Arbutus Biopharma (ABUS) Q1 2021 Earnings Call Transcript

Arbutus Biopharma (ABUS -0.72%)
Q1 2021 Earnings Call
May 05, 2021, 8:45 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Arbutus Biopharma Corporation 2021 first-quarter financial results and corporate update conference call. [Operator instructions] Please be advised that today's conference is being recorded. [Operator instructions]. I would now like to hand the conference to your speaker host today, Pam Murphy.

Please go ahead.

Pam Murphy -- Investor Relations Consultant

Thank you, and good morning. On the call from Arbutus executive team are Bill Collier, president and chief executive officer; Dave Hastings, chief financial officer; Dr. Gaston Picchio, chief development officer; and Dr. Mike Sofia, chief scientific officer.

Bill will begin with the review of the first quarter's accomplishment, clinical development, and remaining 2021 corporate objectives; followed by Dave Hastings, who will provide a the review of the company's first quarter financial results. We'll then open up the call for Q&A. Mike and Gaston will be available to address any research and clinical development related questions. Before we begin, we'd like to remind you that some of the statements made during the call today are forward-looking statements, including statements regarding expectations for Arbutus' proprietary HBV pipeline and pan-coronavirus discovery program, including potential clinical results and timelines for AB-729 and AB-836, and any future compound; our expected cash used and cash runway and the potential for our drug candidates to improve upon standard of care and contribute to a curative combination regimen for HBV.

These forward-looking statements 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 10-K, quarterly report on Form 10-Q and other periodic reports filed with the SEC. Bill?

Bill Collier -- President and Chief Executive Officer

Thank you, Pam, and good morning, everybody. Thank you for joining us today. We really do appreciate your interest in Arbutus Biopharma. I am pleased to report on our progress thus far this year, and to outline our objectives for the rest of 2021.

As we've stated in the past, our goal at Arbutus is to focus on developing a portfolio of products with different mechanisms of action, that when used in combination could result in a functional cure for people living with chronic HBV. During the first quarter, we took another significant step toward that goal when AB-836, our proprietary oral capsid inhibitor began a Phase Ia/Ib clinical trial. 836 is from a novel chemical series, differentiated from competitive compounds with potential for increased efficacy and an enhanced resistance profile. And we look forward to having initial data readouts from this trial in the second half of this year.

In addition, AB-729, our proprietary subcutaneously delivered RNAi agent, continues to demonstrate robust and continuous declines in hepatitis B surface antigen in subjects with chronic HBV, with a favorable safety profile in our ongoing Phase Ia/Ib clinical trial. We expect to provide additional data from ongoing cohorts from this Phase Ia trial in the second quarter of this year, including 60-milligram multidose data with dosing every four and eight weeks and 90-milligram multidose data with dosing interval every eight weeks. Separately, data from the 90-milligram every 12 weeks in HBV negative subjects and the 90-milligram every eight weeks in HBV DNA positive subjects is expected in the second half of 2021. Now, we're very encouraged by the clinical results we've seen thus far with 729, as it demonstrates the inhibition of viral replication and reduction of all HBV antigens, including hepatitis B surface antigen.

As you know, reducing surface antigen is thought to be a key prerequisite to enable reawakening of a patient's immune system to respond to the virus. Therefore, our objective is to advance 729 into two additional proof-of-concept Phase II combination clinical trials with one or more approved or investigational agents in the second half of 2021 with dosing of 729 as infrequently as every eight or 12 weeks. Consistent with our belief that multi-drug combinations will be needed to achieve a functional cure for people with hepatitis B, I am pleased that Arbutus and Assembly Biosciences initiated in the first quarter, a Phase II proof-of-concept clinical trial to evaluate 729 in combination with Assembly lead capsid or core inhibitor candidate, Vebicorvir and an NrtI. Approximately 60 virologically suppressed subjects with HBV e-antigen, chronic HBV will be dosed for 48 weeks with 300 milligrams of Vebicorvir orally once-a-day and 60 milligrams of 729 subcutaneously every eight weeks, with a 48-week follow-up period.

Now, I'd like to turn to our HBV discovery programs, where we're making good progress in our research efforts for a next-generation oral HBV-specific RNA destabilizer, as well as a lead oral compound that inhibits PD-L1. So first, our oral RNA destabilizers have shown compelling antiviral effects in multiple HBV preclinical models. And we remain committed to this area of research. Arbutus is now focused on advancing a next-generation oral HBV-specific RNA destabilizer with distinct chemical scaffolds through lead optimization.

Arbutus also has compounds in lead optimization that are potentially capable of reawakening patients' HBV-specific immune response by inhibiting PD-L1. And we look forward to keeping you up-to-date on how these important research programs are progressing. Finally, to advance our efforts to identify a proprietary oral treatment for COVID and potential future coronavirus outbreaks, we recently announced an important Pan-Coronavirus Discovery Research and License Agreement with X-Chem and Proteros biostructures. Now, this collaboration brings together our own expertise in the discovery and development of antiviral agents with X-Chem's industry-leading DNA-Encoded Library technology and Proteros' protein sciences, biophysics and structural biology capabilities.

This collaboration will allow for the rapid screening of one of the largest small module libraries against Mpro, an essential protein for the coronavirus to replicate itself, and also use state-of-the-art structure guided methods to rapidly optimize Mpro inhibitors. So we look forward to keeping you updated on our pan-coronavirus discovery program as we progress throughout the year. And with that said, I'll now turn the call over to Dave Hastings for a brief financial update, and then we'll open up the call for our Q&A. As Pam mentioned, both Gaston and Mike Sofia are both on the call and can take any additional clinical and discovery questions.

So, over to you, Dave.

Dave Hastings -- Chief Financial Officer

Thanks, Bill, and good morning, everybody. As I've mentioned in the past, our key financial metric is cash and financial runway. Our ending cash, cash equivalents and short-term investments was $132 million as of March 31, 2021, as compared to approximately $123 million as of December 31, 2020. Our cash used from operations for the first quarter of 2021 was approximately $18 million, which was offset by approximately $26 million of net proceeds from the issuance of common shares under Arbutus's ATM program.

For 2021, we expect our cash use to range from $70 million to $75 million. And therefore, we expect our current cash runway is sufficient to fund operations through the third quarter of 2022. So with that, operator, would you please open the call for Q&A.

Questions & Answers:

Operator

[Operator instructions] Our first question coming from the line Ed Arce with H.C. Wainwright.

Ed Arce -- H.C. Wainwright -- Analyst

Just a couple for me. As most investors are eager to find out additional data on your next cohorts in the ongoing Phase Ia/Ib study of 729, wondering if you can tell us for the multi-dose data on the 60 and 90 that you're expecting, how many doses or number of weeks we can expect, given the cohorts both include patients that would be on every eight-week dosing. I was hoping to see at least 24 weeks out, if not more. Just wondering what we can expect later this quarter.

Bill Collier -- President and Chief Executive Officer

Yes. Good morning Ed, its Bill. Thank you very much for that great question. Yes.

I think as we've outlined in the past, we've been operating these cohorts very diligently during the COVID situation and really trying to make sure that we can work in areas where we can select patients and move them forward with full follow-up. So we're pleased with the progress that we've made. And I think we've also been cognizant that when we're looking at dose intervals of either four or eight or 12 weeks, we really do need to have a reasonable timeframe in terms of weeks and months to actually make sense of all the data. So we're closing in on that right now with some of the cohorts where we expect data later on this quarter.

But just with those comments, Gaston, if there's anything else that you would like to add?

Gaston Picchio -- Chief Development Officer -- Analyst

Yes. Hi Ed. Good morning. As Bill stated, we'll be hopefully sharing data on three cohorts.

And to your question, the range of weeks that we will be showing is probably depending what the remarks of Bill that we don't know until the last minute, but it's somewhere between 24 weeks to 48 weeks.

Ed Arce -- H.C. Wainwright -- Analyst

Excellent. OK. And then, I guess, the follow-up to this. And I know, Gaston, you mentioned this numerous times in the past, the importance of having sufficient data to fund or at least to predict a level of plateauing on the different doses.

Is this something that you're hoping to determine with this next data set?

Gaston Picchio -- Chief Development Officer -- Analyst

Well, I mean, I will be able to tell you that once we see the final data. But, yes, we were hoping that with at least 48 weeks of dosing, we will be able to get a better sense of how S-antigen and other HPV antigens are progressing over time.

Bill Collier -- President and Chief Executive Officer

Thank you, Ed. Thank you so much.

Operator

Our next question coming from the line of Kelechi Chikere with Jefferies. Your line is open.

Kelechi Chikere -- Jefferies -- Analyst

Yes. Good morning. Thank you for taking my questions. Just a couple on my end.

I was hoping, can you speak to the preliminary data you'll have for 836 in the second half? What will that be? And I guess, in the big picture, on what metrics are you hoping to see differentiation compared to the other capsid and core inhibitors in development? And I have a follow-up question after that.

Bill Collier -- President and Chief Executive Officer

OK. Good morning Kelly. Yes, I think in our corporate update, we've got the structure of the 836 Phase Ia/Ib study, so it's, I think, a fairly usual clinical structure with healthy volunteers and then single doses in HBV patients and then multiple doses. We are unlikely to get all of that data by the end of the year, but we do expect to have enough to give us confidence to move forward with 836.

So, again, I'll let Gaston add if you've got any further comments to make.

Gaston Picchio -- Chief Development Officer -- Analyst

Yes. So as it can be seen in the corporate deck, I believe its Slide 23 in the corporate deck, you can see the structure, the design of the 836-001 study that has three parts: single ascending, multiple sending and chronic hepatitis B subjects. The study has initiated, as we've stated before. And in the second half, I think, we'll have sufficient data already in chronic hepatitis B subjects provided everything continues as planned, to be able to move 836 forward in combinations.

I cannot give you any more specifics, because it's an ongoing study. Still, as you know, were impacted by the effects of COVID around the world. And, therefore, there's always a certain degree of uncertainty as to whether we can complete everything that we planned. But the study is ongoing and is on track.

Kelechi Chikere -- Jefferies -- Analyst

Thank you. That's very helpful, and that's a great segue to my next question. Just wondering if you can speak to enrollment in your various trials, the 836 study as well as the combo study with 729 and Assembly's core inhibitor. I guess, how is enrollment been going in? What steps have you implemented to ensure you're able to enroll patients in those studies, given everything that's going on?

Bill Collier -- President and Chief Executive Officer

Yes. Gaston, do you want to handle that one?

Gaston Picchio -- Chief Development Officer -- Analyst

Yes. Sorry, can you repeat the first part? were you talking about specifically about the 836 study? Or you were talking about AB-729 by itself or the combo study? I missed that part.

Kelechi Chikere -- Jefferies -- Analyst

Yes, both studies. So 729 combo study that was recently initiated with Assembly, as well as the 836 study that was just initiated. How is enrollment going there?

Gaston Picchio -- Chief Development Officer -- Analyst

Well, we haven't commented. And, obviously, we can't comment on that without our partners at this point in time. But I mean, our partner, Assembly in the combo study has done everything possible to really to speed up enrollment and ensure the timelines are met. So, so far, I mean, we haven't provided any additional guidance on enrollment other than I can reassure that every step has been taken to accelerate enrollment.

And as I said before, the 836 study it's on track and the 729-001 study actually it's fully enrolled, we're following the subjects now.

Bill Collier -- President and Chief Executive Officer

OK. Thank you very much Kelechi.

Operator

And our next question coming from the line of Brian Skorney with Baird.

Brian Skorney -- Baird -- Analyst

Good morning everyone. Thank you for taking the question. On 729, you've seen some really good reductions in S-antigen levels below thresholds that, at least in some Asian countries, it wouldn't be unusual to stop NUC therapy. And we sort of discussed the potential for evaluating what it would look like to take patients off all NUC therapy here.

Could you just speak to your current thinking there? Is that still something on the potential near or medium term horizon? And do you sort of have stopping criteria in mind to look at a value of eight patients off therapy?

Bill Collier -- President and Chief Executive Officer

Yes, Brian, thank you very much. Good question. I think our belief is that we need to get multiple drugs onboard before we start reaching criteria where we can start peeling some of those drugs away, so really understand the basis for the question. Gaston, do you want to comment further on?

Gaston Picchio -- Chief Development Officer -- Analyst

Yes, sure. Thank you. Thanks for the question. So we continue to consider the multiple options that there are in terms of stopping criteria.

Also, those need to be aligned with the recommendations from regulatory agencies around the world, including, obviously, the FDA. So at this point in time, we haven't stopped anyone, and that it's always a possibility. But we haven't done that. Certainly, we continue to consider the 100 IU per ml threshold for service antigen.

The question, I think, that remains is how long that sustained decrease in S-antigen needs to persist before you consider whether stopping the investigational drugs or stopping all therapies, so that would be the NUC. So I mean, we continue to consider multiple options. I think there's no single way of stopping patients right now. Everyone has a different opinion on how it should be done in a safe way.

And, obviously, safety is we're driving force there, just make sure that we don't do anything that results unsafe for the patients.

Operator

Thank you. [Operator instructions] Our next question coming from the line of Roy Buchanan with JMP Securities. Your line is open.

Roy Buchanan -- JMP Securities -- Analyst

Great. Thanks for taking the question. So the first one I wanted to ask about the collaboration, you guys recently announced for SARS-CoV-2 with X-Chem and Proteros. It seems like the DNA-encoded library is kind of a burgeoning space.

I just wondered if you could speak a little bit more in detail about what makes X-Chem's approach industry-leading, how it's differentiated from other libraries? And then I had a financial question for Dave.

Bill Collier -- President and Chief Executive Officer

Yes. OK. So on the X-Chem, Proteros deal, maybe Mike Sofia, so you take that one?

Mike Sofia -- Chief Scientific Officer

Sure. So as we sort of scour the landscape for sort of DEL screening technology, DNA-encoded library technology companies to evaluate who we wanted to partner with. And really X-Chem stood out among all of them, not only because we felt that their expertise was industry leading, they clearly have demonstrated through many, many collaborations they've had with other pharma partners the ability to deliver using their libraries. They probably also have the largest library set out there in the DNA-encoded library arena, including multiple different kinds of libraries that would include both reversible, as well as covalent attachment libraries that we were interested in.

So, overall, we thought that from their level of expertise, their track record that they were the ideal partner to move forward with here. They also had this strategic relationship with Proteros and because Mpro is a nonstructural protein. Its structure is known. It provided a real ideal target to use structured biology, biophysical methods to guide subsequent structure-activity relationship studies and lead optimization studies that we were going to do.

So when you look at the whole package together, it brings together the three companies with really industry-leading expertise and capability to tackle this target and buying new chemical matter that we hope will ultimately lead to clinical candidates that will benefit patients.

Roy Buchanan -- JMP Securities -- Analyst

OK. Great. That's helpful. I mean, just any idea on timing from that partnership for when we could see the first results?

Bill Collier -- President and Chief Executive Officer

Well, obviously, we all agree that the coronavirus issue is front and center on everyone's mind globally. We are driving this as aggressively as we possibly can. And our partners know that. They're fully committed.

This is really a collaboration. It's not a typical CRO relationship. So we hope to have something sooner rather than later, but it's a little early to comment on that right now.

Roy Buchanan -- JMP Securities -- Analyst

Yes. Great. OK. Thank you.

And then just a quick one for Dave, has there been any ATM use since the end of the first quarter? Thanks.

Dave Hastings -- Chief Financial Officer

Yes, Hi Roy. So our typical policy is to disclose ATM sales through sort of the end of the prior quarter. So we'll update everybody on next call for the ATM activity this quarter, Roy.

Roy Buchanan -- JMP Securities -- Analyst

Thank you.

Operator

Our next question coming from line of Mayank Mamtani with B. Riley Securities. Your line is open.

Mayank Mamtani -- B. Riley Securities -- Analyst

Good morning Dave. Thanks for taking my questions. Yes. So on the Assembly trial, if I could clarify, I believe you're starting with the 60 mg dose.

So could you maybe talk about the 90 mg data that you continue to generate? And what, if any, implications you could have to the protocol as you think about balancing S-antigen reduction and maybe safety?

Bill Collier -- President and Chief Executive Officer

Hey, thank you very much for the question. Good morning to you. The Assembly collaboration trial, we've set that dosage for 729 at 60 milligrams every eight weeks. But as you know, we're continuing to look at 90 milligram, eight and 12 weeks, which would potentially allow us to look at that dosage, dependent upon the data in our other Phase II studies.

But, again, Gaston thoughts?

Gaston Picchio -- Chief Development Officer -- Analyst

Yes. Hi. Good morning, Mayank. We felt comfortable with the 60 milligram every eight-week dosing schedule to initiate the collaboration with Assembly, and that's how that study is moving forward.

We don't anticipate having to make any changes to the ongoing study, but that doesn't preclude us from opening other cohorts within this collaboration at different doses or different dosing schedules. But just to be clear that the ongoing study its 60 milligrams every eight weeks.

Mayank Mamtani -- B. Riley Securities -- Analyst

Got it. And sorry, if I missed this on 836. As you're thinking about just longer-term developing this agent and maybe sort of differentiating on the enhanced resistance profile that you have good preclinical data. How, if at all, this program could be developed maybe differently than how current programs are going, combination based RNA plus core capsid? Any insights there beyond 2021?

Bill Collier -- President and Chief Executive Officer

Yes. Mike Sofia, do you want to just talk briefly about what we've shared on the resistance front.

Mike Sofia -- Chief Scientific Officer

Sure, Bill. So yes, I think when you look at 836, it has a number of different differentiating characteristics, right? One is the resistance profile that addresses a number of the emerging resistance issues in the capsid field. The other issue is related to the sort of second mechanism, right. That being able to engage the second mechanism in a clinically relevant dose, which we believe 836 is going to be able to do.

Now with that characteristic, we have the potential of seeing some differentiating profile when we put it in combination with 729. But, I think, everyone should understand that our objective in this combination strategy is ultimately to do the three things that we've said from day one, which is shut down viral replication, which capsid plus NUC will achieve; start the DNA pool with hopefully the capsid will also achieve in association with, I think, our RNAi. And then with the RNAi agent, knocking down the S-antigen to help to reinvigorate the immune system. The other piece of the puzzle here really is the immune modulation piece, which, as Bill had mentioned, we're very excited about our PD-L1 program, which is really maturing very nicely.

And we hope to see great things out of it. And bringing that together does round out the whole picture and strategy that we've been sort of discussing for a number of years now. And so, when you look at our capsid asset, it does have differentiating profile from other competitor compounds, but is a central part of the overall strategy that we set out several years ago.

Mayank Mamtani -- B. Riley Securities -- Analyst

Great. Thanks. Thank you for the comprehensive answer and maybe just if I can squeeze one in for Dave on the IP situation with Moderna. At least from public filings from Moderna it seems like they are taking a relatively different approach from before.

Anything you guys can comment from your end or from Genevant's perspective that gives any color on the lawsuit or the possibility of settlement?

Dave Hastings -- Chief Financial Officer

Well No. We can't comment. We would not lead that effort, Genevant would. But I would say, look, we take our IP very seriously but in terms of sort of the play-by-play with the interactions of the companies, we can't comment on that.

Mayank Mamtani -- B. Riley Securities -- Analyst

Understood. Thanks for taking our questions.

Bill Collier -- President and Chief Executive Officer

Thanks so much Mayank.

Operator

I'm showing no further questions at this time. I would like to turn the call back over to Mr. Bill Collier for any closing remarks.

Bill Collier -- President and Chief Executive Officer

Well, thank you very much for all of your questions and for joining us this morning. We really do appreciate your interest in the company. We look forward to a productive and value building 2021. And I think as you've just heard, we're confident that with further data from our 729 clinical trial, progression of the 729 compound into two Phase II proof-of-concept clinical trials, data from our 836 Phase Ia/Ib clinical trial and continued progress in our HBV discovery programs, that we really have established a strong foundation on our mission to achieve a functional cure for people with chronic HBV.

And also, obviously, looking forward to leveraging our antiviral discovery and research efforts in progressing our pan-coronavirus discovery program. So again, thank you for your interest. And operator, that concludes our call. Thank you.

Operator

[Operator signoff]

Duration: 38 minutes

Call participants:

Pam Murphy -- Investor Relations Consultant

Bill Collier -- President and Chief Executive Officer

Dave Hastings -- Chief Financial Officer

Ed Arce -- H.C. Wainwright -- Analyst

Gaston Picchio -- Chief Development Officer -- Analyst

Kelechi Chikere -- Jefferies -- Analyst

Brian Skorney -- Baird -- Analyst

Roy Buchanan -- JMP Securities -- Analyst

Mike Sofia -- Chief Scientific Officer

Mayank Mamtani -- B. Riley Securities -- Analyst

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