Q1 2020 Earnings Call
[music].
Listen only mode. After the speaker presentation, there will be a question and answer session.
That's the question. During this session you want me to press Star one on your telephone please be advised that today's conference is being recorded.
If you acquired businesses and.
Just cut size you know I would now they tend to compensate us because today Penn Murphy. Please go ahead man.
Well. Thank you well good morning, everyone on the call from the RPM consultants to name a Bill Cosby, President and Chief Executive Officer.
Dr., Michael Sofia, Chief Scientific Officer.
Dave Hastings, Chief Financial Officer, and Dr., Gass don't P. show Chief Development Officer.
Bill will begin with a summary of recent accomplishments and a review of our view this as corporate objective.
Followed by Dr. Sofia, who will then describe the recently announced or if you just 'cause it 19 research effort.
Dave Hastings will then provide any view of the company's first quarter financial results and we'll then open up the coal for QNX.
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 timelines and clinical results for our beautiful proprietary HBV pipeline achievement of the company's 2020.
Objectives, and its expected cash using 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 in the most recent annual report on 10-K quarterly report from form 10-Q, and other periodic reports filed with the FCC.
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With that bill.
Thank you Pam and good morning, everyone. Thank you for joining US today, we hope that all of you a well and staying safe.
Also like many of you I'm sure most of our employees are working virtually no I applaud them for their continued effectiveness in keeping all scientific clinical and corporate operations and timelines on track.
As we previously disclosed we continue to move forward with all clinical development program for a b seven to 960 milligram multidose.
A 90 milligrams single dose with data expected in the second half of Twentytwenty.
We also intend to shed additional data from the 12 week portion of the single dose 60 milligram cohort sometime this quarter.
Additionally, under the direction of Mike Sofia, I'm proud to say that Weve initiated our own cobot 19 preclinical research effort.
Mike will describe the program in more detail in just a few moments.
We've also joined forces with the Cobot, knowing 19 R&D consortium.
The mission of this consortium is to shed day to find the molecules with the greatest rationale for advancement into clinical trials and put them into study is designed to yield the most meaningful results in the fastest manner possible.
Now given the proven expertise in antiviral drug discovery and development that exists that all beautys I'm confident that it's both appropriate and important that we devote resources to address this global crisis.
That said I want to underline that our primary focus and our mission is to find a cure for hepatitis B and that remains unchanged and this is where substantially all of our resources will continue to be directed and we're not changing all cash use guidance for twentytwenty as a result of <unk> co.
David 19 initiatives.
Now just as a reminder, hepatitis b remains a significant unmet medical need with over 257 million people chronically infected worldwide.
Including over 2 million right here in the United States.
At around 900000 people in the will die each year, despite the availability of vaccines.
And UK side and interferon therapists.
These existing therapies have very low cure rates less than 5% in fact, it's our belief that in HBV curative regimen could substantially increase diagnosis and treatment rights.
And to unlock significant market opportunities.
So to conclude my opening comments.
We remain focused on developing a portfolio of products with different mechanisms of action.
That when used in combination.
Would result in a functional cure for HPV and our objectives include the following first advancing all phase one I wont be clinical trial of a b seven to nine.
Second progressing on next generation capsid inhibitor ABT eight through six through R&D, enabling studies.
And thirdly, continuing our research efforts for next generation oral HBV specific all Rene de stabilize them and they lead oral compound that inhibits PDL one.
So with that being said I'll now turn the call over to Dr., Mike Sofia.
Thanks, Bill and good morning, everyone.
Many of our or Buda team members have a great deal of expertise and the discovery and development of safe and effective antiviral therapies.
We've been actively fall in the corner bars pandemic developments from the beginning.
There are many companies already well into the race to address this global health challenge, it's still early and much needs to be done.
We believe we up with potentially important role to play I've developed with solid player, but as both appropriate for a company of our size and one that may lead to a new small molecule anabolic therapy, where kroner bars.
Regarding our internal offer.
This is a long term commitment we're not working on re purpose drugs, but rather the discovery development of new molecular entities that address specific borrow targets that fit well with our expertise.
These targets include the NSP 12, borrow polymerase and the viral proteins.
These targets or a central bar proteins, which are team has much experience and targeted.
Collectively our team has been very successful, bringing novel therapies to the clinic against these types of targets for other bars as much as such as HCV HBV and HIV.
As these targets have been shown to deliver clinical value for patients with other bars is we believe that this is a proven and potentially fruitful approach to four quarter boxes as well.
You are likely to ask how soon.
Have a lead compound or compounds to take into R&D, enabling studies and that's a hard question to answer.
The discovery process doesn't happen overnight and I was I said this is a long term commitment.
In terms of our goals for a new more.
We believe we need a drug that work effectively against a broad patient population start rapidly reduces viral load, especially in patients diagnosed with severe disease.
As a high barrier to resistance works ideally as a parent kuroda bars Asia. So that it can be used in future outbreaks.
Well I also believe hitting the bars hardware the combination of agents with different mechanisms of action is likely to provide the best outcome for patients across a broad patient population.
Also limit resistance.
We will be focused initially on developing single agents, which could be using resistance.
We will be focused initially on developing single agents, which could be used in combination with other new or existing therapies.
Additionally, we're gratified that there has been such a tremendous response to the call the arms and finding ways to controlled as far as.
This unprecedented situation all scientifically sound ideas are worth investigating in an effort to identify something that can help patients.
As we all learn more feel we'll be able to make more educated choices or what to work on.
This is why we have joined the Cobra 19 R&D consortium.
It's hardly organize collaboration among top pharmaceutical and several biotech company R&D leaders as a singular focus coal.
First push for therapies of vaccines against Cobot, 19, as quickly and effectively as possible.
Through this collaboration or abuse will be pulling resources at streamlining early stage discovery processes to identify novel targets in agents, but hibbett, Sars koby too and other criminal bars as.
We both contributing our unique chemical library for screening and then further progressing any active molecules that are done applied the screening efforts.
Through the consortium, we would leveraging certain primary screen capabilities and lead optimization capabilities to identify novel clinical development candidates against both known and potentially unknown targets.
We believe our Beautys is unique position is our focused expertise and capability in enough viral drug discovery and development puts us in a position to rapidly advance new corona bars therapies from discovery through development.
I look forward to keeping you all updated on our progress first with our own portfolio of HBV compounds, including our next generation capsid inhibitor ABT 836, our next generation HBV specific aren't easy stabilizer.
And then oral PDL one compound that we believe may be useful re waking up patients own immune response to the HBV bars, and secondly, with our work on Corona viruses without I will turn the call over to Dave.
Thanks, Mike and a good morning, everybody.
Our ending cash cash equivalents in short term investments was approximately 88 million as of March 31st 2020.
Compared to approximately 91 million as of December 30, Onest 2019.
Our cash use from operations for the first quarter 2020 was approximately $15 million.
In addition, we received approximately $12 million net proceeds from the issuance of shares under our ATM program for the first quarter 2020.
For 2020, we still expect our cash used to range from 54 to 58 million.
And therefore, we expect our current cash runway is sufficient to fund operations into mid 2021.
So with that I'll now turn the call back the bill.
Thank you very much Dave and to make subsea and with that operates in Joe well could you. Please open up the lines for question and answers.
Thank you as a reminder to ask a question you will need to press star one on your side.
Rich I question pest, apparently please standby probably come probably trending there.
My first question comes on line nine Tommy with B. Riley FBR. Your line is out there.
Good morning, Thanks, Dean for taking my questions in a I appreciate the ethics I'd go now at a therapeutics.
First question on the of the I can debate you had a million 80, Meg Ah that's made up could you could you maybe just comment on sort of how to think about this gone breakdown duration, but also obviously you not having that domestic you've seen that.
That is so this could you maybe talk a lot.
Our that movie theater.
Yeah mine could spell let me make a comment first and then I'll hand, it over the gas stone so.
As I'm sure you've already picked up in this particular press release.
There's no new news on the seven to nine obviously a loss press release was a much 26 I think.
What we are still wait till waiting for a moving forward on is the sing 16 multiple dose 90 single days.
But what we have now said is the 12 week day through on the 60 milligram single dose available this quarter.
So that's a slight change I'm in the timeline for the 12 week single day 60 milligram follow up but having said that let me, let me hand of at Augusta.
Yes. Good morning, Good morning did that Oh, you want to answer. The question are you have any further questions them I mean, because without that I'd be show 12 week, although update.
I think it's difficult to speculate.
But maybe.
I was just curious the with the I think like deemed bake you saw us of a deepening of responses even with the single dose. So I was just curious what how to think about the 60 makeshift should we expect this same later I would think the that really comes with them I do does that you're seeing that others.
Bonds.
Yes.
Yeah, I think we I mean, as we said by a on March 30 before the.
One of venue anything ago baked beans.
Our expectations in terms of B.
Our ability and.
One thing is acquiring.
Oh that those so.
We would there with a 60 day 29, we do have the same type of decline that we so.
Basically the nine to one lately, but obviously that's why we're continuing to follow the subjects and I think we need to see debate that due to conclude a wherever we and so forth. So as bill pointed out that base and now we are announcing thats going to be available in the second quarter 22.
Okay. So I.
I'd, rather wait to see that they dealt with before we conclude anything above the six any of them beyond what we already be that.
With 29, which actually by the way I would add that one of the other striking.
Peter.
A major with right from a 60 was though is extremely say from a LCASD level. So as you may recall the levels, where all the normal throughout the 29 day. So Paulo, So we'll see very still what happens with the.
Nicole would go up.
Great I appreciate the clarification on timing and what to expect just on the <unk> in any update you could provide on the on the and really meant friend for either the Multidose 60, Meg or 90, Mig I, just just qualitative color would be has.
Yeah, My and gets Bill again.
He said it back in a much given the coated situation you know, we're trying to progress carefully and thoughtfully. So.
Well.
We Oh I guess, what we can't comment as you know looking at site selection and screening patient screening and you know trying to find locations, where we can conduct these trials safely from a patient protection point of view.
Got work is all underway, we actually haven't disclosed whether well, we've we dose to patient or whatever yet, but we are sticking to our projections that we'll have the data.
But then the second half of the [noise].
Okay, Great and Mike maybe a midsized just switching gears under the current Elias efforts I may have based or have you did you disclose any dog H.I. I know you said, Andy why those and could you maybe this dog food, obviously, we had been running it down about how.
The by this out as.
So lets say its and entered the Sallie just could you talk to what we're trying to pick up there to get back again, and if or how that is incremental to say, but example, then this is there.
Good and could you maybe comment on that.
Sure shortly.
So so source koby two was a positive sense already virus and and you know were specifically interested in direct acting antiviral here. So we chose the NSP 12 viral polymerase Navarro protease, maybe viral proteins because they are key proteins involved in the bars lifecycle.
And appear to be highly conserved across grown of ours.
These targets have similarities to var plum racism pretty just seeing with other R&D viruses like HCV, so as far as clinical agents. They can come from targeting a bar.
Im rates are pretty is you only have to look at HCV HIV or HBV, where nuclear sites are nucleotides opened use a target the var polymerase or viral or reverse transcriptase as backbones of HCV or HIV therapy.
And <unk> and also where producers have been shown to be important components in several therapeutic regimens.
Run DSIP your does target the NSP 12, polymerase and appears to provide some benefit.
It's not the perfect drugs, so theres a lot of room for identifying a much better agent by using a focused approach that we're going to use.
Great that's where that has some things yeah. Thanks for the good execution.
Thank you.
Linda to ask the question you want me to press Star one on your telephone.
Next question comes from that do Kumar with R.W. Baird.
Your line is now open.
Hi, This is Jennifer on permitting thanks for taking my questions.
Just curious as to the E cash from like that you guys at that price increase.
And frankly clinical trials right.
I'll try their current 80 <unk>. Thanks.
Yeah, sorry, you broke up on the last part of your question could you just repeat Jeff.
Yeah, absolutely on so I was wondering if p. cash runway that you guys provided increased regarding clinical trials at 80 830.
Yeah, Hi, this is Dave yes. It does because if you think about the Katherine went into mid 2021.
About wouldn't assume that we would startup phase one.
Hey, one be with our captive.
Okay, Great and then on so in terms of 86 as well do you have any thoughts on that competitor core inhibitor treatment and be discontinued.
Non-GAAP plants, you exactly the same garage kind of fun and also how do you imagine that you may need quite yet as to how long you need to go before stopping there.
So maybe you had not one to Mike first for the first part and then maybe Gaston you can talk about Atlanta therapy.
So.
Issue with with competitor compounds or you know discontinuation.
Look look we really have have had an issue with five or six we discontinued because of LT elevations, we saw and and extended a healthy volunteer study.
No.
That particular molecule was shouldn't be quite clean and safe and preclinical studies in preclinical toxicology studies al to six and nine months studies. Unfortunately, we saw clinical signal without molecule.
Not clear at this point in time, what was the a basis for that that safety signal in patients but.
No Athree six is a completely different chemicals series.
With very differentiating Oh.
Oh profile preclinical profile.
So you know, we're we're very confident that that molecules.
Is.
Oh go to provide the profile that we're looking for clinically including enhanced.
Profile against resistance as well as a much more a potent molecule overall.
Thanks, Mike and guest on just on length says therapy, I guess that we would we need to look at you know one studies stuff when we actually can feel confident about stumping capsid therapy.
Yeah. So thanks for the question. So many owe a clarification about the duration of therapy with gossiping aviator, you mean, specifically for our programs I mean, there's a general question of whether these are were.
Thinking around what will be the duration of therapy with kind of sitting hitters. So they could take sorry.
Sure I would say more that general question, Matt and space.
Yeah. So so that's a they are there rather than important question, obviously I think it will depend upon many factors I think the way we like to look at its into the fairway. One is what's the regimen, so depending on what the raising their needs and I think.
Before the expectations about the duration for example, maybe it would trade with American accounts. It maybe you need long revenue you treat with a new backup system our anyway.
And secondly, I think the other area, where we look to where we look and think about it the area what's the endpoint.
So as you know a base although discussion.
Ron and once for example, if your endpoint would be the.
The most probably irrelevant at this point, which is both shown here are the blindness.
So all right well get viable surface antigen six month up there the therapy with or without by yes.
I think that's got a little below the most challenging endpoint to obtain.
I think we everyone is thinking around somewhere between.
Here in two years of therapy, when things about softer endpoints such as undetectable R&D.
The other endpoint that people are looking at perhaps a shorter therapy would would be sufficient so I think it depends already to whats your regimen and in short what's the endpoint that you're looking for a weather undetectable are they either is relevant to take on your wrote about and going down the road.
We will translate into functional cure I think early early to it to say so we we still are speak into the.
The endpoint of.
Ill defined by the agency functional cure.
Great. Thank you so much.
Thank you.
As a reminder to ask a question you will need to press star one on your telephone.
I'm not showing any further questions at this time I would now like to turn the call back over to Dakolias closing huh.
Thank you very much and thank you for your questions. Let me close out just by thanking you all again for your interest in our beaches.
And I'd also like to repeat my gratitude to our employees for their continued effectiveness in keeping all corporate up operations and timelines on track. So again as summarized on this cool for a b seven to nine we intend to shed additional data from the 12 week a portion of the single day 60 milligram.
Sometime this quarter that Q2.
And also we continue to expect data from the 60 milligram multi dose cohort.
As well as data for the 90 milligram single dose cohort in the second half of Twentytwenty. So thanks again for dialing in and that concludes our coal for today. Thank you.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
[music].
[music].
[music].
[music].
Ladies and gentlemen.
Hello, and welcome to the Buda Biopharma Corporation first quarter 2020.
<unk> corporate update conference call.
Hi, I'm, all participants I know listen only mode. After the speaker presentation, there will be a question and answer session.
Question. During this session you want me to press Star one on your telephone. Please be advised that today's conference is being recorded if you're quite right.
It's cut size yeah.
No teleconference, yes, because today Pantheris <unk>. Please go ahead.
Thank you all good morning, everyone on the call from the Rpms Executive team, a bill Caldwell President Chief Executive Officer.
Dr., Michael Sofia, Chief Scientific Officer.
Dave Hastings, Chief Financial Officer, Dr., Gass don't Pcls Chief Development Officer.
So once again with a summary of recent accomplishments.
Any review of our viewed us as corporate objective.
Followed by Dr. Sofia, who will then describe the recently announced or if you just go get Nike research effort.
Dave Hastings will then provide a review of the company's first quarter financial results and all that open up the call for QNX.
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 timelines at clinical results for our beautiful proprietary H.B.B. pipeline achievement of the company's 2020.
Objectives, and its expected cash using 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 in the most recent annual report on 10-K quarterly report from form 10-Q, and other periodic reports filed suit.
<unk>.
With that Phil.
Thank you.
And good morning, everyone. Thank you for joining US today, we hope that all of you a well and staying safe.
Also like many of you I'm sure most of our employees are working virtually no I applaud them for their continued effectiveness in keeping all scientific clinical and corporate operations and timelines on track.
As we previously disclosed we continue to move forward without clinical development program for a b seven to 960 milligram multidose.
A 90 milligrams single dose with data expected in the second half of Twentytwenty.
We also intend to shed additional data from the 12 week portion of the single day 60 milligram cohort sometime this quarter.
Additionally, under the direction of Mike's <unk> I'm proud to say that Weve initiated already cobot 19 preclinical research efforts.
Mike will describe the program in more detail in just a few moments.
We've also joining forces with the Cobot night 19 R&D consortium.
The mission. This consortium is to shed day to find the molecules with the greatest rationale for advancement into clinical trials.
And put them into study is designed to yield the most meaningful results and the fastest manner possible.
Now given the proven expertise in antiviral drug discovery and development that exists that help you just I'm confident that it's both appropriate and important that we devote resources to address this global crisis.
That said I want to underline that our primary focus and our mission is to find a cure for hepatitis B and that remains unchanged and this is worth substantially all of our resources will continue to be directed.
And we're not changing all cash use guidance for Twentytwenty as a result about cove at 19 initiatives.
Not just as a reminder, hepatitis b remains a significant unmet medical need with over 257 million people chronically infected worldwide.
Including over 2 million right here in the United States.
Around 900000 people in the will die each year, despite the availability of vaccines.
Did you say side and interferon therapists.
These existing therapies have very low cure rate less than 5% in fact, it's our belief that in HBV cumulative regimen could substantially increased diagnosis and treatment rates.
And unlock significant market opportunities.
So to conclude my opening comments.
We remain focused on developing a portfolio of products with different mechanisms of action.
That when used in combination.
Could result in a functional cure for HPV and our objectives include the following.
First advancing all phase one I wont be clinical trial of a b seven to nine.
Second progressing on next generation capsid inhibitor ABT eight through six through I N D enabling studies.
And thirdly, continuing our research efforts for next generation oral HBV specific or and they do you stabilize them and they lead oral compound that inhibits PDL one.
So with that being said I'll now turn the call over to Dr., Mike Sofia.
Thanks, Bill and good morning, everyone.
Many of our argued his team members have a great deal of expertise and the discovery and development of safe and effective anti viral therapies.
We've been actively following the quarter bars pandemic developments from the beginning.
There are many companies already well into the race to address this global health challenge.
It's still early much needs to be dawn.
We believe we up with potentially important role to play I've developed a solid player that is both appropriate for a company of our size and one that may lead to a new small molecule anabolic therapies for chronic bars.
Regarding our internal off for.
This is a long term commitment we're not working on re purpose drugs, but rather the discovery development of new molecular entities.
Dress specific borrow targets that fit well with our expertise.
These targets include the NSP 12, borrow polymerase and the viral proteins.
These targets or a central bar proteins, which are team has much experience and targeted.
Collectively our team has been very successful and bringing novel therapies to the clinic against these types of targets for other boxes watch it such as ACB HBV and HIV.
As these targets have been shown to deliver clinical value for patients with other bars as we believe that this is a proven and potentially fruitful approach depict workwear boxes as well.
You are likely to ask how soon.
I have a lead compound or compounds to take into I'd, enabling studies and that's a hard question to answer.
The discovery process doesn't happen overnight and as I said this is a long term commitment.
In terms of our goals for a newborn.
We believe we need a drug that work effectively against a broad patient population start rapidly reduces viral load, especially in patients diagnosed with severe disease.
As a high barrier to resistance works ideally as a tank rotavirus Asia. So that it can be used in future outbreaks.
Well I also believe hitting the bars hard with a combination of agents with different mechanisms of action is likely to provide the best outcome for patients also brought patient population.
But also limit resistance.
We will be focused initially on developing single agents, which could be using resistance.
We will be focused initially on developing single agents, which could be used in combination with other new or existing therapies.
Additionally, we're gratified that there has been such a tremendous response to the called the arms and finding ways to controlled as far as.
This unprecedented situation all scientifically sound ideas are worth investigating and effort to identify something that can help patients.
As we all were more a feel we'll be able to make more educated choices or what to work on.
This is why we have joined the cobot 19 R&D consortium.
This Holly organize collaboration among top pharmaceutical and several biotech company R&D leaders as a singular focus coal.
First push for therapies of vaccines against cobot, and IP as quickly and effectively as possible.
This collaboration or abuse, we'll be putting resources at streamlining early stage discovery processes to identify novel targets in agents.
<unk> Sars koby too and other core of ours is.
We both contributing our unique chemical library for screening and then further progressing any active molecules that are identified the screening efforts.
Through the consortium, we would leveraging certain primary screen capabilities and lead optimization capabilities to identify novel clinical development candidates against both known and potentially unknown targets.
We believe our Beautys is unique position is our focus expertise and capability and antibiotic drug discovery and development that puts us in a position to rapidly advance new corona bars therapies from discovery through development.
I look forward to keeping you updated on our progress first with our own portfolio of HBV compounds, including our next generation capsid inhibitor <unk> three six our next generation HBV specific aren't easy stabilizer.
And then oral PDL one compound that we believe may be useful reawakening, a patient's own immune response to the HBV bars, and secondly, with our work on Corona boxes with that I will turn the call over to Dave.
Thanks, Mike and a good morning, everybody.
Our ending cash cash equivalents and short term investments was approximately 80 million as of March 31st 2020.
Compared to approximately 91 million as of December 30, Onest 2019.
Our cash use from operations for the first quarter quite 20 was approximately $15 million.
In addition, we received approximately 12 million in net proceeds from the issuance of shares under our ATM program for the first quarter quite 20.
For 2020, we still expect our cash used to range from 50 458 million.
And therefore, we expect our current cash runway is sufficient to fund operations at the mid 2021.
So with that I'll now turn the call back to Bill.
Thank you very much Dave and to make Sofia and with that operates in Joe well could you. Please open up the lines for question and answers.
Thank you.
That's ask a question you want me to press Star one on your thoughts on.
Well, let you guys question pest apparently please standby probably comes out agenda.
My first question comes on line non Tommy with B. Riley FBR. Your line is I love it.
Good morning, Thanks, Dan for taking my questions and I appreciate the ethics I'd go now at a therapeutics.
First question on the up the.
If you had in the 180 Meg that's made up good. Thanks could you maybe just comment on sort of how to think about this young breakdown duration, but also obviously you're not having that meant that you've seen that are that the as soon as could you maybe calculated outstanding movie.
<unk>.
Yeah, Mike It's Bill let me make a comment first and then I'll hand, it over the gas dong so.
I'm sure you've already picked up in this petite kept press release.
The there's no new news on seven to nine.
Obviously, a loss press release was March 26, I think.
We are still we're still waiting for a moving forward on is the sing 60 multiple dose ninetys single dose.
Well, what we have now said is the 12 week dates for on the 60 milligram single dose available this quarter.
So that's a slight change and the timeline for the 12 week single day 60 milligram follow up but having said that let me, let me hand up at Augusta.
Yes. Good morning, Good morning did that help you out. So the question are you have any further questions. So I.
I mean, because without that.
Well, we will update.
I think it's difficult to speculate.
Maybe.
I was just curious the with the I think wide beam bake you saw us of a deepening of this fund says even though the single dose. So I was just curious what how to think about the 60 leg should should we expect the same later I would think the that really comes with them I do does that this yet but I do.
Yes.
Yes.
Well I think we I mean, as we said by a March but before he.
One of anywhere they can you grow data being <unk> beat our expectations in terms of be durability and.
One thing is acquiring.
Oh that those so.
With with a 60 day 29, we will have the same type of that by the way. So a basically the nine <unk> with a one lately, but obviously that's why we're going here, although the subjects and I think wait to see debate that goes to conclude wherever we added.
All forward so as bill pointed out that they but now we are now that's supposed to be available in the second quarter Twentytwenty. So I.
I'd, rather wait to see that they have with four we hope that anything about the 60 of them beyond what we already that we.
29, which actually by the way I would add that one of the other striking.
Pieces of information with ride from 60 was though is extremely say some of the failed.
The level.
As you may recall, the levels, where all the normal throughout the 29 days okay.
So, let's see very so what happens with the political with <unk>.
Great I appreciate the clarification on timing and what to expect just on the <unk> and any update you could provide on the on the Undrilled then fraud.
I don't know that might be those 60 Meg.
90, Meg I, just just qualitative color would be.
Yeah, my and could spell again.
As we said it back in a much given the kind of its situation you know, we're trying to progress carefully and thoughtfully. So.
We Oh I guess, what we can't comment as you know looking at site selection and screening patient screening and you know trying to find locations, where we can conduct these trials safely from a patient protection point of view that work is all underway, we actually haven't disclosed.
Well, we've we dose to patient or whatever yet, but we are sticking to our projections that we'll have the data available in the second half of the [noise].
Great and Mike maybe a.
Switching gears and a growing Elias efforts I may have based or have you did you disclose any dog H.I. I know you said I'd be why those and you could you maybe just dog food.
Obviously, we had the lending that down about how.
The by this out those go lets say its and they decide just could you talk to what what's going to pick up relative value.
And it or how that again, good that business say for example.
There is a.
Good and could you comment on that.
Sure.
So so as far as koby, two was a positive sense already bars and and.
Specifically interested in direct acting antiviral here. So we chose the NSP 12 viral polymerase Navarro protease, they borrow proteus because they are key proteins involved in the bars lifecycle [laughter] and appear to be highly conserved across grown of ours is.
These targets have similarities to borrow one racism pretty agency with other arnie viruses like HCV, so as far as clinical agents. They can come from targeting a bar.
When rates are pretty is you only have to look at HCV, HIV or HBV, where nuclear sites, where nucleotides up and use the target the bar polymerase or viral or reverse transcriptase as backbones of HCV or HIV therapy.
And <unk> and also where producers have been shown to be important components and several therapeutic regimens.
Right. That's of your does target NSP 12 embrace it appears to provide some benefit.
Yeah, it's not the perfect drugs, so theres a lot of room for identifying a much better agent by using a focused approach that we're going to use.
Great. That's very helpful. Thanks, Thanks for the classification.
Thank you.
Linda to ask the question you want me to press Star one on your telephone.
Our next question comes from the do Kumar with R.W. Baird.
Your line is now open.
Hi, This is Jennifer on for Mike. Thanks for taking my question.
Just curious as to the cash from Mike.
Hi included.
So I guess clinical trials.
I will try their core 80 action.
[music].
Yeah, sorry, you broke up on the last part of your question could you just repeat Jeff.
Yeah, absolutely on so I was wondering if the cash runway that you guys provided conclude starting clinical trials at 80 830.
Yeah, Hi, this is Dave yes, it does because if you think about the Katherine what you into mid 2021.
That would assume that we would start if they won a one be with our Catholic.
Okay, Great and then on so in terms of 86 as well do you have any thoughts on that competitor or any other treatment I'd be discontinued.
And that perhaps you at that same logical that's fine I also how do you imagine.
Maybe quite yet or is she got how long you need them to go before stopping there.
So maybe I'm not one to Mike first for the first part and then maybe gas don't you can talk about Atlanta therapy.
So.
The issue with with competitor compounds.
Discontinuation.
Look look we really have have had an issue with five or six we discontinued because of.
LT elevations, we saw and and extended a healthy volunteer study.
No.
That particular molecule was shouldn't be quite clean and safe and preclinical studies in preclinical toxicology studies out to.
Six and nine months studies.
Unfortunately, we saw a clinical signal without molecule.
Not clear at this point in time what was the.
Basis for that that safety signal in patients, but no athree six is a completely different chemical series.
With very differentiating.
Our profile preclinical profile.
So yeah, we're we're very confident that molecules is.
Oh go to provide a profile that we're looking for clinically including enhanced.
Profile against resistance as well as a much more.
Potent volatile overall.
Thanks, Mike and guests on just on let's just therapy, I guess that we need to look at.
Studies stuff when we actually can feel confident about stopping capsid therapy.
Yeah. So thanks for the question, so maybe or clarification about the duration of therapy with GAAP sitting here. Peter you mean, specifically for our programs that you mean, the general question what is our were.
Thinking around or what will be the duration of therapy with capsid inhibitors. So they could take sorry.
Sure I would say more that a general question that.
Yes.
Yeah, so to that.
They are there rather than an important question obviously.
I think it will depend upon many factors I think the way we like to look at it it's into the fairway one it what's the regimen so depending on what the rising anyways. They are they have different expectations about the duration. For example, maybe it would trade with a new going I guess, it maybe any longer than you do trade with a new backups.
All right away.
And secondly, I think the other area, where we look to do we look and think about it the area what the endpoint.
So a deal no there's although discussion.
Right and one for example, if your and when would be the.
The most probably irrelevant the qualities both of your that buying us undetectable or a viable service out of the six month up there in the therapy with or without held by yes.
I think that's got a little below the most challenging endpoint go I think.
I think we everybody's thinking around somewhere between a year and two years of therapy when things about softer endpoints such as undetectable are they.
But the endpoint that people are looking at perhaps a shorter you know therapy would it would be sufficient so I think it depends on what's your read the men and in short with the endpoint that you're looking for a weather undetectable are they either irrelevant, because you're right about endpoint that down the road.
We will translate into functional cure I think it articulate to say so we still are speaking to the.
I'm going to have defined by the agency functional cure.
Great. Thank you so much.
Thank you.
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Thank you very much on thank you for your questions. Let me close out just by thanking you all again for your interest in our beaches.
And I'd also like to repeat my gratitude to our employees for their continued effectiveness in keeping all corporate operations and timelines on track. So again as summarized on this call a b seven to nine we intend to shed additional data from the 12 week portion of the single day 60 milligram.
Sometime this quarter that Q2.
And also we continue to expect data from the 60 milligram multi dose cohort.
As well as data for the 90 milligram single dose cohort in the second half of Twentytwenty. So thanks again for dialing in and that concludes our coal for today. Thank you.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.