Q2 2020 Viela Bio Inc Earnings Call
Good afternoon, ladies and gentlemen, and welcome to the yellow bio second quarter 2020 earnings conference call. At this time, all participants I notice and only mode. Later, we will conduct a question and answer session and instructions will be given at that time as a reminder, this conference call is being recorded.
I would now like to hand, the call over to Mr. Mitchell Chen Chief Financial Officer at Yellow Bio. Please go ahead.
Thanks.
Or the one to our second quarter.
I think 20 earnings call countries with pretty good financial results is available on the Investor and media page of the put their job site.
[laughter] W. dot dot dot com.
Good evening on this call today are bingo, chairman and Chief Executive Officer, and dropping Chief Medical Officer, and head of R&D and they break it Vice president.
Head of commercial.
Actually my guess would be making forward looking statement regarding our finished.
In addition to regulatory.
Development and commercialization plans and research activity.
Statements are subject to risks and uncertainties that may cause actual results could materially differ from those forecasted.
Description of these risks can be found her most recent form 10-Q, one filed with the FCC.
Like many other Pearson to pharma.
Oh pharma sector.
Continue to closely monitored the situation around to cope with Nike and done it including the associated restrictions on travel and what has been implemented let's call it depends what impact on our business, including correct.
The full extent to which could be Nike may impact, that's ultimately depend on the future development, which of course, but highly uncertain and cannot be predicted.
This includes new information, which may emerge concerned that the duty that the credit card and the actions to contain pulled in 19 accreted in park among others.
I'd like to turn the call. It two bingo proceed.
Thank him each good afternoon, everyone. Thank you put your announced today.
It has been quite a busy and productive time at a viola seats were reported I will first quarter earnings be domain.
Just several weeks I forgot to call on June 11, we announced our first U.S. after the approval of up and useless also known as kind of visa ma'am.
Which is now available for Dallas, witnessing ammo anstey core anti <unk> antibody posco.
This of course would not have been possible without taking investigator listened to patients who participated in momentum trial.
Shortly after the approval, we deployed a talented and experienced commercial team under the leadership of Bill recruits who will provide further detail on launch progress during today's call.
We got approval coming into the appeal and the second quarter I'm pleased to see that our launch is off to a slightly to start.
Why reinsuring brand awareness and a patient access I would tell priorities. We're also preparing to initiate a phase three trials with automobile map democracy geographies and I told you for related disease.
Both of which I assume you're autoimmune disease with limited treatment options.
Turning towards the restaurant of our pipeline you might we reported positive interim data from our piece one be study of me I'd 773 or four.
Since then well be paid additional efficacy in a biomarker data unquote, three which confirmed highly efficient PDC depletion in tissues and clinically meaningful reduction in classy scores.
These are resolved formed I won't get selection of FLT, that's where indication for the investigation, yeah phase two trial.
You aren't crop on our Chief Medical Officer will provide further detail on this trial that will be available to take your questions later in the call.
At this moment in time, we remain unfortunate to that they're called 19 pandemic has had limited the effects on our operations.
While were you able to get it back to I walk he sees it gives us broken or walk meal, we have extended I wont work from home policy and I encourage you are we employees to do the airport by closely forming telephonics already cognoids.
Yeah. So you may recall.
We made a decision to temporarily Haas, new patient enrollment if some of our clients you ought to prioritize precision health and does that have the investigators at our clinical trial sites.
We have resumed enrollment our piece to Kyle in kidney transplant rejection, we we IB 49 20.
And we are planning to museum others in Q3 Q4 this year.
Even so covered 90 remains a series public health concern and how it will take US no long term, it's still unclear.
Given our deep understanding of the immune system and our commitment to the patients. We felt you know what our duty to investigate a ways our product candidates March serve those affected by the corner virus.
To that and we plan to initiate a phase one trial Weve re IB 773 pool, which has clinically samaras speaking or ability to regulate kit inflammatory mediators.
The trial would be in patients with come to light here when they did acute lung injury. Yeah. We'll also touch on this trial neither during today's call.
Looking toward our objectives for the rest of the under beyond we are critical to our your best with age with strong support.
We recently raised gross proceeds of approximately 106 $9 million you won't underwritten public offering which was what I will conoco and a commercial execution, while extending our cash runway into 2023.
With that I'd like to kind of the call over to fuel Rickey Vice President head on commercial to provide an overview of our product launch bill.
Thanks, Greg as you just heard this is an exciting time, ICSI Ayala and for animal Westy patients.
Before I get started I want to acknowledge our launch teams who have been doing an incredible job and driving education and awareness of up list.
Despite a very trying external situation with patient visits being down and most offices operating remotely which has made communication and coordination within the office more challenging the launch is progressing as expected with policies being created and former reviews ongoing and we will continue to adapt to the chain.
Aging external environment.
For those unfamiliar with animal Estee. This is a progressive debilitating and potentially fatal neuro inflammatory condition.
Patients experienced unpredictable attacks or relapses that affect the optic nerve and spinal cord, which can lead to permit blindness and paralysis.
Despite the relative rarity of this disorder significant unmet needs remain and we believe up listener could potentially help thousands of patients with animal what's the in the U.S. as well as globally if approved outside the U.S.
Oh listen, though is the first and only be sold to Peter approved for adults with animal Westie, who test positive for the acute before antibody.
And then a body commonly associated with this disorder.
Eight U P for positive patients represent about 80% of the animal west eat population.
We believe uplifting the has a strong product profile was several factors that make it very attractive its potential first line treatment in this patient population.
Beginning with efficacy in our and momentum trial, 89% of patients treated with up listener as monotherapy. We're a tax free at the end of the randomized control period and patience on up listener had an overall reduction in hospitalizations importantly, Oh listen it has a favorable C.
The profile and does not have a black box warning.
Another key characteristic of up listener is its dosing schedule.
Listen all patients are dose on day, one get another dose two weeks later and then come back every six months, which is typically in line with the frequency in which many animal study patients see their doctor.
Finally, Oh listen there is a b cell depleter, a mechanism with which animal west be treating physicians are familiar with and up listener has been engineered for efficient b cell depletion be a CD 19.
No other animal what's the treatment option can offer this full set of benefits.
We know that a successful launch is contingent on having all the necessary pieces in place.
When formulating our strategy, we prioritize three components education.
Access and structure.
Well each place a different role in the launch all are essential for filling our vision for up listener and delivering on our promise to patients.
It starts we understand your customers and education.
We have already established solid relationships with top experts and advocacy groups. In addition to having conducted extensive market research projects to better understand how health care providers payers and patients think about animosity and how they manage this condition.
This strong baseline understanding has allowed us to create impactful educational programs, they're able to be deployed in both face to face and virtual settings.
This is very important given the changing external situation and the different parts of the country are opening up at different speeds.
For example, our peer to peer programs, which are traditionally conducted face to face are now also being conducted virtually along the broader array of health care providers to understand the benefits of listener from animal Westy expert.
We're also working closely with several patient advocacy organizations to provide virtual education initiatives about animal west the to their members via social media channels.
For every launch gaining access is critical to success.
Our payer team has been able to meet with most of the top payers are ready to share information about the burden of Dynamo study and provide our clinical presentation of up listener with the remainder of these payers being primarily scheduled before the end of the month.
We have already filed for our he expects code and we're expecting to hear back from CMS around the ended the third quarter.
Overall, we are progressing as planned on an access from.
To help patients getting access to help listener, we've established our hub yellow VIP.
The yellow VIP since the support program for patients caregivers and health care professionals offering educational resources.
Financial assistance and insurance information to help them with one on one the sport.
The alibi it was committed patient access and we'll continue to partner with payers to establish coverage for patients given the strong value proposition up listener provides.
Last but not least you structure.
We needed to have the right people in place and a culture to support the success of the cheap.
Hi. This is our first product launch we had the unique opportunity hand pick a team dedicated exclusively animal westie.
We put an emphasis on experience prioritized in rare and neurological diseases.
We assembled season teams, including market access and sales representatives, along with the medical affairs MSL team, averaging over 15 years of experience.
We instilled in the line vision and a strong sense of collaboration among the teams while providing each with a set of specific goals to support our launch.
We believe that focusing on these three pillars has allowed us to be well set up for a successful launch.
No. It's early days in the launch based on the song efficacy and safety profile as well as twice a year maintenance dosing, we believe up listen, though will be an attractive first line treatment option for animal SD patients.
Our aim is to help prevent future animal us the attacks, which may lead to permanent disability and we believe that up listener will provide significant value to the animalistic community in this regard.
Prior to receiving approval, we conducted market research with over 75 academic and community based neurologist, who treat animal less eat better understand their perceptions and behaviors when managing this disease.
In this study we learned that nearly all the participants viewed the efficacy and safety profile of up to snuff positively with 99% of neurologists responding favorably to the efficacy profile and 97% responding favorably to the safety profile.
Additionally, based on the same research we learned that over 50% appears colleges already consider themselves to be very we're extremely knowledgeable about b cell depletion, that's a means to treat animal as Steve.
With more neurologists fluffy b cell depletion, that's the most important mechanism of action in animal rescue.
At the outset of our launch we are focusing on animal westy patients who are newly diagnosed and those who are experienced an inadequate response to their current maintenance regimen.
Regardless, if they are being treated in an academic institution for community based setting.
From the market research study referenced on the prior slide most neurologists are looking to decrease their utilization across label animal west the agents and specifically prefer to use and approved agent in first line setting.
Also half physicians would consider changing their patients animal westy treatment regimen, even if they do not have an attack.
In fact, 79% of neurologist said, they would use up listener for patients who are having tolerability issues, 76% would use in patients who are having long term safety concerns with their existing regimen and 75% would use in patients who have been compliance concerns with their current regimen.
Adoption is one of several important factors that we will be measuring over the coming quarters to track our success.
This slide outlined what we have defined as key launch metrics around four areas for us.
Referrals, including the number of referrals and the conversion of referrals to new patient starts.
Prescribers, the number of unique prescribers and the mix between academic and community based neurologist.
Patients.
The number of patients on up listener and whether they are new more had been previously treated on another immunosuppressive agent.
And payers understanding the coverage and policies.
These will be the key indicators of our commercial success.
While our immediate focus is on the successful commercialization of up listener in animal, let's see we continue to evaluate its broader potential within the autoantibody pathway.
With that I would like to hand, the call over to Dr., you weren't Roberts, our chief Medical Officer.
To provide an overview of the current and future development fans of this program as well as an overview of the rest of our pipeline.
Thank you very much bill.
On slide 13 I would.
I'd like to start by covering the lifecycle indications for uplift.
We are not getting close to starting two phase three trials and may see their gravis, but I did you floor related disease, respectively.
Currently projected patient screening for these two drugs will start in the third quarter.
Let's see a gravitas and all the antibody driven nevro inflammatory disease, who spent the Genesis has many similarities to animal spectrum disorder.
In this disease auto antibodies against the acetylcholine receptor or specific kind of impact the neuromuscular junctions, meaning the transmission of signals between nerves and muscles.
This could result in a variety of motor dysfunctions, ranging from I must will dysfunction, all the way to researchers failure.
Our 12 will test whether depletion of Cdnineteen positive cells can meaningfully improve patient and physician assessed outcome measures in this disease.
I just before related disease is a group of diseases characterized by infiltration of I'd for producing cdnineteen positive b cells into various organs and tissues, causing tumor like swelling and subsequent fibrosis resulted in an organ dysfunction.
Commonly involved organs includes the pancreas bile ducts kidneys orbitz celebrate glens.
We believe that depletion of Cdnineteen positive cells has the potential to interrupt or reverse the accumulation of cdnineteen positive cells in this disease.
There are currently no approved treatments why did you for related disease and therapy, largely realize a chronic administration of corticosteroids.
Our Trogele test, whether cdnineteen positive you still depletion and stop or reverse organ dysfunction, and prevent disease recurrence or flares in the absence of concomitant steroid treatment.
The third trial in hiding sensitize patients waiting kidney transplant remains on voluntary hold as a result of the covert 19 pandemic.
This patient population on dialysis is particularly fragile haven't highly susceptible to infections and we will only resume enrollment when the pandemic is under much better control, but it is today.
On slide 14, moving onto the I'd be 7734.
This is our monoclonal antibody targeting Tesla cytogenetics zones.
We have an ongoing phase one trial the design of which is shown on the top analog to slide and we reported interim results from call. It two in May.
Since then we have obtained additional results from Cowen three.
The primary endpoint to the struggle safety.
Important secondary endpoints included PDC depletion and target tissues.
Meaning in skin biopsies and improvements in lupus specific skin score the classy.
Oh data showed that treatment would be 7734 resulted in a rapid and profound depletion of pdcs, both the peripheral blood and skin biopsies taken after treatment.
We also observed clinically meaningful improvements in the class by a variety of measures, including a four point reduction seven punch reduction and the greater than 50% reduction.
All participants have now completed that follow up visits and fight on safety results will become available in the next couple of months.
We intend to report detailed results at an upcoming conference and in publications that operation at this time.
Moving onto slide 16.
Based on these results we have decided to advance the 773 for it to further clinical development, including a phase two trial in systemic lupus erythematosus.
So he was selected as the lead indication for the following reasons.
Ptcs are believed to be central to the pathogenesis of absolutely.
They have been shown to accumulate and inflamed tissues and Lucas they've also been shown to redistribute from the peripheral blood into effect of tissue steering knuckles flavors.
The cartoon on the right. So the slide summarizes some of the ways that Pdcs drive inflammation and lupus.
All of these mechanisms are mediated by type one interferon signaling pathways, whereas others, a thought to be independent of the into.
This in combination with preliminary clinical results, we and others have generated targeting feeding season necessarily strengthen our conviction that this is an attractive mechanism and Lucas.
It's important to understand to bear remains substantial unmet need and Lucas.
But on the one treatment approved in the last six decades, and despite progress into management Lucas there was still substantial morbidity and mortality associated with the citizens.
Our team is currently the process of designing the phase two study and we aim to initiate the study early next year.
Moving on.
Two of the rest of our pipeline.
This slide shows a summary of the pipeline I've already covered in there, but there's a map and 77th before lupus.
Well, if you had before denied 20 or so before the ligand antagonist.
Three ongoing clinical trials, and sjogrens already and kidney transplant, respectively.
As being mentioned, we put a voluntary hold on enrollment to these trials in order to protect patients a trial stuff in the setting up to cope with 19 pandemic.
I'm pleased to report that we have now resumed to screening and enrollment into the kidney transplant trial and we are in the process of Restaging, the Aryan sjogrens turnarounds as well.
We've modified our protocols and study procedures to enable remote assessment and monitoring wherever possible.
If adjusted data collection procedures added cobot 19 screening and designs have implemented epidemiology data driven criteria for safe start depending on local circumstances.
Currently expect that some of the sites may start to come back online in the third quarter and others in subsequent quarters.
I would like to emphasize however that the safety of patients and stuff will always be our number one consideration.
At the bottom of the pipeline short you will notice a new trial of you ought to be 773, four for the prevention of acute lung injury in patients with covered Plenti being has already briefly alluded to this.
A growing body of evidence suggests that the London inflammation observed in patients with severe comic 19 isn't parts driven by the exuberant immune response to the buyers.
It has been shown that in patients with severe inflammation in the setting up infection with Corona viruses, a slow initial ramp up and make defense mechanisms, including type. One interference is followed by a protracted and uncontrolled upper incubation of innate immune responses that itself leads to tissue damage in other words.
Civeo injury in many cases, it's not the result of direct set of Patrick effect of the virus, but the results of an exaggerated hyper inflammatory response.
There's a growing body of evidence that pesticides, what's a good excels they play an important role in this hyper inflammatory response.
And animal models of Corona Vars induced lung damage. It has been shown the ptcs are present in large numbers and the lung they secrete large amounts of pro inflammatory cytokines and activates been cemetery macrophages that are believed to be a key mediator of tissue injury.
Blocking type one it's a fear arms or depleting bdcs anti inflammatory microphones just in these animal models led to a dramatic reduction in lung injury and mortality.
Based on especially now we're planning a phase one study of a single dose of 150 milligrams. Some huge will give you some seven before in patients with Covance 19, what risk for severe lung injury.
These are patients who are hospitalized with severe symptoms, but not yet in need of intubation.
You objective is to assess where the treatment with seven something before can prevent or ameliorate acute lung injury as these patients.
The study will enroll switching patients and its primary endpoint will be the prevention of death or critical illness as defined by the absence of respiratory failure shock or multi organ.
The study will be conducted in collaboration with the Cleveland Clinic Hospital system.
Enrollment is expected to start this month with an initial data readout in the first quarter of 2021.
With that I would like to turn it over back to Mitchell Chen our Chief Financial Officer.
Thanks.
Please turn to slide 18.
I'd like to refer you to our press release issued earlier today first summary financial results for the second quarter ended June Thirtyth 2020 in text opportunity to briefly review a few items.
For the quarter R&D investment totaled $25 million as we continue to advance our R&D pipeline.
So as scrutiny, we invested $14 million into quoted in the second quarter, which included.
Yes commercial launch.
In animal testing.
No.
Total operating expense for the second quarter.
Definitely about $30 million.
Together with our other income.
Operating loss for the second quarter.
That being pretty 2020.
That's pretty $8.9 million, which translates to a GAAP net loss per share 74 cents for Q2 2020.
As mentioned.
At June 2020.
The other completed underwritten public offering.
Common shares for aggregate gross proceeds of having $59 million.
As such the cash.
Ended the second quarter with approximately $448.4 million in cash cash equivalents and investment.
We expect our cash runway to extend into 2023.
The ongoing debit pandemic remains a challenge than many around the world.
The other will continue to monitor the potential impact at the table pandemic, if any on our business and as such we would not be providing sales. Thanks, guys for the rest of 2020.
Healthy balance sheet, however, the taking strong and flexible position to execute our us commercialization plan.
The uplift now while unlocking the value.
Value of a robust R&D pipeline.
With that I'd like to hand, it back over to be.
Thanks, Mitch. Thank you again for joining our call today overall, we had one of our strongest quarter to date marketed by our first.
Mobile and successful public offering.
As we look towards the remainder of the year, our central focus will be the commercial launch how do we have many priorities and upcoming milestones on the clinical front.
Well I know, there's a map additional indications with trying to initiate phase three trials the idea for baby disease and my senior gravis.
Well, we are the 49 20, our plan is to refuel patient enrollment in a sjogrens syndrome, and ARIA trial and to continue patient enrollment in a kidney transplant rejection study.
Well I B 773 fall were preparing for phase two trial in Essex County, and we plan to initiate phase one trial well covered 90, when they did acute rone injury.
For preclinical program, our plan is to submit I'd, but VIP when six by year end.
We look forward to providing updates on these programs throughout the remainder of the year and with that I'd like to open the call two questions operator.
Thank you.
Asked a question you want me to press Star one on your telephone.
<unk> question past the punky.
Stand back will be somebody can stay.
Our first question comes from Seamus Fernandez with Guggenheim. Your line is out there [noise].
Oh, great can you guys hearing.
Yep.
Okay, great. So.
Got a sense of.
I know you guys were focused on the quarter.
But is there anyway, you could just give us a sense of.
How the a the patient uptake is tracking.
Through July.
And if you have patients on therapy now or are those that were on the early access program have converted over to.
The pain patients.
Any color in that regard would be very helpful and then separately.
You know being I, just wanted to get a sense and yarn.
In terms of the preclinical data that.
You saw with VW 7734.
Just hoping to get a sense of when we might see that.
As an official publication I know a lot of this is coming on very quickly. So the it's helpful to know if you might be the publication for probably too.
Coming soon and then finally.
You know.
Well, we in terms of the but the high dose for VIP seven of them before when might we see the the high dose.
Data officially public thanks very much.
Thanks, Seamus I'll start here with the commercial question, then turn it over to my colleagues so to answer the rest of it so.
So far for the launch I think it's going largely as planned I mean, clearly we're in a very difficult external situation with lots of uncertainty there, but so far our teams have done a very nice job of dealing with that uncertainty and being able to meet with our customers. We've been very pleased with a number of customers. We've been able to meet already we've been able to meet with most of our top costs.
Customers, either live or virtually and had had really good discussions with them. Our VIP program. Our hub has been open has been available since the day of launch and have been processing a patient referral films. Those include both of the oil we patients being converted over to commercial along with other patients.
Not part of that and we're going very well that way I mean, we're very pleased with the uptake so far a good discussions people I think are seeing the value of animal this amount based on the complete product profile that we have.
With respect to these seven seven Freeport data I'm not.
Wetter weather understood what preclinical data you're referring to.
The clinical data on some of them before for the Phase one study.
We are currently writing this up.
So we have recently gotten into data from cohort three.
The final safety data, it's going to them they because of the less efficient enough doesn't have to recently approved a week or two ago.
We hope to submitted an abstract late breaker for our but as you know late breaker than never guaranteed that a competition to whether or not the.
The or at a subsequent meeting I cannot promise at the same time in parallel with repeating a manuscript.
That will detail both allows the preclinical experiments that led to the development of different than before.
Well if the clinical result from the phase one a add phase wouldn't be study. So there are going to be in a manuscript and her team isn't the right is going up right there.
Did I answer your question.
[noise] that's perfect yeah. Thank you.
Thank you Sir our next question comes from just hung with Morgan Stanley. Your line is open.
Hey, Thanks for taking the questions can you provide an update on youre seeking compendia listing for the and what the Compendia listing would be for and then for bill any further clarity on the specific pricing. Thank you.
So from a compendia side of things, we were able to submit our compendia within a couple.
Days or weeks, a afterwards from both the pricing and scientific perspective. So that is now available to our payer customers for them to review as part of their evaluation of up listener for policy and for coverage sake from a price side of things, we have announced our price or shortly after approval of a $131000 or don't.
It's making a $262000 for maintenance dosing, which we think really.
Extenuated the value that it has to the marketplace in terms of efficacy safety dosing and more importantly, the indication that it has so that has been relatively well accepted by our customers and we're looking forward to continuing discussions on that front with their customers as well too.
Thank you.
Thank you.
Our next question comes from Paul Choi with Goldman Sachs. Your line is now open.
Hi, Thanks, everyone and good afternoon, a few for me please.
Bill can you maybe comment on what you're seeing with regard to number of patients who are taking.
Planning on using taking are financed using loading doses versus just switching over to maintenance dosing and then second.
Can you maybe help us think about some milestones for lives covered in terms of access I know you talked about CMS being and three Q3, two timeframe, but just any milestones that you can lay out for us in terms of out of covered lives over the course of 2020.
Yes definitely.
Good good questions for sure. So as we look at policy and really start thinking about how that's going to impact us. The R. J code should come at about the into third quarter real will submit that before the end of second quarter, which gets us into that that window. It's been received so things seem to be progressing very straightforward on.
That side of things from a policy side of things those are ongoing we know that a lot of killing T Committee meeting or meeting during the third quarter. Some have happened already we haven't heard all the outcomes yet, but what we have seen from a coverage is very much in line with what we expected or we have not seen any step edits or anything.
Odd that way this is largely in line with what you see in the label we have from inclusion exclusion criteria perspective from the clinical trial.
And on the loading dose question.
On the loading dose question, yes, sorry about that so as you know our label is to have that dose a day, one and day 15, what we're seeing is for patients.
Have come to the system. So far that is what we're filling on that they're getting the two doses. So still obviously very early but that seems to be the way again, how we're indicating how it's being used right now.
Okay, Great. That's helpful color and then two for yarn.
With the EMG phase Threea about to kick off in Q4 here can you maybe provide a little more clarity on the patient population. It wasn't quite clear to watch from the slides will you be stratifying from Moscow or just focusing on a must only population.
And then second.
On having 734, given that the majority of patients where cutaneous and you're deciding to go head into phase two with Ali She maybe just give us.
Some color on what gives you gives you confidence to expand broadly into that suddenly population. Thank you very much for taking our questions.
Sure. Thanks.
So starting with the MG, let's go to enroll abroad UBS wealth of the Mt population.
Both people go and receptor and local specific kind of they will be.
Stratified an analyst separately, though so there will be independent I hope you for the acetylcholine receptor population and them up and specific kind of population.
Most of the endpoints will be different for the people, calling it would be a movie a 12 month and voted for the purpose of it kind of a six month input.
But the full they will both be study, but independently so that we can.
Evaluate for these subpopulation, whether there's any differential in Africa.
Well there with respect to come from before I don't think there's really a good reasons to believe that.
The fundamental.
Genesis is different between patients who have continued disease.
With that fairly so continues with its really mirth is those who have Catania lupus.
But not meeting the of the diagnostic criteria for it really we have both of these in our fees when these roof approximately.
Half of the patients with pretend it's lupus did meet the a diagnostic criteria and the other half did not and we didnt really observed a big difference between these two populations I think.
The the the way I see our results at both the prevailing.
Thinking in the field.
The evidence is that antagonizing pdcs and interfering with both but I wanted to fear on mediated picked up on a if you're an independent PTC biology is probably applicable across a much broader it's one of the signs and symptoms that can come to do definitely.
Great. Thank you for taking your questions.
Thank you.
Our next question comes from Laura Chico with Wedbush. Your line is now open.
Hi, Thanks, very much for taking my questions.
I guess one on the I did you for related disease opportunity and this might be splitting hairs, a little bit, but you've made a change in the language from phase to be to phase three apologies if I missed it but wondering if you could just elaborate on how you're thinking about that study design. There has something changed and could you just elaborate on the regulatory path forward.
Award for I did before in terms of what would be necessary to secure and indirectly indication claim there and then I have just one follow up.
Yeah, so through a certain extent of.
Semantics.
Bottom line is that the trial will be designed and will be conducted.
With the type of rigor that is required for.
Acceptable potential for <unk> for submission for its going to change on how good the results of the.
Data supports really.
Convincing efficacy and safety, we believe the study design will potentially support they submission we've had the appropriate discussions with regulatory agencies in the United States.
And in other parts of the world.
As usual the guidance from regulators is that they can never promise the approval based on a single trial, but I'm going to be a review issue and it's going to depend on the data so.
We will.
Conducted trial with the required rigor to make it a potentially.
The minimal pivotal trial.
Okay. That's helpful yard or maybe one quick follow up then.
I'm sorry for the confusion on my part, but the the 773 or the data that is still ongoing is purely safety and we're not anticipating these numbers to change at all with regards to the efficacy.
That you're reporting Tonight.
As I kind of my clarification, and then with regard to the seven point change on the classic scoring cohorts three could you just confirm it is that statistically meaningful as well I presume, yes, but just wanted to make sure.
Yeah. So we did see a dose dependent response.
Magnitude of the risk both with larger and over three I'm going to go over too. So if we just look at the two or three.
We're all ways to look at the crappy via the forefront decrement seven with decrement over at greater than 50% improvement.
For all clinically meaningful and.
To wrap it up fairly dramatic a differences.
I just wanted to add to that but the study called of power powerful statistical significance.
Well said it was well study with of it had about four placebo and each Gordon eight active.
Oh, no formal statistics there.
With respect to the other because there was up they are not expected to change the you're right.
Primarily what's now go being put together with the final final 50, but the crabby number as well should not change and we are still generating additional biomarker and things like the immunogenicity.
North Korea Mount season, although that is still ongoing but the crazy numbers are not expected to say okay.
Okay, and you know maybe if I could just sneak one of them on seven cents before in codes that are standard of care is dynamic in the space to say the lease. So I'm just kind of curious how do you think about what might be an appropriate placebo response and covered thanks very much.
Yes.
The great questions I think the other is different for different foot populations right to the populations that retargeting, our patient who are hospitalized who have severe symptoms.
Especially refrigerant symptoms, but I'm not yet required to be I'm into beta.
So you're correct that.
The numbers like that are dynamic and outcome.
From somewhat improved but you're still seeing a fairly substantial a proportion of patients who are in the hospital.
Severe covance either.
Become intubated or even dying it at the end of the day. So unfortunately that have.
I'm not dramatically improved although it has improved somewhat so we believe that within 48 patients study, we should at least the a directional signal as to whether I'm. There is an incremental improvement in those patients who have received seven seconds before compared to those with no.
Thank you if you're looking for we look at four I'm really glad equally important the meaningful effect size. So we're not looking for a small improvement into study were looking for a clinically significant large improvement. So that's the nature of before.
That makes sense. Thank you.
Thank you. Our next question comes from Man Silverado with H.C. Wainwright. Your line is now open.
Hi, Thanks, very much for taking my questions are first for Bell I was wondering if you could elaborate on what the nature of the virtual education platforms is that you're using in support of the it was not rollout and what kind of participation interest and participation you're getting so far and also if you expect any particular.
The problematic or challenging prior authorization requirements, you know no matter, who the payer might be what might some of those be going forward and what strategies can you employ to potentially address those as expediently as possible. Thank you.
Very good question, so from a virtual perspective, we're actually using a number of different platforms right now and just checking out kind of how the read results have been we're doing linked in like we've done on Facebook live we've done Adobe connect we've done zoom all of them seem to work fairly well and they've gotten fairly good responses from our audience we.
See very good engagement across the board from the participants are invited these programs. So while we'll continue to monitor this and see if the ones that stands out to both the rest right now right now the content really seems to be driving this in the content seems to be very well accepted regardless of what platform we're using.
In terms of access and prior authorizations, and we've done or homework prior to launch to really make sure. We understood. How we think payers are going to react to minimalism map and the value proposition definable isn't we're not expecting any onerous prior authorizations to be in place I think our team has done a very.
Very good job of talking about the value we provide across efficacy safety dosing an indication here. So that isn't it's not a major concern for us clearly, it's something that we will continue to watch and monitor and react appropriately with clinical data to support our position, but right now we don't see that is as a problem.
For us and we hope that that won't be a problem for us in a few.
Okay, and then just a couple of quick one for John.
Could you elaborate on the specific gating items that you need to see before you resume the kidney transplant desensitization trial with the plus now.
Yes, I think we want to see.
Minimal community based transmission, we want to see a complete resumption of elective procedures and hospital.
I think we want a fairly high level of disease control in order to proceed in this particular.
Particularly since its competitive population. So I think of all the trials that are that were on hold or remain on hold this is likely going to be the last one to be resumed I would not expect it to resume did you.
And then with respect to the I'd UGI for related disease indication just wanted to drill down a little bit on the phase three trial design.
Can you comment on whether you would use the ITD for related disease Responder index at the primary efficacy endpoint or one of the principal efficacy endpoints in the phase three and are you going to exclude patients taking prednisone entirely or use the prednisone cut off dosage Kyle Thank you.
So with respect to the first question our primary endpoint of this trial is.
Tied to flaring very similar to what's been used in the automotive safety study, we will use the index as a secondary and additional and point.
With respect to stay with we actually require patients to be treated with there was initially be what those patients where at the highest risk of disease flare. Those typically do receive third and then there's a prescribed taper a steroid tapering. So after a certain period of time to the left these patients will be completely.
Oh, they're worth and then we will compare become declare in between the active people over.
Okay, and then just lastly on a seven 734 do you have any interest in focusing on lupus nephritis within Sally or is that really not are going to be a focus here, it's really more broadly on the SMB population generally.
Yeah. So for various reasons, it's very difficult to study lupus nephritis and systemic lupus together in one study the problem is that these two populations have very different.
Instead of care treatment regimen and also the outcome measures are completely different footwear for I believe we typically have these composite endpoints such as the fleet or that my leg or look at the right is the accepted importance of relate to kidney function you know craft nuclear so and and then.
And other objective measure so you can't really do these two things in one trial, Oh, we looked at that and explored the possibility, but didnt at the end of the they think it would be likely to be successful to try to do this in one fell swoop so for the initial.
Phase two trial, we will come to we will focus on fairly excluding active proliferative nephritis.
It doesn't exclude the possibility of doing lupus nephritis in the future, though right.
Correct. It does nothing but not preclude the possibility you know that there is the fence unmet medical need in lupus nephritis, but this would have to be a separate study of we have not currently I made any decisions regarding that.
Thank you.
Thank you and next question comes from Yatin Suneja with Guggenheim. Your line is sell open.
Hey, guys. Thanks for taking my question just a couple on Oh place not could you maybe talk about how should we didn't think about the pace of can William for.
Patient to become but not to the commercial dog.
I don't think you have sort of.
Commented on the size up there, but if you can help us almost on both sides on the page glitch in something like this person to commercial done, but we'll be global my model couple of follow ups.
Great. Good question here only conversion is something obviously, we're focusing on but like the overall launch we're expecting this to be a slow ramp up overtime with the six month dosing period, clearly you're not going to have everyone who's even available to switch. It immediately post launch plus we want to we need to make.
Sure as they have coverage our goal is to make sure that every penny patient who is on up listener from the oil we will be able to continue on that and we have to go through a benefits an investigation go through the hub and make sure that we understand what the policy is going to be around that we haven't had challenges as far as coverage on the patients that have gone through where we're starting now.
That process already although again it is very early in the process will continue to monitor that and a change them over to commercial drug as appropriate when they come off their last dose of trial therapy.
Got it and then I'll sort of patients.
But you are able to capture include the hobbled that are coming to the hop could you give us sense of some of the time within rich you are making the drug available just trying to better sense.
The time somebody should have been cut the hub.
The time to receive the drugs.
What does that duration.
Currency on where do you want to be in the future. Once you are sort of ramped up.
Yes, that's a great question and you know obviously, it's very early right now so we really don't have data to kind of saying, it's any specific date, we're expecting to be very long at this point, though knowing that payers do not have policies in place. So this is really all done through exceptions and while the hub has done a great job turning forms over a very quickly. It then goes.
Back to the physician's office to fill out all these forms to answer all the additional questions that people have.
One of the challenges with Cobot 19, and these offices operating more remotely if these people aren't in the same place at the same time traditionally you know if someone had a question. They could go right down the line to different offices and get them. All answered here now it's a game of telephone where someone answers part of within half the handed off and that kind of.
Elongates the process. So we don't have a good day right now, but obviously that will something we'll be monitoring and trying to shorten in future.
Yeah and final question. This is mostly colbert them, they're good on its impact on sort of the prescribe for having that in your competitor that doesn't make a point on let's see on especially if it didn't make a point, but given that on a more as more of them run through them.
Their launch is progressing well then when compared it to maschino beverage and just trying to get a sense from some new given that the machines. So see via its on events happen you need to have a set up the on board. So is there.
Are you seeing similar dynamic in war launch but.
But if somebody is eligible to that the drug the we've got to draw even in this call them.
Yeah. It's a great question, we did some advisory board so before launch to understand how neurologist specifically, we're looking at that and one of the things we learned as they do prioritize animal study is one of the most important conditions. They deal with they see this as a very serious condition, they know that attacks and come out from nowhere.
And can be potentially permanently disabling so they are trying to see the patients on a regular basis. They are encouraging patients to stay on their therapies and continue their therapies not taking medication holidays here. So I think that animal westy has been less affected by than most other conditions out there, but I wouldn't say it has had no.
Fact whatsoever, but definitely less than what we what would be good they're sharing with us from their other conditions are treating.
Got it think about it might just final question from Mitch. This is on the financials can you maybe help us model will be the expense going forward.
I think you guys are on Oh, a milestone on a pool I just had been a common can we own one about the GM. It seems like it came a little bit like and then do I Hope I was just help me model. They just response.
Yeah, no absolutely I think thats, we heard from the call. We're not can provide guidance for 2020, just given the economic environment, we want to maintain flexibility.
Right.
We started in these clinical trials here.
Regarding milestone payment on him it was need.
Right now we have not.
According to the extent when you actually be sitting on our balance sheet, sometimes a will be amortized over over the period.
The next few years. So it was not captured in you know.
Directly.
The payment was made.
So hopefully that kinda huh [laughter] being able to continue to be very mindful, we want to less than where we can.
We wanted to make sure that look commercial launch.
Well again right now the idea here is to monitor the endemic very closely because again the across United States. It's not affecting every city every state equally in factor every day every week.
After we continue to monitor to situation and hence I got interested to hear will be.
Yeah.
Yes. Thank you so much we're putting my question.
Thank you I'm not showing any further questions at this time I would now like to turn the call back over to thing out CEO for closing remarks.
What does thank everyone for joining our call today have a good evening. Please reach out to us if we have additional questions. Thank you.
And gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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