Q3 2021 ChemoCentryx Inc Earnings Call
Good afternoon, and welcome to the Chemo Sentrix third quarter 2021 financial results Conference call.
At this time all participants are in a listen only mode.
Later on we will conduct a question and answer session. As a reminder, this conference call will be recorded.
I'll now turn the call over to Leroy Burns Maquila Mister Roth. Please go ahead.
Thanks, Jesse good afternoon, and welcome to the Chemo Sentrix third quarter of 2021 financial results Conference call.
Earlier this afternoon the company issued a press release, providing an overview of its financial results for the quarter ended September 30th 2021.
This release, along with a few slides that you may find helpful. While you listen to the call are available on the Investor Relations section of the company's website at the chemo Sentrix Dot com.
Joining us on the call today is Doctor Thomas <unk>, President and Chief Executive Officer of Chemo, Sentrix, who will review the company's recent business in clinical progress.
Following his comments Susan can I ask executive Vice President and Chief financial and administrative officer can with Sentrix will provide an overview of the company's financial highlights for the quarter before attending to call back to Tom for closing remarks.
Turning today's call will be making certain forward looking statements is explained on slide to these forward looking statements are based on current information assumptions and expectations that are subject to change and evolve a number of risks and uncertainties. It may cause our actual results to differ materially from those contained in the forward looking statements.
These risks are described in the company's filings made with the Securities and Exchange Commission, including our annual report on Form 10-K filed on March 1st 2021, and a quarterly report on some 10-Q for the quarter ended September 30th 2021, you are cautious not to place any undue reliance on these forward looking statements and chemo sentrix disclaims any obligation to update such.
Statements. In addition, this call contains time sensitive information accurate only as of the date of this live broadcast November 9th 2021, Chemo Sentrix undertakes no obligation to revise or otherwise update any forward looking statements to reflect events or circumstances. After the date of this like call with that said, it's my pleasure to turn the call over to Tom Shaw.
Tom.
Thank you Lee and good afternoon to everyone listening. Thank you for joining us on our third quarter of 2021 conference call. Please.
Please let's move to slide three in our presentation.
Haven't talked in the past of our carpet journey as a voyage into uncharted waters, all of uncertainty, sometimes tempestuous stores and occasionally pushed by their strong winds progress.
Now for the first time in our history, we have arrived at the shore.
World, a new era for the company and I believe the patients who we've always have aim to serve.
All the way to empty approval and anchor vasculitis on October seven are innovative medicines <unk>. The brand name for a barca fan are small molecule selective inhibitor of the compliment C. By Weber sector is now available across the United States.
In retrospect it <unk>.
<unk> seems hard to imagine from concept.
Compound.
Technical development to commercial launch over the past.
16.
Tears.
The voyage was worth it.
<unk> is the first FTA approval Inca vasculitis in a decade.
And with the approval looked at news, we achieve our vision of helping to improve patients' lives.
And becoming an integrated biopharmaceutical company with discovery development and U S commercial capabilities.
Remarkable journey indeed.
Today, I will share a little bit more about the launch of top deals, which I and others held may represent part of a new era for anchor vasculitis patients.
We also aspire to make last month's FTA approval, just the beginning of more contributions bedtime nios may make to patients with rare diseases and you'll have currently inadequate treatment options.
I'll update you today on what comes next where we stand with some of our development programs.
And it bears repeating that all of this is based on our unique proprietary discovery platform capitalizing on our core scientific expertise and targeting specific chemoattractant receptors to block inflammatory responses that lie at the heart of so many diseases.
And recently also applied to the activation of the immune system in cancer therapy, using a true orally active small molecule inhibitor of the major immune checkpoint pathway.
Let's begin by turning to slide for where you will see the indication very recently approved by the FDA.
Yeah.
Indicated as an adjunctive treatment for adult patients with severe active anti neutrophils cytoplasmic auto antibody associated vasculitis also noticed anchor vasculitis associated basketball is spicier.
Specifically granulomatosis with Pollyanna, Angie I district, GPA, and microscopic polyandry ice or MPA two main forms of bank of extra lettuce.
It is given in combination with other standard therapies and does to 30 mix 310, Big capsules twice daily food.
This is a strong late and we are pleased with it.
As you can see from slide five.
We estimate that in the United States, approximately 9500 patients squarely fit the profile outlined in the label these patients being quite similar to the advocate clinical trial populations.
Observers have also noted that would have noticed there is no so called infusion confusion patient simply take their pills with food.
Following approval on October 7th or commercial and the medical affairs teams sprang into action and executed on there many careful preparations.
Finalizing package in search training and certifying that field force and so on.
We received the MTA approval on a Thursday took approximately one week to get everything in place and then launched on Monday October 18th.
And while we are gazing at the stars and our aspirations and our expectations for what we believe can be a blockbuster drug and.
Indication of anchor vasculitis alone.
We also have our feet firmly on the ground as we look upward and forward.
We all know.
Too many launches during this pandemic have not quite lived up to their expectations.
Oh it is complicated many plans for launches across the industry.
To add to the complexity in the case of tab news is the fact that it is a specialty medication.
So turning to slide six we are not naive as to the facts.
We are launching into a world in which.
Which there is considerable uncertainty.
And and which face to face interaction, whether they take place between patients and their clinicians or between our field force and physicians.
Are constrained by a pandemic.
Against this pandemic generated new world disorder.
We have endeavored to arm ourselves with a comprehensive plan and the right tools to execute on that plan.
We are emphasizing quality and everything associated with our commercial execution.
Knowing that a firm foundation is essential to build the structure that brings this new medicine to as many appropriate anchor vasculitis patients and as quickly as we possibly can.
You can see three major channels of action as we just play what is now a fully trained field force with deep experience and nephrology and rheumatology and in rare diseases.
Our field sales force is now educating and detailing physicians following their unbranded disease education interactions and appropriate scientific exchanges that are medical science liaisons had clinicians.
Our field force, including the MSL will focus on approximately 3400 physician comprising key opinion leaders.
[noise] top prescribers and community specialist.
Who are responsible for roughly 80%.
Of all prescriptions and anchor associated the task you lied us.
And the middle box on slide six tab Nios connect is a tool custom built by us to focus on helping the appropriate patients receive top deals with as little effort and his little consternation as possible as we provide practical and if necessary financial support to help pay.
<unk> initiate their treatment the top news.
We know that it takes one or two months to go through the prior authorization process with a new medication is not covered by medical policy.
Avenue is connect allows us to partner in patients as they work with payors to obtain obtain the necessary approvals.
We will also work with players on patient access with the goal of securing appropriate coverage of tasiast and their medical policies.
Following the pre approval clinical information exchanges that our national accounting tells the players which created a lot of interest.
We are now engaged in post approval political presentations and supporting information with the goal of securing appropriate coverage and medical policies.
To be clear or roll out in the early quarters will be focused on patient access.
It is obviously far too soon after lunch to provide much detail on how it is going you can expect more on our queue for a call.
But so far we are pleased with the rollout of our plan the functioning of our customized tools and the interactions to date across key stakeholders.
Turning to slide seven the most meaningful way to measure our progress for these first few quarters is not the revenue line, but instead by tracking three key metrics.
One patient start forms.
Each for a specialty drug as a lead metrics that we will use as a proxy for prescriptions.
Two patients on drug.
This lags patient start forms because of the time it takes before payers set their medical policies and load them onto their <unk>.
And finally, three will be watching the conversion rate from patient start forms to patients on drugs.
Insured again, our initial focus will be firmly on patient access from this in our view essentially all other matrix metrics will follow.
<unk> was also approved to Japan at the end of the third quarter, triggering a milestone payment of $20 million to us from our partner by four farm.
Five four will also pay us royalties in the teens through the mid twenties percent on potential <unk> sales of one aggregate net sales line.
Slide eight shows the next steps for 10 minutes.
In Europe, the committee for medicinal products for human use the so-called CH M. P is meeting over the next few days, we expect to see him.
Th M P. At this meeting to make a recommendation.
E render an opinion.
The European Union as two other cat just suitable for use an anchor associated that school items.
You in turn makes the official decision on the marketing authorization application based on that C. HMP opinion.
We expect the official EU action in January.
So where do we go from here now that we have received approval for top news and anchor vasculitis, we are refocusing our attention on other indications.
As you can see we are hoping to turn <unk> into a pipeline and a drug.
With a further three indications in or about to enter clinical development.
For example, in the debilitating skin disease hydrogenated Super Atiba or Hs. Please these side nine we plan to discuss with the FDA pivotal phase III child of top nyos in patients with severe hs the so-called per the stage three.
<unk>.
As you may recall, the dosage and that patient population were defined in our face to Aurora Trump and hidradenitis Shoeprint even.
We currently envision three to 400 patients for the next trial across two arcs using the hydrogen is super Atiba clinical response or high score as the primary endpoint at 12 weeks with an open label follow up period.
Pending regulatory input we hope to launch this trial and the first part of 2022.
With an estimated 30 to 50000 patients in the U S. Early stage three disease could become another blockbuster indication for 10 years, and we have filed for orphan drug designation.
Turning to slide 10, we also plan to meet with the FDA to discuss the data from our accolade phase two clinical trial of top deals and the very rare kidney disease of C. Three luminaria allopathy.
We note there are no FDA approved therapies for this year rare yet devastating kidney disease.
The accolade trial is a randomized controlled blinded trial testing tap dios's effects on kidney health and <unk> using readouts, including histology.
That is renal biopsy and traditional biomarkers.
Although the trial did not meet its primary endpoint in terms of a change in the C. Three G. Histologic index of disease activity, a measure of acute <unk> inflammation in six months there was a significant improvement in the pre specified secondary endpoint of the C. <unk>.
Histologic index of disease Cross.
Which is a measure of kidney fibrosis or scarring.
As you can see from this granted not only did patients on top views have less fibrotic progression in the placebo group during the first six months of 2006 weeks of the trial.
But also patients on placebo will get greater fibrosis during that first six months when they crossed over to tap newest during the second six months of the trial reversed the scarring trend and showed a significant slowing of fibrosis as indicated by the biopsies taken it too.
And the poster was accepted on these data as of late breaking entry at the American Society of Nephrology annual kidney.
Which just took place last week.
Furthermore.
As you can see from slide 11.
<unk> treatment and <unk> led to an improvement in kidney function as assessed by biomarkers, including a reduction in proteinuria and perhaps most importantly, an improvement and estimated <unk> filtration rate or Egfr.
As opposed to a deterioration in these markers and patients to the controller.
We note again that.
A similar result in Egfr improvement was observed in the advocate trial of town.
Quebec escalates.
Any GFR is widely regarded by Nephrologist as a comprehensive way to measure overall kidney function.
I'll note here too that Egfr has important implications in terms of the third potential indication for the top news lupus nephritis or Ellen.
Disease, which uncontrolled complement activation has been implicated kidney destruction.
Overall, we and others believe that kidney improvements seen in boat anchor vasculitis, and <unk> may bode well for our plans with tap yes in L N.
To this point.
At <unk> could be week last week and abstract was presented with the following conclusion quoting.
D. Five a activation induced macrophage secretion of factors that are known to drive inflammation fiberglass activation and tissue fibrosis may contribute to Ellen disease progression.
Inhibiting C. Five a receptor activity with Avacopan now tapping us blocks fees pathological changes and may provide therapeutic benefit to Helen patients ending quote.
In brief as I mentioned uncontrolled complement activation has been implicated in the profound kidney destruction, vanilla and and the disease is poorly controlled with broad immuno suppression. So the targeted novel anti inflammatory mechanism of <unk> could prove to be an important differentiator can therapy.
For nutrition nephritis.
Our timing for launching clinical development is now the first half of this coming year 2022, and we plan a two step process first to demonstrate the earliest text of Avacopan top news and a focused patient group.
And then expanding to a population of the skull size and length to provide a definitive signing regarding tab dios's potential in this underserved indications.
With an estimated prevalence of 65 to 100000 patients in the United States Lucas Nephritis is yet another orphan disease target for Tommy.
Moving beyond the top Dios pipeline and address program that remind you of other important assets in our pipeline.
Today I'll update you on just one or small molecule immune checkpoint inhibitor Ccf's 559, which is referred to on slide 12.
In Q3, we launched first in human studies of our potent PDL one P. D. One pathway inhibitor CTX 559, following promising preclinical antitumor efficacy data using this molecule and as reported that the meeting of the American Association for cancer Research earlier.
This year.
We initiated the design outlined on slide 13.
And have already moved now through several dosing levels and cancer patients.
We can confirm that the drug does get absorbed at levels that are approximately just personal and that has been well tolerated to date as summarized on slide 14.
We are very pleased with the progress of Ccf's 559 to date, which we believe to be the best in class orally administered PDL one P. D. One pathway inhibitor and buy some appreciable measure at that.
We look forward to report more full data at upcoming oncology meetings and all of these quarterly calls.
Before turning the call over to shoes, let me summarize in three points.
John.
Javier said has been launched.
And launched in the middle of a pandemic.
Revenue will be a stomach trailing indicators, we should focus on patient access and engagement and the first year or so launch.
The long term potential we see as for a blockbuster and this indication of anchor associated vasculitis alone.
Two we have moved forward three additional indications photographers two of these hydrogenated Super Achieva at Lucas Nephritis will involve clinical trials on the third seizure equal Mary Allopathy, we plan to meet with the FDA to discuss the clinical data today and the potential.
You'll pathway to registration and this ultra rare disease.
Three.
We have launched a phase one trial of our first small molecule checkpoint inhibitor and progress is proceeding well two days.
And as you will hear in a moment.
And shall situation is healthy.
Susan.
E Com.
Third quarter of 2021 financially.
I included in our principally these Canadian are summarized on 515.
Okay Avenue is 17.7 million for the third quarter of 2021 compared to 5.1 million for the same period last year.
Police in revenue from 2022 2021.
Beautiful too the 20 million milestone needs were farm for the September 2021, Japanese NDA approval.
Nielsen the treatment of patients Memphis comment <unk> and Granulomatosis with <unk> <unk>.
Research and development expenses for $20 million in it during the quarter of 2021 compared to 18 26 million in the same period in 2020.
Increase was primarily attributable to the manufacture and commercial trumps decline in anticipation of the launch attempt deals and the treatment and income escalated and higher phase one related expenses associated with the development Ah Ccn's five nine.
Orally available small molecule checkpoint inhibitor.
These increases were partially offset by lower phase two related expenses to completion of intent Neil Aurora phase two clinical trial in patients and agents.
General and administrative expenses were $19.6 million for the third quarter of 2021.
4 million theme here is last year.
This increases given the higher employee related expenses, including those associated with our tent Neil launched draining his efforts and hire professional fee.
Net loss for the third quarter of 2021 22.3 million compared to $24 1 million for the same period last year.
Hello shares outstanding in September 30th 2021, where approximately 69.9 million shares.
Lastly, we closed the third order of 2021 with approximately $372 million in cash cash equivalent and investments, we expect to close the year with cash and investments and instead of 350 million Tom.
Thank you Susan.
To summarize where we stand as you can see from slide 16.
<unk> is available in the United States as an adjunctive treatment and anchor associated vasculitis in our initial focus is firmly on getting this drive to patients.
Focused patient access program.
Todd Nios is also approved in Japan.
And a decision on top news is expected soon in Europe.
Beyond anchor we plan to make top news a pipeline and a drug with potential additional indications and hidradenitis Super Atiba C. Three culinary allopathy.
Lupus nephritis.
And perhaps most important at all most important of all we have just begun to realize the potential of our unique discovery platform.
Symbolized by the entry into clinical development and Q3 of our first small molecule immune checkpoint inhibitor is a novel cancer therapeutics.
I will now turn the call over to the operator for your question.
Operator.
Participants we will now begin the question and answer session to ask a question over the phone you May press the star key followed by the number one from your telephone keypads two.
Who would draw your request you May press the pound key.
Again, that's star one to ask a question or the pound key to withdraw your request.
As another reminder, we ask that participants limit themselves to one question per turn.
Speakers. Our first question is from Steve Seedhouse of Raymond James Your lines now open.
Good afternoon, and thanks, so much for taking my questions. I was hoping you could just show the number of patients dark forms that have been received in the U S.
Also curious if you could comment on the log from Japan.
And then if I may I was hoping you could just clarify how the economical divided.
Given your agreement would be four in <unk>, H S and even Lucas nephritis, which territory's in your home within imitations of Europe versus.
<unk>. Thank you.
Thank you Steve.
Too early to share numbers and start farms I'm afraid as you know it's been literally days since we launched the drugs. So if you'll excuse me for differing not to our next call.
I think we're reasonably pleased with how things are going people are on drugs.
Things are rolling along nicely and executing according to plan.
And Japan as far as I can tell there are still pricing negotiations going on <unk>.
Japan is a calendar for that so it's not entirely clear to me.
When the be concluded but sometime early in 2022, I presume and we'll keep you posted on that.
As to the alliance or arrangement with by four is essentially Ah kidney Health Alliance.
The alliance has in it three kidney indications defined in the contract.
One of which is ankh associated vasculitis.
One of his one of which is C. Three glow Mariel apathy and then the third one is still yet to be declared although it could very well become Lucas to Fridays.
Uhm Hidradenitis Super Akiba, it's own Beast and should we be successful in our phase III clinical studies, which we intend to perform as a global study.
We will have to work out how that will be marketed abroad, and there may well be discussions with V for on that aspect, but there would be special economics that they would have to invest in order to get into that program and share in the marketing. So again more on that as we get closer to the <unk>.
<unk> marketing of that drug, but it is a kidney focused alliance with three indications in that alliance with five four.
And then those indications the economics are all that B as I mentioned in Ankara associated vasculitis.
We have one top line aggregate sales number for all of the territory that by four or indeed any of their sublicensee marketed.
From that one aggregate X U S sales number we pulled down our royalty rate, which ranges from the <unk> to the mid twenties based on tears.
<unk>.
That's how did the deal is setup.
For the other two indications we have similar economics that are prenegotiated that we haven't yet discussed, but they're also very good economics.
Terrific. Thanks, so much.
Thank you.
Next question is from Dagon heart of Stifel. Your lines now open.
Great. Good afternoon, thanks for taking our questions I'll stick with one question. So when we think about the blockbuster opportunity that you mentioned Tom is that within the first approval.
Indication of a 9500 or the broader patient population and I guess, if you can kind of go into the strategies.
I know some physicians responses have been more towards as long as they get some real world experience I feel comfortable broadening their their use in their respective practices, but other studies that you have plan that you plan on initiating addressing those patient populations or what would be your strategic alternative. Thank you.
Yes, well.
Well. Thank you that's a great question so.
As I said in.
The label and we showed you the label it talks about severe active disease, Nick associated Avascular for Houston is adjunctive therapy, an adult patients.
And you know that 9500 number.
Very squarely into that prescription based on our market analyses that really is severe incidents major relaxing population.
The addition of theirs. Additionally, 10000 patients that have active disease and the severity is actually evaluated to determine that sort of physician discretion. So as we do research with those positions.
You get various descriptions of severe disease.
Of course, there are some guidelines the ACR and could I go guidelines talk about Oregon or life, threatening disease, but again, how physicians define oregon threatening us.
Frequently characteristic of that individual patients and their natural history of their disease.
But even if one limits themselves just to the 9500 patient population and.
And if one gets a reasonable penetration of that patient population just that core group.
As you know at our normal orphan price that we've determined for the drug wasn't getting quite close to the blockbuster level in the United States alone.
I think any way we look at it we feel very optimistic that the drug is blockbuster potential in the us alone an anchor of escalated smoke and if we add in the revenue opportunities that will take down from a rest of the world royalties.
Think we have very little doubt about its blockbuster potential.
We must have others.
And we'll talk about those other studies at some point in the future about how we expand appropriately the use of of of top gas and other folks are they associated vasculitis.
One circumstance.
Sounds great.
Thank you.
Q.
Next question is from Michelle Gilson of Canaccord Your lines now open.
Hi, Thank you guys. So much for for taking my questions and and congratulations diet and getting the drug launch.
You know and now you have M S L as in sales reps out in the field what what.
What are the common questions that they're getting from sessions and you know.
What I guess education efforts are barriers do you think.
Need to sort of help with on the education side to get sufficient to write that first script.
Yeah.
And then get Scott.
Now I can Steve asked earlier about start forums, but can you just confirm if you're if you've seen any start pouring has come in and you know if any of them have been converted yet.
Yes, I can say, let's start with the bat that part of the question not we have headstart forms come in yes, we have had conversion chests, we have patients on drug guests.
And yes, we have all those good things happening.
But literally were days out.
What I don't want to overextend too much what we what we know so far but the answer is a resounding, yes to all of those so that's a good a good thing I think for all of us.
What are we seeing in the field with Msl's and tech sales reps from physicians.
Where again Covid is hampering so many things because we have we know there are many physicians that have told us and there are patients that are filled us that upon approval of the drug they want to explore how quickly can they get on it how could they can they get access and yet there's the pragmatic restrained meeting face to <unk>.
Race, either at the clinic outside their scheduled visits getting another visit that's not scheduled there is there is there is certainly a COVID-19 influence and we're not unique in that obviously so that's physicians have asked is there any other way that they might.
Accelerates access to the drug.
But of course at the same time, they say well I've got folks scheduled coming in a month two months three months I went away to see them. So that's one thing we hear a lot of.
We are.
Patient identification is has been a theme they like to know.
Tell us a little bit more about glucocorticoids.
And really it actually is not very complicated when they see the label they say.
Didn't expect glucocorticoids be eliminated of course, not I have to use glucocorticoids, if I'm, giving rituxan mab as background therapy. For example, so we understand from your trial designed Cuba Sentrix that you did not eliminate the use of glucocorticoids. We also understand that people, sometimes get worked up with the bullets of Ivy Foucault Court.
Equates when they come in and prices and in fact, maybe even haven't yet been definitively diagnosed so we totally get that.
Ah remind us how you taper those sources in your clinical studies. So we're doing a lot of education around that we get questions about you know I've got subjects or a patient that's been on 20 makes a prednisone for three years and your study what did you do with those patients did you have examples of those so we're we're good.
Going through that and again reminding them that in our trial, yes, we did taper those incidental sources of glucocorticoid exposure the so-called spillover glucocorticoid from pre randomization exposure and they had to be tapered down to 20 mix at the time of the start of the trial and get.
Down from those spillover prednisone, two zero bye bye week for we remind them that we eliminated in the trial the need for the scheduled daily oral prednisone and we remind the physicians in so doing we got rid of about two five grams of prednisone, which is about 86% of the <unk>.
Median overall exposure from Google Court equation all source.
In the therapy of these patients over the course of that essentially the first six months, but certainly over the first year of the trap. So those are the kinds of questions we're getting.
We're getting questions about access to the hub system and so on all of those those sort of logistics questions that you would expect to get.
We do get questions about.
Severe active that's more discussion point with most of the physicians that we've talked to they say to US look this is a very severe disease. If I'm seeing these patients regularly they have active disease. They have severe disease that they're showing detriment kidney function by definition that kidneys.
Is under threat, so they're not really they don't have too much question about severe active which is which is interesting they too dark talk about duration of dosing.
And what we tell them as we've studied the drug for 12 months and so we are really good control data at 12 months.
That's what we're talking about in terms of the largest dataset. They ask about longer term dosing and if anything has been published yes. There are case studies have been published and those can be those can be referenced if they wish to so yeah. Those are the kind of questions were getting in so overall, it's been a very productive exchange and kind of questions that we predicted that we would.
From the healthcare practitioners.
Okay, and if I can just squeeze in a follow up here you mentioned that you are seeing start forms you have patients on drugs on drug and.
Are there any patterns in either patient characteristics or <unk>.
What is it that target prescriber population that you've talked about it in the past is there any color you can give us about either the patience or the prescriber. So it would help us.
To get a sense of who the early adopters are.
Yeah. That's a great question, obviously, it's still really early Michelle.
You're very good scientists scientifically trained I hesitate to make too many trend terminations from fairly small ended early data.
<unk>, we're seeing about 50 50 rooms in that right now.
And so that's interesting, but it's not really a surprise to us so that.
I think that that's pretty much how far I'll go with that one for the moment, but we hope to have a lot richer datasets for you to come through in the not too distant future.
Okay. Thank you so much for for taking my questions.
Thank you.
Next question is from Joseph Schwartz of SBB Leerink your lines now open.
Hi, Thanks, very much I was wondering if you could walk us through what you plan to propose to the F. D. A for <unk> do you have a meeting date scheduled yet that you can share with us.
Yes.
Sure a meeting date, yet Joseph Thank you, but.
But here's what we would love to talk with them about.
We.
We ran what what has been and I think still is.
The largest randomized blinded controlled trial in <unk> ever now I know there's other face.
Three trials that are enrolling now that aspire to have I think upwards of 90 people. We ultimately enrolls I think 53 took quite some years to get that data is you know.
Importantly, we have a very reached rich and deep dataset. It has renal histology with renal biopsies baseline of months six and above 12.
In most cases.
In all cases, but we have a very rich data set we are approaching area and we have egfr now at.
At the time that we set up this trial.
It's never been an example of an agent that changed Egfr.
And differentiated from background medication placebo medication over the course of six or even 12 months.
So we although we prespecified egfr as one of our secondary endpoints the.
Certainly the law at the time and maybe still is it takes a long time for Egfr to change.
During the course of the accolades study we got the anchor associated Vasculitis result.
With top nios that showed that egfr improved and separated by six.
The background met arm, the prednisone or in the case of of anchor vasculitis and that difference was significant or at least the lower end of the confidence interval did not cross zero.
So.
It was really a good example that with this mechanism of action and another kidney disease with some similarities to lupus nephritis.
Egfr could improve and separated in fact from the other medication in a controlled study.
That happened as well in <unk>, even though the numbers. The end was much smaller we had a significant difference at unsex between the tap Nios, taking group and the control group.
And that was a really important finding unseen because after all what are we striving to do and see three cheese, we're trying to at minimum stabilized kidney function.
The Egfr improvements just we're actually increasing filtration efficiency.
So something really intrigued important this happening there potential it was preceded by an overall reduction in proteinuria, another important sign of kidney function to biomarker level.
Many nephrologists will say that a rapid decline in print scenario is the biggest beneficial prognosticater of eventual egfr stabilization or at least slowing of decline.
So that hangs together in this study and then we have this really important and interesting biopsy finding with the C. Three preliminary Allopathy Histology index, which has two different ways of looking at it.
Called activity index of disease or disease activity index, which was developed more to look at acute and ongoing inflammation in and around the grilled airless.
And the C. Three G histology index of disease, <unk>, which is a way of looking more at fibrotic indices, the progression of scarring in and around the Bill Murray lie.
The activity of next didn't show a significant difference numerically it was slower with with tab Nios. There was a lot of variation of baseline.
Especially the placebo group and so that foiled the statistics on that measure.
And.
Well I would say, but the.
That Chronicity index was significantly different it was better with Avacopan statistically during that first six month period and as I described in the slides today, even when we crossed over the <unk> group and took their sequential <unk> 52, all of those reads. We're done blind to this treatment conditioned by the way.
They seem to slow considerably is a fibrotic progression so something it looks like there's some very interesting signal, they're all those signals seem to hang together.
So we would like to ask the FDA, what do you think of these data.
And this is a large data set for this quite rare condition. Some would call then ultra ultra rare disorder. There are no approved therapies.
Is there a path to using this drug.
On some basis short of doing another 678 year trial, which I'm not sure. We would have the stomach to do at this point absence, some sort of maybe conditional approval, but we really want to get their impression more than anything else you want to discuss the data with the age.
Nancy and asked them what do you think about how all the signals seem to trend together.
Sometimes in a significantly significant way, even though it's a fairly small N.
And is that interesting to the agency and what might be due at this in terms of supporting registration of this drug and <unk>. So that will be the general nature of the discussion.
Okay.
Thanks very much.
Thank you.
Next question is from Ted turn off of Piper Sandler Your lines now open.
Great guys. Thanks for taking my question.
<unk> team I just have to I said, that's when we got the approval of the picture.
Or fortitude and steadfast with giving us a purpose so remarkable and I always appreciate all the service on your answers. My question has to do with look Quizzical Fry This and just trying to get a sense with all of the recorded data <unk>.
<unk> appreciating that has to do with the kitchen, how quickly do you think you could enroll and.
And actually start to accelerate data. Thank you so very much.
Yes, that's it thank you too. Thank you for your kind words.
Good question.
I hesitate to to put marks on the timeline at this point.
I first want to make sure.
Learning as we did from our experienced an ankh associated vasculitis that we have a very clear understanding.
With what regulators are most interested in right now.
There have been recent approvals as you know and that space. Those are good drugs, there's certainly advances, but there's still a long way to go right. As you know these permission right says define.
In these trials still are in the maybe at best the 40% mid 40% and Lucas to Fry. This even with the best and newest regiments of care again, that's a great advance over where we were several years ago, but it means that still the majority of people are not experiencing either of these complete or.
Partial remission testifying in the trial protocols. So we have a long way to go.
And we're still using things that are quite immunosuppressive, but now about other consequence. Nevertheless, they are part of the landscape now the endpoint have been refined to some degree.
As the degree to which equal court equates are still used and they are.
And at what levels has changed somewhat although certainly the daily scheduled prednisone doses are far from being eliminated even in the most modern lupus in Friday practice. So all that's by way of saying that we really want to partner with FDA.
Very careful.
Use all of their best input.
To understand the correct trial design.
And what the goals could be with in Asia like Tom cruise, where we have shown.
In other indications that affect the kidney that yes, we can do things with things like schedule JV oral.
We can do things with the increase in Egfr not just trying to Ah rescue rate of decline.
And that yes, we have that evidence for rapid reductions proteinuria. So we have in our.
And are on our drawing board some really important and we think innovative ways to think about.
Innovative in rapid clinical development in that space, but I am going to hesitate to say anything more definitive till we have the really the definitive feedback from regulators and then I can put.
Some greater metrics at milestones on times in the numbers of patients.
Understood and maybe one other quick question that your answers sparked is what <unk>.
<unk> stratification or even biomarker work do you envision doing and the.
Somewhat heterogeneous disease.
Again, the goal would be obviously sticking with kidney function and that's pretty clear unemployment pretty clear classification, but would you be looking at different ways to either stratify patients or potential markers. Thanks.
Short answer is yes.
And we're working with some of the very top experts in the world on this right now so rather than I am going to play those cards, a little bit close to divest for this the next little while but the we're very keen on understanding how we might appropriately look at the different patient population.
And and also maybe look separately it effects cross these various criteria, but we're we're looking very quick very very carefully at that.
Okay cool well, it's gonna be it's gonna be fun I'm gonna be an exciting probably so keep up the great work guys.
Thank you very much then.
Next question is from Ed White of HC Wainwright your lines now open.
Hi, Thanks for taking my questions. Tom you mentioned the patient.
Patient support program and I was just wondering if you can give us some more details on that.
Any projections that you have for free drug how should we be thinking about initial revenues.
Revenues and the impact of the financial support program on that and then also if you can just give us a little bit more color on what you're hearing from payers <unk>.
Where do you expect to see.
Coverage levels at.
Yes that thing said.
In terms of free dry Guy I have noted.
Very very much and accurately what we really are going on hyper focused on his patient access in the first few quarters because from that everything will flow and the conversions to get patients on drugs and then.
Increasing proportion of patients sudden pain drug again will will will occur over time, we very carefully modeled us we've modeled many kind of scenarios. If you will we think we know how that would work.
I won't speak to the specifics at this point other than to say again, I think revenue will be.
Somewhat trailing indicators, so everyone should be aware of that but investments that we make now in both time and money will pay I think handsome dividends as we go forward and I think we will do the greatest service to patient population is the most expeditious fashion. So all of those goals are to the good.
In terms of what payers are saying.
Great pleasure of having our chief operating officer Tosh, Bob here in the room Tosh overseas that part of the business.
Have a lot of direct discussions.
And his team have with Payors Tosh can you give us a little bit of a general idea of our flavor without going into too much detail understood advocated atonement. Thanks for the question Ed.
<unk>.
Fall I think it's fair to say that do recognize the unmet needs associated with this debilitating disease.
The particularly aware of our rights to mortality you all can damage the re that price that occurred and it has to be very.
Encouragingly patients payers are also recognized the side effects of using immunosuppressive drugs and then clinical an economical benefit. They can brief if they're able to avoid scheduling talk pissing and finally I would add is that.
Certainly do appreciate the design and the scale and the intent of the advocate study the results of that study, especially the superior sustained remission of 12 months.
As well as the six or two days.
Supporting the potential for real improvement a lower risk of long term will can beverages relapses all associated with that talkative mechanism of action and they seem to be particularly impressed with that so so far better than providing positive feedback on tab Nielsen clinical benefits that safety profile and more.
Can be done in this area.
Thomas stated earlier generating patient develops and importantly, opening up patient access to launch critical factors that will hyperfocus total at this point in time.
Okay. Thanks, Tom Thanks Tosh.
Thank you Ed.
Next question is from Jan in Zoo of Wells Fargo. Your lines now open.
Oh, Thanks for taking my my two part question, so what might be the types of access restriction appear to me.
Implement beyond the most obvious why which is the prior authorization.
And then based on historical orphan drug lunches when payers embrace a drug and is 40 on board what does the conversion rate uhm look like the patient's dark form to patient on crap conversion rate. It looked like thank you.
Okay. So what I can share with usable profile of the feedback from players on tap Nielsen clinical benefit safety protocols were receiving positive feedback.
We believe.
Re both have needles with restrictions typical in portable further actions as they do for both rid the products.
But given this book coverage will be challenging at launch.
It is absolutely expected to improve.
Begin to conduct a clinical and business review.
And these back to give us Colton fell on top of the discussions we're having that they will see the benefits.