Q2 2020 Cymabay Therapeutics Inc Earnings Call
Greetings and welcome to Cmos based Therapeutics second quarter 2020 earnings Conference call.
This time all participants are in listen only mode. A question answer session will follow the formal presentation.
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The turn the conference so what's the whole then but no vice President Finance. Please proceed sir.
Thank you operator, and good afternoon, everyone.
I hope that you've had a chance to review the press release, we issued announcing our second quarter 2020 financial result business updates.
You can access that release on our website under the investors tab.
Joining me on the call today are suitable Shah Chief Executive Officer, Dr., Chuck Mcwhirter, Chief Scientific Officer.
Clara Dickinson, Chief regulatory and compliance officer.
So do will provide an update on recent progress implants on the development program for Philadelphia as well as a brief summary of our financials before we open the call up pretty today.
Before we begin I'd like to remind everyone that statements made during this conference call, including the queuing <unk> session relating to Cymabays expected future performance business prospects events or plans, including clinical plans regulatory approvals and anticipated timelines and data release date.
And cash runway are forward looking statements as defined under the private Securities Litigation Reform Act of 1995.
Although the company believes that the expectations reflected in such forward looking statements are based upon reasonable assumptions actual outcomes and results are subject to risks and uncertainties I could differ materially from those forecast due to the impact of many factors.
The company assumes no obligation to update for supplement any forward looking statements, whether as a result of new information future events or otherwise, except as required by applicable law.
Participants are directed to the cautionary statement set forth in today's press release.
The risk factors set forth in seem a base quarterly and annual reports filed with the FCC factors that could cause actual results to differ materially from those anticipated in the forward looking statements.
This conference call at the property of Cymabay and any recording a rebroadcast it's expressly prohibited without the written consent seem a bag.
At this time I'd like to turn call over to signal.
Good afternoon, and thank you for joining us.
Given our discussion of enhanced data and plans for continued development of Citadel par in PBC just last week.
Prepared remarks today will be brief and we'll focus on for specific topics.
Key achievements in the first half of the year.
Planned development activities.
Upcoming milestones and summary financial.
Over the past two months.
We have experienced quite a reversal of fortune triggered by the conclusion of an in depth rigorous and independent analysis and review of safety data in the second quarter from a phase two study a sell at El par in patients with nonalcoholic Steatohepatitis or Nash.
First the F.D.A. lifted all clinical hold across all three liver diseases in which sell it LPR had ongoing clinical studies that were halted late last year, namely Nash primary biliary cholangitis, or PBC and primary sclerosing cholangitis or P. S.
Okay.
At the age of this action in short order following receipt I've seen a base submission of a complete responses for each indication that included independent report from a panel of some of the world's most renowned a battle pathologist and Hepatologists expert in Nash.
Drug induced liver injury and the supporting data package that led to their unanimous conclusion that there was no clinical biochemical or histological evidence of cell adult par related liver injury and the Nash phase two study.
And that pending FDA review clinical development of Citadel, partially in Brazil.
Then barely over a week after the F.D.A. lifted all clinical hold the cell Adele par.
On a blinded and reported positive topline results from enhance a global phase three study of cell Adele par in patients with PBC that was terminated early in which the amended primary into key secondary endpoints were met with statistical significance.
For patients on Philadelphia, our 10 milligram.
The results included a nearly 80% response on our primary composite endpoint and accepted regulatory approval endpoint.
Versus 12.5% on placebo.
Almost 30% response on L.P. normalization versus zero on placebo.
And a meaningful and significant placebo controlled effect on reducing pure right is it.
A key clinical symptom of PBC all in just three months.
In addition, sell Adele par appeared to be safe and well tolerated in this study.
We believe these data continue to support the potential for selling dalbar to be a breakthrough therapy for patients with PBC.
And I'll remind you that in the U.S.. So dalbar has breakthrough therapy designation from the FDA.
And in Europe Prime access designation from Yeah me for PBC.
The full details of this data out were discussed last week.
And a recording of the call is available on our website.
The full set of data from this study are being reviewed in detail and will serve to inform design considerations are they new phase three study.
We believe the results from enhance.
Results from previous Phase two studies.
And our growing safety experience would sell Adele par in patients with PBC.
I have the potential to support a smaller overall study focused on comparing celadon apart 10 milligram with placebo.
We are confident that once finalized and approved by regulatory authorities, both in and outside of the United States.
The global Phase three study will be one that we can utilize our experience to enroll and execute expeditiously.
We are moving quickly to finalize the design of this study submitted to regulatory agencies and begin study start up activities that will continue through the remainder of this year with the expectation that enrollment in a new phase three study is likely to begin in the first quarter of 20.
21.
We also hope to have the opportunity to present data from enhance.
At an upcoming medical meeting potentially at E.S.L.D. in November.
In addition to the phase three study we plan as quickly as feasible to Reinitiate. The long term study also terminated last year.
This will provide the more than 100 patients previously treated with cell Adele part in this study to once again receive treatment would sell dalbar, while allowing us to continue building the safety database support of in India.
We intend to allow all PBC patients previously enrolled in a Philadelphia our study.
The opportunity should they qualify and have support of they're treating physician.
To participate in our long term study.
In a new phase three study.
War in any of the other N D, enabling or supportive studies, we initiate to support registration.
For each of these studies, we also plan to incorporate necessary procedures to ensure patient safety in consideration of the current global pandemic involving Colvin 19.
Turning briefly to sell it LPR programs beyond PBC, Let me say, a few words about P.S.C. and Nash.
When we halted development up sell Adele part late last year, we had just the gun a dose ranging phase two study of sell at El par in patients with P.S.C.
Hey, rare orphan call a static disease that shares some attributes with P.B.C., but for which a key differences can make it a more heterogeneous and complex disease to treat.
Many patients with P.S.C. also suffer from inflammatory bowel disease.
I have significant liver inflammation and fibrosis.
And have a significant risk for developing cholangio carcinoma.
We continue to believe the anti call a static anti inflammatory and anti pruritic effects observed with Philadelphia par in PBC.
And the potential anti fibrotic effects of sell it out par warrant exploring and safety and efficacy in patients with PNC.
Well, we will remain highly focused this year on re initiating the development program for settled out par in PBC.
We will continue to consider how and when we may look to re initiate our development efforts in P.S.C. and provide updates appropriately.
There are currently no approved treatments for P.S.C. and we continue to believe there may be a significant opportunity for us to explore citadel part in this indication.
With respect to our development of Philadelphia far in Nash.
Earlier this year, we shared topline results Purcell, Adele par on endpoint of Nash resolution and fibrosis in our phase two study.
The effects on the two key endpoints accepted by regulatory authorities for registration in dash.
What's particularly encouraging for the seller Dalbar 50 milligram dose group versus placebo.
For patients in the cell Adele par 50 milligram dose group.
26.1% experience Nash resolution with no worsening of fibrosis, and 37% experienced at least one point improvement in fibrosis with no worsening of Nash.
First is 8% and 20% for these two end points, respectively for patients in the placebo group.
We believe these data along with the improvements and lifted and overall safety and Tolerability profile observed for sell at El Park in this study and the ease of its administration as an oral agent.
Position sell Adele par well to be combined with other complementary mechanisms being evaluated in Nash today.
Particularly those that have demonstrated effects on weight loss and reductions in total liver fat.
Given the multifactorial nature of Nash and the significant resources required to establish safety and efficacy in clinical studies.
We believe a thoughtful combination strategy and the potential opportunity to advance development through partnerships or collaboration is not only warranted, but would be the most optimal development path forward.
We will look to upcoming medical meetings once again potentially A.S.L.D. in November as an opportunity to share the full data from this study and in parallel well evaluate the best strategic path forward, while our focus and capital resources remain on re initiation and completion.
The development program for cell Adele par in PBC.
Finally, I'd like to highlight a brief summary of our key financial highlights from the second quarter.
We have concentrated intensely on reducing expenses since the end of 2019 and the impact of this effort was particularly evident in the second quarter by the magnitude of our overall cost containment.
While still in the midst of our investigation of Nash findings and expert panel review, we had guided to a June 32020 expected cash balance.
Oh between approximately $156 million to $161 million.
This forecast was based on a six month expected cash burn of between 30 and $35 million incorporating cost associated with termination and close out of contracts and clinical studies.
Severance benefit payments associated with previously announced head count reductions.
And expenses for ongoing operations that were largely focused on the investigation and regulatory efforts that ultimately led to a lifting of the clinical hold for sell it LPR as well as advisory and consulting expenses associated with our ongoing evaluation of strategic options.
The financials that we report today reflect the focus and discipline of how we operate our business.
We successfully dealt with the unexpected in rapid challenges of the Corona virus pandemic.
Delivered on resurrecting the promise of citadel par for patients.
And our shareholders.
While sharply decreasing the second quarter cash expenditures to $7.3 million.
This translates to a total cash burn during the first six months of the year of approximately $22 million.
Greater than 25% lower than the low end of our prior guidance.
Well some of this cash savings is due to a temporary delay and the timing of certain clinical trial shutdown costs. A portion also reflects certain cost savings due to the companys rapid resolution of the clinical hold on the self help our program and the completion of our review of strategic options.
Much sooner than initially planned in our cash forecast.
Cash cash equivalents and short term investments totaled $168.9 million at June 32020.
We have not raise capital since the first quarter of 2019, and we believe our current cash is sufficient to fund our current operating plan, including the re initiation of the full development program for cell del Park in PBC into 2022.
Due to the ongoing impact of the global Corona virus pandemic.
We continue to conduct operations remotely for all employees.
Which has allowed business activities to continue as seamlessly as possible.
Today. These developments have not had a significant impact on our financial condition.
Or our ability to execute our business plan.
We will continue to closely monitor pandemic development and their associated risks to the business, including plans to restart clinical development of cell Adele bar and we'll continue to take actions available to mitigate them where possible.
Further all of our actions will be guided by a commitment to taking all steps possible to ensure the health and safety of our employees as well as patients enrolled in our clinical studies.
We're now happy to take questions operator.
Thank you at this time, we will conduct a question answer session.
If you would like to ask a question. Please press star one when your telephone keypad <unk>.
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One moment well be poll for first question.
My first question comes from Yasmeen Rahimi with Piper Jaffray. Please proceed with your question.
Hi team corporate does mean, congrats on all the progress this quarter, so weve to question today.
First what do we know about the market size for you can see a treat patients.
Who are biochemically biochemically control, but still experience significant levels of crisis.
And second connected to that question, how couldn't additional cohort b incorporate into the upcoming phase three PBC trial to support an additional label indication cried this reduction.
You can see treated biochemical control.
Thanks for taking my questions.
Thank you for the question.
Let me maybe start off and perhaps invite other team members to add any additional color.
We've not really done an in depth analysis fundamentally around what we would consider a commercial opportunity for pure write us, particularly patients that may be adequately treated as eat as you're asking annuity CA itself I think what I can point to however is the fact that.
Despite.
Good portion of patients, having some benefit and even those having benefit that deemed adequate to you do you see a.
You do you see is not in fact as you know been associated with necessarily improving the symptom of pure right. It's in patients with PBC.
So we do believe that overall with the opportunity to potentially have an indication or label claim or even data.
In a final phase three study for registration that supports what we've seen thus far and enhance.
Or sell Adele par showed a significant benefit on reducing pure right is relative to placebo at the 10 milligram dose group. There may in fact, the opportunities for us to continue to expand used in the overall PBC population.
Now I think part of your second question is whether or not there may be ways for us of course to incorporate.
Needed. This this endpoint if you will or potentially another army in the next phase three clinical study in so here, perhaps what I'd like to be able to highlight is.
Yeah. The most significant need today remains for these patients that remain at risk of disease progression.
So those patients that are either inadequate responders to UTI see air our intolerant.
I continue to have a significant need for a safe.
Efficacious well tolerated second line treatment alternative.
Fundamentally we want to do everything we can to accelerate the execution of a new phase three clinical study to get sell Adele par registered for this patient population.
Now we will certainly be exploring the measure of pure right is in the next phase III study as we haven't enhance.
And that along with other potential strategies could in fact allow us to have multiple avenues to explore the effects of p. right. It's not just in the second line treatment alternatives setting, but also for patients that large these will all be considerations that I think our team focus in on a with experts with pay.
Patient advocacy groups as we think about the overall development for program for self-help are moving forward.
Okay.
Okay. Thanks, so much for your answers.
Thank you.
Our next question comes from Steve seat House with Raymond James. Please proceed with your question.
Yeah. Thanks, so much two questions first one's just on the PBC phase three study with respect to running a study of 10 milligrams versus placebo that that enables a smaller phase three could enroll quicker. Just curious if you can talk about whether or not the did you already have from penetration or lower doses would still support.
Those options in and eventual label.
Even if you don't have those arm phase three.
Hi, Steve check Mcwhirter, Yeah, we do think we have a considerable dataset with both safety and.
What I call a static effects in our open label study so the 50 milligram group.
The carry im sorry, the five milligram group Kerry carried over more than 50 patients through a year with good durability in response and and so I think that that really.
What would if we needed lower dose we wouldn't be able to have that available. Our view, though is the 10 milligram growth coats really shines I mean shows really as you've seen in the data set that we released a really great great effects on Allen Fossett case, some decreases in parallel group and in a host of other low.
Ever Chemistries were improved and the and the safety aspects of the drug really support it going forward is the preferred dose.
For patients.
[noise] makes sense, there's no reason to go lower I guess the safety profile as just fine at 10 milligrams and the second question is.
Yes, you spoke suitable.
Confidently about yes see on this call, whereas some of your recent updates.
Focused more on PBC, and obviously that being the priority, but but now the PSC is.
It looks like a second priority for you can you just talk about if you have any data from patients treated in the terminated phase two study if that's informing your confidence here.
Or and or if you've seen it evolution and really an understanding of what endpoints matter most of that type of trial design with you after would prefer or does that.
Last part remain a bit unclear. So thank you.
Yeah. Thank you for the question. It's a good question I think first I'd start off with the fact that I don't think our perspective fundamentally despite the challenging situation we've been through over the last nine months.
Really changes our outlook on PSC relative to where it was.
Last year, when we had embarked on the phase two dose ranging study in that setting.
I think were largely encouraged by the fact that as a call a static liver disease.
We are likely to see some benefit for patients certainly on improving call. This day says.
Given the mechanism of cell Adele par and what we see in terms of reductions in transaction isn't the PBC population.
We're encouraged by the potential that's LDL par may in fact, the also highly anti inflammatory and what is that call a static disease with a greater degree of inflammation and even fibrosis.
I think one nuance point is the.
Initiation and progression of fibrosis.
In Nash is quite unique to Nash and not necessarily the same as what occurs and PSC. Nevertheless.
The mechanism and even what we've seen a Nash I would say gives us some encouragement.
About the potential to see some anti fibrotic benefit even in the PSC population again I caution that the etiology of fibrosis is unique in these two diseases, but I do I wouldn't say that we the we are in fact, Kurt encouraged by what we've seen now.
Across both now the PBC and Nash population, so really as we think about our focus and rare orphan call a static diseases, where there remains significant.
Unmet needs for patients.
That's really the key driver.
In our in our thoughts around continuing to expand sell Adele park in from PBC into PSC I think as I mentioned that prepared remarks. The key thoughts on our end are just about timing and how we would actually progress and I think it's a bit premature for us to be able to provide specific guidance there.
But this is the patient population that again, we do believe there's a potential for us to explore development.
Okay. Thanks, and just to both did you have any data from the terminated study or is there just not enough there.
No you know we had actually only randomized single subject in that phase two study when we halted development at the end of last year and it was a subject to actually on placebo. So no no data in that population as of yet.
Got it thanks, so much appreciate it.
Thank you Steve.
Our next question comes from Alimera with Cantor Fitzgerald. Please proceed with your question.
Yes. Thanks, so much for taking my question and congrats on all the progress I'm just in terms of development plans in Nash. It seems like a collaboration approach is something that you're exploring what could make that change where you would consider developing pardon match up by yourself I mean, I know that it's a complex faced with large studies, but you.
Did you have encouraging histology data on Cyprus Nash resolution.
So curious sort of what could change your outlook in terms of chopping it yourself or sudden cooperation and then also just in terms of the learning a key part Delta biology for what we learn from your National Soggy data versus what we've seen a natural other p. par such an alpha or gamma what do you think of means for PBC long term I know that there.
Other people, there's about met for PBC as well so in terms of what we learned about keep our biology from the Nash data. What do you think this means long term for the competitiveness of your data I'm in PBC long term.
Yes. Thank you for the question now they let me answer the first one and then ill ask Chuck to provide some color around Philadelphia RFP for Delta specifically.
Yes, I think when we look at the dataset in Nash as I mentioned, we are in fact highly encouraged by what was observed particularly at the 50 milligram dose group on both Nash resolution and fibrosis.
This was a relatively small study however, and as we think about what this data informs us.
I think it tells us quite a bit around the ability for cell Adele barge provide some of the key benefits that Nash patients.
Would require to treat the overall disease.
At the same time the totality of the data also gives us a pretty clear understanding and I think this is the case frankly I'd have to save for other agents in development as well around thoughts on what would be the best combinations in order to truly have substantial benefit.
Okay, and a population of Nash patients.
When I talk about this specifically as showing some significant and meaning benefit relative to placebo alone.
I'd argue many agents have have either shown no benefit or marginal one.
Yes, so much of our thought actually comes from the fact that if we were to design. The most optimal development strategy. It would in fact, the one in which we have some better understanding around complementary mechanisms to sell Adele far.
To drive the kind of response that we believe you really want to be able to see to open up on this large patient population.
Of course, there's no question that this also requires significant resources, so, but it's it's a combination of both the most optimal resource as well as the most optimal development plan that really informed us of wanting to make sure that we have this opportunity to explore some of these.
Yes.
Yes, Hi, Ali this is Chuck maybe I'll, just kind of add and some additional information around different profiles for people cars I.
The first thing I would want to caution everybody is is about some of the challenges the making comparisons across studies, where there you know, it's they're not head to head.
Sometimes there can be even minor differences in the population. So it always comes with some big some big qualifiers, who would say that if you looked at resolve that person is our phase to be you as you know.
In resolve that there was no effect on fibrosis, where.
We're although we didn't hit statistical significance, either I think due to the small size of the study only 46 in the 50 milligram group, who was very heartening to see 37%.
Patients with an improvement in one stage in fibrosis versus 20% and placebo.
And then if you focus on some of the differences between an alpha adult and a strong delta.
I point out the effects that we see on for example markers of liver injury. So LT reductions at a year, where about 38 units per liter with cell Adele part and 50 milligrams placebo was was very minor.
And that that is very different than what we're seeing that either golden five or five.
Or and Genfit phase two study that they presented last year and Deanna.
And of course, we haven't seen all the data unresolved it yet so that that's to be determined.
And then if you turn to PBC I think this is where the story really strengthens for cell adult part of the effect that delta.
It's not only on bile acid reduction, then and improving cholesterol disposition, which helps to reduce the powder cellular stress, but reductions that we've seen.
In markers of inflammation and stressed by cable TV.
Both and enhance and in our open label Phase two study really.
I think.
Encourage us to think that Delta really provides everything that the patient. Indeed, if you then think about the pankey par the Atlanta fair been or in the native results that were provided.
Just a month or so ago.
You see that.
Once again I think if you look at the fibrosis effects.
37% versus roughly 40% and then the placebo rates worse very similar again again, they had a much larger study and it was a along with a shorter study is only 24 week study.
So there again I think that.
Lana, probably Norton and selling up our have in common maybe the delta comp on it in fact, I note that Theres a publication.
But just appeared it's in.
Print internal hepatology with the authors basically come to the same conclusion that the anti inflammatory effect supply NFV, nor are driven by by Delta.
Got it very helpful. Thank you.
Thanks, Kelly I.
Our next question comes from Ed Arce H.C. Wainwright. Please proceed with your question.
Hi, everyone. Thanks for taking my questions and congrats on a remarkable turnaround in the last few months.
I just wanted to.
Perhaps drew a bit further.
In some of your remarks through Joel just now.
With regards to Nash and your decision.
Strategically to focus on looking to partner.
Program going forward and I wanted to see if you could just give us a bit more detail.
Around youre thinking in that strategic decision.
With regard to your overall focus as a company.
In rare call a static liver diseases.
And how that played a part of your overall decision.
And and.
And and along with that if you've had any sort of preliminary.
Discussions with any potential partners. Thanks.
Yes, Thank you Ed.
Yeah, Let me maybe start off by just saying that.
We're passionate and compelled by the dataset, we already have in hand.
For the benefit that we're seeing today with sell at El part PBC. We fundamentally believe there is a significant opportunity to advance care for these patients.
That's not fully reflected for example in where even the company is valued today, we think about those patients and the significant need for those patients. We frankly believe that there's an opportunity to even expand.
The overall the patient population based on the latest.
Profile of cell Adele part coming out of enhanced.
And so that keeps us incredibly laser focus on getting sell at El bar in the hands of these patients.
So when we think about Nash then.
Obviously, an area of significant high unmet need as well.
Theres still remain a significant number of open questions.
Whether their clinical regulatory or even commercial.
I think it's fair to say that a lot of questions. We all felt might be answered by now in this setting of Nash remain unanswered.
And so we have an opportunity with with the very clear data that we haven't had would sell it alpine PBC to drive forward and to do the things that we fundamentally need to do to create value and to do so in a very capital efficient manner.
As I mentioned, we're incredibly confident at the overall cash balance we entered the second half of the year with in our ability to really execute our operating plan into 2022.
And so we'll remain very focused on on this key opportunity.
While some of these questions in Nash, our ultimately answer, particularly again as it pertains to regulatory as well as eventually commercial opportunity.
I think as we look at the data we like to always say that the data really needs to do your drive our decision making.
And I would tell you that I think it's the data for cell Adele par that keeps us encouraged.
But also has us focused on thinking of complementary mechanisms to which sell Adele par can be combined.
So when we talk about partnership these can be even a collaborations that are nonexclusive. They don't necessarily have to be arrangements with an exchange of economics.
There really driven towards thinking about again, a thoughtful development approach.
Getting meaningful benefit in the population.
So we'll continue to spend some time thinking about these opportunities.
But again won't take away our operating focus.
On the opportunity that's most near term to bring sell Adele par to patients with PBC.
That's very helpful. Central Thanks for that and then just perhaps one other question on your planned pivotal study for PBC.
Realize.
Enrollment is targeted.
To begin first quarter of next year.
When do you think you might be a position to.
To discuss the full.
Protocol for the study and trial design.
Yes, that's a good question. Thank you Ed I think as I mentioned currently what we're making sure that we do is to delve into the data set in front of us now.
To inform the final study design that will put in front of regulatory agencies.
So we plan to continue to move that forward as expeditiously as possible with the idea that we do want to be thoughtful with the dataset, we haven't had particularly the full data set from enhance.
I think when we think about timeline through the rest of this year as I mentioned, the key will be for us in a relatively short term to put a protocol in front of regulators.
As soon as we have any of their input or require a needs for any kinds of changes to that protocol or the greenlight to advance we'll put it in front of IR bees, and ethics committees very quickly our again as I'll remind folks enhanced with the study that was conducted in over 100 centers across more than 20.
Countries globally, and so our experience here I'm confident we'll give us the opportunity to get back up and running as quickly as possible, but we do have to go through those necessary steps of course with regulators ethics committees and investigational review boards and so that will be those will be activities that remain through the rest of this quarter.
In early into the fourth quarter as well I think in the end, it's hard for us to say, what the timing would be for those groups to get back to us.
But we'll start the study as quickly as possible if we get through a process, where those approvals come even before the end of this year there won't be anything that holds us back from beginning enrollment even sooner I just wanted to make sure that that we set the proper expectations around overall timelines.
Fair enough. Thanks.
Thank you.
Our next question comes from Jay Olson with Oppenheimer. Please proceed with your question.
Oh, hey, thanks for taking the questions.
I was wondering if you could maybe.
Look into the future.
The PBC market dynamics with potentially other new entrance. In addition to Philadelphia are including intercepts on combination of associated with visa fiber route and just.
Speculate as to how you think the market dynamics may shake out.
Yes. Thank you for the question Jay.
I think when we think about the unmet needs for patients today.
We know that there are patients that remain inadequate responders even to second line treatment.
We also know that patients continue to suffer from symptom burden.
So overall those are two of the key things that we know from a rich set of data would sell Adele par, particularly relative to some of these other agents as you mentioned.
That are looking to be explored and the population.
This is a rich set of data that continues to provide us confidence.
In fact, I believe that the data that we have in hand relative for example to things like visa fibrate or even L. A favorite nor.
Where sponsors have discussed advancing these treatments into develop Matt.
I would argue that our data set in terms of overall patient studied in phase two and even in our and our enhanced phase three study.
As a more rich dataset overall.
In a very well controlled global study.
So I can't speak necessarily to what those agents may show I don't have that forward Crystal ball.
But I can tell you that the experience.
Sell Adele par for patients is one that's been very positive.
Theres a tremendous amount of.
Experience with physicians as well as patients globally with cell Adele par and I think that gives us a tremendous advantage as we look to re initiate development.
Maybe I'll ask Chuck to provide some his thoughts on top of that as well, yes. Thank you Jay.
So just to add a little bit too what soja, who is describing I think one comment to think about is.
Some of the combination strategies for example, visa fibrate in OCA really trying to go after subjects, who are not receiving.
Complete response on the single agent. So it's designed to address maybe a shortfall or a perceived shortfall in terms of benefit to the patient and I think sell Adele pars profile as exhibited in enhance really speaks to its ability to to help address that at least in some aspects.
Another thing to consider and we alluded this to this earlier with the trend among medical experts to think about lower alkaline phosphatase pace is always a good goal. If you can normalize it that's an advantage. So they're currently patients who have alkaline phosphatase.
It is at or below let's say 1.67 upper limit a normal for our candidates for entering clinical studies, they still carry risk they still itch and so I think sell Adele parse profile as we think about potential strategies with clinical data to expand the addressable population I think.
Really boat bodes well if we could for example in the lifecycle management approach think about exploring.
It's activity in patients, who still have elevated out for us.
With a drug that is well tolerated that would be an advantage over some of the other.
Agents that you alluded to that carry some tolerability issues, it's more challenging for them to go into lower risk populations, where maybe the tolerability doesn't offset the benefit as much.
Thank you that's super helpful, maybe as a follow on.
I was wondering if assuming that Philadelphia ours efficacy safety and Tolerability profile continue to look as favorable as they do in your Registrational study would you consider studying Philadelphia are in a first line.
Setting potentially in patients who can be identified in advance as.
Potentially on the responsive or intolerant of beauty CA.
Yes, I, absolutely think that aren't attention is really to them to understand.
The benefit in the safety of cell Adele par in PBC patients first in the intended population for the program that we're we're pursuing right now, but ultimately in the broadest population for which there might be benefit.
And so.
I'm not here to say that we're going to try to establish that its frontline therapy at the moment, but I wouldn't rule. It out I think it would be quite interesting to take patients who are naive to you DC and conducted a study to see what the benefit might be and I think that physicians and patients alike would be interested in the outcome of.
Study like that.
Great and Super helpful. Thanks for taking the question.
Our next question comes from Thomas Smith with Espeed Leerink. Please proceed with your question.
Hi, guys. Thanks for taking the questions.
Just a couple of questions on TV see I guess as we look forward to a potential data presentation that a SLB.
Could you give us a sense of what additional data sets, we should been looking for from the enhanced study could we see additional data looking at symptom burden or the ability to improve brightest beyond just the NRF stated that you presented in the topline release.
And then could you also just remind us besides the new phase three study, which trials or clinical activities remain as kind of the gating factors that you would need to complete prior to submitting an NDA for PBC. Thanks.
Yes. Thanks for that question, Yes, I think we're we're going to be receiving additional datasets now so the dataset that we received a little more than a week ago, where the topline data. So we would have an expectation to be able to review a variety of information income.
Routing.
Exploratory biomarkers.
Patient symptom responses things like that that I think that will.
Try to understand first so we'll let the day to drive us what's the most interesting that we would like to combined with what we've already released but I think you can you can look forward with anticipation to really I think a very nice dataset and remains to be seeing whether we'll be accepted it has held the but that's really our hope at our intention.
Maybe I'll ask Clara.
Our chief regulatory officer, and compliance officer talk a bit about the overall development program in some of these other studies.
Thank you thanks.
Question some of the additional studies or just the ancillary studies that most companies have to conduct lines and renal impairment studies.
Interaction studies.
Looking at your prior to be marketed formulations, we attacked.
And then you have also specific study thats looking at hepatic impairment in our patient populations.
The PBC and their data classification based on chunky status.
Okay got it that's helpful. Thanks very much.
Thanks, Tim.
Thank you at this time I would like to turn the floor back to management for closing comments.
Thank you.
I'd like to make just a few comments as we close today.
It's been a remarkable year to say the least for seem a day for our patients and for all of our stakeholders.
In our most difficult days at the company. We found the will to investigate to analyze to learn to forge a path forward and simply just keep fighting to make progress.
From the patients so we left behind late last year.
Today I spent several hours with members of our teams speaking to leaders of several PVC and liver disease patient advocacy groups around the world.
We have been giving these groups as well as investigators an update on what we learned and what we plan to do next.
I can't even begin to describe how important the human element is in everything we all do everyday.
Whether our motivation comes from a desire to support our colleagues.
Patients and their families the medical communities or those groups, who have invested in us that seem a day to create value.
We are grounded by the human element in everything we do.
I can assure you that we will continue to be focused on playing our part.
Focusing on improving the lives of patients with liver diseases.
We'll continue to do so thoughtfully.
With patients at the forefront of our minds.
And efficiently to ensure we are meeting our obligations to all of our stakeholders.
As I mentioned, we're confident we have the capital needed to re initiate development of cell Adele par and I expect us to continue achieving key milestones and providing updates in the months ahead and look forward to our next call.
Thank you all again for joining us today.
Thank you. This does conclude today's teleconference. You may disconnect. Your lines at this time and thank you for your participation.