Q2 2020 Arbutus Biopharma Corp Earnings Call
From a.
Corporate 2022nd quarter financial results and corporate update conference call.
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I'd like to and the conference over 20 years speakers today Ms. Pam Murphy Ma'am. Please go ahead.
Good morning, and thank you for joining our beauty says.
Q2, 2020 conference call.
On the call from their Peters executive teams are built call your President and Chief Executive Officer, Dr., Mike Sofia, Chief Scientific Officer.
Dr Guest on P. show, Chief Development Officer, and Dave Hastings, Chief Financial Officer.
Bill will begin with a summary of recent accomplishments and a review of our view just its corporate objective.
Well, if I guess Donna Mike Sofia Who'll provide you with updates on the clinical development of 80 729.
Our be this is early stage HBV program pipeline and its cobot 19 research efforts respectively.
Dave Hastings will follow and provide a review of the company's second quarter financial results and we'll then open the call for couponing.
Before we begin we'd like to remind you that seems the statements made during the call today are forward looking statements, including statements regarding expectations timelines at clinical results for viewed this is proprietary HPV pipeline.
The patents, providing the or if you just eleni P technology, that's the company license to China fan.
Achievement of the company's 2020 objectives, and its 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 materially including those described.
Most recent annual report on 10-K quarterly reports on 10-Q, and our other periodic reports filed with the FCC.
Ill.
Thank you and good morning, and thank you everyone for joining US today, we hope that all of you all well I know, obviously continuing to stay sites.
To begin I'd like to confirm that despite the challenges of cobot 19.
Oh abuses team continues to execute efficiently and effectively and say well scientific clinical and corporate operations and timelines.
All remain on track.
As described in the press release. This morning, we expect to report a b seven to nine safety and efficacy data in the second half of Twentytwenty for the 60 milligram multi dose cohorts.
For an eight week intervals.
And also the 90 milligrams single dose cohort and an additional cobalt of new data from a 90 milligrams single dose cohort in HBV DNA positive subject.
As most of you know we provided a clinical update on the positive interim seven to nine single dose 60 milligram results in May and gas don't will review these results and provide more details on the ongoing phase one a one be clinical trial program in just a few minutes.
Additionally, we've made progress in our own Tobin 19 preclinical research effort.
As well as you know collaboration with the cobot on deep consortia, whose mission is old used to fund molecules with the greatest rational for advancement into clinical trials and put them into studies designed to yield the most meaningful results in the softest another possible.
Turning to a different topic on July 20 stood twentytwenty, the United States patent and trademark office before the patent trial and appeal Board.
No the decision in Madonna therapeutic and challenge to the validity of the U.S. patent 8058, 069, what will from coal to 069 patent.
And this decision they determined that no challenged claims were patentable.
No well up you just the patent holder.
This patent license to Jennifer.
Oh Beatrice's gratified by this decision upholding the validity of one of the patents protecting LMP technology.
As I said, we'd license the Jonathan.
This decision reinforces all continuing belief in the potential of this technology.
Also on July 23rd Twentytwenty Voisin Recapitalize Gen events, one equity investment income version of previously issued convertible debt securities held fibroids on.
Oh Beautys participated in the recap agenda event with an equity investment of $2.5 million.
Following the recapitalization abuses now owns approximately 16% of the common equity objective.
Importantly, though abuses entitlement to receive future royalties or sub licensing revenue from general and remained unchanged.
Before turning over to coal to gas done on like I'd like to just quickly review of key objectives for the next six to 12 month.
These all especially to advance all phase one day, one be clinical trial of seven to nine all in I only compounds, including the initiation of two new 90 milligram multi dose cohorts.
Second to progress on next generation capsid inhibitor 836 through I, India neighboring studies.
And initiate a phase one they won't be clinical trial with a goal of moving to propose treat combination studies as rapidly as possible.
And thirdly to continue our research efforts to advance the lead oral compound that inhibits PDL, one and the lead all next generation HBV specific or in a de stabilizes.
Let me turn the call Leben after Gastonia will update you on seven to nine.
Thank you and good morning, everyone.
In May we provided you with the interim results from the ongoing phase one they wouldn't be clinical trial for 87 to nine which included data from the single doses 60 milligram cohort has with 12.
These days are they most raises the 60 meters from single dose of withdrawal led to a mean its annual decline of approximately one low but actually much what we sold with a 190 milligram cohort with 12 as well.
Well the subjects, receiving the 60 milligram single dose experienced a significant.
HBV surface antigen baseline and all subjects in this forward abnormal AOCI use analyses throughout the dosing and follow up period.
Importantly, we continue to follow these subjects through with 48 and what would be reporting you follow up data in the second half of the here.
We're currently those in chronic HBV subjects in the following.
To 60 milligram multi dose cohorts evaluating dosing interval for eight weeks on a 90 milligram single dose cohort.
We're also dosing h. BBB and they most of the subjects in a 90 milligram single dose cohort.
With respect is expected in the second half Oh Twentytwenty.
Importantly, this cohort will allow us to evaluate for the first time the impact of 87 to nine on HBV DNA replication.
As mentioned previously we also intend to initiate to my immediate from multi dose cohorts in the second half of this year.
We're also considering several phase two trial designs in combination with other agents and the review what were 60 milligram, mostly those data.
We will be announcing these in the coming.
With that I'll turn the goal over to Mike.
Well discuss phone and good morning.
First I want to update you on baby Athree six our next generation cops inhibitor.
Currently we expect to complete our R&D, enabling studies by December 2020.
Oh looks on track to beat that objective.
In addition, we continue to make progress with our next generation Rural HBV specific RTT stabilizer affordability targets HBV S antigen reduction.
And an oral PDL one club, we believe maybe use for every waking a patient's own immune response to the HPV virus.
In may of this year, we announced our commitment to help address the corona bars global pandemic by establishing a long term effort directed to this problem.
We committed to bring our recognize expertise to the discovery development of new anti viral therapies that were proved to be safe effective against not only Sars koby too, but also against future Corona bars outbreaks.
As we laid out our plan you had tended to focus our directed discovery efforts to target.
The NSP five borrow money protease or the U.S.P. 12 borrow preliminary.
These two targets for Holly conserved recalls Croda barks is crystal structures available for structure based drug design efforts lend themselves to the deep expertise we have within ARPU. This discovery development functions.
In addition, we joined the Cobot R&D consortium to leverage early stage screening capabilities screen, our own proprietary libraries again, Sars koby too.
I hope identifying novel agent.
Central new mechanisms of action.
As of today, we are full execution.
Chemistry underwear to prepare our beautys design molecules the targets the borrow protease and polymerase.
We have already Scream several of you just libraries of small molecules as part of the covert R&D consortium or the process of evaluating the data.
In addition, we continue to feed molecules to the screening effort.
We have also establish a network of testing capabilities that will help us rapidly progress the evaluation of our molecule.
We believe our beautiful koby programs is differentiated our focus expertise and capabilities. It didn't know viral drug discovery development that puts us in a position to rapidly bad Duke wrote of ours therapies.
We are committed long term through this program is the expectation of delivering novel therapies to patients.
With that I'll turn it to call over to Dave.
Okay, Thanks, Mike and good morning.
Our ending cash cash equivalents and short term investments.
Approximately $84 million as of June Thirtyth 20 Twond.
Compared to approximately 91 million after December 31st 2019.
Our cash used from operations for the first and second quarter for 2020.
Well, it's approximately 24 million.
And in addition, we received approximately 17 million net proceeds.
The issuance of shares under our ATM program, the second quarter quite funny.
Now during July.
Our views who utilize the remaining availability.
Under the ATM program, resulting in an additional 36.5 million net proceeds.
Therefore based on our ending second quarter cash cash equivalents in investments of 84 million.
Plus the additional 36.5 million the proceeds received under the ATM program during July.
We now believe our cash position sufficient.
From the company's operations into mid Twentys 22.
Versus our prior guidance mid 2021.
With that I'll turn the call back to you.
Thank you very much Dave and with that operator, Michelle let's go to open up the lines for the question and answer session.
Ladies and gentlemen, if you wish to ask a question at this time. Please press Star then one and you touched on telephone. If your question has been answered I wish them up yourself from the Q. Please press <unk>.
And any background.
Please.
Once your question has some stated.
And my first question comes from the line of Maxatawny with B. Riley. Your line is open. Please go ahead.
Good morning beam. Thanks for taking my question, then and get to head graduates you're making itself.
Just a good three questions and follow up I mean, maybe starting with you guys done.
Any color you know now that we're learning a lot more bad you know.
Targeted therapies, including you know and signed in an extended then.
Good day, so maybe could you just given some color on how you think about seven to nine.
Positioning in the landscape Imputing I did see the learnings you had on the high does.
So started walking through the mid build in the low though you can you just give us an update how you'd think about the competitive positioning.
Sure Hi, So we believe that seven to nine remains very competitive agents in the landscape of R&D Nice thing, we're very satisfied with the rate of decline there sounds agenda, we so with a 16.
Really but I'm I'm single dose cohort all the way squad with 12 and that was with with the as we pointed out with a single those are what we would call alone. So those so we are awaiting that were 90, maybe I'm single those data and obviously, we're awaiting our movie those they though.
Also the safety profile over 60 milligrams single dose was a remarkable.
You know achieving those with the case in the absence of any failed p. flares.
And just remind a one of those subjects actually achieve a 2.4 look decline.
And the way that we are seeing decent because I think will become more clear.
Uh huh.
Becomes available later in the year.
To be able to compare the multi dosing versus the single bills and even to the regular appeal diverse both the we're seeing you know with 60 milligram dose.
We believe that really have some advantages in terms of there that those and leave the frequency of the dosing.
So as you know we're studying for an eight which is.
Different from what others have done, but that's only studies every four weeks, we're going to do.
And they and we are extending that are less frequent dosing schedule to or 90 milligram dose, but we're going to start the 812.
So we see those aspects of the potentially some advantages.
Cooper.
Other agents in the space.
Great and then on the be dad, meaning.
Can you just give us an update you know what what makes sense.
A you know specifically in terms of dining and you know I assume are done.
Filing an appeal any a bid can you provide a next steps.
Yeah, Mike This is bill and so thank you very much for your question, obviously appreciate and understand why you're asking it.
Disclosed.
Previously the intellectual property is licensed agenda then.
And as we also explain today are off to the recap of Gen event, we now have a an equity investment amounting to 16%.
But importantly, still I will receive the future royalties for sub the whole sublicensing revenue from Jennifer.
So.
I think it's important to understand that you know Gen event. The licensee has the fish right to full control of any enforcement actions.
Taken in connection with this IP, so that being said you know I wouldn't want to come until speculate on what those actions maybe.
Okay, great and that diner growth I shouldn't say Mike.
I can you comment then that do baggage that.
You had said that they know about his efforts.
How do you think about you know proof of biology that and I'd say, maybe be specific and the models and deciding timeline that you and thinking about.
Yeah. Thanks, So we're lucky yet to a highly concern targets and the.
And the client of ours do you know right. That's the NSP 12 viral.
Liberates NSP Vod viral.
Proteins.
We chose those because our specific interest is to look at a pen corona bars agent can so we're looking for targets that would be conserved across corona barges. So that was really important to us.
The impact there are these two particular targets have a lot of structure information associated with them. So they help facilitate our drug to design and development efforts.
With regard to this this particular farmers.
You know the proof of biology here is clearly no run does severe.
Those target the NSP 12 viral polymerase. So there's a clearly a direct proof of concept here in the viral protease no. We're looking clearly towards.
Oh, there are other viruses that have proteus is associated with them, specifically HCV and they try to you were pretty issue there butters hub.
Become a part of the Oh regimen for treating those particular diseases, but also even in the Sars Kirby too. There are early leads that people have identified against the undisputed five borrow protease that or at least in preclinical models.
To have <unk> activity. So I think when you look at both of these particular targets.
No I think there's there's ample evidence and support for a the idea of pursuing them as potential therapies for as far as Kirby too.
Great. Thanks for taking my question.
Our next question comes from the line.
Your line is open. Please go ahead.
Hi, Thanks for taking my question. This is Rob on from a do and I was just wondering based on what we've seen for the various HBV.
Programs, what kind of surface antigen declines in the 60 or 90 milligram cohort.
I get excited about seven to nine.
I have to say hi, Chris on here. So I have to say that we were really excited about seven to nine with the magnitude of decades, we saw whether with the 60 in a single goes on the safety profile.
So we anticipate that he is going to continue to decline with wouldn't want to dosing give you a number I think it's.
I think it would be premature to tried to say what our hobbies is is important look too I think what matters here. It is.
Throughout her appear the dosing one would like to see it sounds agent disappear will become unquantifiable at least and remain as such.
So you know in some patients but may be.
Two localizing other patients or maybe three dogs. So it's really variable I would like to really he'd be on number.
But you know, obviously, where we would like to remain competitive but again I just wanted to reiterate that we were very pleased with the K that we sold a 60 after a single goes on with 12.
Alright. Thank you I have another question and it's to what extent do you believe you can distinguish and healthy I live nation, that's a safety signal from one that's an immune.
Oh, well that's a that's a great question, then and it's a question that hasn't been outs or over the past.
20 years, and we continue to discuss it.
As you May recall we.
We took some airports.
Maybe five or six program to try to distinguish them because we so players in one case.
The players where associated potential dreadlocks isn't in another case, we saw his antigen going down on DNA going down.
But even the of DNA is going down and is Anderson has gone down there is no guarantee that that there.
It's happening.
Not related to drugs, such as the I can tell you.
There was a recent meeting bye bye.
The H.B. Forum.
Many of the sponsors presented.
With the president of key opinion leaders as well as regulators and how we continue to discuss these [noise].
I have to I think it's fair to say that the mother hasn't been so there are no. Good biomarkers to say flare, it's potentially related to practices of the versus a beneficial Blair as we understand it even frankenstein's is being so I cannot give you an answer obviously there are certain things that would allow you to the firming up there is a Mac layer searches.
Making it easy criteria and so forth now media ruling elevations and so forth but.
If those things don't happen like Theres, nobody entity that doesn't guarantee that if there is about there. So it's still an uncle question huh.
Okay. Thank you.
Thank you.
A question comes from the line.
And with JMP Securities. Your line is open. Please go ahead.
I have great. Thanks for taking the questions that a few on seven Tonight, and then 1836 so.
I'm for 17, I it sounds like you're honing in on the 90 milligram dose based on the selection for the new cohorts in the phase one.
Seeing any signs of greater efficacy in that dose and the ongoing cohorts or is there like safety signals that we need to choose that 90 milligram dose.
We haven't they migrated a beta yet so.
They don't have we haven't evaluate it so.
You can comment about that is going to me because I said, we're very pleased with where we sort of where there was a 60 milligram single dose.
Okay. Great then on the 60 milligram single dose presented data earlier this year that.
The data later this year, what's the duration on that going to be.
So.
The protocol actually with the movie dosing, so I'm not referring to the multi dosing cohorts and so we and those for six months and there is an option.
Core subjects.
To reconsider and continued those and for an additional six months. So a total of one year the protocol.
The state the duration of dosing the multi dosing cohorts is six months with the option of Puerto Rico, something on a rolling Im not protocol extension to be a wish and continue to those for each on six critical for one year of those so we will how.
Long term dosing beta.
Our next year.
Long term okay.
But for that so you presented three month for the 60 milligrams single dose.
Or in May.
In the second half of this year can you tell for the duration for that cohort and maybe.
Oh, I'm, sorry, I I think you were asking about the duration of the corporates in general So we will focus on.
During the second half of the year will be how.
Two.
Well or beyond.
Okay.
Depending where the big goals and.
I mean, if the data beyond with told us.
Okay, Great and then for 836 that can you.
Give us any details in what remains to be completed for the I'd submission. Thanks.
Hi, This is Mike <unk>.
So probably three six we're in the midst of the no idea enabling studies. So we're completing the 22 toxicology assessment.
No.
All the manufacturing requirements, but everything is clearly on track and.
As we have guided as Bill said, you know we expect to.
Deliver a.
And I'd package by the end of year.
For that molecule.
Great. Thanks for taking the question.
Right.
Thank you and again, ladies and gentlemen.
At this time.
All right.
Hi, I'm showing no further questions and I would like to turn the conference back over to Mr. Bill for any further.
Oh, I'm, sorry, Mr. Collier I do see a question that just popped up from the line.
<unk>.
Your line is open. Please go ahead.
Hi, good morning, so thanks for taking my call I have a slightly different question.
I see course ownership all come ownership and Connecture properties, beating our company and universe.
Has there been any discussion about maybe combined the two companies together to better put the resources as opposed to reflect the potential the combined company and utilize kept the market to read.
Capital for additional are you going forward.
Hi, This is Phil thanks for the question and.
I think that the best response to that is just to kind of outline again, what we.
Said in the press release this morning about the recent recapitalization of Gen event. So.
There's a little bit a history of Wenjun event was formed between abuses and ROI then but.
The most recent update is you know in July 31st win Gen event was recapitalized.
So it is a standalone.
Private company.
Of which we now have a shareholding of 16%.
I think what's important to a beaches in that recap is that.
Didnt impact in any way the a the future royalties or sub licensing revenue.
We may get from Gen event for any sub line. So at the moment abuses agenda that offset companies.
Like I said, the most recent corporate update.
What we've just disclosed I've done it Dave do you want to add anything on to that.
No I think it's well said bill to say look.
Its core mission is to find the functional cure for hepatitis B that remains our core mission.
And that's where the majority or resources, along with our Oh good effort.
Will be dedicated.
Yep. Thank you good fun.
Thank you.
Further questions at this time.
Conference back over to Mr.
For any further remarks.
Thank you very much Michelle let me close out then just by thinking at each of you for your interest in abuses and we do look forward to updating you on all key objectives as we progress through the year now there was objectives as we've summarized today include the following so we look forward to preliminary results of seven to 960 Miller.
Gram dose cohorts.
He said every four and eight weeks or in the second off of the year.
Also in the second half of this year.
We expect well results at week 12 for the month 90 milligrams single dose cohort in both HPV positive and negative subject.
As you've also heard a in the second half of this year, we plan to initiate to 90 milligram multi dose copel.
And in addition to clinical trial results for a b seven to nine we expect to progress on next generation capsid inhibitor ABT 836 to nine DNA being studies and look forward to the initiation of phase one a lumpy trials there often.
Regarding our earliest stage pipeline, we hope to report continued progress for a lead oral next generation HPV specific or in a de stabilizer and a lead oral compound that inhibits PDL one as well as obviously continuing to progress October 19 research program.
So again, thank you very much everyone for joining us on the call. This morning that concludes the meeting thank you.
Ladies and gentlemen.
<unk>.
Disconnect everyone have a great.
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