Q1 2020 Earnings Call
[music].
Question <unk> session and instructions will follow at that time as a reminder, this conference is being recorded at the company's request I went out to know calling call, but to your home [laughter], Lauren stival representing that problem.
Please go ahead.
Thank you operator, good afternoon, everyone and thank you for joining Trueview does that first quarter 2020 fighting children's oak and operational highlights.
Anyone who has not yet had a chance to review our results we issued a press release after the close of trading today, which is available under the investors immediate tab on our website at <unk> Dot com.
You May also listen to this conference call via webcast on our website, which will be archived for 30 be beginning approximately two hours. After this call is completed.
Based on today's call will be they served as president and Chief Executive Officer doesn't sambo.
Well discuss what Corp progress in key milestones and provide an update on clinical development and collaborate connectivity.
Our Chief Financial Officer back Green and review, our first or financial results.
We also have Jim White, then our chief operating officer, and no Ross Campbell, our Chief Medical Officer available today answer questions during QNX.
Following our remarks, well open the lineup for your question.
I'd like to remind listeners that as noted in today's press release management will be making forward looking statements on todays call.
Including for example, the clinical development or a few days and commercial potential of no dose ran and other given all the programs research and development plans and timelines the potential for they turn out to continue to add programs and extend the reach of our technology to additional tissue.
In terms of discovery research and her clunker program expectations related to our collaborations with Novo Nordisk Roche fully Uh huh.
Your ingelheim, and El Nio him and the potential for future collaboration.
And there's no financial condition expectations about current or future clinical data and timeline collaboration funding expenses and cash usage actual results may differ materially from those vacated by these forward looking statements as a result of various important factors, including those books got no risk factor section.
This turned his latest forms 10-Q, and 10-K filed yes, you see.
Well, we may elect to date. These forward looking statement I'm pointing in the future. We specifically disclaim any obligation to do feel if our views changed now I'd like to turn it over to does their broker they served as president and CEO Doug.
Thank you Lord good afternoon, everyone and thanks for joining us.
When I put forth our vision for 2020 in our last quarterly call in February I said that we were starting the year with substantial momentum at the plant and expectations to accelerate that forward progress over the course of the year with multiple important milestones across our clinical development programs organizational growth maturation.
And continued progress with our corporate collaborative alliance.
With the very rapid spread Covance 19.
Came evident in the weeks thereafter that this public health of urgency wouldn't impact nearly every aspect of like global scale, including drug development and including Dykstra.
Well, we have made adjustments to our clinical development expectations and argue they work processes like most of the industry I'm very proud as the incredible work that our dedicated employees have been able to accomplished during this highly uncertain.
Challenging time work that has enabled us to continue to deliver on nearly every aspect of our business within our within an hour and you get control and the plan to prepare and put in place measures that we think should enable us to rapidly move ahead on all fronts. Once currently restrictions are lifted in the various territories.
Across the country and around the world in which we conduct clinical trials source materials and otherwise conduct our business.
With T.I.T. infrastructure and support systems already in place.
Anthony why transition to remote work from mid March was a smooth.
And we've been successful in implementing staggered work schedules inappropriate social distancing for last personnel and other stuff, whose presence has been required.
Cool onsite work.
The entirety of this experience has brought a finer appreciation for the quality of the individuals who make up that sir.
There are some of the best in the business and I am inspired by I'm proud of this team's dedication and ability to adjust to the uncertainties that this pandemic has presented.
Despite the challenges that we are undoubtedly still to face from the virus on a macro level, our strong cash position business model and our people position us well to keep advancing and building upon our recent accomplishments.
The most recent of these with the announcement of two new agreements with El Nio them in early April adding to our portfolio of collaborative arrangements with some of the world's leading biopharmaceutical companies.
These agreements El Nio and I started I have reached common ground that will enhance and accelerate our ability to bring new orphan product candidates market.
Great outcomes for both companies, but above all a great outcomes for patients.
The first of these agreements pertains to than it does around our lead clinical candidate for the treatment of primary hyperoxaluria or ph and ultra rare life threatening genetic disorder that initially manifest as complications and the kidneys.
Our agreement with Alnylam for P. H is a straightforward nonexclusive cross licensing arrangement that relates to both our and Alnylams intellectual property in simple terms disagreement ensures that each party has full freedom with respect to each company's patent portfolios to develop and commercialize.
Our respective investigational rnai therapies for ph and arcades those around targeting the L. D H aging or P.H. types, one two and three and and Alice case, Siron, which targets. The H one machine for ph type one.
As a result of this cross cross license Alnylam will be obligated to pay us mid to high single digit royalties on worldwide sales alumina serum from launch.
And we will be obligated to pay El Nio low single digit royalties on sales of the does around.
We're very pleased with the outcome of this agreement and our gratifying to be any positioned to benefit financially and add a respectable rate from sales of Alnylams candidate well at the same time advancing our differentiated product candidate intended to benefit all patients with ph, regardless of mutation or type.
The second agreement without line item relates to 80, 180 and is a global development and commercialization collaboration that underscores our commitment to this underserved patient population and our conviction and Arnie I asked the optimal modality to treat patients with the liver manifestations of the disease.
118 deficiency is a genetic disorder that causes accumulation of Misfolded, eight 180 protein and deliver which can lead to serious liver disease, and jaundice liver fibrosis and cirrhosis.
There are currently no approved therapies to treat liver manifestations of eight 180 and management involves lifestyle modifications and supportive care.
Patients with advanced disease may require liver transplant.
Under our agreement with Alnylam, we are taking responsibility for their candidate molecule AOL and 82, which like our own is any phase one slash two clinical trial for the treatment of a 180 deficiency associated liver disease.
Her the agreement we intend to take forward the best candidates for these patients based on our evaluation potency safety and development timeline of the two drug candidates.
I will lead development and U.S. commercialization of the selected Canada and Al Mylan has the post pivotal opportunity to opt in for commercialization X U.S.
If alnylam exercises its option right, we will pay each other tiered royalties on net product sales generated in our territories at rates dependent on what candidates. Ultimately commercialize. This means that first alnylam would pay dice are not low double digit too high teens royalties.
And we would fail mylan low single digit to high single digit royalties.
It's alnylam does not opt into its commercialization right, we would retain worldwide commercialization rights in exchange for milestones and royalties also at a rate dependent on which candidate we move forward.
And we would have the ability to partner with another company on X U.S. commercialization.
We're very pleased to now have these two agreements in place enhancing and accelerating our ability to bring these were print product candidates market and in the case up the cross license putting to rest the potential for costly litigation related to our respective IP for our P.H. candidates.
Turning to our pipeline in late March we provided an update on our response to the pandemic and its projected impact on some of the trial supporting our core clinical programs.
Well there are some new updates to share today, they are incremental as the corona viruses impacts and governments responses around the world vary in terms of timing and execution.
Part of those around our Fioptics two pivotal trial continues, albeit at a slower pace and not be outside of the year.
Underway in multiple countries around the globe trial enrollment for Fioptics to has been subject to government responses to the realities of the virus its impact on a local level with clinics responses and actions varying from location to location and overtime.
As of March we gauge. The then current expectations around the pace of enrollment at each of the sites and as a result withdrew our previous expectation for enrollment completion in the first time.
The critical team at dice Sirna led by Ralph Ross Cam has done a remarkable job of staying on top of the situation at each trial site and that's been working with investigators local institutional review boards and regulators in an effort to maintain continuity of care for patients currently enrolled and reflects two pivotal study.
We have been implementing emergency protocol amendments to allow patients to continue this study with nurse administered who based dosing and Tele health safety follow ups with investigators which began in April as a result of these efforts all previously enrolled patients have remained in the trial.
Full resumption of enrollment will be on a site by site basis. Some areas, we'll open up sooner than others as of today, we have begun to see certain sites impacted earlier in the viruses spreads starting to take steps to continue sourcing and screening possible ph patients as of now we believe certain.
Key European and U.S. locations could be back online and enrolling within the next few weeks.
That said it is too soon yet to provide a revised timeline estimate for completion of fioptics to enrollment or to ascertain the impacts to our in D.A. submission timing. So we will continue to closely monitor the situation and provide an update when we have greater clarity.
Also impacted by Cobot 19 is initiation of our planned supplemental plaques trials, namely Fioptics for seven which were expected to begin in the first half and Fioptics eight which we have plans to initiate in the second half of this year each subject to regulatory approvals.
At this time, we do not expect Fioptics, four and 567, we'll be able to initiate as originally planned and we are gauging our options for Fiat skeet initiation.
At the current time, we believe that data from these studies will be available for inclusion in the end da However, none of these studies are required for Andy a submission.
But they are nonetheless studies helpful to characterizing the dose, Iran and our of continued interest to us as they made there on the potential drug label.
For all it is too early to give reliable expectation for study starts so as would finance to we'll continue to monitor the situation do what we can to prepare to initiate when feasible and provide an update when we have a clear line of sight on timing.
Our fioptics three multi dose long term safety trial continues to progress with nearly all patients who required an alternate dosing arrangement due to save restrictions now having transitioned to home based dose administration and Tele health follow up by investigators for most future visits.
As of May 4th we had 17 patients enrolled at Vioxx three up from 14 patients that were included in our March interim results analysis.
As a rollover open label multi dose study greater visibility into those are in safety and efficacy with long term once monthly administration will only expand as more time lapses in the Fiat three trial, but we are nonetheless, very encouraged by the results we saw for the first interim.
Analysis at March.
Of the for patients who had been dose for at least three months.
Three of which are type one patients and want to patient.
All four had normal or near normal urinary oxalate levels on at least two visits and the does ran a pure generally well tolerated with no injection site reactions and no drug related severe adverse events.
At that time total patient exposure had reached nearly two years in the Fivex three trial.
The medical conference OXXO Europe.
Originally planned for the first half this year will now be played taking place in December so instead of that venue, we plan to move forward and present data from plaques three on our own as part of our R&D day planned for August the timing of which should provide us with a much more mature and robust dataset.
To present relative to our preliminary interim results in March.
From a commercial preparation standpoint, we continue to put in place and roll out key infrastructure that we will need for the planned launch of the dose, Iran and are continuing to selectively higher for key roles.
Clearly visibility on timing around the finance to trial and to what extent the slower pace of enrollment will have an impact on timing of R. and D. Ace admission are in mind as we move forward with hiring plans, but we are continuing to add people to the team at appropriate times. So that we will be ready to move ahead once we have greater clay.
Parity on key milestones.
Turning now to Alpha one antitrypsin or eight when 80 deficiency associated liver disease program.
With the anti Trust analysis completed as of mid April and the agreement with Al I loved now effective we have already begun a deeper dive on the data and profile of a L and 82, which will help inform our next steps and evaluating both AOL and 82.
And our own a 180 phase one slash two candidate DCR Eighttwenty tea, which received orphan drug designation from the FDA in March.
We plan to conduct a certain nonclinical studies of AOL and 82 in the near term to better inform our selection between AOL and a geo too and TCR, a when 80 for further clinical development.
We expect to make a selection prior to the initiation of the patient cohorts of the phase one slash two clinical trial program and to advance only one candidate into patient testing.
As we have previously stated we believe our phase one slash two trial will be sufficient for subsequent advancement to pivotal clinical development.
There are currently no approved therapies, specifically designed to treat the liver manifestations of this condition and we strongly believe that with this collaboration for a 180, we're better positioned to advance the candidate best suited to treat patients with this disease.
Following our business update in March enrollment in healthy volunteers portion of our ongoing phase one is less to study of DCR, a 180, plus functionally paused as a result of site restrictions arising from Covidien team would follow up continuing for the current dose cohort.
About a week ago, we've received very encouraging news that certain sites will be in a position to begin enrolling healthy volunteers and the next dosing cohort in the next few weeks.
The net effect for us is that assuming there are no new developments with Covance to change plan dosing in the next cohort should be gated only by the pace of participants screening and enrollment.
Well pleased that we are gaining some clarity on trial continuation for DCR, a when 80 safety for those participating in our trial remains Paramount and we are taking additional precautions in an effort to safeguard their health.
As the trial moves forward any participants presenting with covance like symptoms will be tested.
And the event a participant is diagnosed with Covance 19 post dosing they can receive augmentation therapy, if they're a 118 levels are low.
Despite this positive news for now we are unable to give guidance on completion of the healthy volunteers portion of the DCR eight when 80 trial or the initiation of patient dosing with either Aon and 82 or DCR a when 80.
But we'll continue to monitor the situation gauge our progress and plan to provide updated program timelines at a later date.
Now turning to RG 6346.
Third quarter development program that we are developing in collaboration with Roche Archie 6346, as a galaxy based investigational treatment for chronic hepatitis b virus infection serious liver infection that can result in advanced liver disease or liver cancer, if not treated effectively and which claims more than 800.
And 87000 lives annually.
We are currently conducting a phase one proof of concept study patients with HBV.
As I summarized on our last call. This trial comprises three groups.
A composed of healthy volunteers, which was completed last year group b in patients newly diagnosed with chronic HBV, who aren't naive to standard of care with nukes, and who agreed to forego initiation of new therapy for 12 weeks. These patients receive a single dose of RG.
346 and groups paid in patients previously treated with news and who received four doses of RG 6346 group. She has three cohorts at ascending dose levels.
Patients in group B and C are eligible to enter into an extended follow up observation period, if they achieve reduction of hepatitis b surface antigen greater than or equal to one log from baseline and have reached the end of the formal study period, just 12 weeks for group B and 16.
Thanks for group seat.
As noted on our last quarterly call multiple patients have entered the extended follow up observation period, including representation from both groups B and C.
Note.
Each of the three group seed cohorts consists of four patients treated with RG sixthree for six and two placebo patients now specifically three out of six participants in the 1.5 milligram per kilogram dose cohort and four out of six participants in the three.
The point O. milligram per kilogram dose cohort have entered this conditional on what period.
It's too early to say for the 6.0 milligram per kilogram cohort.
The longest follow up at this point is seven months after the last dose of RG Sixthree for six and obviously that individual is in the 1.5 milligram per kilogram cohort.
All of this said the trial remains blinded and we do not know what treatment regimen patients are receiving but we are nonetheless encouraged by these observations.
The study continues to progress toward completion, though at a slightly slower pace due to cobot 19 impacts.
This may need that we could end up with two or three patients out of the 26 patients planned for groups B and C that will not have completed the formal study period prior to the interbreed for our August R&D day data presentation.
However, these patients are not gating to roche's plans initiation of combination studies and will not impact overall program timeline.
Rounding out our planned presentation at our August R&D day will be new data showing the application of our galaxy platform to other tissues first and foremost the CNS. It will be our first presentation of data and tissues outside the liver we are looking forward to it.
From a collaboration standpoint.
The first part of the year has been quite productive our lab activities have proceeded onto her and essential worker exemption. During this mandatory remote period and we have continued to make good progress in support of our collaborative arrangements first Lily are correct collaboration with Lilly has been moving along well with their.
Second during the quarter of their second county that now named a why 3819469, which advanced preclinical development at Lilly for a cardio metabolic indication.
Lily also remains on track to submit a C.T.A. or I N D. By the end of the year for their first Galaxy candidate Al why 356, and seven seven core.
Second Aleksey on Oh, let's see on its acceptance of our clinical candidate nominations for TCR comp one than DCR comp to earlier this year triggered their progression to the manufacturing and preclinical development phase.
Third.
Well it has literally been just a few months since our agreement with Novo closed the collaboration is making good progress and the initial targets have been selected.
Fourth.
Our discovery research project with bearings, our ingelheim remains on track.
And finally I'm pleased to also note today that Roche has formally nominated the first selected target under the discovery research portion of our agreement deepening our collaboration in HBV as a reminder.
Gross had until receipt of the phase one data from the Archie 6346 study to initiate a research and development collaboration program to select additional targets related HBV.
We are pleased to now take this next step with Roche and include them among our portfolio of collaborative partners engaged with us in the identification and development of new Galaxy molecules.
At this point, we have now delivered five galaxy development candidates, who our partners underscoring the speed and efficiency with which we can turn out new galaxy drug candidates.
Compared to 9.7 million for the first quarter 2019.
The increase was primarily due to employee related expenses related to the increase.
Just headcount to support on growth.
We expect.
C.N.A. expenses to gradually increase in 2020 as compared to 2019.
Largely due to investments in staffing and market readiness activities.
During the first quarter 2020, we recognize 34 million in revenue from collaborative agreements with no vote Roach little.
<unk> Alexi on N.B. I.
Compared to 3.1 million from Lilly Alexia on N.B.I. collaboration than the first quarter of 2019.
Has a much they're pretty first 2020.
We had approximately 500.
$51.1 million of deferred revenue want to have balance sheet.
Representing the aggregate transaction <unk>.
Ice applicable to future performance under our company under our company's collaboration.
Of that Wow, approximately 223.6 million was current deferred revenue expected to be recognized as revenue over the next four quarters.
Approximately 327.5 million was noncurrent deferred revenue expect.
And to be recognized as revenue in future periods.
That's a no regarding the 223.6 million that we expect to recognize over the next four quarters. This is not to be there. This is not a straight line recognition, but ramps substantially next quarter.
More or less levels off over the next three quarters.
Let me take a minute to walk through the components of deferred revenue by collaboration.
With the election on collaboration to Fred revenue totaled approximately $65.2 million with.
36.8 million classified as current.
And the remaining 28.4 million classified as long term.
We expect the majority of the deferred revenue to be recognized through the second quarter of 2022.
Deferred revenue at March 31st 2020 includes $15 million and <unk>.
Search milestones achieved are likely to be achieved.
For the lowly collaboration deferred revenue totaled approximately $126 million with 45.5 million classified as current.
And the remaining 80.5 million classified as long term.
We <unk>.
In fact, the majority of the deferred revenue to be recognized stood the fourth quarter of 2022.
For the Roche collaboration.
100 and 108.
A million was recorded as to for revenue as of March 31st 2020.
Oh that I'm out 106.6 million. His class is classified as current and expected to be recognized as revenue within the next 12 months.
Primarily associated with the completion of phase one study of a g. 634 sex.
We expect the balance to be recognized as revenue during the remain it remained or a three year research term, which is extendable by an additional two years up to treat.
Yes.
<unk> the Nobel collaboration 100.
77.6 million was referred was recorded as to for address.
I mean, new and March 31st 2020.
That I'm out 33.1 million is classified as current and expected to be recognized as revenue within the next 12 months with 144.5 million.
Expected to be recognized over the remaining remaining portion of the five year research term, which is expendable by up to two years and finally <unk>.
Wave that our cash cash equivalence unhealthy maturity investing [noise].
And expected revenue from our existing collaborative <unk> agreements.
We'll be sufficient to find our operating plan into 2023.
This plan includes our expectations too advanced and it goes to Iran to have that they'll development.
Regulatory filing and potential commercial and watch.
Completing the proof of concept study about G. 634 sex in participants with H.T.P. infection.
Conducting non clinical studies of A.L.N.A.T.O., two and advancing either A.L.N.A.A.T.O., two or D.C. or eight 180 through the phase one slash two trials.
Initiating and conducting research and development programs with our collaborative partners.
Finally, as we did not press release. This afternoon, we believe I supply of investigational medicines sufficient to support Mindblowing.
Ongoing clinical trials, and then I supply chain today is fulfilling our requirements across all programs.
We have also taken steps to mitigate potential future impacts to the supply chain by purchasing critical materials and drug substance ahead of near term requirements and by engaging alternate alternative suppliers.
As a result, we have been able to increase our stock in the key materials required to meet the needs of the company and a collaborative partners through <unk> 2021.
With that I would like to turn the call back over to duck.
Thank you Jack.
Are we in the World continue to face uncertainties brought about by the code that night pandemic. There are steps that we have and will continue to take as a society.
Haiti and here at that certain up to prepare for the future we have grown substantially over the past year, yet we remain the nibble company with an honest.
The neural mindset flexibility to adapt quickly to changing circumstances. This coupled with our business model that Mary's together risk mitigation diversification insignificant roads potential as well as our strong cash position all.
Dice or not with a solid foundation, so not only face what lies ahead.
But to enable us to thrive succeed.
With multiple data presentations at our upcoming R.I.D. day in August and.
<unk>.
Oh, the healthcare community, making it possible for scientists and others within our industry to continue to work necessary to create and provide new medicines here in Massachusetts and beyond we applaud you.
<unk>.
For your sacrifices and selflessness.
I would like to now open the call to questions.
If he would like to ask a question. During this time simply quite star followed by the number one on your telephone keypad I forget his star one <unk>.
Yeah.
And you have a question from at art off H.C. Wainwright.
Mm.
Hi, good afternoon, everyone. Thanks for taking my questions and.
Congrats on on a a long series of continued progress through you're <unk>.
The client.
[noise] so first of all.
I I know you're wanting to some links in your prepared remarks dog around the data redoubts anti r. in the past me General now that you have both.
Candidates for any.
When A.T., but I I was hoping you could just further clarify how you see that rolling out to the point.
Where you have a a decision node to make to go with one or the other.
So and I I'm not sure I can give a lot more insight into our selection process.
At this point because we're out very early in the process as you could appreciate so we completed the anti trust analysis, there had been limited data sharing.
Reflecting the potential for us remain competitors in that space and so we are only now I'm doing a deep dive on.
L.N.A.T. to.
I expect that it is going to be some number of months.
So not weeks is not years during which will make the decision and <unk> one's thinking about critical path kind of mine.
We are hoping that in the event, we choose D.C.R.A. 180, either.
There is no divergence from our critical middle Pine path.
So I think that set this up for a decision later this year.
<unk> as I mentioned, you know in in the prepared remarks based on the safety the potency and the pilot.
Extended follow up I, I think I Miss those numbers could you repeat those again.
Sure we gave numbers for the first two or three cohorts and group C. 1.5 milligrams per kilogram, where three or six participants went into extended observation and a 3.0 milligrams per kilogram code word.
We're for up to six went into a extended follow up and noting that only for a six patients in any given cohort receive acted drug in there to to see them.
Excellent.
And then.
The announcement today.
<unk>.
Decided to select a first galaxy target I just wanted to make sure I believe from.
The terms of the agreement there were up to.
Two candidates that could be selected.
Is that right.
I've got the architect deal here, so Jim Yeah, it's good to talk to your it's your wife's Niger.
Actually they they they could select up to five.
And move three four that's the that that's the general structure, it's pretty soon.
Okay.
And then men last week, just a quick question.
On your R. and D. day in August I know that you're still waiting to figure out whether that will ultimately be in person in new york or or virtually.
Can you say that that would be some time in sort of second half of the month.
No I think it'll probably be towards the beginning I mean, we have.
I just sort of her Sammy wait how did we targeting six.
<unk> I know, there's so much debate on what part of the genes targeted for the H.B.B. program and even various companies fall out very differently on this debate and that.
That's fine I guess from our perspective, it'll be very helpful to here you set the expectations appropriately heading into.
<unk> and I had a three part question if I may it's all about the same thing.
So you get very helpful numbers, obviously on the each of the cohorts and M- M- one thing I.
I'm wondering is.
You do have data on some patients up to seven months out can you speak to whether the surface antigen log curve rebounds, or it's more or less durable off at least two log reduction after you take the last us first.
Second your expectations for the depth of production do you think you can hit three log reduction plus consistently multiple patient.
That's because you probably have that on a blind invasive and and finally, just very quickly. If you could remind us if you have both e. engine positive as well as the out as a negative.
Patients. Thank you very much.
Oh sure and thanks, I should be all the call over I I can't answer all all of your questions, but just answered the first two [laughter], so and three out of four so as as you are aware of a we chose to target virus and a different place.
Leads the X. Jean.
On silenced and we did that based on what we believe is the highest banality mouse model now their lives mouse model, whether it's going to translate into humans is.
Course, a experimental question at the clinic craving to look it up we're gonna find that out.
But we are targeting every age.
Transcript that makes s. and so I've always had a lot of confidence that that would very unlikely that that we would do more costly than another program that targeted.
Issue in an additional transcript that parking and they're different brodie.
So I think that the first.
Vacation I that is you know, which do no worse than anybody else, even though we are doing one last Jean now when you look at the behavior on that model, we see a marginally higher suppression s. and we see extended duration before there is a rebound.
The to win a particularly with <unk>.
You're a 1.5 to two logs.
And so I think it would be optimistic Ah overly optimistic for us to set an expectation of knocked down that in addition to that would be very nice if that.
If that's to be seen.
Three logs would be extraordinary we can always keep our fingers crossed but I think that is particularly aggressively optimistic and on the final question. He.
Positive in any negative we do have both in the trial, but we don't have a fixed ratio between them. It's just.
Noted when patients animal.
That's really really helpful dog. Thank you so much.
Mm.
And next question is from your Ron <unk>.
This is brendan on for your think very much for taking a question and not say I actually just wanted to ask to really quick one first just about the R. and D. day later in the air and the look at that file X. three data. He just can't give us a quick sense of what kind of data we might expect them, how many patients numbers and kinda like to read.
That you're you're thinking we might have by then and then my other question is actually I think you mentioned that how you've been able to keep.
Oh, you're currently enrolled patients maintaining their treatment ongoing fireworks trials that things are pretty exciting is this something you guys are kind of considering exploring a little bit more moving forward that you would maybe consider taking into a package at some point, it's not just want to get your thoughts on that thanks very much sure thing I think should island on bread, then let me pass.
To my colleague, Ralph Ross Cam to address or.
Blacks three data on D. day in and maintaining <unk>, yeah that they probably aggressive as near her because they have 70 patients enrolled into pirates. These Bobby.
And.
<unk> look at the day that what to expect them in August.
What are these back the majority of patients of course to have more than <unk>.
We see Oh <unk>.
And we have our first those thing in October all flat yeah.
Yeah. So we expect also a good amount those patients to have that takes at least six <unk> <unk> <unk> <unk>.
Which will give us a good read how that would look like in the two one body. So I think it will be much thought fashion show that in but at least that and then and March right. There on your report from all patients who had at least three months.
Say that so we will have a a more substantial haitian and hadn't paid off at at this time.
The second part of the question of why we haven't lost a annotation, we weren't kind out in lucky situation that we had already bowling lures that's fine too.
Each our patients because we have those homes versus coming to the patients Oh.
The day when they include <unk>, that's fancy follow you around so that when who with and it was a training how what to do but not to do and they came back next day.
To actually they collect that's ready for all your then shift the euro so where are the very unfortunate situation that we had already this homers Adam and.
Alan trials, so what we needed to do it is with a whole nurses.
You made the protocol a management, allowing nosing my whole nurses and taking lots of imposed by Oh.
Nurses to adequately trained the nurses, but they were already have time, they some of that and then use the patients already.
They made it much easier for a lot our company's who didn't have that Adam and and in that trial.
Oh is that answer your question.
Yeah, I guess I was just kind of curious that this is this idea of at home administration, you know maybe on a more commercial basis or something you're looking to explore and moving forward or but that that's not really a priority right now.
Well, we always had the that Fine act. The initial six months three men in dollars I hope wines as you've a control wow.
Random patients rolled over it and how long term trial that patients that and then is that Oh, Oh, because we have this right now is easy fix those rachaman.
And it makes it easy easy <unk>. So that's nine always was to to hack home administration in a row over three along party.
Okay, great. Thanks very much.
[laughter].
Yeah next question is from Stephen really a faithful.
Yeah that you're taking the question is a couple quick ones for me. So you respect to the additional targets that Roach, so I couldn't afford.
Have you indicated as to whether or not those are those are all viral targets per se or is rochelle potentially interested in some some of those targets as well.
The.
Discovery collaboration is primarily focused on hosts Atari.
And.
Just with respect to the I guess the warm undisclosed litter program that you guys still have earmarked to the pipeline.
<unk>, we hear a little bit more about what that program is and then and what the cleanser.
I think it's gonna be next year, I I realize maybe a little bit frustrating. It's it's.
One thing about that program that I think it's important strategically for people to understand is that it's not a rare disease program and.
Putting it on a pipeline, even though undisclosed we are signaling that they start.
It's going to be going after both rare and not rare indications that need our criteria, which include what we believe is on usually high probability of success in the clinic and innovative approach to Ohio that medical neat.
So it's got it's going to stick their as a undisclosed for a few more quarters and I'll be 2021 before we.
<unk>.
Mm.
And your next question is fun money <unk> S.C.D. Eric.
Oh good afternoon, everyone. This is our <unk> I'm just too quick one's an R.N. We were wondering if we get further details on the elite collaboration so again, you're broadly house meeting about the timing of silent Association and the scale of potential economic milestones and a second question is for the A. One A.T. program since you guys.
Be carrying the expense, citing the collaboration how should be thinking about the scale, let me forward.
Alright, Hey, this is jam all into the first question you know, we're gonna leave the target unveiling to our partner as would be customary.
A pivotal development and with the assumption of responsibility for A.O.L.N.A.G.O. Two there is some increasing expense, but because we are only planning to event. It's one of the candidates to patients testing.
That incremental spend it is relatively modest we are initiating sell nonclinical studies have A.O.L.N. Ah A.T.O., two and that's in the single digit millions a expense that will be on top of our development program.
Otherwise I I don't have handy, what we would project the costs through approval.
And I don't think that we uncertainty on on that total cost but.
Going to be.
You know other similar or to the P.H. program expenses that we have face than that to the only program.
Great Okay.
Yeah I know other question then keys.
Alright. Thank you. Thank you all for joining us today on our first quarter of 2020 financial results in business update.
Look forward to our next quarterly updates.
And then it's like you to join US for our August R. and D. day for which we will provide more details from details as we get closer to the date, including the daytime in format. Thank you for joining today's call.
Wow.
Made is in general it's going to today's conference call. Thank you for participating me you may now disconnect.
[noise].
[laughter].
[laughter].
[laughter].
[laughter].
[laughter].
[music].
[music].
[music].