issuance of common shares under Arbutus's at-the-market offering program. These cash inflows were offset by 33.8 million of cash used in operations.

Dave Hastings: Approximately $132 million as of December 31, 2023.

Dave Hastings: During the first half of 2024, we received $44 1 million in net proceeds from the issuance of common shares under our <unk> at the market offering program.

Dave Hastings: These cash inflows were offset by $33 8 million of cash used in operations.

Michael Sofia: As we announced today, we are reducing our workforce by 40%. Importantly, we continue to believe we have the financial and human resources necessary to advance our clinical stage HPV pipeline. Now, with this reduction in workforce, we will incur a one-time restructuring charge of approximately $3.4 million that will be recorded in the third quarter of 2024. We still expect our 2024 cash burn to range from $63 to $67 million. Importantly, with the actions we announced today, we extended our cash runway into the fourth quarter of 2026 and significantly strengthened our ability to fund an anticipated inducer on phase 2B clinical trial.

Dave Hastings: As we announced today, we are reducing our workforce by 40%.

Michael Sofia: In closing, we have a strong financial position to advance our mission of developing our HPV assets to provide a functional cure for chronic HPV.

Michael Sofia: With that, I'll turn the call back to Mike.

Michael Sofia: Thanks, Dave. With the reporting of end-of-treatment data from Improved One and Improved Two, we have now achieved all of our first half of 2024 key milestones. All second half milestones are on track, including reporting preliminary end of treatment data from the new volume app on with the improved two trial and reporting preliminary multiple ascending dose data from healthy subjects in the AB 101, 001 trial.

Operator: All second-half milestones are on track, including reporting preliminary end-of-treatment data from the Novolumab arm of the IMPROVE-2 trial and reporting preliminary multiple ascending dose data from healthy subjects in the AB101-001 trial. Operator, we're now ready to open the call for Q&A. Thank you.

Operator: In closing, I wish the best to our departing employees and again thank them for their dedication and contributions to the company as we continue to pursue our goal of developing a functional cure for patients with chronic hepatitis B. Operator, we're now ready to open the call for Q&A. Thank you. At this time, we will conduct a question in the answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster.

Speaker Change: For patients with chronic hepatitis b.

Speaker Change: Operator, we're now ready to open the call for Q&A.

Speaker Change: Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced.

Speaker Change: To withdraw your question. Please press star one again.

Operator: Please stand by while we compile the Q&A roster.

Speaker Change: Please standby, while we compile the Q&A roster.

Dennis: The first call comes from Denisting with Jeffries. Go ahead; your line is open. Good morning, thanks for keeping up questions. I just had one on the phase 2B that you guys were mentioning. Can you just talk a little bit about what this trial would look like in terms of size and design, and approximately how much it would cost to run. As a follow-up, I'm just curious whether this would include AB 101 as part of the regiment. I guess maybe it would just include Inferron and BTP 300 depending on some more data. I can have this here.

Speaker Change: My first call comes from Dennis Jang with Jefferies. Go ahead. Your line is open.

Dennis Jang: Hi, good morning, Thanks for taking my questions I just have one on the phase two because you guys were mentioning can you just talk a little bit about what this trial would look like in terms of size and design and approximately how much it would cost to run and as a follow up I'm. Just curious with this include <unk> 101, as part of the regimen.

Dennis: Maybe just comment on that as well. Thank you.

Karen Sims: Sure, good morning, Dennis.

Karen Sims: Karen, would you like to handle that question? Sure, that's fine. Hi, Dennis. So there's really not much I can share at this point in terms of the face-to-be study-designed. Obviously, we're in the planning stages of that study. So it would be premature to describe any specific study design features or the timing of the study. So that will allow me to be the subject of a future discussion in terms of, you know, including compounds in that trial. You know, I think we're evaluating all the options. We have at our disposal right now, as you know, we shared very exciting data in Easel with our interferon combination and improved one with DTP 300.

Operator: Sure, that's fine. Hi Dennis.

Operator: Sure, that'll be fine.

Michael J. McElhaugh: So there's really not much I can share at this point in terms of the phase 2b study design. Obviously, we're in the planning stages of that study, so it would be premature to describe any specific study design features or the timing of the study, so that will need to be the subject of future discussions. In terms of, you know, including compounds in that trial, I think we're evaluating all the options we have at our disposal right now.

Michael J. McElhaugh: As you know, we shared very exciting data at ESOL with our interferon combination in IMPROVE-1 with VTP300. We're awaiting that additional Novolumab data from the IMPROVE-2 additional cohort coming later this year. So at this point, I think, you know, all options are open and on the table, and we're evaluating all those as we go.

Karen Sims: We're waiting for additional no-volumab data from the improved to additional cohort coming later this year. So at this point, I think, you know, all options are open and on the table, and you were evaluating all those as we speak.

Dennis: Okay. Thank you.

Operator: Stand by for our next question.

Thomas: Next question comes from Ed. RC with HD Wing Right. Please go ahead. Your line is open.

Thomas: Hello, good morning, everyone. This is Thomas here asking a couple of questions for Ed. Thank you for taking our questions. So first question for the improved to extension cohort data and second and second half this year. Is the data announced and expected to be in conjunction with any major medical conference in the second half of this year?

Karen Sims: Good morning, Thomas. Thanks for the question. I will tell you what we tell you every time we talk about the release of data. We hope that that's the case, but of course we can't commit to that because we don't know the disposition of abstracts yet. So we hope that's the case. We anticipate that that will be the case, but of course we can't confirm that until we get closer to the end of the year.

Operator: Good morning, Thomas. Thanks for the question. I will tell you what we tell you every time we talk about the release of data. We hope that that's the case. But, of course, we can't commit to that because we don't know the, you know, the disposition of abstracts yet. So we hope that's the case. We anticipate that it will be the case. But, of course, we can't confirm that till we get closer to the end of the year.

Karen Sims: I'm the student. And then perhaps, as I add on questions to that, are there any plans to report new interim data from Improved One and Improved Two studies before year end? Yeah, I think the answer to that question, Thomas, is yes; timing TBD. Got it.

Operator: And then perhaps as an add-on question to that, are there any plans to report new interim data from the In Group 1 and In Group 2 studies before year-end?

Michael Sofia: And then perhaps one question for us on the operation string line plans. I think any other impacts on your clinical programs are going to be planned in Group three study. And then also if you can discuss any preclinical programs that are affected by this reminded. Yeah, no, look, the We don't anticipate any other impact on the clinical programs. In fact, the focus really is to focus on the later stage and do certain studies. And that's the intent and using the existing resources we have to fund a phase to be studied, which we believe we can substantially fund with the current cash on hand.

Speaker Change: Any plans.

Dennis Jang: Okay.

Dennis Jang: And the other impacts on your clinical programs other than be plan improved three study.

Dennis Jang: And then also if you can discuss any preclinical programs that are affected.

Speaker Change: Bye Bye this remaining.

Michael J. McElhaugh: Yeah, no, no, look, we don't anticipate any other impact on the clinical programs. In fact, The focus really is to

Speaker Change: Yes, no no.

Speaker Change: Look the we.

Speaker Change: We don't anticipate any other.

Speaker Change: Impacting the clinical programs in fact.

Speaker Change: The focus really is to.

Speaker Change: Focus on the later stage inducer, and studies and Thats and Thats, the intent and using the existing resources we have.

Speaker Change: To fund the Phase <unk> study, which we believe we can substantially fund with the current cash on hand, obviously, we can't give exact guidance after that until the study design is complete but.

Michael Sofia: Obviously, we can't give exact guidance as to that until the study design is complete, but with the streamlining today that positions the company well to advance the disserant quickly.

Thomas: Thank you, Douglas. Thank you again for picking up questions. Of course. Thanks, Thomas.

Operator: Got it. Thank you again for taking our questions.

Operator: And by for our next question.

Operator: Standby for our next question.

Roy Buchanan: The next question comes from Roy Buchanan with Citizens. Go ahead. Your line is open.

Roy Buchanan: Okay, thanks for taking the questions. Just a couple of quick ones.

Roy Buchanan: I guess just to make sure I'm clear, just I'm sure you're going to need to talk to the FDA, but it sounds like the next and possibly only trial that you're going to start is going to be this phase to be. Is that correct? Yeah, Roy, I don't, I don't know how to answer that. I mean, we're what we said today was we're planning to move and do so in the later stage clinical development, which is likely a Phase 2 study. We have lots of thinking to do. We are in the process of doing that.

Roy Buchanan: And you know, we'll come back when we have some more details. Okay, and still some data to see if they I got some data to see that crap. Yeah.

Operator: So some data to see if that's correct. Yeah.

Roy Buchanan: Okay. And then this one, just I guess you're thinking, and I think you mentioned it in the prepared remarks about focusing on patients with baseline HBS less than a thousand. You know, other companies are looking there. Just how are you potentially about that? Yeah, that's that's a good question, Roy. I mean, yes, you're right. You did hear that comment in the in the prepared remarks. One of the things that we found very intriguing about the data that we generated and improved one is that if you looked at the response rate in patients with surface antigen less than a thousand at baseline.

Speaker Change: Improved one is that if you looked at the response rate in patients with surface antigen less than 1000 at baseline the number is.

Roy Buchanan: The number increased dramatically from 33% to 67%. Now, of course, we're going to have to see how that continues to hold as we move forward here. But remember, we're talking about, you know, 350 million patients globally with hepatitis B. So even if you start to cut that down into some patient populations and you think about how you could potentially segment that market, we're still talking about substantial numbers of patients. We're working on specifically what that looks like, but there is a very large base number of patients to work from. So yeah, we're excited about that.

Speaker Change: <unk> dramatically from 33% to 67% now of course, we're going to have to see how that continues to hold as we move forward here.

Speaker Change: But remember we're talking about.

Speaker Change: 350 million patients globally with hepatitis B. So even if you start to cut that down into into some patient populations and you think about how you could potentially.

Speaker Change: Potentially segment that market, we're still talking about substantial numbers of patients. We are working on specifically what that looks like.

Speaker Change: But there are there is a very large base number of patients to work from.

Speaker Change: So yes, we're excited about that.

Roy Buchanan: Okay, thank you.

Speaker Change: Okay. Thank you.

Key: One moment. The next question comes from Key with Shardin. Go ahead.

Speaker Change: One moment.

Speaker Change: Okay.

Speaker Change: The next question comes from key with short Anne Go ahead. Your line is open.

Key: Your line is open. Yeah, thanks. Yeah, just again, not to be the dead horse here, but just trying to understand the path forward for the next clinical trial. It sounds like you're trying to position your resources to be able to at least start this on your own if needed.

Operator: Yeah, thanks. Yeah, just again, not to beat a dead horse here, but just trying to understand the path forward for the next clinical trial. It sounds like you're trying to position your resources to be able to at least start this on your own if needed. But can you just firm up when you think you might start it? I know you can't give us any details on the design, but you're going to have more data, you know, in the second half of this year. So is this a first half, 25 study or later?

Key: Yeah. Thanks, Yeah, just again not to beat a dead horse here, but just trying to understand the path forward for the next clinical trial.

Key: But can you just firm up when you think you might start it? I know you can't give us any details on design, but you know, you're going to have more data, you know, in the second half of this year. So is this the first half 25 study or later? Yeah, okay, good question.

Michael Sofia: Good to have you on the line. Thanks for the thanks for the question. I can't give you any more specifics about design or timing at this point. All I can say is that we'll get it started just as quickly as we possibly can. There are still some discussions to be had. We are, as you know, as you mentioned, we're still waiting for some data, which is obviously going to help drive that decision. But the goal here is to start this as quickly as we can, and yes, we do have the legs to kick this off on our own.

Michael Sofia: And as Dave said, to fund substantially all of it at this point with the cash we have on hand.

Michael Sofia: So, you know, we're diligently working to get this kicked off quickly and, you know, stay tuned for more information.

Key: Okay, thanks. Thank you.

Operator: I'm showing no further questions at this time.

Michael Sofia: I would now like to turn it back to the company for closing remarks. Thank you, everyone, for joining us this morning. We appreciate your continued interest and support of Arbutus. And of course, we look forward to providing updates as we progress development of our HPV assets.

Operator: Operator, that concludes our call. Thank you, and thank you for your participation in today's conference.

Speaker Change: Thank you and thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Operator: This does conclude the program. You may now disconnect.

Key: Yeah.

Key: Okay.

Key: Okay.

Key: [music].