Q1 2021 Arbutus Biopharma Corp Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to Arbutus Biopharma. The Corporation 2021 first quarter financial results and corporate update conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask the question. During the session you will need to be.
The Star then the one key on you touched on the telephone. Please be advised that today's conference is being recorded if you would call operating assistance. Please press Star then zero I would now like to hand, the conference of let you speak of host today Pat Murphy. Please go ahead.
Thank you and good morning on the.
The call from the our beauty executive team or they'll call York, President and Chief Executive Officer, Dave Hastings, Chief Financial Officer Doctor guest on PCI, The Chief Development Officer, and Dr. Mike Sofia, Chief Scientific Officer.
Bill will begin with a review of the first quarter's accomplishments clinical development.
<unk> 2021, corporate objectives, followed by Dave Hastings, who will provide a review of the company's first quarter financial results.
We will then open up the call for Q&A.
I guess time 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.
There are beautiful proprietary HBV pipeline and Pan Corona virus discovery program, including potential clinical results and timelines for a b 729, and a b a three six and any future compounds.
Our expected cash use of cash runway and the potential for our drug candidates to improve upon the 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.
Thank you Pam and good morning, everybody. Thank you for joining US today, we really do appreciate your interest in Arbutus Biopharma.
I'm pleased to report on all of progress thus far this year and to outline of our objectives for the rest of 2021.
As we've stated in the past I'll go at Arbutus is to focus on developing a portfolio of products with different mechanisms of action. The 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 towards that goal when a b 836, all propel it free oral capsid inhibitor of began a phase one a one b clinical trial.
806 is from a novel chemical series differentiated from competitive compounds with potential for increased efficacy and then at homes to resistance profile.
We look forward to having initial data readouts from this trial in the second half of this year.
In addition, a b seven to nine all public free subcutaneously delivered all of an AI agent continues to demonstrate robust and continuous declines in hepatitis b surface antigen and subjects with chronic HBV with a favorable safety profile and are ongoing.
Phase one day, one beach kind of control.
We expect to provide additional data from ongoing cohorts from this phase one trial in the second quarter of this year.
Cleaning 60 milligram multi dose data with dosing every four to eight weeks of 90 milligram multi dose data with dosing interval every eight weeks.
Separately data from the 90 milligram every 12 weeks in HPV negative subjects.
And the 90 milligram every eight weeks in HBV DNA positive subjects is expected in the second half of 2020 one.
Now, we're very encouraged by the clinical results, we've seen thus far with seven to nine of the demonstrates the inhibition of viral replication.
The reduction of all HBV antigens, including hepatitis B surface antigen.
As you know reducing surface antigen is thought to be of key prerequisite to enable reawakening of the patient's immune system to respond to the virus.
Therefore, our objective is to advance the seven to nine into two additional proof of concept phase two combination clinical trials with one or more of approved or investigational agents in the second half of 2021 with dosing of seven to nine as infrequently as every eight or 12.
Weeks.
Consistent with our belief that the multi drug combinations will be needed to achieve a functional cure for people with hepatitis B I'm pleased that Arbutus and assembly biosciences initiated in the first quarter of phase two proof of concept of clinical trial to evaluate seven to nine in combination.
With the assemblies, the lead capsid or core inhibitor candidate that'd be COVID-19 and in and Alteon.
Approximately 60 virological suppress subjects with the HBV E antigen chronic HBV will be dosed for 48 weeks with 300 milligrams of that'd be cool the orally once a day and 60 milligrams of seven to nine subcutaneously every eight weeks with of 48 week follow up here.
Great.
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 L. One.
So first of all RNA destabilizes have shown compelling antiviral effects in multiple HBV preclinical models.
And we remain committed to this area of research abuses is now focused on advancing a next generation oral HBV specific RNA destabilizer.
With distinct chemical scaffolds through lead optimization.
Abuses also has compounds in lead optimization that are potentially capable of reawakening patients' HBV specific immune response.
Inhibiting PD L. One.
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-19 and potential future coronavirus outbreaks.
We recently announced an important part of Corona virus Discovery research and license agreement with ex Kim for terrorists bio structures.
Now this collaboration brings together our own expertise in the discovery and development of antiviral agents with ex Kim's industry, leading DNA encoded library of technology.
Pre terraces protein sciences, biophysics, and structural biology capabilities.
This collaboration will allow for the rapid screening of one of the largest small molecule libraries against and pro an essential protein for the Corona virus replicates itself.
And also use state of the structure of guided methods to rapidly optimize and pro inhibitors.
So we look forward to keeping you updated on all of Pone Corona virus 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 all Q&A as Pam mentioned, both guest on the Mike Sofia all of both on the KOL and can take any additional clinical and discovery questions. Some of the to you Dave.
Thanks, Bill and the 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 from 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 our beauty. This ATM program.
For 2020, one we expect our cash use to range from 70.
The $75 million.
And therefore, we expect our current cash runway of sufficient to fund operations through the third quarter of 2022.
So with that operator would you. Please open the call for Q&A.
Yeah.
Yeah.
Yeah.
Ladies and gentlemen to ask the question at this time. Please press the Star then the ones who of you touched on the telephone.
So the Chinese question press the pound key.
Our first question coming from the line of.
And I see with E. H C. Wainwright your line is now open.
Hi, everyone. Good morning, and thanks for taking my questions.
Hum just of a couple from me.
As most investors are eager.
Eager to find out the additional data on your.
Our next cohorts in the ongoing phase one of the eight one b study of seven to nine.
Wondering if you.
You can tell us for the multi dose data on the 60 and 90 that you were expecting.
Hum.
How many doses or a number of weeks.
We can expect given the Uh huh.
Cohorts spoke to include patients that would be an every eight week dosing.
I was hoping to see at least 20.
24 weeks out if not more of just wondering what we can expect later this quarter.
Yeah. Good morning, Ed It's bill. Thank you very much for the that great question.
Yeah, I think as we've outlined in the past you know we've been operating these cohorts are very diligently during the COVID-19 situation and really trying to make sure that we can work in areas, where we can select patients some of them move them forward.
With the full funnel of up.
So we are.
Pleased with the progress that we've made and I think we've also been cognizant. The you know when we're looking at dose intervals of the full or eight of 12 weeks.
We really do need to have a reasonable time frame in terms of weeks or months to actually make sense of all the data. So we're closing in on that right now with.
Some of the cohorts are where we expect the day to later on this quarter.
But just with those comments the guests tell them if there's anything else that you would like to add.
Yeah, I mean, hi, Ed good.
Good morning.
So it says the.
Stated we'll be.
Hopefully sharing the three cohorts and to your question the range of weeks that we will be showing is probably somewhere between I mean, the pending with the remarks of buildup.
We don't know until the last minute, but it's somewhere between 24 weeks to 48 weeks.
Yeah.
Excellent okay.
And then I guess the follow up to.
To this.
And I know kind of storm you mentioned the scar newmar.
Numerous times in the past the importance of.
Having sufficient data to the farms or at least to predict a level of.
Plateauing.
On the different doses.
Is this something that.
You're hoping to to determine with this next data set.
Okay.
Well I mean, I will be able to tell you that the ones, we see the the final data but.
Yeah, we were hoping that with at least 48 weeks of dosing.
We will be able to get a better sense of how.
M S antigen and other HBV antigens are progressing overtime.
Okay, great. Thanks, a lot.
Thank you Ed. Thank you so much.
Our next question coming from the line of correct you would.
Collections to carry with Jefferies. Your line is open.
Yes, good morning, and thank you for taking my questions. Just a couple of my and I was hoping can you speak to the preliminary data you'll have for <unk> hundred six in the second half of what would that be and I guess in the big picture of what metrics are you, hoping to see differentiation compared to the other capsid inhibitors in development.
And I have a follow up question after that.
Okay. Good morning, Yeah I.
And all of corporate debt, we've got the structure.
Of the 836 phase one the one B study so it's a I think of fairly.
Usual clinical structure with the healthy volunteers and then you know the single doses in HBV patients in the multiple doses and 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 with a three.
Six so again I'll, let our guests don't add if you've got any further comments to me.
Okay.
Yeah, Hi, good morning so.
It can be seen in the corporate deck on I believe it's slide 23 in the corporate debt you can see the the structure of the decline of the 836001 study that has three parts.
The single ascending multiple ascending in chronic hepatitis b subjects.
The study has initiated as we've stated before.
And in the second half I think we will have sufficient data in chronic hepatitis b subjects provided everything continues as planned.
To be able to move 536 forward income.
Combinations I cannot give you any more specifics because it's ongoing study steel as you know were impacted by the effects of COVID-19 around the world and therefore, it's there's always a certain degree of uncertainty as to whether we can complete.
Everything that we plan, but the study is ongoing and is on track.
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 <unk> hundred six study as well as the combo study with <unk>.
709 assemblies core inhibitor I guess housing enrollment has been going in what steps have you implemented to ensure on the youre able to enroll patients in those studies given everything that's going on.
Yeah got stone join the handle that one.
Yeah, sorry can you repeat the first part of it I, Miss where you're talking about specifically about the <unk> hundred six study or you were talking about a seven to nine by itself or the or the.
Combo study.
So both studies both types of 7% to nine combo study that was recently initiated with the assembly as well as the 806 study that was just initiated housing enrollment going there.
Well, we haven't commented on obviously, we're not we can't comment on that without all of our partners are at this point in time, but we can I mean with our partner of assembly in the in the combo study has done everything possible to really to speed.
The speed up enrollment and ensure them at the time those are met.
So so far I mean, we haven't provided any additional guidance on the enrollment other than I can reassure. The every step has been taken to accelerate enrollment.
And as I said before the <unk> hundred six study it's on track.
The seven to nine deals of one study actually it's.
It's a fully enroll the was just following the subjects.
Okay. Thank you very much.
Thank you Claire.
And our next question coming from the line of Brian Kearney with Baird. Your line is open.
Hey, good morning, everyone. Thank you for taking the question.
On the seven to nine you know.
<unk> seen some some really good reductions in S antigen levels below the thresholds that are in or at least in some Asian countries. It wouldn't be unusual to stop nuc therapy.
And we sort of discussed the potential for evaluating a what it would look like to take patients off of all new therapy here.
Could you just speak to your current thinking there or is that still something on the potential near or medium term horizon and you sort of have stopping criteria in mind to walk out of.
Value of the eight patients of all therapy.
Yes, Brian Thank you very much good question.
I think our belief is that we need to get multiple drugs on board before we start reaching criteria the way we can.
You start pulling some of those drugs away.
So really understand the basis for the question.
The Gaston do you want to comment further on.
Yeah sure. Thank you. Thanks for the question. So we continue to consider of the multiple options out there are in terms of stopping criteria also all of those need to be a line the way the recommendations and from regulatory agencies.
Around the world, including obviously the F D a.
So.
At this point in time, we haven't stopped anyone and that it is always a possibility, but we haven't done that certainly we continue to consider the 100, the IU per ml of threshold for surface antigen. The question I think that remains is how long that.
The stained decreasing that sounds of Germany needs to persist before you can see the stopping.
There's nothing out of the investigational drugs or stopping of therapies that would be the nook.
So we I mean, we continue to consider the multiple options.
I think there is no single way of pumping patients right now.
Everyone has a different opinion on how we should be done.
In the safe way, obviously safety is our driving force there just to make sure of that we don't do anything that's the result of an unsafe or for the patients.
Great. Thank you.
And as a reminder, ladies and gentlemen to ask a question. Please press. The Star then the one key on your Touchtone telephone or.
Our next question coming from the line of ROI, the kind of with JMP Securities. Your line is open.
Hey, great. Thanks for taking the question so the.
The first one I wanted to ask about the collaboration and the guys recently announced.
First Sars COVID-19, two with ex Kevin Protos.
It seems like the the DNA encoded libraries of kind of a burgeoning space I just wondered if you could speak of.
A little bit more in detail about what makes the ex chem.
Approach industry, leading how it's differentiated from other.
Libraries, and then I had a types of questions the case.
Yeah, Okay. So on the ex Kemp of terrorists still maybe mics, if you like.
That one.
Sure Hi.
So.
As we sort of scour the landscape for.
Sort of Dell screening technology of DNA encoded library technology companies.
To evaluate who we wanted to partner with them.
Really ex Chem stood out amongst all of them not only because we felt that their expertise within the industry leading.
They clearly have demonstrated through many many collaborations they've had with other farm of partners.
The ability to deliver a.
Using their libraries.
Probably also have the cause of the largest library set out there and the.
The man coded library of arena.
Including multiple different kinds of libraries.
It would include both reversible as well as.
Kuban attachment libraries that we were interested in so so overall, we thought of it.
From their level of expertise there.
Their track record.
They were of the ideal.
Partner to move forward with here.
They also had the strategic relationship with prepare us and because of <unk>.
The.
The non structural protein it's the structure is known.
It provided.
A real ideal.
Well the target to use.
<unk> biology biophysical methods to.
To guide.
Subsequent to the.
The structure activity relationship studies in lead optimization studies that we were going to do.
So when you look at the whole package together.
Things together.
The three companies with really <unk>.
Industry, leading expertise and capability to to tackle this target and buying the new chemical matter that we hope will ultimately lead to.
Two clinical candidates.
Benefit patients.
Okay, Great. That's helpful and have you guys sort of thing on timing from that partnership.
For when we could see the first.
The results.
Well, obviously, we all agree that the.
The coronavirus.
Issue is front and center.
When everyone's mind globally.
We're driving this as aggressively as we possibly can.
And our partners know that they are fully committed this is really of collaboration it's not a typical ciara of relationship.
So.
Uh huh.
We hope that we hope to have something.
Sooner rather than later, but the til.
Little early to comment.
Comment on that right now.
Yeah, great. Okay. Thank you and then just a quick one for.
Davis, if theres been any ATM use.
Since the end of the first quarter.
Yeah, Hi, Roy.
So our typical.
Policy is to disclose ATM sales.
Through sort of the end of the prior quarter or so.
We will update everybody next call for the <unk>.
ATM activity this quarter of ROI.
Okay fair enough. Thank you.
Our next question coming from the line of Ryan Lumb, Tony with B Riley Securities. Your line is now open.
Good morning team, thanks for taking the lessons.
So on the Assembly trial.
The good flattish.
<unk> Youre, starting with the 60 make dose so could you maybe talk about the 90 day.
The data that you.
Continuing to generate and what.
If any implications you could have the the protocol.
As you think about balancing S antigen reduction and maybe safety.
Hey, Thank you very much for the question. Good morning to you and the Assembly collaboration trial, we've set the dosage for seven to nine at 60 milligrams every eight weeks.
But as you know we're continuing to look at the 90 milligram.
Eight and 12 week, which would potentially allow us to look at the dosage.
And.
The dependent upon the data.
And all.
All of the phase two studies.
But again I guess the thoughts.
Yes, hi, good morning.
So the we.
We felt comfortable with the 60 milligram every eight.
Week dosing schedule to initiate the collaboration with the Assembly and that's how about the studies 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 the just to be clear that the ongoing study. It's 60 milligrams every eight weeks.
Got it and maybe Saudi I missed if I missed this on <unk> six.
As you're thinking about just longer.
Developing this agent and maybe sort of differentiating on the enhanced resistance profile that you have good preclinical data.
If it all of this this program could be developed maybe differently than how cutting programs that are growing.
The.
Combination based out of nape less GAAP skill gaps at any.
Any insights there beyond Duane to anyone.
Yeah, Mike Sofia of doing it just talk briefly about what we should on the resistance from.
Sure Joe.
So so yes, I think when you look at <unk> hundred six it has the number of different differentiating characteristics right one of the resistance profile.
The.
Addresses the number of the merger resistance issues in the cancer field.
The other issue is.
Related to the the.
The sort of second mechanism right the MBA.
Being able to engage the second mechanism and of clinically relevant dose, which we believe <unk> hundred six is going to be able to do.
Now the.
With that with that.
The characteristic.
We.
The potential of the seeing some differentiating profile when we put it in combination with seven to nine.
I think everyone.
Sure.
Understand that you know our objective in this combination strategies.
Ultimately.
To do the three things that we've said from from day, one which is shutdown of our replication, Wisconsin, plus newco will achieve.
Star of the DNA pool with the hopefully the cats, who will also of achieving.
Association with with I think our RNA <unk>, and then with the RNA items and knocking down the S attitude pool to reinvigorate the helped to reinvigorate the immune system.
The other piece of the puzzle here really is the immune modulation piece, which you know as Bill mentioned, we're very excited about our PD, one program, which is really maturing very nicely and.
Hope to see great things out of it.
Bringing that together.
It does round out the whole picture of the strategy that we've been sort of discussing for a number of years now.
And so when you when you look at our capsid.
Ted.
It goes how differentiating profile from from other competitor of compounds, but it is a central part of the overall strategy that we set out several years ago.
Great. Thank you for the comprehensive answer and maybe just if I can squeeze one in the U.
On the IP.
The situation with Madonna at least from public filings.
And it seems like the are taking a relatively different approach from the Florida.
Anything you guys can comment from your end of from Gen. One day lens perspective.
That gives any color on the lawsuit of the possibility of a settlement.
No.
No we can't comment.
Obviously.
We would not lead that.
The agenda that wood.
But I would say look we take our IP very seriously.
Awesome.
But in terms of the sort of the play by play.
With the interactions of the companies, we can't comment on that.
Understood. Thanks, Thanks for taking our questions.
Thank you so much money.
I'm showing no further questions at this time I would like to turn the call back over to Mr. Bill <unk> for any closing remarks.
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.
The productive and value building 2021 and I think as you've just heard we're confident that with further data from all of seven to nine clinical trial.
Progression of the seven to nine.
Compound into two phase II proof of concept clinical trials.
Data from 836 phase <unk> clinical trial and continued progress in the HBV discovery programs.
We really have established a strong foundation on a mission to achieve a functional cure for people with chronic HBV and also obviously looking forward to leveraging the antiviral discovery and research efforts and progressing our Pan Coronavirus Discovery program.
So again, thank you for your interest and operator that concludes our call. Thank you.
Ladies and gentlemen that does conclude the conference for today. Thank you for your participation you may now disconnect.
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