Q4 2020 Arbutus Biopharma Corp Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the R. Beauty's.
Biopharma Corporation fourth quarter and year end, 'twenty 'twenty financial results and corporate update conference call.
At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you will need to press star one on your telephone. Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero and I would now like day on the conference over to your speaker.
Today Pam Murphy. Thank you. Please go ahead Madam.
Good morning, and thank you for joining the army and its Biopharma fourth quarter, 2000, and 'twenty conference call and webcast.
On the call today are Bill Collier, President and Chief Executive Officer, Dr. Got still on PCL, Chief Development Officer, Dr. Michael Sofia, Chief Scientific Officer, and day in Hastings, Chief Financial Officer.
Bill will begin with a summary of recent accomplishments and upcoming events and a review and Harvey adjusted 2021 corporate objective.
So I'll, let Mike and John Mike Sofia, and Dave Hastings, who will provide clinical drug discovery and financial updates respectively.
Please note that Don will be using a few clinical slides, which can be viewed on the webcast.
After the Speakers' without and open up the call for Q&A before we begin we'd like to remind you that some other statements made during the call today are forward looking statements, including statements regarding expectations timelines and clinical results.
There are beautiful proprietary HBV pipeline and COVID-19, preclinical research effort.
The company's 2021 objective it and they expect that expected cash use and cash runway.
These forward looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ 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.
I would now like to turn the call over to Bill.
Thank you Pam and good morning, everybody. Thank you for joining us today.
As I approach my two year anniversary with Arbutus, So I'd like to use the next few minutes to summarize the progress we have made and why I believe that arbutus is well positioned to execute on our mission to develop its share for people with chronic hepatitis b.
And as well as advanced new proprietary therapies to treat Corona viruses.
First of all of the guests on pizza will describe in more detail on <unk>.
<unk> product a b seven to nine a subcutaneously delivered on a Oh I age and has demonstrated the potential to be a cornerstone drug and future HBV combination regiments.
We've reported in 2020, a significant body of compelling safety and efficacy data from an ongoing phase one a one b clinical trial.
This data strongly supports our plans to initiate two phase III trials for 17 on in combination with one or more approved or investigational agents and the second half of 2021.
In addition, Arbutus and assembly have initiated screening of a proof of concept phase two clinical trial, combining seventy-nine with assembly biosciences capsid inhibitor that'd be cool them and nucleoside reverse transcriptase inhibitor.
Secondly.
We've completed the Ind's Cta, enabling studies for a B 836 on next generation oral capsid inhibitor.
806 is from a novel Chemical series, which we believe is differentiated from competitor compounds and offers the potential for increased efficacy.
And and enhance resistance profile.
We expect to begin the phase one a one b clinical trials for 836 in the first half book.
On to 'twenty one.
Thirdly, as Mike Sofia will describe we have a number of active drug discovery efforts and the HBV field as.
As well as discovery efforts and the potential oral therapies to treat corona viruses.
Given our experienced chemistry, and biology teams and the investments, we're making in the oral PDL, one inhibitor and RNA Destabilizer programs. We believe these programs have the potential to lead to future proprietary combination regimens to treat HBV.
So the more we're confident that the proven expertise and virology that resides within our discovery team could lead to new oral therapies to treat corona viruses.
And finally as Dave Hastings will describe in a moment, we have a solid financial position with a cash runway now extends through the third quarter of 'twenty 'twenty two and.
Our demonstrated track record of efficiently raising capital.
So with that let me now turn the call over to guests on PQ, Our Chief Development Officer Gusto.
Thanks, Bill and good morning to everyone.
Today I will focus on my time on describing our current perspectives on a day seven to nine on our 'twenty 'twenty, one plans and objectives are.
As it relates to our lead clinical asset.
And as part of my discussion today I will refer to a few slides that are available as part of our webcast and can also be found in our current corporate presentation located on the our beauty was a website.
First let me reiterate build confidence in the growing clinical data that has already emerged from our ongoing phase one day, one be clinical trials for 87 Tonight.
Now you can see in the first.
First line the design of our phase one day, one be single and multi dose clinical trial on the current status of the cohorts that have been completed and reported and <unk>.
These are in on dark red and.
Dark blue.
Notably these from presents a significant dataset and allow us to begin to put in perspective, the potential of this drug which I will address momentarily.
We expect to report additional data from the ongoing cohorts from this trial and the first half of 2021.
Except for the 90 milligram every four week cohort, which is expected in the second half.
Our 2021.
In the next slide number six you can see.
And a single dose and maybe seven to nine provided impressive and comparable mean S antigen declines and withdrawals across all three doses, namely 60, 90 and 180 milligrams.
Yeah.
Moving to slide number seven.
Importantly.
As demonstrated repeat 60 milligram dosing of 87 and benign every four weeks were solid and continuous mean S antigen declines beyond week 12.
Now as the next slide shows repeat dosing using 60 milligrams.
Eight weeks were solid and comparable mean S antigen declines relative to the 60 milligram dose every four weeks at week 16.
With minus 1.8.
And seven low and <unk>.
<unk> is minus one point and 44 and walk them.
Moving to the next slide number nine you can see that in HBV DNA posted and chronic and provide these subjects. A single 90 milligram 87 to nine dose resulted in a robust mean S antigen decline.
Of minus 1.0 to locked in.
Miller to what.
Has been seeing in HBV DNA undetectable subjects.
Notably HBV DNA also decline at week 12, with a mean decline of minus 153 locked in as.
And as well as HBV, RNA and correlated antigen, which are not shown here. So.
Supporting complete target engagement my AVP seven to nine.
Finally.
Slide number 10.
87 to nine continues to be safe and well tolerated, we have not seen any treatment emerging grade three four adverse events or discontinuation in any cohorts to date.
And cohort two.
And two subjects had a symptomatic a L elevations one subjects with a history of great one L elevations prior to trial and entry.
Trunks and great to elevation, which evolved back to grade one.
While another subject and the Trumpf and grade one and the nation.
Further and cohort E.
The two subjects per previously reported with great too and.
And two subjects with great one L elevations have improved to grade one and grade Bureau, respectively.
The week 24.
All seven subjects and the courts have consented to continue dosing with 87 benign for an additional six months.
So stepping back with the totality of data we have seen thus far we believe a day seven to nine can serve a vital role in our future preparatory combination regimens, both in lowering HBV replication and and.
And you and concentrations.
Not only that 87% to nine provide on efficacy and safety profile and competitive with other programs, but also potentially represents a competitive advantage in frequency of dosing.
This gives me great confidence and our plans to aggressively advance 87 to 19 to several phase two trials this year.
We plan on initiating two phase two combination and throws with one or more approved or investigational agents in the second half of this year.
In addition, we have initiated screening and our phase two clinical trial and combining 80 Sevens on line with Assembly Biosciences leap or.
Inhibitor also known as <unk> capsid inhibitor <unk> per barrel.
This proof of concept trial is a randomized multi center open label Phase two clinical trial that will explore the safety pharmacokinetics and antiviral activity of the Triple combination of 87 to nine <unk> and <unk> and RTI compared to the double combinations.
W career with him and RTI and.
87 to nine and now RTI.
This trial is expected to enroll approximately 60 virological suppressed patients with chronic HBV infection.
So with that I turn the call over to Mike Mike.
Thanks, just on and good morning, everybody and <unk>.
To briefly review, our drug discovery objectives and strategies as we progressed on the HBV and coronavirus research fronts.
As you know we are focused on developing proprietary combination regimens that have a powered functionally cure people with HBV.
We have progressed compounds into development that targets two critical pieces of our strategy.
Stopping bar replication and reduced S antigen levels.
The other pillar of our strategy and vision is addressing the immune component of the disease.
To that and we believe our oral PD L. One program has the potential to reawaken, the immune system and HBV patients.
Highly functional HBV specific T cells within our immune system are believed to be required for long term and HBV borrow road resolution.
However, HBV specific T cells become functionally defective and greatly reduced and their frequency to and chronic HBV infection.
One approach to boost HBV specific T cells and the target the PDL one PD one axis to release the brakes on the immune system and lead to removal of infected hepatocytes.
We are in lead optimization with oral compounds, which are potentially capable of reawakening patients' HBV specific immune response by inhibiting PD L. One interactions.
In addition, we believe that on an all oral proprietary combination of agents for millions and objective for us.
We continue to optimize HBV RNA destabilizer, let our small molecule orally available agents the quality of these stabilization and ultimate degradation of HBV Rnas.
Currently we are advancing several promising next generation all HBV RNA destabilizer through lead optimization and candidate selection.
Finally, we believe it is important to leverage our virology expertise and the battle against Corona viruses.
Our effort is focused on the discovery and development of new molecular entities that address specific viral targets, including the NSP 12 viral polymerase and the NSP five viral protease. These.
These targets are essentially.
Central borrow proteins, which have the potential for delivering pan coronavirus therapies, and which are beautiful has experience and targeted.
And as all of you know predicting hard and fast timelines and drug discovery is not possible.
Therefore, we are not yet giving specific guidance regarding when we will nominate lead candidates and these three areas.
That said, we are a capable and experienced drug discovery team and I look forward to updating you on our progress throughout the year.
With that I'll turn the call over to day.
Thanks, Mike Good morning, everybody.
R&D and cash cash equivalents and short term investments was approximately $123 million.
As of December 31, 2020, compared to approximately $91 million.
As of December 31, 2019.
Our cash used from operations for the year ended December 31, 2020 was approximately $51 million.
And we made it and a half million dollars equity investment and general mass in July.
These cash outflows.
Were offset by approximately $86 million of net proceeds.
From the issuance of common shares under and Dr. Beautiful ATM program.
Additionally, thus far during the first quarter of 'twenty and 2021.
We have received $24 million of net proceeds from our ATM program.
We expect our net cash burn of between 70 and $75 million in 2020, one and therefore, we believe our cash runway now extends through the third quarter of 2022.
Finally, as a reminder, our <unk> owns approximately 16% of the common equity of <unk>.
And then event Sciences company are viewed as launch with volume and Sciences and.
And which are beautiful license exclusive rights to its LNP delivery technologies for RNA based applications outside of HBV.
We are entitled to receive tiered low single digit royalties on interest sales of generative and products covered by the license patents.
If gen event sub licenses the intellectual property license by us to gender balance.
We are entitled to receive upon the commercialization of a product developed by such Sublicensee and.
And the lesser of 20 per cent of the revenue received by gender and for such sub licensing and tiered low single digit royalties on product sales by the sub licensee.
So with that Bill I'll turn the call back to you.
Alright, Thank you, Dave and two gas, Don and Mike and I think at this point operator can you. Please open up the lines for questions and answers. Please.
As a reminder, if you would like to ask a question. Please press star one on your telephone to withdraw your question press the pound or hash key.
And your first question comes.
And from Ed Arce with H C Wainwright.
Great Good morning, and thanks for taking my questions.
Gross on a productive year.
Couple of questions for me you.
You mentioned with seven to nine.
Two trials that you're intending to start I think you said and the second half of the year sort of combination trials I'm wondering if you could give us a little more detail on the.
The intended design with those.
In particular have you chosen one or more doses, perhaps the 60 or 90 milligram.
And I view.
And at least and one of those committed to a dosing interval I know that you are very interested and going with once every 12 weeks.
And any other sort of details around the trial designs there would be helpful. Thank you.
Thank you for the question Ed.
Just a couple of comments and then I'll, let guests don't answer with any additional detail them and I think what we're trying to communicate today is on our confidence and 79 going forward were in total we will kick off three phase two studies. This year. The first one obviously being the assembly Ah study, which has and.
<unk>, we did that press release last week and then today, we're talking about an additional two phase two combination study, we've not released too much detail.
About those.
Sage.
But I think you can see that by kicking off three phase II studies, we clearly feel very confident about 17 on moving forward and with that.
Let me hand, it over to guest on.
Yeah, Thanks, Bill and thanks for the question.
As Bill explained we have and where these the details at this point of what those are two additional phase II studies may look like.
So, but obviously we are exploring.
Potential combinations with both our investigation on another approved agents.
And on the obviously try to exceed.
The number of trucks there Bob.
And by tools. So we were looking at.
Three or more drugs and in those studies.
In terms of the dose and schedule is.
You may already know.
We are confident enough based on the data that we presented towards the end of last year to use the every eight weeks in the phase II and collaborations with assembly. So.
I'd just reiterate what was included in.
In the press release announced recently by Assembly on the start of the screening other study.
The dose and there'll be maybe seven to nine would include the 60 milligram dose dose every eight weeks. So we're waiting obviously for the results of the on.
Other.
Cohorts, especially the every 12 weeks to decide whether it makes it also worth exploring a dosing frequency of every.
And every 12, but that's that they day spending.
Great.
That's helpful. And then just one other question from me.
Just to remind us for this year are you expecting to release any new data.
Data.
Our results from any any ongoing studies.
Yes. So this is this is bill.
And I will refer everyone to the last slide and all corporate deck, which was <unk>.
Refreshed and updated as on our website went up this morning.
But there we list out.
What we expect to deliver this year so we're talking.
About additional data from the 60 milligram multi dose cohorts every four and every eight weeks and the first half.
Additional data from the 90 milligram multi dose eight week cohort and the first half.
The 90 milligram 12 week data and the second half.
We also expect to have some 90 milligram.
Sure.
On multi dose eight week dosing interval and HBV DNA positive subjects and the first half.
I've already mentioned the two phase two clinical studies, we hope to kick off and the second half.
And then as we already mentioned on this call we expect to kick off the 836 phase one a one big clinical study and the first half of the year.
Great. Thank you Bill it sounds like you have on your hands full this year with a lot of clinical actor activity.
Thank you again for the question.
Alright.
Our price or do we have additional questions.
Your next question comes from Brian <unk> with Baird.
Hey, good morning, everyone and thank you for taking my questions.
And I guess more of a big picture of long term question on on 72, nine and I mean, we have a pretty good.
In terms of.
Early data and the impact that RNA interference.
And you can have on on some other biomarkers, but I'm just trying to think about long term development plan and you know what sort of data would you be looking to achieve on a biomarker basis to challenge patients to complete antiviral therapy withdrawal and.
And and I mean, what sort of stopping criteria do you think are reasonable.
We use.
A good question. Thank you very much and may.
Maybe Mike and Gaston on guest on first perhaps two to answer that one and.
We're talking hypothetically, a because we have no plans at the moment too to get into this but gusto.
Yes.
Thank you Brian.
In terms of let me just go to the.
Summarize what we've seen with RNA I, so far so I think our and eyes.
And have been shown to obviously lower S antigen.
And also HBV RNA.
Correlated antigen E antigen and I think we probably house one of the most robust data showing.
That seven to nine and also reduce HBV DNA in a very robust and rapid way.
And.
And the Big question I mean, obviously is going to be.
Shall we continue treating and wait until S antigen becomes undetectable or can we before considering stop and patients or could we still patients earlier.
And and see whether on the immune system.
As a sufficiently reawaken to continue that job and unclear on S antigen, and obviously infected by the size and so forth.
And that's a question and obviously that that other.
And think anyone has answers so far.
What is clear on based on the Assembly study that stopping patients with undetectable HBV RNA and HBV DNA, even with a more sensitive assay was not sufficient to achieve functional cure define us and also.
And in six months out there and the therapy.
And so relapse very quickly.
So in that then.
Obviously that study did not include on RNA agent.
And and lowering our standards and May.
Favourably impact the immune system and such a way that upon stopping therapy, how things may look a little bit different but.
And really this is all speculation because nobody has stopped.
All therapies and RNA eye subjects and see.
Sure.
Long and dosing period of at least a year in.
And in combination with other agents and see what happens so.
And we may be and Apple decision to do that later this year and in some of them were cohorts and see what to turn nowadays.
And I can give you on other things.
The balance of what's going to happen, but certainly that's one of the most important questions and the field right now.
Great. Thank you and.
And guest on do you want to just briefly mentioned because on our corporate deck on the slides, we do show how many subjects get below <unk>.
Either 100, or 10 international units per ml for surface antigen, usually on the comment on.
On those numbers.
Yeah. So.
That's a great point.
And as you know in some countries in Asia, especially there's a tendency for subjects, who have being on on nuc therapy from a number of years either S. Andes and drops below a 100, so actually stopped and oak and follow them very closely.
And in some locations the subjects, so achieved less than 100, which is a threshold.
Use I would say clinical and most frequently they tend to.
Zero converts on S antigen and some of them even on the U S.
And when people all of these which is for the conditional functional cure.
And in our studies.
Now we have pretty much so far.
The vast majority like.
Seven.
Six out of seven have reached less and 100.
In cohort E and.
Even a couple of them have reached lift on 10.
So the big question is.
And the setting.
One year of duration on therapy is that going to be sufficient. So these are questions on obviously, where we're trying to do.
And the site whether.
Achieving S antigen and below those thresholds, which have shown in other instances to be clinically relevant and would they be equal you'd rather than towards function and the cure when using RNA I agents on this case 87 and Tonight.
So this is still evolving wearable being I, we're thinking and trying to decide what would be the best approach to stocking therapy in patients who have received at least one euro VI AB seven benign combination with unknown.
And those are sort of encouraging pieces of information.
A large proportion of the subjects that were ready to cross the 100 IU per ml trustco.
Alright, thank you.
Your next question comes from Mike men, Tammy with Brian Lee.
Thanks, Steve for taking my question and from that on the progress so maybe on the.
The same line of thinking on the Triple therapy.
Just two things stood out to me that you are doing and open label study and also the number of subjects 60.
And looking at other trials.
From.
So I'm just curious how you think about data disclosures.
And again, the off treatment and an eight.
And.
And that's specifically yard program, but also like as we look at stuff.
There are different approaches and the colt outfit and limited abroad, and the immuno modulator and approach.
Can you comment Blake just at a high level.
Next day one.
And one versus the other your confidence level and just given like the challenging off treatment rates, we've seen so far.
Yes. Thank you for the question and I think you started just by making reference to the clinical collaboration with Assembly and you correctly pointed out that that's a phase two study with 60.
Virological suppressed subjects with HPV and.
And essentially it.
And is comparing the triple seven to nine plus that'd be cool there plus a nuc the sales.
<unk> 17, nine plus a nuc vs that'd be COVID-19 plus a nuc.
The only thing that we have communicated with our partners Assembly on that is that the study has started and that was the press release last week.
We've not indicated when we will have data available from from that study.
Although it is on open label study so.
We will be able to.
Progress as we go.
As to the second part of your question.
Gaston and I can throw that to you.
Yeah, So so high and Mac.
It's difficult to say because.
To be absolutely.
Absolutely honest, we're not sure what the.
The details of other studies are I mean, I can just reiterate.
And what our study in collaboration with Assembly is going to be looking at.
So basically we're looking at E antigen negative subjects, who are being suppressed for at least six months.
And with no therapy, and theyre going to be a rolling into randomized into three different arms. So obviously there are two arms would function as controls.
And there's a third arm, which is the exciting arm, which is the combination on the three agents. So.
As to exactly the differences with the other study.
Studies that may be looking at similar but not identical approaches.
And I can't really comment because I don't know the details behind their more dealers on what you can find in clinical trials of coal so on.
I think it's always important.
And these based on my experience. This despite the fact that there is a reiteration of the mechanisms of action.
I think at least ive learned over the years that it's always important to see what day.
And assets within a glass and can provide so I.
I wouldn't discount the fact that we are testing three drugs and other.
Companies, maybe testing has.
As a less exciting because I think we've seen some interesting.
Data coming out of those seven and benign and.
And also maybe progress is being well established and in further suppressing HBV DNA and P. G. RNA. So the combination of those three and the population that we selected May may play out differently than in other regimen and so I think we have to wait for the results and from short.
Understood and then just two more quick follow ups.
And one another.
The other day.
Any color you can provide on day in July and be in and just high level, what widen and cannot be used and cancel for example.
And five notes.
And wanted to oncology.
Mike do you want to take that one.
Yes, Hi, Mike.
And so so look we've made great progress on that program and time.
Very excited and optimistic about.
Achieving a clinical candidate nomination and the foreseeable future.
And.
And.
No as I've said from.
On the discovery.
It's hard to give a specific time lines, we want to make sure. We bring forward the very best compounds and we're clearly doing on.
And all the relevant studies that need to be done and those need to be done before I think works, we're comfortable saying we have the candidate that's going to go into the clinic.
And give any guidance there.
On the cancer issue look we're fully aware of the potential for an agent like a PD L. One.
Inhibitor and <unk>.
Other therapeutic areas specifically cancer.
And.
I think we will look at all options on how to exploit.
And these other areas.
And the future, but right now we're really focused on hepatitis b.
Applications for.
For these for these PD one inhibitors.
And thank you for that color and and lost me on the June one and will do.
And litigation continue and just remind us what the next steps on the Apio and <unk>.
Decision that was in July last year.
And what should we watch out for next.
Yeah, Let me, let me tackle that one and then Dave you can chime in with any additional color as well, but you're referring back to the.
The patent case that was announced last year weather was a challenge against one of our Arbutus patents.
And was founded in our favor.
And I think as we've described at the time and subsequently and all various listings that patent is one of those that has been licensed out to Gen event, which Dave described in his comments this morning.
And so unfortunately, it's really not possible for us at Arbutus to comment on what Jennifer may or may not be doing.
Suffice to say that as part of that licensing arrangement.
We've got some very clear terms for any sub licensing that Jennifer on May do which is what Dave summarized and he's in his comments.
So I think that that's about all we can say, Dave unless there's any other additional comments you can think of.
I think you've covered it bill thanks.
Okay great.
Thank you.
Alrighty.
Your next question comes from Caliche Chicken <unk> with Jefferies.
And good luck. Thank you, yes, good morning, and thank you for taking my question.
And I guess and it's fixed.
And the two phase II combo study slated to start later this year can I ask you to speculate on what are some of the investigational or approved each insurer thinking you could potentially pair with 79 I think we're all aware of interferon maybe something on what are some of the other H I should think about any color there would be great. Thank you.
Yeah, Good question and.
And I can say that we want these three studies to be somewhat different.
So that we're exploring different combinations going forward.
I mean, clearly we we have not said today, what those compounds are going to be or.
It could be we've just said by the bulk data on investigational.
And.
And I think the best way to answer that is with reference to our overall hypothesis.
We want to be able to suppress DNA, we want to be able to suppress surface on to Jim <unk>.
And we wanted to be able to boost the immune system. That's all that's all muddle on Australia GE here at Arbutus for you know the way, we can try and construct.
A combination therapy two to achieve this functional cure for hepatitis B.
I think that's about all we can say at the moment so.
Our guest on anything you want to add.
No. Thank you I mean, I think that as you pointed out is how much we can say, but again just reiterate our thinking.
Which is the importance of first low worrying S antigen too.
To give the immune system Houston different approaches as bill outlined to reawaken and and continue on.
The job of clearing and fact that deposit size and we really believe that that lowering of S. Antigen and this is critical to achieve that goal on functional cure.
And then the intervening with other modalities and after that did achieve so keeping that might not be and you can you can imagine.
No.
And with the different modalities and worked on SEDAR.
Got it got it that's helpful. Thank you.
Your next question comes from Roy Buchanan with JMP Securities.
And thanks for taking the question just a quick one sorry, if I missed this but any and.
Additional details and the RNA Destabilizer you can provide and then are you targeting HBV RNA itself are you targeting a host protein and he added.
She'll details thanks.
Hi, Mike Sofia High ROI.
So so we've actually described pretty extensively.
Some of the mechanistic.
Features of how the molecules that we are working with work.
And if they do specifically target HBV RNA and.
And they targeted.
Via a mechanism.
And that engages a host protein that's critical for stabilizing the HBV RNA.
A tale.
And.
And so and so by and.
Inhibiting that host protein.
Interaction with a complex associated with HBV RNA the PR.
And the region of HBV RNA, we're able to destabilize the HBV RNA and.
Lead to the degradation on the poly, a tail, where truncating, a poly and tail and ultimately lead to the degradation of HBV RNA.
So it is HBV RNA targeting.
On.
Modality, but it goes by and a host protein that's critical for maintaining the stability of HBV RNA.
Okay, great. Thank you.
Your next question comes from key and the Kay.
With Chardan.
Yeah. Thanks.
So with the upcoming data.
From the.
60 milligram.
Multi dose and eight week intervals and the 90 at eight and 12 week intervals.
Can you just tee up for us.
How many doses you expect to report on and each of those.
Cohorts.
Yes.
So maybe you can take that one.
I don't want to be value.
In the sense that.
And we haven't released back in on guidance.
But you know some of those cohorts have been ongoing for quite some time.
I think we just need to make sure that we have.
And effective on a realistic time frame.
And to comment on so on.
That all on meeting is that and if you give something monthly then within six months, you've got six doses, but did you give something every 12 weeks.
Within that same timeframe, you've got many fewer doses. So we just want to make sure that we've got.
And appropriate number of doses to comment on.
Gastar anything else you want to add.
Well I mean.
Let me just I.
I mean, our cheerleader question and again I mean, how many doses we're planning to report for both.
The 60 milligram every four and 60 milligram every eight weeks.
As we pointed out on our guidance, so I mean without counting the doses.
And the goal would be to be able to report.
And on therapy.
And for both.
So 48 weeks of treatment.
Okay. Yeah. That's helpful. Because you know at some point your <unk>.
You're making the decision of when when the math is enough and your reporting and so.
That's simply what we're looking for is really how far out do you want to go before you report.
That would be the goal to reported and a therapy.
And then obviously.
Pending a decision around as we were discussing earlier and decisions around who who can and cannot stop.
Later on and report on basically what happens off therapy, and those that may qualify for Scott.
And that would be the structure, let's say of the.
Every cohort that we're doing right now on the and the phase <unk> study.
So just to reiterate that.
The study was a reason on the mental and have a six months of duration in terms of dosing with the different doses and dose and frequencies.
The study was amended and such a way that patients from reaching the end of the six months can re consented, they decide and investigator and besides the warrants.
Continuation from a national six months, so that makes it basically a total of 48 weeks and then after that decision.
A decision will have to major and gotten and scoping either stopping completely all therapy course pumping just seven to nine and remaining on the zone.
So from.
As all of these.
Cohorts mature and they progress.
Specifically to your question per cohort.
Being the 60 every four and 60 every eight the next goal would be to be able to report and the therapy.
Okay.
That's helpful.
Yeah, because you had pushed out the expected reporting of the 90 at 12 weeks. So just trying to understand what's behind that thinking.
Yeah, Okay. It's not so much that I think we pushed that out that was one of the later cohorts stopped.
Taken longer to get through.
Okay.
Thanks.
And showing no further questions at this time I would now like to turn the conference back to Bill Collier.
Thank you very much and thank you all for your questions just to close out I'll quickly.
Quickly review once again, the key objectives for the company for 2021.
So as you've heard on this call we've already initiated the phase two combination clinical trial to evaluate and seven to nine and combination with the assembly biosciences call or capsid inhibitor that'd be COVID-19 and a nucleoside reverse transcriptase inhibitor.
Secondly, we also expect to provide additional data from ongoing cohorts of the phase one a one b clinical trial of seven to nine and the first half of 2021.
And as we also just mentioned the net.
90 milligram every 12 week cohort will actually be.
And we expected and the second half of this year.
We're also excited and expect to initiate two phase two combination clinical trials and HBV subjects include.
Including seven to nine with one or more approved or investigational agents.
And again, that's slated for the second half of 2021 and.
And we also expect to initiate a phase one a one b clinical trial of <unk> hundred six on next generation capsid inhibitor.
And the first half from 2021, so what I'd like to close out by thanking all of the staff at Arbutus.
But importantly, this morning, all of you for joining us today, and we look forward to sharing our progress throughout the coming year. So thank you very much and operator that concludes our call.
Yeah.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
Presenters please hold.
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