Q2 2019 Earnings Call
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Good morning, <unk> the name of the company to college and Wayne.
Hi, good morning, without the actual that's our Q U L E.
Yeah.
And the topic of today's conference.
Q2 2019 earnings.
Thank you.
Yeah, the spelling of your first and last name please.
Sure Rachel Art, if you ate Oh.
I P H.
Thank you and your company name.
Era.
Our aim.
[noise].
Yes your line.
I'm, sorry that Collins and progress Antonini one moment.
Yes. Thank you.
Yeah.
Let me ask it since we file an eye in the from this drug and opens the door to a very exciting next stage for these first and best in class molecule.
What is important to note also.
In conjunction to this decision is that we have observed no additional dose limiting toxicity.
And that a maximum tolerated dose has not been reached for the study.
So this concludes the brief overview of where we are.
These are two of our three one with the most important development.
We have to report since we last discussed this program, we had a conference call with Brian and.
The Voyager caused our TPI at Ohio State.
The rare overgrowth spectrum disorder with neurons that deep our first generation 18, EBITDA. We have continued as planned to initiate sites around the world and we expect to begin dosing produce enpros patients in this region in the two registrational cohorts of the three cohort.
Study.
The steel this summer.
We see considerable interesting considerable enthusiasm from the investigators who have been following these patients for a long time without much therapeutic options other than maybe some off label use of other drugs available and.
We are ever more determined to try to bring a valuable therapy patient.
In addition to.
Following the process of opening the site.
We have also presented.
Dave.
For both Proteus syndrome, and froze at the European Society of human genetics.
So we continue to believe that the data that underpins the registration for that we are currently engaged.
And and we will continue to provide that.
Where necessary drug for compassionate use as we have done in the past impart rollout to conducting the Registrational trial, we do not want to leave anybody behind if we can help it.
Then.
For the corporate update I would focus just on one item and the one item is financial we secured the additional runway for all our clinical programs by raising proceeds of gross proceeds of about 100 million in a very well received and well oversubscribed common stock offering lately.
And.
And that we can discuss further in the Q M&A what would that.
Finance, although much of it is available publicly already in the prospectus that.
The government that transaction.
I would like to express my thanks to our current investors that.
Participated and I would express my warm welcome to number of savvy large and highly specialized investors that have joined nice jewels through this.
Transaction.
As the filings proceeds we will be more evident to the calendar of call investors to participate in fact should watch.
Now.
Let me pass to Brian for a brief clinical update all the corporate.
Thank you.
Thank you Paolo let me start with Air Q 531.
Which is our potent and reversible dual inhibitor of both wild type and C. Eight one mutant BTK.
As Paolo mentioned, we recently presented a poster at the European Society of Hematology for Q five key one in refractory b cell malignancies.
The results were highly encouraging for us and the investigators of the 60 value by Evaluable Seiple eight one as CLL patients who started at 65 milligrams once a day.
Four reported a partial response at the first scan.
Of the four we also reported that two had already received the second scan at cycle five and were confirmed as responders.
In addition, the first Richters transformation patient in this study also reported a partial response at the first scan.
We are happy to report that we have now seen partial responses in four distinct b cell malignancies Follicular lymphoma.
CLL harboring the C 481, S. mutation richters transformation and deal Bcl.
Preliminary results from the ongoing phase one dose escalation study suggests that our Q 531 is well tolerated at 65 milligrams once a day.
And has a manageable safety profile in multiple b cell malignancies.
Pharmacokinetic data showed that subject to receive 65 moneygrams exhibited steady state seaman concentrations above the one micro molar.
Level that we had predicted pre clinically and the plasma half life ranged from 30 from 20 to 30 hours, suggesting a sustained and complete BTK inhibition.
Which can be as achieved 65 milligrams once a day.
Maintaining a sustained seaman concentration above one micro molar at 65 milligram dose is predicted to be a critical factor in achieving anti tumor response.
In summary.
Anti tumor activity was observed at 65 milligram once a day in cohort seven in heavily pre treated subjects with and.
Our our objective response rate of 62.5% in the for relapsed and refractory CLL patients.
Who harbored the BT K C eight when ESP patient.
In addition, one richters transformation patient as mentioned also responded out of the eight evaluable patients in this cohort presented at ESMO.
Subjects will assign rolls in the next dose level of 65 milligrams QD.
Cohort eight.
Though no deal fees will observe some patients reported grade two adverse events, which either led to treatment discontinuation in one subject or dose reduction to 65 milligrams in three subject.
A maximum tolerated dose was not reached first study as per protocol.
We also reported the first patients evaluated for clinical activity in this cohort a deal bcl patients.
Had a partial response.
Based on these promising preliminary results, we determined that the 65 milligram once a day dose will be our recommended starting dose for phase two studies for for Q 531 in subjects with B cell malignancies.
Please remember that Q 531 was chosen for its unique preclinical profile.
And now that we are at the necessary exposure in humans. These attributes are becoming apparent in the clinic as well.
Attributes such as domain selective kinase inhibition profile long residence time.
In the BTK binding pockets.
Good pharmacokinetic profile for once daily dosing and clear activity in a wide range of B cell malignancies.
All coming into focus as the study matures.
In summary.
We couldn't be more pleased with the performance of this drug so far and we look forward to initiating multiple expansion cohorts at 65 milligrams. This summer and presenting a comprehensive update at a major medical conference by the end of this year.
Let me now move on tumor inserted in rare overgrowth spectrum disorders.
Their incentive is a potent and selective 18 EBITDA.
Our objective is to be the first and best in class 18, EBITDA in Proteus and pros family of rare overgrowth diseases.
This family of diseases is ultra Ray.
Very heterogeneous and the patients currently suffer from dismal quality of life and early mortality.
No systemic therapies have been approved for this patient population.
And the only current treatment option is surgery.
As a reminder, our registration program.
The Mosaiq trial, which will consist of one protocol divided into multiple cohorts.
The first cohort will focus on Proteus syndrome.
And we'll enroll at least 10 patients.
The second cohort will focus on the pros family of overgrowth disorders.
And we'll enroll at least 20 patients.
The first cohort will be a signal generation on that includes patients from either group, who did not qualify for cohort one and two but may otherwise benefit from treatment.
These cohorts will be open label and the primary endpoint will be response rate driven based on objective measurable criteria.
We are currently enrolling additional sites globally and expect to dose the first patients very soon.
Our other programs.
For Q seven five won the next generation 18, EBITDA the signal generation work in oncology continues.
In the phase one B study and we plan to present data from this study in the second half of the year.
Finally for their advanced enough our FGF our inhibitor.
Our partners best a layer and Sullivan continued to implement their plans respectively for Registrational phase two trial in IC CA and towards phase one initiation in China.
With that update I would now like to turn it over to Pete.
Thanks, Brian .
Turning to the financials the company reported a net loss of $9.1 million or eight cents per basic share for the quarter ended June 32019, compared with net income of $5.2 million or five cents per diluted share for the quarter ended June 32018.
As of June 30 of this year the company had a total of approximately $182.8 million in cash cash equivalents and marketable securities.
Revenues in Q2, 2000 $19.3 million compared with revenues of $13.7 million in Q2 2018.
Research and development revenues. This quarter was comprised of $254000 of Reimbursable clinical trial costs from our assignment licensing agreement.
$27000 of revenue from Reimbursable costs associated with our vessel lay a licensing agreement.
Research and development expense for Q2, 2019 was $6.3 million compared with $6.8 million for Q2 of 2018.
General and administrative and administrative expense was $3.2 million in Q2, 2019, compared with $2.2 million in Q2 2018.
The $1 million increase was primarily due to higher labor related costs and stock based compensation costs.
For 2019, Arqule expects revenue to range between three and $5 million.
Net loss is expected to range between.
It is.
With that I'd like to turn the call over for queuing <unk> operator, please feel free to open the line for questions.
Ladies and gentlemen, if you have a question at this time. Please press star and then number one key on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.
Your first question comes from Gregory Renzo with RBC capital markets.
Hi, guys. Congratulations on all the developments and thanks for taking my question.
Thank you Greg.
That is perhaps a question for it for.
Brian I'm, just curious if you could perhaps touch a little bit more on some of your thinking in logic around landing on the recommended dose and just perhaps.
No the commentary on some of that incremental data that has been mentioned that perhaps help to secure your confidence around the selection and the path forward. Thank you.
So let me take a post op and then I'll, let Brian .
Chime in.
The.
The book on him that.
It has a loss from the hall.
Finalization of the fourth and.
Speaking to the season, it's a relatively short time, however, they leave that for them to be additional data that has come that the dot com for all money. This side all good the 65 milligram cohort.
We see school would seven meaning we have been able to see.
The dotcom from patients that were initiated at 75.
Both for safety and efficacy and they would then yes, Kelly that to 65. So we have had them some basic understanding of that.
That.
Well the space between 65 and 75.
Also remember we had a number of pieces that had.
Being the dose escalated from lower doses, all the way to 45 and then.
On to 65.
Those patients.
Also we also we have seen Sunday from those patients.
Being those 65.
That's what we all would that we talk about the general understanding of the data, that's where we really talk about that.
A very solid understanding all bar.
The cohort of patients that status 65 from the efficacy point of view and followed the safety point of view and then.
And understanding all work.
Of the of the 45 to 65 and understanding of 75 to 65.
No.
We are still not talking.
A tremendous amount of patients, but our four for the two ends right 75 to 60 545 to 65.
But the core knowledge that we have acquired 65 is now quite robust in terms on.
And the length of follow up.
That's what I would.
That's all without commenting generally Brian you want to add anything.
So thanks for the question I think Palin covered most of the data I think our criteria for selecting the dose.
It was based on a number of criteria. He will be missed one is total faso BTK inhibition.
A.
Comfort level that we see men concentration for patients is above one micro Mona the safety profile, obviously is very Paramount and then the level of activity.
As Paolo mentioned since he saw we have received data.
That we will disclose at an upcoming conference around additional pharmacokinetic additional safety data in both increasing dose and decreasing doses of patients in the trial.
With that information its very clear that if you if you're looking for a drag in CLL with safety is very important together with efficacy the 65 milligram fulfil that criteria.
We would also like to mention that we didnt officially declare a maximum tolerated dose.
So do preserves the option to increase the dose and our latest stage in difficult to treat genotype.
Should you require additional drug.
So this is a great consistent with our strategy. We wanted a a drawl go with the characteristic there Brian has has highlighted as a single agent drug right. We wanted the drugs that will be say first we wanted the drugs that will be effective in the target population. We wanted a drug that that would give us the exposure.
But we also wanted to draw that preserve the ability to play well in combinations with cheese in large part where many of these market segments are moving.
And that was also factoring in the consideration because when you are looking at combination you want the cleanest possible profile.
Safety profile. We also now know that this drug was designed in a way the strike for now a good balance between having a domain selective profile and unacceptable.
Hey, the profile.
So.
We knew that it had very little supply ability also an important factor when you think about combination and now I think we have a dose that.
That is viable both.
A single agent and we will probably mean humor more so as combination remember also when you think about combination down the road is that this is one today so.
The meeting room.
Burden.
The puzzles you burden than one would hope for.
That's great.
Brian . Thank you very much and combination is exactly where I want it to go with my next question Paulo, How does combination planning factor into your next phase with the planned regulatory interactions and your design of the upcoming expansion cohorts. Thank you very much again, yes.
I think Greg combination would would really come into play with regards to al.
Bigger trial, the next phase of development. So we've always commented and always.
Made our initial trial a.
Uncontrolled response rate driven trial in a selected population the C. Eight when its mutant population. We know the field is moving and our confirmatory trial is highly likely to have a combination of with one of the most commonly use drugs in the space. So the next step is to prepare to make sure that our drive these combinable and.
And be ready to move into their confirmatory trial setting in combination.
And.
And there are a number of combination we going to assess as well.
Some might turn out to be.
Creative.
We are running selling kicking off as a matter of fact a.
Second.
A round of lifecycle planning for the drug now that we can better diversify its profile.
And we'll assess those potential combinations in India.
But we believe that we have a drug to hear that demonstrates to be able to stand on its own single agent, which is always important particularly when that is demonstrated through early.
In the process of alliance over drug.
And now we're going to test it for all the elements that we've built in the drug to make is also now send in drug in combination. So we're hopeful for that.
Your next question comes from Jonathan Chang with SVB Leerink.
Hi, guys. Thanks for taking my questions and congrats on the progress.
Thanks.
The clarify his cohort eight still open are you still enrolling and are treating patients at the 75 make those.
No we're not.
We are using all patients at this point in time 65 milligram <unk>.
All the patients that were started on 75 had been de escalators too.
65, all the pieces that were not 45 have been escalated to 65 and older patients with four willing now 65 milligrams and the new patients are likely going to be enrolled but in the expansion cohorts now because the phase one.
Part of this phase one too.
Has served its purpose.
With the dose selection.
So the data coming out here, who will be largely out of this.
Bolus of patients that have now at 65.
Regardless of what those they started.
Got it.
That's right.
As Brian said is.
In summary, as we understand the side effect profile better overtime I, we understand durability as we assess the abroad.
Spectrum of indications we can consider then nor have we reached an MTD, we still have the possibility to disclose for the dose escalation.
In CLL, which she is the target indication in either that view that that was necessary and remember that we went and for those that are joining this call fresh remember that we went into board eight without the benefit of having been able to assess to thoroughly efficacy from call. It six.
Overall seven so by the time, we were initiating cohort a.
We started to get a compelling efficacy from called seven so.
Things need to be put in their historical prospects in order to rationalize them and for those of you on the call that are new to the story.
That's the historical context, you have to consider.
Got it thank you.
And also just to clarify when you mentioned seeing additional data from patients who went from 45 to 65 does that include additional efficacy data or are we talking say, yes, you data.
Yes, it includes efficacy as well.
I see so there have been additional scans or post the transition since patients gone the 65 make those all I can say.
ER include efficacy data Jonathan and.
We had said that some of the patients are 45 were due to be scanned at some point in time during the summer.
You know its common nor is it.
It's public knowledge the frequency of scanning so one could kind of get that we will give the details at ash.
Understood and then just last question if you could elaborate how you're thinking about next development steps for 531 ahead of the planned regulatory interactions.
So so Jonathan in terms of the current rate the regulatory interactions.
We hope to get in front of the FDA at a pre at a meeting at.
Sponsors often taken advantage of the interface when meeting we will discuss on full review of the data.
Our decision for the recommended phase two dose as well as the future developments in CLL. The focus will be on the C. Eight when its mutant development plan moving forward.
In parallel our face our phase the trial that we currently have opened now.
As Paolo mentioned will expand into multiple different cohorts the all seven cohorts.
That have been identified which include.
A cohort, which is BTK intolerant with after mutation BTK intolerant or without the mutation a cohort of Follicular richters.
Mantle cell marginal zone, Waldenstrom and double hit a high grade deal Bcl. So we got a number of different.
Sort of phase.
Evaluate efficacy valuations built into this trial and that will be moving forward with at the agency with CLL first.
Got it thank you very much.
Your.
Your next question comes from Chad Messer with Needham and company.
Great. Thanks, Good morning, and thanks for taking my question.
Yeah. So it seems like you guys have given us really thread the needle here between safety and efficacy with five to one and in fact I was quite impressed by some commentary from from Dr. Ics.
Avoid check on the Hawk call about how how well tolerated drug is.
Just wondering if you guys have any thoughts about how you kindly accomplish that no BTK class most of the side effects are pretty much on target, but you guys seem to have a very potent molecule.
Not outside effects, but with.
With the really good tolerability profile is that something to do with reversible versus your reversible or some other you know PK characteristics or are we just lucky here.
Lucky is always important that had been in everything we do what I would say for fairness is that our the that that is a phase one data set so it could not be competed for safety with the mountain of the the for example, the boot seeps on them.
But equally as far as the cardiovascular side effects goal, which generally emerge with a much longer.
Numbers of patients treated.
That said there.
We have observed.
In the end per week this through the preclinical experiments and the drugs should be tolerable, we had no red flags really coming out of our preclinical.
Well so far.
And.
To me the surprise was more or not the side effects of the side effect profile overall, but how we see a manageable side effect profile in the.
Such a.
Heavily threed.
Population that was.
That surprised me on the upside.
Go until now at least.
Brian I know if you want to meaningful I think Chad you know.
We often view things in a binary way, it's it's a responder it's not a responder if you look at the totality of the data.
This clear an increasing degree of.
Both clinic clinical an objective and an objective measures of response from when we started to get food BTK inhibition at around 20 to 30 milligram. So even though we didn't have much responses.
It appears as if clinical efficacy was clearly coming.
Once we got to the 65 milligram cohort and it was very clear the efficacy was there and then the question was do you go higher or not.
And we know this is a kinase inhibitor that is selected for a bunch of different.
Our families of kinase targets. So the question was do you go higher or do you or do you take that efficacy and just expand we haven't disclosed Seattle will disclose at.
At the next opportunity the full PK profile, you know, we got a big job between.
A 30 and 45, a jump between 45 and 65 and then we'll disclose the full PK long term PK and I think it will be much clearer for everyone. Why the 65 milligram dose is really the doubts we should take forward.
Alright understood look forward to look forward to those data updates.
Okay, and then against 55 up wise.
At the higher rate or the higher end of the range of the effective and safe hopefully those.
Based on the Brazilian experiments so.
Pretty much in line reward the expectation where based on preclinical and we have done as you know Chad because you follow the story probably longer than everybody here.
We did quite a bit of preclinical and I would like to remind the people you're on the call that.
Your next question comes from Hartaj Singh with Oppenheimer and company.
Great. Thank you all for or the the two questions.
One I have is just to maybe just.
Focus on something else going on.
Air Q 751, I know, Brian you've got a read out later this year.
Roche has made a really big deal flow patterns, there are certain their equity inhibitor. They presented some data at HCR.
And it seems like it's you and then sort of.
In the lead in this area the equity.
Inhibition area in sweet pretty interesting.
How do you know can you just sort of frame for us how that.
Those read out should look what are the solid tumors.
That that are interesting to you or.
You are in that study.
You know teams roche's focus on triple negative breast cancer.
And then also the potential for combining with.
You know various immuno oncology approaches with the equity and then I just got a quick follow up on on rents are too. Thank you.
Great.
Thanks Omar.
Maybe I'll take the first one.
For us.
We're still a relatively small company and we have a several programs ongoing.
75, one that for us is.
A program.
That is potentially valuable in many ways.
But unlike.
Our 2531 and that the ramp that would be in rare diseases.
Is dependent.
A little bit award the development set with the.
The judgment that program is going to be in the demented programs are proves to be a phenomenal success. We hope for the patient always there then that program will validate the targets in there and the answer to your question in a variety of hormone sensitive tumors.
And.
In one of our ideal combination so we are really talking.
Of the combination strategy, which we would need to fall on very large studies.
Not terribly likely that we'll be able to to chase after genentech.
Independently, so we will be open to considering.
Partnerships at that point.
Because these are not.
Relatively manageable size studies that we're planning to do 5312 gross or finish line and that we are doing we remain on therapy to cross the finish line there as well.
So that's.
Thats the way, we see right now some of them find one strategically so in the meantime that we wait for genentech to to clear the target being successful or otherwise.
We are preparing for that we'll be able to execute.
Our loan but for what we can.
An important issue probably broader it fast.
Following a strategy there so nothing has changed in our strategy for fund one the capital raise that has been executed recently.
Goes largely to fund physically extensive program that Brian is beginning to be deal 4531.
Brian also has some thoughts that are out of the box for seventh by one that will bring good.
In.
In.
In in this in the synergistic format, where.
531, but we'd rather keep those.
Thoughts to our self but for now if you view for us for that for competitive reasons.
Great No Paul that's a great option to have and really looking forward to more more more insights there on your answer Tim.
You know, we we had done a physician call where the QL who's been really Moulton area and excellent call an excellent call because I think.
Even patient Association.
Made its way to the station associations.
And they were very grateful that you brought attention to such a rare and devastating diseases I touched on there, but I don't think that no no. Thank you. Paul appreciate it right. There was just great to hear the passion of this care while.
One question I had was that as you're kind of thinking about your answer Dave I know that the trial has to be very focused from a structural perspective on the patients that you are looking at you've got three cohorts.
These all got syndromes, a very wide variation of diseases.
In totality.
It can it's very big but the individual parts can be smaller can you just think a little bit so help us to that as you see the data.
For the three cohorts how in the future could you see the program broadening out.
You know from the more focused approach that you have now if it could be broadened out in the future and again. Thank you very much for the questions.
Thanks, Todd Let me just talk a little bit about the philosophy that we have and in discussions primarily with the FDA what out what our picture is so because we are dealing with such a small.
Patient population and so heterogeneous we need to target a.
Hard endpoint for initial approval. So the concept was for Proteus syndrome are hard endpoint because of the work wonderful work done by the NIH with regards to the longer to dual effect of the CCTS lesions, we could use that as a hard endpoint for.
For Proteus disease pros is much more complex.
What's to capture all those other heterogeneous groups.
So that our label potentially could read all pros and old Proteus and not just the ones with a measurable lesions that we'll use in the phase one.
So in in cohort, one and cohort too. So it was it was designed in such a way that we would get hot end points, but we would also get.
A.
As a batch bigger pool, where we would have other endpoints as well the other reason for including more patients was to get the effect on other instruments like quality of life.
On the whole group, which we feel will be very important for the label as well.
Thank you Brian . Thanks question for me around September as well now that.
It's.
His gaming notoriety I would say in the scientific community, we are starting to receive.
Inbound proposals for diseases there are.
Probably.
Of interest for the drugs that we have not thought about and thats. The advantage over drugs are gaining credibility and scientific notoriety.
Through the work with publishing two activities like Youre.
Expert conference call et cetera, so here's while there might be additional opportunities we have not constantly the until now and those as well we'll keep.
We'll keep covert for competitive reasons, but.
At the moment, we are into the site to pursue them independently or through investing initiated investigator initiated activities, which is something we have done in the past and we plan to continue doing that and then we'll be happy to discuss them.
Great. Paul that's great that you have office going off really appreciate the questions you are welcome.
Your next question comes from Matthew crossed with Jones trading.
Hey, guys congrats on the momentous motor and the exciting exciting new results.
Thanks, just a couple of questions from me here.
So among those out there who are still somewhat skeptical about the reversible BTK proposition and maybe believes its a covalent bonding is really necessary long term to burden of efficacy.
Affect our ability seems to be this thing they really want to see.
And as you've alluded to the FL patients who achieved a PR has been on drug for over two years, now, which I think speaks to that somewhat.
But we see now moving on with a phase two dose I was wondering if you could.
Help guide us towards the duration of treatment may see updated at ash.
Maybe the range of treatment duration expected by that time and median time on treatment we should expect.
In.
I think.
We we can all calculate backwards for the patients that were brands and the AD.
Sure sorry Eva.
Those basins and the.
About five months, so there will be some hires in the second forgotten some and not some have received a second scan.
The Uh huh.
So with regard to receive analysis Gan, so you're talking about a nine to 12 months forward those basin. So.
For the patient that that we're up those from a cohort four do you find some have been trying to be a long long time.
Once they were to move to 65, so probably probably longer than that.
The lymphoma patient for example will be going on that point for two and a half years I think and.
For the basis, there were down those from 75 to 65.
Then running the math.
You have the most the most you can observe a six month to 12.
That's as much as I can see.
And then the aspect of the wall.
Contain all the deal.
Perfect. That's all the detail I needed. Thanks, so much for providing it.
And on and on and then just following up a little bit on her tied to his question related to 751.
Are you expecting to present that the full results of this dose escalation by that time. It wouldn't expect so but maybe you could update us on where in that process for the monotherapy signal finding your youre currently.
And Additionally, should we anticipate an update on combination efforts at that time.
Yeah, Yeah, I think the plan is to present as much as we will have a valid you know two ways at that time as we have done for all the reasons that presentation.
And ER and we should be done with the preclinical work for at least one combination no more the one that everybody would expect you know everybody combining were Veneto block. So we're probably not in there as well.
But you'd be mostly preclinical work I don't.
Yeah.
For full factory one.
For selling five one yeah.
We're doing some combinations I thought you were asking fine three one.
Oh, sorry, sorry on 75, one okay sorry.
751 that these four groups will present, an awful. The one group is in combination with Fulvestrant. The other group in combination with Paclitaxel.
Then there is one group with 8-K T. One two and three.
Mutations amplifications, and one group with PR three K. mutation. So you corrected it or it will be very focused on.
Female malignancies, and we hope to have that wrapped up by the end of the year.
Okay, great. Thank you for that for the clarification really appreciate it and I'm looking forward to seeing the results of the discussions with the FDA as far as five to one so yeah.
Further the updates by ash.
Thank you.
And again, ladies and gentlemen, if you have a question. Please press Star then the number one I know touchtone telephone.
Your next question comes from Tony Butler with Roth Capital Partners.
Yes, good morning, Paul O'brien.
The question relates to.
Outside of CLL, 4531, and I understand in the expansion study.
You are looking at mantle cell and Waldenstrom. So.
The question would be would you predict.
That.
Because I would assume you'd like indications there outside of CLL, which is clearly a broad label is better than an error one.
Would you consider running either parallel trials or would it be a larger study.
And I realize you may not have the answer I'm into more interested in how you're thinking about it.
As you walk into that conversation with the FDA.
A little bit later and again the rationale is indications outside of a CLL in those NHL. So populations. Thanks very much.
Thanks, So much for the question I think it's really dependent on the population and we have some internal ideas that we need to solidify but just from a from a big strategic perspective in for example, indications such as Richters one could easily.
Expand the same study.
In other indications, which are much more complicated.
You would have to move it into another study.
So we the way that protocol is written now you look at 10 patients for at least three responses.
24, you added another.
14 patients to get a total of 24 for the cohorts. If you meet the first part of that study.
And then we would make a decision whether to go into a new study or continue their steady.
As a potential registration Paul we've decided to take the CLL C. H one its mutant population.
Our tenant in a new Todd developed to discuss with the FDA as a standalone because that would really be our first indication and you would want that is keen and as well pull through as possible.
And that's where we have the bulk of the view that right now and then as the the accumulate the expansion cohorts then we'll we'll look into the other options and Ah Tony will be able to.
To discuss more thoroughly in the future as soon as we finish this a second round of lifecycle management.
For the drug.
Thank you Paul Thanks, Brian .
You are.
And again that is star one for any questions.
Oh.
I am showing no further questions at this time I will now turn the conference back to Paolo Pucci.
Thank you everybody for your participation today.
Really the rest of the day.
Hi, Mike.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful day you may all disconnect.