Arbutus Biopharma Q2 2023 Earnings Call Transcript

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Provided by Quartr
August 3, 2023

There are 11 speakers on the call.

Operator

Good day and thank you for standing by. Welcome to the Arbutus Biopharma Q2 Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Advising that your hand is raised.

Operator

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lisa Capparelli. Please go ahead.

Speaker 1

Thanks, Jada. Good morning, everyone, and thank you for joining Arbutus' Second 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 Doctor. Mike Sofia, Chief Scientific Officer and Doctor. Karen Sims, Chief Medical Officer.

Speaker 1

Bill will begin with a corporate update followed by Doctor. Sims, who will review recent data shared at the Medical Congress. Dave Hastings will then provide a review of the company's Q2 2023 financial results. After our prepared remarks, we will open the call for Q and A. Doctor.

Speaker 1

Sofia will be joining us at that time to address 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 ks, 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 turn the call over to Bill Collier. Bill?

Speaker 2

Thank you, Lisa, and good morning, everyone, and thank you for joining us today. Our goal at Arbutus has always been to develop a combination of therapeutic agents that will lead to a functional cure of chronic hepatitis B. And today, we are excited to share with you the continued progress that we've made in advancing this effort. We believe that AB-seven twenty nine, which we will now refer to by its generic name, imduciran, Has the potential to be a cornerstone therapy to functionally cure chronic HBV. To date, we've generated meaningful inpatient data Showing that imdusiran appears to be the only RNAi to impact both surface antigen and the reawakening of the HBV specific immune And the effects of imduciran are sustained in some patients even after all therapy is discontinued.

Speaker 2

We remain impressed with the compelling safety and efficacy profile of indusiran and look forward to evaluating indusiran in combination not only with other available But ultimately, with our early stage HBV assets that are concurrently progressing. We expect additional combination data from our ongoing Phase 2a clinical trial with our partner, Vaxatec, in the second half of this year. And with this, we continue to be well positioned to advance our goal of developing a functional cure for HBV And driving value for our company as we advance our broad pipeline of HBV assets. Now with respect to our early stage HBV assets, this morning we announced our CTA has been approved for us to initiate a Phase 1 clinical trial with AB101, our oral PD L1 inhibitor in New Zealand. As you may recall, the The FDA placed the IND application for AB101 on clinical hold before we had initiated a trial or dosed any patients.

Speaker 2

To get AB101 into a clinical trial as quickly as possible, we made the strategic decision to work with New Zealand to advance AB101 while in parallel working to address the FDA concerns. We We continue to believe that AB101 as an oral and thus more rapidly titratable checkpoint inhibitor compared to an antibody approach Has the potential to be an important component of a combination therapy that could be combined with indusiran to provide a functional cure for HBV. Now the Phase 1 clinical trial for our RNA destabilizer AB-one hundred and sixty one is ongoing. 161 is our next generation oral HBV specific RNA destabilizer, which is being developed as part of a potential Oral treatment regimen to functionally cure HBV. We expect to have initial data from the single ascending dose portion of this trial in the second half of the year.

Speaker 2

Now beyond our HBV assets, We remain committed to identifying and developing new antiviral small molecules to treat COVID-nineteen and future coronavirus outbreaks. Our strategy is to target the 2 essential enzymes for the coronavirus lifecycle, SARS CoV-two NSP5 main protease also known as mpro and NSP12 viral polymerase. These enzymes are critical for viral replication and are highly conserved across all known coronaviruses. AB-three forty three is our lead oral EnPro inhibitor designed to address the urgent need for oral antiviral therapies that are both potent and active against circulating SARS CoV-two variants and that do not require ritonavir boosting. The preclinical profile of AB-three forty three is impressive and we're currently in IND enabling studies with plans to complete those studies in the second half of this year.

Speaker 2

Ultimately, we believe that the optimal treatment regimen will consist of both an eMpro inhibitor And an NSP12 inhibitor, differentiating this therapy from other strategies. To that end, our goal is to and nominate an NSP12 inhibitor, which we can then take into IND enabling studies in the second half of this year. And we'll be sharing more updates on these 2 programs as we progress through the year. Before turning the call over to our new Chief Medical Officer, Doctor. Karen Sims to review the imduciran data, I'd like first to congratulate Karen on her appointment as CMO at Arbutus.

Speaker 2

Karen has been with the company since 2017 and has played a crucial role in the clinical development of indusiran, and I'm very happy that Karen has assumed this role and confident that she and her team will continue to effectively execute our mission. So over to you, Karen.

Speaker 3

Thank you, Bill, for those kind words. I'm honored to serve as CMO at Arbutus. And like my colleagues, I believe we have a sound strategic approach to develop a functional cure for HBV and a compelling pipeline of assets to achieve that goal. With respect to our progress in HBV, we are exploring imduceran in combination with other investigational and approved products through our 2 ongoing Phase 2a combination trial, one with Interferon and one with ZaxoTek's HBV antigen specific immunotherapeutic. With both of these trials, Our goal is to identify compounds that can be combined with imbusiran to further stimulate the immune system to induce functional cure in chronic HBV patients.

Speaker 3

I'll start with our Phase 2a clinical trial that is evaluating indusiran in combination with ongoing nucleoside or nucleotide analog therapy And interferon in patients with chronic HBV. Interferon is considered a current standard of care treatment option for chronic hepatitis B that is administered weekly for a finite treatment course, but has a very low chance of achieving functional cure as monotherapy for chronic hepatitis B in most patients. Because interferon is typically poorly tolerated, we are studying only short courses in this trial. And in this trial, we intend to assess the impact of interferon on safety, Tolerability and efficacy as assessed by surface antigen decline when added to ongoing induceiran and nuke therapy. We enrolled 43 e antigen negative patients that underwent a lead in phase with 24 weeks of indusiran and then we're randomized to 1 of 4 treatment arms to receive interferon for either 12 or 24 weeks plus ongoing nuke therapy plus or minus additional doses of imbusiran.

Speaker 3

At the recent EASL Medical Congress, we presented preliminary data, including the first twelve patients that had completed the lead in phase and at least 12 weeks of interferon treatment with or without additional doses of imiduceran. Baseline characteristics were similar across all 4 interferon treatment cohorts. During the imbusiran 24 week lead in phase, Patients experienced a mean surface antigen decline of 1.59 logs from baseline. This is comparable to what has been previously seen in other clinical trials with Indusiran. The mean surface antigen decline from baseline at week 40, which includes 12 weeks of interferon dosing was 1.88 log, which is promising albeit from a small sample size.

Speaker 3

In addition, 4 patients, 1 from Cohort A and 1 from Cohort A2, both of which received interferon plus or minus inducediran for 24 weeks and 2 from Cohort B1, who received interferon plus inducediran for 12 weeks, Reached surface antigen levels below the lower limit of quantitation during the interferon treatment period. These patients had not achieved sustained Surface antigen loss and anti HBF antibody levels were pending as of the date the data was presented and they continue to be followed in the trial. 3 patients, 1 in Cohort A2 and 2 in Cohort B1 have been evaluated to stop nuke treatment and 1 patient from Cohort B1 has to discontinue new treatment. Regardless of the duration of interferon treatment, 12 weeks or 24 weeks, The change in surface antigen from baseline during the interferon treatment period remains below the baseline values, although with considerable variability amongst patients. These data suggest that the addition of interferon to induceiran treatment may result in continued surface antigen declines in some patients.

Speaker 3

However, with most patients still in the interferon treatment period, we are cautious to drawing any meaningful conclusions from this preliminary data set. We are eager to continue to follow these patients through the duration of the interferon treatment period and the new only follow-up period to assess for trends in surface antigen decline and sustained surface antigen loss. As in our other trials, patients that complete the treatment period with induceiran, interferon and Nuke therapy or evaluated to stop all treatment. From a safety standpoint, inducediran with or without interferon was generally well tolerated with most treatment emergent There are no serious adverse events, study discontinuations for imduceran treatment discontinuations or modifications and the interferon dose modifications needed were consistent with the known safety profile of interferon. These preliminary data from a larger Phase 2 trial continue to reinforce our confidence in Inducerin's ability to effectively lower surface antigen, We anticipate providing updates when we have additional meaningful data

Speaker 4

to report.

Speaker 3

Regarding our second Phase 2a combination trial that we are conducting with Vaxatac, The original part of the trial designed to evaluate imduceran, Yuc therapy and Vaxitec's HBV antigen specific immunotherapeutic ETP-three hundred or placebo is fully enrolled. This trial is designed to reduce surface antigen with imbusiran before the patients are randomized to 1 of 2 arms to receive ongoing new therapy plus ETP-three hundred or placebo. Recently, in collaboration with VaxoTech, We have expanded the trial to include an additional treatment arm that will enroll approximately 20 patients to receive low dose nivolumab, A PD-one monoclonal antibody inhibitor approved to treat a number of cancers under the brand name Opdivo with the combination regimen. We will assess if the addition of low dose nivolumab to the booster component of the VTP-three hundred combination Further stimulates immune mediated reduction of surface antigen after the initial treatment with imbusiran and the first dose of BTP-three hundred. We reported in June that the first patient in this additional treatment arm has been dosed.

Speaker 3

We are hopeful that if we can lower surface antigen and stimulate the host HBV immune system with the combination of imduceran and the first dose of VTP-three hundred. The addition of low dose nivolumab will further enhance the stimulation and we may therefore enhance the ability of the immune system to fully suppress the virus and in turn achieve functional cure. As Bill mentioned, we believe that chronic hepatitis B requires a combination of compounds to achieve therapeutic success, and we are encouraged by the progress we have made in these 2 Phase 2 clinical trials to further support our mission. With that, I'll turn the call over to Dave Hastings for a brief financial update. Dave?

Speaker 5

Thanks, Karen. Good morning, everybody. As I've mentioned in the past, our key financial metrics are cash and financial runway. Our cash, cash equivalents and investments Approximately $164,000,000 as of June 30, 2023, compared to approximately $184,000,000 as of December 31, 2022. During the 6 months ended June 30, 2023, we received approximately $25,000,000 of net proceeds from the issuance of common shares under Arbutus' at the market offering program.

Speaker 5

These cash inflows were offset by approximately $47,000,000 of cash used in operations. We expect our 2023 net cash burn to range from between $90,000,000 to 95,000,000 excluding any proceeds received from our at the market offering program. And we believe our cash runway will be sufficient to fund our operations into the Q1 of 2025. So in closing, we have a strong financial position to advance our mission and develop a functional cure for HBV and a treatment for COVID-nineteen and So with that, I'll turn the call back to Bill. Bill?

Speaker 2

Thank you, Dave. So just to wrap up, I'd like to remind everyone of our Coming key milestones for 2023. First of all, we plan to initiate the Phase 1 clinical trial with AB101 this quarter. Secondly, we plan to report initial data from the AB-seven twenty nine-two zero two Phase 2a clinical trial combining imducerin, nuke therapy and VTP-three hundred, and we expect to report that data in the second half of twenty twenty three. We plan to report initial data from the healthy subject single ascending dose portion of our Phase 1 clinical trial for AB-one hundred and 1 in the second half of twenty twenty three.

Speaker 2

And fourthly, we plan to complete IND enabling studies For AB-three forty three, our EnPro coronavirus clinical candidate and also nominate a candidate to commence IND enabling studies in our NSP12 program, both in the second half of twenty twenty three. I'd like to take this opportunity to recognize and thank all the Arbutus We've made significant progress in advancing our pipeline, and I look Forward to sharing more details as we reach our clinical milestones and data readouts later this year. I'm confident that we have the right team And the right strategy in place to deliver on our mission. So operator, we are now ready to open the call for Q and A session.

Operator

Thank you. At this time, we will conduct a question and answer session. Your first question comes from Dennis Ding of Jefferies. Please go ahead.

Speaker 6

Hi, good morning. Thanks for taking my question. Just one for me. From a big picture perspective around hepatitis B, I mean, How should investors think about this space given that it's been challenging and a lot of these studies take very long and You're hearing some pharma companies actually discontinue development here. How and when do you think you could change that narrative Significantly.

Speaker 6

Thank you.

Speaker 2

Thank you, Dennis. This is Bill. Good question. And yes, you're right. Some observations that you've made around J and J, for example, stopping their development program.

Speaker 2

And yes, some of the clinical trials do have some lengthy timelines attached to them. However, There are still several companies that are in this field, both big pharma and small biotech. And I as I said in my comments, I'm confident that the strategy that we have, which is Reduce HPV DNA, suppress surface antigen and boost the immune system is the correct scientific strategy And we're developing assets in those three arenas and testing out different combinations in these trials to find the functional cure. Ultimately, I think there will be some kind of data in this field that reaches some kind of Level of functional cure, I think that will establish a benchmark and then other companies will continue iterate, including ourselves and try and continue to improve that functional QA.

Speaker 6

And maybe as a follow-up, one of the really interesting things about Arbutus is the platform is the SRNA. And A few years ago, Roche did acquire Dicerna for around $1,700,000,000 again for the platform. So I'm just wondering, How else can you leverage that platform? And given your current cash position, is that something That you could do more work on in the near term or maybe some color there would be helpful. Thank you.

Speaker 2

Yes. I mean, as Dave mentioned, we're well capitalized at the moment with a decent cash runway. And I think we've shown in the past that we've been able to raise money through different mechanisms. So some of the royalty monetization, the China rights deal that we did with Qilu being a couple of examples. I think we're also quite judicious in the way that we do our combination clinical trials.

Speaker 2

We try and keep those Relatively simple with fifty-fifty cost sharing between ourselves and our partners, which reduces some of the costs of the clinical trials. And Dave and the whole exec team, we're pretty cautious on what we spend and where we spend it. Beyond that, Mike Mack is here in the room with us and maybe you want to comment on some of the Conversations that we continue to have with different BD partners?

Speaker 7

Sure, Bill. I'm happy to do that. Dennis, as we've mentioned in the past, We have conversations with all players in the field all the time. Any opportunity we have, we take advantage of that. And there's certainly continued interest in the field.

Speaker 7

There are still lots of key players, as Bill mentioned, Working diligently in hepatitis B and we do expect that we're going to be able to drive functional cure rates higher as we continue to iterate with our pipeline. So as things evolve, we'll continue to have those conversations and we'll see how they progress. We obviously can't say much more than that, We're always open to thinking about potential opportunities for the future. So leave it at that.

Speaker 6

Thank you.

Operator

Thank you. One moment for our next question please. Our next question comes from Ed Arce of H. C. Wainwright.

Operator

Please go ahead.

Speaker 4

Hi, good morning, everyone. This is Thomas Yip asking a couple of questions for Eric. Thank you for taking the questions. Perhaps first, we've seen a very encouraging data set from the 201 Phase 2a study at EASL. Can you tell us when can we expect the next dataset?

Speaker 4

Would it be later this year? And also looking Further at which point can investors expect to have an early idea of what the Phase 2b will look like?

Speaker 2

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.

Speaker 2

We should probably wait until we have Some more meaningful, more complete data sets. So I think what we're going to do is wait until January When we typically release our expectations and guidance for the 2024 year, And I think we'll put something in there about when we expect to further update from this study.

Speaker 4

Great. So I assume That will include what are the potential mix ups for the 2 months maybe as well?

Speaker 2

Well, yes, I mean, as always with clinical trials, you have to wait to read out what the data And then we'll be guided by that as to how we determine next steps.

Speaker 4

I see. Okay. And then moving on, the other The 2 2 study in combination with DTP-three hundred, what type of data can we expect In terms of endpoints measurements, would that be comparable to the Tier one study?

Speaker 2

Eira, do you want to take that?

Speaker 3

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 in all of our clinical trials with inducediran as the foundation of many of these Combination studies, so certainly data around surface antigen, we would expect to present at that time. Beyond that, as in most of our trials, we really just need 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.

Speaker 3

So certainly surface antigen beyond that, it's too early to comment.

Speaker 4

Okay. Understood. And then switching gears perhaps to one question about 161 As we expect, single ascending dose data later this year. So clearly, safety data are very important, But what type of should we expect to see some type of efficacy data, specifically F antigen or RNA data? And what would be the next step for NKTR-1 hundred and sixty one if these data are positive?

Speaker 3

Yes. I can address That is well. So as we've mentioned, we are in a Phase 1 clinical trial with AB-one hundred and sixty one, 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-one hundred and sixty one, we need to be in the otitis B patient population, which we wouldn't be ready to share any data from by the end of this year.

Speaker 3

So for this particular trial, just safety data would be what we would be sharing.

Speaker 4

Got it. Thank you so much for taking my questions and looking forward to the data later this

Speaker 2

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.

Speaker 8

Hey, great. Thanks for taking the questions. I guess the first one on AB101, pretty quick getting the clinical trial set up Ex U. S. There, so nicely done on that.

Speaker 8

I guess just any details you can give us around the Phase 1, what it's going to look like? I assume it's not exotic, Just that. And then what's the path look like with the FDA from here on? What do you do? What are the next steps there, I guess?

Speaker 8

And what's the Conversation looks like with the FDA. Thanks.

Speaker 2

Yes. Thank you, Roy. So as we've revealed today and previously, 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 preclinical 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.

Speaker 2

Beyond that, Karen, anything you want to say about the design of the study or?

Speaker 3

No, not in particular. Roy, as you alluded to, nothing surprising at this point in the study in terms of initiating in healthy subjects and then moving into for hepatitis B patients. So, yes, from that standpoint, yes, nothing terribly exotic as you mentioned our It's a typical study, but yes, we are very much looking forward to getting this initiated as soon as possible. We're excited that we have a path forward.

Speaker 8

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

Speaker 3

No, actually we 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 dating in healthy subjects and then moving on to chronic hepatitis B subjects within the same trial.

Speaker 8

Okay, great. And then just a quick one on Chi Liu, just any updates you can give us on the progress there? I mean, I know it's in their hands, probably can't say much, but any sense of what to expect And maybe timing for the next update for that collaboration? Thanks.

Speaker 7

Yes, Roy. This is Mike. Good question. Yes, we continue to work with our partners And Shilu, to move that program forward as quickly as possible, there's not much more we can say beyond that. It's a bit of a slow process in China As I'm sure you're aware, but we're moving as diligently as we can.

Speaker 8

Okay. Can you just remind me where it's at, at this point, like in development or is that Not public.

Speaker 7

Where is it, in development in China?

Speaker 8

Yes.

Speaker 7

We're still working towards submitting an IND to the Chinese regulatory authorities.

Speaker 8

Okay, great. That's it. Thank you.

Speaker 2

Sure. Thank you, Roy.

Operator

Thank you. One moment for our last question. Our last question comes from Brian Skorney of Baird. Please go ahead.

Speaker 9

Hey, good morning. Thanks for taking our questions. This is Charlie on for Brian. Just a couple from us. So I was just kind of curious what your interpretation of the combination data with imduceran and pegyneferon Given that in the A1 and B1 cohorts, it looks like in 1 or 2 patients, there's a sharp drop in surface antigen and then a A bit of a rebound.

Speaker 9

Secondly, we'd be curious if any of the kind of investment calculus has changed for you guys With regards to the coronavirus antivirals, given how the disease landscape has evolved over the past year and a half? And, also just kind of Did you set the table with expectations for when the VTP-three hundred Combination might have an incremental effect from the use of that vaccine and kind of like what you're thinking about In terms of how that combination might be synergistic? Thank

Speaker 2

you. Okay, great. Thanks. So let's chunk this out, maybe the interferon question First with Karen and then we'll go across to Mike Sofia for a comment on coronavirus.

Speaker 3

Yes, sure. Thanks, Phil. So just back to the 201 interferon data that was released. So as we mentioned earlier, I will remind you that this is very preliminary data and that the majority of Subjects have not completed the interferon treatment period when we reported this data. So as we alluded to, I think it's still too early to draw Specific conclusions from the data set that we shared, but we were encouraged by the performance of emduceran in the lead in period, doing exactly what it's supposed We're doing in terms of lowering surface antigen and then the initial data with interferon.

Speaker 3

To your point, it's a little variable. Looking at those Plus in the poster, perhaps I can refer you back there. The s antigen data was presented in a log scale. So while some of those Changes look rather dramatic at the low end. These are subjects that are moving from surface antigen values, for example, less than 5 to less than low than the quantitation and then back to less than 5 or less than 10.

Speaker 3

So the bottom of that scale there is actually A very small window of surface antigen changes, less than 10 IUs per ml, it's undetectable where these subjects are moving around. And I don't think that's surprising given the close follow-up with these subjects. We don't necessarily expect someone to hit lower limit of quantitation necessarily Stay there, they may bounce around a little bit before they settle out into whichever direction they may go, whether they remain undetectable or Have a little bit of surface antigen rebound to your point. So I think the big picture here is we need to keep watching these subjects and let them complete The full interferon treatment period, let them complete the follow-up period. As you know, with interferon monotherapy data, there are At times, we have very interesting outcomes in patients after they've completed their interferon therapy.

Speaker 3

So I think we just need to be patient As the data emerges and then as alluded to, we'll be providing updates on this study when we have additional meaningful data to share.

Speaker 2

And then do you just want to talk about the second part, the potential impact of BTP-three hundred in the other study? And then we'll go across to Correct, Novartis.

Speaker 3

So in terms of VTP-three hundred with the in the two zero two study, So certainly, as we alluded to, we'll be sharing some data from that study towards the end of the year. We've been following bactosex data very closely with their VTC-three 100 study, 2 study, and are encouraged by their results in terms of surface antigen declines, especially in patients to have low surface antigen at the beginning of the study. So keeping that in mind, we're very hopeful that induced urine will continue to Lower surface antigen in this subject in that study to a point where BGP-three hundred will hopefully have a similar effect of additional surface antigen decline and then ideally additional activities that will promote functional cure in those patients.

Speaker 2

Okay. Thanks, Karen. So Mike on the coronavirus approach?

Speaker 10

Sure. So, hi, Charlie. It's Alexia. So I think when you look at the coronavirus space, when you talk To sort of KOLs, there's still a significant medical need for effective therapies, which to a large extent are lacking out there. As you probably heard, we're potentially seeing a surge here and a surge in coronavirus SARS CoV-two diagnosis in the recent news, so Obviously, pointing to the need still for therapeutics.

Speaker 10

And our strategy has always been, I think, differentiated from others with the idea of a combination of 2 direct dactinovirals, the EMPRO as well as NSP12 polymerase inhibitor To provide really a significantly potent therapeutic regimen that we believe could have impact on Not only existing infection in the patient, but also Maybe in pre and post exposure prophylaxis. And finally, this whole issue of long COVID, that's still a concern out there And how do you treat long COVID? And some of the theories are that there is some kind of reservoir virus out there and if you can hit the virus very hard With effective therapeutics, you could possibly address long COVID. So still, we believe that there is a value In a COVID program, right now, there are a number of key important unmet medical needs in the space We think we can address with the strategy that we've implemented.

Speaker 9

Great. Thank you so much for giving that additional color and I appreciate your time today. Thank you.

Operator

Thank you. I will now turn it back over to management for closing remarks.

Speaker 9

All right.

Speaker 2

And I'd just like to take a moment to thank everyone for joining us this morning. We do appreciate your continued interest and support of Arbutus And we look forward to providing you the updates as we progress the development of our HPV and coronavirus assets this year. So thank you everybody. Operator, that concludes our call. Thank you.

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

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Key Takeaways

  • Arbutus’ lead RNAi candidate imduciran continues to demonstrate sustained HBsAg declines and immune reawakening in Phase 2a combo trials with interferon and Vaxatech’s immunotherapeutic, with preliminary data showing mean declines of ~1.88 log and several patients reaching below LLOQ.
  • New Zealand CTA approved for oral PD-L1 inhibitor AB101, enabling initiation of a Phase 1 umbrella trial this quarter to address FDA clinical-hold issues and advance a more titratable checkpoint inhibitor for HBV cure combinations.
  • Early-stage HBV asset AB-161, an oral virus-specific RNA destabilizer, is in an ongoing single-ascending-dose Phase 1 study in healthy volunteers, with initial safety and tolerability data expected in the second half of 2023.
  • Arbutus is advancing its coronavirus antiviral strategy with AB-343—an oral Mpro inhibitor in IND-enabling studies—and plans to nominate an NSP12 polymerase candidate by year-end, targeting an unboosted dual-mechanism regimen.
  • With $164 million in cash and investments as of June 30 and projected net burn of $90–95 million in 2023, Arbutus expects its financial runway to extend into Q1 2025 to support its HBV and coronavirus programs.
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Earnings Conference Call
Arbutus Biopharma Q2 2023
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