Q3 2021 Aptose Biosciences Inc Earnings Call
Your conference operator today, I would like to welcome everyone to the Opco.
Sciences Conference call for our third quarter ended September 30th 2021 at.
At this time all participants are in a listen only mode. After the Speakers' remarks, there will be a question and answer session. If you would like to ask a question. During this time simply press star followed by the number one on your telephone keypad if.
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As a reminder, this conference call may be recorded I would like to introduce MS. Susan Pia to Paula. Please go ahead.
Thank you Wayne good afternoon, and welcome to the <unk> Biosciences conference call to discuss financial and operational results for the third quarter ended September 32021, joining me on today's call are Dr. William G Rice, Chairman, President and CEO, Dr. Yoder them around those senior Vice President Chief Financial Officer, and Chief Business Officer.
And Dr. Rafael Bejar Senior Vice President Chief Medical Officer 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 apoptosis 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 achievement to differ materially from those expressed to learn more about these risks and uncertainties. Please read the risk factors set forth in apoptosis. Most recent annual report on Form 10-K, and S E T and Cedar fair.
All forward looking statements made during this call speak only as of the date. They are made until its undertakes no obligation to revise or update the statements to reflect events or circumstances. After the date of this call except as required by law I will now turn the call over to Dr. Rice, Chairman, President and CEO of <unk> Biosciences, Dr. Rice.
Thank you Susan.
I'd like to welcome everyone to our call. It third quarter ended September 32.
In 'twenty one.
Today, I want to spotlight the auctions.
Taken during the past quarter and over the entire year to build value and outcomes for.
The company focused on the effective treatment.
Logic malignancy in a company with expertise in kinase inhibitors, and with an expanded team to develop.
This includes a look at our newest program <unk> four three to three nine to $3.
Oral once daily myeloid titled inhibitor that already has delivered multiple complete responses.
All spectrum of AML patients.
Which just last week, we announced an exclusive global license agreement with Hanmi pharmaceutical company.
We also will provide an update on our just looks.
Our oral Hollywood non covalent <unk> inhibitor dual activity as a model with <unk> inhibitor and a lymphoid Toronto.
And we will address what this latest transaction with two to three nine means for logs.
From an investment.
Thesis to three nine added to more advanced de risked asset with proven clinical activity to our portfolio.
A molecule that dramatically increases the probability of success for our therapeutic pipeline.
And we believe this deal increases significantly the overall value of <unk> by any rational measure.
Two or three nine is not a sudden revelation to us.
A matter of course, and our proactive business development efforts and our focus we continue to evaluate many compounds even molecules at very early stages as evidenced by our agreement with Crystal notebooks for Lux with.
We developed a relationship with the Hanmi team some time ago and all the while we've been watching to three nine and moving toward a partnership as a clinical validation data begin to emerge over the past 12 months.
Three nine entered the clinic for the treatment of AML patients a year earlier than did our other kinase inhibitor Lux.
And in that time to three nine has achieved multiple complete responses.
With a favorable safety profile.
This is an effective and well tolerated drug that already has changed the lives of critically ill AML patients harboring adverse mutation profiles that render them nonresponsive to other drugs.
So two or three nine fits exactly into the type of agent that defines our goals without dose.
The timing of this deal was driven by the emerging clinical data with 239.
This was illustrated in the Ash abstract released last week and the emerging competitiveness for this program and I want to recognize Dr. Bronco for orchestrating and negotiating the deal.
We're thrilled to take the range for the development of this clinically proven agent as an addition to our evolving pipeline and to move it rapidly through the next steps of development as a key.
Complementary addition to look two to three nine strengthens <unk> ability to treat a wider spread spectrum of AML patients.
So how does this deal for two to three nine impact logs.
To be clear to three nine is in addition to our pipeline. It is not a replacement for logs look stands on its own merits and we intend to develop looks to its full capacity.
<unk> is being tested in relapsed or refractory AML patients where it already has achieved a complete response.
And in Hollywood, relapsed or refractory B cell malignancy patients, where we have begun to see consistent signs of anti tumor activity.
Some of you bluntly, how best if we believe that looks will be active in AML patients.
Why do we in licensed 239.
Short answer is we want to own this therapeutic space and adding 239 to our pipeline along with Lloyd's there is an important step toward that vision.
The longer answer is it's because AML represents a collection of many forms of acute leukemias and not one single disease.
Because AML is sold mutational diverse no one agent can fully cover the range of all oncogenic drivers and all AML patients and we are focused on treating the patients rather than merely treating target.
As we've said in the past there's room for many agents in the treatment of AML.
While some consider email a disease driven by the flit three kinase.
<unk> is only one of the targets that you might want to cover in the disease.
AML patients may have internal tandem duplication targeting kinase domain or gatekeeper gatekeeper mutations in <unk>, three or no mutations at all and flip III or mutations in a multitude of other genes, including NPM One T. P 53, <unk> Ras and many others.
And each mutation or epigenetic alteration can program the sales to behave in a different manner, but therefore is essential to cover as many targets, albeit as safely as possible.
And disrupt as many opportunity pathways and escape routes as possible simply not all genotypes of AML will be effectively targeted by any single drug.
This is why we want looks that cover split three and a particular constellation of kinases operative in AML.
And we want to three nine that also covers flit three but then covers a different constellation of other kinases.
We plan to develop each molecule, which can lead to a broader coverage of <unk> and AML patient populations than any one drug.
For any AML patients, who achieved a complete response with a drug that patients disease must have a target profile that could be subject gated by the drug and the drug must be administered at a level that suppresses those targets.
With $2 three nine those levels already have been achieved in multiple patients reported to date with complete responses.
While we already have achieved therapeutically active levels with two to three nine looks.
<unk> is earlier in development for email yet we already have reported one durable complete response with Lux and in AML patients.
We continue to dose escalate logs now at 900 milligrams with our current formulation to drive higher exposures to suppress additional oncogenic driver kind of basis and effectively treat additional patients.
In parallel to those dose escalations with the current formulation.
Also we're developing a new formulation for logs referred to as generation three or G. III.
Then in animal studies can deliver 30 fold greater exposures per milligram of drug administered the.
G III capsules have been GMP manufacture of Paas stability test.
Plan to introduce <unk> into our ongoing clinical studies in 2022.
We hope G III will reduce significantly the pill burden and the.
Amount of drug substance administered to patients and this could be a meaningful step for logs as we advance through the clinic.
Paul I've spoken about lots being administered to AML patients.
I'll remind you that looks also is a lymphoid current AUM inhibitor and we're developing it for patients with B cell lymphoma malignancies, where we continued to see anti tumor activity and we will update you at ash.
So the progress we are observing with Lux and our ongoing clinical trials over and above other therapies that already have failed. These very difficult to treat patient populations is encouraging and we are hopeful that luxe will prove to be valuable for a diversity of hematologic cancers.
Before I hand, the microphone to Dr. Bexar I'll want to bring the focus back to my original statements. We now have expanded our pipeline we have dramatically increased our potential for pipeline success by adding two to three nine while also maintaining a value stream and conviction to the development of logs no I'll ask Dr. Bexar.
Our chief Medical officer to provide an overview of our clinical activities breath.
Thank you Bill.
Well start with what's happening with our oral highly potent mutation agnostic kinase inhibitor that selectively targets clusters of related <unk> suppresses the mutations that occur in AML and <unk> cells that could render such cells resistant to other agents.
Thus far <unk> has been shown to target the primary drivers of B cell malignancies, and AML, including GTK and flip three with the precision that avoids known targets such as tech Egfr and <unk>, which are often associated with toxicity.
Activities, what sets <unk> apart from other hematology drugs on the market or in development and what makes it compelling to clinical agents.
Let's review Luxe in B cell malignancies, including chronic lymphocytic leukemia, CLO and non Hodgkin lymphoma, or NHL, who have been failed by or intolerant to two or more lines of established therapy. This includes drug such as root nib Rituxan <unk> or are those for whom no. Other treatment options are available patients in our trial received from 2% to 12 regimens prior to enrolling in.
In our study.
I am pleased to report that since our last update we have completed the 750 milligram dose cohort and are now enrolling patients in the 900 milligram dose cohort.
<unk> continues to be well tolerated in patients treated with up to 750 milligrams twice daily over multiple cycles.
Evaluable patients at these dose levels, we've observed repeated tumor reductions across different disease types, including tumor reductions in both aggressive antebellum cancers.
We will get specific data on this activity during our corporate update that during ash in December.
Lots is clearly demonstrating that it is an active drug but like ibrutinib is not well absorbed so we continue to push the dose in order to increase the exposure levels, which is key.
We're looking to get those exposure levels that can achieve complete eradication of tumors as we did in preclinical studies at.
At the same time as Bill just mentioned, we spent a lot of time and effort on a new formulation of <unk> will be better absorbed we're pleased with where we are with that new formulation will keep you posted.
Now, let's turn to Lux and AML.
Acute myeloid leukemia, or AML is a particularly difficult to treat hematologic cancer of all the patients in our AML trial.
Have been treated with and having sales buying but thats currently available therapeutics, which can include <unk> three inhibitors, such as <unk> written it might've storing crinone and <unk>.
Revenue as well as other therapies like <unk> chemotherapy and investigational drugs. So this is an extremely tough to treat patient population.
Earlier in the year, we presented data that demonstrated blast reductions as well as the patient experienced a durable MRV negative complete response.
And this trial like our B cell trial, we are now enrolling patients at the 900 milligram dose cohort and some patients remaining on treatment at lower dose levels.
Also it's important to note that at these doses. We continue to find that <unk> is generally well tolerated with no toxicity signals are trends to date that we believe would prevent further dose escalation or increases in exposure.
This tolerability profile is critical because it is allowing us to reach the higher dose levels and should commit future use of lots in combination with other agents.
Now, let's talk about our newest program <unk> four three to three nine and our clinical plans for this exciting event.
<unk> is currently in a phase one two clinical trial of <unk> six centers three in Korea, and three in the U S.
Last call. We described an impressive preclinical profile to three nine superior to go through them as a single agent and when combined with the Bcl two inhibitor <unk> or they haven't met the patient decided.
This already has translated into strong anti leukemic, Linda leukemic activity and a diverse array of AML patients delivering multiple crs early in a phase one trial, thus far and has been well tolerated to date.
And three of the four <unk> reported in the ash abstract patients underwent it not quite extensive transplantation remain alive.
<unk> occurred in AML patients with the flip the ITD mutation TKD mutation and the wild type form of the <unk> as well.
All of these patients harbored additional mutations in <unk> three <unk> <unk>, two and other important key drivers of that amount.
1315 patients with a complex karyotype <unk> three mutation have experienced durable CR lacking many months.
Another patient with a <unk> TKD mutation, who is refractory to prior treatment with might've storm that later gilts written it achieved a CR was able to undergo allogeneic transplantation.
To summarize and an early dose level 2009 has shown broad activity across several major AML genotype, representing a potentially genotype agnostic agent.
Potential minimum therapeutically effective dose has already been identified however, because of the favorable safety profile to date, we are exploring higher doses.
Trial has cleared the 120 milligram dose level and recently cleared 160 milligram dose cohort with no dose limiting toxicity.
Now were being rolled in the 200 milligram dose cohort.
Based on the strong signals already seen to date as well as new lessons from these later cohorts we plan to move aggressively towards registration directed development. This includes ongoing studies of <unk> hundred 39, as a single agent, particularly difficult to treat patient populations, where those with genetic markers that response as well as combination studies that would allow a 2009 to complement existing therapy and move into earlier lines.
Last week, we distributed a press release on the Ash abstracts that were accepted for presentation in December.
Which include an oral presentation on clinical results rates import through 2009 and poster presentations on blocks in B cell malignancies, and AML as well as opposed to on after two five suite or make rhopressa.
Because of the commission cut updates the Luxe abstracts in particular were largely based on previously announced data. The actual posters will contain some incremental data and a planned corporate event will bring you up to date on our more recent data in all of our ongoing studies.
We are pleased by the progress across our clinical programs and that the safety and Tolerability of all of our drug candidates Lux 2009, and Thats a two phase III are allowing dose escalation in all of our ongoing trials as we treat more patients at higher doses, we're generating additional pharmacokinetic and pharmacodynamic data.
Look forward to providing further updates at the Ash meeting later this year.
For more information on all of our ongoing clinical trials and clinical sites that are recruiting patients. Please visit clinicaltrials Gov.
I will now turn the call over to talk to you any Marengo Chief Financial Officer, and Chief Business Officer, who will review the financial results for the first quarter Jody.
Thanks, Ralph and good afternoon, everyone.
A quick summary of the key terms of the licensing agreement for 2009.
Our exclusive global rights to two to three nine for all indications Hanmi will receive an upfront payment totaling $12 $5 million, which will include $5 million in cash and the rest of those shares.
Hanmi will also receive up to $407 million in future milestone payments contingent upon the achievement of certain clinical regulatory and sales milestones across several potential indications as well as tiered royalties on net sales.
Now, let's go over our quarterly financials.
We ended the third quarter with approximately $95 million in cash cash equivalents and investments.
During the quarter, we utilized approximately $8 1 million in operating activities, which were attributable to activities surrounding our pipeline candidates as well as general and administrative purposes.
Based on current operations cash at hand on September 30th provides the company with sufficient resources to fund all planned company operations into early 2023.
Moving onto the income statement, we had no revenues for the quarter research and development expenses were $7 7 million during the quarter and were attributable to clinical trial costs for our pipeline candidates.
Manufacturing of drug product for our clinical trials, including continuing development of improved formulations for our pipeline candidates.
And personnel costs or head count supporting clinical trials and manufacturing activities.
G&A expenses for the quarter was $3 6 million and our net loss for the quarter was $11 3 million or <unk> 13 per 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 mill.
Thank you Jody.
As 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.
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, we'll pause for just a moment to compile the Q&A roster.
Your first question comes from the line of Alicia Yap with Cantor Fitzgerald. Your line is open.
Hey, guys. Thanks for taking my question.
Congrats on a interest lifestyle.
A couple of questions for me one.
Maybe can you just talk I mean, obviously that looks very interesting as that asked them why we at Hanmi like when I gave up the asset.
One question and I'm just curious.
Right.
The second question.
Yeah.
Escalate right I think the 200 milligram.
But do you think you kind of.
When you think youll see more of that or do you guys feel like Youre saturate the target I mean, obviously it feels like.
The testing the hypothesis that the data looked pretty good.
As they are and then the third question is Lux.
I know there was the abstract but can you characterize maybe what incremental numbers based on the information that we might get asked thanks.
Hi, Alicia this is bill so I'm going to ask Sidoti.
To described interaction with Hanmi and to get the perspective of quote while they might want to give it up and then I'm going to ask Dr. Bexar to talk about the escalation plants Joe.
Hey.
Yes. Thank you Bill and thank you Alicia for for the kind words and the question.
Perhaps.
The way that I would say that.
The question about Hanmi that is probably a more appropriate question to ask them rather than us that the way that I would address it is that they're not really giving up this asset they were seeking a partner that would be able to create amongst value.
And when thinking of it that way they recognized App Joe's being such partner. So they had observed from faraway the way that we licensed Lux.
At the preclinical stage and took it through multiple phase one studies and that was very reassuring in the field of kinase inhibitors. They probably observed the way that we interact and take advice from some of the top leaders in the field.
Some of whom are in our scientific advisory Board.
Physicians and scientists such as Brian Zucker.
Who are some of the father of the field of kinase inhibitors and so.
A lot of these with the lease.
They are in their comfort in their belief and conviction and ability to move this asset forward and to create the most value.
Thank you Jody.
Dr Bejar.
Sure I can address that second question you asked if we are continuing to dose escalate, but have already seen signs of activity. How will we decide when we reached the appropriate dose if I can paraphrase your question.
So you are right that could we already get some Brexit signs of activity and early dose levels in the study and we are continuing to dose escalate I'll remind you that this is not just targeting <unk> three that this drug with multiple different targets and.
Even if one targeted saturated that may not be the driver for that particular patient because we do want to continue to dose escalate to cover the broadest number of targets that we can safely.
We hope will translate into greater activity for a broader set of patients.
AML study, including those patients that don't necessarily have the disease.
Haven't shown already two responses in patients without the mutation.
And then as you said, but.
How many more people with the different dosing levels.
But we haven't given any information publicly yet so with Lux, we're continuing to dose escalate in the B cell malignancy trial, we've completed the 750 worth the 900 milligram dose level, what we have.
So there is that as patients are on drug longer.
And at higher doses, we're beginning to see greater levels of activity. We'll present those data also we continued to dose escalate in the AML trial again, we've completed the sub 50 milligram dose level and we're at the we're exploring the 900 milligram dose level at this time and we will.
We will continue to accumulate the data and present the data on all the patients at a corporate event.
Should occur at or around the same time SaaS.
Thank you Alicia.
Alright, and congrats guys alright. Thank.
Thank you I appreciate that.
Your next question is from the line of Gregory Windsor of capital.
RBC capital markets. Your line is open.
Yes, good afternoon, Bill and team congrats on the progress again and thanks for taking my questions.
Bill of it maybe with respect to tier three and nine just curious if you could comment a little bit about as Hanmi historically has kind of characterized.
Three nine with respect to about <unk>, three inhibition, and what what I'm, specifically or maybe even broadly.
Could you speak to and your team speak to around the broader characterization. If you could just point us to or or highlight again some of the preclinical work that <unk> seen or done or even ongoing that gives you confidence that it is not just that plane inhibitor that.
Leave you and the team.
Fully excited and then maybe secondly, that's helpful. Just on yeah.
Why don't we tackle that one second okay. So it's a really good question. So.
When people think about AML very often this is what I was saying they think about <unk> as a target. So if you have a drug and its a kinase inhibitor.
People often promoted at a flip three inhibitor now if youre going to do that you need to inhibit all the different forms of flip through you need to inhibit the wild type the ITD tyrosine kinase domain gatekeeper all the different forms.
But.
There is no absolutely selective kinase inhibitor out there so as we look across these we want to make sure. We have a compound that as we said can cover flit three but we also look at the broader kind of them that are inhibiting and if theyre going to if this drug is being directed toward AML, we want to make sure that theyre hitting we call it a myeloid kind of them.
Installation of kinases.
<unk>.
We've talked about this one has inhibited sick very potent inhibitor of sick. We made sure all of that was confirmed it doesn't inhibit flip three.
Also mentioned that it also inhibits the mutant but not the wild type forms of C. Kit, so that potentially could taken into other areas, but what I would say is.
Yes.
All of these kinase inhibitors will inhibit a different constellations. The most important aspect here is in preclinical studies when they put it in various animal models.
Out competed guilt written up in a variety of different animal models in which the email sales have mutations in flip three or wild type flip through.
It also worked in.
And collateral and <unk>.
Combination very well in combination with other drugs without inducing additional toxicity of the hopper misleading agents panetta clocks as well as other agents. So it was those early preclinical data and even in.
AML cells that had even other mutations where drugs cant work that will and those strong preclinical data that have been translated into the clinic with humans. So what's absolutely. Most important is that we see those strong preclinical data and then see the data beginning to emerge as you get into the therapeutic levels and home.
<unk> and they've seen the broad activity in humans, so whatever that constellation of kinases is we like it it's the appropriate set of kinase for a broad set of AML patients none of them will cover all AML patients, but we really locked as constellation and where we're seeing the productivity patients. Okay. So.
Question number two.
Actually Bill I think you've even answered my follow ups that's super helpful.
Looking forward to ash, thanks again thanks.
Thanks, so much Greg for being on here.
Your next question is from Joe <unk> with genius of H C. Wainwright. Your line is open.
Hey, guys. Good afternoon, thanks for taking the question.
Logistical question in a corporate question. So first bill when you were discussing the G. III formulation for Lux I guess can you describe the process that will be required to get it included into studies do you have to do a separate bridging study first or do you think youll just be able to start dosing within the current.
Hey, Joe Thanks for being on here. It's really good question. So this is quite a different formulation. So when we had <unk> that was just <unk>.
Machine filled versus Handfield of the original <unk> formulation and it was easy to just blend that into the emergent into the ongoing clinical trial, but this is a very different formulation and it gives us much higher levels of exposure per milligram. So the processes you must understand what it's doing in various animal models.
Done that.
Single dose acute dose toxicity seven day dosing 28 day dosing, we've actually completed all the 2008, a GOP Tox studies.
In rats and dogs, we don't have to report yet, but thats been completed so all of that needs to be done but.
But what we want to do initially is to try to get it into patients as soon as possible get a quick peek at the exposure levels and then didn't make a decision as to what is the appropriate dose levels for multiple dosing for continuous dosing, we will work through that with the FDA again part of the process is making sure that.
<unk> work appropriately with the regulatory agencies have a plan on how youre going to getting into humans present it to them.
Cute Accordingly, and then go back to them and work through this so it's been a long process to get here. It's taken many many months and much much effort to identify this one we're very hopeful for this formulation.
One we've been willing to speak about okay. So that's that's the high level on G. III and then you said you had a corporate question.
Thanks that was very helpful.
Yes look obviously you've had a lot of.
Nice hires over the last several months and even recently so I guess when you look at the corporate plans for the company.
Where do you feel you are right now are you right sized at this point or do you.
Future growth with regard to <unk>.
Certain positions and how we can link that also potential manufacturing needs.
Hello, again very good question very insightful. So yes, we have been expanding the company you're trying to bring on the experience skill sets that were allowed us that would allow us to.
Develop a multitude of molecules.
Again, we want to focus on hematology, we want to focus on kinase inhibitors, and we want to have multiple drugs to move forward.
Across heme malignancies, both AML as well as the lymphoid malignancies.
Just as we brought in Dr. Bexar.
Drove us forward now we have vice President regulatory finance operations clean offs CMC. So all of these key areas. So right now we have the vast majority of key hires that we need I'm not going to preempt any additional hires that we may want to look at into the near future, but the great part is we've been able to gradually.
Built a team the right people at the right time, it's a great mix of the right people and now we have the ability to not only execute on the la acceptance, but also now to bring on this new molecule and make sure that we don't have any missteps. There. So yes, we will continue to grow as appropriate.
Want to waste money, but you want to make sure you have those skill sets at the right time. So did you want to add anything to that.
No nothing to add thank you Joe.
Thank you Joe Thanks, guys.
Sure.
Your next question is from Matt Biegler.
Your line is open.
Hey, guys. Thanks for the question.
Question Bill.
Such on this a little bit in a prior question, but I just kind of want to add to your point like what do you think is attributing the two or three night activity and flit three wild type patients.
Pretty impressive.
And do you think I mean are you guys considering a mutation agnostic label at this point or is it kind of.
Too soon to tell.
Uh huh.
So I'm not going to go into every every potential county to chips or doesn't hit.
So we did mentioned that this drug potently inhibits the wall type III. So in some of these patients that have we'll call it and mutated <unk> III you may actually have overexpression of the wall type flip III that sensitive to a flip three inhibitor. If your drug actually is potent on the Walter.
Often you will also get overexpression of the ligand in the bone marrow that binds to <unk> and so in this case, having the ability to inhibit the wall top tier three is very important.
But also as you look inside the cell youre able to see a variety of pathways that are inhibited we mentioned sick, we're able to watch the <unk> pathway inhibitor the possible sick downstream, where you have the.
<unk> pathways to Earth pathways in a variety of these so we've actually been even though this drug.
Just license it this past week, we've been looking at it inside the cell already to try to understand all of these different pathways and what I will tell you is every AML sale that you look at has a different set of pathways and different redundancies and you just need to hit as many of those as you can but not hit the safety targets and this.
Hit enough of those of the.
Key ones to have broad activity.
So we're very happy with that now in terms of the label.
Again, we're very early in phase one we're thrilled with the activity we've seen.
As Dr. Bexar mentioned.
The patients the activity some of these were <unk> three mutated.
And one that had failed the other TK ice.
<unk> got a drug that can inhibit various.
It can act on patients who have failed other teekay <unk> patients even ballpark that have failed. Some excuse me that have some of these other mutations that other drugs have not been able to address so we believe there are multiple paths for single agent development as well as combination so that was long winded, but.
Dr. Bexar did you want to add anything to that at this point.
No I think you know that exactly there are multiple pathways, including wild type pathways that are operable and AML and the drug that has activity against the Wifi far for three could have activity there as well as the other targets that it had.
Now that makes sense definitely looking forward to full that kind of profile.
It is presented.
I had a quick housekeeping question for you Andy on the finances of the deal.
Are you guys planning on recognizing that $5 million.
<unk> is part of that would that be.
Bulk next quarter or is it going to be spread out.
Yes. Thank you Matt for the question. So we report it and just to give you the larger frame here, we reported a cash balance today with 95 million as of September 30 that does not include the cash component of the upfront payment to Hanmi, which was $5 million.
That amount will be paid within this calendar year.
As you will also find in the full license agreement that is filed on.
Thank you.
Thanks, guys.
Thank you Matt.
Your next question is from John Newman of Canaccord. Your line is open.
Hi, guys. Thanks for the question and.
That's an interesting deal here certainly.
Im just curious in terms of <unk>.
Any forward with I guess, the current study as well as dose escalation.
It looks like in the Ash abstract there were a couple of patients that.
Received the stem cell transplant after a CR, which happens.
Happens in AML, it's not uncommon.
Just curious in terms of the way that you would like to conduct the study.
<unk>.
Some of the higher doses, if you would look to.
Sort of established a framework, where doctors would be encouraged to.
Put patients into stem cell transplant, if they achieve CR or.
<unk>.
If they wouldn't do or if you would just leave it up to them just kind of curious as to how you're looking at that.
Alright, Thanks, John I appreciate you coming on so I am going to give just a very broad statement and then I'm going to ask Dr. Bejar to jump in.
The good news is we have seen very broad activity in AML patients with this drug and its actually great news that they can then be taken with Crs over to transplantation and for walk from what we understand those patients remain alive.
So that's great news people will ask about durability of your drug we actually have one patient who is who.
Was on there for a long time.
That did not go to a stem cell transplant and I believe that was also in the abstract but we're not going to speak beyond what's in the abstract now because the global pie is going to be presenting via all the information at ash.
Oral presentations, but I am going to ask Dr. Bexar just step in on this and talk about the current study in dose escalation.
Yeah. Thanks, Bill you are exactly right I think when we Havent AML study in relapsed refractory population you have the ability to put that person into remission and taken the transplant from a clinical perspective, that's an absolute win.
I know I understand it doesn't help you understand the durability of the drug but.
The patient comes first that said not all patients will be candidates for allogeneic transplant. Some will have been transplanted earlier, some will just simply not good candidates for other reasons and those patients stay on drug until either.
Progressed or some other event.
No.
The data we've seen so far have been incredibly encouraging that in the abstract three out of the five Crs have moved on to transplant and their patients who didn't have bill mentioned had a very durable response lasting many months much longer than the median might expect especially given their genotype, which was one that you would expect to relapsed relatively early so we will not mandating.
One way or the other whether patients should be considered it shouldn't be considered for allogeneic transplant ob at the discretion of the investigators of course, we would be happy if the patient were able to monitor potential curative therapy. After I correct.
So it gets to the point, where you talked about earlier, we want to treat the full patient if we can get them to a transplant and that's the best thing for them, we consider that a win.
Right.
Alright.
What's going to encourage physicians to put patients on here.
The responses will encourage the physicians continue to put patients on alright.
Alright.
And thank you John.
Great. Thank you.
Alright.
And I'm currently showing no further questions I will now turn the call back over to Dr. Rice for closing remarks.
Alright, Thank you and let me just thank everyone for joining us. This afternoon, we believe that both to three nine am looks are truly remarkable and distinct assets that will bring us significant value to the company to our shareholders and we look forward to updating you more on our evolving pipeline next month during the Ash and then also going into 2020, we should have.
Catalyst setup.
Set of catalysts going through 2020 and be sure in Washington.
Thank you so much.
Thank you ladies and gentlemen that concludes today's conference you may now disconnect and have a wonderful day.
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