Q3 2020 Aptose Biosciences Inc Earnings Call
This is Chris and I'll be your conference operator today.
I'd like to welcome everyone to Aptose Biosciences Conference call third quarter ended September Thirtyth 2000, that's why.
At this time all participants are in a listen only mode.
After the speakers remarks, there will be a question and answer session.
Ask a question during this time simply course star followed by the number one on your telephone keypad.
If you would like to withdraw your question. Please press the pound key thank.
Thanks.
As a reminder, this conference call may be recorded.
I would now like to introduce Ms. Susan Pietro please.
Please go ahead.
Thank you Chris Good afternoon, and welcome to the Aptose Biosciences conference call to discuss financial and operational results.
Third quarter ended September Thirtyth 2020, I am Susan Petra Palo Communications representative for Aptose Biosciences, joining me on the call today are Dr., William G. Rice, Chairman, President and CEO Mr., Gregory Chow Executive Vice President and Chief Financial Officer, Dr., Yardi Morando Senior Vice.
President and chief.
Keith business Officer.
Dr. Rafael <unk>, our senior Vice President Chief Medical Officer.
Good.
Do you all hear that.
[music].
How are you.
Before we proceed I would like to remind everyone that certain statements made during this call will include forward looking statements within the meaning of U.S. and Canadian Securities laws.
Forward looking statements reflect aptoses current expectations regarding future events, but are not guarantees of performance and it is possible that actual results and performance could differ materially from these stated expectations. They involve known and unknown risks uncertainties and assumptions that may cause actual results performance and achievements to differ materially from those expressed.
To learn more about these risks and uncertainties. Please read the risk factors set forth in Aptoses. Most recent annual report on form 10-K, and FCC and SEDAR filings. All forward looking statements made during this call speak only as of the date. They are made aptose undertakes no obligation to revise or update the statements to reflect events or circumstances. After the date of this.
Well, except as required by law I will now turn the call over to Dr. Rice, Chairman, President and CEO of Aptose Biosciences Dr. rice.
Thank you Susan.
I want to go up another one for coal <unk> third quarter ended September Thirtyth 2020.
Well in New York, which were up and she's going to euros advancing our clinical programs.
Our recently initiated a phase <unk> clinical trial, we know three clinical studies underway to study with our three M.B.T.K. Foundation here. They don't see June six.
One study in patients with acute myeloid leukemia or email and the other study in patients with chronic lymphocytic leukemia, or CLL and non Hodgkin's lymphoma.
The third problem is ongoing weaker mic inhibitor ABT 123 in patients with email and Mds.
Now to the point, where we're operating smoothly across the board expanding I'd like to teach and drug product manufacturing working with our clinical sites to enroll them right. They change for each trial accelerating the pace of development and training of spectrum that patients would be very challenging relapsed or refractory hematologic cancers.
Warner was one of the blocking and tackling <unk> agents for success we have.
And the rest in 2020 to be one of continued execution.
As we treat more patients at higher doses and begin to generate additional pharmacokinetic and pharmacodynamic data.
Before we discuss the progress in each of our three clinical programs. Let me remind you that ash is only a few short weeks away and today, we will keep our remarks and high level in qualitative and then we will aim to share more quantitative findings during lunch.
Having said that.
First let's start with our most recent news.
We announced the initiation engaging in a phase one clinical trial of TG <unk> in patients with relapsed or refractory email, which as you know is a very serious cancer or the bone marrow in blood and that carries a poor prognosis.
See June six or just I don't see it inhibits the wild type and mutant forms uplift three and BTK into places select clusters of properties is a drug ultragenyx signaling pathways that are offered you a mill, including the fleet three PDGF. We're also seeing standpoint, no our acreage.
T rats arc stat, and sick pathways and by the way when we refer to sick and spleen tyrosine kinase inhibitor spelled S Y K not as I see it.
As you will recall 86 is the only known clinical agent.
Inhibits both lived three and to be Teekay, which gives it a broad therapeutic potential across the spectrum of lymphoid myeloid hematologic malignancies, including AML.
Our email trial is a phase one maybe multicenter open label dose escalation study safety pharmacodynamics and pharmacokinetics of CGT Onesix and ascending cohort.
Three plus three design to determine the maximum tolerated dose for the recommended phase two dose in patients with relapsed or refractory email.
We've highlighted this before but I want to quickly remind you again.
Relapsed or refractory patients are very old and before joining NATO six trial. They already have been treated with and failed other fleet three inhibitors, such as guilty <unk> and or amount of storage and other drugs, such as venetoclax and have failed or or intolerant to do available approved therapies stay.
The standard of care for relapsed or refractory CML patients is insufficient for many patients.
Often not durable and or leading to resist so.
So despite recent advances there remains a tremendous unmet need in relapsed or refractory patients.
And they say a male trial that they don't see it DFT allowed us to skip the two lowest dose levels of 150 milligrams and 300 milligrams and to initiate dosing at a starting dose of 450 milligrams be I'd.
Which as I mentioned in our last call was good news for outcomes and for you know six.
We requested the 450 milligram, starting dose and email patients because that dose when administered to CLL patients in a separate clinical trial appeared safe well tolerated and.
She plasma levels that effectively inhibited fossil fleet three activity, which is a key driver of your mill.
Also at the 450 milligram dose in humans with CLL, we observed steady state plasma levels in the same range as the exposure levels observed in our preclinical work.
Curious about your mill in mice and with no observed toxicity.
These observations in their totality.
To the starting dose of 450 milligram.
I'm pleased to report that since we announced dosing of our first patient in the email trial, we officially enrolled additional patients in this cohort investigators at major clinical sites are eager to place or relapsed or refractory AML patients on you don't see it and they have patients available when slots.
The trial design is the traditional three plus three dose escalation, but it also allows us to enroll more than the minimum three patients at each dose if appropriate.
Five clinical sites currently are screening patients for the trial, including high caliber academic cancer centers and specialty care regional sides.
Having several highly engaged clinical sites now treating patients we are pleased with the pace of enrollment.
Some of you ask specifically, which type of female patients have been enrolled in the study.
It always has been our intention and now we are enrolling patients having email with the Pithree ITD mutation referred to as split three positive email as well as patients with wild type three.
In addition, we believe it will say, it's a compelling candidates for the fragile email Asian population and we are hopeful that April six can provide benefit to the very ill relapsed and refractory AML patients.
Oh sure up today specifics on the email trial at a corporate update that we plan to hold during the ash timeframe for more information on the M.L. trial and clinical sites that are recruiting patients. Please visit one clinical trial dot Gov.
Now lets turn or ongoing turned to our ongoing phase one dose escalation study of 86 in patients with B cell malignancies, including CLL in non Hodgkin's lymphoma again in relapsed and refractory patients failed or are intolerant to current therapies.
Since our last call, we escalated to the fifth dose level of 750 milligrams and we continue to treat patients at the 600 milligram and 750 milligram dose levels improve.
Importantly at the 750 milligram dose we are focusing exclusively on and were enrolling only relapsed or refractory CLL patients I feel is for we have observed indications on target activity and pricing actions to date. In addition to inhibition of BTK.
The induction of on target Lymphocytosis that we've reported previously we have observed nodal reductions in CLL patients.
We fully understand that these are deep refractory patients that may require extended time to truly respond if ever.
But we are hopeful that such findings will portend.
Formal responses as we accrue additional CLL patients over time.
And we plan to provide you with additional color during ash, which is just a few weeks away.
Depending on the level of clinical activity in specific subgroups and this dose escalation phase we may enroll patients across expansion studies that include sub populations with different genotypic for phenotypic properties.
In conjunction with the CLL trial and to facilitate expansion studies, we have developed a scaled up manufacturing process for April six capitals and are transitioning to machine build capsules also called automated field patches and news you're being introduced into the trial.
This step reduces risk to that you know six program and will allow us to place additional cancer patients on eight ounces for.
For more specific information on the B cell malignancy troll and the clinical sites that are enrolling patients. Please visit clinical trial Dot Gov again, we will share a more in depth update of our entire six program with you during ash.
Speaking of Ash, We also announced last week in a press release.
We'll be presenting two posters on Saturday December one.
One on CGM, six and one on Apto two part three.
And there will be another poster on CGM six presented on Sunday by our research partners at the city of Hope and the Oregon Health and Science University or wage as you detailed.
Details are in the press release that we distributed last week and the abstract themselves are now available online.
Overall, we continue to execute carefully and diligently in multiple parallel programs and we believe this ash conference represents yet another mall posed in our steady development available soon.
We have stressed before we believe the April six is a drug candidate like no other with singular biology, and our broad array of potential indications based on our work to date, we remain confident in the potential of our update on six to manifest benefit for cancer patients and build value for aptose shareholders.
Now let me bring you up to date on the status of Apto, two or three or.
Our second clinical candidate currently in a phase one b trial for email and Mds.
To remind you apto two bucks three or just two parts result call it.
The mic inhibitor and the Myc oncogene is a major driver cancer cell proliferation, including human human logic cancers.
In fact is one of the most coveted drug targets in cancer and researchers have been seeking safe mic inhibitor for many years.
For a phase one clinical protocol to five three is being administered once weekly over 28 day cycle at ascending doses.
Patients with relapsed or refractory AML or high risk Mds until the maximum tolerated dose is reached.
Studies designed to then transition as appropriate.
Single agent expansion cohorts in email and for Mds.
I'm pleased to report that our phase one clinical trial of two factory is progressing well.
Thus far we have completed the 28 dosing in the first four dose cohorts since our last call weve enrolled multiple patients at dose level five of 150 milligrams per meter square, which is a 50% increase over that of dose level before.
And two part three continues to be well tolerated.
Spite interest in Myc inhibition as a target to Fivethree has been advancing quietly under the radar screen.
Partly because nobody knows what to expect clinically from a mic inhibitor. We're learning more as we proceed and we continue to believe Pete to factory is an interesting and valuable asset worthy of investment.
These higher doses, we hope to see sustained myc inhibition and begin to see clinical responses.
We will be able to talk to you more about two factory during our event at ash for those of you interested in learning more about the trial specifics and enrollment criteria. Please visit clinical trials dot Gov.
Finally, let me just quickly touch on other corporate highlights.
We are grateful to be part of recent and upcoming healthcare banking conferences during the quarter, we presented at the Canaccord Genuity.
C. Wainwright.
Enter and Oppenheimer conferences, where we hosted a full schedule of one on one meetings.
We also have been invited to the Stifel Healthcare conference, where we will be hosting one on one meetings next week and we will be person participating in the Piper Center Health care conference in early December.
Now I will turn the call over to our executive Vice President and Chief Financial Officer, Mr., Grimshaw, who will review results for the quarter.
Thank you Bill and good afternoon, everyone. We ended the quarter with approximately $133 million in cash cash equivalents and investments compared to approximately $83 million.
June 30 of this year.
In the quarter, we utilize approximately $8.3 million of cash in operating activities, which were attributable to activity surrounding to fight tooth and nail six.
As well as general and administrative purposes based.
Based on current operations cash on hand at September 30 provides the company with sufficient resources to fund our planned company operations, including research and development into Q1 of 2023.
Moving onto the income statement, we had no revenues for the quarter research and development expenses were $7.5 million for the quarter and attributable to eight or six into phase three clinical trial cost manufacturing of drug product for clinical trials.
Couldn't continuing development and putting GMP formulation creative six into phase three and personnel costs for headcount supporting clinical trials and manufacturing activities in research studies.
General and administrative expenses for the quarter were $5.8 million.
Net loss for the quarter was $13.2 million.
Consent a share.
More detailed information can be found in our filings on Edgar and SEDAR I will now turn the call back over to Dr. Rice, though.
Thank you great all.
Ill remic remind everyone that on the line. We also have with US Dr. Jody Morongo, our chief business Officer, and Dr., Ralf Elbit Hart, our Chief Medical Officer.
We open the call for questions. Please feel free to pose a question to any of US operator, if you could please introduce the first question.
Thank you.
At this time I would like to remind everyone that if you would like to ask a question. Please press Star then the number one on your telephone keypad.
Pause for just a moment to compile to join a roster.
Your first question comes from the line of Gregory brings with RBC capital markets. Your line is now.
Hey, good afternoon evening, Bill and team congratulations on all the progress and thanks for taking the questions.
Bill I just wanted to start of course is the natural question is really some of the expectations that you are able to to set for the upcoming events and and Ash data now I do respect that and your your acknowledgment of speaking more more qualitatively, but maybe we can just start.
On the North side as you mentioned certainly enrolling in October maybe just just remind us some of the data collection points and what you think could be meaningful.
Or what to look out for just in light of where we will be just several weeks post at the start of the summer.
Of those patients in the trial. Thank you.
Alright, great. Thanks for thanks for joining us for the question.
So in particular on the mill side, yes.
As we look back to the third quarter, we had the idea lab that allowed us to go into the email patient population.
We then had to mention the blocking and tackling get all the clinical trials up and running ready the sites IR be approvals and the era of code, that's a little bit more challenged but the team did that and we actually enrolled our first patient during Q3.
Since that time, we've had active enrollment the clinical sites have been very active I'm not speaking directly to the number of patients that we put on this study yet I can say is definitely more than one and.
Hopefully, we will be able to collect sufficient data between now and then to give you a snapshot of what we're seeing in these patients of course, we hope that the drug is going to be well tolerated north of 450 milligram dose level. It had been tolerated well in the past at that dose level, but this is new patient population in these patients are very sick. So that's the first.
We hope to see that we watch for the pharmacokinetics.
Determine whether or not it is equivalent to the pharmacokinetic parameters that we saw in this field trial and and then beyond that we will watch for any of the other CBC counts hopefully, we'll we'll be looking at the blast counts for the patients, but I'll also remind you that.
Net.
These patients as they come off their other studies and wash out. These these patients progress very rapidly. These are very sick patients often times during that two week washout. They go on hospice, but then you get them on the trial and during those first couple of weeks, while you're treating them.
Well, having your drug to get up to a steady state levels and we typically don't reach that until the end of the week Warner we too so.
So we hope to patients are able to stay on during that period give the drug time to reach those steady state levels, and we actually hope to see some level of benefit in these patients.
I don't know if we'll have time on these patients to really see if there are any truly meaningful data.
But were several weeks away, we will continue to collect the data between now and then and then will indicate where we are at that time I don't want to either over promise or under promise. What we'll do is present to what we have at that time, but I will remind you that the data will not be quote verified because it takes at least.
A month looking back at your clinical trials sites to collect the data verified through your clinical operations group and then be able to present verified data. So anything that we discussed will be non verified and preliminary data at that time, but we're very hopeful for the game.
Hope that into what that is.
Sure. It does billing if I may just one follow up on the CLL. Aside if you could just remind us and certainly heard the commentary on the extension potential and on the cohorts and sub populations can you just remind us of your latest strategy.
The plans for 8900 Meek.
This level in the cohort there just in terms of.
How should we be thinking.
About that of course, you know with respect to understanding cards at the turnover and the current dosing levels, but I just want to get a refresh on your thoughts there. Thank you.
Well in this protocol, we do have the ability to go to a 900 milligram dose level, if the 750 milligram.
Dose level is determined to be say that requires three patients to complete at least 28 days of dosing.
Currently we're at the 750 milligram dose level, we haven't released any additional information on that level or the lower dose level 600 milligrams, except to say that we do have patients on 600 and the Sevenfifty drew.
During ash, we will be presenting data that we have on these patients.
Particular, we want to be able to show that the pharmacokinetics, we want to hopefully show that these are rising as we continue to dose escalate the patients and then.
We will be able to speak to whether or not we'll be able to go up to the nine or 10 milligram level or not.
If we are if everything is safe and if we are able to move up we will provided we are getting continuing to get increased levels of exposure as we have gone from 150 300, Fourfifty 600, 750, we can show that we're continuing to get additional exposure and we would go up to 900.
If it turns out that for some reason we cannot go to 900, we would look to 750 to say that our our recommended phase two dose if for some reason 750 turned out to be.
Too toxic for some reason then we would back down to the 600, which we have shown is say so all of those are possibilities at this time that's correct.
Thanks, Bill looking towards the upper single summer. Thanks.
Thank you.
Thank you and your next question comes from the line of John Newman with Canaccord analysts now your line is now open.
Hi, guys. Thanks for taking my question and looking forward to the data upcoming ash here, Phil I just wondered if you could comment I think during.
During your prepared remarks.
You talked about some notable nodal reductions in CLL patients just wondering if you could.
I will elaborate on that just a little bit more.
Sure John Thanks, Thanks for the questions. So we refer to these as nodal reductions of course, most people some people call nodal reductions from called tumor reductions.
So whenever a patient comes on the study.
They get their initial scanned before they start dosing with any of the drugs and at that point the identify the target lesions that they're going to follow through on the therapy and typically these aren't lymph nodes and so we will call refer to them is either notable increases no reductions.
And.
I'm going to be really careful here, because we don't want to overplay this or underplayed.
So we've been asked repeatedly whether or not we're getting nodal reductions in any of these patients and what I can say is.
Yet we have seen reductions in more than one patient, but as of yet they are not at the level of formal responses. If they were we would have said formal responses.
So it's we have cautious optimism that we have been able to see some decreases but again, we're very realistic. These are deep relapsed refractory patients who had failed all the drugs out there, including many of our competitor drugs before they come onto our trough.
Where we have seen reductions will be thrilled if those reductions continue and if they ever reached the.
The level of a formal response, but they may not they make plateau off for the patients could continue to progress at any time. So that's why we're being very careful and be candid in saying, yes, we've seen nodal reductions, but it is not at the level the formal level of a of a true reduction.
Did that adequately accurate answer your question or did you want to follow.
Yes, and I had one quick additional question, which was for the animal study you mentioned at the beginning of the call that.
You are looking to enroll both split three HCT patients as well as wild type is there any specific ratio that you're looking to achieve or are you simply looking to include.
Both types of patients with those with that mutational or excuse me with those mutational sets.
Well again, we've been very upfront about this we believe this drug can treat patients with both wild type as well as the three positive.
As with the ITD mutation in Threeq.
We would like to keep at least in the early dose cohorts do you know.
Number of wall patients split three Walton to a minimum we'd like to get one maybe two on there, but we like to have the majority of the agency.
Three positive patients why we know that the patient two or three positive tend to react or respond more quickly to the three inhibitor and so I hate to use the word low hanging fruit, but really as those would be what you would expect to be the most responsive patients to a three inhibitor. So we clearly want to get multiple.
Flip three cost to patients on each of these dose levels, but as we go we continue to dose escalate and get to the higher dose levels.
And once we're able to show activity in the fleet three positive patients assuming that we will we would then look to transition over and get more of the flip through Walter patients on this study as we continue to dose escalate because it might take additional levels of drug to be effective against the patients with wild type.
Great. Thank you.
Thank you John.
Thank you.
And our next question comes from the line.
A leap year young with Cantor Fitzgerald Your line is now.
Great. Thank you for taking my question. This is actually on for at least the Oh I was just wondering what have you learned from the CLL studies. So far that has kind of helped to speed up the process an ambarella besides the.
Starting dose that you mentioned and how many more patients do you think you could potentially interval in the CLL study by match. Thank you.
Hi, I'm Lynn. Please tell me if you we said high.
So what do we learn so as you said the starting dose that was very important for us, but also from the plasma that we collected from those patients we learned that the exposure levels were at or above the levels that they gave us.
True responses in animal models, so they cured animals abate a mill that was split three ITD roughly 3.2 billion mill in mice.
And we're achieving those exposure levels in humans. The other thing is into humans have when we collect the plasma we bring those back of laboratory and put them on reporters sales. We have reporters cell systems now that allow us to look at flip three wall type and three TD three positive sales and we've been able to see.
So that we can turn off the fossil fleet three activity in those sales whether its ought to do your wall type, but beyond that we were able to the plasma not we the plasma was able to turn off the activity of other of these pathways that I mentioned earlier, whether its the PDGF our alpha sick.
Arc stat all these various pathways downstream so that's what gives us comfort.
Comfort that once we go into email patients we hope that the drug is at a level that can then have those effects in an email patient and hopefully we can begin to see responses in those patients over time.
In terms of the number of patients we havent disclosed that yet publicly so we'll be disclosing the number of expected CLL patients as well as a male patients during ash.
Okay. Thank you.
Q.
Thank you and our next question comes from the line.
Joe pencil with H.C. Wainwright. Your line is now open.
Hey, guys. Good evening. Thanks for taking the question Bill I wanted to take the commentary you had on the a nodal response is just a little further if I may but I I suspect my question might fall into the quantitative range not the qualitative. So was just curious if you could describe maybe how many responses when they were so.
Seen within the treatment time period for the patients and at what doses yeah.
Hi, Joe it's great to hear your voice and I'd be disappointed if you didnt ask that question.
But youre right that falls into the quantitative arena, a doctor Bay arc will be presenting those those data at during ash. He has a video presentation.
But I will remind you that we won't have all the up to date information at that time.
He has to record the presentation on the 18th of November which means you have to back up in time about a month or so but to validate all the data. The scans. So he will be able to incorporate some of the data into that presentation, and then around that presentation, which actually will be presented believe on what the November.
Fourth in those time excuse me December 4th in those time frames, we will provide you with any additional updated information that we have at that time.
Again, we hope to see some continued reduction in notes, but absolutely no guarantee and I don't want to.
As I've said earlier, either over or under promise there. It's just just as what we have it's not yet at the level of formal response.
But once you start seeing.
This effect you believe you're getting into the area.
The exposure levels that may be able to deliver responses. If you get the right patients on their own for the right amount of time, but will provide as much data as we can quantitative data.
At the time of fashion.
Thank you Joe Foresi no.
No totally understood. Thanks, a lot guys.
Sure.
Thank you and our.
Next question comes from the line of Matt Biegler with Oppenheimer. Your line is open.
Hey, guys. Thanks for taking my questions.
Tell sorry, sorry to beat a dead horse here, but just on the nodal responses.
Fact that you're seeing lymphocytosis precluding your ability to classify that nodal responses that objective responses or blood counts not at all a factor here.
No as we've said before.
We've achieved dose levels or exposure levels that inhibit BTK and that gives us to limit give us the on target lymphocytosis. So that tells us we're hitting that target and other pathways to.
But that doesn't tell you whether or not you're going to get responses and sometimes you get lymphocytosis.
And it will diminish and then you will get responses sometime to get responses without lymphocytosis, sometimes the lymphocytosis will occur and it will not drop down and you get responses. So it is it is specific to each patient response of your drug and so there is no cut and dry.
Type of pattern that we could expect so perhaps dr. bay hard could could expand on that a little bit to give you his thoughts.
Yes, I think the way you said it exactly right the order to have a PR or CLL patients are calling the idling CLL criteria. There's several different aspects there that need to be met and it may be different aspects are different patients that.
Or the limiting ones before you can say that a patient has had a formal response could be Olympic size because.
You're gonna, mainly it could be the lymphocyte count and they're not necessarily the same for each patient.
Thank you Dr Pepper.
To your question.
Yes.
Thats very helpful. I was I was little confused because I've seen some studies report a PR with lymphocytosis and adds just I wasn't sure if that was different than a nodal response, but it sounds like the print.
Okay.
Well you get <unk>.
And then 50% of the nodal size and that would be a a nodal PR.
Even with the continuation of lymphocytosis.
Got it got it and just quickly can you confirm when the first marrow response assessment has been the ml trial.
No, we can probably speak to that a little bit more when we get up to ash.
Typically it will be a couple of months out.
Depending on what you see in the patient the physician will make a decision.
If you're several months out typically lets say two cycles up if you're really seeing something in that patient that they want to make a judgment call then they might want a a bone marrow at that time, but if they're not seeing anything.
They would likely wait Dr. Bahar may also want to opine on that.
I would just add experienced some other three inhibitor studies and how long it has taken the average time to see a response. The median time for some of these studies is between two and three cycles of therapy for two and three months of therapy.
Might be when you expect to see less patients to respond to we're going to respond.
Thank you.
Got it thanks, guys look at for Dash.
The forward to seeing Hubert.
Thank you.
And again, ladies and gentlemen, if you would like to ask a question at this time. Please press Star then one key.
Key on your Touchtone telephone.
Our next question comes from the line of Matthew Cross with Alliance Global Partners. Your line is now.
Hey, guys. Thanks for the pre ash update and for taking a couple of questions from me really just a couple of quick clarifications on my end I think going back to John's question.
Regarding the the flip three status of patients may be enrolling in the mill trial.
And looking at some some screening around that or maybe at least some some targets for what kinds of patients you'd like to see I. Just wanted to confirm you mentioned built the focus on having some wild type patients. Some split three ITD does that exclude.
I guess or what should we be thinking about this as a split three positive versus wild type or would that also include beyond ITD Teekay D. At some of these more.
They are sub types there and.
As you are looking to meet those kinds of.
Populations.
Hi, Matt creative you to drill down into the detail.
Yes, when people typically say.
Say split three positive typically they are referring to the three D.D.. So I'll like to break it out first and say either put three ITD or three teekay do we would like to have some of those patients on study and what we're going to find is these patients have been treated with so many drugs other fleet three inhibitors phonetically.
All the various drugs out there and combinations. They are going to have a variety of mutations you might find some that have the ITD plus teekay de mutations they may have the T.J.D. money, but not the ITD depends upon the sequence of drugs that they've had passed so over the period of this trial, we would love to see.
A variety of these patients those that have rash mutations ppt three mutations IDH one so all the various mutation types, but at least initially we want to make sure that we can get some three positive patients in their fleet.
Three ITD patients that or are most likely to be able to have a response to the drug, especially at the lower doses here. The fourfifty once we get into the higher doses, maybe up to 750 or so were above.
Point, we might able to be able to see activity with the patients that have a variety of these other mutations along with the play throughout you do fair.
Fair enough.
Fair enough yeah, no. Thanks for correcting me on that on the nomenclature in that and that makes perfect sense then.
Then I guess on the B cell side in your remarks, you mentioned looking to focus at the 750 milligram dose level exclusively on CLL, which I know youve kind of echoed in the past wanting to at least.
Steer the trial investigators towards looking at those patients in particular.
At these higher dose levels. It looks like you know this is obviously dated in the abstract you had an mcl patient in a waldenstrms patient come on so.
So I guess just thinking specifically about the 750 milligram group and that CLL focus is that something that would be really more of a preference communicated to the sites or.
Or something that you might be in the form of a full protocol amendment around enrollment criteria for maybe those those dose levels going forward.
Another drill down question so.
Yeah, when I talk about the third quarter it was blocking and tackling. So this is one of the decisions. We made so getting up to the higher dose levels. All the way through 600 milligrams, we accepted a variety of different types of patients Friday of different lymphomas, CLL CLL all of them to try to get to that higher dose level as quickly as possible and hope.
Really to be able to keep some patients on there, but once we reach the 750 milligram dose level, we made a decision that at that dose level and beyond we're going to focus exclusively on the CLL patients from at this point, we did go back and we've communicated that to the sites as as a preference not always what they are.
Want to hear because they also have lymphoma patients deadlock to get on there, but they understand what we're doing there understanding why and these are the patients that are most likely to give nodal reductions types or responses. So that you can determine whether or not your drug actually has activity in this patient population and then that it makes it a lot.
More developable drug I know, it's not a reward developable for these other types of lymphomas going going forward. So.
That's where we are right now it.
Again that did slow the.
The accrual because we're not taking the lymphomas anymore, we're focusing on the the CLL patients and we also observe that a lot of these patients are very sick patients that are failing the other.
Drugs that are out there competitor drugs, but.
But were happy to get these patients were hopeful that we can provide them to get them stabilized and then hopefully overtime to be able to show benefit.
Okay, great. Thank you for having good answers as always to me getting into the Nitty gritty a bit and looking forward to the full details next month absence.
Absolutely. Thanks, so much.
Thank you.
I'm not showing any further questions on the phone at this time I would now like to turn the call back to Dr. rice for any closing remarks.
I want to I want to thank all of you for joining us. This afternoon Im very proud of our organization people that investigators who are really top notch, but all these clinical sites and importantly, the patients and their family everyone, who participated in these trials and advancing our important work, whether it's the clinical trials or related to manufacturing.
We appreciate the support of all of our shareholders and the analysts who were coming on here today and digging into the data and we look forward to keep you apprised of our progress.
And I want to say, thank you and have a good evening everyone.
Ladies and gentlemen.
Concludes todays conference call may disconnect everyone have a wonderful day.
[music].